On March 7, 2024 Johnson & Johnson (NYSE: JNJ) reported that it has successfully completed the acquisition of Ambrx Biopharma, Inc., a clinical-stage biopharmaceutical company with a proprietary synthetic biology technology platform to design and develop next-generation antibody drug conjugates (ADCs), in an all-cash merger transaction for a total equity value of approximately $2.0 billion, or $1.9 billion net of estimated cash acquired, as announced on January 8, 2024 (Press release, Johnson & Johnson, MAR 7, 2024, View Source [SID1234640945]). The transaction will be accounted for as a business combination.

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"We’re pleased to welcome Ambrx’s talented scientific team and proprietary ADC platform to Johnson & Johnson. We look forward to continuing the development of ARX517, which represents a potential first- and best-in-class PSMA-targeting ADC for the treatment of metastatic castration-resistant prostate cancer," said Yusri Elsayed, MD, MHSc, PhD, Global Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. "This significant opportunity sets the stage for advancing next generation ADCs with the aim of delivering differentiated solid tumor therapies that improve patients’ lives."

The acquisition presents a distinct opportunity for Johnson & Johnson to design, develop and commercialize targeted oncology therapeutics. Ambrx’s proprietary ADC technology incorporates the advantages of highly specific targeting monoclonal antibodies securely linked to a potent chemotherapeutic payload to achieve targeted and efficient elimination of cancer cells without the prevalent side effects typically associated with chemotherapy.

"The Ambrx team has developed a promising pipeline and ADC platform that will be a strong complement and strategic fit to our oncology innovation strategy," said Biljana Naumovic, Worldwide Vice President, Oncology, Johnson & Johnson Innovative Medicine. "ADCs are transforming the solid tumor treatment paradigm by leveraging antibody-antigen interactions to release cytotoxic payload directly to tumor cells. This acquisition underscores our ambition to deliver enhanced, precision biologics to transform the treatment of cancers, including prostate cancer."

On March 7, 2024 3T Biosciences ("3T"), an immunotherapy company changing the future of treatment for solid tumors and other immune-mediated diseases, reported that it has entered into multiple additional collaborations with leading academic centers and principal investigators to further fuel 3T’s best-in-class 3T-TRACE (T-Cell Receptor Antigen and Cross-Reactivity Engine) pHLA target discovery platform (Press release, 3T Biosciences, MAR 7, 2024, View Source [SID1234640944]). These collaborations provide access to high quality patient samples and corresponding critical data to enable the identification of novel cancer targets of interest, including pancreatic, bladder, breast, head and neck, and colorectal cancers.

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Cancer immunotherapies have brought dramatic breakthroughs, but only for a minority of cancer patients. 3T’s platform aims to address this challenge by identifying novel shared T-cell receptor (TCR) targets of productive immune responses and comprehensively screening TCRs and TCR mimetics for specificity and off-target cross-reactivities. The platform identifies the most prevalent and immunogenic targets in solid tumors by uniquely combining high-diversity target libraries with active machine learning. This may lead to tumor-specific, safer therapies that can be delivered at higher doses.

3T is collaborating with multiple decorated academic investigators to partner in its mission to serve patients with solid tumors with high unmet need:

David Oh, M.D., Ph.D. and Larry Fong, M.D., at University of California, San Francisco – Focusing on bladder cancer patients treated with anti-PD(L)1.
Diether Lambrechts, Ph.D., at VIB-KU Leuven – Focusing on breast cancer, including triple-negative breast cancer, treated with checkpoint therapies.
Sabine Tejpar, M.D., Ph.D. at KU Leuven – Focusing on colorectal cancer, including MSS subtype where traditional immunotherapy methods have difficulty engaging immune responses.
Tao Dong, D.Phil., and Ricardo Fernandes, D.Phil., at Oxford University – Focusing on lung and breast cancer.
"At 3T, patients are at the center of everything we do," said Stefan Scherer, M.D., Ph.D., 3T’s president and chief executive officer. "By partnering with the world’s leading academic institutions, we are able to supercharge our discovery efforts in delivering novel therapeutics to patients by leveraging samples from patients themselves to further our understanding of the immune system’s response to cancer."

On March 7, 2024 Verismo Therapeutics, a clinical-stage CAR-T company developing the novel KIR-CAR platform technology, reported that it has activated a second clinical site for its STAR-101 Phase 1 clinical trial at The University of Texas MD Anderson Cancer Center (Press release, Verismo Therapeutics, MAR 7, 2024, View Source [SID1234640943]).

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STAR-101 is a multi-center clinical trial designed to evaluate Verismo Therapeutic’s lead candidate, SynKIR-110, for the treatment of mesothelin-overexpressing ovarian cancer, malignant pleural mesothelioma, and cholangiocarcinoma.

"This milestone marks the steady progress towards our goal of bringing SynKIR-110 to as many patients as possible," said Dr. Bryan Kim, Co-Founder and CEO of Verismo Therapeutics. "We are grateful for the opportunity to work with Dr. Mehmet Altan at MD Anderson to bring us closer to that goal."

Verismo achieved clearance from the FDA to initiate this multi-center clinical trial for SynKIR-110 and has partnered with the Hospital of the University of Pennsylvania as the first clinical site.

Verismo has previously announced that SynKIR-110 received Orphan Drug Designation and Fast Track Designation for the treatment of mesothelin-expressing mesotheliomas.

For more information about the STAR-101 clinical trial, please visit ClinicalTrials.gov NCT05568680.

About the KIR-CAR Platform
The KIR-CAR platform is a dual-chain CAR T cell therapy and has been shown in preclinical animal models to be capable of maintaining antitumor T cell activity even in challenging solid tumor environments. DAP12 acts as a novel costimulatory molecule for T cells using additional T cell stimulating pathways, further sustaining chimeric receptor expression and improving KIR-CAR T cell functional persistence. This continued T cell function and persistence can lead to ongoing regression of solid tumors in preclinical models, including those resistant to traditional CAR T cell therapies. The KIR-CAR platform is being investigated in combination with many additional emerging technologies, such as in vivo gene engineering, advanced cell manufacturing and reprogramming, combinational therapies, and even allogeneic cellular therapies to potentially provide the next-generation multimodal targeted immunotherapy for patients in need.

On March 7, 2024 iOnctura, a pioneering, clinical-stage biotechnology company developing transformative cancer therapies, reported that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its autotaxin inhibitor cambritaxestat for the treatment of pancreatic cancer (Press release, iOnctura, MAR 7, 2024, View Source [SID1234640942]).

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After assessing its novel chemical and biological properties including an attractive non-clinical safety and efficacy profile, the US FDA has granted Orphan Drug Status, conferring certain benefits during development and commercialization.

Following a separate submission process the World Health Organization has proposed the International Nonproprietary Name (INN) of cambritaxestat.

Cambritaxestat is being developed as a first-in-class therapy for highly fibrotic cancer indications. The drug’s lead indication is metastatic pancreatic cancer where it is being combined with standard of care nab-paclitaxel and gemcitabine in the Phase I AION-02 study.

Inhibition of autotaxin is a novel treatment strategy that offers a three-pronged attack on the tumor through direct cancer cell inhibition, immune effector stimulation and inhibition of fibrotic processes, giving drugs and immune cells better access to the tumor.

Translational research showing the potential of cambritaxestat in multiple cancer models, including pancreatic cancer, has recently been published in the ESMO (Free ESMO Whitepaper) journal Immuno-Oncology and Technology (IOTECH), Cancer Research, the Journal of Experimental & Clinical Cancer Research, and Cancers. Across these publications, cambritaxestat showed strong reduction of metastasis and tumor outgrowth in preclinical models, as well as safe and tolerable dosing in healthy volunteers.

Catherine Pickering, Chief Executive Officer, iOnctura, said: "There is an urgent need to develop new therapies for pancreatic cancer which is currently the third largest cause of death by cancer in the U.S., and the fourth in Europe. Although survival of patients with pancreatic cancer has improved in recent years, it still stands at just 13% after five years. This Orphan Drug Designation will support our goal to accelerate cambritaxestat through the clinic to provide a new treatment to patients with limited options."

On March 7, 2024 Xencor presented its corporate presentation (Press release, Xencor, MAR 6, 2024, View Source [SID1234640939]).

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