On June 7, 2022 NorthStar Medical Radioisotopes, LLC (‘NorthStar’), a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, and Curie Therapeutics Inc., a therapeutics company dedicated to transforming cancer care with precision radiopharmaceuticals, reported the signing of a long-term priority access supply agreement for the therapeutic medical radioisotope actinium-225 (Ac-225) (Press release, NorthStar Medical Radiostopes, JUN 7, 2022, View Source [SID1234615721]).

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Under the terms of the agreement, NorthStar will provide Curie Therapeutics with priority access to its electron accelerator-produced, n.c.a. Ac-225. Ac-225 is a high energy alpha-emitting radioisotope that, when combined with a targeting ligand, is of increasing interest for the treatment of solid tumors. Ac-225 carries sufficient radiation to cause cell death in a localized area of targeted cells. NorthStar will use its electron accelerator technology to produce n.c.a. Ac-225 that is free of long-lived radioactive contaminants and byproducts associated with other production methods, which pose regulatory and waste management challenges for hospitals and health systems.

"NorthStar is defining the supply chain for commercial-scale, reliable and environmentally preferred therapeutic radioisotope production. We are very excited to be partnering with Curie Therapeutics, an emerging leader in the development of precision radiopharmaceuticals," said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. "Clinical research and commercial use of Ac-225 are severely constrained by chronic short supply due to limitations of current production technologies. Our company is positioned to be the first commercial-scale producer of Ac-225, utilizing our n.c.a. Ac-225 production technology which utilizes state-of-the-art electron beam accelerator production that provides increased capacity and scheduling flexibility. Construction of our dedicated Actinium-225 Production facility has begun, with initial production of radiochemical grade Ac-225 planned for late 2023. We expect to submit a Drug Master File to the FDA in 2024, which, upon acceptance, will allow NorthStar to provide cGMP grade Ac-225. We are very pleased to enter this Ac-225 supply agreement with Curie Therapeutics, and we look forward to a productive relationship as we both strive to ensure availability of targeted radiopharmaceutical therapy for patients with cancer."

"Curie Therapeutics is broadly developing precision targeted radiopharmaceuticals to address high unmet needs in the treatment of solid tumors," said Simon Read, Ph.D., Chief Executive Officer. "Curie Therapeutics’ ligands are engineered to achieve deep, homogeneous tumor distribution combined with rapid clearance. NorthStar is widely recognized for its leadership in cutting-edge radioisotope production technologies. This agreement secures our domestic sourcing of Ac-225, now and in the future, enabling us to pursue our mission to deliver innovative, safe and effective treatment of patients with solid tumor cancers."

On June 7, 2022 Phost’in Therapeutics (Montpellier, France), a biotech company focused on the discovery and development of N-glycosylation inhibitors for the treatment of cancer and other serious diseases, reported the French National Agency for the Safety of Medicines and Health Products (ANSM) and the Italian Medicines Agency (AIFA) have accepted an adaptive Phase I/II in patients with advanced solid tumors for the First-In-Class selective n-glycosylation inhibitor, PhOx430 (the PhAST trial) (Press release, Phost’in, JUN 7, 2022, View Source [SID1234615742]).

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PhOx430 targets a key glycosylation mechanism responsible for supporting cancer proliferation and suppressing the immune response. The program has demonstrated a significant antitumoral efficacy in several animal models, associated with a promising safety profile in regulatory preclinical studies.

The PhAST trial will begin enrolling two dozen of patients with non-selected tumour types in a dose escalation phase, followed by three expansion cohorts gathering patients with selected tumour types, including Glioblastoma multiforme (GBM), Triple-negative breast cancers (TNBC) and a selection of other solid tumour types, for which few therapeutic options exist.

The primary objective will be to determine the safety and tolerability of PhOx430 in patients. The secondary objectives will include a preliminary evaluation of efficacy, in addition with the identification of biomarkers.

In France, the CTA was submitted and accepted as part of ANSM’s Fast Track procedure designed to reduce processing times for clinical trial authorization requests for innovative medical products.

Karine Chorro, CEO of Phost’in Therapeutics, said: "The approval of this CTA marks an important regulatory milestone for PhOx430. We are grateful to the French and Italian Competent Authorities for their positive feedback on what we believe is a disruptive clinical innovation, and a formidable hope for patients with limited therapeutic options. We will continue our efforts to advance PhOx430 clinical development, and to bring it to patients and their families."

GBM, still a rare disease with a global incidence rate inferior to 10 per 100,000 in Europe and North America, remains one of the most aggressive malignant cancer types, difficult to treat and associated with high mortality. The life expectancy of GBM patients is typically less than 15 months after diagnosis. TNBCs represent 10-15% of all breast cancers, are typically associated with a high risk of early metastasis, including brain metastases, and bad 5-year prognostic. Therefore, there is a critical and unmet therapeutic need for both indications.

The clinical program received the scientific contribution of Gianni Bonadonna Foundation, which collaborated in the conception and design of the research protocol. "The approval of this trial represents the actualization of one of the main goals of the Gianni Bonadonna Foundation: to endorse therapeutic innovation from the earliest phases of research, to achieve the best results in favor of cancer patients" declared Dr. Luca Gianni, President of Gianni Bonadonna Foundation.

Dr. Diego Tosi, Gianni Bonadonna Foundation’s scientific coordinator and head of the Early Clinical Trial Unit-Medical Oncology Department of the Cancer Institute of Montpellier in France, has been entrusted with the international direction of this first-in-human clinical trial, conducted in French and Italian Oncological Centers. "This is the first drug with this type of mechanism of action", Diego Tosi explained. "The antitumor action seems mainly due to the effect on the membrane receptors, and the drug is highly effective in the preclinical setting; there are less data on how the immune response is modified, but our research will try to find answers".

Phost’in Therapeutics has also appointed contract research organization ("CRO") Michelangelo Tech Srl (Milan, Italy) to coordinate the PhAST trial. Owned by the Michelangelo Foundation with the aim of contributing to progress in cancer research and improving treatment options for tumors, Michelangelo Tech Srl provides extensive expertise in early phase clinical development, precisely to favor the rapid clinical application of new therapies.

About PhOx 430 treatment
The aberrant, complex and hypersialylated glycosylation of tumor cells is now recognized as a novel immune checkpoint, affecting key membrane receptors and masking tumor cells from the immune system, via the formation of complex abnormal glycan patterns operating as a shield. PhOx430 targets this aberrant glycosylation directly to the source through selective inhibition of a specific enzyme for a double antitumor effect, inducing simultaneously an anti-cancer immune response and the down regulation of the main receptors implicated in cancer. PhOx430 is the first program from the Phost’ScreenTM platform that combines unique and patented chemical libraries with cutting-edge screening tools to produce selective n-glycosylation inhibitors.

On June 7, 2022 Elevar Therapeutics has reported the Phase II clinical trial results of its small-molecule tyrosine kinase inhibitor (TKI) rivoceranib in progressive recurrent or metastatic adenoid cystic carcinoma (R/M ACC) patients (Press release, Elevar Therapeutics, JUN 7, 2022, View Source [SID1234615922]).

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The open-label Study RM-202 of the orally administered TKI was carried out at 11 sites in the US and South Korea.

It has been designed to investigate the therapy’s safety and efficacy in patients with progressive R/M ACC.

Study RM-202 evaluated rivoceranib in 80 patients, including 53 (66.3%) based in the US.

Within six months before the trial, all the participants demonstrated tumor progression.

An overall response rate (ORR) of 15.1% was observed in the trial, and the remaining 85% of patients had a tumour size reduction, though not an endpoint of the trial.

Elevar Therapeutics CEO Saeho Chong said: "With every participant exhibiting a recent growing lesion upon entering this Phase II trial of rivoceranib, these results demonstrate significant clinical effectiveness and rivoceranib’s promise as a potential new treatment for patients with R/M ACC.

"Our entire Elevar team is greatly encouraged by these results, and we are fully focused on advancing rivoceranib through the regulatory process."

In this trial, 52% of subjects reported a response according to CHOI (size or density), which is believed to be more correlated with median overall survival (mOS) than RECIST v1.1 (size only).

Irrespective of previous vascular endothelial growth factor (VEGFR) therapy, median progression-free survival (mPFS) of nine months was observed versus published data of a baseline of 2.8 months for R/M ACC.

On June 7, 2022 Immatics N.V. (Nasdaq: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, and Editas Medicine, Inc. (Nasdaq: EDIT), a leading genome editing company, reported that the two companies have entered into a strategic research collaboration and licensing agreement to combine gamma-delta T cell adoptive cell therapies and gene editing to develop medicines for the treatment of cancer (Press release, Immatics, JUN 7, 2022, View Source [SID1234615687]). As part of the licensing agreement, Immatics gains non-exclusive rights to Editas Medicine’s CRISPR technology and intellectual property. Editas Medicine is the exclusive licensee of Harvard and Broad Institute’s Cas9 patent estates and Broad Institute’s Cas12a patent estate for human medicines.

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By combining Editas Medicine’s gene editing technology with Immatics’ ACTallo allogeneic, off-the-shelf adoptive cell therapy platform based on gamma-delta T cells, gamma-delta T cells can be redirected to cancer cell targets with the goal of creating cells with enhanced tumor recognition and destruction.

"Engineered cell therapies have the potential to significantly impact the treatment paradigm for cancer, and our partnership with the esteemed team at Editas Medicine will provide us with further versatility and flexibility in how we engineer our ACTallo cell therapies based on a specific tumor target," said Rainer Kramer, Ph.D., Chief Business Officer, Immatics. "It has always been our focus to deliver innovative science to cancer patients and this collaboration with Editas Medicine will enable us to access CRISPR technologies and apply them to our off-the-shelf gamma-delta T cell platform."

"We believe that our gene editing technology can modulate and enhance the potential of cell therapies to deliver transformative medicines for the treatment of cancer. We are excited to work with the team at Immatics to develop new experimental medicines with enhanced tumor fighting abilities to help patients with cancer," said Gilmore O’Neill, M.B., M.M.Sc., President and Chief Executive Officer, Editas Medicine.

Under the terms of the agreement, Editas Medicine will be eligible to receive an undisclosed upfront cash payment as well as additional milestone payments based on development, regulatory, and commercial milestones. In addition, Immatics will pay royalties on future net sales on any products that may result from this collaboration.

On June 7, 2022 Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a biopharmaceutical company focused on autoimmune diseases reported that Dr. Hubert Chen, MD has joined the company as Chief Scientific Officer and President (Press release, Tocagen, JUN 7, 2022, View Source [SID1234615705]).

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"Dr. Chen is a very accomplished drug development scientist and physician and we are very fortunate that he has agreed to join the Forte team," said Paul Wagner, Ph.D., CEO of Forte Biosciences. "This is a very exciting time for Forte and having Dr. Chen join us in this important leadership position reinforces our confidence in the future of Forte."

Prior to joining Forte, Dr. Chen was the Chief Medical Officer of Metacrine, a clinical-stage company focused on the treatment of liver and gastrointestinal diseases. Prior, he was the Chief Scientific and Medical Officer of Pfenex, where he successfully designed and executed the clinical, nonclinical, and regulatory approval strategy for PF708, a teriparatide injectable for the treatment of high-risk osteoporosis, leading to NDA approval in 2019 and MAA approval in 2020. Additional experiences include serving as vice president of clinical development at Aileron Therapeutics, vice president of translational medicine at Regulus Therapeutics, and senior director of clinical research at Amylin Pharmaceuticals. Dr. Chen received his medical training at UCSF and Massachusetts General Hospital, M.D. from Columbia University, and B.A.S. in political science and biology from Stanford University.