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 Hoag reported a new technology using ultrasound energy to precisely destroy liver tumors in a single outpatient visit (Press release, Hoag Cancer Center, OCT 14, 2024, View Source [SID1234647187]).

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HistoSonics Edison Histotripsy System is a precise, non-invasive cancer treatment option and the only FDA-approved therapy of its kind for treating liver tumors. As an alternative to radiation therapy, Histotripsy uses targeted ultrasound waves to wipe out cancer cells. The sound waves produce mini bubbles within the tumor, creating pressure to eradicate unhealthy cells, all while keeping surrounding liver structures and healthy tissue intact.

This FDA-approved treatment is performed by Hoag interventional radiologists and can coincide with chemotherapy and other treatment methods. Histotripsy has little to no side effects and patients usually go home the same day.

Hoag’s investment in Histotripsy underscores the hospital’s commitment to innovation in the name of patient care.

"We are excited to offer the latest advancements in the battle against cancer. Hoag is proud to be among a select few centers nationwide to offer patients access to the best treatments and most advanced technologies available today. This includes Histotripsy, a newly approved therapy which will revolutionize the treatment of cancer utilizing a non-invasive method to destroy cancer in the liver without a single incision," said Trushar Patel, M.D., Chief of Interventional Radiology and Interventional Oncology at Hoag Hospital.

Hoag Digestive Health Institute and Hoag Family Cancer Institute clinicians work together to provide liver cancer patients with the very latest treatment options, resulting in better outcomes.

"The treatment for patients with cancer in the liver can be complex and nuanced. We have a multidisciplinary team of fellowship-trained specialists in hepatology, liver surgery, advanced endoscopy, diagnostic and interventional radiology along with our care counselor and dietician, who will guide you through your entire care journey," said Kenneth J. Chang, M.D., Executive Medical Director of the Digestive Health Institute at Hoag. "The combined expertise of our Digestive Health and Cancer Institutes gives patients access to the most advanced diagnostics, individualized therapies and treatment options as well as groundbreaking clinical trials."

This revolutionary technology is already showing promising results.

"Our early experience indicates that patients with any cancer type with liver metastasis can greatly benefit from this non-invasive, outpatient cancer-fighting procedure," said Tara Seery, M.D., medical oncologist at Hoag. "Histotripsy allows us to offer renewed hope to our patients and their loved ones, especially for those who would otherwise not qualify for surgery."

On October 14, 2024 Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, reported that FDA issues Study May Proceed letter for its developing drug Pidnarulex (CX-5461) in trial entitled "Pilot Study of Pidnarulex Pharmacodynamics in Patients with Advanced Solid Tumors" sponsored by the US National Cancer Institute (NCI) (Press release, Senhwa Biosciences, OCT 14, 2024, View Source [SID1234647186]).

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The study will assess whether Pidnarulex (CX-5461) induces a Rad51 response, in patients with and without homologous repair deficiency (HRD) genetic mutations. This pilot study also aims to explore potential biomarkers beyond BRCA1/2 and PALB2 that may demonstrate synthetic lethality with Pidnarulex (CX-5461). The findings from this study may identify patients who are more responsive to Pidnarulex (CX-5461) treatment, potentially expanding its therapeutic applications, and may accelerate its path to market approval.

In addition to this monotherapy trial, the NCI is considering future clinical trials involving Pidnarulex (CX-5461) in combination with other therapies, such as immunotherapies and antibody-drug conjugates (ADCs). Should these trials proceed as planned, they will be led by the NCI, utilizing its vast medical expertise, scientific resources, and regulatory experience—support that could significantly accelerate the development of Pidnarulex.

Pidnarulex (CX-5461), developed by Senhwa, is a first-in-class small-molecule designed to stabilize G-quadruplex (G4) structures, which are frequently observed in promoters of oncogenes. By stalling replication fork progression, Pidnarulex induces DNA damage and promotes cancer cell death. Through this mechanism, Pidnarulex holds great potential as a therapeutic agent for various cancers.

In recent years, immunotherapy has been the fastest-growing category in the cancer drug market. According to the 2023 global best-selling drug market analysis, the first PD-1 inhibitor Keytruda(Pembrolizumab), developed by Merck, topped the sales charts with $25.11 billion. Immunotherapy and cancer drugs account for nearly half of the market sales. International clinical research indicates that combined immunotherapy can enhance tumor response rates, reduce mortality, and prolong patient survival. Given that only 20% to 25% of patients benefit from effective immunotherapy, Senhwa expects that in future immuno-combination therapy trials, CX-5461 will change the tumor microenvironment with its innovative mechanism, thereby enhancing the efficacy of immunotherapy, realizing the corporate mission of bringing hope to life.

On October 14, 2024 SystImmune, Inc (SystImmune), a clinical-stage biotechnology company, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for BL-M11D1, an antibody-drug conjugate (ADC) binding CD33, a protein on myeloid cells (Press release, SystImmune, OCT 14, 2024, View Source [SID1234647185]). The IND supports the initiation of a Phase 1 clinical trial, BLM11D1-HM-101, to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of BL-M11D1 for the treatment of patients with relapsed/refractory Acute Myeloid Leukemia (AML) in the United States.

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The clearance of this IND application marks an important milestone for SystImmune as the company continues to advance its pipeline of novel therapeutic candidates into clinical development. Dr. Jie D’Elia, Chief Executive Officer of SystImmune, commented, "Our mission at SystImmune is to continue to bring therapies that can provide clinical benefit to patients. The initiation of clinical development for BL-M11D1 emphasizes that commitment."

"We are excited to receive the FDA Study-May-Proceed letter enabling the initiation of our Phase 1 study with BL-M11D1. We believe that this novel, potentially best-in-class ADC can offer an important therapeutic option for patients with relapsed/refractory AML and look forward to implementing this study," expressed Dr. Jonathan Cheng, Chief Medical Officer at SystImmune.

About BL-M11D1
The company is developing BL-M11D1, an ADC comprising a monoclonal antibody component binding CD33 and a linker-payload component that is composed of a topoisomerase I inhibitor payload and a stable enzyme-cleavable linker. BL-M11D1 works by triggering antibody-dependent cellular cytotoxicity (ADCC) when it binds to CD33 on cancer cells. In addition, the binding to CD33 causes its internalization followed by the release of the payload, which then kills the tumor cell.

On October 14, 2024 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported that its randomized Phase II study to evaluate TG4001 in combination with avelumab versus avelumab alone in patients with recurrent or metastatic HPV16-positive cervical and anogenital tumors has not met the primary objective of the study (improvement in progression-free survival) (Press release, Transgene, OCT 14, 2024, View Source [SID1234647184]).

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The pre-planned subgroup analysisshowed a positive efficacy trend in favor of the TG4001 containing regimen in cervical cancer patients, which requires further confirmation through additional analyses, including by PD-L1 status. These patients account for approximately half of the patients enrolled in the study.

The treatment has been well tolerated. Adverse events are consistent with previous observations.

Transgene is currently evaluating the full study results in detail to determine the best way forward for this program and will communicate further once this is completed.

Dr. Alessandro Riva, Chairman and CEO of Transgene, said: "Failure to meet the primary objective in our Phase II study with TG4001 is disappointing. Nevertheless, we are encouraged by the positive efficacy trend in favor of the combination regimen in cervical cancer patients. We plan to complete a full and rigorous analysis of the data before deciding on any path forward for this asset, in particular in cervical cancer, in the context of the evolving treatment landscape. The complete study results will be presented at an upcoming scientific conference. We would like to thank all the patients and caregivers who have taken part in this study for their important contribution. With a diversified portfolio of novel immunotherapies targeting solid tumors, our strategy remains focused on advancing our lead asset, TG4050, an individualized cancer vaccine for head and neck cancers for use following surgery and adjuvant therapy. We expect to report additional data on TG4050 from the 24-month median follow-up of Phase I patients in our head and neck cancer trial in November 2024 at the SITC (Free SITC Whitepaper) conference."