On June 9, 2026 Treos Bio, a clinical-stage company developing off-the-shelf and personalized active cancer immunotherapies, reported three abstracts on its proprietary Promiscuous EPItopes (PEPI) Technology accepted for presentation at the European Association for Cancer Research (EACR) 2026 Congress in Budapest, June 8–11.

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The lead clinical finding is from the OBERTO-101 trial in MSS mCRC, a tumor type that has historically responded poorly to currently available immunotherapy approaches. A patient treated with PolyPEPI1018 at Mayo Clinic in 2019 remains disease-free 77.2 months later, with pathological complete response confirmed across resected tissues, including liver lesions.

MSS disease represents the vast majority of colorectal cancer patients and remains one of the largest unmet needs in cancer immunotherapy. PolyPEPI1018 is TREOS Bio’s lead off-the-shelf multi-peptide immunotherapy candidate, already tested in three phase I/II clinical trials. If clinical efficacy continues to be demonstrated, its off-the-shelf design could offer important practical and commercial advantages compared with fully individualized approaches, including simpler logistics, faster treatment availability and broader scalability.

The presentations reinforce several elements of TREOS Bio’s strategy: advancing PolyPEPI1018 in MSS mCRC, demonstrating the potential of the PEPI platform to support target selection without requiring tumor biopsy, and extending the platform into additional difficult-to-treat cancers, including EGFR-mutant non-small cell lung cancer (NSCLC).

"These presentations highlight the potential of TREOS Bio’s PEPI Technology to support target prediction, broad T-cell activation and durable clinical benefit in difficult-to-treat cancers," said Sunjeet Sawhney, Chief Executive Officer of TREOS Bio. "They also reinforce the rationale for advancing PolyPEPI1018 in combination with standard therapies, while applying the PEPI Platform to additional immune-refractory cancers where current options remain limited."

OBERTO-101: Long-Term Pathological Complete Response in MSS mCRC
Co-authored by Dr. Mojun Zhu (Mayo Clinic), Dr. Joleen Hubbard (Allina Health Cancer Institute) and the Treos Bio scientific team, the case describes subject 01-0007: a patient with initially unresectable liver metastases plus lesions in the colon, lung and diffuse lymphadenopathy. After FOLFOX/cetuximab induction, the patient entered OBERTO-101 (NCT03391232) and received three doses of PolyPEPI1018 on top of standard fluoropyrimidine-based maintenance therapy. Tumor shrinkage led to partial response at week 36 and curative R0 surgery at week 56. Surgical pathology showed no viable tumor cells across the liver, colon and all 27 resected lymph nodes, and the patient remains disease-free.

Translational analyses documented broad immune activation, including:

T-cell responses against all seven PolyPEPI1018-targeted antigens;
Increases in tumor-infiltrating lymphocytes (CD3+ and CD8+ cells) after the third dose;
PolyPEPI1018-specific T-cell clonotypes detected in blood and tumor tissue, supporting intratumoral expansion of treatment-induced immune responses targeting non-mutated shared antigens in MSS mCRC.

EGFR-mutant NSCLC: Personalized Immunotherapy Followed by Tumor Regression on Sequential EGFR-TKI Therapy
A second case describes a 59-year-old with metastatic EGFR-mutant NSCLC and brain metastases, whose disease had progressed despite radiotherapy, EGFR-TKIs, chemotherapy and chemo-immunotherapy.

Under the German "individueller Heilversuch" regulatory framework, the patient received an 11-peptide personalized immunotherapy designed without tumor biopsy, using the patient’s HLA genotype and TREOS Bio’s PEPI Panel platform.

De novo T-cell responses against 7/11 peptides (no baseline responses);
Subsequent tumor RNA-sequencing confirmed expression of 8/11 predicted antigens;
After treatment, subsequent osimertinib produced sustained regression of lung and brain lesions, ongoing >9 months, with gene-expression signatures of an activated tumor microenvironment.

PEPI Panel: Rapid Target Selection Without Tumor Biopsy
The third abstract introduces the PEPI Panel, a library of 3,286 synthetic long peptides covering 184 shared tumor antigens across 19 indications. Built using proprietary data from more than 100,000 tumors and 15,693 HLA genotypes, the Panel is designed to identify peptide targets predicted to be immunogenic for individual patients using only a saliva or blood sample:

across 11 patients with seven tumor types, the PEPI Panel predicted approximately 70% of each patient’s top tumor-expressed antigens;
in 6 patients receiving PEPI-guided immunotherapies, 83% (60/72) of selected peptides induced T-cell responses.

PEPI Panel-based treatments can be designed in days, supporting a potentially faster and less invasive approach to personalized cancer immunotherapy.

(Press release, Treos Bio, JUN 9, 2026, View Source [SID1234666519])

On June 9, 2026 Actuate Therapeutics, Inc. (NASDAQ: ACTU), a clinical-stage biopharmaceutical company focused on developing novel therapies for difficult-to-treat cancers, reported that elraglusib will be evaluated in the BEACON2 clinical trial, an international, multi-arm, multi-stage platform study designed to identify and advance promising treatment approaches for children with relapsed and refractory neuroblastoma.

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Under the BEACON2 trial design, the combination of elraglusib with dinutuximab beta plus chemotherapy will initially be assessed in a dose confirmation cohort of up to 20 patients to evaluate safety and to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and pharmacokinetics (PK) profile of the regimen. Following successful completion of the dose confirmation stage, the regimen may advance into a randomized portion of the platform trial, where approximately 75 patients will be enrolled with a planned interim analysis.

"Selection for inclusion in BEACON2 represents a defining milestone for the elraglusib program and underscores growing recognition of its novel mechanism and potential applicability in treating pediatric cancers," said Daniel Schmitt, President & Chief Executive Officer of Actuate. "Neuroblastoma remains one of the most devastating diseases for many children whose cancer relapses or becomes resistant to treatment, and we are honored to be part of a collaborative effort dedicated to improving outcomes of these patients. BEACON2 is sponsored by the Cancer Research UK Clinical Trials Unit, University of Birmingham, enabling us to generate meaningful clinical data in a capital-efficient manner. We are particularly encouraged by the convergence of compelling preclinical evidence, early clinical evidence in pediatric cancer, including a complete response achieved in a neuroblastoma patient, and regulatory recognition through FDA Rare Pediatric Disease Designation. Together, these factors provide a strong foundation for further exploring the potential of elraglusib in this area of significant unmet medical need."

Scientific Rationale

The scientific rationale for evaluating elraglusib in neuroblastoma is firmly supported by a growing body of preclinical and clinical evidence. GSK-3β inhibition, elraglusib’s primary mechanism, has been shown to suppress neuroblastoma cell proliferation, promote apoptosis, and disrupt pathways involved in MYCN-driven disease biology, a key driver of high-risk neuroblastoma. Preclinical studies demonstrated that elraglusib enhanced the activity of both chemotherapy and anti-GD2-based immunotherapy, producing significant improvements in tumor control and survival across multiple neuroblastoma models. Notably, 60% of Th-MYCN mice treated with elraglusib plus temozolomide/irinotecan (TEMIRI)/14G2a, remained tumor-free at one year of age compared to 0% in the TEMIRI/14G2a only arm (P<0.0001). These effects were associated with increased infiltration of CD4+ and CD8+ T cells and NK cells within the tumor microenvironment, suggesting a meaningful immunomodulatory component.

Clinical findings further support the development in neuroblastoma. In the Phase 1/2 (NCT04239092) study of elraglusib in combination with cyclophosphamide plus topotecan chemotherapy, patients with advanced relapsed or refractory disease achieved clinical responses or disease control. Importantly, a heavily pretreated neuroblastoma patient with a high-risk molecular profile achieved a complete bone marrow response within 9 cycles.

About BEACON2

BEACON2 (EudraCT 2024-516115-24) is an international, open-label, multi-arm, multi-stage randomized Phase 1/2 trial evaluating multiple treatment regimens aimed at identifying treatment approaches that will lead to improved outcomes. BEACON2 is being conducted by the Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, one of the most respected academic clinical trials organizations in the world and one of only eight units directly funded by Cancer Research UK, the UK’s largest cancer research charity. The trial is currently active across 14 UK sites and has received European regulatory approval via CTIS, with an international network spanning up to 60 sites across 16 countries, including the European Union, UK, Switzerland, Israel, Australia, and New Zealand.

BEACON2 builds on the original BEACON trial, which established a pan-European platform for evaluating and comparing treatment regimens in relapsed and refractory neuroblastoma. Conducted between 2012 and 2021, BEACON enrolled 225 patients across Europe, making it the largest randomized clinical trial ever conducted in this patient population. The study successfully identified two combination regimens worthy of further investigation, including irinotecan and temozolomide and dinutuximab beta administered with a chemotherapy backbone, which demonstrated one-year progression-free survival rates of 65% and 49%, respectively.

About Neuroblastoma

Neuroblastoma is a rare pediatric cancer that develops from immature nerve cells and remains associated with persistently poor outcomes following relapse. Despite advances in frontline therapy, treatment options remain limited for patients whose disease recurs or becomes resistant to treatment, highlighting the need for new therapeutic approaches.

(Press release, Actuate Therapeutics, JUN 9, 2026, View Source [SID1234666518])

On June 9, 2026 Tango Therapeutics, Inc. ("Tango") (Nasdaq: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, reported the pricing of an underwritten offering of 18,166,667 shares of its common stock and pre-funded warrants to purchase up to 1,833,395 shares of its common stock (the "Offering"). The offering price of each share of common stock is $30.00. The offering price of each pre-funded warrant is $29.999, which represents the per share offering price for the common stock less the $0.001 per share exercise price for such pre-funded warrant. The gross proceeds from the Offering, before deducting underwriting discounts and commissions and offering-related expenses, are expected to be approximately $600 million. All of the shares and pre-funded warrants in the Offering are to be sold by Tango. The Offering is expected to close on or about June 11, 2026, subject to customary closing conditions. In addition, Tango has granted the underwriters a 30-day option to purchase up to an additional 3,000,009 shares of common stock at the public offering price, less the underwriting discount.

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J.P. Morgan, Leerink Partners, Cantor and Stifel are acting as joint bookrunning managers for the Offering.

The Offering is being made pursuant to an effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement, accompanying prospectus and a free writing prospectus relating to the Offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. A final prospectus supplement and accompanying prospectus relating to the Offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement, accompanying prospectus and the free writing prospectus relating to the Offering may also be obtained, when available, by contacting: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109; by telephone at (800) 808-7525 ext. 6105; or by email at [email protected]; Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, or by e-mail at [email protected]; and Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, or by telephone at (415) 364-2720, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Tango Therapeutics, JUN 9, 2026, View Source [SID1234666517])

On June 9, 2026 Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicines for immunological diseases, reported that the first participant has been dosed in the first-in-human Phase 1 clinical trial evaluating KT-485 (SAR447971), an oral, potent and selective IRAK4 degrader, in adult healthy volunteers and hidradenitis suppurativa (HS) patients. The Phase 1 trial (NCT07629336) is being conducted by the Company’s partner Sanofi. Under the terms of the collaboration, dosing of the first participant triggered a $20 million milestone payment to Kymera from Sanofi.

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Per the collaboration, Sanofi is leading development, regulatory, and commercial efforts for the program. Kymera is eligible to receive up to $975 million of potential clinical, regulatory and commercial milestones related to KT-485.

"Advancing KT-485, our second generation IRAK4 degrader, into the clinic is an important milestone for our collaboration with Sanofi and our efforts to ultimately bring this important oral therapy to patients," said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. "There remains a significant need for novel oral options that can address key inflammatory pathways implicated in several immuno-inflammatory conditions, and we are excited to collaborate with Sanofi on this work."

The Phase 1 trial will evaluate the safety, tolerability, pharmacokinetics and additional exploratory endpoints of orally administered KT-485. The three-part study includes double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) cohorts, as well as an open-label MAD cohort.

About KT-485/SAR447971
KT-485 is a second generation, oral degrader of IRAK4, that demonstrated increased potency and specificity with a favorable safety profile in preclinical testing. IRAK4 is a scaffolding kinase and key protein of the myddosome complex that mediates signaling through IL-1 and toll-like receptors. IRAK4 acts at the interface of the innate and adaptive immune responses with a variety of functions depending on its kinase activity and scaffolding function. Eliminating IRAK4 completely through degradation impacts both the kinase and scaffolding functions, therefore having the potential to achieve a broad, well-tolerated, anti-inflammatory effect providing a novel oral therapeutic approach for a variety of immuno-inflammatory diseases. KT-485 is being developed under Kymera’s collaboration with Sanofi for IRAK4 degraders outside of oncology and immuno-oncology. Kymera has the option to participate in future development and commercialization, and 50/50 profit split, in the United States and double-digit tiered royalties in ROW.

(Press release, Kymera Therapeutics, JUN 9, 2026, View Source [SID1234666516])

On June 9, 2026 Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, reported the participation in a Virtual Investor KOL Connect segment featuring Ira S. Winer, MD, PhD, FACOG, Scientific Advisory Board Member at Ernexa Therapeutics, Professor in the Division of Gynecologic Oncology at Wayne State University School of Medicine and gynecologic oncologist at the Barbara Ann Karmanos Cancer Institute.

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During the discussion, Dr. Winer provided perspective on the significant unmet need that continues to exist in ovarian cancer, limitations associated with current treatment approaches and the growing focus on overcoming immunologically "cold" tumors that remain resistant to many immune-based therapies.

The segment also explored the broader evolution of immune and cell therapies in solid tumors and discussed how scalable, off-the-shelf engineered cell therapy approaches may potentially play an increasing role in future oncology treatment paradigms by improving manufacturing scalability, expanding accessibility and offering new hope for patients with difficult-to-treat cancers.

Additionally, Dr. Winer discussed Ernexa’s ERNA-101 program, including the potential importance of activating immune responses within the tumor microenvironment and the differentiated aspects of the Company’s engineered IL-7/IL-15 fusokine-iMSC platform. The discussion highlighted the potential advantages of ERNA-101’s dual mechanism approach, including tumor microenvironment remodeling, immune activation, off-the-shelf manufacturing scalability and the potential to support broader affordability and patient access compared to more complex personalized cell therapy approaches.

The discussion also highlights the potential advantages of Ernexa’s engineered allogeneic induced mesenchymal stem cell (iMSC) platform, including the opportunity to develop scalable, off-the-shelf cell therapies designed to improve accessibility and overcome manufacturing challenges associated with traditional autologous approaches.

"Ovarian cancer remains one of the most challenging solid tumors to treat, particularly as patients progress through later lines of therapy and face increasingly limited treatment options," said Dr. Ira Winer. "There continues to be a significant need for innovative approaches capable of addressing the immunosuppressive tumor microenvironment that characterizes many ovarian cancers. Emerging engineered cell therapy strategies designed to activate immune responses and potentially convert immunologically ‘cold’ tumors into more responsive tumors may not only create new treatment possibilities, but also potentially improve scalability and accessibility for patients in need."

The Virtual Investor KOL Connect segment featuring Ernexa Therapeutics is now available here.

(Press release, Ernexa Therapeutics, JUN 9, 2026, View Source [SID1234666515])