On January 15, 2025 Imagenomix Corp., a leader in AI-driven precision medicine, reported a groundbreaking partnership with Alterome Therapeutics Inc., a pioneering oncology drug development company (Press release, Alterome Therapeutics, JAN 15, 2025, View Source [SID1234649734]). This collaboration will leverage Imagenomix’s cutting-edge artificial intelligence technologies to optimize clinical trial efficiency, improve patient stratification, and accelerate the development of Alterome’s targeted cancer therapies.

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The partnership represents a convergence of Imagenomix’s advanced AI expertise with Alterome’s innovative approach to precision oncology. Together, the companies aim to set a new standard for using AI to transform clinical trials and deliver life-saving treatments to patients faster.

Travis Wold, CEO of Imagenomix Corp., emphasized the transformative potential of the partnership:
"We are honored to collaborate with Alterome Therapeutics Inc., a trailblazer in precision oncology. At Imagenomix, we are committed to leveraging AI to advance medicine, and this partnership exemplifies the extraordinary impact of combining state-of-the-art technology with innovative therapeutic development."

Dr. Andrew Chi, Chief Medical Officer of Alterome Therapeutics Inc., shared his perspective on the collaboration:
"We are excited to integrate Imagenomix’s AI-powered analytics into our clinical trials., Together, we have an opportunity to redefine the way precision oncology clinical trials are conducted. By developing methods to rapidly identify critical patient selection biomarkers with unparalleled efficiency and scale we can potentially pave a new path to faster, more effective precision oncology trials. This approach could easily translate into routine patient care and ultimately improve patient outcomes."

Key Highlights of the Partnership:

Accelerated Drug Development: The Imagenomix Predict AI platform will streamline clinical trial timelines and improve cost-effectiveness.
Enhanced Precision: Advanced analytics aims to identify critical biomarkers with unprecedented speed, scale, and efficiency to ensure targeted patient selection for Alterome’s targeted therapy trials.
Industry Innovation: The partnership represents a paradigm shift in leveraging AI for oncology clinical trials, setting a new benchmark for the field.
This strategic collaboration underscores the shared commitment of Imagenomix Corp. and Alterome Therapeutics Inc. to harness the power of innovative technologies in delivering precision medicine breakthroughs.

On January 15, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported positive topline results from the China subpopulation of the global Phase 3 innovaTV 301 study, demonstrating a clinically meaningful improvement in overall survival with TIVDAK treatment for patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy (Press release, Zai Laboratory, JAN 15, 2025, View Source [SID1234649751]).

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The China subpopulation results were consistent with those in the global population:

TIVDAK demonstrated a 45% reduction in the risk of death compared to chemotherapy (HR: 0.55 [95% CI: 0.27-1.15] in the China subpopulation who had received prior standard systemic therapies, with more than half of this Chinese population having received prior anti-PD(L)1 therapy. Median OS for patients treated with TIVDAK was not reached versus chemotherapy 10.7 months [95% CI: 6.0-not reached] with a median follow-up of 11.5 months.
Secondary endpoints of PFS and confirmed ORR also favored treatment with TIVDAK compared to chemotherapy.
The safety profile of TIVDAK in the China subpopulation was manageable and consistent with the global profile.
"Recurrent or metastatic cervical cancer remains a significant challenge for patients, highlighting a critical unmet need for effective treatments that extend survival after relapse," said Dr. Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. "The consistent and positive results in the China subpopulation of the global Phase 3 study reinforce the potential for TIVDAK, the only ADC therapy in this disease setting, to increase options in this therapeutically unmet clinical setting. If approved, we expect TIVDAK to add to ZEJULA and augment our commercial franchise in women’s tumors."

"There are approximately 150,000 new cases of cervical cancer annually in China1, and patients face limited treatment options once their cancer recurs or spreads after initial treatment," said Dr. Lingying Wu, Professor of the Department of Gynecologic Oncology of National Cancer Center / Cancer Hospital Chinese Academy of Medical Sciences. "While the recent adoption of immunotherapy as a first-line treatment in China represents progress, there is a lack of effective options for patients following relapse. The promising results from TIVDAK, which demonstrated superior survival extension in patients whose disease progressed after initial treatments, including prior anti-PD(L)1 treatment, offer hope for addressing this critical unmet need."

In April 2024, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) granting full approval for TIVDAK (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The approval was based on results from the global, randomized, Phase 3 innovaTV 301 clinical trial (NCT04697628), which met its primary endpoint, demonstrating overall survival (OS) benefit in adult patients with previously treated recurrent or metastatic cervical cancer treated with TIVDAK compared to chemotherapy.

TIVDAK demonstrated a 30% reduction in the risk of death compared to chemotherapy (hazard ratio [HR]: 0.70 [95% CI: 0.54-0.89], two-sided p=0.0038)2. Median OS for patients treated with TIVDAK was 11.5 months [95% CI: 9.8-14.9] versus chemotherapy 9.5 months [95% CI: 7.9-10.7].
PFS and confirmed ORR were also significantly improved compared to chemotherapy.
The safety profile of TIVDAK was consistent with its known safety profile as presented in the U.S. prescribing information, and no new safety signals were observed.
Based on these encouraging results, Zai Lab intends to submit an NDA for TIVDAK to China’s National Medical Products Administration (NMPA) in the first quarter of 2025. The full China subpopulation data will be presented at a future medical conference in 2025.

About innovaTV 301 Trial Design

The innovaTV 301 trial (NCT04697628) is a global, 1:1 randomized, open-label Phase 3 trial evaluating TIVDAK (tisotumab vedotin) versus investigator’s choice of single agent chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed) with recurrent or metastatic cervical cancer who received chemotherapy.

Patients with recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology, and disease progression during or after treatment with chemotherapy doublet +/- bevacizumab and an anti-PD-(L)1 agent (if eligible) are included. The primary endpoint was overall survival. The main secondary outcomes were progression-free survival and objective response rate.

The study was conducted by Seagen, which was acquired by Pfizer in December 2023, in collaboration with Genmab, European Network of Gynaecological Oncological Trial Groups (ENGOT, study number ENGOT cx-12) and the Gynecologic Oncology Group (GOG) Foundation (study number GOG 3057), as well as other global gynecological oncology cooperative groups.

For more information about the Phase 3 innovaTV 301 clinical trial and other clinical trials with tisotumab vedotin, please visit www.clinicaltrials.gov.

About Cervical Cancer in China

Cervical cancer remains one of the leading causes of cancer death in women in China and globally. An estimated 150,000 new cases of cervical cancer occur annually in China1. Current treatment options are limited for patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy. TIVDAK is well positioned to provide a new option for previously treated advanced cervical cancer patients who currently have limited treatment options and poor outcomes.

About TIVDAK (tisotumab vedotin)

TIVDAK (tisotumab vedotin) is an antibody-drug conjugate (ADC) composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Pfizer’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Nonclinical data suggest that the anticancer activity of tisotumab vedotin is due to the binding of the ADC to TF-expressing cancer cells, followed by internalization of the ADC-TF complex, and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity.

TIVDAK received accelerated approval from the FDA in September 2021 and full approval in April 2024 for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Please see full prescribing information, including BOXED WARNING for TIVDAK here.

Zai Lab has an exclusive license from Seagen Inc., a company later acquired by Pfizer, to develop and commercialize TIVDAK in Greater China (mainland China, Hong Kong, Macau, and Taiwan, collectively).

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.

On January 15, 2025 Be Biopharma, Inc. ("Be Bio" or "the Company"), a leader in B Cell Medicines (BCMs), reported the closing of its $92M Series C financing (Press release, Be Biopharma, JAN 15, 2025, View Source [SID1234649737]). The round includes participation from new investor Nextech with existing investors including ARCH Venture Partners, Atlas Venture, RA Capital Management, Alta Partners, Longwood Fund, Bristol Myers Squibb, and Takeda Ventures, among others. In conjunction with the financing, Melissa McCracken, Ph.D. of Nextech will join Be Bio’s Board of Directors.

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The proceeds from the Series C financing will be used to generate clinical proof-of-concept for BE-101 in the ongoing BeCoMe-9 Phase 1/2 clinical trial for people with hemophilia B and to advance BE-102 for the treatment of hypophosphatasia to the clinic. Both programs are built on Be Bio’s BCM product platform, creating durable, titratable, and redosable therapeutics that require no preconditioning and produce sustained and constant levels of therapeutic proteins.

"With this funding in hand, we are well-equipped to advance our two lead programs and solidify our position as a multi-program, clinical-stage company," said Joanne Smith-Farrell, Ph.D., Chief Executive Officer of Be Bio. "We are on track to demonstrate clinical proof-of-concept for BE-101 in Hemophilia B this year. Additionally, BE-102 is poised to enter the clinic next year, potentially demonstrating BCMs’ potential to become a new gold standard in enzyme replacement by providing hypophosphatasia patients with a transformative new option. I am grateful to our existing and new investors, who share our vision that BCMs can transform the treatment landscape for a wide range of diseases with potentially best-in-class medicines."

"We are excited to partner with Be Biopharma at this pivotal stage," stated Melissa McCracken, Ph.D., Partner at Nextech. "Be Bio has established itself as a leader in this field with their lead programs having best-in-class potential. We believe BCMs, as a class, could revolutionize treatment paradigms across indications . We look forward to supporting their groundbreaking work and witnessing the transformative impact on patient care."