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.

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 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 18, 2024 BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported U.S. FDA (FDA) authorization of an Expanded Access Policy (EAP) for metastatic breast cancer (MBC) patients (Press release, BriaCell Therapeutics, SEP 18, 2024, View Source [SID1234646765]).

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FDA requires BriaCell to have an EAP policy, as a condition of granting BriaCell’s Fast Track designation , and to help MBC cancer patients in need of novel treatments. The EAP provides access to cancer patients beyond the scope of BriaCell’s pivotal Phase 3 trial (ClinicalTrials.gov as NCT06072612 ) to receive treatment with the Bria-IMT regimen.

"FDA authorization for the EAP highlights its awareness of the safety and efficacy profile of Bria-IMT and patients’ need to access such a novel treatment. While we are conducting our pivotal Phase 3 trial of Bria-IMT regimen with an immune checkpoint inhibitor, Bria-IMT may provide a treatment option for cancer patients in need," stated Dr. William V. Williams, BriaCell’s President and CEO. "Despite numerous approved drugs, breast cancer remains the second leading cause of cancer death in American women. With our novel immunotherapy, we expect to bring hope to patients and families suffering from this deadly disease."

"Given the recently reported impressive survival and clinical benefit of Bria-IMT regimen in metastatic breast cancer patients who failed multiple prior treatments, more patients would be able to benefit from the EAP with BriaCell’s novel immunotherapy approach," stated Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. "We hope that our novel immunotherapy will become a new standard of care for metastatic breast cancer patients."

On September 18, 2024 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the peer-reviewed journal Nature Medicine published results from the SCRUM-Japan GOZILA study confirming that selecting targeted therapy on the basis of Guardant360 CDx liquid biopsy results may significantly extend survival for patients with advanced cancer (Press release, Guardant Health, SEP 18, 2024, View Source [SID1234646731]).

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The study, led by a research group out of National Cancer Center Hospital East in Kashiwa, Japan, investigated the effects of personalized treatment based on results of the Guardant360 CDx test in 4,037 patients with advanced cancer. The results showed that 24% of participants were able to receive targeted treatment tailored to them based on comprehensive genomic profiling results from the test, which analyzes 74 cancer-related genes. The patients who received targeted treatment guided by liquid biopsy results lived approximately twice as long as those who did not.

"Compared to conventional tissue biopsies, liquid biopsies have several advantages: they are less invasive for patients, allow for repeated testing, and can simultaneously examine cancer characteristics from various parts of the body. However, until now, it was unclear whether treatment selection using liquid biopsies actually helped improve patient outcomes," said Yoshiaki Nakamura, M.D., Ph.D., chief, International Research Promotion Office, Department of Gastroenterology and Gastrointestinal Oncology at National Cancer Center Hospital East in Kashiwa, Japan, and a co-lead author of the study. "The GOZILA study is the first to demonstrate the survival-extending effect of liquid biopsy-based personalized cancer treatment on a large scale across various cancers. The results of this study have the potential to bring about a paradigm shift in cancer treatment."

Selecting therapies for patients based on the liquid biopsy results enabled study investigators to identify targeted treatment options they could not discern using traditional methods. The researchers then followed the progress of treated patients and analyzed their treatment response and survival time. Patients who received targeted therapy had a median survival of 18.6 months compared to 9.9 months for those who did not.

"The GOZILA study adds significantly to the body of evidence supporting the clinical utility of the Guardant360 CDx liquid biopsy to guide therapy selection in advanced cancer," said Craig Eagle, M.D., Guardant Health chief medical officer. "These study results confirm, across a large study population and multiple tumor types, that personalized therapy guided by liquid biopsy has the potential to significantly extend patient survival."

About Guardant360 CDx

The first FDA-approved comprehensive liquid biopsy for all advanced solid tumors, Guardant360 CDx provides oncologists with genomic profiling results from a simple blood draw in less than seven days to pair patients with targeted therapies. The test detects guideline-recommended actionable biomarkers across all four major alteration classes, with a panel that assesses 74 genes.1 Guardant360 CDx is FDA-approved as a companion diagnostic (CDx) for multiple targeted therapies in non-small cell lung cancer (NSCLC) and is the only FDA-approved CDx to identify patients eligible for breast cancer therapy targeting ESR1 mutations.