GRAIL to Present at TD Cowen 45th Annual Health Care Conference

On February 21, 2025 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported that company management will present at the TD Cowen 45th Annual Health Care Conference in Boston on Tuesday, Mar. 4 at 9:10 a.m. ET (Press release, Grail, FEB 21, 2025, View Source [SID1234650444]).

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Live and replay webcasts may be accessed in the investor relations section of GRAIL’s website at investors.grail.com. The webcast will be archived and available for reply for at least 30 days after the event.

Geron to Participate at Upcoming Investor Conferences in March 2025

On February 21, 2025 Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company, reported that members of the management team are scheduled to participate in fireside chats at the following investor conferences (Press release, Geron, FEB 21, 2025, View Source [SID1234650442]):

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TD Cowen 45th Annual Health Care Conference
Monday, March 3rdat 3:10pm ET (Boston, MA)

Leerink Global Healthcare Conference
Monday, March 10th3:00pm ET (Miami, FL)

Barclays 27thAnnual Global Healthcare Conference
Tuesday, March 11th10:30am ET (Miami, FL)

A live webcast of each fireside chat will be available through the Investors & Media section of the Geron’s website under Events. A replay of the webcast will be archived and available on Geron’s website for 30 days.

Kelun-Biotech’s Novel ADC SKB445 Receives IND Approval from NMPA in China

On January 21, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") reported that the Company has received a clinical trial notice approving the investigational new drug application for the innovative drug SKB445 developed by the Company from the Center for Drug Evaluation of the National Medical Products Administration (Press release, Kelun, FEB 21, 2025, View Source [SID1234650307]).

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SKB445 is a novel ADC drug with proprietary intellectual property rights developed by the Company based on the biological characteristics of the target and using the technology of the OptiDC platform, which has demonstrated promising efficacy and safety window in preclinical studies and is intended to be used for the treatment of advanced solid tumors.

ReCerise Signs New Research Collaboration Agreement towards Development of Innovative Treatment for Hepatocellular Carcinoma

On February 20, 2025 ReCerise Therapeutics Inc. ("ReCerise"), a company committed to research and development of first-in-class therapeutics in oncology, reported to have entered into a research partnership with the National Cancer Centre Singapore ("NCCS") to develop innovative treatments utilizing multi-omics data analyses in hepatocellular carcinoma (HCC) (Press release, ReCerise Therapeutics, FEB 20, 2025, View Source [SID1234650438]).

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This collaboration will be conducted under the PLANet programme (Precision Medicine in Liver Cancer across an Asia-Pacific Network), which was conceptualized and led by NCCS based on the intra-tumoral heterogeneity of liver tumors and its highly dynamic tumor microenvironment (TME). The longitudinal study performs comprehensive multi-omics profiling of tumor and blood samples from liver cancer patients. This collaboration will leverage the processed multi-omics data collected under the PLANet programme, and will be led by Prof. Pierce Chow Kah Hoe, a prominent global expert in the field of HCC. Prof Chow is a Senior Consultant Surgeon in the Division of Surgery and Surgical Oncology at Singapore General Hospital (SGH) and NCCS, and principal investigator of the PLANet programme.

HCC is a highly prevalent cancer with a poor prognosis due to late diagnosis and low response to existing immunotherapeutic treatment options. ReCerise was established with the purpose of investigating and developing new therapeutic modalities to address such unmet medical needs. So far, basic research and proof-of-concept studies on a liver specific protein have demonstrated promise as a potential solution. ReCerise hopes to expand upon this background knowledge by utilizing real-life evidence in collaboration with NCCS to investigate an HCC patient cohort and confirm the target’s expression and its effect on the liver microenvironment.

"We are excited to collaborate with NCCS to accelerate the development of an innovative new drug for the treatment of liver cancer that ReCerise has been working toward," said Yong-Bae Kim, CEO of ReCerise Therapeutics. "Through this joint research, we plan to conduct multi-faceted studies on the development potential of RCT1213, a hepatocellular carcinoma treatment candidate currently under development, by utilizing the various omics data and research database of Asian HCC patients at NCCS."

The research collaboration between these two parties is a research and development project funded by the Korean government and is subject to the management and supervision of the Korea Evaluation Institute of Industrial Technology (KEIT).

CEL-SCI to Initiate Multikine Confirmatory Phase 3 Cancer Trial

On February 20, 2025 CEL-SCI Corporation (NYSE American: CVM) reported it is in the final stages for the launch of its 212-patient Confirmatory Registration Study for Multikine* (Leukocyte Interleukin, Injection) in newly diagnosed locally advanced head and neck cancer patients (Press release, Cel-Sci, FEB 20, 2025, View Source [SID1234650437]). This final Registration Study is specifically designed to confirm the statistically significant efficacy and safety results from CEL-SCI’s previously completed randomized controlled Phase 3 trial.

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This new Registration Study targets the population of previously untreated resectable stage 3 and 4 head and neck cancer patients who had no lymph node involvement and low PD-L1 tumor expression. During the completed Phase 3 clinical trial, the 5-year survival rate of the target patient population increased to 73% when patients were treated with Multikine vs 45% for control patients who received only the standard of care treatments.

Key aspects of the new Confirmatory Registration Study are as follows:

Enlisting clinical sites and investigators in numerous countries across 3 continents
Full enrollment expected by Q2 2026 with plans to seek early approval at that time based on early tumor responses—Potential to set a new standard of care
FDA concurred with the overall design of the Registration Study in meetings last year
Final clinical protocol submitted to FDA in December 2024
Multikine extended median overall survival by nearly 4 years in prior Phase 3 study
A new model for healthcare—Immunotherapy given before surgery to boost the immune system and make the first cancer treatment more successful – may set the first new standard of care in more than half a century
"Now that the clinical protocol for our final marketing Registration Study has been submitted, we are proceeding to sign up investigators and open clinical sites. We are receiving a very positive response and high levels of interest from head and neck cancer physicians who see the abundance of data on Multikine and want to deliver this option to their patients," stated CEL-SCI CEO Geert Kersten. "We believe that this small 212-patient trial will enroll relatively quickly precisely because Multikine has proven what it can do in terms of safety and efficacy in this specific target patient population which has not had a new option for treatment in decades."

"We are very confident in this Registration Study’s chance of success since we already know that this type of patient showed an almost 4 year increase in median survival in our last study. The many studies we have done have helped us figure out who benefits from the drug and who does not. Early tumor responses measured after treatment with Multikine and prior to surgery have been shown to be correlated with 5-year overall survival outcomes. We plan to seek accelerated and/or conditional marketing approval based on this finding. Data regarding early tumor responses following Multikine treatment should become available shortly after the last patient has been treated, expected by the second quarter of 2026," Kersten concluded.

CEL-SCI has been advised by a biostatistician with expertise in the design and analysis of oncology studies that this final Confirmatory Registration Study has an over 95% chance of success because it will include only the target population of patients who benefited most from Multikine in the prior Phase 3 study. These patients had much longer overall survival and had tumor responses including size reduction and total tumor elimination confirmed by pathology following three weeks of Multikine treatment. The favorable efficacy results in this target patient population exhibited a hazard ratio of 0.35 with an upper 95% confidence interval of 0.66, therefore CEL-SCI can expect (at 95%) to reach a favorable hazard ratio in the Confirmatory Registration Study.

There were no safety signals identified, Multikine administration did not interfere with disease directed treatment/therapy, and Multikine did not add to the treatment burden imparted by the standard of care.

Following the U.S. Food and Drug Administration’s (FDA) go-ahead to conduct the Registration Study, CEL-SCI finalized the clinical protocol based on constructive comments from FDA reviewers and senior staff. The final clinical protocol was submitted to the FDA in December 2024. The study is titled:

"A Phase III, Open Label, Randomized, Controlled, Multi-Center Study of the Effects of Neoadjuvant Leukocyte Interleukin, Injection (LI) Plus Standard of Care Versus Standard of Care Only in Treatment Naïve Adults With Resectable Locally Advanced Primary Squamous Cell Carcinoma of the Head and Neck (Oral Cavity) Who Present With No Nodal Involvement and Low Tumor Programmed Death Ligand 1 Expression (Defined as Tumor Proportion Score <10)"

Ergomed, the clinical research organization (CRO) for the Registration Study, is currently identifying clinical sites and investigators. Sites are initially expected to open in four countries across three continents, with the first clinical site expected to initiate in the United States.