Flagship Pioneering Unveils Abiologics to Pioneer Supranatural Biologics, A New Biotherapeutic Class

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.

NorthStar Medical Radioisotopes and BWXT Medical Sign Supply Agreement Supporting Actinium-225 Production

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.

Sensorion Announces Positive Recommendation From the Data Safety Monitoring Board (DSMB) Regarding the Continuation of NOTOXIS, its Phase 2a Clinical Trial of SENS-401 in Cisplatin-Induced Ototoxicity

On July 22, 2024 Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, reported that the independent Data Safety Monitoring Board (or DSMB) has undertaken a review of the safety data for the patients participating in the NOTOXIS Phase 2a Proof-of-Concept (POC) clinical study of SENS-401 for the prevention of Cisplatin-Induced Ototoxicity (CIO) (Press release, Sensorion, JUL 22, 2024, View Source [SID1234645009]).

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The DSMB has recommended the continuation of the study and confirmed the absence of any concern as to the safety of SENS-401 when administered in adult patients receiving a daily dose of 43.5 mg, administered twice daily, over a period of up to 23 weeks. Data previously published in December 2023, indicated a favorable safety profile when administered continuously for up to 11 weeks in patients receiving SENS-401.

The patient enrolment continues to progress at a steady pace, in 13 clinical centers open to date. Sensorion’s management team will report preliminary safety and efficacy data of the Phase 2a POC clinical trial of SENS-401 CIO at the World Congress of Audiology, to be held on September 19-22, 2024, in Paris, France.

The NOTOXIS Phase 2a trial is a multicenter, randomized, controlled, open-label study designed to assess the efficacy of SENS-401 in preventing cisplatin-induced ototoxicity in adult patients with neoplastic disease, four weeks after completion of cisplatin-based chemotherapy. The trial assesses several endpoints, including the rate and severity of ototoxicity, changes in pure tone audiometry (PTA) (dB) throughout the study compared to before cisplatin treatment, and tolerability.

About SENS-401
SENS-401 (Arazasetron), Sensorion’s clinical stage lead drug candidate, is an orally available small molecule that aims to protect and preserve inner ear tissue from damage responsible of progressive or sequelae hearing impairment. Sensorion currently develops SENS-401 in a Phase 2a for the prevention of residual hearing loss in patients scheduled for cochlear implantation and in a Phase 2 clinical trial for the prevention of Cisplatin-Induced Ototoxicity. SENS-401 has been granted Orphan Drug Designation by the EMA in Europe for the treatment of sudden sensorineural hearing loss, and by the FDA in the U.S. for the prevention of platinum-induced ototoxicity in pediatric population.

TCBP Announces Dosing of 6th Patient in ACHIEVE Study in Patients with Acute Myeloid Leukemia

On July 22, 2024 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported that on July 16, the sixth patient in ACHIEVE (UK) was treated (Press release, TC Biopharm, JUL 22, 2024, View Source [SID1234645008]). This is the first patient treated with a higher dose of TCB-008 post the amendment approved by the MHRA on Feb 22, 2024.

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The ACHIEVE UK clinical trial is an open-label, phase II study designed to evaluate the efficacy and effectiveness of TCB-008 in patients with AML or MDS/AML, with either refractory or relapsed disease. ACHIEVE is comprised of two cohorts representing separate disease states. The protocol allows for either cohort to be advanced as an independent Phase III Pivotal Trial upon completion of the cohort, presuming the primary efficacy endpoints is met.

Cohort A represents relapsed/refractory patients who have been unable to attain remission and are in palliative care as they are unable to tolerate further chemotherapy. Initially, 5 patients were treated at the lower dose. Up to 14 patients may be recruited into this cohort at the higher dose. Pending confirmation of the primary endpoints, a further 10 patients may be recruited into Cohort A for a total of 24 patients.

Cohort B represents patients who have attained remission following prior treatment, however, continue to have a detectable residual disease. Up to 14 patients may be recruited into this cohort at the higher dose. Pending confirmation of the primary endpoints, a further 10 patients may be recruited into Cohort B for a total of 24 patients.

Interim data review is not reliant on the completion of either Cohort, and consequently the Company is not required to complete investigation of both Cohorts prior to advancing to a Pivotal Phase 3 study in one or both Cohorts simultaneously.

Enrolled patients will be treated with an increased dose of TCB-008, containing up to 230,000,000 cells per dose compared to the previous dose of 35,000,000. The increased dose is commensurate with the proposed medium dose cohort in the Company’s FDA trial in AML. Eligible patients will receive up to three additional infusions of TCB008, starting 14 days after the previous infusion and administered every subsequent 14 days, representing a total of 4 doses of TCB-008 or approximately 1,000,000,000 cells. Details of the ACHIEVE Study can be found at View Source

"The dosing and restart of ACHIEVE represents an important milestone in our progress towards Phase 2b efficacy data in AML with an interim data announcement in the next six to nine months, as well as proof in our ability to successfully navigate potentially arduous regulatory and clinical trial environments in both ACHIEVE and ACHIEVE2," said Bryan Kobel, CEO of TC BioPharm. "In addition to dosing our 6th patient and restarting ACHIEVE, we’ve screened and enrolled additional patients into the trial and expect to dose up to 10 more in 2024 and expect to open at least one additional clinical trial site in Q3. These efforts, combined with additional refinement of TCB-008 over the last 6 months, escalating the dose size in the ACHIEVE trial and existing data, have us poised for inflection points in 2024 and confidence in our ability to continue to execute on our clinical trial plans. Based on the substantial clinical safety and efficacy data to date and encouraging tolerability information generated in the five-patient safety cohort of ACHIEVE, we are excited to realize the potential of TCB-008 as a mono-therapy and continue to pursue partners for combination therapies."

Precision Biologics Announces the United States Patent and Trademark Office (USPTO) has granted a Patent for its Lead Monoclonal Antibody, NEO-201, For Methods and Compositions for Targeting Treg Cells

On July 22, 2024 Precision Biologics, Inc. ("Precision"), a clinical-stage immunotherapy and targeted oncology company, reported that on July 16, 2024, the USPTO granted another patent for its lead clinical asset, NEO-201, which is currently being tested in Phase 2 human Clinical Trials in the US (Press release, Precision Biologics, JUL 22, 2024, View Source [SID1234645007]).

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NEO-201 is a humanized IgG1 monoclonal antibody with multiple mechanisms of action. It has been shown previously to kill cancer cells expressing its target (truncated Core 1 O-glycans) which is expressed in numerous cancers; however, it does not bind to most normal tissues. In addition, NEO-201 binds to immune suppressor cells, including regulatory T cells (Treg cells) and granulocytic myeloid-derived suppressor cells (gMDSCs), which are thought to diminish the efficacy of cancer immunotherapy.

The patent granted by USPTO on July 16, 2024 (Patent No. US 12,037,410B2) describes the ability of NEO-201 to bind to Treg cells, and its use in targeting Treg cells. NEO-201 may be used for isolation and detection of Treg cells. In addition, the patent claims that NEO-201 can mediate the killing of Treg cells through complement mediated cytotoxicity (CDC) in vitro. Therapeutic methods and combination therapies using NEO-201 in combination with another anti-cancer agent are also described in the patent.

According to claims of the patent, in the Phase I clinical trial, using NEO-201 as single agent for the treatment of subjects with advanced solid tumors which have progressed on or not responded to standard treatments, NEO-201 was proven to bind and reduce the amount of circulating Tregs in subjects with stable disease after treatment.

This finding supported the rationale of the ongoing phase II clinical trial evaluating the activity of NEO-201 with pembrolizumab (Keytruda) in adults with solid tumors resistant to prior checkpoint inhibitors. This trial is currently enrolling patients with metastatic Non-Small Cell Lung Cancer (NSCLC), Head and Neck Cancer, Endometrial Cancer and Cervical Cancer, whose disease has previously progressed through prior checkpoint inhibitor therapy (including prior Keytruda). (View Source)

This ongoing Phase 2 trial is testing to see if combining NEO-201 with Keytruda can reactivate the effectiveness of checkpoint inhibitors when they no longer work.

Data from the ongoing Phase 2 trial was recently presented on June 1st, 2024, at ASCO (Free ASCO Whitepaper) Annual Meeting 2024, at the Mc Cormick Convention Center, Chicago, Illinois, USA. This data demonstrated that NEO-201 reduces the quantity of regulatory T cells and gMDSCs in peripheral blood mononuclear cells (PBMCs) of cancer patients and this reduction is associated with durable stabilization of disease. (click here).

In addition, a recent study, performed by Drs. Atsushi Tanaka and Shimon Sakaguchi from Osaka University, Japan, independently analyzed by flow cytometry the ability of NEO-201 to recognize Treg cells in from PBMCs from healthy donors, confirming findings from Precision Biologics in PBMCs from cancer patients. This study was presented as poster at the Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024 on April 8th, 2024. Here there is the link to the poster: View Source