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First patient enters Oncopeptides study aiming to gain real-world insights from Pepaxti in Germany

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.

TransCode Therapeutics, Inc. Announces Proposed Public Offering of Common Stock

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.

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.

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]).

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]).

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.

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."