On October 1, 2024 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotech developing RNA interference (RNAi) therapies for KRAS-driven cancers, reported new preclinical findings for SIL-204, its second-generation siRNA candidate, following the optimization of its extended-release formulation (Press release, Silexion Therapeutics, OCT 1, 2024, View Source [SID1234646989]). These latest findings demonstrate that the latest SIL-204-microparticle formulation can inhibit the growth and induce necrosis of the human pancreatic cell line that bears the KRAS G12D mutation xenotransplanted into mice. Given that this mutation constitutes the largest segment of pancreatic cancer subtypes, it represents a significant in the development of SIL-204.

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Key new pre-clinical findings include:

Significant Anti-tumor Activity: In recent mouse xenograft studies, SIL-204 demonstrated substantial tumor reduction in the human pancreatic tumor cell lines with the KRAS G12D (Panc -1) mutations using the innovative approach of oncogene silencing with siRNA. Previous studies showed this effect using unformulated siRNA with daily injections. The new studies further show this effect with a single administration of SIL-204 encapsulated in an extended-release formulation. Moreover, histopathological examination of treated tumors showed a very high induction of tumor necrosis.
Improved Formulation In Vivo: The transition from PLGA depot rods to PLGA microparticles (MPs) has resulted in a superior extended-release profile, enhancing the therapeutic potential. We now report in vivo results indicating that our new modified PLGA-microparticle formulation has superior properties over previous extended-release formulations (Loder).
Silexion plans to initiate toxicology studies with SIL-204 within the upcoming months and has plans to advance SIL-204 into Phase 2/3 clinical trials in the first half of 2026, focusing initially on locally advanced pancreatic cancer (LAPC) which has a notoriously high mortality rate. In parallel, the company plans to initiate preclinical studies for SIL-204, in colorectal cancer models.

"These optimizations represent a significant step forward in our development of SIL-204," said Ilan Hadar, Chairman and CEO of Silexion. "The improvements in cellular uptake and the enhanced extended-release formulation further strengthen our confidence in SIL-204’s potential. We look forward to commencing our next set of studies in preparation for our Phase 2/3 clinical trial."

On October 1, 2024 Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (Chemomab), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, reported that senior management will participate in two upcoming investor conferences (Press release, Chemomab, OCT 1, 2024, View Source [SID1234646973]).

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Chemomab management will meet with investors at the Third Annual ROTH Healthcare Opportunities Conference at the Metropolitan Club in New York City on October 9, 2024, and Chemomab co-founder and Chief Executive Officer Dr. Adi Mor will participate in a fireside chat with senior biotechnology analyst Michael Okunewitch at the Maxim Healthcare Virtual Summit on October 16, 2024 at 9:00 am ET.

These conferences are by invitation only. A recording of the Maxim Healthcare Summit fireside chat will be available via a link on the Chemomab investor relations website after the conference completes.

Chemomab Participation in Third Annual ROTH Healthcare Opportunities Conference

Date: October 9, 2024
Time: 900 am ET-5:00 pm ET
Venue: Metropolitan Club, New York City
Format: One-on-one meetings with investors
Information: View Source

Chemomab Participation in 2024 Maxim Healthcare Virtual Summit
Date: October 16, 2024
Time: 9:00 am ET
Venue: Virtual
Format: Fireside chat with CEO Dr. Adi Mor
Link: Recording will be available at investors.chemomab.com post-conference.
Information: https://m-vest.com/events/healthcare-10152024

On October 1, 2024 CEL-SCI Corporation (NYSE American: CVM) reported its renewed collaboration with Ergomed Clinical Research for its upcoming U.S. Food and Drug Administration (FDA) confirmatory Registration Study of Multikine (Leukocyte Interleukin, Injection) in head and neck cancer (Press release, Cel-Sci, OCT 1, 2024, View Source [SID1234646991]).

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Ergomed will provide global comprehensive clinical operations support to ensure the timely and efficient execution of the trial, supporting CEL-SCI in bringing a new treatment option for patients with locally advanced primary head and neck cancer to the market.

This partnership marks a continuation of the successful cooperation between the two companies, building on their previous collaboration for the Phase 3 trial of Multikine, which was the largest study ever conducted in head and neck cancer.

In addition to the positive outcome from its recent meeting with the FDA regarding the path to approval for its first-line investigational cancer immunotherapy, CEL-SCI achieved other major milestones including receiving pediatric waivers from the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).

This confirmatory study represents a crucial step toward potential marketing approval of Multikine. The study, set to enrol 212 newly diagnosed patients with locally advanced primary head and neck cancer, will focus on patients with no lymph node involvement and low PD-L1 tumour expression. Patients will be enrolled across multiple sites globally, underscoring the strength of Ergomed’s global clinical trial management capabilities.

Geert Kersten, CEO of CEL-CI commented, "Ergomed is a trusted partner. Our past experience taught us that they are highly competent and motivated. Their enrolment was fast and the study was clean. The plan is for the study to commence in Q1 2025 in multiple countries."

Dr. Sy Pretorius, CEO of Ergomed Group, added, "We are excited to once again partner with CEL-SCI on this significant trial for Multikine. Our prior collaboration has set a strong foundation for this new phase, and we are committed to leveraging our global expertise in oncology clinical research to support this critical confirmatory study. Together, we aim to advance innovative therapies that can make a real impact on patients’ lives."

Multikine has already demonstrated promising results in its prior studies, showing a significant improvement in survival rates. In the target population for the confirmatory study, patients treated with Multikine had a 5-year survival of 73% vs 45% survival in the control patients, with a hazard ratio of 0.35. The confirmatory study is designed to provide the final data required for regulatory approval, bringing Multikine one step closer to becoming a breakthrough treatment option for head and neck cancer patients worldwide.

On October 1, 2024 Clarity Pharmaceuticals (ASX: CU6) ("Clarity", "the Company"), 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 presentation of two abstracts at the EANM 2024 Congress (Press release, Clarity Pharmaceuticals, OCT 1, 2024, View Source [SID1234646923]). The data showcases Clarity’s optimised bisPSMA product for imaging and treatment of prostate cancer patients.

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Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "We are very excited about the trajectory of development for our optimised prostate-specific membrane antigen (PSMA) targeting agent, SAR-bisPSMA, for both imaging and therapy. The EANM Congress is one of the most prestigious conferences in nuclear medicine, and it is fantastic to receive this recognition from our industry. SAR-bisPSMA, built at the benchtop of Australian science, was constructed after thoroughly understanding the limitations of first-generation PSMA targeting molecules, and with the use of some novel chemistry, we were able to overcome these limitations by increasing the uptake and retention of this molecule in prostate cancer. The abstracts accepted for presentation highlight the exciting possibilities of our SAR-bisPSMA product, uniquely positioned for this molecule to become best in class for both the treatment and diagnosis/staging of cancer.

"We are excited to share this remarkable data as we continue to adhere to the highest standards of clinical research, work with world-class clinical sites and generate promising results, while continuously expanding the platform into new indications, targeting high unmet need in the oncology field, so that we can positively impact outcomes for patients in need of innovative treatment options.

"The COBRA results showed that 64Cu-SAR-bisPSMA was able to detect prostate cancer lesions in patients in biochemical recurrence (BCR) of prostate cancer, who had a negative or equivocal standard of care scan at study entry. The study was selected as a Top-Rated Oral Presentation, which underscores the strength of the data and the potentially transformative clinical impact of 64Cu-SAR-bisPSMA in the BCR setting. Regarding our theranostic platform, the case report highlights the potential of 67Cu-SAR-bisPSMA to treat patients with mCRPC. It describes the case of a heavily pre-treated patient who achieved a complete response (anatomical, molecular and biochemical) following 2 cycles of 67Cu-SAR-bisPSMA (8 GBq per cycle). We look forward to further developing our existing and novel Targeted Copper Theranostic (TCT) products and continuing to provide better treatment options for children and adults with cancer."

Product Abstract Title Conference
64Cu-SAR-bisPSMA COBRA: Assessment of safety and efficacy of 64Cu-SAR-bisPSMA in patients with biochemical recurrence of prostate cancer following definitive prostate cancer therapy Presentation Number: OP-428
Session Number: 1006

Session Title: Clinical Oncology Track – Top-Rated Oral Presentation. Session: Oncology & Theranostics Committee – Prostate: Biochemical Recurrence and Re-staging

Session Date: Monday, October 21, 2024

Session Time: 3:00:00 PM – 4:30:00 PM (presentation at 3:50:00 PM – 4:00:00 PM)

Session Hall: Hall Z

67Cu-SAR-bisPSMA Treatment of metastatic castrate-resistant prostate cancer patient with two cycles of 67Cu-SAR-bisPSMA (8 GBq) leads to complete response (RECIST) and undetectable PSA level: A case report Presentation Number: OP-509
Session Number: 1111

Session Title: Case Report Session 1 – Building Our Collective Knowledge on Theranostics

Session Date: Monday, October 21, 2024

Session Time: 4:45:00 PM – 6:15:00 PM

Session Hall: Hall Y1-Y3

More information on the abstracts can be found in the EANM’24 Abstract Book: View Source

Presentations will be available on Clarity’s official website after the EANM 2024 Congress: claritypharmaceuticals.com/pipeline/scientific_presentations

On October 1, 2024 Curium, a world leader in nuclear medicine, reported that it has entered into a strategic partnership with PDRadiopharma Inc, a wholly-owned subsidiary of PeptiDream, for the clinical development, regulatory filing, and commercialization in Japan of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T (Press release, Curium Pharma, OCT 1, 2024, View Source [SID1234646974]). The two agents 177Lu-PSMA-I&T and 64Cu-PSMA-I&T target prostate specific membrane antigen (PSMA) expressed on prostate cancer cells and are being investigated for prostate cancer treatment and diagnostics. Both target tumors with high levels of PSMA expression and thus potentially forming a theranostic (therapeutic & diagnostic) pair.

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Under the terms of the partnership, Curium and PDRadiopharma will jointly collaborate on clinical development activities of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T in Japan, with PDRadiopharma leading regulatory filing, manufacturing, commercialization, and distribution activities in Japan. Curium will continue to lead global development of the two agents and support PDRadiopharma through technology transfer to support the set-up of manufacturing lines in Japan – including a high throughput Copper 64 manufacturing line based on Curium’s proprietary technology.

Patrick C. Reid, President & CEO of PeptiDream commented: "Targeted radiopharmaceuticals are rapidly revolutionizing how we both diagnose and treat cancer. At PeptiDream and PDRadiopharma we are focused on expanding our pipeline of these powerful targeted therapies, and we are thrilled to be able to accelerate those efforts by partnering with Curium to bring their highly promising prostate cancer targeting radiopharmaceuticals to patients in Japan."

Masato Murakami, President of PDRadiopharma & CMO of PeptiDream commented: "We are excited to partner with Curium in the development of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T, highly promising products for both the diagnosis and treatment of PSMA-expressing prostate cancer. We look forward to working with Curium to deliver these much-needed agents to prostate cancer patients in Japan as quickly as possible."

Chaitanya Tatineni, Curium’s CEO International Markets commented: "As a global innovator in the field of radiopharmaceuticals with a promising late-stage oncology pipeline, Curium is delighted to partner with PDRadiopharma which has more than four decades of experience in Japan. Curium and PDRadiopharma plan to leverage their complementary strengths to accelerate the development of innovative products for the benefit of prostate cancer patients in Japan."

Prostate cancer continues to be widely prevalent in Japan. Annually, there are approximately 90,000 – 100,000 new cases, with patients with metastatic castration-resistant prostate cancer having an overall survival rate of approximately three years in clinical trial settings, and even shorter in the real-world, and there remains a significant unmet medical need for therapies.

177Lu-PSMA-I&T, a PSMA inhibitor conjugated with the radioisotope Lutetium 177, is currently being tested by Curium in a global pivotal Phase 3 ECLIPSE trial (ClinicalTrials.gov identifier; NCT05204927). ECLIPSE is a multi-center, open-label, randomized clinical trial comparing the safety and efficacy of 177Lu-PSMA-I&T versus hormone therapy in patients with metastatic castration-resistant prostate cancer. The ECLIPSE trial enrolled over 400 patients, across 51 trial sites in the United States and Europe.

64Cu-PSMA-I&T PET is currently being investigated in 2 multicenter Phase 3 trials; SOLAR RECUR testing the diagnostic performance in men with biochemical recurrence of prostate cancer (ClinicalTrials.gov identifier NCT06235099) and SOLAR STAGE testing the diagnostic performance in men with newly diagnosed unfavorable intermediate- to high-risk prostate cancer (ClinicalTrials.gov identifier; NCT06235151). The first in human Phase 1/2 SOLAR trial met the co-primary endpoints of region-level correct localization rate and patient-level correct detection rate in patients with histologically-proven metastatic prostate cancer. PSMA-targeted PET/CT imaging is increasingly emerging as a highly sensitive method for detection of locally recurrent or metastatic lesions in the context of biochemical recurrence and for localization of primary prostate cancer.

Curium and PDRadiopharma have a long-standing relationship in the radiopharmaceutical field.