On October 9, 2024 Boehringer Ingelheim and Circle Pharma (Circle) reported a new research collaboration and license agreement with the shared goal to develop a first-in-class cyclin inhibitor that can halt the growth of cancer cells potentially offering hope to those living with hard-to-treat cancers (Press release, Circle Pharma, OCT 9, 2024, View Source;utm_medium=rss&utm_campaign=boehringer-ingelheim-and-circle-pharma-announce-new-research-collaboration-to-develop-a-novel-precision-cancer-treatment [SID1234647107]).

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Uncontrolled cell growth is a common feature in most tumor types and is a driving force in the formation of tumors. Genetic alterations like mutations or amplifications in the genes encoding the regulatory machinery of cell division contribute to malignant growth in a significant fraction of all solid tumors. That is why Boehringer Ingelheim is targeting the proteins involved in this process, a promising strategy for new cancer treatments.

Current methods targeting cyclin-dependent kinases can be limited by low selectivity and toxicity. Circle has developed a possible solution to these challenges by creating macrocycle therapies that directly inhibit cyclins, the proteins that regulate cell division.

"We’re delighted to be joining forces with Circle’s scientists to develop an innovative cancer treatment based on their proprietary macrocycle platform molecules to achieve our goal of transforming the lives of people living with cancer," said Clive R. Wood, Ph.D., Senior Vice President and Global Head of Discovery Research at Boehringer Ingelheim. "This new collaboration complements our oncology research portfolio, and further reinforces our commitment to tackling intractable targets."

David Earp, Ph.D., JD, chief executive officer, Circle Pharma said, "With our lead program, CID-078, a Cyclin A/B RxL inhibitor, we have demonstrated the capability of our MXMOTM platform to deliver oral macrocycles against a target that was previously considered to be undruggable. We’re excited to partner with Boehringer Ingelheim to leverage the platform against another challenging cyclin target that offers the potential to address high unmet need cancer indications."

This partnership is a significant step toward Boehringer Ingelheim’s goal of transforming cancer care. It bolsters the already robust oncology pipeline of cancer cell-directed and immuno-oncology investigational therapies for smart combinations that may offer the greatest benefit for people living with cancer.

As part of the agreement, Circle Pharma will receive an upfront payment and potential development, regulatory, and sales milestone payments of up to USD $607 million.

On October 9, 2024 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, reported the Company’s oncology drug candidate, Namodenoson, has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the indication of pancreatic cancer, one of the most aggressive malignancies (Press release, Can-Fite BioPharma, OCT 9, 2024, View Source [SID1234647106]). The designation as an orphan drug will provide among others, potential for market exclusivity for seven years after approval and several and regulatory advantages (View Source)

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Can-Fite is now completing all the preparatory work for a Phase II study in patients with pancreatic cancer. The study will be a multicenter open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least 1st-line therapy. The trial will evaluate the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this patient population. All patients will receive oral Namodenoson 25 mg, administered twice daily for consecutive 28-day cycles. Patients will be evaluated regularly for safety. Approximately 20 evaluable patients will be enrolled. The primary objective of this trial is to characterize the safety profile of Namodenoson, and the secondary objective is to evaluate the clinical activity as determined by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS).

"We are advancing our plans to start our Phase 2 study in pancreatic cancer and aim to commence the study by the end of year; we are thrilled that the FDA has granted Orphan Drug Status," stated Can-Fite CEO Motti Farbstein".

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR), on the surface of liver and pancreatic cancer cells. Namodenoson, induces apoptosis of these cancer cell types. Namodenoson was evaluated in Phase II liver cancer trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On October 9, 2024 BullFrog AI Holdings, Inc. (NASDAQ: BFRG; BFRGW) ("BullFrog AI" or the "Company"), a technology-enabled drug development company using artificial intelligence (AI) and machine learning to enable the successful development of pharmaceuticals and biologics, reported the publication of new research in the peer-reviewed journal Cell Reports supporting the potential of BullFrog AI’s drug candidate, BF-114 (SPTBN1 siRNA), in treating a range of liver diseases, including metabolic dysfunction-associated steatotic liver disease (MASLD), metabolic dysfunction-associated steatohepatitis (MASH), and hepatocellular carcinoma (HCC) (Press release, Bullfrog AI, OCT 9, 2024, View Source [SID1234647105]). The research was generated in a study led by Lopa Mishra, MD, professor of medicine, Merinoff Endowed Chair and co-director of the Institute for Bioelectronic Medicine at Feinstein Institutes for Medical Research at Northwell Health, Cold Spring Harbor Laboratory.

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"This research strengthens the scientific foundation for BF-114 and its potential role in addressing complex liver diseases," said Vin Singh, CEO of BullFrog AI. "Dr. Mishra’s work offers compelling evidence that our approach could change the treatment landscape for these metabolic disorders."

Dr. Mishra’s research demonstrates that β2-spectrin, a protein encoded by the SPTBN1 gene, mediates the effects of environmental factors that drive the progression of MASH. By reducing β2-spectrin levels, BF-114 has been shown to halt the progression of MASLD and MASH in animal models, while also reducing liver damage.

These findings strengthen and extend previously published data from Dr. Mishra’s laboratory that support BullFrog AI’s development of BF-114 for the treatment of obesity and liver diseases.

BullFrog AI plans to leverage its proprietary AI-driven platform to analyze single-cell data from animal models and human patients. This analysis will provide additional mechanistic understanding of the effects of SPTBN1 silencing in obesity and liver disease. The insights gained are expected to inform the continued development of BF-114 and may potentially reveal additional therapeutic applications.

BullFrog AI is also pleased to welcome Dr. Mishra to its Scientific Advisory Board. Dr. Mishra will provide guidance as the Company advances its BF-114 program. Dr. Mishra received her MBBS from the University of London and completed fellowships in Medicine and Gastroenterology at Royal Northern/Whittington Hospital (London), Mount Sinai Medical Center, and Johns Hopkins Hospital. With over 100 peer-reviewed publications relevant to the field and an H-Index of 66, her expertise will be instrumental in guiding the continued development of BF-114.

Dr. Mishra commented, "I am excited to join BullFrog AI’s Scientific Advisory Board and continue our work in targeting SPTBN1. The combination of BullFrog AI’s approach to drug development and the promising results we’ve seen with BF-114 provides a strong foundation for the continued exploration of its potential in treating obesity and liver diseases. I look forward to contributing to the advancement of BF-114 and exploring its multiple therapeutic possibilities."

On October 9, 2024 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through development of potentially best-in-class IL-2 therapeutics, reported that pharmacokinetic data for evaluation of AU-007 in the Phase 2 portion of its Phase 1/2 clinical trial will be presented at the 36th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics (Press release, Aulos Bioscience, OCT 9, 2024, View Source [SID1234647104]). AU-007 is a human IgG1 monoclonal antibody designed using artificial intelligence to harness the power of interleukin-2 (IL-2) to eradicate solid tumors in patients with unresectable locally advanced or metastatic cancers. The EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) symposium is being held October 23-25, 2024, in Barcelona, Spain.

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"With the Phase 1 trial of AU-007 completing the dose escalation and expansion phase, we are pleased to share the pharmacokinetic data used to determine dose selection of AU-007 for the Phase 2 portion of the trial," said Aron Knickerbocker, Aulos Bioscience’s president and chief executive officer. "We’re excited by the continued progress and distinct findings with our investigational therapy in the clinic, and we are grateful to the clinicians and patients who participate in this important study."

Details of the poster presentation are as follows:

Poster Number and Title: PB452: Determination of the phase 2 dose of AU-007, an AI-designed human monoclonal antibody that redirects IL-2 to T effector cells
Abstract: 464
Session: New therapies in immuno oncology
Session Date and Time: Friday, October 25, 2024, 9:00 a.m.-3:00 p.m. CEST

The poster will be presented in the Exhibition Hall at the Centre de Convencions Internacional de Barcelona (CCIB).

About AU-007
AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

To learn more about the AU-007 Phase 1/2 clinical trial program, including study locations in the United States and Australia, please visit ClinicalTrials.gov (identifier: NCT05267626), www.solidtumorstudy.com (U.S.) and www.solidtumourstudy.com (Australia).

On October 9, 2024 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, reported that it has engaged Philippe Pultar, MD as his senior medical advisor to support Aprea with developing and advancing APR-1051, Aprea’s potential best in class WEE1 inhibitor (Press release, Aprea, OCT 9, 2024, View Source [SID1234647103]).

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Dr. Pultar is a seasoned pharmaceutical executive with extensive experience in oncology, including the development of a WEE1 inhibitor (azenosertib) from early to late-stage clinical development. Dr. Pultar has extensive experience in clinical development within both large and early-stage pharmaceutical companies. Engaging Dr. Pultar aligns with Aprea’s commitment to provide its WEE1 inhibitor program with all the necessary resources, including the best available professional talent and expertise, to succeed. Dr. Pultar was most recently employed at Zentalis Pharmaceuticals where he played a key role in the strategy and execution of the global clinical development of azenosertib, a WEE1 inhibitor.

Patient enrollment is currently ongoing in the Phase 1 ACESOT-1051 study, designed to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of single-agent APR-1051 in advanced solid tumors harboring certain cancer-associated gene alterations. Aprea intends to provide an update on the progress of this clinical study by year end 2024. The WEE1 program is part of Aprea’s portfolio of DDR-targeted therapeutics aimed to deliver precision medicine solutions that ensure the right patients receive the most effective Aprea treatment, with the goals of improving outcomes and reducing treatment resistance.

"WEE1 inhibition is a promising therapeutic approach in oncology and my prior experience has given me a thorough understanding of biomarker driven clinical studies, the development and regulatory landscape as well as the likely attributes for a successful therapeutic," said Dr. Pultar. "Aprea has a great opportunity to be a leader in this space. I am quite impressed by the progress the team has made advancing APR-1051, which has a differentiated profile, and is supported by compelling pre-clinical data. I am very excited to be associated with this program and I believe APR-1051 has the potential to be best in class. I look forward to working with the talented scientists at Aprea with the goals of advancing its WEE1 program and bringing new treatments to patients battling difficulty-to-treat cancers."

"Dr. Pultar is a highly capable scientific leader with a track record of successfully leading programs through late-stage development and regulatory approval," said Oren Gilad, Ph.D., President and CEO of Aprea. "Given the recent initiation of our Phase 1 ACESOT-1051 clinical trial evaluating our promising WEE1 inhibitor, APR-1051, we are excited to bring on a high caliber advisor such as Dr. Pultar. Dr. Pultar’s prior experience in managing multiple clinical trials for a WEE1 inhibitor is particularly relevant and we hope to leverage his expertise as we advance our own program and maximize the therapeutic potential of APR-1051. His addition to the team is part of our broader strategy to bring in exceptional talent with the experience and skills to successfully advance our programs."

Dr. Nadeem Mirza will be stepping down as Chief Medical Officer effective as of October 9, 2024, to pursue other professional endeavors but will remain with the Company through a date not later than December 13, 2024, to ensure a smooth leadership transition.

About Philippe Pultar, MD

Dr. Pultar brings over 17 years of extensive experience in early and late-stage clinical development. From 2020 to 2023 he was Vice President, Clinical Development at Zentalis Pharmaceuticals where he was responsible for the strategy and execution of the global clinical development of azenosertib, working closely with co-development partners GSK, Pfizer, and Zentera for China. He initiated seven Phase 1 and Phase 2 trials with azenosertib as single agent and in combination with chemotherapy and targeted agents across multiple indications. Prior to Zentalis, he spent seven years at Novartis Oncology (2013 to 2020), including as Senior Clinical Development Medical Director. He was appointed Medical Lead in rare diseases and was assigned to New Drug Application (NDA) activities for Isturisa (osilodrostat). He led the writing and review of key EU and US NDA documents for Isturisa, resulting in its approval with broad indication in Cushing’s syndrome with limited post-approval commitments. He was also Medical Lead for Phase 2, 3 and 4 trials on Isturisa, Signifor (pasireotide) and Odomzo (sonidegib). Prior to Novartis he was employed in senior clinical development roles at Agennix AG (2011 to 2013) and ImClone Systems (2007 to 2011). Earlier in his career, he held positions at GPC Biotech, ALTANA Pharma, REDEON and MEDICERCLE.

Dr. Pultar earned his medical thesis from Université de Médecine de Poitiers, France and practiced as a physician for several years. His foundational education includes Medical Studies and Residency at Université de Médecine de Poitiers, providing him with a solid academic background to complement his extensive practical experience in clinical development.