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 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 22, 2024 Oncopeptides, a biotech company focused on difficult-to-treat cancers, reported entry of the first patient in a new study evaluating the real-world effectiveness and safety of Pepaxti in German patients (Press release, Oncopeptides, JUL 22, 2024, View Source [SID1234646794]). The study, which will include 100 patients across around 50 sites in Germany, aims at gathering evidence on Pepaxti’s effectiveness and safety in a real-world clinical practice and is the first Pepaxti study engaging treating physicians at multiple German sites.

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The study, named HARBOUR, will assess real-life clinical outcomes of Pepaxti treatment of patients suffering from refractory, relapsed multiple myeloma (RRMM) in a patient population that mirrors the indication of Pepaxti. The study marks another step forward in Oncopeptides’ ongoing efforts to strengthen the medical understanding of Pepaxti and will support the evidence base for the Pepaxti indicated population.

"Initiating the HARBOUR study with the enrollment of the first patient is a pivotal step forward to address the unmet needs of RRMM patients," says Dr. med. Johannes Waldschmidt, the Scientific Leader of the study from Universitätsklinikum Würzburg, Germany. "This partnership with Oncopeptides offers an opportunity for the German medical community to contribute to significant advancements in myeloma treatment and patient care."

"Our aim is to understand the performance of Pepaxti in the real world. It is important evidence to generate, not only for the German market but for the full European commercialization," says Sofia Heigis, CEO of Oncopeptides. "We are happy to for the first time initiate a study across Germany and also the very first study that is fully focused on our target population."

For more information, please visit the German Clinical Trials Register or Oncopeptides’ web site where questions and answers for investors will also be published.

On July 22, 2024 TransCode Therapeutics, Inc. (Nasdaq: RNAZ) ("TransCode" or the "Company"), a clinical-stage RNA oncology company committed to more effectively treating cancer using RNA therapeutics, reported that it intends to offer to sell shares of its common stock (and/or pre-funded warrants ("Pre-funded Warrants") in lieu thereof) in a best efforts public offering (Press release, TransCode Therapeutics, JUL 22, 2024, View Source [SID1234645046]). All of the shares of common stock (and/or Pre-funded Warrants) are to be sold by the Company.

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ThinkEquity is acting as the sole placement agent for the offering.

The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. The Company intends to use the net proceeds from the offering primarily for product development activities, including one or more clinical trials with TTX-MC138, its lead therapeutic candidate, and related investigational new drug (IND) enabling studies, and for working capital and other general corporate purposes.

The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-268764), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on December 13, 2022, and declared effective on December 16, 2022. The offering will be made only by means of a written prospectus forming part of the effective shelf registration statement. A preliminary prospectus supplement describing the terms of the offering, and an accompanying prospectus has been or will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. Before investing in this offering, interested parties should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such preliminary prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

On July 22, 2024 NorthStar Medical Radioisotopes, LLC (NorthStar) and BWXT Medical Ltd., a subsidiary of BWX Technologies, Inc. (NYSE: BWXT) reported that they have signed a Master Services Agreement (MSA), which will facilitate the production of actinium-225 (Ac-225), a critical medical isotope used to kill cancer cells while minimizing the impact to healthy tissues (Press release, NorthStar Medical Radiostopes, JUL 22, 2024, View Source [SID1234645010]).

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Medical isotopes are essential for a wide range of diagnostic and therapeutic procedures, including cancer treatments and advanced imaging techniques. Pursuant to the multi-year MSA, the companies will work together to process and purify radium-226 that will be irradiated to produce Ac-225. The scope of the agreement also includes potential target design projects and exploration of opportunities to provide backup supply to each other’s customers.

Jonathan Cirtain, president and chief executive officer of BWXT Medical, stated, "We are pleased to enter into this agreement with NorthStar. This collaboration is a significant step forward in our mission to support healthcare providers and patients by providing high-quality medical isotopes. Together, we are accelerating our radium-226 target design and fabrication efforts and establishing another irradiation relationship that will enable us to expand our production of Ac-225."

BWXT Medical will collaborate closely with NorthStar, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, to streamline production processes, enhance safety protocols and innovate new methods of isotope generation. This collaboration will leverage the strengths of both organizations, combining cutting-edge technology with extensive industry knowledge.

"At NorthStar, we believe we’re on the cusp of a global paradigm shift in the development and commercialization of effective new radiodiagnostics and radiotherapies that can potentially be applied to devastating cancers and rare, complex conditions," said Dr. Frank Scholz, NorthStar’s president and chief executive officer. "This agreement could be instrumental to the radiopharmaceutical industry and patient health. We are excited to collaborate with BWXT on actinium production and believe our complementary technical capabilities will play a critical role in bringing novel therapies to patients who so urgently need them."

BWXT Medical recently announced that it has submitted a Drug Master File (DMF) for Actinium-225 API to U.S. Food and Drug Administration (FDA). DMFs are submissions to FDA used to provide confidential, detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of human drug products.

An active DMF enables clinical investigators or pharmaceutical companies to reference the filing in their regulatory submissions. BWXT Medical’s Ac-225 has been used in an early clinical study, and the DMF is now ready for reference to support later stage clinical studies and, ultimately, new drug applications.