On August 3, 2026 Forlong Biotechnology, a clinical-stage biotech company focused on developing transformative cytokine therapies for patients with severe unmet needs, reported that its manufacturing partner, JOINN Biologics, has successfully completed production of the FL115 pivotal batch, which will support the company’s upcoming Phase III clinical trial in non-muscle invasive bladder cancer (NMIBC).

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FL115 is an engineered IL-15/IL-15Rα-Fbody fusion protein. Fbody is a single-chain Fc engineered to preserve FcRn affinity while eliminating binding to FcγRs and complement systems, with the goal of optimizing protein half-life and biodistribution. FL115 drug substance and drug product have demonstrated excellent stability and solubility at concentrations up to 20 mg/mL, supported by a robust, low-cost GMP manufacturing process.

A clinical study of FL115 (NCT07122414) in BCG-unresponsive NMIBC is ongoing. Following the first patient dosing in August 2024, 10 patients have been dosed with FL115 alone and 52 patients have been dosed with FL115 at 3 dose levels in combination with BCG, all via intravesical delivery.

"FL115 in combination with BCG has shown impressive safety and efficacy data in patients with BCG-unresponsive NMIBC, with the potential to be the best-in-disease therapy," said Dong Wei, Ph.D., Chief Executive Officer of Forlong Biotechnology. "Successfully manufacturing and releasing the pivotal batch is an important milestone for the FL115 program, and we greatly appreciate the professional expertise and diligent effort of JOINN Biologics as our manufacturing partner. Together, we will advance FL115 into the pivotal Phase III clinical trial for NMIBC in 2027."

About FL115

FL115 is an engineered IL-15/IL-15Rα-Fbody fusion protein designed to enhance anti-tumor immunity through IL-15-mediated signaling on NK and CD8+ T cells, while minimizing the complexity associated with an Fc domain. FL115 has demonstrated significant anti-tumor activity in vivo, both as a monotherapy and in combination therapy, and can be manufactured through a robust, efficient process with excellent product stability. Clinically, FL115 has shown a favorable safety profile and preliminary clinical responses as a monotherapy, and has best-in-class potential to synergize with current and emerging T cell–targeting immunotherapies through combination approaches that could meaningfully improve treatment outcomes for patients.

FL115 is currently being investigated in combination with Bacillus Calmette-Guérin (BCG) in a Phase II clinical trial evaluating safety and preliminary efficacy in patients with non-muscle invasive bladder cancer (NMIBC), and in combination with an anti-PD-1 monoclonal antibody in a Phase I clinical trial evaluating safety and preliminary efficacy in patients with advanced solid tumors. A Phase I clinical trial of FL115 subcutaneous injection is also being initiated in Australia.

(Press release, Forlong Biotechnology, AUG 3, 2026, View Source [SID1234669627])

On August 3, 2026 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to zocilurtatug pelitecan (zoci, formerly ZL-1310), the Company’s potential first-in-class Delta-like ligand 3 (DLL3) antibody-drug conjugate (ADC), for the treatment of neuroendocrine carcinomas (NECs). NECs are aggressive malignancies that frequently express DLL3. There are no available targeted therapies and no approved standard of care for NECs in previously treated patients.

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"Zoci has now received important regulatory designations around the world, signifying its potential to become an important new therapeutic option for patients with multiple types of cancer with DLL3 expressions." said Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. "Given the need among the NEC patient community, we are focused on efficiently advancing our clinical programs for this investigational DLL3-targeting ADC."

The U.S. FDA previously granted Fast Track designation (FTD) to zoci for extrapulmonary NECs (epNECs), as well as FTD and ODD to zoci for small cell lung cancer (SCLC), the most significant pulmonary NEC and one of the most aggressive and lethal solid tumors.1,2 The European Medicines Agency (EMA) has also granted ODD to zoci for pulmonary NECs.

Benefits of the ODD include eligibility for certain development incentives, including a waiver of the Prescription Drug User Fee Act registration application fee; tax credits for certain clinical trials; and the potential to receive a seven-year U.S. market exclusivity period granted upon product approval.

About Zocilurtatug Pelitecan (Zoci, ZL-1310)

Zoci targets Delta-like ligand 3 (DLL3), a validated therapeutic target that is overexpressed in many neuroendocrine carcinomas, such as small cell lung cancer (SCLC) and extrapulmonary neuroendocrine carcinomas (epNEC), and is generally associated with poor clinical outcomes. Zoci is on track to potentially become Zai Lab’s first global oncology launch, with plans for three registration-enabling studies across second- and third-line SCLC, first-line SCLC, and epNECs by the end of 2026. Its potential best-in-class safety profile, coupled with compelling systemic and intracranial efficacy, support its potential role as a new standard of care in previously treated extensive-stage SCLC as well as epNEC, and a backbone DLL3-targeting antibody-drug conjugate (ADC) in first-line combination regimens, including those that reduce the burdens of chemotherapy, such as checkpoint inhibitors and T-cell engagers.

(Press release, Zai Laboratory, AUG 3, 2026, View Source [SID1234669626])

On August 3, 2026 Inocras Inc., a bioinformatics-led company harnessing the power of whole-genome data and proprietary analytics to deliver curated insights, reported that it has raised $31 million in an oversubscribed Series B-3 financing.

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The financing brings Inocras’s total funding to approximately $100 million and supports the company’s growth. Inocras plans to expand its whole-genome sequencing and proprietary bioinformatics platform in the United States, building on demonstrated clinical deployment across Asia. As whole-genome sequencing moves toward broader adoption in oncology, Inocras is positioned to build on years of experience translating complex whole-genome data into curated, clinically actionable insights.

The round included participation from new and existing financial investors as well as strategic investors NDS Corporation and Aimed Bio Inc. New investors included IMM Investment, Korea Investment & Securities, LoftyRock Investment, DT& Investment, Woori Investment & Securities, and Shinhan Securities. Existing investors DSC Investment, Dunamu & Partners and InterVest also participated.

Inocras has established a record of real-world clinical adoption across Asia, with its whole-genome sequencing solutions currently used by more than 100 cancer institutions and in thousands of patient cases. The company has also established a significant commercial presence in Hong Kong and is supporting approximately thirty hospitals in South Korea.

Through its proprietary bioinformatics and automated interpretation capabilities, Inocras supports precision oncology applications spanning comprehensive tumor profiling with CancerVision and molecular residual disease detection with MRDVision.Across both solutions, the company analyzes genomic alterations and complex biomarkers across the cancer genome and translates those findings into clinically relevant insights. Inocras will use the proceeds to build on this momentum by expanding its U.S. commercial and operational infrastructure.

"We have already seen meaningful adoption across cancer institutions in Asia, where our technology has been used in thousands of patient cases," said Jehee Suh, CEO of Inocras. "Our next objective is to bring that clinical experience to the United States and help make whole-genome analysis a standard part of cancer care. This financing gives us the resources to expand our clinical presence, support adoption within hospitals, and build the evidence and infrastructure required to achieve that goal."

The financing follows continued clinical and scientific validation of Inocras’s whole-genome approach. Through its collaboration with researchers at the Broad Institute, Inocras recently analyzed whole-genome data from The Cancer Genome Atlas across thousands of cancer cases, demonstrating the utility of standardized whole-genome analysis at scale and informing broader use of comprehensive genomic information in oncology.

(Press release, Inocras, AUG 3, 2026, View Source [SID1234669625])

On August 3, 2026 Pheast Therapeutics, a clinical-stage biotechnology company advancing next-generation macrophage-directed immunotherapies for cancer, reported it will host an educational webinar on Monday, August 10, 2026 from 12:00 p.m. – 2:00 p.m. ET. The webinar will focus on the emerging role of macrophage checkpoint biology for the treatment of solid tumors as well as Pheast’s lead program, PHST001, a novel, high-affinity IgG4 anti-CD24 monoclonal antibody currently in Phase 1 clinical development for multiple solid tumor types, including ovarian cancer.

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The webinar will feature participation from key opinion leaders (KOLs) in cancer immunotherapy:

Aurélien Marabelle, M.D., Ph.D., Professor of Clinical Immunology, University of Paris Saclay; Senior Medical Oncologist in the Drug Development Department (DITEР) at Gustave Roussy Cancer Center; and Head of the Laboratory for Translational Immunotherapy Research (LRTI)
Thomas Marron, M.D., Ph.D., Professor of Immunology and Immunotherapy at the Icahn School of Medicine at Mount Sinai and Associate Director for Translational Research at Tisch Cancer Center
Please click here to register for the live webinar. A replay of the webinar will also be made available under the Presentations section of the Pheast Therapeutics website following the live event.

About PHST001

PHST001 is an anti-CD24 macrophage checkpoint inhibitor designed to overcome immune suppression in the tumor microenvironment. CD24 is highly expressed across many cancers, where high expression is associated with poor prognosis. Pheast has engineered PHST001 to be a potential best-in-class antibody designed to induce macrophages to phagocytose cancer cells and initiate a powerful immune response. PHST001-101 is an open-label, multicenter Phase 1 study in patients with advanced solid tumors (ClinicalTrials.gov Identifier: NCT06840886) evaluating safety, tolerability, and dose optimization, with secondary objectives assessing pharmacokinetics and preliminary anti-tumor activity. PHST001 received FDA Fast Track Designation for the treatment of ovarian cancer in June 2025.

(Press release, Pheast Therapeutics, AUG 3, 2026, View Source [SID1234669624])

On August 3, 2026 Pathos AI, a clinical-stage AI and technology company advancing its own pipeline of cancer therapies, reported a licensing agreement with Jiangsu Alphamab Biopharmaceuticals Co., Ltd. ("Alphamab"), a wholly-owned subsidiary of Alphamab Oncology (Stock Code: 9966.HK), on JSKN016, a first-in-class (FIC) TROP2/HER3 bispecific antibody-drug conjugate (ADC) independently developed by Alphamab.

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Pursuant to the licensing agreement, Alphamab granted Pathos an exclusive license to research, develop, manufacture and commercialize JSKN016 in territories outside the Chinese Mainland, Hong Kong, Macau and Taiwan, with Pathos bearing all related development and commercialization costs and expenses under the agreement. Alphamab retains its full and exclusive rights to develop, manufacture and commercialize JSKN016 in the Chinese Mainland, Hong Kong, Macau and Taiwan.

Under the terms of the agreement, Alphamab is entitled to receive a non-refundable upfront payment of US$125 million and milestone payments based on the achievement of certain development and commercialization milestones, totaling up to US$2,093 million, as well as tiered royalties at high-single digit to low-double digit percentage rates according to aggregate annual net sales in the licensed territories.

Accelerated by AI: The Foundry Advantage

JSKN016 was identified and prioritized through Foundry, Pathos’s proprietary AI-driven decision platform for oncology drug development. Foundry utilizes thousands of AI agents working in parallel, powered by the Pathos’ proprietary AI models, to analyze biological, clinical, and real-world data at scale; surfacing high-potential assets, designing clinical trials, and matching the right patients to the right therapies faster and more safely than traditional methods allow.

Every major asset-level decision at Pathos flows through Foundry. JSKN016 becomes the fourth clinical-stage program advanced into the Pathos pipeline through the platform.

"JSKN016 is a next-generation bispecific ADC with the potential to address significant unmet need across a range of solid tumors, and we are excited to advance it in partnership with Alphamab. This program was identified through Foundry, the same platform that continues to guide portfolio decisions across our clinical pipeline. This collaboration reflects our shared commitment to bringing differentiated therapies to patients."

— Iker Huerga, CEO of Pathos AI

"JSKN016 represents the best of our next-generation bispecific ADC platform, and we are excited to partner with Pathos. With Pathos’s leading capabilities in AI-driven precision development, we are confident this collaboration will accelerate the global clinical advancement of JSKN016 and bring a potential breakthrough therapy to more patients with solid tumors. This partnership reflects our shared commitment to delivering differentiated innovation to patients worldwide."

— Dr. Ting Xu, Chairman and CEO of Alphamab Oncology

A Growing Mission to Transform Oncology

The addition of JSKN016 expands Pathos’s clinical pipeline to four assets across multiple solid tumor indications. JSKN016, a TROP2/HER3 bispecific ADC, joins pocenbrodib, currently in development for metastatic castration-resistant prostate cancer (mCRPC) and relapsed/refractory multiple myeloma (RRMM); DO-2, for MET-altered non-small-cell lung cancer (NSCLC); and AZD4241, an ERα PROTAC for ER+/HER2- breast cancer being advanced under a collaboration with AstraZeneca. Every program in the Pathos pipeline has been identified, evaluated, or accelerated by the Foundry platform, reinforcing the company’s commitment to AI-native drug development.

About JSKN016

JSKN016 is a TROP2/HER3 targeting bispecific ADC developed using the proprietary single-domain antibody and bispecific antibody platforms. It is conjugated via site-specific glycosylation to generate a homogeneous and stable ADC with a drug-to-antibody ratio (DAR) of 4. JSKN016 binds to TROP2 and/or HER3 on tumor cells, blocks the corresponding signaling pathways and releases topoisomerase I inhibitors through cellular endocytosis, exerting anti-tumor effects.

JSKN016 has demonstrated superior efficacy and a favorable safety profile across multiple solid tumors. Multiple clinical studies of JSKN016 as monotherapy and in combination therapies for lung cancer, breast cancer, and other indications have been initiated. The Phase III clinical study evaluating JSKN016 for the treatment of triple-negative breast cancer (TNBC) is currently ongoing. The Phase Ib clinical study in China and the Phase I clinical study in Australia of the subcutaneous formulation of JSKN016 are both ongoing.

(Press release, Pathos AI, AUG 3, 2026, View Source [SID1234669623])