On January 4, 2023 Bicycle Therapeutics plc (NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Bicycle’s BT8009 monotherapy for the treatment of adult patients with previously treated locally advanced or metastatic urothelial cancer (Press release, Bicycle Therapeutics, JAN 4, 2023, View Source [SID1234625788]). BT8009 is a potential first in class Bicycle Toxin Conjugate (BTC) targeting Nectin-4, a protein that is highly expressed in urothelial cancer (UC) and other solid tumors.

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"FTD represents another positive step in the development of BT8009 and reflects the pressing need for a clinically meaningful, differentiated therapy compared to what is available for patients," said Kevin Lee, Ph.D., Chief Executive Officer. "We believe this designation is a valuable component of our future clinical and regulatory strategy as we work to align with the FDA to address the pressing unmet needs of people living with urothelial cancer."

FTD is intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition. This unmet medical need is defined as providing a therapy where either none exists or providing a therapy which may prove superior to existing therapy. A clinical program that receives FTD may benefit from more frequent meetings and communications with the FDA to discuss development plans and ensure the collection of appropriate data needed to support approval. Clinical programs conducted under FTD may be eligible for Accelerated Approval and Priority Review if relevant criteria are met. More information on the Fast Track process is available here.

On January 4, 2023 Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics designed to modulate the tumor microenvironment to elicit a potent and durable anti-tumor response, reported that Claire Mazumdar, Ph.D., MBA, Chief Executive Officer of Bicara Therapeutics, will present a corporate overview at the 41st Annual J.P. Morgan Healthcare Conference being held in San Francisco, CA, on Wednesday, January 11, 2023 at 9:30 am PST (Press release, Bicara Therapeutics, JAN 4, 2023, View Source;utm_medium=rss&utm_campaign=bicara-therapeutics-to-present-at-41st-annual-j-p-morgan-healthcare-conference [SID1234625787]).

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On January 4, 2023 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company reported that the Company will participate in the J.P. Morgan 41st Annual Healthcare Conference on Monday, January 9, 2023 at 1:30 p.m. PT (Press release, BeiGene, JAN 4, 2023, View Source [SID1234625786]).

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A live webcast can be accessed from the investors section of BeiGene’s website at View Source An archived replay will be available for 90 days following the event.

On January 4, 2023 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that John Houston, Ph.D., President and Chief Executive Officer of Arvinas, will present a company overview at the 41st Annual J.P. Morgan Healthcare Conference on Wednesday, January 11, 2023 at 1:30 p.m. PT in San Francisco, Calif (Press release, Arvinas, JAN 4, 2023, View Source [SID1234625785]).

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A live audio webcast of the presentation will be available here and on the Events & Presentations section of the Investors & Media section of the Company’s website.

On January 4, 2023 Aravive, Inc. (Nasdaq: ARAV, the "Company"), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported that the achievement of full enrollment in the registrational Phase 3 trial of batiraxcept plus paclitaxel for platinum-resistant ovarian cancer (PROC)(Press release, Aravive, JAN 4, 2023, View Source [SID1234625784]). The global, randomized, double-blind, placebo-controlled Phase 3 AXLerate-OC trial is evaluating efficacy and tolerability of 15 mg/kg batiraxcept in combination with weekly paclitaxel versus placebo in combination with weekly paclitaxel. The trial was planned to enroll approximately 350 patients with platinum resistant, high grade serous ovarian cancer who received 1-4 prior lines of therapy at approximately 165 sites in the U.S. and Europe.

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"Completing enrollment of this pivotal study brings us closer to the day when batiraxcept potentially is available to patients," said Scott Dove, Ph.D., Chief Operating Officer of Aravive. "Public reporting of topline data remains on track for mid-2023 and, if successful, are expected to support a Biologics License Application for PROC at the end of 2023. I would like to thank the patients enrolled in the trial, the clinical investigators, our CRO partners, and the Aravive team who worked tirelessly to advance the trial to this stage."

"The majority of patients with ovarian cancer will develop platinum resistance and have residual side effects from previous treatments," said Katherine Fuh, MD, PhD, John A. Kerner Chair in Gynecologic Oncology, Associate Professor, Department of OB/GYN, Director of Basic and Translational Research, Division of Gynecologic Oncology, University of California, San Francisco. "There is a need to develop effective novel agents with little to no side effects. As overall response rates for current treatments in platinum-resistant ovarian cancer range from 4% to 30%, we anticipate that batiraxcept and paclitaxel could be an option for our patients."