On November 23, 2020 Teneobio, Inc., a clinical stage next generation, multi-specific antibody therapeutics company, reported that in 2020, Poseida exercised four options to commercial licenses for Teneobio human heavy chain only domain antibodies, UniDabs, to develop novel CAR T therapies (Press release, TeneoBio, NOV 23, 2020, View Source;utm_medium=rss&utm_campaign=poseida-commercial-license-options-for-unidabs-target-cart-cell-terapies [SID1234571576]). Poseida will apply licensed UniDab binders, which possess significant advantages over traditional single chain variable antibody fragment (scFv) binders, to develop its next generation CAR-T therapies. Targets were not disclosed.

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This announcement follows the expansion of a commercial license agreement between the companies that was announced in August of 2018. Under the terms of that agreement, Teneobio would generate multiple UniDab product candidates using its proprietary UniRat transgenic human antibody ‘heavy-chain only’ rodent platform and its state-of-the-art sequence-based discovery engine, TeneoSeek. Poseida would have exclusive global licensing rights for the clinical development and commercialization of specific UniDabs for CAR cell therapies.

Teneobio Inc. receives commercial licensing fees for these milestones and is eligible to receive future research, development and regulatory milestone payments per UniDab candidate, with total potential earnings of over $250 million for CAR-T therapies developed by Poseida. Teneobio would also receive royalties on worldwide net sales of each CAR-T therapy.

"We are excited that Poseida has exercised multiple commercial license options on UniDabs to create the next generation of cell therapies," said Omid Vafa, CBO of Teneobio. "UniDabs have been preclinically and clinically validated as excellent human single domain antibody targeting moieties of CAR T-cells. They have demonstrated both in vivo specificity and robust efficacy. Their advantageous smaller in size, and superior developability relative to standard scFv’s make them ideal for CAR T-cell products."

Eric Ostertag, CEO of Poseida, added, "We have evaluated a large number of binding technologies for use in our CAR-T platforms and view single domain antibodies as one of the most superior. In our view, the fact that Teneobio’s VH binders are fully human makes them a better option than camelid VHH single domain antibodies."

On November 23, 2020 Boston Scientific Corporation (NYSE: BSX) reported to participate in the 2020 Evercore ISI HealthCONx Conference on December 1 (Press release, Boston Scientific, NOV 23, 2020, View Source [SID1234571575]).

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Mike Mahoney, chairman and chief executive officer, and Susie Lisa, vice president, Investor Relations will participate in a 45-minute question-and-answer session with the host analyst beginning at approximately 8:00 a.m. EST.

A live webcast and replay of the webcast will be accessible at investors.bostonscientific.comView Source The replay will be available beginning approximately one hour following the completion of each event.

On November 23, 2020 Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, reported that it had entered into a commercial supply agreement with Blueprint Medicines following FDA approval of GAVRETO (pralsetinib) (Press release, Catalent, NOV 23, 2020, https://www.catalent.com/catalent-news/catalent-signs-commercial-supply-agreement-with-blueprint-medicines-following-fda-approval-of-gavreto-pralsetinib/ [SID1234571574]). Developed by Blueprint Medicines, GAVRETO is a new therapy indicated for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.

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This agreement will continue Catalent’s involvement in the GAVRETO program, which has been supported by Catalent’s Nottingham, U.K., site since 2015.

GAVRETO is a once-daily oral RET-targeted therapy that is designed to selectively and potently inhibit RET alterations that drive many cancer types, including approximately one to two percent of patients with metastatic NSCLC. Currently, RET is one of seven NSCLC biomarkers that can be targeted with an FDA-approved therapy.

"We have a long-standing relationship with Blueprint Medicines, and this approval marks an amazing accomplishment, reflecting the hard work, dedication and determination of the entire team," commented Jonathan Arnold, President of Oral and Specialty Delivery at Catalent. "The expertise that our scientists in Nottingham brought to the development program supported Blueprint Medicines’ efforts to rapidly gain regulatory approval, and through expedient tech transfer within our company’s global network, our team in Kansas City can effectively support commercial supply."

In February 2020, Catalent announced a commercial supply agreement for Blueprint Medicines’ AYVAKIT (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations.

Catalent’s Kansas City, Missouri site is home to the company’s Oral & Specialty Drug Delivery business, where it provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The 421,665-square-foot facility is the commercial manufacturing Center-of-Excellence for accelerated development programs and roller compaction. It also houses large-molecule analytical services and provides clinical supply services.

Blueprint Medicines, AYVAKIT and GAVRETO are trademarks of Blueprint Medicines Corporation.

On November 23, 2020 Vividion Therapeutics, a biotechnology company discovering and developing selective small molecule medicines that drug traditionally inaccessible targets, reported that Jeffrey Hatfield has been appointed as the company’s chief executive officer (Press release, Vividion Therapeutics, NOV 23, 2020, View Source [SID1234571572]). Mr. Hatfield brings more than 35 years of successful industry leadership to Vividion, having held multiple senior executive, CEO and board director roles during his career at both Fortune 500 pharmaceutical and emerging biotechnology companies.

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"Jeff is a highly accomplished industry leader who can help us deliver the full potential of Vividion’s differentiated discovery platform," said Richard Heyman, Ph.D., chairman of the Vividion board of directors. "Jeff brings decades of relevant experience, including building platform-based companies, advancing first-in-class programs, executing financing strategies to drive near and long-term value growth, negotiating innovative business development partnerships and strategic transactions, and cultivating collaborative, high-performance cultures. The board is confident in Jeff’s ability to drive significant future growth, and we are thrilled to welcome him to the team."

"Vividion is built on unprecedented insights into emerging and synergistic technologies, which together, create a powerful drug discovery platform with the potential to tremendously expand horizons for small molecule discovery – beyond what we consider possible today," said Mr. Hatfield. "The company stands well positioned for success, with several rapidly advancing firstin-class programs in oncology and immunology, major pharmaceutical collaborations with BMS and Roche, a multi-year cash runway, and the significant backing of top-tier life science investors. I am excited to join this highly talented team as we work together to bring forward important new medicines that have the opportunity to extend and enhance the lives of millions of patients around the world."

Among Mr. Hatfield’s many career leadership roles, he previously served as the CEO of Vitae Pharmaceuticals, Inc., a pioneer in computational structure-based drug discovery, where he led the company from start-up to clinical-stage advancement of multiple first-in-class programs, and ultimately to its $640 million acquisition by Allergan Plc. Earlier, he served as a senior executive at Bristol-Myers Squibb (BMS), where he held roles including senior vice president, Immunology and Virology Divisions; president, BMS-Canada; and head of U.S. market access. Mr. Hatfield currently serves as chairman of the board of miRagen Therapeutics, Inc. and as a board member at aTyr Pharma. He also serves as a Key Advisory Board member for the Harvard Business School’s Blavatnik Fellowship in Life Science Entrepreneurship, and is a faculty member at Purdue University, where he teaches entrepreneurship to doctoral students. Mr. Hatfield holds an MBA from The Wharton School, University of Pennsylvania, and a B.S. from the Purdue University College of Pharmacy.

On November 23, 2020 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported clinical and regulatory progress by multiple partners utilizing antibodies from its OmniAb discovery platform (Press release, Ligand, NOV 23, 2020, View Source [SID1234571570]). Two large multinational pharmaceutical companies with a license to OmniAb have reached clinical-development milestones with their programs. The progress by these companies resulted in a total of $4.5 million in milestone payments being earned by Ligand.

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In addition, CStone Pharmaceuticals recently announced that China’s National Medical Products Administration has accepted for review CStone’s New Drug Application (NDA) for sugemalimab (CS1001), an OmniAb-derived anti-PD-L1 monoclonal antibody used in combination with chemotherapy for the first-line treatment of advanced squamous and non-squamous non-small cell lung cancer (NSCLC). This marks the first regulatory submission by CStone for sugemalimab. Last month, CStone announced a major financial and commercial partnership with Pfizer to commercialize sugemalimab in greater China. Ligand is entitled to a 3% royalty on worldwide commercial sales of sugemalimab.

CStone also announced that positive clinical data based on a pre-planned interim analysis of the GEMSTONE-302 clinical study were disclosed in an oral presentation at European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia Virtual Congress 2020 on November 21, 2020 (link to full release here). The GEMSTONE-302 trial is the first randomized, double-blind, Phase 3 study of an anti-PD-L1 monoclonal antibody plus platinum-based chemotherapy as first-line treatment for stage IV squamous or non-squamous NSCLC. The results showed sugemalimab plus chemotherapy as first-line treatment for advanced NSCLC demonstrated statistically significant and clinically meaningful benefit in progression free survival (PFS) compared to chemotherapy across PD-L1 expression levels and histologies. Specifically, sugemalimab in combination with chemotherapy reduced the risk of disease progression or death by 50% and produced an objective response rate (ORR) of 61.4%. The combination therapy was well-tolerated with no new safety signals detected. CStone reported that these Phase 3 data are amongst the best of those reported by other anti-PD-L1 monoclonal antibodies.

"We are very pleased with the progress and impressive data our partners are reporting with their Ligand OmniAb-derived antibodies," said John Higgins, Chief Executive Officer of Ligand. "There are currently more OmniAb programs than ever under development, and as programs advance Ligand is now collecting more and larger milestone payments that are contributing to our strong financial performance. Next year we anticipate the first two OmniAb-derived antibodies could receive regulatory approvals, and these events could start the first OmniAb royalty revenue to Ligand. With partnership and royalty rights on programs that extend to 2040 and beyond, we believe we are in the early days of a substantial growth trajectory from our OmniAb business."

About OmniAb

OmniAb is a three-species transgenic-animal platform consisting of five different technologies used for producing mono- and bispecific human therapeutic antibodies. OmniRat animals comprise the industry’s first human monoclonal antibody technology based on rats. Because they have a complete immune system with a diverse antibody repertoire, OmniRat animals generate antibodies with human idiotypes as effectively as wild-type animals make rat antibodies. OmniMouse is a transgenic mouse that complements OmniRat and expands epitope coverage. OmniFlic is an engineered rat with a fixed light chain for development of bispecific, fully human antibodies. OmniChicken animals comprise the industry’s first human monoclonal antibody technology based on chickens. The OmniClic chicken is specifically developed to facilitate the generation of bispecific antibodies and retains the ability to generate diverse, high quality affinity matured antibodies. All five types of OmniAb therapeutic human antibody platform, OmniRat, OmniFlic, OmniMouse, OmniChicken and OmniClic, use patented technology, have broad freedom to operate, produce highly diversified, fully human antibody repertoires optimized in vivo for immunogenicity, manufacturability, and therapeutic efficacy, and deliver fully