ACAD
38.88
-0.68
-1.72%
AEMD
3.78
+0.03
+0.80%
APRI
3.068
-0.012
-0.3766%
ARNA
1.47
+0.05
+3.52%
ATEC
3.55
+0.28
+8.56%
CNAT
4.95
+0.13
+2.70%
CRXM
0.22
0.00
+1.70%
CYTX
1.71
-0.07
-3.93%
DXCM
78.5
+0.54
+0.69%
GNMK
11.25
+0.31
+2.83%
HALO
12.27
+0.23
+1.91%
ILMN
160
-1.01
-0.63%
INNV
0.158
+0.003
+1.6129%
INO
6.68
-0.22
-3.19%
ISCO
1.3
-0.05
-3.70%
ISIS
57.56
0.00
0.00%
LGND
100.38
-2.46
-2.39%
LPTN
2.93
-0.08
-2.66%
MBVX
3.06
-0.01
-0.33%
MEIP
1.71
+0.02
+1.18%
MNOV
6.1
+0.1
+1.67%
MRTX
5.6
-0.1
-1.75%
MSTX
0.12
0.00
-2.52%
NBIX
42.72
-0.36
-0.84%
NUVA
74.76
+0.25
+0.34%
ONCS
1.39
-0.03
-2.11%
ONVO
2.97
0.00
0.00%
OREX
4.44
+0.46
+11.56%
OTIC
14.55
-0.4
-2.68%
QDEL
21.15
-0.26
-1.21%
RCPT
231.96
0.00
0.00%
RGLS
1.1
+0.05
+4.76%
RMD
71.96
+0.34
+0.47%
SPHS
2.59
-0.04
-1.52%
SRNE
5.1
-0.1
-1.92%
TROV
2
0.00
0.00%
VICL
2.167
+0.017
+0.7814%
VOLC
18
0.00
0.00%
ZGNX
10.5
-0.1
-0.94%
ACAD
38.88
-0.68
-1.72%
AEMD
3.78
+0.03
+0.80%
APRI
3.068
-0.012
-0.3766%
ARNA
1.47
+0.05
+3.52%
ATEC
3.55
+0.28
+8.56%
CNAT
4.95
+0.13
+2.70%
CRXM
0.22
0.00
+1.70%
CYTX
1.71
-0.07
-3.93%
DXCM
78.5
+0.54
+0.69%
GNMK
11.25
+0.31
+2.83%
HALO
12.27
+0.23
+1.91%
ILMN
160
-1.01
-0.63%
INNV
0.158
+0.003
+1.6129%
INO
6.68
-0.22
-3.19%
ISCO
1.3
-0.05
-3.70%
ISIS
57.56
0.00
0.00%
LGND
100.38
-2.46
-2.39%
LPTN
2.93
-0.08
-2.66%
MBVX
3.06
-0.01
-0.33%
MEIP
1.71
+0.02
+1.18%
MNOV
6.1
+0.1
+1.67%
MRTX
5.6
-0.1
-1.75%
MSTX
0.12
0.00
-2.52%
NBIX
42.72
-0.36
-0.84%
NUVA
74.76
+0.25
+0.34%
ONCS
1.39
-0.03
-2.11%
ONVO
2.97
0.00
0.00%
OREX
4.44
+0.46
+11.56%
OTIC
14.55
-0.4
-2.68%
QDEL
21.15
-0.26
-1.21%
RCPT
231.96
0.00
0.00%
RGLS
1.1
+0.05
+4.76%
RMD
71.96
+0.34
+0.47%
SPHS
2.59
-0.04
-1.52%
SRNE
5.1
-0.1
-1.92%
TROV
2
0.00
0.00%
VICL
2.167
+0.017
+0.7814%
VOLC
18
0.00
0.00%
ZGNX
10.5
-0.1
-0.94%
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San Diego biotech news from BioSpace, Xconomy, PR Newswire, Marketwired and other sources, click on headlines to read the full story.

Symic Bio Announces Last Patient Enrolled in SHIELD Trial of SB-030 for Interventions in Peripheral Artery Disease

February 24, 2017 – 7:00 am

— Top-Line Results of Safety and Efficacy are Expected in the Fourth Quarter of 2017 —

SAN FRANCISCO, Feb. 24, 2017 /PRNewswire/ — Symic Bio, a biopharmaceutical company focused on matrix biology that is developing a new category of therapeutics, announced today the completion of enrollment for the SHIELD clinical trial of SB-030 in peripheral artery disease. The trial will evaluate the safety and efficacy of SB-030, a locally administered single-use therapeutic, in the reduction of restenosis following angioplasty.

“We’re pleased to have reached this critical development milestone for SB-030,” said Nathan Bachtell, M.D., Chief Medical Officer of Symic Bio. “SB-030 represents a pioneering matrix biology approach for addressing restenosis after vascular interventions, a prevalent and costly complication that is inadequately addressed by current therapies. We look forward to top-line results from this proof-of-concept study in the fourth quarter of 2017.”

“Completion of enrollment of the SHIELD trial is very encouraging,” stated Michael Conte, M.D., Professor and Chief of the Division of Vascular & Endovascular Surgery at the University of California, San Francisco (UCSF), and Co-Director of the UCSF Center for Limb Preservation. “If successful, positive proof-of-concept results will pave the way for additional studies of SB-030 in endovascular and surgical indications.”

About the SHIELD trial

The proof-of-concept Phase 1/2a SHIELD (Study in Humans to Investigate the Efficacy and Safety of Luminal SB‐030 Delivery in peripheral artery disease) trial is a parallel, blinded, randomized (2:1) clinical trial that involves multiple sites in Australia and New Zealand. The trial enrolled 67 patients with symptomatic peripheral artery disease. It will compare the safety and efficacy of balloon angioplasty with or without the administration of SB‐030 in patients undergoing angioplasty to address reduced blood flow (occlusions) within the femoral artery. The trial includes a primary efficacy measurement of late lumen loss at 6 months, a standard measure of restenosis following vascular injury, and will also evaluate other clinically relevant outcomes such as target lesion revascularization.

About SB-030

Symic Bio is developing SB-030 (previously SBCV-030) as a locally administered single-use treatment for use during cardiovascular procedures. SB-030 is designed to reduce platelet binding and activation to the injured vessel wall caused by vascular procedures, and is intended to reduce inflammation and thus decreased restenosis due to scar tissue (neointimal hyperplasia). Restenosis is a leading cause of occlusions following peripheral vascular procedures and can lead to severe complications such as critical limb ischemia and amputation.

About Symic Bio

Symic Bio is a biopharmaceutical company focused on matrix biology that is developing a new category of therapeutics. These therapeutics, with potential applications in a wide variety of disease states, are inspired by naturally occurring macromolecules that play key regulatory roles within the extracellular matrix. Symic Bio currently has two clinical candidates, SB-030, which will initially target the prevention of peripheral vein graft failure and SB-061, directed at disease modification and pain management in the treatment of osteoarthritis. In addition, Symic Bio is investigating applications in the areas of fibrosis, oncology and diseases of the central nervous system. For additional information please visit the company’s website at www.symic.bio, LinkedIn page at www.linkedin.com/company/symic-bio or follow on Twitter at www.twitter.com/symicbio.

Investor Contacts
Gitanjali Jain Ogawa
The Trout Group
(646) 378-2949
gogawa@troutgroup.com

Media Contacts
David Schull or Rich Allan
Russo Partners, LLC
(212) 845-4271
(212) 942-5588
david.schull@russopartnersllc.com  
rich.allan@russopartnersllc.com  

 

SOURCE Symic Bio

Aethlon Medical CEO Note: Bill Gates on the Threat of Bioterrorism

February 24, 2017 – 6:25 am

SAN DIEGO, Feb. 24, 2017 /PRNewswire/ — Aethlon Medical, Inc. (Nasdaq: AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce.

In a chilling address at the Munich Security Conference last Saturday, Bill Gates warned world leaders that a genetically engineered virus could kill more people than nuclear weapons. Mr. Gates expressed his concern, which is also supported by U.S. and U.K. intelligence agencies, that scientific terrorists have access to the necessary tools to design biological viruses to be weapons that could kill tens of millions of people. He also concluded that in the face of such knowledge, governments around the world remain complacent and are neither prepared nor equipped to respond to these threats.

If you are a shareholder of Aethlon Medical, you may recognize the concerns of Mr. Gates to be eerily similar to our own. As a recent example, I encourage you to review the bioterror related article that we published last year on the 21st of December.

http://aethlonmedical.investorroom.com/2016-12-21-Passage-of-the-21st-Century-Cures-Act-and-its-Potential-Implications-on-Biodefense

For those dedicated to the advancement of bioterror treatment solutions, Mr. Gates is a welcome and respected voice with the visibility, influence and knowledge to recognize that therapeutic innovation will be required to counter deadly viruses created by man.

If bioterrorists were to release such a virus, I am sincerely unaware of a clinical-stage candidate beyond our Hemopurifier® that could be deployed as a post-exposure treatment countermeasure.

The void in bioterrorism treatment countermeasures is driven by a historic emphasis to align a disease-specific drug or vaccine which only targets one specific pathogen threat. Such strategies have had limited success against the breadth of threats that are known to be infectious to man and cannot be considered as a strategy to treat unknown viruses created by man.

In reality, only a fraction of the 300+ viruses known to be infectious to man are addressed with an FDA-cleared drug or vaccine.  Since 2001, our government has spent an estimated $80 billion on biodefense initiatives, yet just one of 13 viruses classified as “Category A” are addressed with an approved therapy.  “Category A” pathogens are those biological threats that pose the highest risk to national security and public health.  In addition, these types of viral pathogens maintain the potential to be genetically engineered to be used as weapons that are even more deadly and resistant than those viruses that are naturally occurring.

Our Hemopurifier® is a first-in-class medical technology currently being advanced in FDA approved studies.  In previous studies, our technology has demonstrated the ability to capture a wide range of bioterror related, pandemic, chronic and latent infectious viral pathogens. 

We believe the Hemopurifier® can fulfill the broad-spectrum medical countermeasure objective of the U.S. Department of Health and Human Services (HHS) Public Health Emergency Medical Countermeasure Enterprise (PHEMCE).  This initiative is directed toward bioterror, pandemic threats and other pathogens that are not well addressed with traditional drug or vaccine therapies.

A little more than a decade ago, we were invited to attend an international scientific symposium hosted by the National Center for Biodefense. At the time, our Hemopurifier® was still a development-stage vision. Regardless, the keynote speaker, who formerly led the Soviet Union’s biological weapons program, emphasized our approach to be the only way to counter the breadth of viruses that could emerge naturally through mother nature or be created by man as agents of bioterror.

We never forgot that statement.

About the Aethlon Hemopurifier®

The Aethlon Hemopurifier® is a first-in-class medical technology currently being advanced in FDA approved studies as a broad-spectrum treatment countermeasure against infectious viral pathogens.  Named a “Top 25 Invention” and one of the “Eleven Most Remarkable Advances in Healthcare,” by TIME Magazine, the Hemopurifier® has previously been administered to individuals infected with Ebola virus, Hepatitis C virus and the Human Immunodeficiency virus, which leads to HIV AIDS.

Beyond human treatment experiences, pre-clinical Hemopurifier® studies have validated the capture of Chikungunya, Dengue, Middle East Respiratory Syndrome Coronavirus, West Nile and Zika virus, as well as Vaccinia and Monkey pox, which serve as models for human Smallpox infection.  Specific to pandemic influenza threats, Aethlon has validated the capture of H5N1 avian flu, H1N1 swine flu, and the reconstructed 1918 influenza virus, which represents a model for the strain of influenza that killed an estimated 50 million victims in 1918 and 1919.

The Hemopurifier has also been demonstrated to capture Cytomegalovirus (CMV), Epstein-Barr virus (EBV) and Herpes Simplex virus 1 (HSV1), which are latent viruses often associated with increased mortality in immune-suppressed sepsis patients.  These pathogens also contribute to organ rejection in transplant patients.  To validate treatment performance, the Hemopurifier is supported by the HP Virus Capture Assay, which quantifies the number of viruses captured within the Hemopurifier and no longer circulating in the patient. 

About Aethlon Medical

Aethlon Medical (AEMD) is a leading developer of immunotherapeutic technologies to combat infectious disease and cancer.  To augment the body’s natural immune defenses, the Aethlon Hemopurifier® eliminates life-threatening disease targets that are often shielded from the immune system and not well addressed by traditional drug therapies. The technology captures circulating viruses, bacterial toxins and cancer promoting exosomes through affinity attachment to a unique structure that cloaks these targets from immune detection. At present, the Hemopurifier® is being advanced under an FDA approved clinical study. Aethlon is also the majority owner of Exosome Sciences, Inc., a company focused on the discovery of exosomal biomarkers to diagnose and monitor life-threatening diseases.  Aethlon is part of the Russell Microcap® Index.  Additional information can be found online at www.AethlonMedical.com or you can connect with us on Twitter, LinkedIn, Facebook and Google+.

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as “may,” “believe,” “anticipate,” “expect,” “intend,” “plan,” “project,” “will,” “projections,” “estimate,” or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. Factors that may contribute to such differences include, without limitation, the Company’s ability to maintain its listing on the Nasdaq Capital Market, or any other national securities exchange, that the Company or its subsidiary will not be able to commercialize its products, that the FDA will not approve the initiation or continuation of the Company’s clinical programs or provide market clearance of the Company’s products, including any products relating to the Zika or MERS-CoV viruses or relating to sepsis, the Company’s ability to raise capital when needed, the Company’s ability to complete the development of its planned products, the Company’s ability to manufacture its products either internally or through outside companies, the impact of government regulations, patent protection on the Company’s proprietary technology, the ability of the Company to meet the milestones contemplated in its contract with DARPA, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. The foregoing list of risks and uncertainties is illustrative, but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended March 31, 2016, and in the Company’s other filings with the Securities and Exchange Commission. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.

Contacts:

Jim Frakes
Chief Financial Officer
Aethlon Medical, Inc.
858-489-7800 extension 3300
Jfrakes@aethlonmedical.com

 

SOURCE Aethlon Medical, Inc.

Bio Roundup: Trump Backlash, Verdine Plans, Sarepta Sale & More

February 24, 2017 – 3:30 am

A short week makes for a shorter roundup. As we’ve come to expect, however, there was no dearth of health and life-sciences news from Washington, D.C. A bipartisan group of Congress members who…

[[Click headline to continue reading.]]

OncoSec to Host KOL Event Focused on New ASCO-SITC Melanoma Data and Clinical Strategy on Tuesday, February 28 in New York City

February 24, 2017 – 3:01 am

Key Opinion Leaders in Melanoma and Company Representatives to Discuss Unmet Needs in Immunotherapy

SAN DIEGO, Feb. 24, 2017 /PRNewswire/ — OncoSec Medical Incorporated (“OncoSec”) (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, will host a Key Opinion Leader event to highlight new clinical data that will be featured as an oral and poster presentation at the upcoming 2017 ASCO-SITC Immuno-Oncology Symposium and the Company’s melanoma development plan. The KOL event will be held in-person and via live webcast on Tuesday, February 28 at 12:00 PM EST / 9:00 AM PST at the Lotte New York Palace Hotel in New York City.

The KOL event will feature a presentation by Alain Algazi, MD, skin cancer specialist in the Melanoma Center at the UCSF Helen Diller Family Comprehensive Cancer Center, who will discuss the latest clinical data from the Phase II Investigator Sponsored Trial led by the University of California, San Francisco. This trial is evaluating the combination of OncoSec’s investigational therapy, ImmunoPulse® IL-12, and the approved anti-PD-1 therapy, pembrolizumab in patients with unresectable metastatic melanoma. Additionally, Dr. Algazi will address the current treatment landscape for melanoma patients and describe where there is still an unmet medical need for new treatment options.

Sharron Gargosky, PhD, OncoSec’s Chief Clinical and Regulatory Officer, and Chris Twitty, PhD, OncoSec’s Director of Clinical Science, will provide an overview of the Company’s ongoing clinical research with ImmunoPulse® IL-12 in patients with advanced melanoma who are anti-PD-1 non- responders. Their discussion will focus on the target patient population and the Company’s clinical strategy moving forward.

Following the presentation, all presenters will be available for questions. This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance if you plan to attend in-person, as space is limited. To reserve a spot, please contact LifeSci Advisors, LLC at mac@lifesciadvisors.com.

To view the live webcast, please access the following link at the time of presentation:  http://lifesci.rampard.com/20170228/reg.jsp. An archived version of the webcast will be available on OncoSec’s website: http://ir.oncosec.com/events-presentations.

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. In Phase I and II clinical trials, ImmunoPulse® IL-12 has demonstrated a favorable safety profile and evidence of anti-tumor activity in the treatment of various solid tumors as well as 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 non-responsive to anti-PD-1/PD-L1 therapies. In addition to ImmunoPulse® IL-12, 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. 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 our 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 ability to enroll patients in clinical trials and the risk of adverse events; unexpected new data, safety and technical issues; our 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.

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.

 

CONTACTS:
Punit Dhillon President & CEO
OncoSec Medical Incorporated 855-662-6732
media@oncosec.com

Media:
Laura Radocaj
Dian Griesel International 212-825-3210

 

SOURCE OncoSec Medical Incorporated

OncoSec to Host KOL Event Focused on New ASCO-SITC Melanoma Data and Clinical Strategy on Tuesday, February 28 in New York City

February 24, 2017 – 3:01 am

Key Opinion Leaders in Melanoma and Company Representatives to Discuss Unmet Needs in Immunotherapy

SAN DIEGO, Feb. 24, 2017 /PRNewswire/ — OncoSec Medical Incorporated (“OncoSec”) (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, will host a Key Opinion Leader event to highlight new clinical data that will be featured as an oral and poster presentation at the upcoming 2017 ASCO-SITC Immuno-Oncology Symposium and the Company’s melanoma development plan. The KOL event will be held in-person and via live webcast on Tuesday, February 28 at 12:00 PM EST / 9:00 AM PST at the Lotte New York Palace Hotel in New York City.

The KOL event will feature a presentation by Alain Algazi, MD, skin cancer specialist in the Melanoma Center at the UCSF Helen Diller Family Comprehensive Cancer Center, who will discuss the latest clinical data from the Phase II Investigator Sponsored Trial led by the University of California, San Francisco. This trial is evaluating the combination of OncoSec’s investigational therapy, ImmunoPulse® IL-12, and the approved anti-PD-1 therapy, pembrolizumab in patients with unresectable metastatic melanoma. Additionally, Dr. Algazi will address the current treatment landscape for melanoma patients and describe where there is still an unmet medical need for new treatment options.

Sharron Gargosky, PhD, OncoSec’s Chief Clinical and Regulatory Officer, and Chris Twitty, PhD, OncoSec’s Director of Clinical Science, will provide an overview of the Company’s ongoing clinical research with ImmunoPulse® IL-12 in patients with advanced melanoma who are anti-PD-1 non- responders. Their discussion will focus on the target patient population and the Company’s clinical strategy moving forward.

Following the presentation, all presenters will be available for questions. This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance if you plan to attend in-person, as space is limited. To reserve a spot, please contact LifeSci Advisors, LLC at mac@lifesciadvisors.com.

To view the live webcast, please access the following link at the time of presentation:  http://lifesci.rampard.com/20170228/reg.jsp. An archived version of the webcast will be available on OncoSec’s website: http://ir.oncosec.com/events-presentations.

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. In Phase I and II clinical trials, ImmunoPulse® IL-12 has demonstrated a favorable safety profile and evidence of anti-tumor activity in the treatment of various solid tumors as well as 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 non-responsive to anti-PD-1/PD-L1 therapies. In addition to ImmunoPulse® IL-12, 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. 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 our 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 ability to enroll patients in clinical trials and the risk of adverse events; unexpected new data, safety and technical issues; our 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.

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.

 

CONTACTS:
Punit Dhillon President & CEO
OncoSec Medical Incorporated 855-662-6732
media@oncosec.com

Media:
Laura Radocaj
Dian Griesel International 212-825-3210

 

SOURCE OncoSec Medical Incorporated

Halozyme Therapeutics To Present At Upcoming Healthcare Conferences

February 23, 2017 – 1:30 pm

SAN DIEGO, Feb. 23, 2017 /PRNewswire/ — Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, will be presenting at the Cowen & Company 37th Annual Healthcare Conference in Boston on Tuesday, March 7 at 11:20 a.m. ET/8:20 a.m. PT. Dr. Helen Torley, president and chief executive officer will provide a corporate overview. On Wednesday, March 15, Halozyme will also present at the Barclays Capital Global Healthcare Conference in Miami at 4:50 p.m. ET/1:50 p.m. PT. Laurie Stelzer, senior vice president and chief financial officer, will provide a corporate overview.

The presentations will be webcast through the “Investors” section of www.halozyme.com, and a recording will be made available for 90 days following each event. To access the live webcast, please visit Halozyme’s website approximately 15 minutes prior to the presentation to register and download any necessary audio software.

About Halozyme
Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme’s lead proprietary program, investigational drug PEGPH20, applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor in animal models. PEGPH20 is currently in development for metastatic pancreatic cancer, non-small cell lung cancer, gastric cancer, metastatic breast cancer and has potential across additional cancers in combination with different types of cancer therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies including Roche, Baxalta, Pfizer, Janssen, AbbVie and Lilly for its ENHANZE™ drug delivery platform. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

Contacts:
Jim Mazzola
858-704-8122
ir@halozyme.com

Chris Burton
858-704-8352
ir@halozyme.com

 

SOURCE Halozyme Therapeutics, Inc.

OncoSec Announces Positive Phase II Data Demonstrating Company’s ImmunoPulse® IL-12 in Combination with Pembrolizumab Increased Response Rates in Anti-PD-1 Non-Responder Melanoma Patients

February 23, 2017 – 8:30 am

New Data Showed 48% Best Overall Response RateComprehensive Immune Monitoring Data Demonstrated Combination of ImmunoPulse® IL-12 and Pembrolizumab Can Convert “Cold” Tumors to “Hot” Tumors

SAN DIEGO, Feb. 23, 2017 /PRNewswire/ — OncoSec Medical Incorporated (“OncoSec”) (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today reported new positive clinical data from a Phase II Investigator Sponsored Trial assessing the combination of OncoSec’s investigational intratumoral therapy, ImmunoPulse® IL-12, and the approved anti-PD- 1 therapy (pembrolizumab), in patients with unresectable metastatic melanoma. The results of this single-arm, open-label trial, which was led by the University of California, San Francisco (UCSF), indicated that ImmunoPulse® IL-12 can increase response rates in patients who are not expected to respond to anti-PD-1 therapy alone.

The trial is evaluating the following key endpoints: best overall response rate (BORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune-related Response Criteria; safety and tolerability; duration of response; 24-week landmark progression-free survival (PFS); median PFS; and overall survival (OS). The study results showed an overall response rate (ORR) at 24 weeks of 43% (9/21), and BORR of 48% by RECIST v1.1. There were 24% (5/21) complete responders (CR), 19% (4/22) partial responders (PR), and 9% (2/21) stable disease (SD) for a total disease control rate of 52% (11/21). These data are consistent with, and expand upon, previously reported preclinical and clinical data that provide a strong rationale for combining ImmunoPulse® IL-12 with anti-PD-1 blockade.

“Collectively, these data suggest that intratumoral IL-12 DNA with electroporation in combination with pembrolizumab can effectively alter the tumor microenvironment by triggering adaptive resistance,” said Alain Algazi, M.D., the study’s lead investigator, and skin cancer specialist in the Melanoma Center at the UCSF Helen Diller Family Comprehensive Cancer Center. “This increases the substrate for a therapeutic PD-1/PD-L1 blockade while driving systemic anti-tumor immunity and concordant clinical responses in patients unlikely to benefit from anti-PD-1 monotherapy.”

Dr. Algazi presented the study findings today in an oral presentation titled, “Immune monitoring outcomes of patients with stage III/IV melanoma treated with a combination of pembrolizumab and intratumoral plasmid interleukin 12 (pIL-12)” (Abstract #78), at the ASCO-SITC Clinical Immuno-Oncology Symposium in Orlando, FL.

In this trial, a biomarker that has previously been shown to be predictive of response to checkpoint inhibitor therapy was used to enroll 22 patients who have a low likelihood of responding to an anti-PD-1 therapy. These patients were treated with the combination of intravenous pembrolizumab and ImmunoPulse® IL-12 for more than 24 weeks.

The combination therapy continued to demonstrate a favorable safety profile and was well tolerated. Importantly, of the 22 patients enrolled, nine had previous checkpoint inhibitor therapy; ORR for this subset of patients was 33% (3/9).

Comprehensive immune monitoring of blood and tissue samples showed that the combination  of ImmunoPulse® IL-12 with pembrolizumab produces a safe and powerful systemic immune response. This response leads to an increase in tumor-specific CD8+ T-cells and an “adaptive immune resistance” that broadly supports an immune-directed mechanism that is differentiated between responders and non-responders. Analysis of the biomarker data suggests that the combination of ImmunoPulse® IL-12 with pembrolizumab is transforming “cold” tumors, which would be predicted to not respond to anti-PD-1 therapy, into “hot” tumors, thus increasing the potential for a meaningful clinical response to the checkpoint inhibitor therapy. Moreover, an analysis of pre-treatment samples using various analytical methods that have also been demonstrated to predict response to anti-PD-1 therapy, including immunohistochemistry (IHC) and RNA expression of critical immune-related genes by NanoString®, correlate with the predictive biomarker used to enroll patients for this study.

“OncoSec’s vision to bring intratumoral gene therapies to the oncology market continues to advance with these positive, impactful data, which hold immense promise for cancer patients who are unlikely to benefit from immunotherapy,” said Punit Dhillon, OncoSec President and CEO. “These results provide a strong foundation for our planned Phase II registration trial, which will evaluate the combination of ImmunoPulse® IL-12 and an anti-PD-1 therapy in melanoma patients who have previously failed an approved anti-PD-1 therapy alone. We expect to initiate this study later in 2017.”

The full-text abstract is available and can be viewed on ASCO-SITC’s website at www.immunosym.org. The presentation is available in the Publications section of OncoSec’s website.

About the ASCO-SITC Clinical Immuno-Oncology Symposium
The ASCO-SITC Clinical Immuno-Oncology Symposium is a three-day meeting focused on clinical and translational research in immuno-oncology and the implications for clinical care. This is a new meeting, one that will address the high level of need for clinical education in a field where all aspects of care are fundamentally different from traditional therapies. For more information, please visit www.immunosym.org.

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. In Phase I and II clinical trials, ImmunoPulse® IL-12 has demonstrated a favorable safety profile and evidence of anti-tumor activity in the treatment of various solid tumors as well as a systemic immune response. OncoSec’s lead program, ImmunoPulse® IL-12, is currently in clinical development for several indications, including 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 non-responsive to anti-PD-1/PD-L1 therapies. In addition to ImmunoPulse® IL-12, 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.

University of California Disclaimer
The information stated above was prepared by OncoSec Medical Incorporated and reflects solely the opinion of the corporation. Nothing in this statement shall be construed to imply any support or endorsement of OncoSec, or any of its products, by The Regents of the University of   California, its officers, agents and employees.

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. 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 our 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 ability to enroll patients in clinical trials and the risk of adverse events; unexpected new data, safety and technical issues; our 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.

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:

Punit Dhillon
President & Chief Executive Officer
OncoSec Medical Incorporated
855-662-6732
media@oncosec.com

Media:
Laura Radocaj
Dian Griesel International
212-825-3210

 

 

SOURCE OncoSec Medical Incorporated

MIODx Licenses Key Immunotherapy Technologies from UCSF

February 23, 2017 – 7:00 am

SAN JOSE, Calif., Feb. 23, 2017 /PRNewswire/ — MIODx announced today that it has signed an exclusive license for two key immunotherapy technologies from the University of California, San Francisco (UCSF).  The first technology provides a method to monitor a patient for response to immune checkpoint inhibitor therapy such as PD-L1 and CTLA-4.  The second license extends the technology with a method to detect if a patient is likely to have an immune-related adverse event (IRAE) from their immunotherapy regimen.

“Diagnostic assays that help guide immunotherapies represent a huge unmet clinical need,” said Lawrence Fong, MD, a science advisor to MIODx and leader of the Cancer Immunotherapy Program at the Helen Diller Family Comprehensive Cancer Center at UCSF. “Rather than treating all patients, we need to select patients who can respond to these treatments as well as determine which patients may develop side effects.” 

Immunotherapies have shown tremendous gains in the treatment of certain cancers.  The field of cancer immunotherapies has exploded with hundreds of drugs currently in clinical trials or in development. 

“While we are very excited by what we see in terms of the effect these drugs have on certain patient populations, we believe that there remains a critical need to monitor patients, as there is still a huge unknown on what is happening to their immune system,” said MIODx CEO M. Allen Northrup, PhD, FRSC.

This partnership was facilitated by the UCSF Office of Technology Management (OTM), which coordinates UCSF’s efforts in forging collaborations and licensing technologies that translate cutting-edge science on campus into products and therapies that directly benefit people worldwide.

MIODx also announced that they have entered into an agreement with UCSF to provide immunosequencing services as part of the validation and commercialization of the technology. 

“We plan on having two paths forward for the immunosequencing platform,” said Sean Givens, the company’s COO.   “As a research service for pharma and academics working on checkpoint inhibitor therapies, and as a doctor-ordered test for oncologists to monitor their patients that are undergoing immunotherapy.”

MIODx has already begun working with collaborators and expects to launch the research service in Q2 2017.

About MIODx

MIODx is a privately held company leading the discovery of early detection and prognostic cancer biomarkers through the company’s proprietary platforms. The company’s VerifyDx™ platform utilizes a highly sensitive, multiplex PCR assay and advanced bioinformatics to interrogate multiple DNA and RNA pathways that are implicated in highly metastatic cancer. In addition to the VerifyDx™ platform, MIODx utilizes high throughput immune sequencing to generate information on T and B cell diversity that is being applied to monitoring a patient’s response to immunotherapy.

 

SOURCE MIODx

UC San Diego Astrophysicists Contribute to Major Planet Discovery

February 23, 2017 – 7:00 am

The announcement yesterday that NASA’s Spitzer Space Telescope had revealed the first known system of seven Earth-size planets around a single star was the biggest news of the year for the space agency.

A Pendant Fit for a King

February 23, 2017 – 7:00 am

The jewel—a jade pendant worn on a king’s chest during key religious ceremonies—was first unearthed in 2015. It is now housed at the Central Bank of Belize, along with other national treasures. Braswell recently published a paper in the Cambridge University journal Ancient Mesoamerica detailing the jewel’s significance. A second paper, in the Journal of Field Archaeology, describes the excavations.