On March 17, 2026 Voro Therapeutics, a biotechnology company pioneering tumor-activated biologics using its proprietary PrimeBody platform, reported a research collaboration with Daiichi Sankyo (TSE: 4568) through its Daiichi Sankyo Research Institute San Diego.

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The collaboration will evaluate Voro’s PrimeBody platform to generate masked antibody drug conjugate (ADC) candidates designed to improve therapeutic index through tumor-selective activation by incorporating proprietary masking domains and protease-cleavable linkers to keep biologics inactive in circulation and healthy tissues, with activation occurring selectively within the tumor microenvironment.

"Unlocking the full potential of highly potent payloads requires a new level of control over where and when activation occurs," said Ugur Eskiocak, Ph.D., Co-Founder and CEO of Voro Therapeutics. "PrimeBody is designed to potentially provide that level of control through tumor-selective activation and expand the target universe to include antigens historically considered too broadly expressed. We believe this approach has the potential to fundamentally expand the therapeutic index of ADCs. We are excited to collaborate with Daiichi Sankyo, a global leader in ADC innovation with a proven track record of developing transformative medicines for patients."

Under the agreement, Voro Therapeutics will apply its PrimeBody masking and linker technologies to design and characterize masked ADC candidates directed against a selected oncology target. The collaboration will leverage Voro’s previous experience and demonstrated success in creating tumor-activated biologics, including its lead CD47 blocker program, which has shown improved therapeutic index in preclinical studies.

(Press release, Voro Therapeutics, MAR 17, 2026, https://www.businesswire.com/news/home/20260317680457/en/Voro-Therapeutics-Announces-Research-Collaboration-with-Daiichi-Sankyo-to-Advance-PrimeBody-Technology-for-Next-Generation-Tumor-Activated-ADCs [SID1234663655])

On March 17, 2026 Synthekine Inc., an engineered cytokine therapeutics company, reported that updated clinical and translational data from a Phase 1a/1b clinical trial of its α/β biased IL-2 partial agonist, STK-012, will be presented in an oral presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 taking place in San Diego, CA from April 17 – 22, 2026. In this now fully enrolled study, STK-012 is being evaluated in combination with standard-of-care pembrolizumab + chemotherapy in first-line nonsquamous (NSQ) non-small cell lung cancer (NSCLC) patients with features of immune resistance such as PD-L1 negative histology and STK11/KEAP1 mutations.

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"We are encouraged to share updated clinical and translational data from first‑line NSQ NSCLC patients treated with STK‑012, building on our prior oral presentation at SITC (Free SITC Whitepaper) 2025 and further supporting our novel and differentiated, α/β‑biased IL‑2 approach to precision immunotherapy," said Debanjan Ray, chief executive officer of Synthekine. "40% or more of newly diagnosed NSQ NSCLC patients have features of immune resistance, including PD‑L1‑negative histology or STK11/KEAP1 mutations, and typically derive limited benefit from standard‑of‑care chemoimmunotherapy. We believe STK‑012, in combination with pembrolizumab and chemotherapy, has the potential to meaningfully improve outcomes in this underserved patient population, and we look forward to presenting these updated data at AACR (Free AACR Whitepaper). Development of STK-012 is ongoing in our SYNERGY-101 study, a global, randomized Phase 2 trial which is currently enrolling patients."

Details are as follows and are available in the AACR (Free AACR Whitepaper) Online Program Planner:

Title: Selective immune activation of antigen activated T cells with STK-012, an a/b IL-2 receptor biased partial agonist, with pembrolizumab and chemotherapy in 1L PD-L1 negative non-squamous NSCLC
Session Title: Immunotherapy: Mechanisms and Responses
Session Date & Time: Tuesday, April 21, 2026, 2:30 – 4:30 PM PT
Location: Listed in the AACR (Free AACR Whitepaper) Online Program Planner
Abstract Number: 6740

A copy of the presentation will be available on Synthekine’s website following presentation at the meeting.

(Press release, Synthekine, MAR 17, 2026, View Source [SID1234663654])

On March 17, 2026 Pfizer Inc. (NYSE: PFE) reported positive topline results from the randomized Phase 2 FOURLIGHT-1 study evaluating atirmociclib in combination with fulvestrant, versus fulvestrant or everolimus plus exemestane, in people with hormone receptor (HR)-positive, human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC) who had received prior cyclin-dependent kinase (CDK) 4/6 inhibitor-based treatment. The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) as assessed by the investigator [HR: 0.60 (95% CI: (0.440, 0.825)), p=0.0007].

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The PFS results were consistent across all prespecified subgroups, including performance status, menopausal status, presence of visceral disease, duration of treatment with prior CDK4/6 inhibitor (< or > 12 months), and regardless of prior CDK4/6 inhibitor received. More than 90% of patients initiated treatment with atirmociclib within three months of their last CDK4/6 inhibitor treatment. Overall survival (OS), a secondary endpoint, was not mature at the time of the analysis, with approximately 20% of participants having an event. These are the first randomized Phase 2 data in HR+ MBC for atirmociclib, an investigational, potential first-in-class CDK4 inhibitor.

"These results are especially encouraging given that the FOURLIGHT‑1 study enrolled patients whose disease had progressed soon after prior CDK4/6 inhibitor therapy, a difficult-to-treat population," said Jeff Legos, Chief Oncology Officer, Pfizer. "The strength of these data reinforces our confidence that atirmociclib may meaningfully differentiate from the CDK4/6 inhibitor class, the standard-of-care backbone in HR-positive breast cancer, with the potential for improved efficacy and tolerability. We are continuing to accelerate development of this next-generation cell cycle inhibitor in earlier lines of therapy where it may offer even greater benefit for patients."

In FOURLIGHT-1, atirmociclib demonstrated manageable safety and was well tolerated, with 6.4 percent of patients discontinuing atirmociclib due to treatment-emergent adverse events. Its safety profile was consistent with prior studies, and no new safety signals were identified. Detailed results will be submitted for presentation at a future medical meeting.

These findings support Pfizer’s strategy to advance atirmociclib in first-line and early-stage disease, where durable endocrine-based control has the potential to have the greatest impact. A Phase 3 registrational study for atirmociclib in the first-line metastatic setting is ongoing and results from a Phase 2 neoadjuvant study in early breast cancer will be shared at a future medical meeting.

About the FOURLIGHT-1 Trial

FOURLIGHT-1 (NCT06105632) is an interventional, open-label, randomized, multicenter Phase 2 study evaluating atirmociclib plus fulvestrant compared with fulvestrant or everolimus plus exemestane, in adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC). The trial enrolled 264 patients in 14 countries whose disease progressed after cyclin-dependent kinase (CDK) 4/6 inhibitor-based treatment. The primary endpoint was progression-free survival (PFS) as determined by investigator assessment. Secondary endpoints include overall survival, objective response, duration of response and clinical benefit response.

About Atirmociclib

Atirmociclib is an investigational oral inhibitor of cyclin-dependent kinase 4 (CDK4), a key regulator of the cell cycle that triggers cellular progression. It was conceptualized and discovered at Pfizer and is being developed for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2-negative (HER2-) breast cancer.

(Press release, Pfizer, MAR 17, 2026, View Source [SID1234663653])

On March 17, 2026 Forlong Biotechnology, a clinical-stage biotech company focusing on developing transformative cytokine therapies for patients with severe unmet needs, reported that preclinical data from its IL-15 and IL-18 programs will be presented at the 2026 AACR (Free AACR Whitepaper) Annual Meeting held April 17-22, 2026 in San Diego, California.

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IL-15 Programs: FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein and has demonstrated best-in-class (BIC) profile as monotherapy in heavily pre-treated patients with late stage solid tumors, of which 3 patients (~10%) remain on treatment and progression-free currently at 9, 11 and 20 months respectively. Poster 7932 further elucidated mechanism of action underlying FL115 BIC profile, with Cryo-EM analysis of FL115/FcRn/β2M complex. In vivo, RNA-Seq and single-cell transcriptomics revealed FL115 reshaped the tumor microenvironment by enhancing NK and T cells infiltration without not triggering activation of neutrophils and macrophage. Poster 6459 showed significant potential of FL115 subcutaneous formulation. Compared to IV injection, subcutaneous injection of FL115 resulted in drastic lowering of Cmax (up to 26.7×) with bioavailability at ~60% as well as good linearity in PK file. FL115 at approximately 9 mg per injection site in rabbits showed no significant gross skin irritation.

IL-18 Programs: using structural modeling with our AI-driven Intelligent Biomolecular Discovery Platform, we developed a series of engineered IL-18 variants (IL-18v) that fully escape IL-18BP neutralization while providing tunable IL-18R1 affinity, enabling customizable cytokine potency, as described in Poster 7779. Based on one such IL-18v, we developed FL116, a PD-1/interleukin-18 (IL-18) bispecific antibody.
Poster 1777 showed FL116 achieved potent anti-tumor activities and rechallenge-confirmed immune memory while maintaining systemic immune homeostasis in multiple tumor models, and re-ignited intratumoral cytotoxic immunity while reshaping the TME toward a highly inflamed, effector-dominant state.

"Forlong’s pipeline strategy is to modulate the immune system with precision via stimulation of specific immune cell subpopulation through engineered cytokines, providing new options for patients," said Dong Wei, Ph.D., Chief Executive Officer of Forlong Biotechnology, "IL-15 and IL-18 have long been believed to be attractive cytokines for cancer immunotherapy, and we appreciate the opportunity to present initial data of FL115 and FL116 programs to leading immuno-oncology experts in this prestigious forum."

Poster Details:

Title: A tunable interleukin-18 (IL-18) platform engineered for complete escape from the decoy receptor IL-18 binding protein (IL-18BP)
Poster Number: 7779
Date & Time: 4/22/2026

Title: FL116, a PD-1/IL-18 bispecific antibody, enables cis-activation of PD-1⁺ T cells and reshapes the suppressive tumor microenvironment (TME)
Poster Number: 1777
Date & Time: 4/20/2026

Title: FL115, a novel IL-15 superagonist rationally designed to minimize safety risks for cancer immunotherapy
Poster Number: 7932
Date & Time: 4/22/2026

Title: Development of FL115, a novel IL-15 superagonist, as subcutaneous injection for cancer immunotherapy
Poster Number: 6459
Date & Time: 4/21/2026

About FL-115

FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein, aiming to enhance anti-tumor immunity via IL-15-mediated signaling on NK and CD8+ T cells while minimizing complexity from Fc. FL115 has demonstrated significant anti-tumor activities as a monotherapy or as part of combination therapy in vivo, and can be manufactured by a robust and efficient process with excellent product stability. Clinically, FL115 has demonstrated favorable safety profile and preliminary clinical responses as a monotherapy, and has the best-in-class potential to synergize with current and emerging T cell-targeting immunotherapies through combination therapy to significantly improve the treatment outcome for patients. It is currently being investigated in combination with Bacillus Calmette-Guérin (BCG) in a Phase 2 clinical trial to evaluate safety and preliminary efficacy in patients with nonmuscle invasive bladder cancer (NMIBC) and in combination with an anti-PD1 monoclonal antibody in a Phase 1b/2 clinical trial to evaluate safety and preliminary efficacy in patients with advanced solid tumors.

(Press release, Forlong Biotechnology, MAR 17, 2026, View Source [SID1234663652])

On March 17, 2026 Akamis Bio, a clinical-stage oncology company working to advance the standard of care in colorectal cancer, reported an upcoming poster presentation of initial clinical data from the FORTRESS study of NG-350A, an oncolytic immunotherapy for the treatment of mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC), at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, taking place April 17-22 in San Diego.

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The ongoing Phase 1b FORTRESS study (NCT06459869) is assessing the anti-tumor effects of NG-350A plus chemoradiotherapy (CRT) following a 12-week active treatment period to establish whether NG-350A can improve response rates relative to expected outcomes from CRT alone. The trial is enrolling adult patients with pMMR LARC and at least one risk factor for local or distant recurrence.

NG-350A is an intravenously delivered oncolytic immunotherapy designed to drive intratumoral expression of a CD40 agonist monoclonal antibody triggering the activation of antigen-presenting cells (APCs) resident in solid tumors and their draining lymph nodes. Once activated, APCs recruit T cells into the vicinity of the tumor to deliver a potent anti-tumor immune response.

Poster Presentation Details

Title: Phase 1b trial of NG-350A, a CD40 agonist antibody expressing adenoviral vector, in combination with chemoradiotherapy (CRT), in patients with mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC): Initial results from the FORTRESS study
Session Title: Phase II and Phase III Clinical Trials
Date and Time: April 20, 2:00PM – 5:00PM PST
Location: Poster Section 52
Poster Number: 19

About NG-350A
NG-350A is a clinical-stage, intravenously delivered Tumor-Specific Immuno-Gene (T-SIGn) therapeutic designed to drive intratumoral expression of a CD40 agonist monoclonal antibody triggering the activation of antigen-presenting cells (APCs) resident in solid tumors and their draining lymph nodes. Once activated, APCs recruit T cells into the vicinity of the tumor to deliver a potent anti-tumor immune response. Akamis Bio has evaluated NG-350A’s safety, tolerability, and preliminary efficacy as a monotherapy (FORTITUDE study) and in combination with pembrolizumab (FORTIFY study) in patients with metastatic or advanced epithelial tumors. Across these studies, NG-350A has demonstrated a consistent safety and tolerability profile, as well as strong evidence of tumor-selective delivery, replication and transgene expression.

About the FORTRESS Study
The Phase 1b FORTRESS study (NCT06459869) is an open-label, single-arm, and multicenter trial of NG-350A in combination with chemoradiotherapy (CRT) in adult patients with mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC) and at least one risk factor for local or distant recurrence or with oligometastatic disease. The FORTRESS study builds upon the Akamis Bio-supported, CEDAR study, which showed a significantly greater response rate in LARC patients treated with a combination of Akamis Bio’s first generation oncolytic immunotherapy and chemoradiotherapy (CRT), relative to expected outcomes using standard-of-care CRT alone. The FORTRESS study is planning to enroll approximately 30 patients aged eighteen and older with histologically confirmed adenocarcinoma of the rectum which is locally advanced (clinical stage II-III based on pelvic MRI). During the 12-week active treatment period, patients will receive NG-350A plus CRT (oral capecitabine plus long-course intensity-modulated radiotherapy). The primary endpoint for the study is the proportion of patients achieving a response (complete clinical response [cCR] or near complete clinical response [ncCR]) at week 12. Key secondary endpoints include the incidence and severity of adverse events, characterization of the anti-tumor effects of NG-350A in combination with CRT (including clinical response outcome and magnetic resonance tumor reduction grade [mrTRG]), and measurement of levels of circulating tumor DNA (ctDNA) clearance. Patients recently diagnosed with pMMR LARC interested in learning more about the FORTRESS trial can visit www.FortressStudy.org.

About Locally Advanced Rectal Cancer (LARC)
Colorectal cancer (CRC) is the second leading cause of cancer-related death in the United States (US), and it has recently emerged as the leading cause of cancer-related death in patients under 50 years of age. There are 159,000 people newly diagnosed with CRC in the US each year, with approximately 30,000 of these people diagnosed specifically with LARC. In patients with LARC, tumors have either grown through muscle and into the outermost layers of the rectum, or in more severe cases, through the wall of the rectum where they may attach to other organs and/or into the lymph nodes. Approximately 95% of LARC patients have mismatch repair-proficient (pMMR) tumors indicating that their tumor cells have a functional DNA repair system.

(Press release, Akamis Bio, MAR 17, 2026, View Source [SID1234663651])