On October 26, 2022 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company) a leader in the development of targeted radiotherapies, reported that it will be participating in the Bio-Europe conference being held virtually November 2 – 4, 2022 (Press release, Actinium Pharmaceuticals, OCT 26, 2022, View Source [SID1234622406]).

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Members of Actinium’s business development team will be participating in 1-on-1 meetings during the conference. Meetings with Actinium can be requested through the partneringONE system https://informaconnect.com/bioeurope/ or by contacting Andrew Olsen, Ph.D., Senior Associate, Scientific and Business Analysis at [email protected].

Bio-Europe is the largest European biopharma partnering meeting with over 4,000 attendees from 2,200 companies and over 27,000 1-on-1 meetings scheduled.

On October 26, 2022 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today reported proof of mechanism in KURRENT-HN, the Company’s Phase 1/2 clinical trial of tipifarnib in combination with alpelisib in patients with HRAS- and/or PIK3CA-dependent head and neck squamous cell carcinoma (HNSCC) (Press release, Kura Oncology, OCT 26, 2022, View Source [SID1234622405]). The preliminary data are being presented at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium in Barcelona.

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In a poster entitled, "HNSCCs overexpressing wild-type HRAS are sensitive to combined tipifarnib and alpelisib treatment," Kura highlights a patient with stage III squamous cell carcinoma of the tonsil, including a PIK3CA mutation and HRAS overexpression, who has achieved a durable partial remission on study. The 35-year-old patient enrolled in KURRENT-HN after failing two prior treatments, experienced an 81% reduction in target lesions after one cycle of tipifarnib and alpelisib and an 84% reduction after three cycles. As of September 14, 2022, the patient continued on study for more than 27 weeks. Treatment-related adverse events in the study have been consistent with the known safety profiles of each drug and are manageable, with no dose-limiting toxicities reported to date. A copy of the poster is available at www.kuraoncology.com.

Although tipifarnib has shown single-agent clinical activity in a highly selected population of HRAS mutant HNSCC1, and alpelisib has shown single-agent clinical activity in patients with PIK3CA-mutant, ER-positive/HER2-negative breast cancer2, no objective responses have been observed with either agent as a monotherapy in patients with PIK3CA-mutant HNSCC.

"These preliminary data from KURRENT-HN are encouraging, supporting the biologic rationale that combining a farnesyl transferase inhibitor with a PI3Kα inhibitor can achieve meaningful clinical responses in PIK3CA-dependent HNSCC," said Stephen Dale, M.D., Chief Medical Officer of Kura Oncology. "In addition, our new preclinical data support the potential of this combination to address approximately 45% of HNSCC tumors that harbor an actionable HRAS and/or PIK3CA mutation or overexpression. We are now working to identify a recommended Phase 2 dose and schedule for the combination and remain committed to bringing this important new treatment option to patients with recurrent or metastatic HNSCC who are in dire need of better therapies."

About KURRENT-HN

The KURRENT-HN trial is a biomarker-defined cohort study designed to evaluate the safety, determine the recommended combination dosing and assess early anti-tumor activity of tipifarnib and alpelisib for the treatment of HNSCC patients whose tumors are dependent on HRAS and/or PI3Kα pathways. The initial cohort in the trial is comprised of patients who have PIK3CA-dependent HNSCC. In August, Kura announced the first patient was dosed in a second cohort comprised of patients with HRAS overexpression. For more information about the trial, refer to www.kuraoncology.com/kurrent/.

About HNSCC

Head and neck squamous cell carcinoma (HNSCC) is the seventh most common cancer worldwide, accounting for more than 500,000 new cases each year. Despite advances in immunotherapy, the prognosis for advanced HNSCC patients remains poor, with an estimated median overall survival of 13-15 months in patients when stratified by PD-L1 expression. Although the anti-epidermal growth factor receptor (EGFR) antibody, cetuximab, was approved more than a decade ago, development of biomarker-directed therapies in HNSCC has been stymied by the limited number of druggable targets in the genomic landscape and the challenge of managing drug refractory, recurrent/metastatic HNSCC.

On October 27, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported its diagnostic 64Cu SAR-bisPSMA trial (COBRA NCT052491271) for patients with prostate cancer has reached the fifty percent recruitment milestone, with 25 out of 50 participants now having been enrolled and imaged (Press release, Clarity Pharmaceuticals, OCT 26, 2022, View Source [SID1234622404]).

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COBRA (Copper-64 SAR-BisPSMA in Biochemically Recurrent prostAte cancer) is a Phase I/II Positron Emission Tomography (PET) trial of participants with biochemical recurrence (BCR) of prostate cancer following definitive therapy. It is a multi-centre, single arm, non-randomised, open-label trial of 64Cu-labelled SAR-bisPSMA in 50 participants. The primary objectives of the trial are to investigate the safety and tolerability of 64Cu-SAR-bisPSMA as well as its ability to correctly detect the recurrence of prostate cancer.

Dr Neal Shore MD, FACS, Lead Principal Investigator in the COBRA trial and CMO – Urology/Surgical Oncology, GenesisCare, US and the Medical Director of Carolina Urologic Research Centre, commented, "We are very pleased with the progress of the COBRA trial, specifically in regard to the pace of recruitment and the quality of data we are generating to explore and validate the clinical benefits associated with the novel SAR-bisPSMA agent. The growing amount of data from Clarity’s three clinical trials with the 64Cu SAR-bisPSMA product, namely, COBRA, PROPELLER and SECuRE trials, all indicate high uptake of the diagnostic agent by prostate cancer cells. This is especially important for patients with suspected prostate cancer recurrence where SAR-bisPSMA shows promise of improving prostate cancer detection.

"We look forward to recruiting the remaining participants in the COBRA trial and commencing the analysis of the study data. Ultimately, we want to enhance diagnostic accuracy for patients with BCR of prostate cancer as well as improve ease of access to the product across the US, enabled by the logistical advantages of Clarity’s Targeted Copper Theranostic platform."

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are excited to have recruited half of the patients planned for the COBRA trial so quickly. We now have 6 sites actively recruiting the remaining participants with suspected recurrence of their prostate cancer across the US.

"Since opening recruitment into the COBRA trial in March 2022, we have been able to generate strong preliminary data and further strengthen and validate our on-demand distribution model of TCTs with all three of our 64Cu-labelled products, SAR-bisPSMA, SARTATE and SAR-Bombesin, being shipped to numerous trial sites in the US from a central manufacturing facility. TCTs have the potential to enable patient access to critical treatments that are safe and efficacious, on time and at any treatment centre with a positron emission tomography camera.

"This shows promise of substantially growing the radiopharmaceutical field into the large oncology market, moving towards the big pharma model with ready-to-use products on-demand and minimising logistical hindrances associated with the current generation of products. We believe this advancement will help us reach our goal of improving treatment outcomes for children and adults with cancer by focusing on the needs of the patients and their treating staff," said Dr Taylor.

Clarity’s Prostate Cancer clinical trial program overview

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two prostate-specific membrane antigen (PSMA) binding motifs to Clarity’s proprietary sarcophagene (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide2. The National Cancer Institute estimates in 2022 there will be 268,490 new cases of prostate cancer in the US and around 34,500 deaths from the disease3.

On October 26, 2022 NuCana plc (NASDAQ: NCNA) reported that non-clinical data from two poster presentations at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Annual Meeting being held from October 26 to 28, 2022 (Press release, Nucana BioPharmaceuticals, OCT 26, 2022, View Source [SID1234622403]).

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Abstract 185: NUC-3373 is a potent TS inhibitor and induces DNA damage in NSCLC cancer cells regardless of histological subtype

Pemetrexed is an important therapeutic option for first-and second-line adenocarcinoma lung cancers, but is not recommended in squamous lung cancer due to higher levels of thymidylate synthase (TS) expression. NUC-3373 was shown to be a more potent inhibitor of TS than both pemetrexed and 5-FU. NUC-3373 generated high intracellular levels of the anti-cancer metabolite FUDR-MP, resulting in TS inhibition, and the DNA-targeting metabolite, FUDR-TP. This resulted in extensive DNA damage in both adenocarcinoma and squamous carcinoma cell lines. These data highlight that NUC-3373 may be an effective treatment for non-small cell lung cancer (NSCLC) regardless of histological subtype and basal TS expression.

Abstract 128: NUC-3373 induces DAMPs from NSCLC cells potentiating a favorable immunogenic microenvironment

NUC-3373 causes NSCLC cells to release damage associated molecular patterns (DAMPs), molecular signals that activate immune cells leading to immunogenic cell death (ICD). NUC-3373 also enhanced the cell surface expression of the transmembrane protein PD-L1 in lung cancer cell lines, highlighting a potential role for NUC-3373 to enhance immunotherapy efficacy. The addition of pembrolizumab, an anti-PD-1 antibody, to NUC-3373 in a co-culture system where NSCLC cells were incubated alongside human-derived immune cells also enhanced ICD, highlighting a potential role for NUC-3373 as an attractive combination partner for immune checkpoint inhibitors in NSCLC.

Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer, said: "These data are highly supportive of our strategy to combine NUC-3373 with pembrolizumab and to investigate NUC-3373 in patients with NSCLC. We have initiated the NuTide:303 study evaluating NUC-3373 in combination with either pembrolizumab in patients with advanced solid tumors or in combination with docetaxel in patients with non-small cell lung cancer. We have also initiated a randomized study in second-line CRC patients comparing NUFIRI plus bevacizumab to FOLFIRI plus bevacizumab, the global standard of care, and we look forward to sharing data from both of these studies in 2023."

On October 26, 2022 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported that it will be presenting two preclinical posters at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) ("ENA") annual meeting to be held October 26-28, 2022 (Press release, Cogent Biosciences, OCT 26, 2022, View Source [SID1234622402]). Presentations and posters are available to registered attendees for on-demand viewing at View Source and will also be posted to the "Posters and Publications" page of Cogent’s website.

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The first poster discussion will provide an update on Cogent’s next-generation fibroblast growth factor receptor 2 (FGFR2) program, which retains potency across all primary, gatekeeper and molecular brake resistance mutations. The poster includes an overview of ongoing optimization of the Cogent lead series, pharmacokinetic and pharmacodynamic assessment of an FGFR1-sparing novel molecule, as well as robust efficacy in model of FGFR2 clinical resistance (N549K).

The second poster will provide initial preclinical results from Cogent’s novel ErbB2 mutant selective program. Currently available oral ErbB2 inhibitors struggle to provide broad mutant coverage while sparing EGFR activity. Cogent’s exemplar molecule demonstrates robust cellular inhibition of all key resistance and primary driver mutations, while sparing wild type EGFR target engagement. In addition, the advanced compound demonstrates dose ascendable pharmacokinetics, robust tumor phospho-ErbB2 suppression (L755S), and superior tumor growth inhibition when compared to tucatinib.

"The preclinical data presented today highlight an update on two of the first programs undertaken by the Cogent Research Team," said Andrew Robbins, Cogent’s President and Chief Executive Officer. "In the case of both FGFR2 and ErbB2 driven cancers, we believe there remains significant unmet need for therapeutic options with better product profiles than available therapies. Starting with bezuclastinib and continuing with these two targets, our singular focus is to deliver best-in-class medicines for patients fighting genetically driven diseases."