On May 12, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that Dr. Pamela D. Garzone, Chief Development Officer of Anixa, will present a poster at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place on May 30 – June 3, 2025, in Chicago, Illinois (Press release, Anixa Biosciences, MAY 12, 2025, View Source [SID1234652862]). Lead author on the poster is Dr. Robert Wenham, Chair of the Gynecologic Oncology Program at Moffitt Cancer Center, and the principal investigator of the Phase 1 clinical trial of Anixa’s ovarian cancer CAR-T immunotherapy.

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Presentation Details:

Title: Phase 1 clinical trial of autologous T-cells genetically engineered with a chimeric receptor to target the follicle-stimulating hormone receptor (FSHR) in recurrent ovarian cancer (OVCA)
Session: Developmental Therapeutics—Immunotherapy
Session Type: Poster Session
Date & Time: June 2, 2025, 1:30 PM – 4:30 PM CT
Abstract ID: TPS2682

On May 12, 2025 Galectin therapeutics presented its corporate presentation (Presentation, Galectin Therapeutics, MAY 12, 2025, View Source [SID1234652880]).

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On May 12, 2025 Caris Life Sciences(Caris), a leading next-generation AI TechBio company and precision medicine pioneer, reported MET Immunohistochemistry (IHC) testing as standard of care for all non-squamous non-small cell lung cancer (NSQ NSCLC) patients and is poised for future drug approvals (Press release, Caris Life Sciences, MAY 12, 2025, View Source [SID1234652896]). This advanced testing protocol aims to provide deeper insights into the molecular characteristics of NSQ NSCLC, facilitating more personalized and effective treatment strategies.

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Approximately 50% of NSQ NSCLCs lack a targetable gene driver mutation, making MET protein expression an important additional personalized target. Caris is addressing these challenges by leveraging the power of MET IHC testing, which evaluates the expression of the MET protein in cancer cells. This protein is known to play a crucial role in cell proliferation, invasion, and survival, making it a vital biomarker for targeted therapies.

"To our knowledge, Caris is the only lab in the US that has historically and is currently offering the MET (SP44) RxDx assay for NSQ NSCLC," said Caris President David Spetzler, MS, PhD, MBA. "With MET IHC testing already in place, we are poised and ready to provide a detailed molecular profile to inform targeted therapies and future drug development approvals."

Key Highlights of MET IHC Testing:
Comprehensive Molecular Profiling: Caris utilizes a multi-platform approach, including immunohistochemistry (IHC) and next-generation sequencing (NGS), to provide a detailed molecular profile of NSQ NSCLC tumors.

Identification of Actionable Targets: The MET IHC testing helps identify overexpression of the MET protein, which is associated with poor prognosis and can be targeted by specific therapies.

Enhanced Treatment Personalization: By understanding the molecular makeup of NSQ NSCLC tumors, oncologists can tailor treatment plans to the individual needs of patients, potentially improving outcomes and quality of life.

Caris remains committed to advancing cancer diagnostics and treatment through innovative technologies and rigorous scientific research. Deployment of MET IHC testing for NSQ NSCLC patients underscores this commitment and highlights Caris’ dedication to improving patient care and outcomes.

Caris’ comprehensive molecular profile testing includes MI Cancer Seek and Caris Assure. Caris received FDA approval in November of 2024 for MI Cancer Seek, a tissue-based assay which is the first and only simultaneous Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS)-based assay with FDA-approved CDx indications for molecular profiling of solid tumors. Caris Assure is a powerful blood-based assay that uniquely identifies somatic tumor, incidental clonal hematopoiesis and incidental germline variants by sequencing both plasma and buffy coat through a WTS and WES-based assay.

On May 12, 2025 ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported financial results for the first quarter ended March 31, 2025, and highlighted recent Company progress (Press release, ArriVent Biopharma, MAY 12, 2025, View Source [SID1234652863]).

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"We continued our strong execution across our oncology-focused pipeline and are preparing for several near-term milestones. Importantly, our late-stage firmonertinib program continues to show differentiated potential to address unmet needs across EGFR-mutant non-small cell lung cancer (NSCLC)," said Bing Yao, Chairman and Chief Executive Officer of ArriVent. "ARR-217 (MRG007), our recently acquired antibody drug conjugate (ADC) targeting the gastrointestinal marker CDH17 with best-in-class potential, is expected to be the first ADC from our pipeline to enter the clinic."

Dr. Yao continued, "In the year ahead, we plan to present updated data for firmonertinib in first line EGFR PACC mutant NSCLC, including Progression Free Survival (PFS) and duration of response, and provide our clinical development plan on the PACC program in the second quarter of 2025. We expect topline data in 2025 in our event-driven global pivotal Phase 3 study for firmonertinib monotherapy in first-line NSCLC harboring EGFR exon 20 insertion mutations."

First Quarter 2025 and Recent Highlights

Firmonertinib

● Completed enrollment for pivotal trial. During the first quarter of 2025, we completed enrollment in the the global pivotal Phase 3 FURVENT study of firmonertinib monotherapy in first-line NSCLC EGFR exon 20 insertion mutations (NCT05607550). Firmonertinib, an oral, highly brain-penetrant, and broadly active mutation-selective epidermal growth factor receptor (EGFR) inhibitor, received FDA Breakthrough Therapy Designation in this patient population.
Pipeline

● Expanded our pipeline to include ARR-217 (MRG007). In January 2025, ArriVent entered into a collaboration agreement with Lepu Biopharma for ARR-217, a CDH17-targeted ADC with the potential to treat gastrointestinal cancers. Under the agreement, ArriVent obtained the exclusive rights to develop and commercialize ARR-217 worldwide outside of greater China. In March 2025, our first IND was submitted in China with an initial clinical development focus in colorectal, pancreatic and other GI cancers. Pre-clinical data presented recently at the American Association

On May 12, 2025 ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, reported certain operational results following approval of the permanent J-code (J9028) in January 2025, as well as its financial results for the first-quarter ended March 31, 2025 (Press release, ImmunityBio, MAY 12, 2025, View Source [SID1234652881]).

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With the issuance of the permanent J-code (J9028) in January 2025, ImmunityBio has seen increased sales momentum supporting a trend of increases month-over-month as well as quarter-over-quarter, with March unit sales volume increasing 69% over February, and Q1 2025 unit sales volume exceeding unit sales volume achieved for all of fiscal year 2024.
ImmunityBio earned net product revenue of approximately $16.5 million during the three-month period ended March 31, 2025, which represented an increase of 129% over the $7.2 million of net revenue earned during the fourth quarter of 2024.
"We are seeing a steady growth in revenue as urologists increase their use of ANKTIVA to treat NMIBC carcinoma in situ (CIS) patients, particularly since we addressed the BCG shortage with the launch of our rBCG EAP in February," said Richard Adcock, President and CEO of ImmunityBio. "Nearly 200 urological practices are in early stages of implementation or have already begun administering rBCG to patients, many of them in rural areas where patients otherwise would not have access to this treatment. This not only lets us help more patients, it opens a new marketplace for ImmunityBio’s therapies."
"ANKTIVA’s increasing use by urologists shows the real-world benefits of our unique approach to immunotherapy," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, Global Chief Scientific & Medical Officer of ImmunityBio. "We’re making excellent progress in developing our pipeline, and now have multiple sites open for our second-line lung cancer study as well as having submitted an EAP protocol for ANKTIVA for the treatment of lymphopenia. We are confident that we will continue to deliver more advanced treatment candidates based on our solid science."

First-Quarter Ended March 31, 2025 Financial Summary and Comparison to Prior Year Quarter
Product Revenue, Net

Product revenue, net increased $16.5 million during the three months ended March 31, 2025, as compared to the three months ended March 31, 2024, due to sales of ANKTIVA, which was approved in April 2024.

Research and Development Expense

Research and development (R&D) expense decreased $5.1 million to $48.2 million during the three months ended March 31, 2025, as compared to $53.3 million during the three months ended March 31, 2024. The decrease was primarily driven by lower external manufacturing costs, research agreement expenses, stock-based compensation expenses, equipment expenses, and consulting costs.

Selling, General and Administrative Expenses

Selling, general and administrative expense (SG&A) decreased $9.2 million to $32.7 million during the three months ended March 31, 2025, as compared to $41.9 million during the three months ended March 31, 2024. The decrease was due to lower costs related to litigation settlements and commercial consulting activities.

Net Loss Attributable to ImmunityBio Common Stockholders

Net loss attributable to ImmunityBio common stockholders was $129.6 million during the three months ended March 31, 2025, compared to $134.1 million during the three months ended March 31, 2024. The reduction of loss was primarily driven by product revenue, lower R&D and SG&A expense described above, lower related-party interest expense, and changes in the fair value of derivative liabilities, partially offset by changes in the fair value of our related-party convertible note and an increase in interest expense related to the revenue interest liability.

Cash and Marketable Securities Position

As of March 31, 2025, on a pro forma basis, the Company had consolidated cash and cash equivalents, and marketable securities of $136.4 million after giving effect to net proceeds of $74.8 million from an equity financing in April.