On July 24, 2025 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company") reported that listed on the Main Board of The Stock Exchange of Hong Kong Limited (HKEX) under the stock code "09887" (Press release, Nanjing Leads Biolabs, JUL 24, 2025, View Source [SID1234654507]).

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The clinical-stage biotech company priced its IPO at HKD 35 per share, offering 36.86 million shares (excluding green shoe option). The deal included a Hong Kong public tranche of 16.03 million shares (43% of the total) and an international placement of 20.84 million shares (57%). Morgan Stanley and CITIC Securities acted as joint sponsors of the transaction.

Gross proceeds totaled approximately USD 189 million (including green shoe option). According to Leads Biolabs, the proceeds will be allocated as follows:

~65% for ongoing and planned clinical trials and regulatory affairs;
~15% for advancing preclinical assets, expanding existing pipelines, and optimizing technology platforms
~10% for upgrading manufacturing capacity and commercialization preparedness post-approval;
~10% for working capital and general corporate purposes.
Dr. Xiaoqiang Kang, Founder, Chairman, and CEO of Leads Biolabs, commented:

"Our HKEX debut represents a major leap from laboratory innovation to global capital markets, accelerating our innovation-driven international expansion. For more than a decade, we’ve pursued one goal: becoming a global leader in immuno-oncology therapeutics. At this inflection point, we reaffirm our founding commitment to eradicating disease while maintaining the entrepreneurial vigor that defines us. Through strengthened global execution and accelerated translation of breakthrough therapies from bench to bedside, we will deliver paradigm-shifting treatments to patients across the globe."

Founded in 2012, Leads Biolabs is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of innovative therapies to address unmet medical needs in oncology, autoimmune, and other severe diseases both in China and globally. The Company has built a differentiated pipeline of 14 innovative drug candidates, including six clinical-stage drug candidates, of which four lead products are among the top-tier clinically advanced candidates globally.

Leads Biolabs operates an integrated business model encompassing in-house discovery, development and commercialization of innovative tumor immunotherapies. The Company has strategically developed assets in three areas: Immuno-oncology 2.0 (IO 2.0), T-cell engagers (TCEs), and antibody-drug conjugates (ADCs). Its oncology pipeline includes 12 investigational products, including 3 monoclonal antibodies, 5 bispecific antibodies, 3 ADCs and 1 bispecific fusion protein. The Company is also progressing two promising candidates for autoimmune diseases—a bispecific fusion protein and a trispecific antibody.

Leads Biolabs’ R&D is powered by multiple proprietary technology platforms that feature integrated, AI-powered and diversified antibody engineering capabilities, including LeadsBody (a CD3 T-cell engager platform), X-body (a 4-1BB engager platform) and its linker-payload platform for ADC development. These platforms have demonstrated clinical proof-of-concept, particularly with bispecific antibody combinations.

The LeadsBody platform delivers strong technological capabilities for developing CD3-targeted bispecific antibodies. Its innovative molecular design enables precise affinity modulation between TCEs and both CD3 and tumor-associated antigens (TAAs). With spatially optimized steric hindrance architecture, the platform enables conditional T-cell activation exclusively within the tumor microenvironment (TME), significantly lowering the risk of cytokine release syndrome (CRS) and systemic toxicity. This molecular engineering approach is designed to optimize the therapeutic index through customized spatial configurations that reduce treatment interruptions due to toxicity. By minimizing adverse systemic effects, the platform enables extended treatment durations and, ultimately, aims to improve patient quality of life (QoL).

Building on this platform, Leads Biolabs has established a position of leadership in the promising field of solid tumor immunotherapies. The company has developed six differentiated TCE therapeutic candidates, forming a portfolio spanning three major therapeutic areas: hematologic malignancies, solid tumors, and autoimmune diseases.

Hematologic Malignancies:

LBL-034: A GPRC5D/CD3 bispecific antibody for the treatment of multiple myeloma (MM)
LBL-043: A LILRB4/CD3 bispecific antibody targeting acute myeloid leukemia (AML) and multiple myeloma (MM)
Solid Tumors:

LBL-033: A MUC16/CD3 bispecific antibody targeting solid tumors overexpressing MUC16, with a focus on gynecologic cancers including ovarian cancer, cervical cancer, and endometrial carcinoma
LBL-054: A CDH17/CD3 T-cell engager under development for colorectal cancer (CRC), gastric cancer, pancreatic ductal adenocarcinoma (PDAC), and neuroendocrine neoplasms (NENs)
LBL-058: A first-in-class TCE-ADC (antibody-drug conjugate) targeting DLL3, demonstrating encouraging efficacy in DLL3-positive small cell lung cancer (SCLC) and NENs
Autoimmune Diseases:

LBL-051: A first-in- class CD19/BCMA/CD3 trispecific antibody designed to block autoantibody production by B cells and plasma cells while regulating B-cell hyperactivation, differentiation, and plasmacytic transformation. The candidate’s unique mechanism of action enables broad-based B-cell modulation, potentially delivering superior clinical outcomes. The program is being advanced through a strategic collaboration with NewCo, a portfolio company of leading biotech investor Aditum Bio.
The company’s X-body platform utilizes advanced antibody engineering to develop 2:2 bispecific antibody structures. Its lead candidate, LBL-024 (PD-L1/4-1BB), represents a key advance in 4-1BB agonist therapies, becoming the first agent in this class to enter global registrational trials. The platform’s 2:2 configuration is designed to restrict 4-1BB activation to the tumor microenvironment (TME), addressing systemic toxicity issues, particularly hepatotoxicity, that have undermined earlier efforts in this category. This platform-driven approach enables precise control of immune activation within the TME, minimizing off-target adverse effects while reactivating exhausted T cells and driving clonal expansion. The mechanism has shown particular promise in tumors resistant to PD-1/PD-L1 inhibitors, as well as in so-called immunologically "cold" tumors. The successful execution of this strategy with LBL-024 underscores its potential as a best-in-class immunotherapy candidate.

At the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting, Leads Biolabs presented data from a multicenter Phase Ib/II trial evaluating LBL-024 in combination with etoposide and platinum-based chemotherapy in first-line advanced extra-pulmonary neuroendocrine carcinoma (EP-NEC). The study reported a 75.0% objective response rate (ORR) and a 92.3% disease control rate (DCR) among the efficacy-evaluable population (n=52). In the 15 mg/kg cohort, ORR reached 83.3%, with a DCR of 100%. Overall, 57.7% of patients (30/52) achieved tumor reduction exceeding 50%. These results substantially outperformed historical benchmarks for chemotherapy alone, which typically show ORR in the 30–55% range. While progression-free survival (PFS) data were not yet mature at the April 15, 2025 cutoff (median follow-up: 8.2 months), all dose cohorts showed favorable trends compared with historical controls.

EP-NEC is a rare and aggressive cancer with poor advanced-stage outcomes and no approved second-line or later therapies. Recognizing this unmet medical need, China’s National Medical Products Administration (NMPA) granted approval on April 30, 2024 for a pivotal single-arm registrational trial of LBL-024 in EP-NEC, potentially establishing it as the first approved therapy for this indication.

As the world’s first 4-1BB-targeted molecule to have reached registrational stage, LBL-024 could establish 4-1BB as the fourth approved immuno-oncology target following PD-1/L1, CTLA-4 and LAG-3. The candidate has earned Breakthrough Therapy Designation from China’s NMPA for relapsed/refractory EP-NEC and Orphan Drug Designation from U.S. FDA for neuroendocrine neoplasms (NENs).

LBL-024 has also secured regulatory approvals to investigate indications including small cell lung cancer (SCLC), biliary tract cancer (BTC), ovarian cancer (OC), non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), and gastric cancer (GC). Early clinical data have shown promising antitumor activity in SCLC, BTC and OC, supporting its potential as a broad-spectrum oncology therapeutic.

On July 24, 2025 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, reported that results from a multi-site global Phase 2 study of neoadjuvant darovasertib in primary uveal melanoma was accepted for a Proffered Paper oral presentation at the 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) meeting, taking place on October 17-21 in Berlin, Germany (Press release, Ideaya Biosciences, JUL 24, 2025, View Source [SID1234654508]). A summary of the data from the abstract will be shared at a future date.

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"We are excited to share clinical data at ESMO (Free ESMO Whitepaper) 2025 on the effects of neoadjuvant darovasertib in primary uveal melanoma across both plaque brachytherapy and enucleation cohorts. Its potential to impact the natural history of this disease and its management will be highlighted in the presentation. We continue to advance our clinical strategy for darovasertib in earlier stage disease, with the recent initiation of a randomized Phase 3 neoadjuvant registrational trial in primary uveal melanoma," said Dr. Darrin Beaupre, Chief Medical Officer, IDEAYA Biosciences.

Details of the Proffered Paper Oral Presentation are as follows:

Title (Abstract #5053): Enucleation prevention and vision preservation in primary uveal melanoma (UM): preliminary results from a phase 2 study of neoadjuvant darovasertib

Presenter: Dr. Marcus Butler, MD, Associate Professor, Princess Margaret Cancer Center at the University of Toronto

On July 24, 2025 Pierre Fabre Pharmaceuticals Inc. (PFP) reported the acceptance by U.S. Food and Drug Administration (FDA) of the Biologics License Application (BLA) and Priority Review of tabelecleucel, indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy (Press release, Pierre Fabre, JUL 24, 2025, View Source [SID1234654509]).

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Atara Biotherapeutics Inc. (Nasdaq: ATRA) resubmitted the tabelecleucel BLA on July 11, having in collaboration with PFP, swiftly addressed the third-party manufacturing facility observations outlined in the January 2025 Complete Response Letter.

"Patients diagnosed with relapsed or refractory EBV+ PTLD have no approved FDA treatment options, and following failure of initial therapy their survival is unfortunately measured in only weeks to months. Today’s BLA acceptance gives hope to these patients and is a significant step towards making this innovative cell therapy available in the United States," said Adriana Herrera, Chief Executive Officer of PFP, the Pierre Fabre Laboratories Pharmaceutical subsidiary in the U.S. "We are now completely focused on preparing for potential FDA approval of this innovative new treatment option."

Tabelecleucel is an allogeneic, off the shelf, EBV-specific T-cell immunotherapy which targets and eliminates EBV-infected cells. The BLA includes data covering more than 430 patients treated with tabelecleucel including the ongoing pivotal ALLELE study investigating the therapy in adults and children two years of age and older with relapsed or refractory EBV+ PTLD following SOT or HCT.

Tabelecleucel was granted marketing authorization under the brand name EBVALLO in December 2022 by the European Commission (EC). Marketing authorization was also granted by the Medicines and Healthcare Products Regulatory Agency in the United Kingdom in May 2023 and by Swissmedic in Switzerland in May 2024.

Since March 31, 2025, PFP has assumed global responsibility for tabelecleucel manufacturing of commercial product for European markets and for global clinical trial supply. On July 15, 2025, Atara Biotherapeutics transferred the tabelecleucel Investigational New Drug Application to Pierre Fabre Medicament, a subsidiary of Pierre Fabre Laboratories. As per the terms of the restated exclusive worldwide licensing agreement between Atara and Pierre Fabre Laboratories announced in November 2023, Atara is responsible for regulatory procedures up until BLA transfer to Pierre Fabre Pharmaceuticals.

On July 24, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the United States Patent and Trademark Office (USPTO) will issue U.S. Patent Number 12,370,244 on July 29, 2025, covering key aspects of the Company’s breast cancer vaccine technology (Press release, Anixa Biosciences, JUL 24, 2025, View Source [SID1234654510]). The patent protects novel methods of immunizing patients against breast cancer by administering an immunogenic composition containing human α-lactalbumin protein—a protein typically found in breast tissue during lactation but also expressed in certain breast cancers, making it an attractive target for immunoprevention strategies.

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Anixa’s breast cancer vaccine, developed in collaboration with Cleveland Clinic, represents a novel approach to the prevention and treatment of breast cancer. The vaccine was invented at Cleveland Clinic, and this patent—along with others related to this technology—has been exclusively licensed to Anixa Biosciences. This issuance builds upon the Company’s broad and expanding intellectual property portfolio, extending foundational patent protection for the breast cancer vaccine program into the mid-2040s. The expanded claims provide additional coverage for immunogenic formulations, further enhancing Anixa’s ability to develop and commercialize differentiated immunopreventive solutions.

Despite significant progress in breast cancer treatment, the disease remains the most commonly diagnosed cancer among women worldwide. In the United States alone, over 297,000 new cases of invasive breast cancer are projected in 2025, with approximately 43,000 women expected to die from the disease. No FDA-approved vaccine currently exists to prevent breast cancer, representing a major and unmet need in the field of preventive oncology.

Anixa’s investigational vaccine aims to stimulate the immune system to recognize and eliminate pre-malignant and malignant cells expressing α-lactalbumin—while sparing normal tissue. By targeting this "retired" protein, which is generally absent from adult tissues except during lactation, the vaccine has the potential to minimize off-target effects and provide long-lasting immune protection.

The breast cancer vaccine platform represents a potential multi-billion dollar market opportunity, particularly among women at elevated risk of developing triple-negative breast cancer (TNBC)—an aggressive subtype with limited treatment options and poor long-term prognosis. As clinical data and regulatory frameworks evolve, the technology may also have broader applications for average-risk populations.

"Our breast cancer vaccine program is a cornerstone of our long-term strategy to develop next-generation preventive immunotherapies, and this patent issuance further secures our leadership in this field," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "With a robust portfolio of issued and pending patents in the U.S. and internationally, we are well-positioned to bring forward a vaccine that could transform how we address breast cancer risk in healthy women."

On July 24, 2025 Kling Bio ("Kling" or "the Company"), a biotech company developing antibody-based drugs for cancer and infectious diseases, reported it has entered into a collaboration and license option agreement with Sanofi for the discovery of antibodies and epitopes using its groundbreaking B cell immortalization and screening platform, Kling-Select (Press release, Kling Biotherapeutics, JUL 24, 2025, View Source [SID1234654511]).

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Kling-Select is a proprietary, clinically and commercially validated B cell immortalization platform that has played a pivotal role in the discovery of potent neutralizing antibodies. By leveraging patient-derived B cells, Kling-Select enables rapid identification of novel antibodies and conserved viral epitopes, significantly enhancing vaccine and therapeutic design. Utilizing function-first screening workflow, Kling-Select uncovers rare and highly effective immune targets, accelerating the development of next-generation prophylactics and treatments. The platform’s proven success includes validated antibody candidates against RSV, COVID-19, and influenza, underscoring its broad utility and scientific impact.

The objective of the collaboration is to identify and characterize monoclonal antibodies with potent neutralizing activity against a clinically relevant human viral pathogen. Insights gained from this joint discovery effort may enable the development of next-generaton antiviral therapeutics and inform the design of more efficacious vaccine candidates.

"This collaboration with Sanofi highlights the broad potential of our Kling-Select platform to address global health challenges by enabling the discovery of first-in-class, human-derived antibodies," commented Michael Koslowski, MD, Chief Executive Officer of Kling Bio. "Kling-Select provides a powerful window into the human immune response and accelerates the identification of functional antibodies and novel epitopes. We are excited to combine our expertise with Sanofi’s leadership in vaccine development to advance next-generation therapeutics and vaccines."