On July 23, 2025 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage oncology company leveraging its proprietary RADR artificial intelligence (AI) platform to systematically transform drug discovery paradigms, reported that a heavily pretreated patient with aggressive Grade 3 non-germinal center B-cell diffuse large B-cell lymphoma (DLBCL) achieved a complete metabolic response in the ongoing Phase 1 clinical trial of LP-284 (Press release, Lantern Pharma, JUL 23, 2025, View Source [SID1234654493]). This represents the first complete response observed with LP-284 and displays profound clinical activity in one of the most therapeutically challenging hematologic cancers.

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The RADR-driven, AI approach enables Lantern to rapidly determine mechanisms of action of any cancer focused molecule, identify biomarker-driven subpopulations and optimize combination strategies for the clinical setting.

The 41-year-old patient had previously failed three aggressive treatment regimens over 18 months over the last 15 months. These included: standard R-CHOP/Pola-R-CHP chemotherapy, CAR-T cell therapy (liso-cel), and CD3xCD20 bispecific antibody therapy (glofitamab). Following enrollment in April 2025, the patient achieved complete metabolic response with non-avid lesions after completing just two 28-day cycles of LP-284 administered on days one, eight, and 15. This remarkable clinical outcome supports LP-284’s synthetic lethal mechanism and is an initial step towards a potential new paradigm for treating refractory aggressive lymphomas and B-cell malignancies.

Paradigm-Shifting Observation of Complete Response in Therapeutically Exhausted Patient

"This extraordinary clinical observation represents a transformative moment for our computationally guided, therapeutic development paradigm," said Panna Sharma, President and CEO of Lantern Pharma. "Our RADR platform’s systematic analysis of molecular vulnerabilities enabled us to rapidly advance LP-284 from computational concept to a clinical milestone in a patient in under three years at approximately $3 million — demonstrating how AI-driven precision has the promise to fundamentally reshape pharmaceutical innovation. This complete metabolic response in a patient who had exhausted all conventional therapeutic options strongly supports our strategic thesis that computational approaches can unlock previously inaccessible therapeutic opportunities."

LP-284, a computationally optimized next-generation acylfulvene, was systematically developed with guidance from Lantern’s RADR platform to exploit synthetic lethal interactions in cancer cells harboring specific DNA damage repair deficiencies. The compound represents a fundamentally different therapeutic strategy with the potential to preferentially target malignant cells while preserving healthy tissue function — a precision approach aimed at delivering transformative clinical benefit for patients who have failed multiple prior treatment modalities.

Potential to Address a Critical Therapeutic Void in Refractory DLBCL

This patient’s clinical journey exemplifies the devastating trajectory of aggressive DLBCL in the refractory setting. Despite achieving an initial complete metabolic response with CAR-T therapy (liso-cel) at day 30, the patient experienced disease progression by day 90. Subsequent treatment with the CD3xCD20 bispecific antibody glofitamab resulted in progressive disease with multifocal new lesions. At study entry on the LP-284-Phase 1 trial in April 2025, the patient presented with extensive multifocal bony lesions across thoracic and lumbar spine locations and hips — representing an extremely challenging clinical scenario.

The achievement of complete metabolic response with non-avid lesions following just two cycles of LP-284 therapy represents a potential future paradigm-shifting alternative for treating therapeutically exhausted DLBCL patients. This encouraging outcome underscores LP-284’s potential to address critical gaps in the therapeutic armamentarium for patients who have failed both conventional and cutting-edge immunotherapeutic approaches.

Advancing Strategic Clinical Development and Global Expansion

The complete metabolic response achievement positions LP-284 for accelerated development pathways and strengthens Lantern’s strategic position in the competitive hematologic oncology landscape. This clinical milestone provides important confirmation of the company’s systematic approach to therapeutic development and creates additional opportunities for international partnership expansion and collaborative research initiatives.

Lantern’s ongoing Phase 1 dose-escalation study (NCT06132503) is designed to evaluate LP-284’s safety profile, optimal dosing parameters, and preliminary efficacy signals across multiple aggressive lymphoma subtypes.

The trial’s systematic design enables precise evaluation of LP-284’s therapeutic potential across genetically defined patient populations, with a current focus on aggressive NHL subtypes including mantle cell lymphoma and high-grade B-cell lymphomas. LP-284’s multiple FDA Orphan Drug Designations position the compound for potential expedited regulatory pathways and enhanced market exclusivity frameworks.

Transforming Global Oncology Through Computational Precision

This clinical development provides important confirmation of the transformative potential of Lantern’s RADR platform, which leverages over 200 billion oncology-focused data points and 200+ machine learning algorithms to assist in systematically identifying and optimizing therapeutic opportunities. The platform’s computational efficiency enabled Lantern to rapidly advance the LP-284’s program into the clinic in under three years at a cost of approximately $3 million — representing striking development efficiency compared to traditional pharmaceutical paradigms.

The complete metabolic response achievement positions LP-284 to seek a future role within a global blood cancer market focused on B-cell cancer that is estimated at $4 billion annually, with DLBCL representing the largest aggressive lymphoma subtype affecting approximately 200,000 patients globally each year. The critical unmet need in refractory/relapsed settings represents a substantial commercial opportunity for innovative therapeutic approaches that can deliver meaningful clinical benefit to therapeutically exhausted patient populations.

Next Steps and Future Development

Lantern plans to continue enrollment in the Phase 1 trial while closely monitoring the responding patient and other potential future patients for durability of response and efficacy signals. The company anticipates providing additional clinical updates as the trial progresses and more patients reach evaluable timepoints.

The complete response achievement positions LP-284 for potential accelerated development pathways and creates opportunities for strategic partnerships as Lantern advances its synthetic lethal portfolio toward later-stage clinical trials.

About LP-284

LP-284 is an investigational next-generation acylfulvene designed to exploit synthetic lethal interactions in cancer cells with DNA damage repair deficiencies. Developed with guidance from Lantern’s AI platform RADR, LP-284 represents a novel therapeutic approach with potential to address critical gaps in the treatment of relapsed or refractory non-Hodgkin’s lymphoma and other hematologic malignancies. The compound is currently being evaluated in a Phase 1 clinical trial (NCT06132503) to determine its safety profile, optimal dosing, and potential activity in patients with aggressive NHL subtypes who have failed standard therapies.

LP-284 has received multiple Orphan Drug Designations from the U.S. Food and Drug Administration, including designations for mantle cell lymphoma and high-grade B-cell lymphomas, recognizing its potential to address significant unmet medical needs in rare cancer populations.

On July 23, 2025 Crossbow Therapeutics, Inc., a biotechnology company developing T-Bolt therapies, a novel class of T-cell receptor (TCR)-mimetic antibody therapeutics, reported the nomination of its second development candidate, CBX-663, for the treatment of a broad range of solid tumor and hematologic malignancies (Press release, Crossbow Therapeutics, JUL 23, 2025, View Source [SID1234654494]). The next-generation T-cell engager targets telomerase reverse transcriptase (TERT), a protein that drives tumor growth and is expressed in up to 95% of cancers.1,2

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CBX-663, a bispecific antibody, binds to TERT-derived peptide human leukocyte antigen (pHLA) complexes on the surface of tumor cells and activates T-cells through a CD3-binding arm. The molecule includes two binding domains for TERT, which increase its ability to engage tumor cells and boost immune activation.

"CBX-663 illustrates how Crossbow’s TCR-mimetic platform can unlock new opportunities for antibody-based cancer therapies," said Briggs Morrison, MD, Chief Executive Officer of Crossbow. "With strong preclinical performance selectively targeting a pHLA expressed across a broad range of cancers, CBX-663 has the potential to offer a meaningful new treatment option for patients with limited therapeutic options."

In preclinical studies, CBX-663 drove potent, antigen-specific tumor killing across multiple TERT-positive cancer models, with minimal activity against TERT-negative or HLA-mismatched cells. The candidate also demonstrated a favorable safety profile and pharmacokinetics comparable to conventional antibody therapies. Crossbow presented data summarizing the initial characterization of CBX-663 at the 2025 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

Although TERT resides inside the cell, HLA molecules can present fragments of the protein, known as peptides, on the tumor surface. CBX-663 recognizes one of those peptides, the HLA-A*02:01-restricted TERT540 peptide, and redirects T-cells to attack tumor cells. CBX-663 demonstrated broad cytotoxic activity in vitro in both solid and hematologic cancer cell lines, as well as in primary patient samples ex vivo. In vivo studies further confirmed its anti-tumor efficacy and tolerability.

"CBX-663 reflects the depth of antibody discovery and protein engineering that underpins our T-Bolt platform and our ability to generate highly selective, potent molecules against difficult cancer targets," said Dmitri Wiederschain, PhD, Chief Scientific Officer of Crossbow. "Its performance in preclinical models reinforces the promise of TCR-mimetic therapeutics, and we’re excited to continue advancing this program."

Crossbow discovered and developed CBX-663 through its proprietary T-Bolt platform, which uses optimized antibody libraries and precision screening to find high-affinity, specific binders to intracellular tumor antigens displayed as pHLA complexes.

The nomination of CBX-663 underscores the platform’s potential to deliver a scalable pipeline of T-cell engagers for difficult-to-treat cancers.

On July 22, 2025 Alloy Therapeutics Co. Ltd. ("Alloy Japan") reported the signing of a Memorandum of Understanding (MOU) with the Kansai Startup Academia Coalition ("KSAC"), represented by Kyoto University, to foster the global expansion of university-affiliated life science startups across Japan (Press release, Alloy Therapeutics, JUL 22, 2025, View Source [SID1234654446]). This strategic collaboration is designed to accelerate research and development (R&D) activities by providing critical support and connecting academic innovations with the global biopharmaceutical industry.

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KSAC is a coalition of more than 90 academic institutions located in western Japan, formed under the leadership of Kyoto University and with support from Japan’s Ministry of Education, Culture, Sports, Science and Technology (MEXT). KSAC’s mission is to bridge academia and industry by managing GAP funds for research, delivering entrepreneurship education, supporting digital workshop networks, and showcasing early-stage technologies through events and exhibitions both domestically and internationally.

Alloy Therapeutics Inc. ("Alloy") is a Boston-based biotechnology ecosystem company that democratizes access to foundational biologics discovery technologies. Through its suite of platform technologies and discovery services as well as its venture studio, 82VS, Alloy enables scientists and entrepreneurs around the world to accelerate the discovery of medicines. Alloy recently launched its Japan subsidiary, Alloy Japan, which is focused on iPS cell therapy development and is continuing to broaden its offerings by supporting ecosystem growth throughout Japan and greater Asia.

Through this MOU, Alloy Japan and KSAC will collaborate to connect promising academic seeds from Japan to global Biopharma markets, while also bringing valuable insights from the global community back to strengthen Japan’s startup ecosystem. Together, they aim to enrich critical capabilities across Japan’s academic and entrepreneurial communities to foster the development of globally competitive life science startups.

"Alloy’s capabilities and global network bring a highly complementary strength to our mission of empowering academic startups to compete internationally. Alloy Japan offers a highly distinct and complementary contribution to our activities with Global Incubators and Venture Capital firms," said Koji Murota, Director-General of the Office of Institutional Advancement and Communications at Kyoto University, representing KSAC. "By collaborating with ecosystem builders like Alloy Japan, we can provide our researchers and entrepreneurs with access to additional scientific resources, global Biopharma insights, and opportunities to scale their innovations beyond Japan."

As a first step, Alloy Japan will support KSAC’s GAP Fund program, which provides funding to selected academic projects within the KSAC network. Over the three-year term of the MOU, the collaboration is expected to expand to additional KSAC initiatives aimed at building a globally integrated and innovation-driven biotech community.

"Our collaboration with KSAC builds on Alloy Japan’s commitment to deep, sovereign partnerships that nurture innovation at the academic and early translational stages," said Victor Stone (Yoshihide Ishii), CEO of Alloy Japan. "By working alongside KSAC and its network of universities, we aim to strengthen the bridge between Japanese academic excellence and the Biopharma ecosystem, accelerating the global growth of life science startups."

On July 22, 2025 Hanmi Financial Corporation (NASDAQ: HAFC, or "Hanmi"), the parent company of Hanmi Bank (the "Bank"), reported financial results for the second quarter of 2025 (Press release, Hanmi, JUL 22, 2025, View Source [SID1234655566]).

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On July 22, 2025 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing early-stage cancer diagnostics including CyPath Lung, the Company’s commercially available test for early-stage lung cancer, reported its patent related to a method to detect lung disease through flow cytometry analysis of sputum has been allowed by the Canadian Patent Office (Press release, BioAffinity Technologies, JUL 22, 2025, View Source [SID1234654467]). This patent strengthens the international protection of the Company’s diagnostic platform that powers its flagship test, CyPath Lung.

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"As with the recent announcement of the award of our patent in China, this Canadian patent reflects our continued execution toward building long-term shareholder value through innovation, protection of our unique assets, and a clear focus on early cancer detection that can save lives," said Maria Zannes, President and CEO of bioAffinity Technologies.

Lung cancer is the leading cause of cancer death in Canada, according to the Canadian Cancer Society. In 2024, approximately 31,000 Canadians were diagnosed with lung cancer, and approximately 20,700 people died of the disease. More than 70% of the lung cancer deaths were linked to smoking.

"We believe that the award of this patent by the Canadian Patent Office further validates the diagnostic platform behind CyPath Lung, expands the global footprint of our intellectual property portfolio and highlights the strength of our science," Ms. Zannes said. "Recent case studies highlight CyPath Lung’s ability to detect lung cancer at its earliest stages, making our test all the more valuable in Canada where 50% of all lung cancer cases are diagnosed late at Stage IV with the five-year survival rate overall of about 19% in Canada, according to government statistics."

The Canadian patent (Patent No. 3,136,245) – titled "System and Method for Determining Lung Health" – protects the use of defined antibodies and the porphyrin TCPP to label cell populations in sputum and the use of flow cytometry to determine the presence of lung cancer cells in the sputum.

CyPath Lung is the Company’s first commercial product, with clinical study results demonstrating 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters.

About CyPath Lung

CyPath Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit www.cypathlung.com.