On February 21, 2022 Oxilio Ltd is a privately held pharmaceutical development company reported that focused on repurposing known drugs for the treatment of cancer through a programme of corporate alliances coupled with rapid proof of concept clinical development (Press release, Quotient Sciences, FEB 21, 2022, View Source [SID1234621608]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Oxilio signed an exclusive global licensing agreement with TRx Biosciences on 20th October 2021 for the use of their platform technology to support the development of Oxilio’s formulation, OXL001. Oxilio has since progressed the product and now signed a significant service contract with Quotient Sciences, a drug development and manufacturing accelerator, to support the formulation development and preparation of clinical trials for OXL001.

Mark Egerton, CEO of Quotient Sciences said, "By leveraging our integrated development and clinical testing platform, Translational Pharmaceutics, Oxilio and TRx Biosciences will have the flexibility to adjust formulations based on emerging clinical data within their study, enabling us to improve their likelihood of success, reduce their development time and ultimately get new medicines to patients faster. We look forward to working with both companies as we prepare to take OXL001 into the clinic later this year."

Commenting, Oxilio Director Dr Simon Yaxley said: "Quotient has significant capabilities for scientific innovation and adaptation which will further complement Oxilio’s already substantial scientific capacity. We look forward to taking Oxilio’s highly promising formulation OXL001 into the clinic later this year which, if successful, offers tremendous near-term potential benefit for cancer patients."

On Feb. 21, 2022, Applied Pharmaceutical Science, Inc. reported that APS03118, a next-generation selective RET inhibitor, has recently been granted Fast Track Designation by U.S. Food and Drug Administration (FDA) for the treatment of metastatic RET fusion-positive non-small cell lung cancer (NSCLC) previously-treated with a selective RET inhibitor (Press release, Applied Pharmaceutical Science, FEB 21, 2022, View Source [SID1234613100]). The Fast Track Designation is based on preclinical data of APS03118, which will be presented as an electronic poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April 2022. Investigational New Drug (IND) application of APS03118 was approved by FDA in January 2022, the global clinical trials are in initiation.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

RET aberrances contain fusions and mutations, which can lead to over-activation of RET signaling pathways and uncontrolled cell growth. Because RET oncogene is present in lung cancer, thyroid cancer, rectal cancer, breast cancer, pancreatic cancer and other solid tumors, and it has become an important target of "unlimited cancer" therapy. Cancers with RET alterations primarily rely on abnormal activation of this kinase to promote their proliferation and growth, therefore RET positive cancers are sensitive to RET inhibitors.

NSCLC patients with RET gene alterations are not rarely seen in clinic, particularly in younger, non‐smoking patients with adenocarcinoma histology, with an incidence of 7%-17%. In addition, the brain metastases often occur in lung cancer patients which is highly related with RET fusion, and the cumulative incidence is more than 60% within 24 months. Although first-generation selective RET inhibitors have achieved great success in the therapy of RET positive of NSCLC, patients inevitably acquire resistance.

APS03118 is a next-generation RET inhibitor with innovative chemical structure, and this breakthrough progresses expected to accelerate its registration process and bring new hope to RET aberrance patients. The FDA Fast Track Designation is based on preclinical data:APS03118 showed significant nanomolar level potent antitumor activity in inhibition to various RET fusion and mutations including RET gatekeeper V804M/L/E and solvent frontier G810R/S/C mutations which lead to resistance to selective RET inhibitors. In a brain tumor model, APS03118 completely eliminated brain tumors and all animals survived after dosing, demonstrating the therapeutic advantages of APS03118 for patients with brain metastases.

Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. A drug that receives Fast Track Designation is eligible for some or all of the following: More frequent meetings with FDA to discuss the drug’s development plan; Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met, and the opportunities of Rolling Review.APS03118 is granted Fast Track Designation for the treatment of metastatic NSCLC previously-treated with a selective RET inhibitor, which will help to strengthen the communication with FDA, and accelerate the progress of clinical trials and reach the market expeditiously.

Applied Pharmaceutical Science, Inc. is a biopharmaceutical high-tech company specialized on innovative cancer precision therapy, focusing on small molecule precision cancer therapy. Dr. Jun Zhong, R&D vice president of APS, stated, APS03118 granted the Fast Track Designation of FDA, which is another breakthrough of APS in precision cancer therapy. Meanwhile, RET alterations is related to multiple malignant tumors, and we expect to extend APS03118 to other cancer therapies and reach the global market.

On February 21, 2022 Silence Therapeutics plc, Nasdaq: SLN ("Silence" or "the Company"), a leader in the discovery, development and delivery of novel short interfering ribonucleic acid ("siRNA") therapeutics for the treatment of diseases with significant unmet medical need, reported that Craig Tooman, previously Chief Financial Officer ("CFO"), has been appointed President, Chief Executive Officer ("CEO") and Board member of Silence, and Mark Rothera has stepped down as President, CEO and Board member, effective immediately (Press release, Silence Therapeutics, FEB 21, 2022, View Source [SID1234608362]). Rhonda Hellums, previously Vice President, Finance, has been appointed CFO.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"On behalf of the Board, I would like to thank Mark for his contributions over the last 18 months and we wish him well," said Iain Ross, Chairman at Silence. "Craig is a seasoned leader who understands all aspects of our corporate strategy and the immediate need to maximize our potential going forward. With Craig as CEO and Dr. Giles Campion leading our exceptional research and development efforts, I am confident that Silence is now well-positioned to capitalize appropriately on the positive data we recently reported with SLN360 and ensure long-term shareholder value."

Craig Tooman, President and CEO, commented, "I am extremely pleased to have the opportunity to lead Silence and have come to appreciate the strong stewardship of Iain Ross as Chairman of the Board. I look forward to working with Giles, the executive team, and full Board, to take Silence through its next exciting stage of growth."

Craig Tooman joined Silence in January 2021, and brings more than 30 years of operational, financial and merger and acquisition ("M&A") experience. Most recently, he was Chief Operating Officer and CFO at Vyome Therapeutics, and prior to this was CEO of Aratana Therapeutics where he successfully negotiated a merger with Elanco. Before Aratana, Mr. Tooman was the CEO of Avanzar Medical Inc., a private oncology company, and CFO of Enzon Pharmaceuticals until its acquisition by Sigma Tau. Prior to that he led the $1.1 billion M&A initiative and integration of ILEX Oncology and Genzyme Corporation. He also held key positions at Pharmacia and Upjohn. Mr. Tooman currently serves on the Supervisory Board and Audit Committee of CureVac, which accomplished a successful initial public offering on Nasdaq in August of 2020. He holds a BA in Economics from Kalamazoo College and an MBA from the University of Chicago.

Rhonda Hellums has over 25 years of corporate finance, accounting, strategic planning, M&A, treasury management, investor and public relations. Prior to joining Silence in April 2021, she held management positions at several large healthcare companies, including KCI (now 3M+KCI) and Genzyme Corporation. She previously served as CFO of Deer Oaks Mental Health and prior to that, CFO of Aratana Therapeutics, a publicly traded pet therapeutics company. Ms. Hellums received her BBA degree in Accounting and Information Systems and MBA from the University of Texas at San Antonio.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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."