On June 29, 2022 CanariaBio Inc. (developing its biotechnology assets through its subsidiaries, MH C&C and OncoQuest Pharma US Inc.) reported that it has reached 50% of target enrollment of 602 patients for its pivotal Phase III clinical study of its lead product oregovomab, in combination with standard of care chemotherapy (carboplatin and paclitaxel) for the treatment of front-line advanced ovarian cancer patients (Press release, CanariaBio, JUN 29, 2022, View Source [SID1234616385]).

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This double blind and placebo controlled multinational trial (FLORA-5, GOG-3035, NCT04498117) is currently accruing patients at over 137 centers in Argentina, Belgium, Brazil, Canada, Chile, Czech Republic, Hungary, Italy, Korea, Mexico, Poland, Spain, Taiwan and US; with additional sites in India and Romania being activated. This study seeks to confirm the observations of Brewer et al (Gynecology Oncology 2020 156:523-529) that demonstrated oregovomab in combination with carboplatin and paclitaxel improved both progression free and overall survival relative to chemotherapy which was statistically significant and clinically meaningful in the absence of incremental toxicity.

For this ongoing Phase-III study, the last Independent Data Safety Monitoring Board (IDSMB) meeting held in March 2022 identified no safety concerns and IDSMB recommended to continue the study without modifications.

"We are excited about reaching this important milestone, which is a testament of the hard work that all our investigators, GOG leadership, team members and collaborators has put in, and are grateful to the patients that have participated in the study," said Dr. Sunil Gupta MBBS, FRCPC, Chief Medical Officer of OncoQuest Pharma US, Inc. (a subsidiary of CanariaBio Inc.) "We remain on track with our projected enrollment, and we are excited about the potential benefits that our drug may bring to patients with ovarian cancer."

About Oregovomab.
Oregovomab is a murine IgG against CA 125. Indirect immunization with oregovomab interacts with immune modulating properties of infused paclitaxel and carboplatin resulting in synergistic clinical benefit as observed in a phase 2 trial. In a randomized Phase 2 clinical trial of 97 patients, treatment with Oregovomab in combination with chemotherapy had demonstrated a highly statistically significant and clinically meaningful outcome for both progression-free and overall survival compared to standard of care chemotherapy (carboplatin and paclitaxel). The risk of progression and of death was reduced by more than 50% when compared to control arm, and safety data showed that oregovomab did not add incremental toxicity to the chemotherapy regimen. Clinical and translational results were published in Gynecology Oncology 2020 156:523-529) and Cancer Immunology and Immunotherapy 2020 69: 383-397, respectively. To learn more, visit www.FLORA-5.com.

On June 29, 2022 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that its novel inhibitor of the embryonic ectoderm development (EED) protein, APG-5918, has been cleared by the US Food and Drug Administration (FDA) to enter a first-in-human (FIH) study that will assess the safety, pharmacokinetics, and preliminary efficacy of APG-5918 in patients with solid tumors or hematologic malignancies (Press release, Ascentage Pharma, JUN 29, 2022, View Source [SID1234616384]).

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This multicenter, open-label Phase I study is designed to assess the safety and tolerability, and determine the dose-limiting toxicity, maximum tolerated dose, and recommended Phase II dose (RP2D) of orally administered APG-5918. Prof. Joseph Paul Eder, Clinical Director of the Early Drug Development Program at Yale Cancer Center will be the Principal Investigator of this multicentric clinical trial.

EZH2, which is highly expressed in multiple tumors in humans, was found to promote the development and progression of tumors, and the targeted inhibition of EZH2’s methyltransferase activity has already been proven as an effective mechanistic approach for cancer treatment. However, the secondary mutation of EZH2 may lead to acquired drug resistances, while the homologous EZH1 also has methyltransferase activity that could limit the effects of EZH2 inhibitors. Furthermore, EED protein can stimulate the methyltransferase activity of EZH2, thus making the allosteric targeting of EED an effective approach. EED inhibitors have shown good therapeutic potential in many kinds of solid tumors and hematologic malignancies.

Discovered and developed by Ascentage Pharma, APG-5918 is an orally active, potent, selective, small-molecule EED inhibitor with high binding affinity. As an allosteric inhibitor, APG-5918 selectively binds to the EED protein. By regulating tumor epigenetics and microenvironment, APG-5918 can potentially overcome tumor resistance and deliver complete and durable tumor regression.

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, commented, "I am excited that we are poised to initiate the FIH study of APG-5918 under the leadership of Prof Paul Eder. In preclinical studies, APG-5918 showed potent binding activity with the EED protein, in vitro antiproliferative activity, and in vivo antitumor activity."

"We look forward to advancing the clinical development of APG-5918 to hopefully bring clinically meaningful benefits to patients as early as possible", added Prof Paul Eder.

On June 29, 2022 TAE Life Sciences (TLS), a biological-targeted radiation therapy company developing next-generation boron neutron capture therapy (BNCT), reported in vivo and in vitro boron delivery data using the company’s novel compounds at the 60th Particle Therapy Co-Operative Group (PTCOG) Conference, occurring June 27 – July 2, 2022 (Press release, TAE Life Sciences, JUN 29, 2022, View Source [SID1234616383]).

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"The identification of these targeted drugs as alternatives to boron phenylalanine (BPA) coupled with the development of a modern neutron source have the potential to provide a paradigm shift in cancer treatment," said Bruce Bauer, PhD, CEO of TAE Life Sciences. "We are committed to developing BNCT as a treatment modality for difficult to treat tumors and bringing new hope to patients."

Title: Development of a novel accelerator system and new targeted drugs for BNCT
Abstract Number: PTC60-0255
Session Title: Boron Neutron Capture Therapy
Presenter(s): Michael Sandhu, Vice President of Business Development, EMEA, TAE Life Sciences
Date: Wednesday, June 29, 2022
Time: 17:51 – 17:59

About BNCT

BNCT is a combination treatment based on the reaction that occurs when a non-toxic compound containing boron-10 is irradiated with a low-energy neutron beam. BNCT differs radically from other radiation therapy and shows promise in becoming the next-generation cancer treatment. Research has shown BNCT has the capability of killing cancer cells that are resistant to traditional radiation therapy with limited harm to healthy tissue. Current advances in both neutron radiation technology and medicinal boron drug targeting are enabling BNCT’s potential to improve patient care while also improving treatment economics. To date, approximately 2,000 patients have been treated with BNCT at research sites worldwide.

On June 29, 2022 Bayer AG reported the opening of its new Research and Innovation Center at Kendall Square in Boston-Cambridge, Massachusetts (U.S.A.), expanding the company’s footprint into one of the world’s most innovative pharmaceutical research and development locations (Press release, Bayer, JUN 29, 2022, View Source [SID1234616381]). Representing a total $140M USD investment into the area, Bayer’s 62,100-square-foot facility houses a new center of precision molecular oncology research equipped with state-of-the-art laboratories and offices for the development of novel targeted cancer therapies for patients. In addition, the center comprises a newly established research team focused on leveraging chemical biology techniques to further propel the company’s oncology drug development process.

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"Our new Bayer research and innovation center at Kendall Square is part of our strategy to be at the forefront of scientific discovery and breakthrough innovation for better patient healthcare," said Stefan Oelrich, Member of the Board of Management, Bayer AG and President of Bayer’s Pharmaceuticals Division. "Being part of this unique innovation ecosystem will support our teams in creating breakthrough innovations for patients together with the experts here."

"Bayer is undergoing significant growth in the United States in both research and development and our commercial operations," said Sebastian Guth, Ph.D., President of Bayer Pharmaceuticals, Americas Region. "The opening of our new precision molecular oncology research center in Kendall Square reflects the deep commitment Bayer is making to scale our oncology presence in the United States. It also builds on collaborations already in place in Boston in cardiovascular, another key area of focus for Bayer, with our with joint laboratories in precision cardiology with the Broad Institute of MIT and Harvard."

Spanning across two floors, the new center currently provides space for 100 employees, while the company is prepared to fill an additional 50 roles in the coming months. It is designed to enhance the collaboration between Bayer research and development, its internal partners such as BlueRock Therapeutics, Asklepios BioPharmaceutical (AskBio) and Vividion Therapeutics, as well as external partners to accelerate the development of transformative treatments for patients. In addition to the new center at Kendall Square in Cambridge, Bayer has also established strategic research collaborations with top scientific partners in Boston, including joint laboratories in the areas of lung disease with Brigham and Women’s Hospital and Massachusetts General Hospital and precision cardiology with the Broad Institute of MIT and Harvard.

The Research and Innovation Center also marks a strategic investment into Bayer’s oncology innovation to transform healthcare for people living with cancer worldwide, and at the same time to, ensure sustainable long-term growth for the company. Striving to become a top 10 oncology company by 2030, Bayer is investing a significant portion of its global R&D budget toward oncology. The new precision molecular oncology research center will drive the development of targeted next-generation cancer therapies, including efforts to help people living with cancer benefit from molecular tests and targeted treatments through biomarker testing.

Bayer has a 160-year track record of delivering scientific innovation for patients in areas of high medical need and has long embraced external innovation and partnering. Since 2020, Bayer has secured more than 40 transactions in business development and licensing and has invested $1.2B USD in innovative healthcare companies through Leaps by Bayer. The new center is expected to play a role for future partnering investments and collaborations.

With this new center, Bayer is expanding its operations in the leading life sciences cluster worldwide. Boston-Cambridge is home to approximately 1,000 biotechnology companies, with Kendall Square being the center of pharmaceutical innovation on the East Coast of the USA. The company is now present in four of the largest biotechnology hubs in the United States – Boston, San Francisco, San Diego and Research Triangle Park, NC.

On June 29, 2022 Fuzionaire Diagnostics, Inc. ("Fuzionaire Dx") reported a collaborative research agreement with McMaster University ("McMaster") under which theranostic radiopharmaceuticals developed with Fuzionaire Dx’s HetSiFA platform will be evaluated at McMaster’s comprehensive preclinical nuclear medicine facilities (Press release, Fuzionaire Diagnostics, JUN 29, 2022, View Source [SID1234616380]).

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The collaboration expands Fuzionaire Dx’s capabilities to evaluate oncologic theranostics made from its HetSiFA platform. The collaboration will begin with the biological and preclinical evaluation of multiple theranostic candidates targeting an undisclosed type of cancer and selection of promising candidates for further development.

Fuzionaire Dx creates theranostic candidates by combining its HetSiFAs, or heteroaromatic silicon-fluoride acceptors, with cancer-targeting peptides and other ligands. With the HetSiFA library, new theranostic candidates are created within weeks. The HetSiFA platform is compatible with fluorine-18, the leading radionuclide used in positron-emission-tomography (PET) imaging, and leading alpha- and beta-emitting radionuclides used for therapy, providing unique flexibility in creating new candidates.

Theranostics is a term that describes a "see it, treat it" approach to cancer that uses one radioactive drug to reveal tumor locations and a second radioactive drug to deliver therapy that kills cancer cells.

Primary leadership for the scientific collaboration includes Christopher Waldmann, PhD, Chief Scientific Officer of Fuzionaire Dx, and Saman Sadeghi, PhD, Associate Professor, Chemistry & Chemical Biology, and Principal Investigator, Radiochemistry & Radiopharmaceuticals, at McMaster University.