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.

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."

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

On July 22, 2024 QDX, a computational drug discovery company, reported a collaboration with Prelude Therapeutics, a clinical-stage precision oncology company, targeting undisclosed, previously undrugged oncology targets (Press release, Prelude Therapeutics, JUL 22, 2024, View Source [SID1234645006]).

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QDX integrates its world-leading quantum mechanical simulation technology, supercomputing, artificial intelligence, and deep drug discovery expertise to advance computational chemistry and drug discovery.

Peggy Scherle, PhD, CSO of Prelude, commented: "Computational approaches to drug discovery are showing increasing promise. We are pleased to work with the talented team at QDX to leverage their blend of high-performance computing, quantum simulations, and AI on these historically challenging targets."

Loong Wang, Co-Founder and CEO of QDX, stated: "We are thrilled to be working with the team at Prelude to help break new ground on these programs. This collaboration with Prelude exemplifies the kind of bespoke partnerships that QDX engages in across academia and industry, deploying our best-in-class quantum technology, our massively parallel supercomputing, and AI systems."

Kelvin Neu, MD, Co-Founder and Chair of QDX, added: "The accomplished biology and chemistry teams at Prelude have been very productive, generating a pipeline of small molecules against important and often challenging oncology targets. QDX has built a powerful platform by thoughtfully integrating complementary disciplines, guided by the practical needs and challenges of novel drug discovery, with a particular focus on select traditionally difficult-to-crack areas. We are honored that Prelude has chosen QDX to support them on these challenging targets and look forward to a productive collaboration."

On July 22, 2024 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, reported that it will jointly present a poster on initial clinical results from the Phase I part of the ongoing Phase I/IIa trial of BT-001 at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting. ESMO (Free ESMO Whitepaper) will take place in Barcelona, Spain, from September 13 to 17, 2024 (Press release, Transgene, JUL 22, 2024, View Source [SID1234645005]).

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Poster and abstract title: "Initial clinical results of BT-001, an oncolytic virus expressing an anti-CTLA4 mAb, administered as single agent and in combination with pembrolizumab in patients with advanced solid tumors." 
Presentation topic: Investigational immunotherapy 
Presentation number: 1024P 
Speaker: Stéphane Champiat

The abstract will be available on ESMO (Free ESMO Whitepaper)’s website on September 9, 2024, at 0:05 a.m. CEST. BT-001 is an oncolytic virus generated using Transgene’s Invir.IO platform and its patented large-capacity VVcopTK-RR-oncolytic virus, which has been engineered to encode both a Treg-depleting recombinant human anti-CTLA-4 antibody generated by BioInvent’s proprietary n-CoDeR/F.I.R.S.T platforms, and the human GM-CSF cytokine.

BT-001 is expected to induce a much stronger and more effective antitumoral response by selectively targeting the tumor microenvironment, thereby potentially enhancing the safety and tolerability profile of the anti-CTLA-4 antibody through reduced systemic exposure.

The ongoing Phase I/IIa study (NCT04725331) is a multicenter, open label, dose-escalation trial evaluating BT-001 as a single agent and in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab). Patient inclusions are ongoing in Europe (France, Belgium) and the trial has been authorized in the US.