On October 26, 2021 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that management will host a conference call and webcast to provide details related to the launch of its Phase 3 first-line gastroesophageal adenocarcinoma (GEA) pivotal study, HERIZON-GEA-01, and to discuss the commercial potential of zanidatamab in gastrointestinal cancers (Press release, Zymeworks, OCT 26, 2021, View Source [SID1234591964]).

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HERIZON-GEA-01 is a randomized, global Phase 3 study evaluating zanidatamab plus chemotherapy with or without tislelizumab, versus standard of care (trastuzumab plus chemotherapy), for first-line treatment of locally advanced, unresectable, or metastatic HER2-positive GEA.

Event: HERIZON-GEA-01 Conference Call and Webcast

Date: Tuesday, November 9th

Time: 4:15 p.m. ET

Interested parties can access a live webcast via a link from Zymeworks’ website at View Source, which will also host recorded replays available afterwards.

About Zanidatamab

Zanidatamab is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. Zanidatamab’s unique binding properties result in multiple mechanisms of action including HER2-receptor clustering, internalization, and downregulation; inhibition of growth factor-dependent and -independent tumor cell proliferation; antibody-dependent cellular cytotoxicity and phagocytosis; and complement-dependent cytotoxicity. Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. The FDA has granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified biliary tract cancer (BTC), and two Fast Track designations to zanidatamab, one as monotherapy for refractory BTC and one in combination with standard of care chemotherapy for first-line gastroesophageal adenocarcinoma (GEA). These designations mean zanidatamab is eligible for Accelerated Approval, Priority Review and Rolling Review, as well as intensive FDA guidance on an efficient drug development program. Zanidatamab has also received Orphan Drug designations from the FDA for the treatment of GEA and BTC and from the European Medicines Agency for the treatment of biliary tract and gastric cancers.

On October 26, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported new data demonstrating the clinical utility of the company’s Decipher Prostate genomic classifier for guiding the timing and intensity of treatment in men experiencing prostate cancer progression following radical prostatectomy (Press release, Veracyte, OCT 26, 2021, View Source [SID1234591963]). The data, from a randomized, phase 3 trial conducted at 24 centers in Belgium, Germany, and Switzerland (SAKK 09/10), were presented today at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2021 (abstract #94).

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Following radical prostatectomy, physicians typically monitor prostate cancer patients’ prostate-specific antigen (PSA) to identify biochemical recurrence. For those men who experience a subsequent rise in PSA, determining the optimal timing to initiate treatment and whether to add androgen deprivation therapy (ADT) to radiotherapy is challenging. Conventional clinical measures such as PSA and pathological findings following surgery are often insufficient to predict which patients will experience favorable oncologic outcomes with radiotherapy alone, and which will have disease that continues to progress.

To determine whether the Decipher Prostate genomic classifier could help identify those patients who would benefit from earlier intervention with radiotherapy or the addition of ADT to radiotherapy in this setting, researchers in the Swiss Group for Clinical Cancer Research (SAKK) and collaborating cancer centers assessed the outcomes and Decipher Prostate genomic risk for 226 prostate cancer patients from the SAKK 09/10 phase 3 randomized clinical trial. This study involved men experiencing a rise in PSA following radical prostatectomy, all of whom received radiotherapy without the addition of ADT. Patients in the Decipher Prostate analysis were followed for a median of 6.3 years.

"We’re pleased to have participated in this study, which explored a critical decision point in the management of men with prostate cancer," said Elai Davicioni, Ph.D., Veracyte’s senior vice president of Scientific and Clinical Operations, Urologic Cancers. "The side effects of ADT when given concurrently with radiotherapy are often difficult for patients to manage. Being able to identify those patients who are likely to have favorable outcomes with radiotherapy alone, as well as the men who would benefit most from adding ADT to radiotherapy, could significantly improve the management of men with biochemically recurrent prostate cancer."

The data shared at ASTRO today show that men with disease classified as Decipher high-risk were more than twice as likely as those whose disease was classified as Decipher low/intermediate-risk to experience biochemical and clinical progression with radiotherapy alone. Additionally, Decipher high-risk patients with PSA levels above 0.5 ng/mL who received radiotherapy alone had a nearly 90% risk of cancer recurrence in the five years following treatment.

"The results of our study suggest that men with higher Decipher Prostate scores should be considered for earlier intervention when experiencing a rise in PSA, and depending on PSA level at time of treatment, these men may receive the most benefit from the addition of ADT to radiotherapy," said Alan Dal Pra, M.D., director of Clinical Research at Sylvester Comprehensive Cancer Center, associate professor of radiation oncology at the University of Miami Miller School of Medicine, and lead author on the ASTRO abstract. "This type of genomic, risk-based approach can support more informed, individualized treatment planning."

On October 26, 2021 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel therapies for serious rare and ultra-rare genetic diseases, reported that it will host a conference call on Tuesday, November 2, 2021 at 5pm ET to discuss its financial results and corporate update for the quarter ended September 30, 2021 (Press release, Ultragenyx Pharmaceutical, OCT 26, 2021, https://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-host-conference-call-third-quarter-2021-financial [SID1234591962]).

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The live and replayed webcast of the call will be available through the company’s website at View Source To participate in the live call by phone, dial (855) 797-6910 (USA) or (262) 912-6260 (International) and enter the passcode 1098326. The replay of the call will be available for one year.

On October 26, 2021 Ubiquigent Limited (Ubiquigent) reported the extension and expansion of its long-term collaboration with Bristol Myers Squibb (Press release, Ubiquigent, OCT 26, 2021, https://www.ubiquigent.com/ubiquigent-extends-and-expands-drug-discovery-collaboration-with-bristol-myers-squibb/ [SID1234591961]). Under the terms of the agreement, Ubiquigent will provide Bristol Myers Squibb with increased access to its deubiquitylase (DUB) enzyme inhibitor drug discovery platform to provide further support to additional therapeutic areas.

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The central role of ubiquitylation in diverse cellular processes, including but not limited to protein degradation, makes the enzymes responsible for ubiquitylation and de-ubiquitylation highly attractive drug targets with the potential to address a wide range of human pathologies.

Recently, there has been further growing interest in the development of modulators of various components of the ubiquitin-proteasome system (UPS) for therapeutic benefit. Strategies that are being actively pursued include the exploitation of the UPS via PROTACs and molecular glues to target the undruggable proteome and the development of DUB inhibitors.

Ubiquigent has established itself as a respected global partner in the UPS field with a particular focus on the development of DUB inhibitors, with an established track record of supporting the drug discovery efforts of its partners via access to its Drug Discovery Screening Platform and by providing access to its own developing portfolio of novel DUB inhibitors as part of larger partnerships.

Ubiquigent’s CEO, Jason Mundin commented: "We are delighted to have the opportunity to build on our existing relationship with Bristol Myers Squibb in this rapidly evolving field to provide additional support to the development of novel DUB inhibitors for patients with unmet medical needs."

On October 26, 2021 Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) reported that it will report its third quarter 2021 financial results after market close on Tuesday, November 2, 2021 (Press release, Rigel, OCT 26, 2021, View Source [SID1234591960]). Rigel senior management will follow the announcement with a live conference call and webcast at 4:30pm Eastern Time (1:30pm Pacific Time) to discuss the financial results and give an update on the business.

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Participants can access the live conference call by dialing 877-407-3088 (domestic) or 201-389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company’s website at www.rigel.com. The webcast will be archived and available for replay for 90 days after the call via the Rigel website.