On January 4, 2022 AbbVie (NYSE: ABBV) reported that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to investigational telisotuzumab vedotin (Teliso-V) for the treatment of patients with advanced/metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with high levels of c-Met overexpression whose disease has progressed on or after platinum-based therapy (Press release, AbbVie, JAN 4, 2022, View Source [SID1234598041]).

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The FDA’s BTD program is intended to expedite the development and review of medicines with preliminary clinical evidence that indicate that the investigational treatment may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.1

Despite advances in treatment, lung cancer remains the leading cause of cancer-related deaths in both men and women in the U.S. and throughout the world. It is the most common cancer in males and the third most common cancer in females worldwide, with incidence rates (per 100,000) of 31.5 and 14.6, respectively.2 Approximately 85% of lung cancers are classified as NSCLC.3 Patients whose disease progresses after standard of care therapies, including prior platinum, have limited treatment options and poor prognosis.

"Patients with non-small cell lung cancer have a high unmet need and Teliso-V has the potential to provide them with an additional treatment option to manage their disease," said Mohamed Zaki, M.D., Ph.D., Vice President and Global Head of Oncology Clinical Development at AbbVie. "Today’s announcement marks an important step in our mission to advance new oncology treatments across tumor types to improve standards of care for patients with cancer."

This BTD designation is supported by data from LUMINOSITY (Study M14-239), an ongoing Phase 2 study designed to identify the target NSCLC populations that overexpress c-Met best suited for Teliso-V monotherapy in the second line or third line setting, and then to expand the groups to further evaluate efficacy in the selected populations. The primary endpoint is overall response rate (ORR) per central review in patients with ≥ 12 weeks follow-up. Among patients with EGFR WT nonsquamous NSCLC, ORR was 53.8% in the c-Met high group and 25.0% in the c-Met intermediate group at a previously reported interim analysis. Teliso-V is also being evaluated in combination with osimertinib in the ongoing Phase 1 study M14-237 in patients with previously treated c-Met overexpressing NSCLC. In addition, it will be further evaluated as monotherapy in patients with previously treated c-Met overexpressing NSCLC in the randomized Phase 3 study TeliMET NSCLC-01 (Study M18-868).

AbbVie will present Teliso-V data at upcoming scientific congresses. Additional information on clinical trials for Teliso-V is available at www.clinicaltrials.gov.

Teliso-V is an investigational antibody-drug conjugate (ADC) targeting c-Met, a receptor tyrosine kinase that is overexpressed in tumors including NSCLC. Teliso-V is not approved by any regulatory authority and its safety and efficacy have not been established. Currently there are no approved cancer therapies specifically for patients with c-Met overexpressing NSCLC.

On January 4, 2022 Abbott (NYSE: ABT) reported that it will announce its fourth-quarter 2021 financial results on Wednesday, Jan. 26, 2022, before the market opens (Press release, Abbott, JAN 4, 2022, View Source [SID1234598040]).

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The announcement will be followed by a live webcast of the earnings conference call at 8 a.m. Central time (9 a.m. Eastern), and will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the call will be available later that day.

On January 4, 2022 Exelixis, Inc. (Nasdaq: EXEL) reported the appointment of Vicki L. Goodman, M.D., as Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer (Press release, Exelixis, JAN 4, 2022, View Source [SID1234598030]). Dr. Goodman has more than 20 years of oncology experience as a drug development leader at global biopharmaceutical organizations, regulator and clinician. She joins Exelixis from Merck, where she served as Vice President, Clinical Research and Therapeutic Area Head, Late Stage Oncology; her previous tenures in the biopharmaceutical industry include clinical development leadership positions at Bristol Myers Squibb and GlaxoSmithKline. Dr. Goodman joins Exelixis as the company continues to maximize the clinical potential of CABOMETYX (cabozantinib), its global oncology franchise, while rapidly advancing its pipeline of promising investigational small molecules and biologics to treat cancer.

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"With her track record of targeted therapy and immunotherapy drug development success at the global biopharma level, as well as her experience as an FDA reviewer and hematologist-oncologist, Dr. Vicki Goodman is ideally positioned to be Exelixis’ next Chief Medical Officer," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. "We are thrilled to welcome Dr. Goodman to Exelixis as we execute on the ongoing CABOMETYX phase 3 pivotal trials, expedite late-stage clinical development of XL092, our next-generation oral tyrosine kinase inhibitor, and advance an exciting clinical pipeline of small molecules and biologics, including XB002, our first antibody-drug conjugate."

As Exelixis’ CMO, Dr. Goodman will lead Exelixis’ clinical development and medical affairs functions, leveraging experience gained throughout her varied career. While at Merck (2020-2021), she was responsible for overseeing key elements of the company’s late-stage development portfolio, including KEYTRUDA (pembrolizumab) and other late-stage assets, in thoracic malignancies, head and neck cancers, breast and gynecologic cancers, and hematology. Prior to joining Merck, Dr. Goodman served at Bristol Myers Squibb for five years, during which time she was a member of the company’s Oncology Senior Leadership Team. Initially, as Vice President Development Lead (2015-2017), she managed the cross-functional team developing OPDIVO (nivolumab)/YERVOY (ipilimumab) for melanoma and genitourinary tumors, which included collaborating with Exelixis on the design of the CheckMate -9ER trial. In 2017, she was promoted to Vice President and Head, New Asset Development Teams, a role that included oversight of teams advancing a variety of assets between proof of concept and approval. Previously, from 2007 to 2015, Dr. Goodman served in roles of increasing responsibility at GlaxoSmithKline (GSK), including as Project Physician Leader for dabrafenib from phase 1 expansion through regulatory approval, as well as Lead Physician in GSK’s cancer epigenetics unit, where she was responsible for development strategy and clinical oversight for several assets initially entering clinical development.

"With a global oncology franchise in CABOMETYX, a growing clinical pipeline of novel small molecules and biotherapeutics – including the company’s first antibody-drug conjugate – and ambitious plans to pursue new mechanisms, therapeutic modalities, and disease settings, Exelixis is at an inflection point," said Dr. Goodman. "I’m excited to draw on my extensive drug development and regulatory affairs experience, as well as my clinical training, to lead Exelixis’ talented Product Development and Medical Affairs teams toward even more progress on the company’s mission to help cancer patients recover stronger and live longer. I am also deeply honored to succeed Dr. Gisela M. Schwab, a trailblazing clinical development professional and biopharma executive, in the role of Chief Medical Officer."

Dr. Goodman will be based in the Greater Philadelphia area. As part of her role overseeing the company’s product development operations, she will play a leadership role in building a new Exelixis team that will expand the company’s development activities on the East Coast. Exelixis’ East Coast presence will complement the company’s strong and growing West Coast development team and enable the company to move even faster on behalf of patients, including by laying additional groundwork for potential future growth outside the United States. Founded in Cambridge, Massachusetts, in 1994, Exelixis has called California home since 1997, and it will continue to maintain and expand its global headquarters and oncology drug development activities in Alameda. Exelixis will share more information on its East Coast plans as they evolve over the course of this year.

Prior to entering the biopharmaceutical industry, from 2004 to 2007 Dr. Goodman was a Medical Officer in the then-Division of Drug Oncology Products, part of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration. Before that, from 2001 to 2004 she completed a clinical fellowship in hematology and medical oncology at the University of Michigan, Ann Arbor, where she also undertook her internship and residency. Dr. Goodman obtained her M.D. from Albert Einstein College of Medicine, and her B.A. in Biochemistry with Honors from Rutgers University.

On January 4, 2022 Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, reported that Laurence Reid, Ph.D., Chief Executive Officer of Decibel, will participate in a fireside chat at the H.C. Wainwright BioConnect Conference (Press release, Decibel Therapeutics, JAN 4, 2022, https://ir.decibeltx.com/news-releases/news-release-details/decibel-therapeutics-present-hc-wainwright-bioconnect-conference [SID1234598029]). The fireside chat will be available for on-demand viewing starting Monday, January 10, 2022 at 7:00 am ET.

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A webcast of the fireside chat may be accessed by visiting the Investors section of the Decibel Therapeutics website at View Source An archived replay of the webcast will be available on the Company’s website for approximately 90 days following the fireside chat.

On January 4, 2022 Ascendis Pharma A/S (Nasdaq: ASND) reported that the Company is scheduled to participate in the upcoming 40th Annual J.P. Morgan Healthcare Conference (Press release, Ascendis Pharma, JAN 4, 2022, View Source [SID1234598028]). Company executives will provide a business overview and update on the company’s pipeline programs.

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Details

Event 40th Annual J.P. Morgan Healthcare Conference
Location Virtual
Date Monday, January 10, 2022
Time 3:00 p.m.-3:40 p.m. Eastern Time
A live webcast of the event will be available on the Investors & News section of the Ascendis Pharma website at View Source A webcast replay will be available on the site shortly after conclusion of the event and will stay available for 30 days.