On December 20, 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 3 patients have now completed the full-dose regimen in the ACHIEVE Phase 2b trial in the UK with no drug-related Adverse Events seen in any of the restart patients (Press release, TC Biopharm, DEC 20, 2024, View Source [SID1234649243]).

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The ACHIEVE UK clinical trial is an open-label, phase II study designed to evaluate the efficacy and effectiveness of TCB008 in patients with AML or MDS/AML, with either refractory or relapsed disease.

To date, 10 patients have received their first dose, 9 patients have received their second dose, 4 patients have received their third dose, and 3 patients have received their fourth and final dose. 9 out of 10 patients recruited to date are in Cohort A, representing relapsed/refractory patients who have been unable to attain remission. One patient has been enrolled into Cohort B, representing patients who have attained remission following prior treatment yet continue to have a detectable residual disease. The patient enrolled in Cohort B received their fourth and final dose in November 2024. Initially, 14 patients are planned to be recruited into Cohort A and Cohort B and, following confirmation of study endpoints, a further 10 patients will be recruited into each cohort, giving a total of 48 patients.

The preliminary safety data shows that the 5mL dose of TCB008 is well tolerated, with no drug-related Adverse Events. These data outputs remain aligned with TCB008’s safety profile, in support of the ACHIEVE study safety objectives and endpoints.

"Recruitment into the ACHIEVE trial has been an overwhelming success in 2024," said Alison Bracchi, Executive Vice President of Clinical Operations. "Currently, more than half of the patients in the initial stage of Cohort A have been recruited into the ACHIEVE study. We’re also thrilled to observe the progression of Cohort B. This expedited rate of recruitment has been accomplished in less than 5 months due to the hard work and dedication of both the ACHIEVE Clinical sites and the entire TCBP team. The TCBP team and I look forward to continued success with recruitment and preliminary data from the ACHIEVE study in 2025."

"As we progress with Cohort B, there is the potential for an expedited review given these patients’ stage and disease expression," said Bryan Kobel, CEO of TC BioPharm. "We believe minimal residual disease represents a high opportunity for TCB008 to be extremely impactful. We could see a response indicating high responsiveness in fewer than the currently proposed cohort size. At this trial stage, we are still collating data, due to the regulatory framework, we cannot yet comment on efficacy specifically, but we are encouraged to see patients completing the dosing regimen successfully and without any safety issues. Our immediate clinical focus will be high recruitment on Cohort B in 2025 and completing the Cohort A patient set for data review. We appreciate the hard work of the King’s College Hospital and our fantastic investigator group including Dr. Victoria Potter, and Dr. Emma Nicholson. The recruitment has been exceptional and we look forward to continuing our work with them in 2025."

On December 20, 2024 Verismo Therapeutics, a clinical-stage CAR T company developing novel KIR-CAR platform technology, reported the completion of a merger in which the company has become a wholly-owned subsidiary of HLB Innovation (KOSDAQ: 024850), a publicly traded company in South Korea and a member of the HLB Group (Press release, Verismo Therapeutics, DEC 20, 2024, View Source [SID1234649244]). The merger certificate is expected to be filed shortly.

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The merger will accelerate the clinical development of SynKIR-110 and SynKIR-310 for solid tumor and blood cancer patients, respectively, solidifying Verismo’s and HLB Group’s collective mission to advance its innovative KIR-CAR platform for patients worldwide.

"We are thrilled to take this next step with HLB Innovation as our parent company," said Bryan Kim, Chief Executive Officer of Verismo Therapeutics. "This merger not only strengthens our resources by leveraging HLB Group’s dynamic bio-ecosystem, but also enhances our ability to rapidly advance our clinical pipelines. We’re confident that with HLB Innovation’s backing, Verismo is well-positioned to bring transformative therapies to areas of unmet medical need."

The HLB Group, which has a diverse portfolio that spans biopharma, medical devices, healthcare, lifestyle, and other sectors, previously held a majority stake in Verismo. This merger aligns with HLB Group’s strategic commitment to expanding its capabilities in next-generation cell therapies.

About the KIR-CAR Platform
The KIR-CAR platform is a multi-chain CAR T cell therapy and has been shown in preclinical animal models to be capable of maintaining antitumor T cell activity even in challenging tumor microenvironments. Using NK cell derived KIR and DAP12 split signaling provides a novel combined activation and co-stimulation separate from the usual T cell stimulation pathways. It also enables sustained chimeric receptor expression and improves KIR-CAR T cell long term function. This results in prolonged T cell functional persistence and leads to regression of solid tumors in preclinical models that are resistant to traditional CAR T cell therapies.

On December 20, 2024 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that China’s National Medical Products Administration (NMPA) has approved a New Drug Application (NDA) of DOVBLERON (taletrectinib adipate capsule), a next-generation ROS1 tyrosine kinase inhibitor (TKI), for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs. DOVBLERON marks the 13th addition to Innovent’s commercial portfolio, representing an innovative precision therapy expected to benefit more lung cancer patients alongside our strong TKI franchise (Press release, Innovent Biologics, DEC 20, 2024, View Source [SID1234649245]).

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Lung cancer continues to have one of the highest global incidences and mortality rates, with NSCLC accounting for about 85% of all cases. In China, it is estimated that approximately 2.6% of patients living with NSCLC are ROS1-positive[i]. Furthermore, brain metastases are a common challenge, affecting up to 35% of patients newly diagnosed with metastatic ROS1-positive NSCLC, and increasing to as much as 55% of patients whose cancer has progressed following initial treatment. In addition, patients treated with approved ROS1 TKIs often develop resistance mutations to these therapies, representing a major limitation for patients in terms of duration of response. The approval of DOVBLERON provides a new and effective treatment option for patients who are no longer responding to previously approved therapies.

The approval is based on positive results from the pivotal Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated taletrectinib in Chinese patients with advanced ROS1-positive NSCLC. The findings, presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and published in the Journal of Clinical Oncology (JCO), demonstrated the potential of DOVBLERON to address unmet needs, particularly in patients with limited therapeutic options after treatment with prior ROS1-targeted therapies. [Link]

In addition, a second NDA for DOVBLERON was accepted and granted Priority Review Designation by China’s NMPA in March 2024 for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who have not previously been treated with ROS1 TKIs.

Caicun Zhou, M.D., Ph.D., Director of the Department of Oncology at Shanghai East Hospital, Tongji University, commented: "The treatment landscape for advanced ROS1-positive NSCLC remains challenging, especially for patients with brain metastases, who account for more than half of patients who have progressed following initial treatment with a ROS1 TKI, as well as those patients who develop resistance mutations. DOVBLERON demonstrated significant therapeutic effects on brain lesions, as well as efficacy in crizotinib-resistant patients. Moreover, DOVBLERON has a favorable safety profile and tolerability with low rates of dose reduction and treatment discontinuation due to adverse events. The efficacy and safety profile of DOVBLERON offers a new hope for patients and I look forward to its benefit in the ROS1-positive NSCLC patients in China ."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "The approval of DOVBLERON is a reflection of its potential best-in-class efficacy and safety profile, as demonstrated in the TRUST-I trial. We are delighted about the approval of DOVBLERON and will bring this precision therapy to NSCLC patients who need novel treatment options. Innovent’s robust TKI product pipeline—including RETSEMOV, PEMAZYRE, DUPERT and DOVBLERON—showcases our leadership and synergistic strengths in precision oncology. We endeavor to advance more innovative medicines to enhance patients’ quality of life."

About ROS1-positive Non-small Cell Lung Cancer

Lung cancer continues to have one of the highest global incidences and mortality rates, with NSCLC accounting for about 85% of all cases. In China, it is estimated that approximately 2.6% of patients living with NSCLC are ROS1-positive Up to 35% of patients newly diagnosed with metastatic ROS1-positive NSCLC have tumors that spread to their brain, increasing to as much as 55% for those whose cancer has progressed following initial treatment. Despite recent progress for patients with ROS1-positive NSCLC, there remains a need for more effective and tolerable treatment options.

About DOVBLERON (Taletrectinib Adipate Capsule)

DOVBLERON is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1-positive NSCLC. Taletrectinib, the active ingredient in DOVBLERON is being evaluated for the treatment of patients with advanced ROS1-positive NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II(NCT04919811), a global study.

In December 2024, DOVBLERON was approved by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who have previously been treated with ROS1 TKIs. In addition, a second NDA for taletrectinib was accepted and granted Priority Review Designation by China’s NMPA for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who have not previously been treated with ROS1 TKIs.

Taletrectinib has been granted Orphan Drug Designation by the U.S. FDA for the treatment of patients with ROS1-positive NSCLC and other NSCLC indications, and Breakthrough Therapy Designations by both the U.S. FDA and China’s NMPA for the treatment of patients with locally advanced or metastatic ROS1-positive NSCLC. Based on pooled results of the TRUST-I and TRUST-II clinical studies, Nuvation Bio Inc. (NYSE: NUVB) submitted an NDA for taletrectinib to the U.S. FDA for the treatment of patients with advanced ROS1-positive NSCLC (line agnostic, full approval).

In June 2021, Innovent and AnHeart Therapeutics (Hangzhou) Co. Ltd., a Nuvation Bio Inc. company, entered into an exclusive license agreement for the co-development and commercialization of taletrectinib in Greater China, including mainland China, Hong Kong, Macau and Taiwan.

On December 20, 2024 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches for precision T cell activation, reported the dosing of the first patient in the Phase 2 portion of its STARt-001 trial. The clinical study builds on the Phase 1/2 trial evaluating invikafusp alfa as a monotherapy in biomarker-enriched patients with advanced anti-PD-1 resistant solid tumors (Press release, Marengo Therapeutics, DEC 20, 2024, View Source [SID1234649246]).

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The results of the Phase 1 portion of the STARt-001 trial were recently presented during a plenary late-breaking oral session at the SITC (Free SITC Whitepaper) Annual Meeting and an oral presentation at the 2024 ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress. The data collectively validate Marengo’s STAR platform design and demonstrate early single agent anti-tumor activity of invikafusp alfa (STAR0602), including clinical benefit in heavily pre-treated, anti-PD-1 resistant cancer patients. Invikafusp alfa exhibited a manageable safety profile consistent with its novel mechanism of action, reinforcing its potential as a treatment option across high tumor mutation burden (TMB-H) cancers or virally associated malignancies.

The Phase 2 clinical trial will treat patients with the RP2D (0.08mg/kg) and is now enrolling patients in Europe at leading oncology centers, with initial activation of sites in France and Spain.

"We are thrilled to advance invikafusp alfa into Phase 2 with the addition of premier European oncology centers," said Ke Liu, M.D., Ph.D., Chief Development Officer of Marengo Therapeutics. "The single-agent anti-tumor activity observed in Phase 1, particularly in PD-1-resistant ‘cold’ tumors like colorectal cancer, gives us confidence in our approach and fuels our hope to reach as many patients as possible. The addition of renowned European institutions expands our geographical footprint and enhances our ability to enroll more PD-1 resistant patient populations. Through our Phase 2 study, we aim to deepen our understanding of invikafusp alfa’s mechanism of action across diverse tumor types."

On December 20, 2024 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its executives will be speaking at the following investor conference (Press release, Gilead Sciences, DEC 20, 2024, View Source [SID1234649247]):

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J.P. Morgan Healthcare Conference on Monday, January 13, 2025 beginning at 11:15 a.m. Pacific Time
The live webcast can be accessed at investors.gilead.com and the replay will be available for at least 30 days following the presentation.