On September 19, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported that the Deltacel-01 Safety Monitoring Committee (SMC) has unanimously voted in favor of proceeding with the expansion phase of the Deltacel-01 clinical trial (Press release, Kiromic, SEP 19, 2024, View Source [SID1234646745]). This trial is evaluating Deltacel (KB-GDT-01), the Company’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.

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This recommendation by the SMC follows a favorable review of safety data from the first two cohorts, including recent results from the 40-day follow-up visit of the sixth patient in Deltacel-01, which demonstrated a positive safety and tolerability profile with no dose-limiting toxicities (DLTs) observed.

As part of the expansion phase of Deltacel-01, Kiromic will enroll approximately nine patients. Screening for new participants is expected to commence later this month. The expansion phase, or Part 2 of Deltacel-01, will further assess the effectiveness of Deltacel treatment.

"We are delighted to receive unanimous SMC approval to move forward with the expansion phase of the Deltacel-01 trial," said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. "As we enter this next phase with more activated clinical sites, we expect a solid cadence of patient enrollment. We are optimistic about the potential to further evaluate Deltacel’s impact on patient outcomes and address critical unmet needs in solid tumors."

About Deltacel-01

In Kiromic’s open-label Phase 1 clinical trial, titled "Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer" (NCT06069570), patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the Deltacel-01 trial is to evaluate safety, while secondary measurements include objective response, progression-free survival, overall survival, time to progression, time to treatment response and disease control rates.

About Deltacel

Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of stage 4 metastatic NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is the leading candidate in Kiromic’s GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial clinical focus on NSCLC, which represents about 80% to 85% of all lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.

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 Kaida BioPharma ("Kaida" or the "Company"), an early-stage pharma company dedicated to advancing ovarian cancer treatment through innovative drug development, reported the launch of its new corporate social media channels. To stay up to date with Kaida’s latest news and events, connect with the Company on X, LinkedIn and Facebook.

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Craig Pierson, Founder and Chairman of Kaida BioPharma commented, "Ovarian cancer represents a serious unmet need with limited options for patients once they are diagnosed on their choice for care and approximately 90% of patients in need of an effective treatment option. Current therapies offer limited efficacy and no durable response. We believe Kaida represents an exciting opportunity to potentially treat the cause and not the problem for ovarian cancer and other high value oncology indications with unmet need including breast cancer and uterine. We invite you to connect with us on our social media channels as we work to establish a presence across the investment, patient and industry partner communities and provide a much-needed solution for gynecologic cancers."

Kaida is advancing targeted anti-cancer hormonal therapies to address the root cause of cancers affecting women. The Company’s lead program, KAD101 is a novel biologic that blocks the prolactin receptor to prevent cancer cell growth signals and incite autophagy initially targeting ovarian cancer. KAD101 has demonstrated encouraging results in a human clinical study with all patients showing tumor reduction with a clean safety profile as a daily injectable. The Company continues to progress the development of KAD101 toward the launch of its Phase 1 study, expected to commence in 2025. Additionally, the Company is advancing KAD102, an enhanced pure antagonist of KAD101, for the treatment of uterine cancer.

(Press release, Kaida BioPharma, SEP 18, 2024, View Source [SID1234663811])