On September 19, 2024 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported ADI-001 clinical biomarker data from the Phase 1 GLEAN trial which further reinforces the potential of ADI-001 as a best-in-class allogeneic cell therapy for autoimmune diseases (Press release, Adicet Bio, SEP 19, 2024, View Source [SID1234646757]). Notably, ADI-001 demonstrated robust tissue trafficking resulting in high levels of ADI-001, significant chimeric antigen receptor (CAR) T cell activation, and complete CD19+ B cell depletion in secondary lymphoid tissue. These data will be presented by Dr. Blake Aftab, Chief Scientific Officer, at the 9th Annual CAR-TCR Summit on Thursday, September 19, 2024 in Boston, MA.

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"These results clearly support the potential of ADI-001 and Adicet’s off-the-shelf gamma delta CAR T cell platform, by demonstrating robust trafficking and complete B cell depletion in tissue, while providing superior exposure of ADI-001 in secondary lymphoid tissue compared to published third-party data reported for alpha-beta CAR T therapies," said Blake Aftab, Ph.D., Chief Scientific Officer of Adicet Bio. "Together, the totality of our findings provide multiple levels of evidence highlighting the significant advantages of our approach and present a compelling opportunity for ADI-001 to extend B cell targeting into tissues, as we look to address a range of autoimmune diseases in the clinic."

A summary of the results is reported below:

ADI-001 demonstrated significant levels of CAR T cell activation and tissue exposure in lymph node biopsies in the GLEAN trial, with a mean exposure of 236,701 CAR T cells per million across all dose levels, representing a range of 27-64% of total cellular material detected by ddPCR in evaluable biopsies at the 1E9 dose, and exceeding levels previously reported for patients who received autologous alpha-beta CAR T therapies. CAR T cells detected in tissues also demonstrated a robust activation profile, based on in situ detection of granzyme B.
Recently published studies have demonstrated depletion of CD19+ plasmablasts, memory B cells and naïve B cells in peripheral blood using anti-CD20 targeted antibodies, however, these CD20-targeted antibody modalities failed to deplete B cells within secondary lymphoid tissues.
Concurrent with ADI-001 tissue trafficking and activation, complete depletion of CD19+ B cells within analyzed secondary lymphoid tissue was also observed. These results support ADI-001’s potential for achieving complete B-cell depletion in peripheral blood and within tissues.
Adicet is advancing the ADI-001 clinical program in lupus nephritis, systemic lupus erythematosus, systemic sclerosis and anti-neutrophil cytoplasmic autoantibody associated vasculitis (AAV) and expects to report initial clinical data in the first half of 2025.

Company webcast information

A listen-only webcast with an accompanying presentation by Dr. Aftab is accessible under Presentations & Events | Adicet Bio in the Investors section of Adicet Bio’s website. The archived webcast will be available for 30 days.

About the GLEAN trial

The Phase 1 GLEAN study was an open-label, multi-center study of ADI-001 enrolling adults diagnosed with B-cell malignancies who have either relapsed, or are refractory to, at least two prior regimens.

On September 19, 2024 Achilles Therapeutics plc (NASDAQ: ACHL) reported the discontinuation of its TIL-based cNeT program and closure of the Phase I/IIa CHIRON and THETIS clinical trials (Press release, Achilles Therapeutics, SEP 19, 2024, View Source [SID1234646741]). The Company will refocus its strategy to explore further engagement with third parties who are developing alternative modalities to target clonal neoantigens for the treatment of cancers, such as neoantigen vaccines, ADCs, and TCR-T therapies. Concurrently, the Company has engaged BofA Securities as a financial advisor in the process of exploring and reviewing value-maximizing strategies.

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"Our data continue to illustrate the importance of clonal neoantigens as targets and show some clinical activity, however our studies in lung cancer and melanoma have not met our goals for commercial viability. We are grateful for the support and commitment of our patients, investigators, employees and shareholders throughout this journey," said Dr Iraj Ali, Chief Executive Officer of Achilles Therapeutics. "We are actively exploring new opportunities to leverage our substantial assets and cutting-edge technology platforms. Our goal remains to drive the development of effective treatments for patients and create long-term value for our shareholders."

In connection with the strategic update, the Company is implementing an employee consultation process in line with UK legislation proposing a workforce reduction and undertaking other cost-cutting measures. The Company recognizes the significant contributions of its talented team and is committed to supporting all employees throughout this transition period. Achilles intends to retain all employees essential for supporting value-realization as part of its strategic review.

As of June 30, 2024, the Company had $95.1 million in cash and cash equivalents.

The full clinical data generated from the Phase I/IIa CHIRON trial in patients with advanced non-small cell lung cancer (NSCLC) and the Phase I/IIa THETIS trial in patients with recurrent or metastatic melanoma will be presented in an upcoming forum.

The process of exploring strategic alternatives may include, but is not limited to, an acquisition, merger, reverse merger, business combination, asset sale, licensing, or other transactions. There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or as to the timing of any such agreements or transactions. Achilles Therapeutics does not intend to discuss or disclose further developments regarding the exploration of strategic alternatives unless and until its Board of Directors has approved a definitive action or otherwise determined that further disclosure is appropriate or required by law.

On September 19, 2024 TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical stage biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported that an abstract highlighting NOX-A12 data from preclinical studies performed by the U.S. National Cancer Institute (NCI) has been selected for poster presentation at the 2024 Society for Neuro-Oncology (SNO) Annual Meeting, taking place in Houston, Texas, USA, November 21-24, 2024 (Press release, TME Pharma, SEP 19, 2024, View Source [SID1234646758]). NCI is part of the National Institutes of Health.

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The research was conducted at the NCI under the material transfer agreement established with TME Pharma in June 2022 to explore the effects of TME Pharma’s CXCL12 inhibitor NOX-A12 in brain tumors.1

The SNO Annual Meeting, the world’s largest neuro-oncology conference, attracts researchers and clinician scientists from over 40 countries. As a premier forum for sharing knowledge and gaining insights into the future of neuro-oncology research and treatment, the meeting spans all neuro-oncology disciplines, professions, and interests. TME Pharma will participate at the annual event as a supporting partner, with its team attending the conference and available for meetings with industry leaders.

Details of the poster presentation at the 2024 SNO Annual Meeting are as follows:

Title: Potentiating the efficacy of immune check-point inhibitors in glioblastoma by inhibition of CXCL12
Presenter: Dr. Chen Cam-El Makranz, Neuro-Oncology Research Fellow, National Cancer Institute, National Institutes of Health
Session: Poster Session, Poster number EXTH12
Time and Date: 7.30-9.30 p.m. CDT, Friday, November 22, 2024

The full abstract will be published in the SNO official journal Neuro-Oncology on Friday, November 11, 2024. Both the abstract and poster presentation will be made available on the TME Pharma website following the conference.

On September 19, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM") reported positive preliminary data from the Phase 1b/2 study ("DURIPANC") evaluating the combination of AIM’s Ampligen (rintatolimod) and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of late-stage pancreatic cancer (Press release, AIM ImmunoTech, SEP 19, 2024, View Source [SID1234646742]).

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DURIPANC is an investigator-initiated, exploratory, open-label, single-center study. AIM previously announced that investigators at Erasmus Medical Center ("Erasmus MC") in the Netherlands had completed the safety evaluation of subjects enrolled in the first dose level of the dose escalation design, finding the combination therapy to be generally well-tolerated with no severe adverse events or dose-limiting toxicities. That first cohort has now reached the pre-determined 6-month stability assessment timepoint and AIM is pleased to announce that two of the three subjects remain stable. The subjects will continue to be treated and receive formal assessment of progression every three months. The standard for calculating median progression-free survival ("PFS") requires that 50% or more of the subjects have seen disease progression. Because 67% of the patients in the cohort evaluated at 6 months have remained stable, AIM cannot yet report on PFS.

Two of the three subjects in the higher-dose second cohort of subjects also have stable disease, although they have not yet reached the 6-month stability assessment timepoint. Investigators continue to treat and monitor these subjects.

Prof. Casper H.J. van Eijck, MD, PhD, Pancreato-biliary Surgeon at Erasmus MC and Coordinating Investigator for the DURIPANC study, commented: "First of all, we have observed improvements in quality of life and we saw no toxicity at all – with ‘quality of life’ recognized as an indicator of stable disease. As a comparison, approximately 80% of patients at Erasmus with similar disease, but who did not receive the treatment, showed disease progression after only three months. While this new data is extremely preliminary, it is also highly encouraging. To have multiple patients with metastatic pancreatic cancer who still have stable disease after six or seven months of maintenance therapy is remarkable – as is having stable disease for 15 or more months after starting FOLFIRINOX. Based on the changes we have seen in immune infiltration into metastatic lesions, I am optimistic that there is a chance that these patients could still have partial or complete responses to this therapy."

"Ampligen continues to demonstrate its synergistic potential as a combination therapy with checkpoint inhibitors and these data – following the positive data from the Dutch-government approved Early Access Program – underscore Ampligen’s potential for the treatment of late-stage pancreatic cancer, where there remains a significant and lethal unmet need," commented AIM Chief Executive Officer Thomas K. Equels.

Read more at ClinicalTrials.gov NCT05927142 – "Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy effect"

Learn more about the clinical collaboration between AIM, AstraZeneca and Erasmus MC.

On September 19, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported that the University of Arizona Cancer Center (UACC) has been activated as the fifth clinical trial site in the Deltacel-01 Phase 1 trial evaluating Deltacel (KB-GDT-01), Kiromic’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies (Press release, Kiromic, SEP 19, 2024, View Source [SID1234646744]).

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The UACC is one of the 57 NCI-Designated Comprehensive Cancer Centers in the U.S. Dr. Ricklie Ann Julian, Assistant Professor of Medicine at UACC, will serve as Principal Investigator at the site.

"We are delighted to partner with UACC, expanding our Deltacel-01 clinical trial to a fifth site. We believe we are well-positioned to enroll the next cohort of patients, and we are optimistic that we will continue to register encouraging results in the expansion phase of the study. The UACC has earned a reputation as a premier research institution actively engaged in clinical trials and delivering the highest-quality care to those with cancer. We look forward to working with their team," stated Pietro Bersani, CEO of Kiromic BioPharma.

The site initiation visit at UACC has been completed and patient enrollment is expected to begin in the coming weeks.