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Anaveon Announces Presentation of Positive ANV600 Clinical Data at ASCO 2026 and Actively Seeks Partners for its Legacy Oncology Portfolio

On May 11, 2026 Anaveon, a late-stage preclinical biotechnology company focused on reprogramming the immune system for the treatment of autoimmune and inflammatory diseases, reported that new clinical data from its legacy oncology asset ANV600 (sunekafusp alpha) will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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Following its strategic pivot to immunology, Anaveon is actively seeking global development and commercialization partners for its oncology portfolio to maximize the potential of these highly differentiated assets.

ANV600 is a first-in-class, non-blocking PD-1-targeted IL-2R-βγ agonist designed to selectively expand tumor-reactive PD-1+ CD8+ effector T cells while reducing the toxicities historically associated with IL-2 therapy. It is compatible with existing checkpoint inhibitors and is positioned for use in CPI-resistant and CPI-relapsed settings.

Key results from the EXPAND-1 Phase 1 study will be highlighted in the poster:

Manageable safety profile as monotherapy and in combination with pembrolizumab
Clear proof-of-mechanism: preferential proliferation of PD-1+ CD8+ T cells over regulatory T cells
Encouraging early clinical activity, including tumor shrinkage in a meaningful proportion of patients (including post-CPI and CPI-naïve), disease control, and durable benefit
Recommended Phase 2 dose established
ASCO Annual Meeting abstracts may be accessed online via View Source

Details of the poster presentations are as follows:

Presentation Details:

Title: EXPAND-1: A phase 1 dose escalation study of the novel PD-1 targeted IL-2R-βγ agonist Sunekafusp alpha (ANV600) as a single agent and in combination with Pembrolizumab in patients with advanced solid tumors

First Author: Markus Joerger

Abstract number: 2587

Session Title: Development Therapeutics-Immunotherapy

Poster board: 377

Location, Date and Time: Hall A, May 30, 2026, 1:30 to 3:00 pm, local time

"ANV600 has delivered compelling clinical proof-of-mechanism and a promising safety-efficacy profile in patients with advanced solid tumors," said Thaminda Ramanayake, Chief Executive Officer of Anaveon. "With strong interest from physicians at clinical sites for Phase 2 development, we believe this asset is ideally suited for a partner with the resources and expertise to bring it forward in CPI-resistant NSCLC and other immuno-oncology indications."

Anaveon’s oncology portfolio also includes ANV700, a preclinical proximity-activated PD-1-targeted IL-21 fusion protein with potential for synergistic effects when combined with IL-2-based approaches.

The company is now prioritizing its core immunology pipeline and is open to various partnering structures (license, co-development, or acquisition) for the oncology assets.

(Press release, Anaveon, MAY 11, 2026, View Source [SID1234665478])

Erasca Announces Clinical Trial Collaboration and Supply Agreement with Merck to Evaluate ERAS-0015 in Combination with KEYTRUDA® (Pembrolizumab)

On May 11, 2026 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported a clinical trial collaboration and supply agreement (CTCSA) with Merck, known as MSD outside of the United States and Canada.

This agreement supports a clinical proof-of-concept study, AURORAS-1, evaluating the pan-RAS molecular glue ERAS-0015 in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of patients with RAS-mutant (RASm) solid tumors. Erasca is sponsoring the study, and Merck is supplying pembrolizumab at no cost.

"We are excited to work with Merck to advance this promising investigational combination in RAS-driven cancers," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "RAS mutations activate the RAS/MAPK pathway and promote an immunosuppressive environment. Non-clinical data suggest that targeting the pathway with ERAS-0015 may complement PD-1 blockade by reducing immunosuppression and driving more robust and durable tumor responses."

Worldwide, approximately 2.7 million patients are diagnosed annually with RASm tumors. Lack of effective treatments targeting multiple mutations and emergence of resistance mechanisms continue to challenge the ability to achieve and maintain responses across RAS-driven tumors. Erasca is exploring whether pan-RAS inhibition with ERAS-0015 in combination with pembrolizumab can further improve therapeutic benefits and limit the development of treatment resistance.

About ERAS-0015
ERAS-0015 is an investigational, oral, highly potent pan-RAS molecular glue designed to inhibit RAS signaling with a potential best-in-class profile. Erasca is evaluating ERAS-0015 in the AURORAS-1 Phase 1 trial in patients with RAS-mutant solid tumors. Early dose escalation data in AURORAS-1 demonstrated favorable safety and tolerability results, well-behaved, linear PK, and confirmed and unconfirmed partial responses in multiple patients across multiple tumor types with different RAS mutations, including confirmed and unconfirmed partial responses at doses as low as 8 mg once daily (QD). ERAS-0015 is also designed to prevent resistance against mutant-selective inhibitors through inhibition of RAS wildtype variants. In addition, ERAS-0015 has demonstrated favorable absorption, distribution, metabolism, and excretion (ADME) and pharmacokinetic (PK) properties in multiple animal species.

(Press release, Erasca, MAY 11, 2026, View Source [SID1234665477])

Bicara Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update

On May 11, 2026 Bicara Therapeutics Inc. (Nasdaq: BCAX) reported financial results for the first quarter ended March 31, 2026 and provided a business update.

"The first quarter of 2026 reflects strong progress as we work to position ficerafusp alfa as the cornerstone of treatment in HPV-negative head and neck cancer. In addition to advancing our FORTIFI-HN01 pivotal trial, we continued to enroll patients in additional Phase 1b signal-seeking studies as we aim to unlock the full blockbuster potential of ficerafusp alfa. Based on recent FDA discussions, we plan to initiate a randomized study to evaluate a loading and every-three-week maintenance dosing regimen – further differentiating ficerafusp alfa and expanding optionality for patients and providers. We also look forward to sharing an important data update at ASCO (Free ASCO Whitepaper) 2026, which will further characterize the role of TGF-β in driving depth and durability of response across three 1L R/M HNSCC expansion cohorts," said Claire Mazumdar, Ph.D., Chief Executive Officer at Bicara Therapeutics. "Alongside our clinical progress, we are rapidly evolving toward becoming a commercial-stage company, and to support that evolution, today we announced several executive changes. David Raben has transitioned from Chief Medical Officer to a Senior Executive Advisor role after three years of instrumental contributions, and Bill Schelman, formerly Executive Vice President of Clinical Development, has stepped into the Chief Medical Officer role. We have also welcomed Chris Sarchi as our Chief Commercial Officer, who brings extensive oncology commercialization and leadership experience as we build toward launch."

First Quarter 2026 Highlights and Recent Progress

FORTIFI-HN01: Pivotal Phase 2/3 Clinical Trial of Ficerafusp Alfa in First Line (1L) Recurrent or Metastatic (R/M) HPV-Negative Head and Neck Squamous Cell Carcinoma (HNSCC)

Continued strong execution in FORTIFI-HN01, our pivotal trial in 1L HPV-negative R/M HNSCC; expect to be substantially enrolled by the end of the year to enable an interim analysis in mid-2027 to support potential accelerated approval.
Based on recent discussions with the U.S. Food and Drug Administration (FDA), the company plans to initiate a randomized clinical study that will evaluate ficerafusp alfa in combination with pembrolizumab, administered as a 12-week loading dose of 1500mg weekly (QW) followed by maintenance dosing of 2250mg every three weeks (Q3W). The company expects to initiate the study in the third quarter of 2026 to have results in time for potential U.S. accelerated approval.
Phase 1b Studies of Ficerafusp Alfa Across HNSCC and Other Solid Tumor Types

Continued to enroll multiple Phase 1b expansion cohorts to identify early proof-of-concept signals and inform ficerafusp alfa development strategy beyond 1L R/M HPV-negative HNSCC.
Published a manuscript detailing results from a Phase 1b expansion cohort evaluating 1500mg of ficerafusp alfa QW in combination with pembrolizumab in 1L R/M HNSCC in the Journal of Clinical Oncology. Read the manuscript here.
Corporate Highlights

Announced that effective May 8, 2026, Bill Schelman, M.D., Ph.D., previously the company’s Executive Vice President, Clinical Development, has succeeded David Raben, M.D., as Chief Medical Officer, and Dr. Raben has transitioned to serve as a Senior Executive Advisor. With this promotion, Dr. Schelman is responsible for medical affairs and clinical development. In his new role, Dr. Raben will advise on clinical development strategy across the company’s portfolio.
Announced that effective May 8, 2026, Chris Sarchi was appointed as Chief Commercial Officer. In this role, he will lead the commercial organization in preparation for launch readiness.
Key Anticipated Upcoming Milestones

HNSCC

Present long-term follow-up data, which will further characterizing the role of TGF-β inhibition in driving depth and durability of response, from three Phase 1b expansion cohorts of ficerafusp alfa in combination with pembrolizumab in 1L R/M HPV-negative HNSCC at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held from May 29-June 2, 2026 in Chicago, IL.
Other Solid Tumors, Including mCRC

Present data from Phase 1b expansion cohort evaluating ficerafusp alfa both as monotherapy and in combination with pembrolizumab in patients with 3L+ mCRC (RAS/BRAF wild type MSS) in the second half of 2026.
First Quarter 2026 Financial Results

Cash, Cash Equivalents and Marketable Securities: As of March 31, 2026, Bicara had cash, cash equivalents and marketable securities of $539.8 million, compared to $414.8 million in cash, cash equivalents and marketable securities as of December 31, 2025. The company received approximately $161.8 million in net proceeds from an oversubscribed public offering in the first quarter of 2026. Based on its current operating and development plans, the company expects that its existing cash, cash equivalents and marketable securities will fund operations into the first half of 2029.
Research and Development Expenses: Research and development expenses were $47.5 million for the first quarter of 2026 as compared to $34.3 million for the first quarter of 2025. The increase was primarily due to costs associated with the ongoing FORTIFI-HN01 pivotal trial, as well as the company’s ongoing Phase 1/1b dose expansion cohorts, and an increase in personnel costs.
General and Administrative Expenses: General and administrative expenses were $12.7 million for the first quarter of 2026 as compared to $7.5 million for the first quarter of 2025. The increase was primarily due to additional personnel costs and professional fees to support advancement of our clinical trials.
Net Loss: Net loss totaled $56.2 million for the first quarter of 2026 compared to $36.8 million for the first quarter of 2025.
Upcoming Investor Conferences

Bicara Therapeutics will participate in two upcoming investor conferences:

BofA Securities Health Care Conference 2026 on Wednesday, May 13, 2026 at 9:20 a.m. PT.
TD Cowen 7th Annual Oncology Innovation Summit: Insights for ASCO (Free ASCO Whitepaper) & EHA (Free EHA Whitepaper) on Wednesday, May 27, 2026 at 10:30 a.m. ET.
A live webcast of the fireside chats will be accessible through the Investor Relations section of Bicara’s website under Events and Presentations. A replay of the webcast will be archived and available for 30 days following the event.

Conference Call Information

Bicara will host a live conference call and webcast at 8:30 a.m. ET today to discuss first quarter 2026 financial results and recent business activities. Individuals may register for the conference call by clicking the link here. Once registered, participants will receive dial-in details and a unique PIN that will allow them to access the call. An audio webcast will be accessible through the Investor Relations section of Bicara’s website under Events and Presentations. An archived replay will also be available for 30 days following the event.

(Press release, Bicara Therapeutics, MAY 11, 2026, View Source [SID1234665476])

Sironax’s SARM1 Inhibitor SIR2501 Granted FDA Fast Track Designation in Chemotherapy-induced Peripheral Neuropathy (CIPN)

On May 11, 2026 Sironax, a global clinical-stage biotechnology company developing transformative therapies for neurodegenerative, inflammatory and immunologic, metabolic, and rare diseases, reported that the U.S. Food and Drug Administration (FDA) has designated its SARM1 inhibitor SIR2501 as a Fast Track product for chemotherapy-induced peripheral neuropathy (CIPN). SIR2501 is a first-in-class allosteric inhibitor of SARM1, a key driver of nerve damage in a broad range of neurological diseases.

The FDA grants Fast Track designation to facilitate the development and expedite the review of drugs to treat serious conditions, fill unmet medical needs, and bring promising therapies to patients more quickly. Drugs granted this designation are eligible for more frequent interactions with the agency regarding development plans, a rolling NDA/BLA review, and potential priority review and accelerated approval.

"Fast Track designation for SIR2501 in CIPN is a meaningful recognition of the urgent unmet medical need and the potential of our entire SARM1 program," said Dr. Shefali Agarwal, Sironax President and CEO. "The FDA’s designation not only validates our approach in CIPN, but also the broader potential of SARM1 inhibition to address additional neurological diseases. We are inspired to advance this potential therapy for millions of patients around the world."

CIPN is a common nerve-damaging side effect of chemotherapy that affects the hands and feet. Symptoms include burning or shooting pain, loss of temperature and tactile sensation, muscle weakness, and impaired fine motor skills. A significant number of cancer patients receive high-risk chemotherapy (e.g., taxanes, platinum, vinca alkaloids), develop CIPN, and subsequently discontinue or reduce chemo regimen due to the disease.

"For too long, millions of cancer patients have found themselves in the difficult position of experiencing painful symptoms while receiving their cancer treatment," said Dr. Robert Coleman, Gynecologic Oncologist, Texas Oncology, and Chief Medical Officer of Vaniam Group; and one of the country’s preeminent gynecologic oncologists. "Unfortunately, the severity of these symptoms has led many patients to either curtail or completely stop their treatment regimens. I’m pleased that a potential treatment for CIPN is advancing that could at last address this condition."

About SIR2501
SIR2501 is a first-in-class allosteric inhibitor of SARM1, a key driver of nerve damage in diseases such as CIPN and amyotrophic lateral sclerosis (ALS). By binding SARM1 away from its active site and maintaining the enzyme in an inactive state, SIR2501 is designed to protect nerves and prevent degeneration, while avoiding potential adverse effects observed with orthosteric inhibitors. SIR2501 has demonstrated strong neuroprotective effects in multiple preclinical models, and global Phase 1b/2 clinical trials evaluating SIR2501 in patients with CIPN and ALS are ongoing.

(Press release, Sironax, MAY 11, 2026, View Source [SID1234665475])

Jabez Biosciences Presents First-in-Human Pharmacokinetic and Pharmacodynamic Data for JBZ-001 at AACR Annual Meeting 2026

On May 11, 2026 Jabez Biosciences, Inc., a clinical-stage biopharmaceutical company developing novel therapies targeting cancer metabolism, reported the presentation of first-in-human pharmacokinetic (PK) and pharmacodynamic (PD) data from the ongoing Phase 1 clinical trial of JBZ-001 (HOSU-53) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026. The poster, titled "Clinical Pharmacokinetic and Pharmacodynamic of JBZ-001 (HOSU-53): Comparison of First-in-Human Data with Translational Preclinical Predictions," was presented by investigators from The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) and the START Center for Cancer Research.

Phase 1 Clinical Data Highlights

Investigators reported PK and PD data from the first four dose levels (5 mg, 10 mg, 17.5 mg, and 25 mg) of the Phase 1 dose-escalation study (NCT06801002), with data as of March 2026. Key findings include:

No Dose-Limiting Toxicities: A total of 15 patients have been enrolled across the first four dose levels — 3 patients at 5 mg and 4 patients each at 10 mg, 17.5 mg, and 25 mg — with no dose-limiting toxicities reported as of March 2026. The best response observed to date is stable disease.

Dose-Proportional Pharmacokinetics: JBZ-001 demonstrated approximately dose-proportional increases in exposure following both single and multiple doses, with low to moderate interindividual variability across all dose levels evaluated. This linear PK behavior supports predictable exposure-response relationships as dose escalation continues.

Concordance with Preclinical Predictions: Observed human PK was broadly consistent with preclinical allometric predictions generated using a physiologically based pharmacokinetic (PBPK) model developed prior to trial initiation, with slightly higher Cmax, AUC, and half-life observed clinically compared to predictions. This concordance validates the model-informed drug development (MIDD) framework applied to JBZ-001 and supports its use in guiding ongoing dose escalation decisions.

Pharmacodynamic Biomarker Confirmation: Plasma dihydroorotate (DHO) — the direct substrate of DHODH — accumulated in blood with increasing JBZ-001 dose, confirming on-target DHODH inhibition in humans. DHO levels remained within the safety exposure threshold of <1,000 µM·h established across three preclinical species, and the concordance between predicted and observed DHO suppression provides confidence in the exposure-response assumptions guiding dose selection.

Enrollment Advancing to Dose Level 5: The trial is currently enrolling patients at Dose Level 5 (32.5 mg daily). Updated PK/PD data combined with model-informed simulations will continue to support optimal biological dose (OBD) selection and data-driven decision-making as the Phase 1 study progresses.

"The data presented at AACR (Free AACR Whitepaper) represent a significant milestone for JBZ-001 and validate the rigorous preclinical work conducted at Ohio State. Seeing the PBPK model predictions confirmed in humans — with no dose-limiting toxicities across four cohorts — gives us strong confidence as we advance to higher dose levels. We are committed to moving quickly and responsibly toward identifying the optimal biological dose that will define our path to Phase 2."

— Tamara Jovonovich, PhD, Chief Executive Officer, Jabez Biosciences, Inc.

Poster Presentation Details

Title Clinical Pharmacokinetic and Pharmacodynamic of JBZ-001 (HOSU-53): Comparison of First-in-Human Data with Translational Preclinical Predictions
Conference AACR Annual Meeting 2026
Presenting authors Min Hai, Nicole Abbott, James O. Larkin, Zhiliang Xie, Chris Coss, Tamara Jovonovich, Zuzana Jirakova Trnkova, Philippa Graham, William B. McKean, Asrar A. Alahmadi, Mitch Phelps
Institutions The Ohio State University College of Pharmacy; Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute; Jabez Biosciences Inc.; Bexon Clinical Consulting, LLC; START Center for Cancer Research–Mountain Region
Trial registration NCT06801002

About JBZ-001

JBZ-001 (HOSU-53) is an orally bioavailable, potent, and selective inhibitor of dihydroorotate dehydrogenase (DHODH), the rate-limiting enzyme in the de novo pyrimidine biosynthesis pathway. By blocking DHODH, JBZ-001 depletes pyrimidine nucleotides essential for the rapid division of cancer cells. The compound has demonstrated broad preclinical antitumor activity across lymphoma, leukemia, and solid tumor models, with a favorable safety profile.

JBZ-001 received IND approval from the FDA in 2024 and entered first-in-human clinical development in March 2025. The Phase 1 trial (NCT06801002) is currently enrolling patients with advanced solid tumors and Non-Hodgkin Lymphoma (NHL) at OSU-CCC and the START Center for Cancer Research–Mountain Region in Utah. The trial is funded by Jabez Biosciences, Inc.

(Press release, Jabez Biosciences, MAY 11, 2026, View Source [SID1234665474])