On January 16, 2025 Caris Life Sciences (Caris), a leading next-generation AI TechBio company and precision medicine pioneer, reported a strategic and multi-faceted collaboration with Ontada, a business dedicated to oncology real-world evidence, clinical education and point of care technologies, to advance molecular research and cancer care, enhance the healthcare delivery system and ultimately drive precision medicine by supporting life sciences companies in the development of next-gen oncology therapies (Press release, Caris Life Sciences, JAN 16, 2025, View Source [SID1234649762]).

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"Rooted in a commitment to rigorous science and cancer care, the collaboration between Caris and Ontada includes strategic pillars spanning the development and delivery of multimodal data solutions, innovative research strategies and data-driven practices to provide actionable cancer care intelligence," said Caris President David Spetzler, MS, PhD, MBA. "By seamlessly integrating key entities of research, biopharma and patients, we collectively aim to revolutionize cancer research, drive innovation, advance precision medicine and improve patient outcomes."

"By bringing together two of the most extensive clinical and genomic data sets in community oncology, we have developed a unique resource for life sciences companies. Our goal with this resource is to empower them to address complex questions, potentially leading to groundbreaking research and improved cancer care," said Christine Davis, Ontada President. "Given the rapid evolution of oncology, this collaboration enables us to deliver insights more quickly, conduct more robust research and continue advancing precision care."

The collaboration leverages Caris’ molecular-rich, multimodal database generated from over 6.5 million tests producing over 13 quadrillion datapoints, and Ontada’s industry-leading real-world oncology data representing over 2.4 million cancer patient records available for research across more than 80 tumor types derived largely from community settings where, according to the National Cancer Institute, an estimated 85% of cancer patients are treated. Bringing together a synergistic convergence of cancer care, diagnostics and drug development, the collaboration extends beyond a combined data solution to advance oncology treatment through joint research projects.

"Caris and Ontada will collaboratively work to bridge the gap between research and real-world application, creating a streamlined pathway from research and development to clinical practice to benefit patients with faster access to more informed treatment decisions, personalized therapies, clinical trials and improved outcomes," said Chairman of the Caris Precision Oncology Alliance, James Hamrick, MD, MPH. "This collaboration marks a transformative approach to cancer care, fostering innovation, efficiency and patient-centered outcomes in oncology."

On January 16, 2025 Prelude Corporation (PreludeDx), a leader in precision diagnostics for early-stage breast cancer, reported that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device designation for its DCISionRT test (Press release, PreludeDx, JAN 16, 2025, View Source [SID1234649763]).

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DCISionRT provides individualized risk assessment and predicts the benefit of radiation therapy (RT) for women diagnosed with ductal carcinoma in situ (DCIS), also known as Stage 0 breast cancer. DCISionRT represents a significant advancement in DCIS patient care by combining tumor biology with clinicopathologic factors to deliver personalized results. The test analyzes seven protein biomarkers and four clinical factors to generate a Decision Score that helps physicians identify which patients are most likely to benefit from RT and can help reduce over- and under-treatment.

"DCISionRT addresses an unmet need for DCIS patients by answering the questions, ‘Do I need radiation therapy?’, and ‘will I benefit?’. DCISionRT helps patients and their physicians to make a better and more informed treatment decision." says Dan Forche, President and CEO of PreludeDx.

The test is designed for women aged 30-85 with DCIS and:

Predicts the benefit of radiation therapy after breast conserving surgery (BCS)
Is Prognostic for 10-year risk of breast cancer recurrence
Identifies patients with residual risk even after BCS and radiation therapy
The FDA’s Breakthrough Device designation is reserved for medical devices that provide for more effective treatment or diagnosis, and offer significant advantages over existing approved or cleared alternatives. Breakthrough Devices will receive priority review by the FDA, which can significantly shorten the time it takes to get approval.

Forche continued, "We will continue to work closely with the FDA and we remain committed to providing access to advanced precision diagnostics in breast cancer care that improve patient outcomes through new and innovative tools."

About DCISionRT for Breast DCIS

DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. Patients with DCIS have cancerous cells lining the milk ducts of the breast, but they have not spread into surrounding breast tissue. In the US, over 60,000 women are newly diagnosed with DCIS each year. DCISionRT, developed by PreludeDx on technology licensed from the University of California San Francisco, and built on research that began with funding from the National Cancer Institute, enables physicians to better understand the biology of DCIS. The test provides a DecisionScore that identifies a woman’s risk as low, elevated, or residual risk. Unlike other risk assessment tools, the DCISionRT test combines protein expression from seven biomarkers and four clinicopathologic factors, and uses a non-linear algorithm to account for multiple interactions between individual factors in order to better interpret complex biological information. DCISionRT’s intelligent reporting provides a woman’s recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. In turn, this new information may help patients and their physicians to make more informed treatment decisions.

On January 16, 2025 Silexion Therapeutics (NASDAQ: SLXN), a clinical-stage biotech advancing RNA interference (RNAi) therapies for KRAS-driven cancers, reported compelling new preclinical data for SIL-204, its next-generation siRNA candidate (Press release, Silexion Therapeutics, JAN 16, 2025, View Source [SID1234649764]). These findings reaffirm the company’s innovative approach to addressing some of the most challenging cancers, including pancreatic cancer, which is marked by KRAS mutations in over 90% of cases.

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The newly released data reveal significant synergy between SIL-204 and first-line chemotherapy agents, including 5-fluorouracil, irinotecan, and gemcitabine. In human pancreatic tumor cell models harboring KRAS G12D mutations, SIL-204 amplified the efficacy of these standard therapies, resulting in greater reductions in cancer cell confluence compared to chemotherapy alone. This underscores SIL-204’s potential to enhance treatment regimens for pancreatic cancer and other KRAS-driven cancers, potentially addressing a substantial unmet medical need.

Building on the success of its first-generation LODER platform, which improved overall survival in Phase 2 trials, SIL-204 takes Silexion’s RNAi approach further by targeting a broader spectrum of KRAS mutations. With toxicology studies set to begin soon and Phase 2/3 trials planned for 2026, Silexion remains on track to advance its groundbreaking candidate into the clinic.

Shortly releasing this new data, Silexion also announced the pricing of a $5 million public offering to support its preclinical and clinical efforts. While this may introduce near-term dilution, if the offering is to close, the additional capital seems to bolster the company’s ability to drive innovation and achieve key clinical milestones as it moves forward.

As KRAS-driven cancers continue to be among the most aggressive and elusive to treat, Silexion’s progress with SIL-204 positions it as an important innovator to watch in the precision oncology space, offering hope for transformative therapies that could redefine cancer care.

On January 15, 2025 Axcynsis Therapeutics Pte Ltd ("Axcynsis"), a privately held biopharmaceutical company specialized in delivering Antibody Drug Conjugates (ADCs) with breakthrough potential, reported the clearance of its Investigational New Drug application (IND) by the United States Food and Drug Administration (FDA) of AT03-65 for the treatment of patients with CLDN-6 positive solid tumors (Press release, Axcynsis Therapeutics, JAN 15, 2025, View Source [SID1234649735]). Axcynsis is planning to initiate a Phase 1 multicentre clinical trial in the United States in 1Q 2025.

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AT03-65 is a differentiated ADC that selectively binds to CLDN6 with strong affinity. It is enabled by AxcynDOT, a proprietary payload that incorporates a derivative of an approved oncology therapeutics with unique mechanism of action and broad anti-tumor activity, and coupled with a cleavable and hydrophilic proprietary linker. CLDN6 is overexpressed in many cancers including lung, ovarian, endometrial, uterine, testicular, and gastric cancers while exhibiting minimal expression in normal tissues. AT03-65 is designed to deliver targeted therapy to improve patient outcomes with advanced or metastatic CLDN6-positive cancers.

"This is a transformational event for Axcynsis and a significant milestone for our proprietary ADC platform using AxcynDOT," said Dr. Zou Bin, CEO of Axcynsis. "We are pleased that FDA has cleared AT03-65 which leverages our AxcynDOT technology for this first-in-human study. We are very excited with the potential of offering a transformative therapeutic option for patients with CLDN6-positive tumors as well as advancing our pipeline with differentiated and effective ADCs using AxcynDOT to improve the lives of cancer patients worldwide".

The upcoming Phase 1 multicentre clinical trial in the United States will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of AT03-65 in patients with advanced CLDN6-positive solid tumors.

About AT03-65

AT03-65 is a recombinant anti-CLDN6 monoclonal antibody conjugated to AxcynDOT, a proprietary payload developed by Axcynsis with a differentiated mechanism of action and broad anti-cancer activities. AT03-65 is designed to target advanced, recurrent, or metastatic CLDN6+ solid tumors in patients who have progressed on or after standard systemic treatment or for whom no standard therapies are available.

The antibody of AT03-65 is rationally engineered for high affinity and specificity to CLDN6. Upon binding to CLDN6-expressing tumor cells, the ADC is internalized into lysosomes, where it releases its payload to inhibit tumor growth effectively. Preclinical studies demonstrate that AT03-65 not only directly kill CLDN6-positive tumor cells but also exhibits bystander killing effect, targeting neighboring CLDN6-negative tumor cells to enhance its anti-tumor efficacy. AT03-65 has demonstrated promising anti-tumor activities in multiple tumor mouse models and a favorable safety profile in non-human primates.

About AxcynDOT

This is a proprietary payload developed by Axcynsis. It is a derivative of trabectedin, an approved chemotherapy in the United States, Europe and selected Asian countries, with a unique mechanism of action that is differentiated from other DNA alkylating payloads. AxcynDOT is optimized with enhanced potency and improved safety profile compared to trabectedin.

On January 15, 2025 Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported the pricing of its previously announced public offering of 4,857,780 shares of common stock at a public offering price of $0.30 per share (Press release, Azitra, JAN 15, 2025, View Source [SID1234649736]). The gross proceeds for the offering are expected to be approximately $1.5 million before deducting placement agent fees and other offering expenses. This offering is expected to close on January 16, 2025, subject to customary closing conditions. Azitra intends to use the net proceeds of this offering for working capital and general corporate purposes.

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Maxim Group LLC is acting as sole placement agent in connection with the offering.

The public offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-280648), previously filed with the U.S. Securities and Exchange Commission (the "SEC") on July 1, 2024, as amended, and declared effective on July 8, 2024. The shares may be offered only by means of a prospectus. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the public offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. A final prospectus supplement and an accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement and accompanying prospectus, and when filed, the final prospectus supplement and accompanying prospectus, relating to the public offering may also be obtained by contacting Maxim Group LLC, at 300 Park Avenue, 16th Floor, New York, NY 10022, Attention: Prospectus Department, or by telephone at (212) 895-3745 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.