On February 19, 2026 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, reported new translational and clinical biomarker data from its Phase 1b C-800-01 trial (NCT03860272) evaluating botensilimab (BOT), an Fc-enhanced anti–CTLA-4 antibody, in combination with balstilimab (BAL), an anti–PD-1 antibody. The data were presented today at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Immuno-Oncology (AACR-IO) Conference in Los Angeles.

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The retrospective analyses demonstrate that survival with BOT+BAL is associated with the balance of two opposing biological factors: systemic inflammation in the blood (associated with poorer outcomes) and tumor immune activity within the tumor microenvironment (TME) (associated with more favorable outcomes). Notably, BOT+BAL enabled clinical benefit even at levels of immune infiltration typically considered insufficient for conventional checkpoint inhibitors, suggesting the Fc-enhanced mechanism lowers the threshold of baseline immunity required for activity. Integrating blood-based inflammatory markers with tumor immune features improved overall survival stratification in microsatellite-stable metastatic colorectal cancer (MSS mCRC), a population historically resistant to conventional checkpoint inhibitors.

Traditional biomarkers such as PD-L1 expression and tumor mutational burden have shown limited predictive value in MSS mCRC. These findings suggest that a broader view of inflammatory and immune biology may better define patients most likely to benefit from next-generation immunotherapy.

Durable Clinical Activity Across Historically "Cold" Tumor Types

In 341 efficacy-evaluable patients with advanced, treatment-refractory cancers and available biomarker data (data cutoff December 13, 2025):

Objective response rate (ORR): 17%
Clinical benefit rate (CBR): 26%
Median overall survival (OS): 17.2 months
24-month overall survival rate: 38%
Clinical activity was observed across tumor types commonly considered immunologically "cold," including MSS mCRC, ovarian cancer, sarcoma, and PD-1 relapsed or refractory non-small cell lung cancer. Notably, durable benefit was observed in patients both naïve to and resistant/refractory to prior anti–PD-(L)1/CTLA-4 therapies.

To better understand the biological drivers of these outcomes, integrated translational analyses evaluated both systemic inflammation and tumor microenvironment immune features.

Biomarker Insights Identify Patient Subgroups in Immunologically "Cold" Cancers

Systemic Inflammation Negatively Impacts Survival
Baseline indicators of systemic inflammation were significantly associated with shorter OS, including elevated neutrophil-to-lymphocyte ratio, C-reactive protein and other markers reflective of inflammatory and organ stress.

Even Low Immune-Infiltration of TME Associated with Longer Survival
Survival benefit was observed across immunologically "cold" tumors, including at low levels of tumor-infiltrating lymphocytes (≥34 cells/mm²), demonstrating activity beyond conventional checkpoint biomarker thresholds.

Integrated Blood and Tumor Biomarkers Improve Survival Stratification in MSS mCRC
Combining blood and tumor features distinguished biologically distinct MSS mCRC subgroups with markedly different survival outcomes (C-index up to 0.73).

Early Immune Activation Correlates with Benefit
Patients who experienced immune-mediated adverse events (imAEs) within the first 12 weeks of treatment demonstrated longer median OS (22.4 months vs. 13.7 months), consistent with distinct baseline immune features.
"These data show that outcomes with BOT+BAL are shaped by the interplay between systemic inflammation and tumor immune biology," said Dhan Chand, PhD, Vice President of Research and Development at Agenus. "By integrating blood- and tumor-based features, we are establishing a biologically grounded approach to patient stratification in immunologically ‘cold’ cancers such as MSS colorectal cancer, where conventional biomarkers provide limited guidance. Notably, the activity observed at low levels of immune infiltration further underscores the differentiated immune-modulating profile of botensilimab."

The poster (No. B036), titled "Systemic and Tumor-Microenvironment Inflammation Shape Outcomes in Patients with Immunologically Cold, Treatment-Refractory Tumors Treated with Fc-Enhanced Anti–CTLA-4 Botensilimab," was presented during the General Poster Session and is available in the Publications section of the Company’s website at www.agenusbio.com/publications

(Press release, Agenus, FEB 19, 2026, View Source [SID1234662797])

On February 19, 2026 Moderna, Inc. (Nasdaq:MRNA), reported its participation in the following upcoming investor conferences:

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TD Cowen 46th Annual Healthcare Conference, on Tuesday, March 3rd at 1:50pm ET

Barclays 28th Annual Global Healthcare Conference, on Tuesday, March 10th at 9:30am ET

A live webcast of each of these presentations will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com.

A replay of each webcast will be archived on Moderna’s website for at least 30 days following the presentation.

(Press release, Moderna Therapeutics, FEB 19, 2026, View Source [SID1234662798])

On February 19, 2026 Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported that it will present at the BIO Investment & Growth Summit taking place in Miami Beach, Florida, March 2-3, 2026.

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The presentation will highlight recent updates and progress in Azitra’s pipeline, including ATR-12, currently in a Phase 1b clinical trial in adult patients with Netherton syndrome; ATR-04, being developed in a Phase 1/2 trial for the treatment of moderate to severe EGFRi-associated dermal toxicity in adults; and ATR-01 targeting ichthyosis vulgaris, which is undergoing IND-enabling studies.

Details are as follows:

Event:

BIO Investment & Growth Summit

Date & Time:

Monday, March 2, 2026, 2:15 PM ET

Location:

Ballroom 2C, Eden Roc Miami Beach Hotel

Presenter:

Travis Whitfill, Chief Operating Officer

Registration:

View Source

During the events, members of Azitra’s management team will conduct one-on-one meetings with registered investors and potential partners, showcasing the Company’s clinical development strategy, recent corporate achievements, and anticipated milestones.

(Press release, Azitra, FEB 19, 2026, View Source [SID1234662781])

On February 19, 2026 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer. Phio Pharmaceuticals Corp. reported leadership appointments as the Company prepares for upcoming regulatory discussions and key clinical milestones for PH-762, while continuing work on PH-894.

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The Company promoted Lisa Carson to Chief Financial Officer and Jennifer Phillips, Pharm.D., to Senior Vice President, Regulatory and Corporate Affairs. In addition, Kimberly Man joined Phio as Vice President of Program Development and Strategic Planning, reporting to Robert Bitterman, President and Chief Executive Officer.

"Upcoming regulatory discussions and clinical milestones demand a team built for follow-through," said Robert Bitterman. "These appointments strengthen finance and regulatory leadership to support PH-762 as it moves into its next stage, while we continue work on PH-894. Our focus is delivering the next set of milestones with discipline and consistency."

In her role as Chief Financial Officer, Ms. Carson will oversee financial operations, capital planning and financial reporting to support Phio’s clinical programs. She joined Phio in May 2025 and brings more than 20 years of finance and accounting leadership experience. Prior to Phio, she served as Vice President, Finance and Controller at Prelude Therapeutics, where she supported the company’s IPO and subsequent expansion, and previously held finance leadership roles at TELA Bio and PhaseBio Pharmaceuticals.

In her expanded role, Dr. Phillips will lead regulatory strategy and agency engagement as Phio prepares for upcoming regulatory interactions and clinical milestones. She joined Phio in February 2023 and has more than 25 years of regulatory affairs experience, including senior roles spanning major pharmaceutical organizations such as Aventis and Wyeth and regulatory leadership at Cutanea Life Sciences.

Ms. Man will lead day-to-day program coordination for PH-762 and support longer-term program work on PH-894. She has over 20 years of experience in program and portfolio leadership, product development, and clinical and regulatory operations, including roles at Sandoz and Cutanea Life Sciences.

These appointments support near-term regulatory priorities while strengthening the foundation for the next phase of clinical development.

(Press release, Phio Pharmaceuticals, FEB 19, 2026, View Source [SID1234662799])

On February 19, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported a $100 million royalty funding agreement with funds managed by RTW Investments, LP (RTW), subject to FDA approval of aglatimagene in intermediate- to high-risk, localized prostate cancer.

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"This non-dilutive strategic financing will support the U.S. launch of aglatimagene besadenovec, assuming FDA approval, and will allow us to further invest in what we believe will be a world class commercial program" said Paul Peter Tak, M.D., Ph.D., FMedSci, President and CEO of Candel. "We remain on track to submit the BLA for aglatimagene in Q4 of this year, and we look forward to collaborating with the FDA to pursue an expeditious approval of aglatimagene. We are thrilled with our RTW partnership, as we seek to provide a new treatment option for patients in the early stages of prostate cancer who are treated with curative intent, a disease that has seen minimal innovation over the past two decades."

"The pivotal phase 3 clinical trial demonstrated the potential of aglatimagene besadenovec in early, localized prostate cancer, and today’s commitment reflects our confidence in Candel and the strong commercial potential of this therapy," said Roderick Wong, M.D., Managing Partner and Chief Investment Officer, RTW Investments, LP. "We are proud to partner with the Candel management team and look forward to supporting their efforts to bring this meaningful treatment to patients with localized prostate cancer."

The commercial launch royalty financing will become available upon FDA’s approval of aglatimagene, and satisfaction of certain other customary conditions. Under the terms of the agreement, RTW will receive a tiered single digit percentage of annual net sales of aglatimagene in the U.S., subject to a cap.

(Press release, Candel Therapeutics, FEB 19, 2026, View Source [SID1234662782])