On November 17, 2025 Johnson & Johnson (NYSE: JNJ) reported that it has entered into a definitive agreement to acquire Halda Therapeutics OpCo, Inc. (Halda), a clinical-stage biotechnology company with a proprietary Regulated Induced Proximity TArgeting Chimera (RIPTAC) platform to develop oral, targeted therapies for multiple types of solid tumors, including prostate cancer, for $3.05 billion in cash. The transaction is expected to close within the next few months, subject to antitrust clearance and other customary closing conditions.

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The lead candidate, HLD-0915, is a clinical-stage therapy for prostate cancer, of which new diagnoses are projected to reach 1.7 million globally by 20301. Given the existing unmet need, this once-daily therapy has the potential to transform patient outcomes with its novel precision cancer cell-killing approach that can overcome mechanisms of resistance to treatment. The acquisition also includes several earlier candidates for breast, lung and multiple other tumor types. Halda’s pipeline and platform may also enable the creation of novel targeted therapies beyond oncology.

"This acquisition further strengthens our deep oncology pipeline with an exciting lead asset in prostate cancer and a platform capable of treating multiple cancers and diseases beyond oncology, providing a potential mid- and long-term catalyst for growth," said Jennifer Taubert, Executive Vice President, Worldwide Chairman, Innovative Medicine, Johnson & Johnson. "We look forward to combining Halda’s pipeline, platform and people with our world class R&D, commercial and manufacturing capabilities and advancing our goal of bringing these therapies to patients around the world."

"Many therapies lose effectiveness over time due to resistance. Halda’s innovative technology is designed to work even when cancers no longer respond to standard treatments using a novel mechanism that enables the selective killing of cancer cells," said John C. Reed, M.D., Ph.D., Executive Vice President, Innovative Medicine, R&D, Johnson & Johnson. "Results seen with HLD-0915 demonstrate impressive preliminary efficacy and a strong early safety profile in prostate cancer. We are eager to accelerate the ongoing Phase 1/2 clinical trial of HLD-0915 and progress a pipeline of novel product candidates based on RIPTAC technology​."

The planned acquisition underscores Johnson & Johnson’s longstanding commitment to prostate cancer and industry-leading oncology portfolio, adding new therapies with novel and complementary mechanisms of action. Halda’s pipeline of differentiated assets, if successful, will provide critical new options for patients.

About the Acquisition Agreement

Under the terms of the agreement, Johnson & Johnson will acquire Halda. The transaction will be accounted for as a business combination and is expected to close within the next few months, subject to antitrust clearance and other customary closing conditions. The Company expects dilution in 2026 of $0.15 to Adjusted Earnings Per Share (EPS) due to short-term financing and a non-recurring charge related to the equity awards for Halda employees upon closing. Johnson & Johnson will provide commentary on full year 2026 guidance during the fourth quarter earnings call on Wednesday, January 21, 2026.

(Press release, Johnson & Johnson, NOV 17, 2025, View Source [SID1234660042])

On November 17, 2025 Solve Therapeutics, a clinical-stage biotechnology company developing best-in-class antibody-drug conjugates (ADCs) for solid tumor malignancies, reported it has raised $120 million in an oversubscribed and upsized financing to accelerate the development of its clinical pipeline and proprietary CloakLink linker platform.

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The round was led by Yosemite, with participation from Abingworth, Ally Bridge Group, B Capital, Balyasny Asset Management, Merck & Co., and SymBiosis, and existing investors Alexandria Venture Investments, AyurMaya Capital Management, DC Global Ventures, General Atlantic, and Surveyor Capital (a Citadel company). This latest funding follows a $75 million financing completed in December 2024, bringing Solve’s total capital raised to $321 million.

Solve Therapeutics was founded to develop next-generation ADCs capable of addressing unique challenges presented by solid tumors. Traditional ADCs often face limitations related to payload hydrophobicity, including sub-optimal pharmacokinetics and plasma stability, which can compromise safety and efficacy.

Solve’s proprietary CloakLink technology was engineered to overcome these barriers by increasing ADC stability and decreasing ADC hydrophobicity across a broad range of drug-to-antibody ratios. The result is a class of ADCs with improved pharmacokinetics, enhanced plasma stability, and reduced toxicity, enabling improved therapeutic indices and overall performance.

The company’s lead programs, SLV-154 and SLV-324, are currently in Phase 1 clinical trials in patients with solid tumors. Both utilize the CloakLink platform and targeting antibodies that are specifically engineered for superior ADC performance. The ADCs are paired with novel diagnostic approaches to enable precision patient selection. The new funding will support the completion of Phase 1b studies for both programs and expand the company’s operational capabilities as it advances toward later-stage clinical development.

"We’re thrilled to partner with an outstanding syndicate of investors who share our vision for developing best-in-class ADCs," said Dave Johnson, CEO & Co-Founder, Solve Therapeutics. "Since founding the company, we’ve built a differentiated platform that combines next-generation ADC engineering, a superior hydrophilic linker system, and novel patient-selection diagnostics. This investment syndicate represents a strong endorsement of our science, our team, and our mission to develop more effective and safer targeted therapies for patients with solid tumors."

"Solve is the next wave of ADC innovation," said Dan McHugh, Investor at Yosemite and Solve Therapeutics board member. "By integrating therapeutic development with a novel diagnostic platform, Solve is pushing the boundaries of precision oncology and enabling a more personalized, effective approach to cancer care. Yosemite is excited to support the excellence and innovation demonstrated by this best-in-class team."

Founded by leaders behind VelosBio (acquired by Merck) and Acerta Pharma (acquired by AstraZeneca), Solve Therapeutics is applying decades of combined oncology and ADC expertise to build a pipeline of pioneering therapeutics and diagnostics targeting solid tumors with high unmet need.

(Press release, Solve Therapeutics, NOV 17, 2025, View Source [SID1234660041])

On November 17, 2025 CorriXR Therapeutics, Inc., an oncology-focused biotherapeutics company pioneering a novel gene editing platform to overcome drug resistance in solid tumors, reported the publication of a manuscript in Molecular Therapy Oncology detailing results from a preclinical study evaluating CRISPR-directed gene editing for the treatment of squamous cell lung carcinoma (LUSC). The study was conducted in collaboration with scientists at ChristianaCare’s Gene Editing Institute (GEI).

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"This foundational work strengthens CorriXR’s strategy of disrupting cancer cell survival pathways to restore sensitivity to standard therapies," said Eric B. Kmiec, Ph.D., Founder and Chief Executive Officer of CorriXR Therapeutics and Executive Director of GEI. "These findings build on more than a decade of GEI research into NRF2, a master regulator of cellular stress responses and known driver of treatment resistance. We are encouraged by the consistency of results across in vitro human lung cancer models and our in vivo studies and are actively pursuing IND-enabling work to bring this promising approach to patients."

Key findings from the study include:

Restoration of chemosensitivity: Editing 20-40% of LUSC cells to disrupt NRF2 was sufficient to resensitize tumors to chemotherapy, resulting in significant reductions in tumor growth.
Reduced cancer-driving signals: Edited tumors reduced NRF2 expression and downregulation of its downstream markers, demonstrating effective pathway disruption.
No off-target editing above background: Unintended edits remained below 0.2% supporting the specificity and safety of the gene editing approach.
Strong translational potential: The lipid nanoparticle (LNP) delivery system achieved robust editing in both engineered and patient-derived tumor models, reinforcing the feasibility of advancing towards clinical development.
"Treatment resistance remains one of the greatest challenges in oncology, and these data demonstrate that targeting NRF2 can meaningfully resensitize tumors with minimal off-target effects," said Kelly Banas, Ph.D., lead author of the study and Associate Director of Research at GEI. "This approach has the potential to lower chemotherapy doses, reduce toxicity and help patients remain healthier throughout treatment." Kmiec added, "Instead of creating entirely new drugs, we are using gene editing to make existing ones effective again."

The study also highlights that the biology of NRF2 driven resistance extends beyond lung cancer. "While this work focused on LUSC, NRF2 overactivation drives treatment resistance across multiple solid tumors, including head and neck squamous cell carcinoma (HNSCC)," said Kmiec. "These data indicate that CRISPR-enabled targeting of NRF2 may disrupt the tumor microenvironment and address a shared mechanism of therapeutic failure."

LUSC is an aggressive form of non-small cell lung cancer (NSCLC), representing 20-30% of lung cancer cases and affecting an estimated 190,000 people annually in the U.S. Chemotherapy remains a cornerstone of care, but many patients develop resistance, leaving limited options beyond dose escalation, which increases toxicity and typically worsens quality of life. NRF2 overactivation is a well-established driver of this resistance across multiple solid tumors, including HNSCC, esophageal and liver cancers – representing a significant unmet medical need.

These findings provide a compelling foundation to advance CorriXR’s lead program for HNSCC, as well as the Company’s LUSC program, into clinical development. CorriXR and GEI are now independently validating results at commercial CROs, conducting the required safety and regulatory studies to support an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for approval of human trials, and are exploring partnerships to accelerate clinical translation.

The full publication: Functional characterization of tumor-specific CRISPR-directed gene editing as a combinatorial therapy for the treatment of solid tumors – ScienceDirect is available online in Molecular Therapy Oncology.

(Press release, CorriXR Therapeutics, NOV 17, 2025, View Source [SID1234660040])

On November 17, 2025 Acuitas Therapeutics, a global leader in lipid nanoparticle (LNP) delivery systems for the acceleration of partners’ clinical development, reported its Next-Generation LNP advancements, a suite of novel and enhanced technologies that expand the range of diseases treatable with mRNA-LNP medicines, at the 13th International mRNA Health Conference in Berlin. Also at the conference, the company highlighted additional preclinical data on its LNP formulations’ applicability in cancer vaccines, potency, and safety.

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"Commercial validation of our technology has provided both an important milestone of success and the impetus for continued advancement," said Dr. Thomas Madden, CEO of Acuitas Therapeutics. "Our research, presented at the mRNA Health Conference, is focused on two key goals: expanding the application of our technology into new therapeutic areas and enhancing the potency and safety of the platform itself, with novel LNP formulations and various improvement strategies. Underpinning both is our commitment to improving the translatability of preclinical data, which is essential for accelerating the journey of mRNA and personalized therapies from the laboratory bench to the clinic."

Next-Generation LNP for mRNA-based Therapeutics

At the conference, Acuitas’ Chief Scientific Officer, Dr. Ying Tam, showcased the company’s Next-Generation LNP advancements, a comprehensive approach that uses multiple technologies and strategies to improve all aspects of LNP utility and applicability – from potency, safety, extrahepatic targeting, to manufacturing.

The advancements were featured in an oral presentation titled "Next-Generation Lipid Nanoparticles for Clinical Development of mRNA-based Therapeutics." The presentation detailed Acuitas’ efforts in advancing mRNA-LNP beyond current clinical standards and broadening the range of diseases these therapies can treat. Key highlights of the presentation include:

Novel LNP candidates engineered for significantly improved potency, as high as a four-fold increase for some cases, in gene editing and vaccine applications.
Optimized lipid structures reduced liver exposure, leading to increased tolerability, lowered liver enzymes, while preserving therapeutic activity in mice.
DARPin-conjugated LNP candidates that achieved highly targeted delivery to immune cells (T-lymphocytes), with a long-circulating format further enhancing uptake efficiency and expression levels.
Mucous penetrant mRNA-LNP candidates capable of extrahepatic delivery to airway epithelial cells in cystic fibrosis lung models, enabling effective gene editing compared to control LNP.
An alternative LNP manufacturing approach, called pre-formed vesicles (PFV), with equivalent potency to standard benchmark manufacturing methods, offered significant improvements in cost, storage, distribution, and flexibility of LNP manufacturing, especially for personalized mRNA-LNP therapies.
Additional Posters Presented

In addition to its lead presentation, Acuitas also showcased three posters that elucidated the mechanics of LNP delivery and assessed its existing slate of lipids, as well as explored novel options for future formulations.

Applying Clinically Approved ALC-315 in Cancer Vaccines

Acuitas’ ALC-315 ionizable lipid — used in the Pfizer-BioNTech COVID-19 vaccine (COMIRNATY) — was assessed for its cancer vaccine development potential. The research directly compared Acuitas’ LNP to lipoplexes and evaluated modified mRNA against the unmodified mRNA predominantly used in current cancer vaccine trials. Key highlights of this data include:

Using LNP comprised of ALC-315, unmodified RNA induced a stronger antigen-specific CD8 T-cell response compared to a nucleoside-modified mRNA incorporating N1methylpseudouridine-encoding OVA payload as a model tumour antigen, while maintaining strong immunogenicity at one-tenth of the initially tested dose.
Using LNP comprised of ALC-315, mRNA delivered intramuscularly induced equal or superior cellular and humoral immunity compared to intravenously (IV) administered mRNA lipoplexes – an alternative mRNA cancer vaccine format in clinical development – despite mRNA lipoplexes being administered at four-fold higher doses and with more boosts.
Several potent novel proprietary lipids were identified that achieved equivalent cellular responses to ALC-315. Further assessment will be conducted to compare potency and activity using syngeneic neoantigen models.
Novel Lipids with Improved Activity for Prophylactic Vaccine Development

Acuitas identified and validated six novel lipids that induce higher virus-specific immunogenicity compared to ALC-315. Key findings related to these novel lipids include:

The six novel lipid candidates induced equivalent neutralizing antibody titres at a five-fold lower dose than ALC-315.
The lipid candidates demonstrated favorable reactogenicity profiles comparable to ALC-315, while eliciting stronger cellular- and B-cell responses.
Innate immune responses induced by LNP correlated with their reactogenicity, but not with adaptive and innate immune responses.
Several lipid candidates achieved higher in vivo expression in secondary lymphoid organs and reduced liver expression compared to ALC-315.
Impact of Body Weight and Medications on mRNA-LNP Safety in Monkeys

As the industry continues using larger nonhuman primates in translational work, Acuitas sought to understand how body weight, premedications (steroid, H1 and H2 blockers), and concomitant medications (meloxicam) impact LNP activity and tolerability. The study was conducted in monkeys using an IV-administered mRNA-LNP encoding human IgG. Key highlights of this data include:

LNP tolerability is reduced in larger monkeys (>6 kg).
Premedications helped reduce the elevation of liver transaminases.
Premedications improved tolerability but reduced the level of IgG mRNA expression.
Platelet count decreases were greatest in large monkeys and monkeys given meloxicam.
More information on posters presented at the mRNA Health Conference and Vaccine R&D Conference can be found here.

(Press release, Acuitas Therapeutics, NOV 17, 2025, View Source [SID1234660039])

On November 17, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO) approved "liraltagene autoleucel" for the non-proprietary name of the Company’s novel FSHR-targeted CAR-T therapy for recurrent ovarian cancer. The INN nomenclature scheme for CAR-T cell therapies follows a two-word structure describing the gene and cell component.

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"The assignment of the non-proprietary name represents an important step in the development and potential future commercialization of our CAR-T therapy. The INN naming process meticulously evaluates proposed drug names for adherence to nomenclature guidelines and potential conflicts, followed by expert consensus and public review. With this INN approval, we have the ability to establish a universally recognized and conflict-free non-proprietary drug name for our CAR-T therapy," said Dr. Amit Kumar, Chairman and CEO of Anixa. "Looking ahead, we remain focused on the successful execution of our ongoing Phase 1 trial of liraltagene autoleucel for the treatment of ovarian cancer, and look forward to commencing the 5th dose cohort in the coming weeks. The Phase 1 study is being conducted in partnership with Moffitt Cancer Center."

Each INN name is unique and is used to identify active pharmaceutical ingredients. Each active substance that is to be marketed as a pharmaceutical must be granted a unique name of worldwide acceptability to ensure the clear identification, safe prescription and dispensing of medicines to patients. Anixa will transition to the use of liraltagene autoleucel, or lira-cel, in future communications.

Jose R. Conejo-Garcia, M.D., Ph.D., Professor of Immunology in the Department of Integrative Immunobiology at the Duke University School of Medicine and the co-inventor of Anixa’s CAR-T technology, stated, "It is gratifying to see this technology advance under Anixa’s guidance and through the work being performed at Moffitt Cancer Center. Receiving its non-proprietary name from the WHO is an exciting step in the process toward commercialization of this technology."

About liraltagene autoleucel
Liraltagene autoleucel, or lira-cel, is a follicle stimulating hormone receptor (FSHR)-mediated chimeric antigen receptor-T cell (CAR-T) technology that targets FSHR, which is exclusively expressed on normal ovarian cells, tumor vasculature, and certain cancer cells. Since the target is a hormone (chimeric endocrine) receptor, and the target-binding domain is derived from its natural ligand, this technology is also known as CER-T (chimeric endocrine receptor-T cell) therapy, a new type of CAR-T. Liraltagene autoleucel is currently being evaluated in a first-in-human trial (NCT05316129) that is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies. The study is designed to evaluate safety, identify the maximum tolerated dose, and monitor clinical activity. Lira-cel is based on technology exclusively licensed to Anixa by The Wistar Institute.

(Press release, Anixa Biosciences, NOV 17, 2025, View Source [SID1234660038])