San Diego biotech news from BioSpace, Xconomy, PR Newswire, Marketwired and other sources, click on headlines to read the full story.
By the end of this year, for the first time, patients with certain deadly types of blood cancer might have a new option, CAR-T cell therapy, to prolong their life. Immunotherapy could further…
[[Click headline to continue reading.]]
SAN DIEGO, June 26, 2017 /PRNewswire/ — Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of cancer patients, announces that is has been added to the Russell Microcap® Index. Each June, the Russell Microcap® Index is realigned and recalibrated to reflect market changes during the past year, with membership primarily determined by objective, market-capitalization rankings, and style attributes.
Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. According to FTSE Russell, approximately $8.4 trillion in assets are benchmarked against Russell’s U.S. indexes.
“Inclusion in this index will contribute to additional investor awareness of Biocept, with the potential to broaden our investor base as we build on our leadership position in the liquid biopsy market,” said Biocept’s President and Chief Executive Officer Michael Nall. “This is an exciting time at Biocept as we execute on our stated initiatives that include signing additional health plan agreements to support third-party reimbursement for our tests, collaborating with top-tier oncology institutions to further validate the use of our tests, broadening our test menu by introducing new clinically actionable oncology biomarker assays, and increasing our market share of the liquid biopsy segment.”
More information on the Russell Microcap® Index is available on the “Russell Reconstitution” section of the FTSE Russell website.
Biocept, Inc. is a molecular diagnostics company with commercialized assays for lung, breast, gastric, colorectal and prostate cancers, and melanoma. The Company leverages its proprietary liquid biopsy technology to provide physicians with clinically actionable information for treating and monitoring patients diagnosed with cancer. Biocept’s patented Target Selector™ liquid biopsy technology platform captures and analyzes tumor-associated molecular markers on circulating tumor cells (CTCs) and in circulating tumor DNA (ctDNA). With thousands of tests performed, the platform has demonstrated the ability to identify cancer mutations and alterations to inform physicians about a patient’s disease and therapeutic options. For additional information, please visit www.biocept.com.
Forward-Looking Statements Disclaimer Statement
This news release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to be correct. Forward-looking statements are generally identifiable by the use of words like “may,” “will,” “should,” “could,” “expect,” “anticipate,” “estimate,” “believe,” “intend” or “project,” or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this news release are not strictly historical, including, without limitation, statements as to our ability to improve the outcomes of cancer patients, the utility and effectiveness of our intellectual property protections, the financial impact of new contracts, and our ability to increase the number of products or services provided or the value of the Company, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors as set forth in our Securities and Exchange Commission (SEC) filings. The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this news release. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. Readers are advised to review our filings with the SEC at www.sec.gov.
SOURCE Biocept, Inc.
Trovagene Announces Expansion of Key Claims for its NPM1 Patent Portfolio for Acute Myeloid Leukemia
SAN DIEGO, June 26, 2017 /PRNewswire/ — Trovagene, Inc. (NASDAQ: TROV), a precision medicine biotechnology company, today announced that the U.S. Patent and Trademark Office, and separately, the European Patent Office, have allowed claims for Patent Application 13/959739 and Patent Application EP10184598.0, respectively, entitled “Nucleophosmin Protein (NPM) Mutants, Corresponding Gene Sequences and Uses Thereof.” These patents encompass NPM1 mutation detection and minimal residual disease (MRD) monitoring of patients with acute myeloid leukemia (AML).
“These allowed NPM1 patent claims in the U.S. and Europe further strengthens the patent portfolio supporting our drug candidate, PCM-075, and its clinical development in AML,” said Bill Welch, Chief Executive Officer of Trovagene. “Importantly, knowing the NPM1 mutational status of all AML patients is recommended within the National Comprehensive Cancer Network (NCCN) guidelines to help inform treatment decisions.”
“We believe that monitoring for minimal residual disease and quantitative detection of NPM1 mutations will be an essential component in managing patients with AML, with the potential for closely following the impact of new treatments,” said Sandra Silberman, MD, PhD, a Clinical Advisor and Hematologist/Oncologist at Duke VAMC.
PCM-075 is a highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK 1) enzyme, which is over-expressed in several different hematologic malignancies, as well as solid tumors such as breast, prostate, ovarian, lung, gastric and colon cancers. PCM-075 is orally bioavailable and has been explored in an initial Phase 1, open-label, dose-escalation safety study in patients with advanced metastatic solid tumor cancers. In this study, PCM-075 demonstrated an acceptable safety profile, as well as anti-tumor activity. Trovagene plans to initiate clinical trials of PCM-075 in AML, since it has significant advantages over prior PLK1 inhibitors evaluated in this indication, including a higher selectivity, greater potency, oral bioavailability and shorter half-life.
About Trovagene, Inc.
Trovagene is a precision medicine biotechnology company developing oncology therapeutics for improved cancer care by leveraging its proprietary Precision Cancer Monitoring® (PCM) technology in tumor genomics. Trovagene has broad intellectual property and proprietary technology to measure circulating tumor DNA (ctDNA) in urine and blood to identify and quantify clinically actionable markers for predicting response to cancer therapies. Trovagene offers its PCM technology at its CLIA/CAP – accredited laboratory and plans to continue to vertically integrate its PCM technology with precision cancer therapeutics. For more information, please visit https://www.trovagene.com.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Trovagene’s expectations, strategy, plans or intentions. These forward-looking statements are based on Trovagene’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, our need for additional financing; our ability to continue as a going concern; clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; our ability to develop tests, kits and systems and the success of those products; regulatory, financial and business risks related to our international expansion and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that any of our technology or products will be utilized or prove to be commercially successful, or that Trovagene’s strategy to design its liquid biopsy tests to report on clinically actionable cancer genes will ultimately be successful or result in better reimbursement outcomes. Additionally, there are no guarantees that future clinical trials will be completed or successful or that any precision medicine therapeutics will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Trovagene’s Form 10-K for the year ended December 31, 2016, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Trovagene does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
VP, Corporate Communications
SOURCE Trovagene, Inc.
Kindred Biosciences Announces Acquisition of Kansas Manufacturing Plant and Execution of Commercial Manufacturing Agreement for Zimeta
Company to Hold Conference Call and Webcast at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time on Monday, June 26, 2017
SAN FRANCISCO, June 26, 2017 /PRNewswire/ — Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced that it has acquired a manufacturing facility in Elwood, Kansas. The purchase of this property, formerly owned by Boehringer Ingelheim and by Strategic Veterinary Pharmaceuticals, Inc., includes approximately 8 acres of land and two buildings encompassing approximately 180,000 square feet with clean rooms, utility, equipment, and related quality documentation suitable for small molecule and biologics manufacturing. The total purchase price was $3,750,000 and the Company expects to close within 30-days, subject to the completion of the inspection/diligence period and satisfactions of the conditions of escrow.
KindredBio also announced the execution of a commercial manufacturing agreement with Corden Pharma S.p.A for the manufacture of Zimeta™ (dipyrone injection) for the control of pyrexia (fever) in horses. This agreement is for an initial 3-year term, and permits for an automatic renewal period of 2-years upon the conclusion of the initial term. The agreement provides for production to supply KindredBio’s initial launch and future commercial campaigns upon regulatory approval, with capabilities to grow along with demand.
“We are very pleased to acquire this plant, which will allow KindredBio to meet the anticipated manufacturing needs of our promising pipeline, lower our costs of goods, and increase our margins. The plant will be an ideal large-scale complement to our manufacturing plant in Burlingame, CA, which will be ready for cGMP manufacturing activities shortly,” stated Denise Bevers, Co-Founder and COO of KindredBio. “We are also pleased to finalize the commercial supply agreement for Zimeta, which provides reliable and scalable drug supply from a well-regarded manufacturer.”
Separately, the Company also announced the completion of its ATM financing.
The Company will host a conference call at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time today.
Interested parties may access the call by dialing toll-free (855) 433-0927 from the US, or (484) 756-4262 internationally, and using conference ID 45257837.
The call will also be webcast live at http://edge.media-server.com/m/p/izdfc9hq.
A replay will also be available at that link for 30 days.
About Kindred Biosciences
Kindred Biosciences is a development-stage biopharmaceutical company focused on saving and improving the lives of pets. Its mission is to bring to pets the same kinds of safe and effective medicines that human family members enjoy. The Company’s strategy is to identify compounds and targets that have already demonstrated safety and efficacy in humans and to develop therapeutics based on these validated compounds and targets for dogs, cats and horses. The Company has a deep pipeline of novel drugs and biologics in development across many therapeutic classes.
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our expectations about the trials, regulatory approval, manufacturing, distribution and commercialization of our current and future product candidates, and statements regarding our anticipated revenues, expenses, margins, profits and use of cash.
These forward-looking statements are based on our current expectations. These statements are not promises or guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results to be materially different from any future results expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: our limited operating history and expectations of losses for the foreseeable future; the absence of significant revenue from our product candidates for the foreseeable future; our potential inability to obtain any necessary additional financing; our substantial dependence on the success of our lead product candidates, which may not be successfully commercialized even if they are approved for marketing; the effect of competition; our potential inability to obtain regulatory approval for our existing or future product candidates; our dependence on third parties to conduct some of our development activities; our dependence upon third-party manufacturers for supplies of our product candidates; uncertainties regarding the outcomes of trials regarding our product candidates; our potential failure to attract and retain senior management and key scientific personnel; uncertainty about our ability to develop a satisfactory sales organization; our significant costs of operating as a public company; our potential inability to obtain patent protection and other intellectual property protection for our product candidates; potential claims by third parties alleging our infringement of their patents and other intellectual property rights; our potential failure to comply with regulatory requirements, which are subject to change on an ongoing basis; the potential volatility of our stock price; and the significant control over our business by our principal stockholders and management.
For a further description of these risks and other risks that we face, please see the risk factors described in our filings with the U.S. Securities and Exchange Commission (the SEC), including the risk factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K and any subsequent updates that may be contained in our Quarterly Reports on Form 10-Q filed with the SEC. As a result of the risks described above and in our filings with the SEC, actual results may differ materially from those indicated by the forward-looking statements made in this press release. Forward-looking statements contained in this press release speak only as of the date of this press release and we undertake no obligation to update or revise these statements, except as may be required by law.
SOURCE Kindred Biosciences, Inc.
SAN DIEGO and VANCOUVER, British Columbia, June 23, 2017 /PRNewswire/ — Sophiris Bio Inc. (NASDAQ: SPHS) (the “Company” or “Sophiris”), a late stage clinical biopharmaceutical company developing topsalysin (PRX302) for the treatment of patients with urological diseases, today announced that it has been added to the Russell Microcap® Index, effective after the close of market on June 23, 2017.
The Russell Microcap® Index represents 2,000 small cap and micro-cap stocks that captures the smallest 1,000 companies in the Russell 2000®, in addition to 1,000 smaller U.S.- based listed stocks.
Russell indices are widely used by investment managers and institutional investors for index funds and as benchmarks for both passive and active investment strategies. Russell Investments determines membership for each index based on objective market capitalization rankings and style attributes.
Certain statements included in this press release may be considered forward-looking. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on Sophiris’ current beliefs as well as assumptions made by and information currently available to Sophiris and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Sophiris in its public securities filings; actual events may differ materially from current expectations. Sophiris disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Sophiris Bio Inc. is a late stage clinical biopharmaceutical company developing topsalysin (PRX302) for the treatment of patients with urological diseases. Topsalysin is in Phase 2 clinical development for the focal treatment of localized prostate cancer as well as Phase 3 clinical development for the treatment of lower urinary tract symptoms of benign prostatic hyperplasia (BPH). Topsalysin is a highly potent ablative agent that is selective and targeted in that it is only activated by enzymatically active PSA which is found in high concentrations in the transition zone of the prostate and in and around prostate tumor cells. More than 400 patients have received treatment with topsalysin, which continues to appear to be safe and well tolerated. For more information, please visit www.sophirisbio.com.
Chief Financial Officer
Corporate Communications Contact:
SOURCE Sophiris Bio Inc.
All eyes are on the nation’s capital this week, where the Senate released its version of the American Health Care Act (now called the Better Care Reconciliation Act) and the White House worked…
[[Click headline to continue reading.]]
Eli Lilly (NYSE: LLY) has completed a $90 million expansion of its biotechnology R&D center in San Diego, added new automated synthesis equipment, and plans to build out its next-generation…
[[Click headline to continue reading.]]
BELMONT, Calif., June 22, 2017 /PRNewswire/ — LakePharma, the leading biologics company specializing in antibody and protein engineering, cell line development, and protein production, announced today the appointment of Hajime Tada, J.D. to the General Counsel position.
“LakePharma is on a strong growth momentum. Our newly established Antibody Center under the leadership of Aaron Sato is a great example how we are building world-class technology and service capabilities, ” said Hua Tu, Ph.D., Founder and CEO. “We are excited to have Haj join LakePharma as General Counsel. He brings over twenty years of legal experience, most recently as Vice President and Deputy General Counsel of Agilent Technologies, Inc. Haj is a great addition to our commercial team and we look forward to his expert insights and legal guidance.”
“I am very excited to join Hua and his great team at LakePharma. I had the tremendous opportunity of supporting Agilent on its long road from HP spinoff to becoming an industry-leading life-sciences company. The same great future lies before LakePharma, but on a much quicker trajectory. I am looking forward to helping LakePharma on its exciting journey of growth and success,” said Haj Tada.
Haj Tada received his JD from New York University School of Law, and BA from Yale University. Prior to LakePharma, he spent 16 years with Agilent Technologies, Inc., most recently serving as lead counsel to Agilent’s Life Sciences Group. Before Agilent, he held various legal positions at the City Attorney’s Office in San Francisco, and McCutchen Doyle Brown & Enersen.
LakePharma is the leading biologics company specializing in antibody engineering, antibody discovery, molecular engineering, protein chemistry, bioexpression, biofunction, bioprocessing, and bioanalytics. LakePharma focuses on integrated platforms to support projects throughout the drug discovery process. LakePharma offers dedicated client services and sophisticated software to provide real-time access to project data via a secure cloud-based portal. For more information, please visit lakepharma.com.
VP, Commercial Operation
FDA Approves Genentech’s RITUXAN HYCELA, A Subcutaneous Rituximab Coformulated With Halozyme ENHANZE Technology
SAN DIEGO, June 22, 2017 /PRNewswire/ — Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved Genentech’s RITUXAN HYCELATM, a combination of rituximab and Halozyme’s hyaluronidase human ENHANZE® technology, for subcutaneous injection in multiple blood cancer indications.
“We are pleased that RITUXAN HYCELA will now provide another treatment option for U.S. patients,” said Dr. Helen Torley, president and chief executive officer. “RITUXAN HYCELA has the potential to reduce the treatment burden and administration time, and is an option preferred by many patients.”
RITUXAN HYCELA has been approved for patients with follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia, and is expected to be available within one to two weeks. Including all approved indications, Roche reported total 2016 sales of rituximab in the United States of approximately $3.9 billion. Across all of its global collaboration and licensing agreements, Halozyme earns on average a mid-single-digit royalty on sales of products using the ENHANZE technology.
Today’s approval was preceded by an FDA Oncologic Drug Advisory Committee in March that voted 11 to 0 in favor of the benefit/risk profile for rituximab/human hyaluronidase subcutaneous (under the skin) injection for patients in the proposed indications of follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia.
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 technology. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE, the possible method of action of ENHANZE, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, potential royalties to be received on sales using ENHANZE technology formulation, the number of collaborative targets actually chosen, whether such products are ultimately developed or commercialized, whether milestones triggering milestone payments will be achieved and statements concerning facilitating more rapid delivery of injectable medications through subcutaneous delivery that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words “believe,” “enable,” “may,” “will,” “could,” “intends,” “estimate,” “anticipate,” “plan,” “predict,” “probable,” “potential,” “possible,” “should,” “continue,” and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected expenditures and costs, unexpected results or delays in development, regulatory review and commercialization, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company’s most recently filed Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission.
SOURCE Halozyme Therapeutics, Inc.
“You have the opportunity to create a better world, a happier world,” said His Holiness the 14th Dalai Lama, who delivered the keynote address to 25,000 University of California San Diego graduates and their families June 17 at the university’s All Campus Commencement. His message to graduates centered on the power of compassion, the importance of emotional knowledge and the responsibility that younger generations have to make the world a better place.