On October 14, 2024 MEDiC Life Sciences ("MEDiC"), a Silicon Valley biotech startup, reported that it has entered a research collaboration with Hanmi Pharmaceutical ("Hanmi"), a leading biopharma company in Korea (Press release, MEDIC Life Sciences, OCT 14, 2024, View Source [SID1234647188]). In this collaboration, MEDiC will use its MCAT platform to identify cancer biomarkers for one of Hanmi’s clinical assets.

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MCAT is MEDiC’s next-generation functional genomics platform that can simultaneously measure millions of gene-to-drug interactions between a cancer drug and all possible genetic mutations. Using this platform, MEDiC identifies SLS biomarkers—a set of multiple genetic mutations that exhibit synthetic lethality with a given cancer drug—maximizing response rates in patients whose cancer harbors any of these mutations. This platform can also expand the market potential of cancer drugs by providing multiple biomarkers, whose combined prevalence in patients can be significant.

"We are very excited that Hanmi Pharmaceutical, a leading biopharma company, has selected MEDiC as a collaborator to advance its oncology programs," said Kyuho Han, Ph.D., co-founder and chief executive officer of MEDiC. "We look forward to working with Hanmi to identify synthetic lethal biomarkers for their clinical assets, advancing effective new treatments for cancer patients."

Under the terms of the agreement, MEDiC has received upfront payments for the research collaboration and a strategic investment from Hanmi.

In Young Choi, Head of Hanmi’s R&D Center, stated, "Hanmi is conducting research on various cancer therapeutics, including immuno-oncology, and targeted therapies, achieving meaningful results in the clinical development of innovative cancer drugs." He added, "Through this collaboration with MEDiC, which possesses outstanding biomarker technology, we expect to strengthen the value of Hanmi’s new cancer drugs by improving the possibility of success in clinical trials." He also stated, "Along with research collaboration, strategic investment will empower the relationship between Hanmi and MEDiC, allowing the synergy by ascending the value of assets for each company."

MEDiC has developed a proprietary functional genomics platform that uses patient tumor-like cancer models to identify optimal gene targets and biomarkers for cancer treatment. While functional genomics approaches have been widely used to screen whole genomes for gene functions in cancer, MEDiC is the first to demonstrate that using 3D tumor models, rather than traditional 2D cultures, can significantly improve the accuracy and translatability of functional genomics. With this technology, MEDiC can identify novel cancer targets and biomarkers for developing drugs for solid tumor indications. MEDiC’s unique approach has already attracted partners, including Bristol Myers Squibb, Hanmi Pharmaceutical, and other undisclosed companies, who are seeking novel targets and biomarkers for drug development.

On October 14, 2024 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported the first patient has been dosed in the Company’s Phase 1 (POLAR) clinical trial evaluating RP-3467, a Polθ ATPase inhibitor, alone and in combination with the poly-ADP ribose polymerase (PARP) inhibitor, olaparib. RP-3467 is Repare’s fourth clinical program (Press release, Repare Therapeutics, OCT 14, 2024, View Source [SID1234647189]).

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"RP-3467, our potential best-in-class Polθ ATPase inhibitor, has demonstrated highly compelling preclinical results, including complete and durable tumor regressions in combination with olaparib, the leading PARP inhibitor, with no additive toxicities. This combination is designed to meaningfully improve patient outcomes by mitigating PARP inhibitor resistance, a significant area of high unmet medical need," said Maria Koehler, MD, PhD, Executive Vice President and Chief Medical Officer of Repare. "In addition, Repare’s previously reported data established the potential for RP-3467 to improve efficacy and limit toxicity in combination with radioligand therapy and chemotherapy-bearing antibody drug conjugates (ADCs), and we look forward to exploring those areas."

The POLAR clinical trial (NCT06560632) is a multicenter, open-label, dose-escalation Phase 1 clinical trial to investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RP-3467 alone or in combination with the PARP inhibitor, olaparib, in adults with molecularly selected advanced solid tumors. The study is expected to enroll approximately 52 patients with locally advanced or metastatic epithelial ovarian cancer, metastatic breast cancer, metastatic castration-resistant prostate cancer, or pancreatic adenocarcinoma. The primary objectives of the study are to assess the safety and tolerability of RP-3467 alone and in combination with olaparib, and to define a preliminary recommended Phase 2 dose of RP-3467 in combination with olaparib.

On October 14, 2024 TriSalus Life Sciences Inc. ("TriSalus" or the "Company") (Nasdaq: TLSI), an oncology company dedicated to enhancing outcomes for patients with liver and pancreatic cancer through its advanced delivery technology and novel immunotherapy, nelitolimod, reported that Mary Szela, Chief Executive Officer and President of TriSalus, will participate in a fireside chat at the 2024 Maxim Healthcare Virtual Summit on Thursday, October 17, 2024 (Press release, TriSalus Life Sciences, OCT 14, 2024, View Source [SID1234647190]).

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Details for the fireside chat are as follows:

Date: Thursday, October 17, 2024
Time: 12:30 p.m. EDT / 11:30 a.m. CDT
Presenter: Mary Szela, Chief Executive Officer and President of TriSalus

To attend the event, please register by clicking here.

On October 13, 2024 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for sunvozertinib for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) who have not received prior systemic therapies (Press release, Dizal Pharma, OCT 13, 2024, View Source [SID1234647171]).

This designation is the fourth BTD that Dizal has received for sunvozertinib in EGFR exon20ins NSCLC. It follows the grant by the U.S. Food and Drug Administration (FDA) for the first-line setting in April this year. Sunvozertinib was previously granted BTDs by both the U.S. FDA and the China CDE for relapsed or refractory patients.

BTD procedures in the US and China are designed to expedite the development and regulatory review of new medicines that are intended to treat serious or life-threatening conditions with preliminary clinical evidence indicating substantial improvement over available therapies. Drug candidates with BTD can be considered for priority review when submitting a New Drug Application (NDA).

"The total of four Breakthrough Therapy Designations by both the U.S. and China’s regulatory agencies, reflects not only sunvozertinib’s transformative potential in EGFR exon20ins NSCLC, but also Dizal’s commitment to developing groundbreaking new medicines to address unmet medical needs globally." said Xiaolin Zhang, PhD, CEO of Dizal, "Sunvozertinib is the world first and only oral drug approved for the treatment of lung cancer patients with EGFR exon20ins. We are accelerating ongoing clinical studies and regulatory submissions, hoping to bring this new treatment option to more patients as quickly as possible."

The CDE granted the BTD based on results from the pooled analysis of the global multi-center phase I/II study (WU-KONG1) and the phase II study (WU-KONG15) focused on patients from China. Results from these studies showed that sunvozertinib, as a single oral agent, produced a confirmed objective response rate (cORR) of 78.6% and a median progression-free survival (mPFS) of 12.4 months in treatment-naïve patients with advanced or metastatic NSCLC with EGFR exon20ins. Additionally, sunvozertinib is well tolerated with overall safety profile similar to classic EGFR-TKIs.

Currently, sunvozertinib is being evaluated in the WU-KONG28 study, a phase III, multinational, randomized study to compare sunvozertinib vs. platinum doublet chemotherapies in treatment naive patients globally.

NSCLC with EGFR exon20ins are difficult to treat due to their unique spatial conformation, diverse mutation subtypes, and high heterogeneity. In some parts of the world, an antibody with platinum containing chemotherapies is the only treatment option in the first line setting.

Sunvozertinib was approved in China for the treatment of relapsed or refractory NSCLC with EGFR exon20ins in 2023 based on WU-KONG6 study results. In an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, Dizal revealed its WU-KONG1 Part B study results, a multinational study with patients from Asia, Europe, North America, and South America. The study met its primary endpoint. Regulatory submissions for market approvals are ongoing.

About sunvozertinib (DZD9008)

Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In August 2023, sunvozertinib received approval from NMPA to treat advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies. The approval is based on the results of WU-KONG6 study, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The primary endpoint of the study was the confirmed overall response rate (cORR) as assessed by the Independent Review Committee (IRC) reached 60.8%. Anti-tumor efficacy was observed across a broad range of EGFR exon20ins subtypes, and in patients with pretreated and stable brain metastasis. In addition, sunvozertinib also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins.

Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable.

Two global pivotal studies are ongoing in ≥ 2nd line (WU-KONG1 Part B) and 1st line setting (WU-KONG28), respectively, in NSCLC patients with EGFR exon20ins.

Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery (IF:39.397) and The Lancet Respiratory Medicine (IF: 76.2).

On October 13, 2024 Akeso Biopharma (9926. HK) ("Akeso", the "Company" ) reported that it has successfully raised approximately $250 million USD through a share placement (Press release, Akeso Biopharma, OCT 13, 2024, View Source [SID1234656029]). This offering has earned notable recognition among international investment firms, with the majority of our final subscribers being long-term funds and healthcare funds.

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This marks Akeso’s second successful share placement in 2024. Following this transaction, the Company’s cash on hand is expected to be 1.064 billion USD (7.5 billion RMB).

Seventy percent of the financing will be allocated to accelerating the global clinical development of innovative drugs developed internally by Akeso, with a primary focus on its core products in both China and international markets.

Dr. Xia Yu, Founder, Chairwoman, President, and Chief Executive Officer of Akeso Biopharma, stated: "The efficient completion of this share placement reflects Akeso’s long-term investment value being highly recognized by international long-term institutional investors and specialized institutions in the healthcare sector. The success of this financing will bolster Akeso’s global development strategy for a diversified pipeline of independently developed new drugs, particularly by accelerating multi-center international clinical trials led by Akeso. This initiative will enhance the global value exploration of our internally developed new drugs and further strengthen our competitiveness in the international market."