On July 23, 2024 Flagship Pioneering, the bioplatform innovation company, today unveiled Abiologics, a company reimagining biologics with the creation of a new class of supranatural and programmable medicines, called Synteins (Press release, Abiologics, JUL 23, 2024, View Source [SID1234645011]). Synteins are computationally-generated and synthesized with novel building blocks, endowing them with extraordinary properties to bring life-changing treatments to patients across a wide range of diseases. Flagship has initially committed $50 million to advance the company’s platform and develop a diverse pipeline of medicines, with an initial focus on oncology and immunology indications.

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"Biologics have transformed medicine in the past forty years, but only a fraction of their potential has been realized because we’ve been limited by the boundaries of nature," said Noubar Afeyan, Ph.D., Founder and CEO of Flagship Pioneering and Co-Founder and Chairman of the Strategic Oversight Board of Abiologics. "With the convergence of advancements in generative artificial intelligence, automated polymer synthesis and chemical functionalization coupled with a vision to develop more powerful medicines with unprecedented diversity, we asked, what if we could design biologics entirely from new building blocks that could overcome the most critical limitations of today’s medicines?"

The Abiologics platform is a fully integrated digital and automated wet-lab infrastructure to create supranatural biologics with powerful, desirable pharmacological properties. The platform leverages state-of-the-art generative artificial intelligence (AI) to computationally-design Synteins de novo using a broad set of artificial building blocks, far beyond the 20 naturally occurring amino acids that form the basis of today’s biologic medicines. These include biologics built with D-amino acids, chemically identical mirror images of standard amino acids. Once designed, Abiologics chemically synthesizes its digitally-optimized Synteins with pioneering new technologies. As a result, Synteins can be programmed to interact with virtually any therapeutic target while evading the body’s natural defenses. By surpassing the limitations of traditional biologics discovery tools, Abiologics is the first to discover, prototype and scale-up polymers composed solely of artificial building blocks, and to date, has successfully generated Synteins made entirely of D-amino acids that bind a diversity of therapeutically relevant targets while remaining ultrastable.

"For the first time, we are able to imagine and generate chemically synthesized biologics at scale and with increasing programmability, offering a new class of medicines with transformative potential," said Avak Kahvejian, Ph.D., Co-Founder and CEO of Abiologics and General Partner at Flagship Pioneering. "Creating protein biologics with artificial building blocks rather than naturally occurring amino acids allows Synteins to go unrecognized by the immune system, offering significant advantages compared to today’s biologics such as less frequent dosing, oral delivery and the ability to reach parts of the body that were previously impossible to access and treat. With Synteins, Abiologics is poised to bring boundary-breaking medicines to patients across a range of diseases."

In addition to Afeyan and Kahvejian, Abiologics’ founding team includes Mike Hamill, Ph.D., Chief Innovation Officer of Abiologics and Senior Principal at Flagship Pioneering, Kala Subramanian, Ph.D., Founding President of Abiologics and Operating Partner at Flagship Pioneering, Jaclyn Dunphy, Ph.D., Senior Director of Strategy and Research Operations at Abiologics, and Alicia Kaestli, Ph.D., Senior Associate at Flagship Pioneering. Bradley Pentelute, Ph.D., Professor of Chemistry at MIT, is an Academic Co-Founder of Abiologics.

On July 23, 2024 AffyImmune, a clinical-stage biotechnology company committed to developing novel, first-in-class chimeric antigen receptor (CAR) T cell therapies, reported the designation of Regenerative Medicine Advanced Therapy (RMAT) by the U.S. Food and Drug Administration (FDA) for its CAR T-cell product candidate, AIC100 as a potential treatment for patients with recurrent anaplastic thyroid cancer (ATC), the most aggressive form of the disease (Press release, AffyImmune Therapeutics, JUL 23, 2024, View Source [SID1234645027]).

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"We believe this important recognition from the FDA further supports the therapeutic potential of AIC100 to change the current treatment paradigm in advanced thyroid cancer and potentially other forms of aggressive solid tumors," said Daniel Janse, Ph.D., CEO at AffyImmune. "RMAT designation was granted following the FDA’s review of safety and efficacy data from the first ten patients dosed with AIC100 in our Phase 1 study. We believe the RMAT designation reinforces the potential ability of AIC100 to meet the high unmet medical need in recurrent ATC, an aggressive disease where a standard of care is currently not available."

RMAT designation was designed to expedite the development and review of regenerative medicine therapies. A regenerative medicine therapy is eligible for RMAT designation if it is intended to treat, modify, reverse or cure a serious condition, and preliminary clinical evidence indicates the therapy has the potential to address unmet medical needs for the disease. Sponsor companies receiving RMAT designation can benefit from increased interactions with the FDA involving senior managers, with the goal of expediting drug development.

"We remain focused on advancing the development of AIC100 for patients and families living with this devastating cancer," said Sonal Gupta, M.D., Ph.D., Senior Vice President and Head of Clinical Development. "Receiving RMAT designation helps facilitate this goal by enabling increased dialogue with the FDA to expedite our development plan for our affinity-tuned CAR T therapy. We look forward to working closely with the FDA and other regulatory agencies as we continue to advance this program."

At ASCO (Free ASCO Whitepaper) 2024, AffyImmune reported interim results from their Phase 1 study evaluating the safety and efficacy of AIC100, an ICAM-1 targeting and affinity-tuned LFA-1 binder CAR T-cell therapy, in patients with advanced thyroid cancer. Notably, a metabolic complete response was achieved in one patient with ATC, the most aggressive form of the disease.

For more information about the Phase 1 study, visit www.clinicaltrials.gov (NCT04420754).

On July 23, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that its collaborator, Moffitt Cancer Center (Moffitt), has received approval by the U.S. Food and Drug Administration (FDA) of an individual patient Investigational New Drug Application (IND) to allow a second dose of its CAR-T therapy for a patient that may be demonstrating clinical activity to the initial treatment (Press release, Anixa Biosciences, JUL 23, 2024, View Source [SID1234645012]).

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Dr. Robert Wenham, Chair, Department of Gynecologic Oncology at Moffitt, and the principal investigator of the trial, stated, "In the first cohort and at the lowest dose administered, despite an initial increase in tumor size that met criteria for progression, one patient has remained off new therapy for many months with no new disease. Even her tumor marker that was initially elevating later began to fall. A biopsy demonstrated tumor with necrosis, inflammation and T cell infiltration by Immunohistochemistry (IHC). Based on these findings, we sought approval from the FDA to administer a second treatment to her, aiming to increase the likelihood of a partial or complete response. Recently, we received that approval from the FDA."

"I am pleased with the very long duration absent of any further disease and the possible response that my patient has exhibited with this innovative therapy, as she had no other realistic options. I look forward to evaluating her progress with successive dosing, as well as future patients who have no other alternatives," stated Dr. Monica Avila, the patient’s treating oncologist.

Dr. Amit Kumar, CEO of Anixa Biosciences commented, "We were somewhat surprised and quite encouraged to see such a notable response this early, given the low dose in the first cohort. We truly hope we can help this patient, as well as all other women fighting this terrible disease."

The Phase I clinical trial at Moffitt is treating recurrent ovarian cancer patients who have failed standard-of-care therapies. To date, six patients have been treated in the dose escalation trial, three in the first cohort and three in the second cohort. Dose escalation will continue after confirming the previous dosages are safe.

On July 23, 2024 Blue Earth Therapeutics, a Bracco company and emerging leader in the development of innovative next generation therapeutic radiopharmaceuticals, reported the signing of a clinical research collaboration with University College London (UCL) (Press release, Blue Earth Therapeutics, JUL 23, 2024, View Source [SID1234645028]). The collaboration is centered on a Phase 1/2 trial designed to evaluate the safety, tolerability, radiation dosimetry and anti-tumour activity of the company’s 225Ac-rhPSMA-10.1 in men with metastatic castrate-resistant prostate cancer who have previously responded to lutetium 177 (177Lu)-PSMA therapy. The work will be conducted at the UCL Cancer Institute in London, UK, by the Treatment Resistance Group under the leadership of Professor Gerhardt Attard, MD PhD FRCP. Professor Attard is the John Black Charitable Foundation Endowed Chair in Urological Cancer Research, and is a highly regarded prostate cancer clinical trialist.

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225Ac-rhPSMA-10.1 is the second compound in Blue Earth Therapeutics’ investigational pipeline. It is based on innovative radiohybrid PSMA technology, which allows for development of therapeutic radiopharmaceuticals that may be labelled with either beta- or alpha-emitting isotopes. The pharmacokinetic profile of rhPSMA-10.1 was carefully optimised during development to maximise the retention of radioactivity in tumour deposits whilst sparing normal tissue as far as possible. Pairing these properties with longer lived isotopes like 225Ac may allow the delivery of very high radiation doses to the cancer cells. Blue Earth Therapeutics has an ongoing clinical trial underway that uses the beta-emitting radioisotope lutetium 177 (177Lu) to radiolabel rhPSMA-10.1, and is building on that work by now radiolabelling the compound with the alpha-emitting radioisotope 225Ac.

"Our goal at Blue Earth Therapeutics is to deliver precise, targeted therapy specific to a patient’s condition," said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Therapeutics. "This collaboration aims to rapidly translate alpha-labelled rhPSMA-10.1 from the laboratory to the clinic, with the hope to help patients who have advanced prostate cancer. We are delighted to collaborate with an illustrious academic institution such as UCL which is regularly ranked in the top 10 academic institutions globally, and look forward to working with Professor Attard and his group on this important UK clinical research initiative."

"We are pleased to enter into this broad research collaboration with UK-based Blue Earth Therapeutics, as both of our institutions share a vision to improve cancer treatment for patients," said Professor Attard, MD PhD FRCP. "Despite the development of several new therapeutic options for castration resistant prostate cancer in the last 20 years, treatment resistance is common and leads to thousands of premature deaths annually in the UK. Precision-delivered radiation therapy using radioligands provides an opportunity for selectively targeting resistant prostate cancer. We believe that delivery of radiation by means of alpha particles is a very promising area of research and we look forward to starting clinical testing of rhPSMA-10.1 for patients with aggressive, treatment-resistant prostate cancer."

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) compounds consist of a radiohybrid ("rh") Prostate-Specific Membrane Antigen-targeted receptor ligand, which is internalised by prostate cancer cells, which can be radiolabelled with imaging isotopes for PET imaging, or with therapeutic isotopes for therapeutic use – providing the potential for creating a true theranostic technology. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Therapeutics and Blue Earth Diagnostics work closely on the development of 177Lu‐rhPSMA‐10.1 and 225Ac-rhPSMA-10.1. rhPSMA compounds for therapeutic use are investigational agents and have not received regulatory approval.

On July 23, 2024 Evogene Ltd. (Nasdaq: EVGN, TASE: EVGN) (the "Company" or "Evogene"), a leading computational biology company targeting to revolutionize life-science-based product discovery and development utilizing cutting edge computational biology technologies, across multiple market segments, reported that a reverse share split of its issued and outstanding Ordinary Shares, at a ratio of 1-for-10, is expected to be implemented after market close on July 24, 2024 (Press release, Evogene, JUL 23, 2024, View Source [SID1234645013]). The Company’s Ordinary Shares will begin trading on the Nasdaq Capital Market on a post-reverse split basis at the market open on July 25, 2024, and on the Tel Aviv Stock Exchange at the market open on July 28, 2024, in each case under the Company’s existing trading symbol "EVGN".

The reverse share split was approved by the Company’s shareholders at the Company’s Annual Meeting of Shareholders held on June 13, 2024, to be effected at the board of directors’ discretion within approved parameters.

Following the implementation of the reverse split, the Company’s registered share capital under the Company’s amended and restated articles of association, as currently in effect (the "Articles"), which as of the date hereof consists of NIS 3,000,000 divided into 150,000,000 Ordinary Shares of NIS 0.02 par value each, will be adjusted to consist of NIS 3,000,000 divided into 15,000,000 Ordinary Shares of NIS 0.2 par value each. The reverse split will adjust the number of issued and outstanding Ordinary Shares of the Company from approximately 50,790,000 Ordinary Shares to approximately 5,079,000 Ordinary Shares (subject to any further adjustments based on the treatment of fractional shares).

No fractional Ordinary Shares will be issued as a result of the reverse split. In accordance with the Company’s Articles, all fractional shares shall be rounded to the nearest whole ordinary share, such that only shareholders holding fractional consolidated shares of more than half of the number of shares which consolidation constitutes one whole share, shall be entitled to receive one consolidated share. No cash will be paid with respect to any fractional shares. In addition, proportionate adjustments will be made to the number of shares issuable upon the exercise of all outstanding options entitling the holders to purchase Ordinary Shares (with a reciprocal increase in the per share exercise price) and to the number of Ordinary Shares underlying outstanding Restricted Share Units (RSUs).

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