ACAD
36.32
+0.49
+1.37%
AEMD
0.989
+0.009
+0.9082%
APRI
1.82
0.00
0.00%
ARNA
27.28
-0.03
-0.11%
ATEC
4.15
+0.03
+0.73%
CNAT
5.06
+0.05
+1.00%
CRXM
0.137
+0.034
+32.9767%
CYTX
0.5
+0.03
+7.53%
DXCM
44.78
-0.2
-0.44%
GNMK
7.92
+0.08
+1.02%
HALO
17.82
+0.05
+0.28%
ILMN
209.88
+4.7
+2.29%
INNV
0.087
0.00
0.00%
INO
6.23
-0.02
-0.32%
ISCO
1.65
+0.11
+7.14%
ISIS
57.56
0.00
0.00%
LGND
143.93
+0.58
+0.40%
LPTN
2.93
-2.93
-100.00%
MBVX
0.71
-0.03
-4.0146%
MEIP
2.68
+0.06
+2.29%
MNOV
6.14
-0.05
-0.81%
MRTX
15.75
+0.2
+1.29%
MSTX
0.13
-0.01
0.00%
NBIX
59.03
+0.07
+0.12%
NUVA
55.05
+0.48
+0.88%
ONCS
1.251
-0.039
-3.023%
ONVO
1.61
+0.21
+15.00%
OREX
1.78
-0.04
-2.20%
OTIC
3.45
-0.02
-0.72%
QDEL
41.77
-0.18
-0.43%
RCPT
231.96
0.00
0.00%
RGLS
1.21
-0.04
-3.20%
RMD
79
+0.21
+0.27%
SCIE
0
+0.00
+50.0000%
SPHS
2.33
+0.09
+4.02%
SRNE
2.8
+0.3
+12.00%
TROV
0.805
-0.004
-0.519%
VICL
2.38
0.00
0.00%
VOLC
18
0.00
0.00%
ZGNX
39.75
+0.1
+0.25%
ACAD
36.32
+0.49
+1.37%
AEMD
0.989
+0.009
+0.9082%
APRI
1.82
0.00
0.00%
ARNA
27.28
-0.03
-0.11%
ATEC
4.15
+0.03
+0.73%
CNAT
5.06
+0.05
+1.00%
CRXM
0.137
+0.034
+32.9767%
CYTX
0.5
+0.03
+7.53%
DXCM
44.78
-0.2
-0.44%
GNMK
7.92
+0.08
+1.02%
HALO
17.82
+0.05
+0.28%
ILMN
209.88
+4.7
+2.29%
INNV
0.087
0.00
0.00%
INO
6.23
-0.02
-0.32%
ISCO
1.65
+0.11
+7.14%
ISIS
57.56
0.00
0.00%
LGND
143.93
+0.58
+0.40%
LPTN
2.93
-2.93
-100.00%
MBVX
0.71
-0.03
-4.0146%
MEIP
2.68
+0.06
+2.29%
MNOV
6.14
-0.05
-0.81%
MRTX
15.75
+0.2
+1.29%
MSTX
0.13
-0.01
0.00%
NBIX
59.03
+0.07
+0.12%
NUVA
55.05
+0.48
+0.88%
ONCS
1.251
-0.039
-3.023%
ONVO
1.61
+0.21
+15.00%
OREX
1.78
-0.04
-2.20%
OTIC
3.45
-0.02
-0.72%
QDEL
41.77
-0.18
-0.43%
RCPT
231.96
0.00
0.00%
RGLS
1.21
-0.04
-3.20%
RMD
79
+0.21
+0.27%
SCIE
0
+0.00
+50.0000%
SPHS
2.33
+0.09
+4.02%
SRNE
2.8
+0.3
+12.00%
TROV
0.805
-0.004
-0.519%
VICL
2.38
0.00
0.00%
VOLC
18
0.00
0.00%
ZGNX
39.75
+0.1
+0.25%
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AcelRx’s DSUVIA(TM) Clinical Trial Results Selected as a “Top Abstract” for Oral Presentation at ASA’s Annual Meeting – ANESTHESIOLOGY® 2017

October 20, 2017 – 4:00 am

DSUVIA clinical trial results was one of the top eight abstracts featured as an oral presentation at an opioid pharmacotherapy symposium at ANESTHESIOLOGY® 2017

REDWOOD CITY, Calif., Oct. 20, 2017 /PRNewswire/ — AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) (AcelRx), a specialty pharmaceutical, today announced its clinical data presentation on the safety and efficacy of DSUVIA(sufentanil sublingual tablet), 30 mcg classified by age group across four clinical trials at the American Society of Anesthesiologists'(ASA) ANESTHESIOLOGY® 2017 Annual Meeting. The information presented during the session was authored by Karen DiDonato, MSN, RN; Jacob Hutchins, MD; James Miner, MD; Harold Minkowitz, MD; and Pamela Palmer, MD, PhD.

“We are honored to be one of the top eight abstracts featured as an oral presentation at the Frontiers in Opioid Pharmacotherapy symposium at ANESTHESIOLOGY® 2017. Our inclusion in this important symposium acknowledges the potential clinical relevance of DSUVIA for the management of moderate-to-severe acute pain in medically supervised settings,” said Pamela Palmer, MD, PhD, Co-Founder and Chief Medical Officer, AcelRx.

AcelRx will also host a breakfast satellite symposium that discusses the pharmacokinetics and dynamics of sublingual sufentanil tablets. This symposium will be led by Eugene Viscusi, MD; Albert Dahan, MD, PhD; and Dennis Fisher, MD.

The ANESTHESIOLOGY® 2017 Annual Meeting is hosted by the American Society of Anesthesiologists (ASA) and is taking place on October 21-25 in Boston, Massachusetts. ANESTHESIOLOGY 2017 is expected to welcome nearly 15,000 attendees. For more information on ASA, please visit www.asahq.org.

Details of the presentations are as follows:

Title:              

Safety and Efficacy of Sufentanil Sublingual Tablet 30 mcg by Age Group for the   Treatment of Acute Pain in Medically Supervised Settings         

Authors:        

Karen DiDonato, MSN, RN of AcelRx Pharmaceuticals; Jacob Hutchins, MD of the University of Minnesota in Minneapolis, MN; James Miner, MD of the Hennepin County Medical Center in Minneapolis, MN; Harold Minkowitz, MD of the Memorial Hermann Memorial City Medical Center in Houston, TX; Pamela Palmer, MD, PhD of AcelRx Pharmaceuticals

Time/Place:   

9:00 am – 12:00 pm on October 22, 2017 at the Westin Boston Waterfront Grand Meeting Room 206 A/B

Title:              

ASA® Non-Accredited Satellite Symposium: Pharmacokinetics and Dynamics of Sublingual Sufentanil

Authors:        

Eugene Viscusi, MD, Professor, Jefferson University Hospitals in Philadelphia, PA; Albert Dahan, MD, PhD, Professor, Leiden University Medical Center in Leiden, Netherlands; and Dennis Fisher, MD, Professor Emeritus, University of California, San Francisco.

Time/Place:   

6:30 am – 8:00 am on October 23, 2017 at the Westin Boston Waterfront Grand Ballroom B – E
                       

About DSUVIA™ (sufentanil sublingual tablet), 30 mcg
DSUVIA (sufentanil sublingual tablet, SST, 30 microgram), known as ARX-04 outside the United States, is designed to treat moderate-to-severe acute pain and dosing errors associated with IV administration via its non-invasive single-dose applicator (SDA) in medically supervised settings. Sufentanil is an opioid analgesic currently marketed for intravenous (IV) and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually potentially avoids the high peak plasma levels and short duration of action observed with IV administration. In the EU, the European Medicines Agency (EMA) has notified the company that the ARX-04 Marketing Authorization Application (MAA) is under scientific review.

Clinical and Rehabilitative Medicine Research Program (CRMRP)
DSUVIA is funded in part by the Clinical and Rehabilitative Medicine Research Program (CRMRP) of the U.S. Army Medical Research and Materiel Command (USAMRMC) under contract No. W81XWH-15-C-0046. The CRMRP was established in 2008 to foster research and technology advances for regeneration, restoration, and rehabilitation of traumatic injuries. In accordance with USAMRMC guidelines, in the conduct of clinical research, AcelRx has adhered to the policies regarding the protection of human subjects as prescribed by Code of Federal Regulations (CFR) Title 45, Volume 1, Part 46; Title 32, Chapter 1, Part 219; and Title 21, Chapter 1, Part 50 (Protection of Human Subjects).

About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain. AcelRx’s proprietary, non-invasive sublingual formulation technology delivers sufentanil with a consistent pharmacokinetic profile. The company is simultaneously developing ZALVISO® (sufentanil sublingual tablet system, SST system, 15 microgram) as an innovatively designed patient-controlled analgesia (PCA) system for treatment of moderate-to-severe pain in medically supervised settings. The company recently completed a Phase 3 clinical trial, IAP312, which included input from the FDA on the study protocol. This study was designed to evaluate the effectiveness of changes made to the functionality and usability of the ZALVISO device, to evaluate the incidence of inadvertent dosing, and to take into account comments from the FDA on the study protocol. AcelRx intends to resubmit the NDA for ZALVISO to the FDA by the end of the year. AcelRx has successfully received EU Marketing Approval for ZALVISO® in the EU. Grunenthal Group holds the rights for ZALVISO® in Europe, where a commercialization across multiple countries is underway. In June 2017, ZALVISO®   was selected for a Red Dot Award in the category of Product Design – Life Sciences and Medicine.

For additional information about AcelRx’s clinical programs, please visit www.acelrx.com.

Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the process and timing of anticipated future development of AcelRx’s product candidates, DSUVIA™ (sufentanil sublingual tablet, 30 mcg), known as ARX-04 outside the United States, and ZALVISO® (sufentanil sublingual tablet system), including U.S. Food and Drug Administration, or FDA, review of the New Drug Application, or NDA, for DSUVIA; and evaluation of the CRL and AcelRx’s plans for resubmission of the NDA for DSUVIA with the FDA.  These forward-looking statements are based on AcelRx Pharmaceuticals’ current expectations and inherently involve significant risks and uncertainties. AcelRx Pharmaceuticals’ actual results and timing of events could differ materially from those anticipated in such forward-looking statements, and as a result of these risks and uncertainties, which include, without limitation, risks related to AcelRx Pharmaceuticals’ DSUVIA and ARX-04 development programs, including the EMA review of the ARX-04 MAA, and the possibility that EMA may dispute or interpret differently clinical results obtained from the ARX-04 Phase 2 and 3 studies; the possibility that the FDA may dispute or interpret differently the results of the ZALVISO development program, including the results from the IAP312 clinical trial; the resubmission of the ZALVISO NDA to the FDA; any delays or inability to obtain and maintain regulatory approval of its product candidates, including DSUVIA in the United States, ARX-04 in Europe and ZALVISO in the United States; the uncertain clinical development process, including adverse events; the success, cost and timing of all development activities and clinical trials; and other risks detailed in the “Risk Factors” and elsewhere in AcelRx’s U.S. Securities and Exchange Commission filings and reports, including its Quarterly Report on Form 10-Q filed with the SEC on August 2, 2017. AcelRx undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.

View original content with multimedia:http://www.prnewswire.com/news-releases/acelrxs-dsuvia-clinical-trial-results-selected-as-a-top-abstract-for-oral-presentation-at-asas-annual-meeting—anesthesiology-2017-300540319.html

SOURCE AcelRx Pharmaceuticals, Inc.

Bio Roundup: Kite’s CAR-T Approved, Obamacare Fix & Lilly mRNA Deal

October 20, 2017 – 2:35 am

Kite Pharma wasn’t expecting a regulatory decision for its non-Hodgkin lymphoma treatment until November, but this week, the company got the FDA’s O.K. The approval of axicabtagene ciloleucel…

[[Click headline to continue reading.]]

Clinical Data from Phase 1 PK/PD Study of Octreotide for Intranasal Delivery to be Presented at North American Neuroendocrine Tumor Society Symposium

October 19, 2017 – 8:10 am

SAN DIEGO, Oct. 19, 2017 /PRNewswire/ — Dauntless Pharmaceuticals, Inc., a privately held biopharmaceutical company focused on the development of specialty therapeutics, announced today that data from its Phase 1 clinical study of octreotide acetate for intranasal administration (DP1038), will be presented at the annual North American Neuroendocrine Tumor Society (NANETS) Symposium, October 19-21, in Philadelphia, Pennsylvania.

Dr. Matteo Levisetti, Chief Medical Officer for Dauntless, will present data from the recently-completed Phase 1 clinical study that assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of DP1038, an intranasal formulation of octreotide acetate, in healthy volunteers.  DP1038 demonstrated an excellent safety and pharmacokinetic profile as well as on-target pharmacological effects that support the continued development of the product.

DP1038 leverages patented technology for enhanced intranasal absorption developed by Aegis Therapeutics, LLC, and is being developed as a non-injectable alternative for the treatment of patients with acromegaly and the symptomatic treatment of patients with carcinoid tumors. Specifically, octreotide has been shown to be efficacious in reducing the debilitating diarrhea and flushing episodes associated with metastatic carcinoid tumors.  The somatostatin analog market currently exceeds $2 billion annually with all commercially available formulations requiring subcutaneous or intramuscular injections.

For more information on the DP1038 program or to download a copy of the poster from the NANETS Symposium meeting, please visit www.dauntlessph.com.

About Dauntless
Dauntless Pharmaceuticals, Inc. develops specialty therapeutics via a one-asset, one-company model that is structured to facilitate operational efficiencies.  Dauntless 1, its first asset company, was formed to develop DP1038, a therapeutic agent for the treatment of acromegaly and neuroendocrine tumors.  Launched in 2015, Dauntless Pharmaceuticals has raised committed capital of $32 million from Sofinnova and Canaan Partners.

 

View original content:http://www.prnewswire.com/news-releases/clinical-data-from-phase-1-pkpd-study-of-octreotide-for-intranasal-delivery-to-be-presented-at-north-american-neuroendocrine-tumor-society-symposium-300538521.html

SOURCE Dauntless Pharmaceuticals, Inc.

John Lithgow: An Actor’s Lessons

October 19, 2017 – 6:00 am

Being an actor is hard. It is fraught with rejection, failure, insecurity and envy. Just ask John Lithgow. “It is a profession that is very hard on your ego,” he told a small group of UC San Diego master of fine arts in acting students during a visit to the campus last week. Even worse, he said with comic theatricalism, is the “humiliation of being rejected by people you have contempt for,” a well-rehearsed line that garnered laughs from the students. Still, he admitted, “I fret all the time.” It seems like an odd confession from an actor whose career has spanned decades and been marked by numerous accolades and awards, including his recent Emmy for his role as Winston Churchill in the Netflix series “The Crown.”

Cybercrime Fighter Wins Genius Award

October 19, 2017 – 6:00 am

A few weeks ago, Stefan Savage, a UC San Diego computer science professor started receiving calls on a daily basis—sometimes more than once a day—from a phone number with a Chicago area code. The caller didn’t leave a voicemail. Savage never answers calls from a number he doesn’t recognize. He is a security researcher and at least one of his collaborators has been targeted by cybercriminals. So he looked up the phone number. To his relief, it tracked back to the MacArthur Foundation’s headquarters in Chicago.

Arena Pharmaceuticals Announces Late Breaking Presentation of Positive Phase 2 Results with Ralinepag in Patients with Pulmonary Arterial Hypertension at the American College of Chest Physicians 2017 Annual Meeting

October 19, 2017 – 4:30 am

Significant improvement in pulmonary vascular resistance (PVR) with ralinepag compared to placebo

SAN DIEGO, Oct. 19, 2017 /PRNewswire/ — Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that results of the Phase 2 clinical study of ralinepag (APD811), the Company’s next-generation, oral, selective prostacyclin receptor (IP) agonist, intended for the treatment of pulmonary arterial hypertension (PAH), will be presented at the American College of Chest Physicians 2017 (CHEST) Annual Meeting, taking place October 28November 1 at the Metro Toronto Convention Centre in Toronto, Canada.

Presentation Details
Title: Hemodynamic Effects of the Oral Prostacyclin (IP) Receptor Agonist Ralinepag in Pulmonary Arterial Hypertension (PAH)
Session: 4060 – Late-breaking Abstracts 2
Date/Time: Wednesday, November 1st, 3:45 p.m. – 4:00 p.m. EDT
Location: Convention Center – 603

“These Phase 2 results are extremely compelling, particularly considering the contemporary patient population of our trial in which 65% patients were already receiving dual background therapies and all patients were receiving at least one therapy,” said Preston Klassen, M.D., MHS, Executive Vice President, Research and Development and Chief Medical Officer of Arena. “We look forward to our upcoming discussions with the FDA and advancing into a Phase 3 clinical program.”

Prostacyclin deficiency results in increased pulmonary vascular resistance and is a key factor contributing to disease progression in PAH ultimately leading to right ventricular failure and death if untreated. Drugs targeting the prostacyclin receptor should be considered a cornerstone of optimal PAH therapy as they address a central pathophysiologic mechanism of the disease. Earlier and broader use of parenteral and oral prostacyclin analogues have been limited by inconvenient modes of administration, poor tolerability and sub-optimal pharmacokinetics. Ralinepag was strategically designed in an effort to overcome many of these limitations.

The primary efficacy analysis in the Phase 2 study demonstrated a statistically significant absolute change from baseline in pulmonary vascular resistance (PVR) with ralinepag compared to placebo. Ralinepag also demonstrated a numerical improvement in 6-minute walk distance (6MWD). Adverse events observed in the study were consistent with other prostacyclin receptor agonists used for the management of PAH.

The ralinepag Phase 2 study was a randomized, double-blind, placebo-controlled, dose-ranging study in 61 adult patients with PAH, WHO/NYHA functional class II-IV. Study medication was titrated over 9 weeks, followed by a 13-week treatment period. The primary efficacy analysis was absolute change from baseline in pulmonary vascular resistance (PVR) at week 22. Additional endpoints included change from baseline in 6MWD, proportion of subjects who exhibit clinical worsening and safety and tolerability. Patients who completed week 22 could transition to an open-label ralinepag extension study.

About Ralinepag
Ralinepag (APD811) is an oral, next-generation, selective IP receptor agonist targeting the prostacyclin pathway and intended for the treatment of pulmonary arterial hypertension (PAH). Arena discovered and developed this drug candidate internally. Ralinepag’s potency on vasodilation, inhibition of proliferation of vascular smooth muscle cells, and inhibition of platelet aggregation, combined with an extended half-life support its application as a potentially best-in-class agent for the treatment of PAH. Ralinepag is an investigational compound that is not approved for any use in any country.

About the American College of Chest Physicians
The American College of Chest Physicians is the global leader in advancing best patient outcomes through innovative chest medicine education, clinical research, and team-based care. With more than 19,000 members representing 100+ countries around the world, its mission is to champion the prevention, diagnosis, and treatment of chest diseases through education, communication, and research. This includes connecting health-care professionals to the latest clinical research and a wide array of evidence-based guidelines through the CHEST Journal, while also serving as a total education resource for clinicians through year-round meetings, books, mobile apps, and live courses in pulmonary, critical care, and sleep medicine. The first medical association with a clinical simulation program accredited by the Society for Simulation in Healthcare, the American College of Chest Physicians also provides hands-on training through innovative simulation education. The CHEST Foundation, its philanthropic arm, provides members with grants, patient education tools, and other resources to help their patients live and breathe easier.

About Arena Pharmaceuticals
Arena Pharmaceuticals is a biopharmaceutical company focused on developing novel, small molecule drugs with optimized receptor pharmacology designed to deliver broad clinical utility across multiple therapeutic areas. Our proprietary pipeline includes potentially first- or best-in-class programs for which we own global commercial rights. Our three most advanced investigational clinical programs are ralinepag (APD811) which has completed a Phase 2 trial for pulmonary arterial hypertension (PAH), etrasimod (APD334) in Phase 2 evaluation for multiple autoimmune indications, and APD371 in Phase 2 evaluation for the treatment of pain associated with Crohn’s disease. In addition, Arena has collaborations with the following pharmaceutical companies: Eisai Co., Ltd. and Eisai Inc. (commercial stage), Axovant Sciences (Phase 2 candidate), and Boehringer Ingelheim International GmbH (preclinical candidate).

Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These statements may be identified by introductory words such as “will,” “look forward to,” “upcoming,” “intended,” “potentially,” “designed to,” or words of similar meaning, or by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements include statements about the upcoming presentation of ralinepag data, future discussions with the FDA, plans for a Phase 3 trial of ralinepag, the use of drugs targeting the prostacyclin receptor, our focus, and the potential of ralinepag and our other programs and collaborations. For such statements, we claim the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from our expectations. Factors that could cause actual results to differ materially from the forward-looking statements include: topline data may not accurately reflect the complete results of a particular study or trial; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; clinical trials and other studies may not proceed at the time or in the manner expected or at all; the timing and outcome of research, development and regulatory review is uncertain; enrolling patients in our ongoing and intended clinical trials is competitive and challenging; we expect to need additional funds to advance all of our programs, and you and others may not agree with the manner we allocate our resources; our drug candidates may not advance in development or be approved for marketing; risks related to developing and commercializing drugs; our revenues are based in part on estimates, judgment and accounting policies, and incorrect estimates or disagreement regarding estimates or accounting policies may result in changes to our guidance or previously reported results; government and third-party payor actions, including relating to reimbursement and pricing; risks related to relying on collaborative arrangements; the entry into or modification or termination of collaborative arrangements; unexpected or unfavorable new data; nonclinical and clinical data are voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than us or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; our and third parties’ intellectual property rights; satisfactory resolution of litigation or other disagreements with others; and those factors disclosed in our filings with the Securities and Exchange Commission, including our Form 10-Q for the quarter ended June 30, 2017. These forward-looking statements represent our judgment as the time of this release. We disclaim any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.

Corporate Contact: 
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and 
Chief Financial Officer 
klind@arenapharm.com 
858.210.3636

Media Contact: 
Matt Middleman, M.D.
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com 
646.627.8384

 

View original content:http://www.prnewswire.com/news-releases/arena-pharmaceuticals-announces-late-breaking-presentation-of-positive-phase-2-results-with-ralinepag-in-patients-with-pulmonary-arterial-hypertension-at-the-american-college-of-chest-physicians-2017-annual-meeting-300539549.html

SOURCE Arena Pharmaceuticals, Inc.

OncoSec Presents Positive Phase 2 Data for ImmunoPulse® IL-12 in Combination with Pembrolizumab Demonstrating a Best Overall Response Rate (BORR) of 50% in Predicted Anti-PD-1 Non-Responder Melanoma Patients

October 19, 2017 – 2:00 am

Data from Recently Completed Phase 2 Monotherapy and Combination Therapy Studies Presented at the 2017 9th World Congress of Melanoma – A Joint Meeting with the Society for Melanoma Research8 of 21 (38.1%) Achieved RECIST v1.1 Durable Complete Response (CR) in Predicted Anti-PD-1 Non-Responder Melanoma Patients at 24 WeeksComprehensive Immune Monitoring Data Demonstrated Combination of ImmunoPulse® IL-12 and Pembrolizumab Can Convert “Cold” Tumors to “Hot” TumorsFavorable Safety Profile with

SAN DIEGO, Oct. 19, 2017 /PRNewswire/ — OncoSec Medical Incorporated (“OncoSec” or “Company”) (NASDAQ:ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today announced updated Phase 2 clinical and immune monitoring data from patients treated with its investigational therapy, ImmunoPulse® IL-12 as a monotherapy versus the combination of ImmunoPulse IL-12 and the approved anti-PD-1 therapy pembrolizumab. These data were presented today in an oral presentation at the 2017 9th World Congress of Melanoma – A Joint Meeting with the Society for Melanoma Research, and continue to support the rationale for the Company’s recently initiated global, open-label, Phase 2b registration directed trial, PISCES/KEYNOTE-695.

The Phase 2 OMS-I100 monotherapy and Phase 2 OMS-I102 combination with pembrolizumab studies included 51 and 22* patients, respectively, with metastatic melanoma. The combination study patients were selected based on their baseline biomarker data, which predicted that patients would not respond to anti-PD-1 therapy. Monotherapy patients were treated with ImmunoPulse IL-12 alone and patients in the combination study also received pembrolizumab every 3 weeks per protocol. Fewer than 10% of patients in both studies reported treatment related serious adverse events (9.8% in the monotherapy and 8.7% in the combination studies). Data also demonstrate that ImmunoPulse IL-12 can trigger key immunologic events driving a cellular response leading to an inflamed tumor with increased TIL frequency whether as a monotherapy or combined with pembrolizumab, converting “cold” tumors to “hot”, which were further enhanced with the addition of an anti-PD1 antibody.

*Includes one CR with non-evaluable RECIST lesions

Key Findings

OMS-I102 Combination with Pembrolizumab

50% (11/22) BORR observed at 24 weeks (42.9% [9/21] achieved RECIST v1.1 BORR).

41% (9/22) complete responders (CR), 9% (2/22) partial responders (PR), and 9% (2/22) stable disease (SD) for a total disease control rate of 59% (38.1% [8/21] achieved RECIST v1.1 durable CR).

Data demonstrate that the combination of ImmunoPulse IL-12 and pembrolizumab prime a coordinated innate and adaptive immune response, suggesting a synergistic relationship with anti-PD-1.

OMS-I100 Monotherapy

25-34.6% best overall response rate (BORR) by a modified “skin” RECIST.

Favorable safety profile (no life threatening or grade 4 AE).

In patients (n=26) treated with ImmunoPulse IL-12 on a 90-day cycle, there were 19.2% (5/26) complete responders (CR), 15.4% (4/26) partial responders (PR), and 34.6% (9/26) stable disease (SD) for a total disease control rate of 69.2%.

In the protocol addendum where patients (n=20) were treated with ImmunoPulse IL-12 on a 6-week cycle, there were 0 complete responders (CR), 25% (5/20) partial responders (PR), and 40% (8/20) stable disease (SD) for a total disease control rate of 65%.

“We are encouraged by the data from these analyses, which continue to show that ImmunoPulse IL-12 can prime the immune system to help improve patient response to anti-PD-1,” said Dr. Alain Algazi, Lead Trial Investigator, Associate Professor, Department of Medicine (Hematology/Oncology), at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center. “The complete response rates observed in the Phase 2 study assessing the combination of ImmunoPulse IL-12 and pembrolizumab in the predicted anti-PD-1 non-responder patient population provide compelling early evidence that the combination could lead to a clinically meaningful impact on patient outcomes.”

“Collectively, these study findings reinforce the combination of ImmunoPulse IL-12 and pembrolizumab to address a significant unmet medical need in melanoma patients who are unlikely to respond to anti-PD-1 therapies,” said Punit Dhillon, CEO and President of OncoSec. “We look forward to presenting additional data from our ongoing Phase 2 combination study at the upcoming 2017 Society for Immunotherapy of Cancer Annual Meeting, in addition to our global, open-label, registration directed phase 2b clinical trial, PISCES/KEYNOTE-695, which we anticipate reporting initial data in mid-2018.”

The full-text abstract is available and can be viewed on the World Melanoma Congress – Joint Meeting with the Society of Melanoma Research website at https://worldmelanoma2017.com/. The presentation is available in the Publications section of OncoSec’s website.

About PISCES (Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study)

PISCES is a global, multicenter phase 2b, open-label trial of intratumoral plasma encoded IL-12 (tavokinogene telseplasmid or “tavo”) delivered by electroporation in combination with intravenous pembrolizumab in patients with stage III/IV melanoma who have progressed or are progressing on either pembrolizumab or nivolumab treatment. The Simon 2-stage study of intratumoral tavo plus electroporation in combination with pembrolizumab will enroll approximately 48 patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. The primary endpoint will be the Best Overall Response Rate (BORR).

About OncoSec Medical Incorporated

OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulse®, for the treatment of cancer. ImmunoPulse is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as IL-12 (tavokinogene telseplasmid [pIL-12] or “tavo”). In Phase 1 and 2 clinical trials, ImmunoPulse® IL-12 has demonstrated a favorable safety profile, evidence of anti-tumor activity in the treatment of various solid tumors, and the potential to reach beyond the site of local treatment to initiate a systemic immune response. OncoSec’s lead program, ImmunoPulse IL-12, is currently in clinical development for metastatic melanoma and triple-negative breast cancer. The program’s current focus is on the significant unmet medical need in patients with melanoma who are refractory or have relapsed on anti-PD-1 therapies. In addition to tavo, the Company is also identifying and developing new immune-targeting agents for use with the ImmunoPulse platform. For more information, please visit www.oncosec.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including statements about OncoSec’s business strategies, including advancement of its lead melanoma program and its broader clinical portfolio and plans to pursue collaborations with industry partners, as well as the potential contributions and impact of new directors on these strategies. Forward-looking statements can be identified by words such as “can,” “may,” “will,” “suggest,” “look forward to,” “potential,” “understand,” and similar references to future periods.

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on management’s current preliminary expectations and are subject to risks and uncertainties, which may cause OncoSec’s results to differ materially and adversely from the statements contained herein. Potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, the following: uncertainties inherent in pre-clinical studies and clinical trials, such as the substantial time, costs and unpredictability of such studies and trials, the ability to enroll patients in clinical trials and the risk of adverse events; unexpected new data, safety and technical issues; OncoSec’s ability to raise additional funding necessary to fund continued operations; and the other factors discussed in OncoSec’s filings with the Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarter ended April 30, 2017.

Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. OncoSec disclaims any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

CONTACT:

Investor Relations:
OncoSec Medical Incorporated
Phone: 855-662-6732
investors@oncosec.com

Media Relations:
OncoSec Medical Incorporated
Phone: 855-662-6732
media@oncosec.com

 

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Kite Nabs First Adult CAR-T Approval With Notable Uptick Of Cures

October 18, 2017 – 2:49 pm

For the second time in two months, remarkable recoveries from desperate cases of cancer have led to early approval of a cutting-edge therapy called CAR-T, which is made from a patient’s own…

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BioMarin Highlights Breadth of Innovative Development Pipeline at R&D Day on October 18th in New York

October 18, 2017 – 8:24 am

Selection of BMN 290 Next IND Drug Development Candidate for Treatment of Friedreich’s AtaxiaBMN 270 gene therapy for Severe Hemophilia A: IND and CTA Active, Phase 3 to start 4Q17Vosoritide for Achondroplasia Demonstrates Sustained Increase in Annualized Growth Velocity Over 30 Months of TreatmentPegvaliase BLA on Track for FDA Action 1H 2018, EU MAA Filing Q1 2018

SAN RAFAEL, Calif., Oct. 18, 2017 /PRNewswire/ — BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) updated the investment community on the Company’s development portfolio, which is focused on innovative therapies to treat rare and ultra-rare diseases.

“We are pleased to share the progress of our development programs in therapies to treat rare genetic diseases; hemophilia A, PKU, achondroplasia and our next IND into Friedreich’s Ataxia,” said Hank Fuchs, M.D., President Worldwide Research and Development of BioMarin.  “In the near term, we are expecting an FDA decision on pegvaliase to treat adults with uncontrolled PKU in the first half of next year, and we continue to be rapidly and decisively developing the potential first gene therapy for severe hemophilia A.”

BioMarin Selects BMN 290 for Friedreich’s Ataxia

BioMarin announced today that it has selected BMN 290, a selective chromatin modulation therapy, for the treatment of Friedreich’s Ataxia (FA).  FA is a rare autosomal recessive disorder with worldwide prevalence of approximately 15,000, which results in disabling neurologic and cardiac progressive decline.  Currently there are no approved disease modifying therapies for FA.  In preclinical models, BMN 290 increases frataxin expression in affected tissues more than two-fold.  BMN 290 is a second generation compound derived from a compound acquired from Repligen that had human clinical data demonstrating increases in frataxin in FA patients.  BMN 290 was selected for its favorable penetration into the central nervous system and cardiac target tissues, and its preservation of the selectivity of the original Repligen compound.  The company expects to submit the IND in 2H 2018.

BMN 270 Gene Therapy for Severe Hemophilia A

BioMarin announced today that the FDA has completed their review of the IND application for BMN 270, an investigational gene therapy treatment for severe hemophilia A, and concluded that it can proceed.  The IND application included 52-week data at the 6e13 vg/kg dose and the protocol for the Phase 3 study using the 6e13 vg/kg dose.  The protocol for the second Phase 3 study using the 4e13 vg/kg dose has also been submitted to the FDA. 

BioMarin also announced today that the Phase 3 Clinical Trial Application was approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). 

The company expects to initiate the global Phase 3 program in the fourth quarter of 2017.

Data Update on Phase 1/2 Study of 4e13 vg/kg Dose

In addition, the company provided an update on the ongoing open-label Phase 1/2 study of the 4e13 vg/kg dose at up to 36 weeks of observation at the September 14, 2017 data cut.  Since the last data update provided during the Q2 earnings call on August 2, 2017, five of the six patients at the 4e13 vg/kg dose tracked to the low range of normal, and the sixth is in the mild range for Factor VIII levels.  Median annualized bleed and factor VIII use rates for 4e13 and 6e13 vg/kg were zero after Week 4.

Factor VIII Levels (%) of 4e13 vg/kg Dose Patients* by Visit (N=6)

Week**

4

8

12

16

20

24

28

32

36

4e13 vg/kg
Dose

n

6

6

6

6

6

6

6

3

3

Median
Factor VIII
Level*** (%)

4

15

21

29

34

28

31

51

45

Mean
Factor VIII
Level*** (%)

5

13

19

26

31

29

30

51

47

Range
(low, high)

(2,10)

(3,21)

(6,32)

(5,38)

(7,45)

(7,43)

(4,44)

(48,54)

(41,55)

*All patients had severe hemophilia A, defined as less than or equal to 1% of Factor VIII activity levels, expressed as a percentage of normal factor activity in blood.

**Weeks were windowed by +/- 2 weeks

*** Bolded numbers are in the mild to normal range of Factor VIII activity as defined by the World Federation of Hemophilia, http://www.wfh.org/en/page.aspx?pid=643 (link current as of Oct. 17, 2017). Factor VIII levels are determined by one-stage assay.

 

BMN 270 Reduces Bleeds and Factor VIII Use:  Summary of Mean Annualized Bleeding Rate (ABR) and FVIII Use Rate of 4e13 vg/kg Dose for Patients Previously on Prophylaxis (N=6) at September 14, 2017 data cut

Before BMN 270 Infusion

After BMN 270 Infusion

Median (mean, SD)

Median (mean, SD)

Annualized Bleeding Rate*
(bleeding episodes per
year per subject)

8.0 (12.2, 15.4)

0.0 (0.8, 1.9)

Annualized FVIII Use Rate*
(infusions per year per subject)

155.5 (146.5, 41.6)

0.0 (2.7, 6.7)

*Post-infusion data were based on data after Week 4

BMN 270 Generic Name is Valoctocogene Roxaparvovec

BioMarin was issued the International Nonproprietary Name (INN) valoctocogene roxaparvovec for BMN 270.  The World Health Organization (WHO) has approved the INN “valoctocogene roxaparvovec” for the Company’s gene therapy to treat hemophilia A.  International Nonproprietary Names (INN) identify pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name.

Gene Therapy Manufacturing

BioMarin has constructed one of the largest gene therapy manufacturing facilities in the world, which is located in Novato, California.  Good Manufacturing Practices (GMP) production of BMN 270 has commenced and will support clinical development activities and anticipated commercial demand. This facility is capable of supporting approximately 2,000 patients per year, and the production process was developed in accordance with International Conference on Harmonisation guidance for Pharmaceuticals for Human Use facilitating worldwide registration with health authorities. 

Vosoritide Data Update

BioMarin provided an update on its open-label Phase 2 study of vosoritide, an analog of C-type Natriuretic Peptide (CNP), in children with achondroplasia, the most common form of disproportionate short stature in humans.

Vosoritide for achondroplasia demonstrates sustained increase in average growth velocity over 30 months of treatment in 10 children, who completed 30 months of daily dosing at 15 µg/kg/day.  Over this period of time, patients have experienced mean absolute growth increase of approximately 4 cm over what their baseline growth velocity would have predicted. 

The sustained increase in annualized growth velocity was accompanied by sustained improvements over time in height compared to age- and gender-matched unaffected children as measure by z-scores.  In addition, treatment with vosoritide shows continued improvement over time in proportionality as measured by a ratio of the upper and lower body measurements or U/L ratio. 

Pegvaliase Program Update

The Pegvaliase Biologics License Application (BLA) remains on Track for FDA Action during the first half of 2018.  The company plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in Q1 2018. 

2017 Full-year Total Revenue and Non-GAAP Guidance reaffirmed

Today, the Company commented on their Total Product Revenue and Non-GAAP trends for the third quarter and full-year 2017.  In terms of the overall commercial business, BioMarin stated that sales of products in markets throughout most of the world are performing at or above internal expectations.  However, the Company said the one exception is Brazil, where a slowdown in Federal purchasing orders has extended into the third quarter of this year.  As a result, third quarter revenues are expected to be negatively impacted.  For the fourth quarter, if orders are placed in Brazil as expected, Total Product Revenue for full-year 2017 is anticipated to be in the mid-point of guidance.  However, if sales to Brazil continue to be slow in the fourth quarter, full-year 2017 Total Product Revenue may be at the low end of guidance.  Regardless of Brazilian ordering patterns for the remainder of the year, and based on careful expense control, the Company still expects to be in the mid to high-end of Non-GAAP profitability guidance for full-year 2017.

About BioMarin and Disease Information

BioMarin is a global biotechnology company that develops and commercializes innovative therapies for patients with serious and life-threatening rare and ultra-rare genetic diseases. The company’s portfolio consists of six commercialized products and multiple clinical and pre-clinical product candidates. For additional information, please visit www.biomarin.com. Information on BioMarin’s website is not incorporated by reference into this press release.

About Friedreich’s Ataxia

Friedreich’s ataxia (FA) is a progressive, neurological disorder that affects approximately 15,000 people in the United States and Europe, typically resulting in wheelchair dependence in young adulthood and early death due to cardiac failure. It is caused by mutations in the FXN gene, and is inherited in an autosomal recessive manner. FXN mutations result in reduced expression of frataxin protein, manifesting in progressive neurological and cardiac damage. Major neurological symptoms include muscle weakness and ataxia, a loss of balance and coordination. These symptoms typically appear between 10 and 15 years of age, but FA has been diagnosed in people from ages 2 to 50 with earlier onset associated with a more severe course.

BMN 270 Safety

Overall, BMN 270 has been well-tolerated by patients across all doses, including the two patients that received the lowest doses of 6e12 and 2e13 vg/kg, respectively.  No patients developed inhibitors to Factor VIII and no patients withdrew from the study.  The most common adverse events (AEs) across all dose cohorts were alanine aminotransferase (ALT) elevation (11 patients, 73%); arthralgia, aspartate aminotransferase elevation, and headache (7 patients each, 47%); back pain and fatigue (5 patients each, 33%).  Two patients reported Serious Adverse Events (SAEs) during the study.  One patient was hospitalized for observation after developing Grade 2 pyrexia with myalgia and headache within 24 hours of receiving BMN 270.  The event resolved within 48 hours following treatment with paracetamol, an over-the-counter treatment for pain and fever.  The event was assessed as related to BMN 270.  The other SAE was assessed as not related to BMN 270, attributed to a planned knee surgery to treat hemophilic arthropathy, and Grade 1 in severity.  No complications were reported. 

About Hemophilia A

Hemophilia A, also called Factor VIII (FVIII) deficiency or classic hemophilia, is a genetic disorder caused by missing or defective Factor VIII, a clotting protein. Although it is passed down from parents to children, about 1/3 of cases are caused by a spontaneous mutation, a new mutation that was not inherited. As an X-linked disorder, hemophilia A mostly affects males, occurring in approximately 1 in 5,000 male births. People living with the disease are not able to form blood clots efficiently and are at risk for excessive bleeding from modest injuries, potentially endangering their life. People with severe hemophilia often bleed spontaneously into their muscles or joints. The standard of care for the 43% of hemophilia A patients who are severely affected, is a prophylactic regimen of Factor VIII infusions three times per week. Even with prophylactic regimens, many patients still experience microbleeds and spontaneous bleeding events that result in progressive joint damage.

Vosoritide Safety

Vosoritide was generally well tolerated at all doses. The majority of adverse events (AEs) were mild and no serious AEs were reported as study drug-related. Across all doses, injection site reactions and hypotension were the most common drug-related AEs.  All injection site reaction events were transient. AEs of hypotension were mild, transient and resolved without medical intervention, and the majority were asymptomatic and reported in context of routine blood pressure measurements. No new safety findings were observed at the 30 µg/kg/day dose.

About Achondroplasia 

Achondroplasia, the most common form of disproportionate short stature in humans, is characterized by failure of normal conversion of cartilage into bone, which results in disproportionate short stature. This condition is caused by a mutation in the fibroblast growth factor receptor 3 gene (FGFR3), a negative regulator of bone growth. Beyond disproportionate short stature, people with achondroplasia can experience serious health complications, including foramen magnum compression, sleep apnea, bowed legs, mid-face hypoplasia, permanent sway of the lower back, spinal stenosis and recurrent ear infections. Some of these complications can result in invasive surgeries such as spinal cord decompression and straightening of bowed legs. In addition, studies show increased mortality at every age.

More than 80% of children with achondroplasia have parents of average stature and have the condition as the result of a spontaneous gene mutation.  The worldwide incidence rate of achondroplasia is about one in 25,000 live births.  Vosoritide is being tested in children whose growth plates are still “open,” typically those under 18 years of age.  This is approximately 25 percent of people with achondroplasia.  In the United States, Europe, Latin America and the Middle East, there is currently no licensed medicines for achondroplasia.

Pegvaliase Safety

The safety data set for all pegvaliase trials includes exposure up to seven years and approximately 680 patient years of treatment, 300 of which are from the Phase 3 program.  Most Adverse Events (AEs) were mild or moderate in severity.  8.5% of patients reported AEs leading to study withdrawal.  The most common Adverse Events (AEs) were arthralgia (69.5%), injection site reaction (65.1%), headache (51.9%), nasopharyngitis (41.1%), and rash (40.2%).

Pegvaliase treated patients had acute systemic hypersensitivity adverse events (4.6%) as defined by the broad National Institute of Allergy and Infectious Disease and the Food Allergy and Anaphylaxis Network (NIAID/FAAN) (Sampson’s) criteria for anaphylaxis by expert external adjudication.  Hypersensitivity adverse events and acute systemic hypersensitivity events mainly occurred in the first year of treatment.  With prolonged exposure, AE rates declined for almost all categories.  Using high-sensitivity assays, anti-drug IgE was undetected in the observed acute systemic hypersensitivity events.  Eight of the 13 patients with acute systemic hypersensitivity events were re-dosed and six of the eight re-dosed patients continued therapy.

About Phenylketonuria

Phenylketonuria (PKU) is a genetic disorder affecting approximately 50,000 diagnosed patients in the developed world and is caused by a deficiency of the enzyme PAH.  This enzyme is required for the metabolism of Phe, an essential amino acid found in most protein-containing foods. If the active enzyme is not present in sufficient quantities, Phe accumulates to abnormally high levels in the blood and becomes toxic to the brain, resulting in a variety of complications including severe intellectual disability, seizures, tremors, behavioral problems and psychiatric symptoms. As a result of newborn screening efforts implemented in the 1960s and early 1970s, virtually all individuals with PKU or PAH deficiency under the age of 40 in developed countries are diagnosed at birth and treatment is implemented soon after. PAH deficiency can be managed with a Phe-restricted diet, which is supplemented by low-protein modified foods and Phe-free medical foods; however, the strict diet is difficult for most adult patients to adhere to the extent needed for achieving adequate control of blood Phe levels.  To learn more about PKU and PAH deficiency, please visit www.PKU.com. Information on this website is not incorporated by reference into this press release.

Forward Looking Statement

This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including, without limitation, statements about its development programs and regulatory actions related to these programs, including the expected timing of the filing of the MAA for pegvaliase and an FDA decision on pegvaliase, the timing of its anticipated submission of an IND for BMN 290, BioMarin’s BMN 270 program generally, the timing of the initiation of the global Phase 3 program, the expected design and size of the Phase 3 studies and a Phase 1/2 study in subjects with pre-existing antibodies against AAV5, expected regulatory actions related to BMN 270, the expectations of total BioMarin revenues for the third quarter and full year 2017 and the financial performance of BioMarin as a whole, and statements about the anticipated capacity of the Company’s gene therapy manufacturing facility.  These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: results and timing of current and planned preclinical studies and clinical trials of our product candidates, the continued clinical experiences of the patients in the current clinical studies; the content and timing of decisions by the U.S. Food and Drug Administration, the European Commission and other regulatory authorities; the content and timing of decisions by local and central ethics committees regarding the clinical trials; our ability to successfully manufacture our product candidates for the preclinical and clinical trials; the ordering patterns for our commercial products, particularly orders from Brazilian governmental entities; and those other risks detailed from time to time under the caption “Risk Factors” and elsewhere in BioMarin’s Securities and Exchange Commission (SEC) filings, including BioMarin’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, and future filings and reports by BioMarin. BioMarin undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events or changes in its expectations.

BioMarin® is a registered trademarks of BioMarin Pharmaceutical Inc.

Contacts:

Investors

Media

Traci McCarty

Debra Charlesworth

BioMarin Pharmaceutical Inc.

BioMarin Pharmaceutical Inc.

(415) 455-7558

(415) 455-7451

 

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DotLab Honored by Goldman Sachs for Entrepreneurship

October 18, 2017 – 7:00 am

CEO Heather Bowerman Among 100 Most Intriguing Entrepreneurs at 2017 Builders + Innovators Summit

SANTA BARBARA, Calif., Oct. 18, 2017 /PRNewswire/ — Goldman Sachs is recognizing DotLab and its CEO and Founder, Heather Bowerman, as one of the 100 Most Intriguing Entrepreneurs of 2017 at its Builders + Innovators Summit in Santa Barbara, California. Goldman Sachs selected Bowerman as one of 100 entrepreneurs from multiple industries to be honored at the two-day event.

DotLab has developed the first-ever diagnostic test for endometriosis, a chronic disease marked by infertility and pain that affects 1 in 10 women worldwide and carries a $78 billion cost. Today, the disease can only be diagnosed via laparoscopic surgery under general anesthesia, and the average timeframe from onset to diagnosis is ten years. “DotLab is committed to revolutionizing the standard of care for the 176 million women who suffer from endometriosis,” said Bowerman. “Our goal is to help them live healthier, more productive, and happier lives.” For her work in biomedical engineering, Bowerman was also named by the MIT Technology Review as one of the top 35 global innovators and as a World Technology Award Finalist for Health & Medicine.

“We are pleased to recognize Heather Bowerman as one of the most intriguing entrepreneurs of 2017,” said David M. Solomon, President and Co-Chief Operating Officer at Goldman Sachs. “This is the sixth year that we’ve hosted the Builders + Innovators Summit where emerging business leaders gather to discuss their common interests in building prosperous organizations.”

For more than 145 years, Goldman Sachs has been advising and financing entrepreneurs as they launch and grow their businesses. In addition to honoring 100 entrepreneurs, the Summit consists of general sessions and clinics led by Goldman Sachs experts, seasoned entrepreneurs, academics and business leaders as well as resident scholars.

About DotLab
DotLab is a San Francisco-based healthcare technology company. DotLab’s first product, DotEndo, is a saliva test that replaces surgery for the diagnosis of endometriosis– and after initial diagnosis, the test monitors disease progression, recurrence, and therapy response. The results of a prospective study on the biomarkers will be presented at the 2017 American Society of Reproductive Medicine Scientific Congress and Expo in San Antonio, TX. For more information, please visit www.dotlab.com.

 

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