On June 30, 2025 AbbVie (NYSE: ABBV) and Capstan Therapeutics, Inc. ("Capstan"), a clinical-stage biotechnology company dedicated to advancing in vivo engineering of cells through RNA delivery using tLNPs, reported a definitive agreement under which AbbVie will acquire Capstan, including CPTX2309, a potential first-in-class in vivo tLNP anti-CD19 CAR-T therapy candidate, currently in Phase 1, in development for the treatment of B cell-mediated autoimmune diseases (Press release, AbbVie, JUN 30, 2025, View Source [SID1234654178]). Additionally, AbbVie will acquire Capstan’s proprietary tLNP platform technology designed to deliver RNA payloads, such as mRNA, capable of engineering specific cell types in vivo.

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"Scientific innovation is required to address not just the symptoms of autoimmune diseases, but also to resolve and potentially cure the underlying disease," said Roopal Thakkar, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "By advancing CPTX2309 and utilizing Capstan’s novel platform technology, AbbVie and Capstan aim to transform the care of those living with autoimmune diseases by developing treatments that have the potential to reset the immune system."

"In vivo CAR-T represents a potential new treatment modality in medicine – embodying the transformative power of cell therapy with the accessibility and scalability of an off-the-shelf biologic. This technology has the potential to become a first-in-class platform to treat a wide range of autoimmune diseases," said Laura Shawver, Ph.D., president and chief executive officer, Capstan. "Through AbbVie’s world-leading expertise in immunology research, clinical development, and its commercialization capabilities, we believe that this transaction moves us closer to delivering on our shared mission to bring these innovative therapies to patients in need."

B cells contribute to the pathogenesis of autoimmune diseases. CD19 is a cell surface receptor expressed on B cells and is a clinically validated target for B cell depletion using ex vivo CAR-T cell therapy in autoimmune diseases. CPTX2309, a product of Capstan’s proprietary technology platform that includes hepatic de-targeting, delivers an mRNA payload encoding an anti-CD19 CAR preferentially to reprogram CD8-expressing cytotoxic T cells. This process is achieved in vivo, without the need for lymphodepletion preconditioning and complex ex vivo manufacturing. The in vivo-modified CD8-expressing T cells will transiently express the CD19 CAR and deplete B cells in the periphery and tissues. Depletion of autoreactive antibody-producing pathogenic memory B cells and repopulation with naïve B cells, resulting in immune reset, has the potential to prevent disease progression and induce clinical remission.

Under the terms of the agreement, AbbVie will pay up to $2.1 billion in cash at closing to acquire Capstan, subject to certain customary adjustments. The transaction is subject to the satisfaction of customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

Advisors

Capstan’s exclusive financial advisor was Centerview Partners LLC and Cooley LLP served as legal advisor.

On June 30, 2025 Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or "the Company"), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported that INT230-6 achieved complete responses in a murine models of Malignant Peripheral Nerve Sheath Tumor ("MPNST") (Press release, Intensity Therapeutics, JUN 30, 2025, View Source [SID1234654179]). In a study conducted in the Staedtke-Bai laboratory at Johns Hopkins University, at 21 days, animals tested with INT230-6 (n=5) all achieved a complete response, whereas all animals’ tumors in the control group (N=5) continued to grow.

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"We are excited to see complete responses in a murine model of malignant peripheral nerve sheath tumors, an effect that no small molecule drug before INT230-6 has achieved in our lab before," said Renyuan Bai, PhD, Kennedy Krieger Institute, Associate Professor, Department of Neurosurgery and Oncology Center, Johns Hopkins University School of Medicine, and the coordinating scientist for the study. "We are encouraged that these results can be achieved in this difficult-to-treat neurological model and look forward to continuing to work with Intensity on other preclinical models of neurological tumors."

"MPNST is the first neurological-specific tumor for which INT230-6 has been used. We are pleased to see that INT230-6 achieved meaningful results in MPMNST that are similar to the results we saw in other in vivo models where INT230-6 has been tested," said Lewis H. Bender, President and CEO of Intensity. "We look forward to conducting further preclinical research with the Staedtke-Bai laboratory in other neurological cancer models."

About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that facilitates the dispersion of potent cytotoxic drugs throughout tumors, allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

About Malignant Peripheral Nerve Sheath Tumor
Malignant peripheral nerve sheath tumor (MPNST) is a rare and aggressive type of sarcoma that originates from the peripheral nerves or their surrounding sheath. Few therapies have been proven effective despite extensive efforts, and the five-year survival is 20 to 50%. Current treatment involves surgery, chemotherapy and radiation. The disease is characterized by its tendency to recur after treatment and metastasize to distant sites, making it a challenging cancer to manage. MPNSTs can arise spontaneously or are associated with neurofibromatosis type 1, referred to as NF1. They develop from the cells of the peripheral nerve sheath. One in 3,000 people can carry NF1 gene alternations and are predisposed to tumor formation, which can occur anywhere in the body. MPNSTs are most commonly found in the extremities and trunk. Common sites include the sciatic nerve, brachial plexus, and sacral plexus.

On June 30, 2025 Nektar Therapeutics (Nasdaq: NKTR), a clinical-stage biotechnology company focused on the development of innovative medicines in the field of immunotherapy, reported that it has commenced an underwritten public offering of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock (Press release, Nektar Therapeutics, JUN 30, 2025, View Source [SID1234654180]). All of the shares of common stock and pre-funded warrants to be sold in this offering are being offered by Nektar. In addition, Nektar intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of shares of its common stock at the public offering price per share, less underwriting discounts and commissions. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Nektar intends to use the net proceeds from the offering for general corporate purposes, which may include research and development, clinical development and manufacturing costs to support the advancement of its drug candidates, as well as other general corporate purposes.

Jefferies and Piper Sandler are acting as joint bookrunning managers for the offering.

The securities described above are being offered pursuant to a shelf registration statement on Form S-3 (No. 333-286222) that was filed with the U.S. Securities and Exchange Commission (the "SEC") on March 28, 2025 and declared effective on April 1, 2025. This offering is being made only by means of a prospectus supplement and an accompanying prospectus that form a part of the registration statement.

A preliminary prospectus supplement related to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and an accompanying prospectus related to the offering may also be obtained, when available, from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, or by telephone at (800) 747-3924, or by e-mail at [email protected].

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

On June 30, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported the Phase 3 FORTITUDE-101 clinical trial evaluating first-line bemarituzumab plus chemotherapy (mFOLFOX6) met its primary endpoint of overall survival (OS) at a pre-specified interim analysis (Press release, Zai Laboratory, JUN 30, 2025, View Source [SID1234654181]).

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Bemarituzumab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS as compared to placebo plus chemotherapy in people living with unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer with FGFR2b overexpression and who are non-HER2 positive. FGFR2b overexpression was defined as 2+/3+ staining in ≥10% of tumor cells by centrally performed immunohistochemistry (IHC) testing.

Gastric cancer is the fifth leading cause of cancer-related death worldwide, with nearly one million new cases and over 650,000 deaths globally each year 1, highlighting a critical unmet medical need. In China, there are over 350,000 new cases each year. The disease is associated with a poor prognosis, particularly in advanced stages where the five-year survival rate is less than 10%. There are currently no approved therapies specifically targeting FGFR2b overexpression in gastric cancer in China.

"Bemarituzumab is the first FGFR2b inhibitor to demonstrate a statistically and clinically significant overall survival benefit in a randomized Phase 3 trial for the first-line treatment of FGFR2b-positive gastric cancer," said Dr. Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. "The success of the global Phase 3 FORTITUDE-101 study highlights the potential of bemarituzumab to redefine the standard of care for a patient population that has faced poor outcomes with existing therapies. We are proud to have contributed meaningfully to this pivotal trial, including a substantial number of patients enrolled in China. Based on these results, and the regulatory Breakthrough Designation, we plan to move rapidly toward regulatory submission in China to bring this transformative therapy to patients as quickly as possible."

The most common treatment-emergent adverse events (>25%) in patients treated with bemarituzumab plus chemotherapy were reduced visual acuity, punctate keratitis, anaemia, neutropenia, nausea, corneal epithelium defect and dry eye. While ocular events were consistent with the Phase 2 experience and observed in both arms, they occurred with greater frequency and severity in the Phase 3 bemarituzumab arm.

Detailed results from the trial will be shared at a future medical meeting.

Zai Lab holds the development and commercialization rights for bemarituzumab for mainland China, Hong Kong, Macau, and Taiwan. Bemarituzumab has been granted Breakthrough Therapy designation by the China Center for Drug Evaluation of the National Medical Products Administration for the treatment of FGFR2b-positive gastric and gastroesophageal junction adenocarcinoma.

A Phase 3 study of bemarituzumab plus chemotherapy and nivolumab is also ongoing in patients with first-line gastric cancer, with data readout anticipated in H2 2025.

About FGFR2b

The FGFR2b protein (also known as fibroblast growth factor receptor 2b) is an emerging biomarker which, when overexpressed, promotes aberrant signaling leading to tumor cell proliferation.2

The FGFR2b protein is overexpressed by G/GEJ tumor cells in approximately 38% of patients with advanced G/GEJ cancer. FGFR2b protein overexpression is defined as 2+/3+ staining intensity on tumor cell membrane, as detected by immunohistochemistry (IHC) testing. In approximately 16% of patients with advanced G/GEJ cancer, FGFR2b protein overexpression is observed on ≥10% of tumor cells by IHC.3

About FORTITUDE-101

FORTITUDE-101 is a randomized, multi-center, double-blind, placebo-controlled Phase 3 study of bemarituzumab plus mFOLFOX6 versus placebo plus mFOLFOX6 as first-line therapy in advanced G/GEJ cancer with FGFR2b overexpression. The FORTITUDE-101 trial spanned 300 sites across 37 countries, with 547 patients enrolled.

The primary outcome measure of the trial is overall survival in patients with FGFR2b ≥10% 2+/3+ tumor cell staining. Key secondary outcome measures include progression-free survival and overall response rate. Candidates were excluded from the trial if they were known to be human epidermal growth factor receptor 2 (HER2) positive. FORTITUDE-101 included more comprehensive ocular-related monitoring than previous studies of bemarituzumab.

About Gastric Cancer in China

Gastric cancer is the fifth most common cancer worldwide, while China bears one of the highest gastric cancer burdens in the world with an estimated 358,700 new cases and 260,400 deaths annually.4 In China, approximately 80% of gastric cancer patients are diagnosed at an advanced or metastatic stage5. For those diagnosed with Stage IV gastric cancer, the overall 5-year survival rate is less than 10%6. Patients with advanced gastric and GEJ cancer that overexpress the FGFR2b protein may be associated with poor prognosis.

On June 30, 2025 NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of oncology diagnostic solutions that enable precision medicine, reported the launch of PanTracer Tissue, a next-generation solid tumor profiling assay, including the option to add testing for homologous recombination deficiency (HRD) (Press release, NeoGenomics Laboratories, JUN 30, 2025, View Source [SID1234654182]). These new options can provide faster, actionable insights to help physicians navigate complex treatment decisions more confidently.

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PanTracer Tissue evaluates over 500 cancer-related genes and aligns with clinical guidelines, covering key biomarkers recommended for therapy selection and additional genomic insights for clinical trial enrollment. Results may be delivered in as little as 8 days, enabling physicians to rapidly initiate treatment strategies. Minimal specimen requirements make it suitable for a wide range of tumor types and practice settings. The assay builds on the company’s tissue-based CGP platform, previously known as NeoComprehensive Solid Tumor.

The addition of PanTracer Tissue + HRD offers enhanced tumor profiling by incorporating homologous recombination deficiency analysis into a single, guideline-aligned test for ovarian cancer. The PanTracer Tissue + HRD offering includes BRCA mutation status and a genomic instability score—critical biomarkers that can help guide the use of PARP inhibitors and other therapies targeting DNA repair pathways. The combined approach streamlines ordering and can shorten time to actionable results by capturing a broader range of clinically relevant genomic alterations, gene fusions, and DNA repair deficiencies.

"With PanTracer Tissue and PanTracer Tissue + HRD we’re unlocking a more complete genomic view from a single sample, giving physicians clearer answers, sooner," said Warren Stone, President and Chief Operating Officer at NeoGenomics. "With the addition of PanTracer Tissue + HRD, we are expanding our portfolio to address the unmet need for ovarian cancer therapy selection with the objective of improving patient care."

PanTracer Tissue and PanTracer Tissue + HRD are part of NeoGenomics’ broader portfolio of precision oncology solutions designed to improve patient outcomes through high-quality, guideline-aligned testing. Revealed at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, the continually expanding PanTracer portfolio reflects the company’s dedicated focus on advancing diagnostic tools that support more informed, personalized care.