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U.S. FDA Approves FoundationOne®CDx as a Companion Diagnostic for KEYTRUDA® (pembrolizumab) to Identify Patients with Microsatellite Instability-High (MSI-H) Solid Tumors

On February 21, 2022 Foundation Medicine, Inc. reported that it received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne CDx to be used as a companion diagnostic to identify patients with Microsatellite Instability High (MSI-H) status solid tumors who may be appropriate for treatment with Merck’s KEYTRUDA (pembrolizumab) (Press release, Foundation Medicine, FEB 21, 2022, View Source [SID1234608361]). FoundationOne CDx is the first and only FDA-approved companion diagnostic to aid in identifying patients with MSI-H solid tumors for whom treatment with KEYTRUDA may be appropriate.

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In tumors that are defined as MSI-H, the DNA repair mechanisms are faulty, and as a result, tumor cells can acquire a significant number of mutations that can make them recognizable by the immune system. MSI-H status is more commonly found in colorectal, endometrial and gastrointestinal cancers, but it can also be seen in other types of cancer.1 KEYTRUDA was granted accelerated approval to treat certain patients with MSI-H solid tumors in May 2017, making it the first targeted therapy approved to treat patients based on a genomic signature, instead of where the tumor originated in the body.

"Immunotherapy has huge promise as a potential treatment option for patients with advanced cancer; however, identifying those who may benefit is complex and requires high-quality diagnostics," said Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. "Not only could this approval allow more patients to benefit from KEYTRUDA, but it also underscores an important shift toward tumor-agnostic cancer care."

Foundation Medicine is committed to providing oncologists and patients with the insights they need to make informed treatment decisions. This FDA approval of FoundationOne CDx to identify patients with MSI-H solid tumors, and its previous approval of the test to identify patients with TMB-H solid tumors who may benefit from treatment with KEYTRUDA, reinforces the assay’s analytical and clinical validity for guiding immunotherapy treatment decisions and therapy development. This is the third tumor agnostic companion diagnostic approval for FoundationOne CDx, which now has 26 companion diagnostic claims and two group claims across 27 targeted therapies.

"We’re proud to see this collaboration with Foundation Medicine, which drew on the deep scientific expertise of both organizations, result in another companion diagnostic approval for use in identifying patients who may be appropriate for KEYTRUDA," said Eric Rubin, senior vice president, early-stage development, clinical oncology, Merck Research Laboratories.

Mevion Selected to Equip Proton Therapy Center at Tongji Hospital in China

On February 21, 2022 Mevion Medical Systems reported it has been selected by Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology to equip their new proton therapy center with a MEVION S250i Proton Therapy System in Wuhan, China (Press release, Mevion Medical Systems, FEB 21, 2022, View Source [SID1234608360]).

The system at Tongji Hospital will feature Mevion’s industry leading HYPERSCAN Pencil Beam Scanning (PBS) technology, coupled with the industry’s only proton multi-leaf collimator, the Adaptive Aperture. This powerful duo provides faster and more precise targeted dose delivery to tumors thus further minimizing the damage to surrounding healthy tissue and organs at risk. The system also integrates a diagnostic CT imaging system and a surface tracking system for high precision patient positioning and intra-fraction motion management.

Founded in 1900 and listed as the 6th top hospital in Fudan’s 2020 China Hospital Ranking, Tongji Hospital provides over 6 million annual outpatient visits. The contract for the new proton therapy center was completed in late 2021, and construction of the new 135,000 square-foot proton therapy center at Tongji Hospital’s Optics Valley campus is expected to be completed by December 2022. The installation of the MEVION S250i is planned to commence in July.

Tongji Hospital will build a second proton vault simultaneously, making it China’s first proton center applying the One Plus One multi-system installation approach. This allows Tongji Hospital the flexibility to add a second system in the future to correspond to the growth of patient volume and clinical expertise. This staged installation significantly reduces the financial burden at the start of the clinical proton therapy program and minimizes the risk of technology obsolescence.

"Mevion is proud to partner with the distinguished Tongji Hospital to provide accessible proton therapy to their patients," said Tina Yu, Ph.D., chief executive officer and president of Mevion. "Mevion strongly believes health care systems will greatly benefit from expanding their proton centers at their optimal pace with the most advanced technology to best serve their patients."

Prestige BioPharma’s Herceptin Biosimilar, Tuznue®, Receives EU-GMP Certification

On February 21, 2022 Prestige BioPharma Limited (950210: KRX), a Singapore-based biopharmaceutical with operations in USA and South Korea, reported that the manufacturing facility for its Herceptin biosimilar, Tuznue, in Prestige Biologics Co., Ltd. (334970: KOSDAQ), has received European Union Good Manufacturing Practices (GMP) certification (Press release, Prestige BioPharma, FEB 21, 2022, View Source [SID1234608359]). EU-GMP certification is one of the highest standards of pharmaceutical production in the world, and it provides pharmaceuticals with the foundation to start selling their products into European markets.

Tuznue, HD201, is a proposed biosimilar to Roche’s Herceptin and can be prescribed for the treatment of HER2 positive breast and metastatic gastric cancer. Tuznue’s equivalence to the originator has been demonstrated in 2 Phase 1 trials conducted in Europe and Australia and a global Phase 3 trial, which has been published in scientific journals and conferences. Tuznue has secured global distribution partnerships in major markets, and is currently under Marketing Authorization Application (MAA) review in EU EMA, Canada and South Korea.

Prestige BioPharma has strong pipeline portfolio comprising biosimilars and first-in-class antibody drugs. Following the frontrunning Tuznue, a biosimilar to Avastin, HD204 (Vasforda) is wrapping up the global Phase 3 clinical trial targeting filing to FDA and EMA this year. PBP1510 (Ulenistamab), first-in-class antibody drug for pancreatic cancer, and PBP1502, a biosimilar to Humira are currently in Phase 1/2a and Phase 1 clinical trial in Europe, respectively.

Lisa S. Park, CEO of Prestige BioPharma, commented: "EU GMP certification of our manufacturing arm in Korea demonstrated our global standard biomanufacturing facility and system that are applied to all of our products. By achieving one of the key requirements for product registration, we are one step closer to global launch of Tuznue that can enhance affordability of trastuzumab to the patients in need."

Horizon Therapeutics plc to Present at the Cowen and Company 42nd Annual Health Care Conference

On February 21, 2022 Horizon Therapeutics plc (Nasdaq: HZNP) reported that the Company will present at the following conference in March (Press release, Horizon Therapeutics, FEB 21, 2022, https://ir.horizontherapeutics.com/news-releases/news-release-details/horizon-therapeutics-plc-present-cowen-and-company-42nd-annual [SID1234608358]):

Cowen and Company 42nd Annual Health Care Conference (Virtual)

Date: Tuesday, March 8, 2022
Presentation time: 11:10 a.m. ET
The presentation will be webcast live and may be accessed by visiting Horizon’s website at View Source A replay of the webcast will be available following the event.

Novavax to Host Conference Call to Discuss Fourth Quarter and Full Year 2021 Financial Results and Operational Highlights on February 28, 2022

On February 21, 2022 Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, reported it will report its fourth quarter and full year 2021 financial results and operational highlights on Monday, February 28, 2022, following the close of U.S. financial markets (Press release, Novavax, FEB 21, 2022, View Source,-2022 [SID1234608357]).