On March 15, 2024 Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported the successful completion of cohort 3 and advancement to cohort 4, the first multi-dose cohort in the SECuRE trial (Press release, Clarity Pharmaceuticals, MAR 15, 2024, View Source [SID1234641160]).

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The SECuRE trial (NCT04868604)1 is a Phase I/IIa theranostic trial for identification and treatment of Prostate-Specific Membrane Antigen (PSMA) expressing mCRPC using 64Cu/67Cu-SAR-bisPSMA. 64Cu-SAR-bisPSMA is used to visualise PSMA expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm, dose escalation trial with a cohort expansion involving up to 44 patients in the US. The aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of prostate cancer.

Cohort 3 of the dose escalation phase of the trial, where 6 participants received a single administration of 12GBq of 67Cu-SAR-bisPSMA, has been successfully completed. No DLTs have been reported in any of the participants dosed in this cohort to date. The SRC, responsible for assessing safety of participants and overseeing the general progress of the trial, has assessed the data and recommended progressing the trial to cohort 4 where participants will be treated with multiple therapy cycles of 67Cu-SAR-bisPSMA at a dose level of 12GBq, the highest dose level in the dose escalation phase of the trial.

Anti-tumour effect of 67Cu-SAR-bisPSMA

All participants in the SECuRE trial had advanced prostate cancer (stage IV, mCRPC). Assessment of the baseline characteristics of these patients showed that they were heavily pre-treated before entering the study, having received multiple therapies for their disease. Those treatments included ADT, ARPI, several investigational agents (targeting different pathways of the cancer), chemotherapy and other radioligand therapies. Most trial participants had received chemotherapy (67%, 10/15) and the median number of lines of therapy prior to receiving 67Cu-SAR-bisPSMA was 4. The median PSA at study entry was 117.1 ng/ml (range 0.11-1,494.2).

Preliminary data shows that despite having high levels of PSA and having received multiple treatments, 60% (9/15) of participants across all cohorts (including the lowest dose cohort of 67Cu-SAR-bisPSMA at 4GBq) showed reductions in PSA levels of greater than 35% from a single therapy cycle of 67Cu-SAR-bisPSMA. PSA reductions of greater than 80% were seen in 27% of all trial participants. In cohorts 2 and 3 (8 and 12GBq, respectively), PSA reductions of greater than 35% were observed in almost 80% (78%, 7/9) of participants and PSA was reduced by greater than 80% in 44% (4/9) of participants so far.

Participants in cohort 3 had the highest median baseline PSA and the highest median number of systemic therapies across all cohorts (median baseline PSA 122.6, 47.2 and 140.3 ng/ml; median lines of therapy 4, 3 and 5.5; cohorts 1, 2 and 3, respectively). Nevertheless, two-thirds (67%) of participants in this cohort so far have shown reductions in PSA greater than 35%, with the last participants in this cohort dosed in January 2024. Importantly, a single dose of 12GBq of 67Cu-SAR-bisPSMA was effective in reducing PSA levels in the majority of these patients despite receiving the most lines of prior therapy

On March 14, 2024 Stada reported its annual report for year 2023 (Presentation, Stada, MAR 14, 2024, View Source [SID1234642401]).

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On March 14, 2024 Shanghai Ailes Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Ailes") reported that its independently developed AST2169 liposome for injection (hereinafter referred to as "AST2169" ) has recently obtained the "Drug Clinical Trial" approved and issued by the State Food and Drug Administration (Press release, Allist Pharmaceuticals, MAR 14, 2024, https://www.allist.com.cn/newsd/101/2078.html [SID1234642112]). Approval Notice", approving its Phase I clinical study on safety, tolerability, pharmacokinetics and preliminary efficacy in patients with KRAS G12D mutated advanced solid tumors.

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AST2169 is a KRAS G12D selective inhibitor with global intellectual property rights independently developed by Alex . KRAS G12D mutation is a common subtype of KRAS mutation and is found in many types of cancers such as non-small cell lung cancer, colorectal cancer, and pancreatic cancer. Although the role of KRAS mutations in human cancer has been known for decades, the development of anti-cancer therapies targeting KRAS mutations has been slow . Currently, no KRAS G12D inhibitors have been approved for marketing globally , and the growing clinical demand cannot Be satisfied.

According to statistics from the World Health Organization ( WHO ), there will be approximately 2.21 million new cases of lung cancer and 1.15 million new cases of colorectal cancer in the world in 2020 . In 2020 , there will be approximately 820,000 new cases of lung cancer and approximately 550,000 new cases of colorectal cancer in China . KRAS is a commonly mutated driver gene, and the incidence of KRAS mutations in cancer patients is 14%-30% . KRAS G12D is the predominant mutation subtype among KRAS mutations and is detected in approximately 30% of pancreatic cancers, 12% of colorectal cancers, and 4% of non-small cell lung cancers.

Mr. Du Jinhao, Chairman and General Manager of Ellis, said: "Alice has accumulated nearly 20 years of research and development experience in the field of oncology, and has been deeply involved in research and development, commercialization and other stages of precision treatment of lung cancer, aiming to continuously launch innovative products. , innovative solutions to meet the growing clinical needs of cancer patients and bring good news to cancer patients. "

On March 14, 2024 Sibylla Biotech reported a drug discovery collaboration with Ono Pharmaceutical Co., Ltd. (TSE: 4528) that will access Sibylla’s cutting-edge Pharmacological Protein Inactivation by Folding Intermediates Targeting (PPI-FIT) technology to identify and develop candidates for multiple therapeutic targets in the field of Central Nervous System (CNS) disorders (Press release, Sibylla Biotech, MAR 14, 2024, View Source [SID1234641502]). Under the terms of the collaboration, Sibylla is entitled to a total deal value in the three-digit millions of U.S. dollars, including upfront payment, research, development and sales milestones, and royalties on sales. Further financial details on the collaboration have not been disclosed.

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Sibylla Biotech utilizes its PPI-FIT technology to design Folding Interfering Degraders (FIDs). FIDs are small molecules that induce the degradation of a target protein by interfering with its folding pathway. The technology targets specific proteins, particularly those considered "undruggable" due to the absence of suitable pockets in their native state. Ono Pharmaceutical plans to harness this technology to address some of the most challenging aspects of CNS drug development by targeting proteins involved in complex neurological pathways.

"Sibylla’s PPI-FIT technology platform has the potential to surpass the limitations of conventional methods and uncover novel CNS therapeutic targets," said Toichi Takino, Senior Executive Officer/Executive Director, Discovery & Research of Ono Pharmaceutical. "This collaboration is a key part of our strategy to increase efficiency in developing our pipeline in CNS areas and bring innovative solutions to patients facing serious neurological disorders."

"Our partnership with Ono Pharmaceutical represents a fusion of Sibylla’s cutting-edge technology in protein folding simulation with Ono’s extensive experience in CNS research. Together, we aim to unlock new therapeutic possibilities for patients worldwide," commented Lidia Pieri, PhD, Co-Founder and Chief Executive Officer of Sibylla Biotech. "I am honored to collaborate with the Ono Pharmaceutical team, whose rich history, expertise and culture I greatly appreciate, and all of us at Sibylla look forward to working closely with them."

On March 14, 2024 Biotheus Inc. (Biotheus), a clinical-stage biotech company focusing on the discovery and development of biologics for oncology and inflammatory diseases, and Hansoh Pharmaceutical Group Co., Ltd. (Hansoh Pharma,03692.HK), China’s leading innovation-driven pharmaceutical company, jointly announced that the two parties will further expand their strategic collaboration, following their current partnership since 2022. Biotheus will grant Hansoh Pharma a license to use the proprietary anti-EGFR/cMet bispecific antibody PM1080/HS-20117 independently developed by Biotheus for the development of antibody-drug conjugates products (ADC Product).

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Under the terms of the agreement, Hansoh Pharma will obtain exclusive worldwide rights from Biotheus to use PM1080/HS-20117 for the development, production, and commercialization of ADC Product, with the right of sublicense. Biotheus will be eligible to receive up to 5 billion RMB in upfront and success-based milestones for ADC Product, as well as tiered royalties based on global net sales from Hansoh Pharma.

PM1080/HS-20117 is a 1+1 heterodimeric structure of EGFR/cMet bispecific antibody, which can inhibit the growth and survival of tumors by specifically targeting the tumor antigens EGFR and cMet, and is currently in phase I clinical trials.

"This is the second collaboration between Hansoh and Biotheus. We really appreciate Hansoh’s confidence in the potential of PM1080", said Mr. Xiaolin Liu, Co-founder, Chairman and Chief Executive Officer of Biotheus. "Bispecific ADCs have a potential advantage for better tumor enrichment, overall efficacy and safety. Hansoh develops an outstanding ADC platform, and this collaboration will facilitate the synergy between Hansoh’s ADC expertise and Biotheus’ antibody capabilities. Through this collaboration, we hope to develop a novel EGFR/cMet bispecific ADC with better efficacy and safety for cancer patients worldwide."

"We are delighted to expand our partnership with Biotheus." Said Ms Eliza Sun, Executive Director of the Board at Hansoh. "This collaboration combines Hansoh’s proprietary ADC Platform technology with Biotheus’ novel bispecific antibody. We hope this new approach will further increase the clinical benefit in patients with NSCLC or other solid tumors. We are confident in our ability to offer transformative treatment options to cancer patients in China and worldwide. This is made possible through our extensive experience in clinical development, exceptional commercialization efforts, and external partnerships."