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

On November 23, 2020 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported the filing of an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) for ON 123300, the Company’s proprietary, differentiated, first-in-class multi-kinase inhibitor (Press release, Onconova, NOV 23, 2020, View Source [SID1234571568]). The IND seeks permission to begin a Phase 1 trial with ON 123300 in relapsed/refractory advanced cancer including patients with HR+ HER 2- metastatic breast cancer with resistance to approved second-generation CDK4/6 inhibitors.

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"We believe that ON 123300, based on its novel mechanism of action, presents an innovative approach to study advanced cancers including in HR+ HER 2- metastatic breast cancer that is or has become resistant to commercial CDK4/6 inhibitors. We are delighted to have filed our IND on schedule, and look forward to enrolling patients in the U.S. to complement the ongoing Phase 1 dose-escalation study underway in China by our partner HanX Biopharmaceuticals," said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. "The HanX Phase 1 ON 123300 study, which began in September 2020, has enrolled three patients to date and is expected to continue to enroll patients with advanced relapsed/refractory cancer at two sites until the recommended Phase 2 dose is identified. We believe that data from these two studies will generate important information to inform anticipated later-stage studies."

As currently envisioned, the Phase 1 trial in the U.S. will assess the safety, tolerability, and pharmacokinetics of ON 123300 administered orally as monotherapy at increasing doses starting at 40 mg daily or higher for consecutive 28-day cycles. The Phase 1 trial is planned for patients with relapsed/refractory advanced cancer, including but not limited to patients with HR+ HER 2- metastatic breast cancer with clinical resistance to the approved second-generation CDK4/6 inhibitors. Once the recommended Phase 2 dose is established, the Company’s plan is to enroll additional HR+ HER 2- postmenopausal metastatic breast cancer patients refractory to approved second-generation CDK4/6 inhibitors, as well as patients diagnosed with advanced non-Hodgkin’s lymphoma with a special interest in mantle cell lymphoma.

This trial design in the U.S. differs from the study in China because HanX is dosing patients daily for 21 days. Notably, of the three currently approved CDK4/6 inhibitors, two are approved for dosing in 21-day cycles and one is approved for dosing in a 28-day cycle. All three are blockbuster drugs marketed by well-known pharmaceutical companies, and all of these approved therapies require concomitant treatment with an aromatase inhibitor.

"Beyond metastatic breast cancer, we believe that ON 123300 may present an innovative approach to treating other cancers including mantle cell lymphoma, multiple myeloma, advanced colorectal cancer, advanced hepatocellular carcinoma, and inoperable glioblastoma based on preclinical studies suggesting ON 123300 crosses the blood-brain barrier," added Richard Woodman, M.D, Chief Medical Officer.

Commenting on the expected timetable and next steps with this program, Dr. Fruchtman added: "Once the FDA approves our IND, we will seek Institutional Review Board approval at the site where this Phase 1 trial will be conducted. We anticipate the first patient to be enrolled during the first half of 2021. With the ON 123300 program advancing, investigator-sponsored trials underway with our pipeline product rigosertib, and an active business development campaign to evaluate additional compounds, we look forward to an expanding portfolio of novel therapeutics for large, underserved oncology indications."

About ON 123300

Onconova’s lead pipeline product is the novel small molecule ON 123300, a proprietary, first-in-class multi-kinase inhibitor targeting tumor-driving kinases including CDK4/6 and ARK5. ON 123300 is reported to simultaneously inhibit both cell cycle and cellular energy metabolism through CDK4/6 and ARK5, respectively, and in vitro has been shown to be cytotoxic to cancer cells (killing the cancer cells) rather than just cytostatic (inhibiting the growth of cancer cells), which is how the currently commercial CDK inhibitors are reported to work. With its differentiated mechanism of action, ON 123300 may present an innovative approach for treating solid tumors and hematologic malignancies that are refractory to or have become resistant to other CDK4/6 inhibitors.

Based on experiments in preclinical models, ON 123300 exhibits single-agent cytotoxicity, may have utility for certain types of cancers including breast cancer and non-Hodgkin’s lymphoma, and may also have utility for mantle cell lymphoma, multiple myeloma, advanced colorectal cancer, advanced hepatocellular carcinoma, and inoperable glioblastoma.