On November 19, 2024 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company developing targeted cancer therapies using its proprietary RADR AI platform, reported that the first patient has been dosed – as part of the expansion cohort – in Japan for its Phase 2 HARMONIC clinical trial evaluating LP-300 in never-smoker patients with non-small cell lung cancer (NSCLC) who have progressed after receiving treatment with tyrosine kinase inhibitors (TKIs) (Press release, Lantern Pharma, NOV 19, 2024, View Source [SID1234648508]).

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The dosing of the first patient in Japan marks a significant expansion of the HARMONIC trial into Asia, where there is a notably higher prevalence of never-smoker NSCLC patients compared to Western populations. The trial is being conducted at five sites across Japan, including the National Cancer Center Japan under the leadership of Dr. Yasushi Goto, a renowned physician-researcher focused on lung cancer.

"The initiation of patient dosing in Japan is a significant milestone for the HARMONIC trial and our mission to develop LP-300 as a potential new treatment option for never-smoker NSCLC patients," said Panna Sharma, President and CEO of Lantern Pharma. "Japan and other Asian countries have a significantly higher proportion of never-smokers among NSCLC patients, with estimates suggesting that 33-40% of new lung cancer cases in Japan occur in never-smokers. This expansion allows us to accelerate enrollment while addressing a critical unmet need in a region where this disease has a particularly high impact."

Dr. Reggie Ewesuedo, VP of Clinical Development at Lantern Pharma commented, "This marks the achievement of a significant milestone for the Harmonic Trial. It is the beginning of an anticipated acceleration in enrollment following activation of sites in Japan as well as active screening of patients across sites in Taiwan. We are encouraged by the high level of interest from our clinical partners in Asia in this unique trial aimed at improving survival among never-smokers with lung cancer after relapsing from tyrosine kinase inhibitor-based treatment regimens."

The expansion into Japan and Taiwan follows encouraging preliminary results from the U.S. trial’s initial safety lead-in cohort, which demonstrated an 86% clinical benefit rate and 43% objective response rate among the first seven patients. The HARMONIC trial is evaluating LP-300 in combination with carboplatin and pemetrexed in never-smoker NSCLC patients who have recurrent NSCLC and have stopped responding to tyrosine kinase inhibitor (TKI) based therapies.

ABOUT THE HARMONIC TRIAL

The HARMONIC trial is a multicenter, open-label, randomized Phase 2 trial designed to evaluate the efficacy and safety of LP-300 in combination with standard-of-care chemotherapy (pemetrexed/carboplatin) versus chemotherapy alone. The trial is expected to enroll approximately 90 patients across sites in the United States and Asia. The primary endpoints are progression-free survival (PFS) and overall survival (OS).

On November 19, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that data were published on Roswell Park Comprehensive Cancer Center’s Phase 1 study evaluating AIM ImmunoTech’s drug Ampligen (also known as rintatolimod) as a component of a chemokine-modulating (CKM) regimen in early-stage triple-negative breast cancer (TNBC) (Press release, AIM ImmunoTech, NOV 19, 2024, View Source [SID1234648494]). Results of the study were reported in The Journal for ImmunoTherapy of Cancer.

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"We are very excited with these promising results from our study of a new treatment combination for patients with this most highly aggressive form of breast cancer, triple-negative breast cancer," said study principal investigator Shipra Gandhi, MD, Associate Professor of Oncology and staff physician in the Department of Medicine at Roswell Comprehensive Cancer Center. "Because this initial study was in a small number of patients, it will be important to validate these findings in a larger study."

For more information on the data reported, please visit Roswell Park’s website to read its press release titled, "Roswell Park Clinical Trial Points Toward Promising New Therapy for Most Aggressive Type of Breast Cancer."

AIM CEO Thomas K. Equels stated: "The results of this pilot study suggest that the Ampligen-containing chemokine modulation regimen is capable of modifying the tumor microenvironment and releasing cytokines that attract killer T-cells into the early-stage triple-negative breast cancer tumor. These data are similar to those we have seen with Ampligen previously in late-stage TNBC, advanced recurrent ovarian cancer and pancreatic cancer. We look forward to collaborating with Roswell Park as this study advances to Phase 2. We believe in the power of Ampligen to work in conjunction with a variety of chemotherapy regimens and/or immune checkpoint inhibitors."

For more information about the study, please visit ClinicalTrials.com: NCT04081389.

About Roswell Park Comprehensive Cancer Center

From the world’s first chemotherapy research to the PSA prostate cancer biomarker, Roswell Park Comprehensive Cancer Center generates innovations that shape how cancer is detected, treated and prevented worldwide. Driven to eliminate cancer’s grip on humanity, the Roswell Park team of 4,000 makes compassionate, patient-centered cancer care and services accessible across New York State and beyond. Founded in 1898, Roswell Park was among the first three cancer centers nationwide to become a National Cancer Institute-designated comprehensive cancer center and is the only one to hold this designation in Upstate New York. To learn more about Roswell Park Comprehensive Cancer Center and the Roswell Park Care Network, visit www.roswellpark.org, call 1-800-ROSWELL (1-800-767-9355) or email [email protected].

On November 19, 2024 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that the Company has entered into an agreement under which Orion Corporation has settled all future contractual milestones, royalty and any other commitments towards Alligator in relation to two preclinical bispecific antibodies resulting from the discovery collaboration between the companies (Press release, Alligator Bioscience, NOV 19, 2024, View Source [SID1234648495]). No further development activities will be conducted under the collaboration agreement.

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"I am pleased that our successful collaboration has grown to this logical outcome. This divestiture sharpens our focus on our lead candidate mitazalimab, and this non-dilutive income constitutes an important element in advancing mitazalimab towards Phase 3" says Søren Bregenholt, CEO of Alligator Bioscience. "Following the unprecedented 18-month survival data announced earlier this year we expect several value inflection points on mitazalimab in the coming months. Notably among them, 24-months follow-up, as well as key progress in Phase 3 preparations in pancreatic cancer, which we are expected to further facilitate partnership discussions."

Van Lanschot Kempen acted as financial adviser to Alligator on the transaction.

On November 18, 2024 Alentis Therapeutics ("Alentis"), the clinical-stage biotechnology company developing treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ALE.P02 for the treatment of advanced or metastatic CLDN1+ squamous cancers irrespective of the organ of origin (Press release, Alentis Therapeutics, NOV 18, 2024, View Source [SID1234648462]). ALE.P02 is an investigational antibody-drug conjugate (ADC) targeting CLDN1, developed for CLDN1+ squamous cancers including but not limited to lung, head and neck, cervical and esophageal cancers.

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"We are encouraged by the FDA’s recognition of ALE.P02’s potential as a treatment for CLDN1+ squamous cancers," said Roberto Iacone, Chief Executive Officer of Alentis Therapeutics. "It reflects the importance of advancing ALE.P02 through clinical development, and it brings us one step closer to providing a new treatment option for patients."

Fast Track designation is designed to expedite the development and review of drugs that treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.

"We have set out to develop ALE.P02 in the most rational way, following CLDN1 science and the clinical understanding of squamous cancers. The FDA’s support in this endeavor is certainly motivating," added Luigi Manenti, Chief Medical Officer of Alentis. "We are optimistic about the potential of ALE.P02 and look forward to the start of our first-in-human clinical trial in Q1 2025."

"Squamous cancers of various origin have been shown to overexpress CLDN1, making ALE.P02 a promising ADC to address the unmet medical needs of these patients," said Tony Mok Professor of Clinical Oncology at the Chinese University of Hong Kong. "CLDN1 is an exciting new target for ADCs and Alentis has been the frontrunner in developing anti-CLDN1 therapeutics."

About ALE.P02
ALE.P02 is a first-in-class ADC designed by linking a tubulin inhibitor, a potent cancer drug, to our antibody that specifically targets a unique CLDN1 epitope exposed on cancer cells. This combination could be a powerful new tool to fight the many squamous cancers that overexpress CLDN1 with less toxicity than traditional cancer drugs. The IND application for ALE.P02 to commence a Phase 1/2 clinical trial in advanced or metastatic CLDN1+ squamous solid tumors was recently cleared by the FDA.

On November 18, 2024 SK Biopharmaceuticals, a biotech company, reported that it has entered into an agreement with the Korea Institute of Radiological and Medical Sciences (KIRAMS), Korea’s premier research institution dedicated to the study and advancement of radiological and medical sciences, to collaborate on discovering and developing preclinical radiopharmaceutical drug candidates (Press release, SK biopharmaceuticals, NOV 18, 2024, View Source [SID1234648479]).

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This marks the first collaborative research agreement in which both sides will aim to discover radiopharmaceutical compounds and investigate novel oncological treatments, using actinium-225 (225Ac), an alpha-particle emitting radioisotope that selectively kills cancer cells. The research for radiopharmaceutical therapy (RPT) focuses on this application that has been gaining attention for its high potential in nuclear medicine.

SK Biopharmaceuticals has already initiated its 225Ac-based research as it secured a supply of the radioisotope from TerraPower Isotopes, a subsidiary of TerraPower, a nuclear innovation company whose investors include SK Biopharmaceuticals’ parent SK Inc. and Bill Gates.

SK Biopharmaceuticals and KIRAMS will seek to submit an Investigational New Drug application by 2027, as they leverage each other’s resources to optimize their drug discovery efforts. SK Biopharmaceuticals said it could significantly reduce the time and cost of new drug development, with KIRAMS’ researchers, facilities and equipment using the radioisotope, enabling the company to further accelerate in securing and expanding its RPT pipeline and capability.

The agreement is in line with SK Biopharmaceuticals’ so-called "RPT Roadmap" recently introduced to become a global leading RPT player by 2027, as the company will fortify its RPT business by discovering new drug compounds, extending supply and production capacities, and developing a tech platform, via strengthened internal assets and strategic partnerships.

In addition to the 225Ac supply agreement aligned with its roadmap, the company has in-licensed SKL35501 (FL-091) radiopharmaceutical compound targeting neurotensin receptor 1 (NTSR1) solid tumors.

Jinkyung Lee, President of KIRAMS, stated, "Through this joint research agreement, we aim to take a leading role in developing innovative radiopharmaceutical therapeutics, in alignment with the Ministry of Science and ICT’s strategic initiative to drive advancements in Radiation Biology. We look forward to contributing to the growth of the domestic radiopharmaceutical industry in close collaboration with SK Biopharmaceuticals."

Donghoon Lee, CEO and President of SK Biopharmaceuticals, said "This agreement is one of key steps in enhancing SK Biopharmaceuticals’ research capabilities. We will seek to spur SK Biopharmaceuticals to become a leading global RPT player through strengthened ties."