Blog

SUZHOU, China, Dec. 16, 2018 /PRNewswire/ — Innovent Biologics, Inc. (Innovent) (HKEX: 01801) and Incyte (NASDAQ: INCY) today announced that the companies, through their respective subsidiaries, have entered into a strategic collaboration agreement for three clinical-stage product candidates discovered and developed by Incyte—pemigatinib (FGFR1/2/3 inhibitor), itacitinib (JAK1 inhibitor) and parsaclisib (PI3Kδ inhibitor). Under the terms of the agreement, Innovent will pay Incyte US$40 million in cash up front, and Incyte shall be eligible to receive an additional US$20 million in consideration in connection with the first investigational new drug (IND) application by Innovent in China, which is expected to be achieved in 2019. Innovent will receive the rights to develop and commercialize the three assets in hematology and oncology in Mainland China, Hong Kong, Macau and Taiwan.

“The collaboration and partnership with Innovent provides us with an important and strategic opportunity to further serve the oncology community around the world by potentially bringing new, innovative medicines to patients with high unmet medical needs in China,” said Hervé Hoppenot, Chief Executive Officer of Incyte. “We believe Innovent’s experienced leadership team and sizeable clinical network will expand our clinical trials for itacitinib, pemigatinib and parsaclisib, and, if any of these product candidates are approved, will provide access to our innovative therapies to patients and healthcare providers in China.”

Read more

Boston, USA, London, UK, and Martinsried, Germany, December 14, 2018 / B3C newswire / — Orchard Therapeutics (NASDAQ: ORTX), a leading commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare diseases through innovative gene therapies, and SIRION Biotech GmbH today announced the entry into a license agreement, pursuant to which Orchard has licensed SIRION’s LentiBOOST™ technology to enhance manufacturing efficiency for certain of Orchard’s ex vivo autologous hematopoietic stem cell gene therapy drug candidates.

“At Orchard Therapeutics, we are establishing manufacturing capabilities to deliver potentially transformative gene therapy products to rare disease patients around the globe. Optimization of lentiviral transduction through a technology such as LentiBOOST™, along with the build-out of our recently announced manufacturing facility, are representative of our continued efforts to increase efficiencies and further streamline our approach to manufacturing gene therapy candidates,” said Stewart Craig, Ph.D., chief manufacturing officer of Orchard. “Current studies using LentiBOOST™ in our laboratories have resulted in encouraging data, and we look forward to examining the impact on our portfolio of gene therapy product candidates.”

Under the terms of the agreement, SIRION will provide Orchard with a license to its proprietary lentiviral transduction enhancer LentiBOOST™ for development and commercialization activities for select Orchard programs. SIRION will be entitled to upfront and milestone payments and is eligible to receive royalties on net sales of future products that utilize the LentiBOOST™ technology.

“LentiBOOST™ was designed to enhance lentiviral transduction performance for difficult cell types like primary T-cells and hematopoietic stem cells,” said Dr. Christian Thirion, founder and chief executive officer of SIRION. “We make our technology available to a wide range of companies and academic agencies – from explorative research hospitals to commercial gene therapy companies. We are delighted that the LentiBOOST™ technology may help Orchard further enhance the efficiency of its lentiviral-based manufacturing processes.”

Read more

New facility expected to create more than 100 new jobs, supporting extensive gene therapy pipeline

Enhances Orchard’s capacity to develop and deliver lentiviral vector and gene-corrected hematopoetic stem cells for wide range of diseases on a global scale

BOSTON and LONDON, Dec. 13, 2018 (GLOBE NEWSWIRE) — Orchard Therapeutics (NASDAQ:ORTX), a leading commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare diseases through innovative gene therapies, today announced that it has signed a long-term lease agreement to build-out a gene therapy manufacturing facility in Fremont, California. The new 150,000-square-foot facility significantly increases Orchard’s California footprint and adds to the Foster City and Menlo Park, California sites, which oversee the ongoing development and validation of the manufacture of Orchard’s ex vivo gene therapy product candidates.

Once operational, the new site will provide significant additional CGMP manufacturing capacity for both lentiviral vector and cryopreserved cell therapy products, enhancing Orchard’s ability to manufacture and deliver gene-corrected hematopoetic stem cells for a wide range of diseases on a global basis. In addition to this expanded capacity, Orchard also plans to continue its close collaborations with the Company’s contract manufacturing partners.

“The expansion of our California operations to now include a manufacturing facility is a critical step in advancing Orchard’s capabilities to supply products for our ex vivo gene therapy programs,” said Stewart Craig, Ph.D., chief manufacturing officer of Orchard. “We believe that this new facility, as an early investment in our own manufacturing, will not only drive efficiencies and scalability in terms of lentiviral vector and drug product development, it will also complement the capabilities of our existing vector and drug product manufacturing partners to support the potential launch of our gene therapy clinical product candidates.”

Read more

BERKELEY, Calif.–(BUSINESS WIRE)–Caribou Biosciences, Inc., a leading genome editing company, announced today that it has appointed Natalie Sacks, MD to its Board of Directors. Dr. Sacks is an accomplished industry leader and oncology expert who has played a key role in the development and approval of several oncology therapeutics.

“We are excited to welcome Dr. Sacks to our Board of Directors,” said Rachel Haurwitz, PhD, President and Chief Executive Officer of Caribou. “Her strong record of achievements at both large and small companies is a valuable addition to our Board’s expertise. We look forward to capitalizing on her experience and insights as we continue our advancement of multiple therapeutic categories.”

Dr. Sacks is currently the Chief Medical Officer at Harpoon Therapeutics, focused on the development of novel T cell therapeutics. Dr. Sacks previously served as Chief Medical Officer at Aduro Biotech, a company focused on the advancement of novel immuno-oncology technologies. She also served as Vice President of Clinical Development at Onyx Pharmaceuticals (acquired by Amgen) where she played a key role in business development efforts along with the development and approval of Kyprolis.® She also previously served as Vice President of Clinical Research for Exelixis where she directed the development of a portfolio of small molecules, including the late-stage development of Cometriq.® Earlier in her career, Dr. Sacks served as Vice President of Clinical Development at Cell Genesys, a company focused on the development of cancer vaccines and engineered chimeric antigen receptor (CAR) T cells. Dr. Sacks was an Assistant Clinical Professor at the University of California, San Francisco, and served as volunteer Attending Physician in Hematology-Oncology at San Francisco General Hospital for more than a decade.

Read more

Expanded Leadership Team and Funding Supports Advancement of Clinical Development of Checkmate’s TLR9 Agonist, CMP-001

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Checkmate Pharmaceuticals Inc., a clinical stage biopharmaceutical company focused upon activation of innate immunity to treat advanced cancer, has appointed Barry Labinger as President and CEO. Arthur M. Krieg, MD, Checkmate’s founder and current President and CEO, will assume the newly-created role of Chief Scientific Officer. Both Mr. Labinger and Dr. Krieg will serve on Checkmate’s Board of Directors.

Checkmate also announced the completion of a $22 million financing led by a new investor, Decheng Capital. The financing also included participation from existing investors, Sofinnova, venBio, and F-Prime.

“Checkmate’s encouraging early clinical data provide a strong foundation for its further growth as a leading cancer immunotherapy company with broad potential. Barry’s deep experience in oncology drug development and commercialization, along with this additional funding, will support Checkmate’s further progress,” commented Mike Powell, Chairman of the Board of Checkmate, and General Partner, Sofinnova Ventures. “Art has successfully led the company to this critical stage in its growth, including this planned leadership transition. We are delighted to have Barry as CEO and Art as CSO. We are confident that they will successfully guide Checkmate to its next stage of evolution,” continued Dr. Powell.

Mr. Barry Labinger brings to Checkmate nearly three decades of pharmaceutical and biotech industry experience, most recently serving as President, CEO, and Director of Biothera Pharmaceuticals, a clinical stage cancer immunotherapy company focused on innate immune activation. Prior to Biothera, he was Executive Vice President and President, Biosciences Division, at Emergent BioSolutions Inc., where he led the development and commercialization of oncology, immunology, and hematology products and product candidates. He previously held leadership roles at Human Genome Sciences, 3M Pharmaceuticals, and Immunex.

Read more

SUZHOU, China, /PRNewswire/ —Innovent Biologics Inc. (Innovent) (HKEX: 01801), a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs, announced today that IBI305, a recombinant humanized anti-VEGF monoclonal antibody being developed as a potential biosimilar to Avastin (Bevacizumab), has met pre-defined primary endpoints in two randomized, head to head, clinical trials comparing IBI305 versus branded bevacizumab: a phase III clinical trial (CIBI305A301) in patients with advanced non-squamous non-small cell lung cancer (NSCLC) and a pharmacokinetic study (CIBI305A201) in healthy subjects. The details of these studies will be disclosed in future publications in scientific journals and conferences.

CIBI305A301 is a multi-center, randomized, double-blinded, parallel, positive-controlled phase III clinical trial that enrolled 450 patients to evaluate the efficacy and safety of IBI305 and bevacizumab in the first-line treatment of patients with advanced non-squamous NSCLC. The objective of the study is to compare the clinical activity and safety between IBI305 and bevacizumab when they are in combination with paclitaxel/carboplatin. The primary endpoint is objective response rate (ORR).

CIBI305A201 is a randomized, double-blinded, parallel, positive-controlled single-dose clinical trial to compare the pharmacokinetic profile, safety, tolerability, and immunogenicity between IBI305 and bevacizumab in 100 healthy subjects. The primary objective of the study is to compare the pharmacokinetic (PK) profile of these two agents.

Read more

REDWOOD CITY, Calif., Dec. 10, 2018 (GLOBE NEWSWIRE) — Menlo Therapeutics Inc. (NASDAQ: MNLO), a late-stage biopharmaceutical company focused on the development of serlopitant for the treatment of pruritus (itch), today announced positive top-line results from MTI-109 (PSORIXA), a 204-patient Phase 2 clinical trial of serlopitant for the treatment of pruritus associated with psoriasis.  The trial successfully met its primary endpoint, showing a statistically significant reduction in pruritus based upon a 4-point improvement responder analysis.  In the trial, 33% of patients treated with serlopitant 5 mg daily achieved a 4-point or greater improvement on the worst-itch numeric rating scale, or WI-NRS, at week 8 compared to baseline (primary efficacy endpoint) vs. 21% of patients treated with placebo (p= 0.028).

The trial also prospectively defined three key secondary endpoints for sequential step-down analyses at week 4 and days 7 and 3. The trial successfully met the secondary endpoint of WI-NRS responder rate at week 4.  At week 4, 21% of patients treated with serlopitant achieved a 4-point or greater improvement on the WI-NRS vs. 11% of patients treated with placebo (p=0.039).  Assessment of the secondary endpoints of the absolute change in WI-NRS from baseline to day 7 and day 3 for serlopitant compared to placebo showed a greater numerical, but not statistically significant, improvement for the serlopitant group.  At every assessed time point in the trial (daily in week 1 and average weekly scores through week 8), the serlopitant treated group demonstrated greater numerical improvement than the placebo group in both the WI-NRS 4-point responder analysis and in the mean change in WI-NRS from baseline.

Serlopitant was well-tolerated in this clinical trial.  No serious adverse events were reported for serlopitant treated patients.  Treatment-emergent adverse events assessed as likely related to treatment were observed with similar frequency in both groups (4.0% for placebo and 4.9% for serlopitant).  The consolidated safety summary for serlopitant now includes more than 1,600 evaluable patients, including patients who have received treatment for up to one year.

Read more