On May 23, 2022 Alpha Tau Medical, the developer of the pioneering alpha-radiation cancer therapy Alpha DaRT, reported that the first patients in its French multicenter trial for skin cancer were treated with Alpha DaRT, at the Leon Berard Center in Lyon, France by Dr. Pascal Pommier and his team (Press release, Alpha Tau Medical, MAY 23, 2022, View Source [SID1234614939]). The Leon Berard Center specializes in radiotherapy for cancer and is affiliated with the National Federation of Cancer Centers in France – UNICANCER Group. Dr. Pommier is the Principal Investigator of the French multicenter study and has more than 20 years of experience in radiation oncology and leading clinical trials.

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The trial is currently being conducted at six cancer centers in France, on patients with malignant cutaneous lesions (including SCC, BCC, lentigo maligna melanoma, and carcinosarcoma), and is evaluating two cohorts: (1) newly diagnosed patients (up to 49 subjects), and (2) patients with locally recurrent disease (36 subjects). The primary effectiveness endpoint is the assessment of the overall response rate using RECIST criteria, 9 to 11 weeks after Alpha DaRT source insertion.

Alpha Tau CEO Uzi Sofer remarked, "We are thrilled to have our first patients treated in this important French multicenter study, our first protocol assessing first-line treatment irrespective of other available standard-of-care therapies. I want to thank Dr. Pascal Pommier for leading the study and successfully delivering treatment to the first two Alpha DaRT patients in France."

"It is very exciting to offer an innovative treatment, such as the Alpha DaRT, to cancer patients who may not have other attractive treatment alternatives," added Dr. Pascal Pommier. "This novel application of alpha radiation aims to utilize a focused and highly powerful radiation that may destroy tumors while minimizing toxicity. I found the treatment simple and straightforward, and look forward to helping other patients soon using the Alpha DaRT."

"With our international clinical study program progressing in several countries, we look forward to producing results on a larger scale in France with Dr. Pascal Pommier and his experienced staff," said Alpha Tau CMO, Dr. Robert Den.

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral insertion of radium-224 impregnated seeds. When the radium decays, its short-lived daughters are released from the seed, and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

On May 23, 2022 INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help protect people from infectious diseases and treat people with cancer and HPV-associated diseases, reported that Jacqueline Shea, Ph.D., President and CEO, and Jeffrey Skolnik, M.D., SVP of Clinical Development for Oncology and HPV Therapeutics, are scheduled to participate in a fireside chat and 1×1 investor meetings at the Jefferies 2022 Healthcare Conference on Wednesday, June 8th, 2022 at 1:00 PM EDT (Press release, Inovio, MAY 23, 2022, View Source [SID1234614935]).

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Jefferies 2022 Healthcare Conference
Date: Wednesday, June 8, 2022
Time: 1:00 PM EDT
Presentation Format: Fireside Chat

A webcast of the presentation will be available through the INOVIO Investor Relations Events page at View Source The presentation time is subject to change.

On May 23, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported acceptance of its abstract titled, "CD206 Targeted Delivery of Bisphosphonate Payloads Alter Human Macrophage Phenotypes Towards M1-like" for presentation of a poster at this year’s Tumor Myeloid-Directed Therapies Summit (Press release, Navidea Biopharmaceuticals, MAY 23, 2022, View Source [SID1234614934]).

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The 2nd annual Tumor Myeloid-Directed Therapies Summit meeting will be held June 14-16, 2022 in Boston, MA. The presentation will take place Tuesday, June 14. Meeting information can be found on the conference website (View Source).

The poster will present information related to the synthesis of two novel bisphosphonate drugs that have been attached to Navidea’s CD206-targeted drug delivery platform molecule, Manocept. These constructs use a novel degradable linker to release the therapy only once they have been internalized into a CD206-expressing cell, such as a tumor associated macrophage. The new therapeutic constructs were evaluated in human macrophage cell culture assays to compare the ability of the new constructs with unbound free therapy to shift the phenotype of macrophages toward a proinflammatory gene expression pattern. The new drug delivery constructs successfully shifted the phenotypes of human macrophages towards a proinflammatory state and compared favorably to the unbound free therapy. The new drug constructs also induced a highly significant reduction in macrophage expression of signal regulatory protein alpha ("SIRPα"), the receptor for the "don’t eat me" signal that, when activated, suppresses the ability of macrophages to attack and phagocytize disease associated cells such as cancer cells. The ability to induce this type of phenotypic change in macrophages could have far-reaching applications in cancer immunotherapy.

Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "These new therapeutic constructs demonstrate the power of our adaptable platform technology to deliver a wide array of small molecule payloads in a targeted fashion to macrophages involved in the propagation of a variety of severe illnesses including cancer."

On May 23, 2022 Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, reported the publication of findings from a preclinical study showing enhanced anti-tumor function and eradication of solid tumors by combining its Amphiphile (AMP) platform vaccine, carrying cognate peptide and adjuvant cargos, with T cell receptor T cell therapies (TCR-Ts) (Press release, Elicio Therapeutics, MAY 23, 2022, View Source [SID1234614933]). These results, co-authored by Drs. Dylan Drakes and Peter DeMuth, with Elicio colleagues, were published in the preprint server, bioRxiv, and can be found here.

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"The AMP platform continues to show boosting capabilities in our preclinical studies of cancer immunotherapies by successfully targeting the lymph nodes," said Peter DeMuth, Ph.D., Chief Scientific Officer. "T cell receptor (TCR)-modified T cell therapies have historically shown promise but challenges to clinical efficacy against solid tumors persist. Often, suboptimal clinical performance can be attributed to insufficient in vivo persistence of current treatments and tumor antigen escape. With this study, we’ve shown that combining TCR-T cell therapies with our lymph node targeted AMP-vaccines can overcome these challenges to significantly improve preclinical efficacy in animal models of solid tumors."

Robert Connelly, Chief Executive Officer at Elicio, added, "Our AMP platform has huge potential to address some of the major challenges that continue to plague the field of immuno-oncology. We are delighted to share the results of this study because it provides rationale and evidence to support combining our AMP-peptide vaccine with TCR-T cell therapies to augment clinical responses."

About the Amphiphile Platform
Our proprietary Amphiphile, or AMP, platform delivers investigational immunotherapeutics directly to the "brain center" of the immune system – the lymph nodes. We believe this site-specific delivery of disease-specific antigens, adjuvants and other immunomodulators may efficiently educate, activate and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability. We believe our AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes.

Our AMP platform, originally developed at the Massachusetts Institute of Technology, or MIT, has broad potential across cancers, infectious diseases and other disease indications to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.

The Amphiphile platform has been shown to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. In preclinical models, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability.

On May 23, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the US Food and Drug Administration (FDA) has accepted and filed the Biologics License Application (BLA) for mirvetuximab soravtansine monotherapy in patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with 1 to 3 prior systemic treatments (Press release, ImmunoGen, MAY 23, 2022, View Source [SID1234614932]). The application has been granted Priority Review designation and FDA has set a Prescription Drug User Fee Act (PDUFA) action date of November 28, 2022.

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"FDA’s acceptance of our BLA under Priority Review reinforces our belief in the potential for mirvetuximab soravtansine to serve as a new standard of care for patients with FRα-high platinum-resistant ovarian cancer," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "We are pleased to be one step closer to realizing the promise of our technology and are working closely with FDA to support the evaluation of our application. We are moving quickly to build out the commercial and medical infrastructure required for a successful launch and look forward to the prospect of delivering mirvetuximab soravtansine to patients later this year."

Priority Review designation is granted to applications for therapies that may offer significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications and shortens the FDA review period to six months following acceptance.

The BLA seeks approval of mirvetuximab soravtansine under the FDA’s accelerated approval pathway, which was instituted to allow for expedited development of drugs that treat serious conditions and provide a meaningful advantage over available therapies based on a surrogate endpoint and is based on results from the pivotal Phase 3 SORAYA trial. Top-line data from SORAYA were announced in November 2021 and full data from the study were presented at the Society of Gynecologic Oncology (SGO) 2022 Annual Meeting. ImmunoGen continues to enroll patients in the confirmatory MIRASOL trial, which is intended to convert the potential accelerated approval to full approval, and expects to announce top-line data from this study in early 2023.

ABOUT MIRVETUXIMAB SORAVTANSINE
Mirvetuximab soravtansine (IMGN853) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin-targeting agent, to kill the targeted cancer cells.