On October 20, 2021 Point32Health and Takeda Pharmaceuticals America, Inc. reported that they have signed an innovative risk-sharing agreement around Takeda’s ALUNBRIG (brigatinib), a potent and selective tyrosine kinase inhibitor (TKI) that is approved for adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test (Press release, Takeda, OCT 20, 2021, View Source [SID1234594767]).

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The agreement will make ALUNBRIG broadly available to Point32Health’s more than two million members – with Takeda standing behind the medicine with a unique outcomes-based structure. The agreement is among the first risk-sharing contracts in oncology and the very first in ALK+NSCLC.

"Given the importance of facilitating cutting-edge oncology treatment and also the reality that not all patients show a positive response, reimbursement for oncology treatments is an area that is prime for innovative financing approaches," said Michael Sherman, MD, chief medical officer and executive vice president, Point32Health. "We’re excited to be able to demonstrate the value of ALUNBRIG as a treatment option for people with ALK+ NSCLC. Collaborating with Takeda to share risk makes this agreement a crucial milestone in bringing cost-effectiveness to cancer care."

"Takeda is committed to identifying and collaborating with payers on innovative and bold solutions that help ensure patients have access to our transformative therapeutics," said Dion Warren, vice president, head, U.S. Business Unit, Takeda Oncology. "Through this collaboration, Point32Health is able to allow broader access to ALUNBRIG because Takeda stands behind the value of its medicine and is willing to minimize the financial risk."

On October 20, 2021 BC Platforms (BCP), a global leader in healthcare data management and analytics, reported an expanded partnership with Bumrungrad International Hospital (Bangkok, Thailand), one of the largest private hospitals in Southeast Asia and a world leader in healthcare delivery and pioneering clinical research (Press release, Debiopharm, OCT 20, 2021, View Source [SID1234591830]).

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The extended partnership, first formed in February 2019, builds on clinical sample management functionalities and existing automated workflows for genotype-based wellness reporting and NGS-based neonatal screening supported by BCP solutions. Bumrungrad will now utilize BCP’s Personalized Medicine Platform, powered by BC|GENOME, to implement end-to-end clinical NGS workflows for germline and somatic tumour testing, enabling data-driven personalized care for patients. Additionally, BCP will provide its Discovery and Research Platform, BC|INSIGHT, for curating and analysing clinical and omics data in a secure format to enhance translational research capabilities at Bumrungrad and boost research collaborations. Bumrungrad will also become a BCP data partner, for which it will contribute valuable, diverse data samples for research.

Dr Teeradache Viangteeravat, Director of Research and Development at Bumrungrad International Hospital, commented: "At Bumrungrad we have a commitment to provide precision medicine using big data; genomic and other omics data. We require a big data platform to support sample management, data processing, informatics pipelines, reporting and structured storage. BC Platforms is a world leader in this space and are able to provide a suite of integrated solutions, which support our strategic objectives and also support searching of genotypic and phenotypic data, for collaborative research projects. We are proud to be working with BC Platforms to provide a world class Precision Medicine Platform to continue to deliver the high-quality support our patients and clinicians demand."

Nino da Silva, Deputy Managing Director, BCP, said: "We are delighted to expand our partnership with Bumrungrad, making full use of our platforms to accelerate the shift towards precision medicine in southeast Asia. This powerful NGS infrastructure will deliver whole genome analysis to Bumrungrad’s clinical healthcare production system while supporting advanced clinical research. This is another great example of how we are partnering on an international level to seamlessly connect genomics healthcare and research."

On October 20, 2021 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that it has entered into a collaboration agreement with Ab Magnitude Ventures Group, LLC and Ab Magnitude Fund, LP (collectively, "Ab Magnitude") for the development of next-generation targeted oncology therapeutics (Press release, SpringWorks Therapeutics, OCT 20, 2021, View Source [SID1234591821]). Ab Magnitude is led by Yibing Shan, Ph.D., a leading structural computational biologist who was a founding member of D.E. Shaw Research, a pioneering computational biochemistry research company. Dr. Shan’s simulations of protein structural dynamics have previously yielded important insights on the activity of key oncogenic proteins and the identification of novel binding sites suitable for small molecule therapies. SpringWorks and Ab Magnitude will collaborate on target discovery and initial hit finding to advance next generation oncology therapeutics. In addition, the parties will also collaborate on a portfolio of novel EGFR inhibitors recently in-licensed by SpringWorks from the Dana-Farber Cancer Institute with Ab Magnitude supporting optimization and characterization of the portfolio using its computational platform.

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"We believe that Dr. Shan’s track record of identifying novel druggable targets for the design of new cancer therapies is unparalleled and represents a natural complement to our strategy of developing differentiated targeted therapies on behalf of cancer patients," said Badreddin Edris, Ph.D., Chief Operating Officer of SpringWorks. "We look forward to collaborating with Ab Magnitude and we believe that by incorporating these cutting-edge computational approaches into our early-stage drug discovery and development capabilities, we will be well positioned to continue expanding our emerging preclinical pipeline and advancing promising candidates into the clinic."

"I am excited to collaborate with SpringWorks on discovering novel oncology therapeutics using computational molecular and structural modeling approaches and to further optimizing the portfolio of novel EGFR inhibitors that SpringWorks recently in-licensed," said Dr. Shan. "This collaboration has the potential to expedite discovery of novel oncology therapeutics and advancement of promising therapeutic candidates by integrating Ab Magnitude’s computational modeling and target identification expertise with a vertically-integrated biopharmaceutical partner that has the capital resources and expertise to optimize promising candidates to development candidate stage and into clinical studies."

Under the terms of this agreement, Ab Magnitude is eligible for low single-digit percentage royalties on future net sales of products or other realizations of value arising from the collaboration.

On October 20, 2021 AstraZeneca reported that it has paused an active phase 1 trial of AZD5991, a direct inhibitor of MCL-1, citing the need to suss out a potential safety issue (Press release, AstraZeneca, OCT 20, 2021, View Source [SID1234591820]).

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The trial suspension, noted only through ClinicalTrials.gov, came Oct. 19: "The study has been put on hold to allow further evaluation of safety related information," the brief update said. AstraZeneca did not immediately respond to a request for comment on the trial’s suspension.

The trial was assessing the drug, known as AZD5991, either alone or combined with AbbVie/Roche’s approved blood cancer medicine Venetoclax in relapsed or refractory hematologic malignancies. The drug works by targeting apoptosis, the process of programmed cell death, specifically in blood cancer.

RELATED: Amgen shares hit after analysts expose buried FDA trial halt

This class has seen safety issues before: Back in 2019, Amgen’s oral small-molecule MCL-1 inhibitor AMG 397 was hit with an FDA halt given a "safety signal for cardiac toxicity."

And that’s not all: After AMG 397 showed some potential safety issues, Amgen then voluntarily halted enrollment for another early-stage test for AMG 176, given that it too is an MCL-1 inhibitor. Enrollment was, however, then opened back up.

Back in February, work on AMG 397 was stopped, and the focus shifted to AMG 176, which is now in phase 1 for blood cancers and uses an intravenous route of administration.

On October 20, 2021 Cytokinetics, Incorporated (Nasdaq: CYTK) reported that it is scheduled to report third quarter results on November 3, 2021 at 4:00 PM Eastern Time (Press release, Cytokinetics, OCT 20, 2021, View Source [SID1234591697]). Following the announcement, Cytokinetics’ senior management will host a conference call at 4:30 PM Eastern Time to discuss operational and financial results and the company’s outlook for the future .

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The conference call will be simultaneously webcast and can be accessed from the homepage and in the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 5885725.

An archived replay of the webcast will be available via Cytokinetics’ website until November 17, 2021. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 5885725 from November 3, 2021 at 7:30 PM Eastern Time until November 17, 2021.