Fapon Biopharma’s Anti-CD47 Antibody FP002 Earns IND Approval from FDA

On February 22, 2023 Fapon Biopharma, an innovative biotech company, reported that its Investigational New Drug (IND) application of FP002, an anti-CD47 monoclonal antibody drug candidate, has been approved by FDA for clinical trials (Press release, Fapon Biopharma, FEB 22, 2023, View Source [SID1234634116]).

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FP002 is a humanized anti-CD47 IgG4 monoclonal antibody, developed and patented by Fapon Biopharma. It binds strongly to the CD47 protein on the surface of tumor cells, and weakly to human red blood cells. This novel antibody does not cause hemagglutination. It has proven to be safe, and in comparison with similar products, have shown better efficacy in multiple tumor models in preclinical research. In demonstrating stronger anti-tumor efficacy and higher reliability, FP002 shows great potential in becoming the best-in-class drug worldwide.

Under this IND, the Company intends to initiate a single-armed, dose escalation and dose expansion study to investigate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) activity of FP002 in subjects with advanced malignancies. Apart from the FDA submission, it has also been submitted for IND application in China.

"The FDA approval to commence our clinical trial for FP002 is a significant milestone for Fapon Biopharma," said Vincent Huo, President of Fapon Biopharma. "This is our first project that includes IND application in both China and the US. With our cutting-edge technology platform and a competitive pipeline, we are committed to enabling more reliable and affordable biologics for patients all over the world."

BioInvent International AB Year-end report January 1 – December 31, 2022

On February 22, 2023 BioInvent reported its year-end report January 1 – December 31, 2022 (Presentation, BioInvent, FEB 22, 2023, https://www.bioinvent.com/sites/bioinvent/files/pr/20230222-b063fc0d-51a7-495f-8413-79f7771ad6b9-1.pdf?ts=1677049214 [SID1234630378]).

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Initial Results From First Patient Dosed With Perspective Therapeutics’ Lead Drug VMT-?-NET Presented at The Treatment of Neuroendocrine Disorders at the 2023 PET/RTRC Annual Workshop Scientific Session

On February 22, 2023 Perspective, Therapeutics, Inc. (formerly known as "Isoray, Inc.") (NYSE AMERICAN: CATX), a precision oncology company developing alpha-particle therapies and complementary diagnostic imaging agents and an innovator in seed brachytherapy powering expanding treatment options for multiple cancers, reported the presentation of extremely encouraging results regarding 212Pb-VMT-α-NET, its lead preclinical candidate for neuroendocrine tumors (NET), currently being used therapeutically in India on a compassionate use basis (Press release, Perspective Therapeutics, FEB 22, 2023, View Source [SID1234628315]). Dr Vikas Prasad presented the results at the 2023 PET Radiotracer Translation and Resource Center (PET-RTRC) Workshops & Scientific Session hosted by the Mallinckrodt Institute of Radiology (MIR) at Washington University in St. Louis.

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Highlights of the presented results include:

The result from first patient dosed with 212Pb-VMT-α-NET in India on a compassionate use basis showed favorable responses after the first dose.
The initial response was measured by a somatostatin imaging agent 68Ga-DOTANOC and demonstrated encouraging results after a single low dose of 212Pb-VMT-α-NET.
Dr. Prasad noted, "The patient data gathered in the clinic under a compassionate use basis is not only remarkable but an extremely encouraging sign for Perspective Therapeutics’ VMT-α-NET program for the treatment of neuroendocrine tumors. Despite advancement in traditional therapies, novel approaches and therapies are required to further increase patients’ overall survival and improve quality of life. There is an urgent need of bringing these kind of therapies in the first line of management of functionally active neuroendocrine tumors."

Dr. Vikas Prasad, MD, who is an Associate Professor of Radiology, Mallinckrodt Institute of Radiology (MIR), Washington University School of Medicine in St. Louis, presented the 212Pb- VMT-α-NET results. Prior to MIR, Dr. Prasad subsequently performed the first human images of 203Pb-VMT-α-NET while serving as MD, Vice Chair in the Department of Nuclear Medicine at the University Hospital of Ulm, Ulm, Germany.

"We are grateful that the science and medicine that is in development at Perspective Therapeutics has provided a meaningful intervention in a NET patient’s care journey. The results give us hope that we are standing at the beginning of a new era of precision oncology medicine. We look forward to continuing the progress of our pipeline of targeted radiopharmaceuticals for imaging and therapeutic use," said Mr. Thijs Spoor, CEO of Perspective Therapeutics.

VMT-α-NET is being developed for the treatment and diagnosis of somatostatin receptor subtype 2 (SSTR2) expressing neuroendocrine tumors, which are a rare and difficult-to-treat type of cancer. The dosed patients were diagnosed with confirmed-advanced somatostatin expressing neuroendocrine tumors (NETs). In early December, VMT-α-NET, the Company’s lead drug for the treatment of neuroendocrine tumors was administered to patients in India on a compassionate use basis, independent of a planned U.S. trial. No acute adverse reactions were observed post administration and patients remained stable and in good condition.

The administration of VMT-α-NET was performed under the supervision of the patients’ doctor, Dr. Ishita Sen MBBS, DRM, DNB, Director and Head of Nuclear Medicine at Fortis Hospital, New Delhi, in partnership with BJ Madan, a diagnostic & therapeutic radiopharmaceutical company in New Delhi. Radiopharmaceutical was produced (under the direction of Dr. Sen) by Dr. Parul Thakral Dash PhD and administered following appropriate quality control testing. Patients were imaged immediately prior to their first therapeutic dose and immediately prior to the second therapeutic dose. The results seen between the 1st and 2nd doses implied that the patients had a strongly favorable response which was unexpected at such low doses of the drug. Dr. Sen expressed her pleasure at the patients’ progress and said, "Preclinical and clinical data associated with this new radiopharmaceutical demonstrates significant potential to help our NET patients."

Under compassionate use circumstances, VMT-α-NET may be made available to qualified doctors in some countries. In this circumstance, Perspective Therapeutics (formerly Viewpoint Molecular Targeting, Inc.) supplied drug precursors and isotopes for the local production of its proprietary radiotherapeutic, VMT-α-NET. The safety and effectiveness of the treatments will be evaluated by Dr. Sen’s team with laboratory testing, observation of NET-associated symptoms, and repeat medical imaging.

In the U.S., VMT-α-NET will soon enter a Phase 1 imaging and therapy study to be conducted at various hospitals and clinics. The administration of VMT-α-NET for compassionate use is completely independent from and not within the scope of the Company’s Phase 1 trial.

Under compassionate use circumstances, VMT-α-NET may be made available to qualified doctors in some countries. In this circumstance, Viewpoint supplied drug precursors and isotopes for the local production of its proprietary radiotherapeutic, VMT-α-NET. The safety and effectiveness of the treatments will be evaluated by Dr. Sen’s team with laboratory testing, observation of NET-associated symptoms, and repeat medical imaging.

Contacts

Legacy Isoray Investor Relations: Mark Levin (501) 255-1910

Legacy Viewpoint Molecular Targeting Investor Relations: Chuck Padala (917) 741-7792

Media and Public Relations: Sharon Schultz (302) 539-3747

Grid Therapeutics Initiates a Phase 2 Investigator-Sponsored Trial of GT103 in Combination with Merck’s Pembrolizumab in Patients with Advanced Stage Non-Small Cell Lung Cancer

On February 22, 2023 Grid Therapeutics, LLC, a clinical stage biotechnology company developing human-derived antibodies, reported the initiation of a combination Phase 2 investigator-sponsored study of its lead asset, GT103 (Press release, Grid Therapeutics, FEB 22, 2023, View Source [SID1234627739]). In this clinical trial, Grid’s GT103, a novel, first-in-class antibody targeting complement factor H, will be administered in combination with KEYTRUDA (pembrolizumab), the anti-PD-1 therapy from Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. The trial will enroll patients with refractory non-small cell lung cancer ("NSCLC") who have progressed on no more than two lines of systemic therapy, including prior PD-1 treatment.

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"We are very excited to initiate this study to determine whether the therapy demonstrates clinical activity and tolerability observed in patients with advanced stage lung cancer in the Phase 1b study of GT103 alone"

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In this open-label, multi-center, single-arm Phase 2 clinical trial, Merck and Grid are each providing their respective drugs and funding support. This study is led by Jeff Clarke, M.D, member of the Duke Cancer Center Thoracic Clinic, Durham, NC. The study is managed by the Hoosier Cancer Research Network, a full-service contract research organization dedicated to providing efficiency and expertise in clinical trial services.

"We are very excited to initiate this study to determine whether the therapy demonstrates clinical activity and tolerability observed in patients with advanced stage lung cancer in the Phase 1b study of GT103 alone," said Dr. Clarke. "NSCLC is a difficult-to-treat cancer and patients, particularly in the relapsed/refractory setting, will benefit from novel therapeutic options to help improve disease outcomes."

About the Study

The Phase 2 open-label, clinical trial of GT103 is designed to assess the safety and tolerability of GT103 in combination with Merck’s pembrolizumab, as well as anti-tumor activity, response rates and overall survival. The study will enroll subjects with refractory NSCLC. Please refer to www.clinicaltrials.gov for additional clinical trial details.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

United Therapeutics has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

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