On June 3, 2022 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, reported that the Company will present at the 2022 Jefferies Global Healthcare Conference on Friday, June 10, 2022 at 9:00 AM ET in New York, New York (Press release, Fate Therapeutics, JUN 3, 2022, View Source [SID1234615515]).

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A live webcast, if recorded, of the presentation can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website shortly after the event.

On June 3, 2022 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, reported its participation in a neoadjuvant screening trial in partnership with the Lung Cancer Research Foundation (LCRF) and Lung Cancer Mutation Consortium (LCMC) (Press release, Foundation Medicine, JUN 3, 2022, View Source [SID1234615531]). This screening trial, entitled "LCMC4 Evaluation of Actionable Drivers in EaRly Stage Lung Cancer" (LEADER), is the fourth study conducted through the LCMC and is a collaborative effort involving numerous academic study sites and pharmaceutical supporters. Foundation Medicine will be the sole provider of comprehensive genomic profiling (CGP) in the LEADER trial, which will utilize both of Foundation Medicine’s FDA-approved CGP tests: the tissue-based FoundationOneCDx and the blood-based FoundationOneLiquid CDx.

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The LEADER trial is utilizing an umbrella trial design to screen for 11 actionable driver mutations in 1,000 patients with high-risk, resectable non-small cell lung cancer (NSCLC). These patients are candidates for neoadjuvant therapy, which is treatment given as a first step to shrink a tumor before the main treatment, often surgery. By identifying patients with biomarker-positive tumors for enrollment to several matched therapeutic trials, the LEADER trial aims to develop essential data that can be used to support oncologists in their personalized treatment planning for cancer patients prior to such patients undergoing surgery.

"The neoadjuvant setting is a rapidly evolving space for the development of precision treatment options in lung cancer. Enabling trials in this setting will continue to help us understand the impact of targeted therapies in the curative treatment of NSCLC," says Dr. Geoff Oxnard, Foundation Medicine’s VP, Head of Clinical Development. "At Foundation Medicine, we are committed to being an engaged collaborator in the pivotal research needed to shape the future of cancer care for patients at all stages, so that patients can get on the right therapy at the right time for their specific cancer."

The results from both FoundationOne CDx and FoundationOne LiquidCDx will be used by LEADER trial sites to screen patients for actionable driver mutations. While circulating tumor DNA (ctDNA) shed is often lower in early disease, the goal of using both tests in the LEADER trial is to help researchers understand how blood-based CGP testing can complement tissue-based CGP testing to inform targeted treatment in resectable NSCLC.

In the past two years, the FDA has granted approvals for the first tyrosine kinase inhibitor and checkpoint inhibitor, respectively, for the adjuvant treatment of resected NSCLC, each requiring testing for precision biomarkers. The FDA has also recently granted approval for neoadjuvant immunotherapy for resectable NSCLC, as well as the first-and-only immunotherapy-based treatment for neoadjuvant use in NSCLC, reinforcing the value of targeted therapies as a component of curative lung cancer. These FDA approvals could better position early-stage NSCLC patients, like those who are enrolled in the LEADER trial, to become potential candidates for these personalized treatment approaches.

The LEADER trial is now open to enrollment and will include participation from trial sites and investigators across the oncology community, including MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, Dana Farber Cancer Institute, Yale Cancer Center/Smilow Cancer Hospital and many others.

In a new "Trial in Progress" abstract being presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting from June 3-7, Boris Sepesi, M.D., associate professor of Thoracic and Cardiovascular Surgery at The University of Texas MD Anderson Cancer Center, and principal investigator of the LEADER Trial, and Mark Kris, M.D., Attending Physician, Thoracic Oncology Service, Department of Medicine at Memorial Sloan Kettering Cancer Center will detail LEADER’s primary objective of determining the proportion of resectable NSCLC patients within the trial who possess actionable oncogenic drivers. Results from Foundation Medicine CGP testing will inform the LEADER trial sites on their selection of neoadjuvant therapy and enrollment onto independent therapeutic trials with genomically matched neoadjuvant treatment, standard therapies or other trials if no driver is detected. Read more on ASCO (Free ASCO Whitepaper).org, and visit Foundation Medicine at Booth #13019 to learn more. Follow along on Twitter and LinkedIn for more details about Foundation Medicine’s data being presented at ASCO (Free ASCO Whitepaper)22.

On June 3, 2022 Taiho Oncology, Inc. reorted updated results of the Phase 2 FOENIX-CCA2 trial of futibatinib, confirming results observed in an earlier analysis (Press release, Taiho, JUN 3, 2022, View Source [SID1234615547]). The trial was conducted in patients with locally advanced or metastatic unresectable intrahepatic (inside the liver) cholangiocarcinoma (iCCA) harboring FGFR2 gene rearrangements including fusions . These data were presented as an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago.

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"Updated data from the pivotal FOENIX-CCA2 Phase 2 trial reinforce the durable efficacy and continued tolerability of futibatinib in previously treated patients with locally advanced or metastatic iCCA harboring FGFR2 gene rearrangements including fusions," said medical oncologist Lipika Goyal, MD, MPhil, of the Massachusetts General Hospital Cancer Center in Boston, and lead investigator on the study. "These data add to the body of evidence supporting futibatinib as a potential treatment option for patients living with this rare cancer that traditionally has had limited treatment options."

Each year, approximately 8,000 individuals in the U.S. are diagnosed with cholangiocarcinoma (CCA),1 a cancer of the bile ducts of the liver. Worldwide, approximately 0.3-6 people per 100,000 individuals live with CCA.2 CCA is mainly seen in people 65 years of age or older,3 and treatment options are limited. FGFR2 gene rearrangements, including gene fusions, which can form a hybrid gene and promote tumor proliferation, are observed more frequently in the iCCA patient population, with approximately 10-16% of patients having tumors with these rearrangements.4,5,6,7,8

The Phase 2 FOENIX-CCA2 trial included 103 patients with locally advanced or metastatic unresectable iCCA harboring FGFR2 gene rearrangements including fusions who had received one or more prior lines of systemic therapy. Patients received futibatinib 20 mg once daily until disease progression or unacceptable toxicity. The primary endpoint of the trial was objective response rate (ORR) as assessed by independent central review.

At the time of the data cutoff for this updated analysis, with a median follow-up of 25.0 months, the ORR was 41.7%. Responses were durable, with a median duration of response (DoR) of 9.5 months (74% of responses lasted greater than six months). In addition, the disease control rate was 82.5%, median progression-free survival was 8.9 months and median overall survival was 20.0 months.

The most common treatment-related adverse events (TRAEs) were hyperphosphatemia (85%), alopecia (33%), dry mouth (30%), diarrhea (28%), dry skin (27%) and fatigue (25%). Most TRAEs were of mild or moderate intensity and manageable. There were two patients with grade 4 TRAEs and four patients discontinued treatment due to TRAEs. No treatment-related deaths occurred.

"Taiho Oncology remains committed to addressing unmet treatment needs in patients living with a broad range of cancers, and these data from the FOENIX-CCA2 trial demonstrate the clinical activity of futibatinib," said Volker Wacheck, Vice President, Clinical Development, Taiho Oncology, Inc. "We are looking forward to continued discussions with regulatory authorities around this important investigational therapy."

In March 2022, the U.S. Food and Drug Administration (FDA) accepted for priority review the New Drug Application (NDA) for futibatinib in the treatment of patients with previously treated locally advanced or metastatic CCA harboring FGFR2 gene rearrangements, including gene fusions. The FDA provided an anticipated Prescription Drug User Fee Act (PDUFA) action date of September 30, 2022. The FDA previously granted Breakthrough Therapy Designation (BTD) for futibatinib in CCA in February 2021.

About Futibatinib
Futibatinib (TAS-120) is an investigational, oral, potent, selective and irreversible tyrosine kinase inhibitor of FGFR1, 2, 3 and 4. This irreversible binding to the ATP binding pocket of FGFR1-4 results in the inhibition of FGFR-mediated signal transduction pathways, reduced tumor cell proliferation and increased cell death in tumors with FGFR1-4 genetic aberrations. Futibatinib is being studied alone as a potential treatment for patients with advanced solid tumors with FGFR1-4 genomic aberrations, including cholangiocarcinoma, or in combination with chemotherapy or other therapies.

On June 3, 2022 Experimental Drug Development Centre reported a made-in-Singapore cancer drug, ETC-159, has advanced into the dose expansion portion of its Phase 1B clinical trial (Press release, Experimental Drug Development Centre, JUN 3, 2022, View Source [SID1234654034]). The Phase 1B dose expansion study tests the preliminary efficacy and safety of ETC-159 in a subset of genetically defined patients with microsatellite stable (MSS)1 cancers. MSS tumours have few genetic aberrations and patients are usually unresponsive to immunotherapy like pembrolizumab, a checkpoint inhibitor used in the treatment of many cancers. To date, the first portion of the Phase 1B trial, the dose escalation study, has been completed and a safe dose of ETC-159 in combination with pembrolizumab has been defined. ETC-159 was previously shown to be safe as a monotherapy in its Phase 1A trial.

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ETC-159 was jointly developed by Duke-NUS Medical School (Duke-NUS) and the Experimental Drug Development Centre (EDDC), a national platform for drug discovery and development hosted by the Agency for Science, Technology and Research (A*STAR). This small molecule drug targets a range of solid tumours including colorectal, endometrial, ovarian and pancreatic cancers, which contribute to a significant fraction of Singapore’s cancer burden. A subset of these cancers are caused by hyperactivity in a cell signalling pathway known as the Wnt pathway.

The Phase 1B dose expansion study will have two groups.
In one group, ETC-159 will be tested as a monotherapy in MSS colorectal cancer (CRC) patients who have a specific genetic mutation, called "RSPO Fusion". This mutation is present in about 8% of CRC patients and it activates the Wnt pathway, making these patients sensitive to Wnt inhibitors like ETC-159. A diagnostic test designed by EDDC was manufactured and clinically validated at POLARIS @ A*STAR’s Genome Institute of Singapore (GIS). Supported by the Diagnostics Development (DxD) Hub, this test will be used to select colorectal cancer patients with RSPO Fusion to participate in the trial. RNA Extraction from Formalin-Fixed Paraffin-Embedded (FFPE)2 tissue samples followed by testing of Fusion genes will be done at POLARIS @ GIS.

In the second dose expansion patient group, ETC-159 will be tested in combination with the immune checkpoint inhibitor pembrolizumab in MSS colorectal cancer patients who do not have RSPO fusions, as well as in patients with MSS endometrial and MSS ovarian cancers. The ability of ETC-159 to sensitise MSS cancers to pembrolizumab will be investigated. The combination of ETC-159 and pembrolizumab has been demonstrated to be synergistic in preclinical studies.

As in earlier trials, investigators will track the biological effect of ETC-159, also known as its pharmacodynamics, in patients participating in the dose expansion study. The pharmacodynamics of a drug can be measured from tumour samples taken through biopsies, such as during surgery or an invasive procedure. EDDC established that it will also be possible to measure the pharmacodynamics of the drug through monitoring the levels of Axin2 mRNA in hair follicles. Axin2 is a downstream protein in the Wnt pathway, and its levels are reduced when ETC-159 effectively acts on the pathway. This minimally invasive measurement of ETC-159’s biological effect will allow investigators to understand how well the drug is working in patients over the course of study.

Patients for the dose expansion study will come from two sites in Singapore as well as seven sites in the United States. The trial is expected to be completed by 2024.

On June 3, 2022 Bristol Myers Squibb (NYSE:BMY) and Turning Point Therapeutics, Inc. (NASDAQ:TPTX) reported a definitive merger agreement under which Bristol Myers Squibb will acquire Turning Point Therapeutics for $76.00 per share (Press release, Turning Point Therapeutics, JUN 3, 2022, View Source [SID1234615500]). The transaction was unanimously approved by both the Bristol Myers Squibb and Turning Point Therapeutics Boards of Directors and is anticipated to close during the third quarter of 2022.

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Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of investigational medicines designed to target the most common mutations associated with oncogenesis. Turning Point Therapeutics’ lead asset, repotrectinib, is a next-generation, potential best-in-class tyrosine kinase inhibitor (TKI) targeting the ROS1 and NTRK oncogenic drivers of non-small cell lung cancer (NSCLC) and other advanced solid tumors. Repotrectinib has been granted three Breakthrough Therapy Designations from the U.S. Food and Drug Administration. In the Phase 1/2 TRIDENT-1 clinical trial, longer duration of response has been observed in the landmark analysis with repotrectinib than with existing ROS1 agents in first-line NSCLC.

Bristol Myers Squibb expects repotrectinib to be approved in the U.S. in the second half of 2023 and become a new standard of care for patients with ROS1-positive NSCLC in the first-line setting. The company also plans to continue to explore the potential of Turning Point Therapeutics’ promising pipeline of novel compounds.

"The acquisition of Turning Point Therapeutics further broadens our leading oncology franchise by adding a best-in-class, late-stage precision oncology asset," said Giovanni Caforio, M.D., Board Chair and Chief Executive Officer, Bristol Myers Squibb. "With this transaction, we are continuing our strong track record of strategic business development to further enhance our growth profile."

"Today’s news builds upon our long legacy of pioneering next-generation medicines for patients with cancer," said Samit Hirawat, M.D., Chief Medical Officer, Global Drug Development, Bristol Myers Squibb. "With repotrectinib, we have the opportunity to change the standard of care and address a significant unmet medical need for ROS1-positive non-small cell lung cancer patients."

"Through this transaction, we will be able to harness the full potential of our precision oncology platform to advance the standard of care for cancer patients. Since our founding, we have leveraged our deep scientific expertise to develop a pipeline of promising precision oncology assets," said Athena Countouriotis, M.D., President and Chief Executive Officer, Turning Point Therapeutics. "With Bristol Myers Squibb’s leadership in oncology, strong commercial capabilities and manufacturing footprint, we will be able to further accelerate the pace at which we can bring our novel medicines to benefit people diagnosed with cancer around the world."

Financial Details and 2022 Financial Guidance

The transaction supports Bristol Myers Squibb’s medium- to long-term growth strategy with accretion to non-GAAP earnings per share (EPS) beginning in 2025. The transaction is expected to be up to $0.08 per share dilutive to non-GAAP EPS in 2022 prior to any impact from an acquired in-process research and development charge based on final accounting treatment. The accounting treatment as a business combination or asset acquisition will be determined upon the expected close of the transaction in the third quarter of 2022.

Transaction Terms and Financing

Under the terms of the merger agreement, Bristol Myers Squibb will promptly commence a tender offer to acquire all of the outstanding shares of Turning Point Therapeutics’ common stock at a price of $76.00 per share in an all-cash transaction for a total consideration of $4.1 billion in equity value. Turning Point Therapeutics’ Board of Directors unanimously recommends that Turning Point Therapeutics shareholders tender their shares in the tender offer.

The transaction is subject to customary closing conditions, including the tender of a majority of the outstanding shares of Turning Point Therapeutics’ common stock and the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Following the successful closing of the tender offer, Bristol Myers Squibb will acquire all remaining shares of Turning Point Therapeutics that are not tendered into the tender offer through a second-step merger at the same price of $76.00 per share.

Bristol Myers Squibb expects to finance the acquisition with cash on hand.

Advisors

Gordon Dyal & Co., LLC is serving as the exclusive financial advisor to Bristol Myers Squibb, and Kirkland & Ellis LLP is serving as legal counsel. Goldman Sachs & Co. LLC is serving as the exclusive financial advisor to Turning Point Therapeutics, and Cooley LLP is serving as legal counsel.