Salubris Biotherapeutics Announces Expansion Cohort Data for JK06, 5T4-Targeted Antibody Drug Conjugate, at the American Association for Cancer Research Conference

On April 17, 2026 Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, reported expansion cohort data from the Phase 1/2 study of JK06, a 5T4-targeted antibody drug conjugate (ADC), in patients with unresectable locally advanced or metastatic cancer, including non-small cell lung cancer (NSCLC) and breast cancer, which is being presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 on April 17-22, 2026 in San Diego, California.

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"JK06 continues to demonstrate encouraging and durable efficacy among heavily pre-treated metastatic solid tumors. Partial responses have now been observed across four different cancers, including NSCLC and breast cancer, at multiple dose levels. These data are complemented by a consistently favorable safety profile, underscoring our belief that JK06 has the potential to be an important new first-in-class ADC that can address the unmet needs of patients with 5T4-expressing cancers," said Sam Murphy, Chief Executive Officer of Salubris Biotherapeutics. "These results provide a robust foundation for further exploration of JK06 in NSCLC and breast cancer and will propel our efforts to interrogate the pan-tumor opportunity. We look forward to progressing this study into the next stages of expansion cohorts, including additional monotherapy cohorts and evaluation of JK06 in multiple combination therapy regimens."

Expansion cohort data presented at AACR (Free AACR Whitepaper) include 112 patients enrolled in Europe with advanced relapsed/refractory solid tumors who were treated with JK06 once every three weeks, including two randomized dose cohorts (3.7 mg/kg, 4.5 mg/kg) in NSCLC and breast cancer and a basket cohort consisting of multiple tumor types known to express 5T4. The data cutoff was March 29, 2026.

Key efficacy findings include:

Among 38 response-evaluable NSCLC patients, 10 attained confirmed PRs (ORR 26%), including three out of seven response-evaluable squamous cell NSCLC patients (ORR 43%), and two of three response-evaluable Epidermal Growth Factor Receptor (EGFR) mutant patients.
Five out of 19 response-evaluable breast cancer patients attained PRs (ORR 26%), including four out of nine hormone receptor-positive (HR+) breast cancer patients (ORR 44%).
Among other tumor types, the first and only response-evaluable gastric cancer patient enrolled attained a partial response (PR, -55%), and one of four response-evaluable cervical cancer patients attained a partial response (PR, -49%).
Among 112 safety-evaluable patients enrolled in expansion cohorts, key safety findings include:

Treatment with JK06 at doses ≤ 5.2 mg/kg was generally well-tolerated with predominantly low grade (Grades 1 and 2) treatment-related adverse events (TRAEs) and manageable toxicities.
All JK06-related AEs of any grade are below 10% frequency overall except for asthenia (11% overall).
Only three total Grade 3 events have been observed to date among the 112 patients (fatigue, gait disturbance, keratitis), and no Grade 4 or 5 events have been observed.
Of the total 153 patients enrolled across all dose levels in dose escalation and expansion, only seven patients have dose-reduced due to a TRAE resulting from JK06.

The Phase 1/2 open-label, dose-escalation and expansion study (NCT06667960) to assess the safety, pharmacokinetics, and preliminary efficacy of JK06 is ongoing.

Details of the AACR (Free AACR Whitepaper) presentation are as follows:

Title: A Phase 1/2 Study of JK06, a 5T4-Targeted Antibody Drug Conjugate (ADC), In Patients with Unresectable Locally Advanced or Metastatic Cancer
Presenter: Omar Saavedra, M.D., Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain
Abstract #: CT250
Session: Phase II Clinical Trials
Date/Time: April 21, 2026 | 2:00 – 5:00 PM PT

About JK06

JK06 is a first-in-class quadrivalent, biparatopic ADC that selectively targets 5T4 with a monomethyl auristatin E (MMAE) payload. 5T4 is an oncofetal protein that is overexpressed in a wide range of solid tumors, including non-small cell lung cancer (NSCLC), breast, gastric and genitourinary cancers, and is associated with more aggressive tumor progression and reduced survival. JK06 has demonstrated picomolar affinity for 5T4 and enhanced internalization resulting from the biparatopic design. Together with stable, site-specific payload conjugation, JK06 has demonstrated the potential for robust efficacy and a favorable safety profile.

(Press release, Salubris Biotherapeutics, APR 17, 2026, View Source [SID1234664553])

Interim results from IPH5201 phase 2 trial (AACR 2026)

On April 17, 2026 OREGA Biotech, the biotech company committed to the discovery of novel immuno-oncology targets for cancer immunotherapy, reported that the AACR (Free AACR Whitepaper) 2026 abstract reporting interim results from the phase 2 MATISSE trial of IPH5201 plus durvalumab (durvalumab) and platinum-based chemotherapy in patients with resectable early stage non-small cell lung cancer (NSCLC) has been published.

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Summary of the abstract: Perioperative PD-(L)1 inhibitors combined with chemotherapy are now standard for resectable early-stage NSCLC, but further improvements in pathological complete response (pCR) and survival are still needed. IPH5201, an anti-CD39 antibody, aims to enhance antitumor immunity by reducing immunosuppressive adenosine and increasing ATP levels. In the Phase 2 MATISSE study, IPH5201 was added to durvalumab and chemotherapy in patients with stage II–IIIA NSCLC. Among 40 patients, the treatment showed a favorable safety profile and achieved a pCR rate of 27.5% (all), rising to 35.7% in PD-L1 ≥1% and 50% in PD-L1 ≥50% patients, comparing favorably with the 17.2%, 21.2% and 27.5% reported for durvalumab + chemo in the AEGEAN study (Heymach, 2023). Biomarker analyses confirmed CD39 target engagement and suggested a link between CD39+ tumor cell density and response. These results compare favorably to prior standards and support the continuation of the study with the recruitment of PD-L1≥1% pts.

Presentation details:

Session CTPL04 – Advances in Immunotherapy
CT231 – Dual CD39 and PD-L1 inhibition: Interim results from the phase 2 MATISSE trial of IPH5201 plus durvalumab (durva) and platinum-based chemotherapy (CT) in patients (pts) with resectable NSCLC.

Session Date/Time: April 21, 2026, 10:45 AM – 11:00 AM Hall H – Ground Level – Convention Center

Presenter: Pr. Fabrice Barlesi, CEO of Institut Gustave Roussy

About IPH5201 antibody
IPH5201 is a humanized CD39 blocking antibody codeveloped by Innate Pharma and AstraZeneca (AZ).
OREGA Biotech entered into an exclusive and worldwide License Agreement with Innate Pharma in 2016. The lead antibody (IPH5201) has been further partnered with AstraZeneca in 2018. AstraZeneca conducted a multicenter, open-label, dose-escalation Phase 1 trial in advanced solid tumors (NCT04261075) with IPH5201 alone or in combination with durvalumab (anti PD-L1 antibody).

About NCT05742607 clinical trial
MATISSE is a Phase 2 multicenter single-arm study (NCT05742607) evaluating neoadjuvant and adjuvant treatment with IPH5201 in combination with durvalumab (anti-PD-L1, AZ) and chemotherapy in treatment-naïve patients with resectable early-stage non-small cell lung cancer (NSCLC). The primary objectives of the study are to assess antitumor activity of neoadjuvant treatment based on pathological complete response (pCR) and safety. More information on the Phase 2 clinical trial is accessible online.

(Press release, OREGA BIOTECH, APR 17, 2026, View Source [SID1234664546])

Enveric Biosciences Announces Closing of Up To $13.9 Million Private Placement Priced At-The-Market Under Nasdaq Rules

On April 17, 2026 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company advancing novel neuroplastogenic small-molecule therapeutics to address psychiatric and neurological disorders, reported the closing of its previously announced private placement priced at-the-market under Nasdaq rules for the purchase and sale of 2,222,223 shares of its common stock (or pre-funded warrants in lieu thereof), Series I warrants to purchase up to an aggregate of 2,222,223 shares of common stock and short-term Series J warrants to purchase up to an aggregate of 2,222,223 shares of common stock, at a purchase price of $2.25 per share (or pre-funded warrant in lieu thereof) and accompanying warrants. The warrants have an exercise price of $2.00 per share and are exercisable immediately upon issuance. The Series I warrants will expire five years after the effective date of the Resale Registration Statement (as defined below) and the short-term Series J warrants will expire eighteen months after the effective date of the Resale Registration Statement.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering were approximately $5 million before deducting placement agent fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the Series I warrants and the short-term Series J warrants, if fully exercised on a cash basis, will be approximately $8.9 million. No assurance can be given that any of the warrants will be exercised, or that the Company will receive cash proceeds from the exercise of the warrants. The Company intends to use the net proceeds from the offering for product development, working capital and general corporate purposes.

The securities described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants sold in the offering, have not been registered under the Securities Act or applicable state securities laws. Accordingly, such securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Pursuant to a registration rights agreement, the Company has agreed to file one or more registration statements with the SEC covering the resale of the unregistered securities to be issued in the offering (the "Resale Registration Statement").

This press release does 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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

(Press release, Enveric Biosciences, APR 17, 2026, View Source [SID1234664518])

MiNK Therapeutics Reports Phase II Data on Immune Reprogramming and Durable Survival in PD-1 Refractory Gastroesophageal Cancer

On April 17, 2026 MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic invariant natural killer T (allo-iNKT) cell therapies to restore immune balance and treat immune-mediated diseases and cancer, reported data from an investigator-initiated Phase II trial at Memorial Sloan Kettering Cancer Center, evaluating agenT-797, MiNK’s allo-iNKT cell therapy, in combination with botensilimab (BOT) and balstilimab (BAL), ramucirumab and paclitaxel in patients with advanced PD-1 refractory gastroesophageal adenocarcinoma. The data are being presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 17-22, 2026, in San Diego, CA.

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This Phase II trial—the first to evaluate agenT-797 in combination with BOT and BAL in patients with gastroesophageal cancer progressing after frontline therapy, was designed to assess the impact of immune priming and sequencing, with patients receiving induction (agenT-797 alone or with BOT/BAL) followed by combination therapy, or the combination without induction, alongside longitudinal biomarker analyses; in this study (n=17), treatment achieved a 77% disease control rate (DCR) with long-term survival beyond 20 months in a subset, with emerging signals in patients who received the induction strategy had meaningful improvements in PFS (6.9 vs. 3.5 months; HR 0.19; p=0.015) and OS (9.5 vs. 5.2 months), with 43% of patients alive at 12 and 18 months—highlighting durability and survival, rather than response rate, as the most relevant measures of clinical benefit in this PD-1 refractory setting.

"This study reinforces the potential of agenT-797 as an immune orchestrator capable of re-engaging anti-tumor immunity in highly resistant cancers," said Jennifer Buell, Ph.D., President and Chief Executive Officer of MiNK Therapeutics. "These findings suggest that sequencing of treatment may be as important as the treatment itself, as we observed longer survival without disease progression in patients who received an early immune-priming step before the full regimen, together with evidence of immune activation and tumor microenvironment remodeling. The durability of survival observed in induction-treated subset, together with evidence of immune activation, is central to how we, our potential partners, and the FDA evaluate meaningful outcomes and will shape our next phase of development in this hard to treat population."

Efficacy findings from the Phase II (n=17) study included:

DCR was observed in 77% of all treated patients, and long-term survival beyond 20 months was seen in a subset of patients.
Patients treated with an induction cycle had longer progression-free survival (PFS) than those treated without induction, with median PFS of 6.9 months versus 3.5 months (HR 0.19; p=0.015), supporting the potential importance of immune priming and treatment sequencing.
Median overall survival (OS) was 9.5 months in the induction cohort versus 5.2 months without induction, with 43% of induction-treated patients alive at both 12 and 18 months, compared with 20% and 0%, respectively, in the non-induction cohort.
The study did not meet its primary endpoint of ORR; however, disease control and longer-term survival observed in a subset of patients support further study of this approach.
Correlative analyses showed that treatment with BOT, BAL, and agenT-797 was associated with significant intratumoral T cell and dendritic cell infiltration, the formation of organized tertiary lymphoid structures in on-treatment biopsies from a patient with prolonged benefit, and activation of peripheral CD4 and CD8 T cells.

The safety profile was consistent with the component agents. The most common treatment-emergent adverse events among all patients included fatigue, fever, diarrhea, anorexia, nausea and mucositis.Immune-related adverse events included dermatitis, colitis, gastritis, enteritis, hepatitis and hypothyroidism.

Additional analysis of the full biospecimen dataset is ongoing and is expected to provide further insight into immune mechanisms, optimal sequencing, and potential biomarkers that could help identify patients most likely to benefit.

Presentation Details:

Abstract Title: A phase II study of agenT-797, botensilimab (BOT) and balstilimab (BAL) in PD-1 refractory gastroesophageal cancer (GEC)
Presenter: Samuel L. Cytryn M.D.; Gastrointestinal Medical Oncologist, Memorial Sloan Kettering Cancer Center
Session Name: Phase II and Phase III Clinical Trials
Date/Time: April 20, 2026 | 2:00–5:00 PM PT; 5:00-8:00 PM EDT
Poster Section: 52
Abstract No.: CT166

(Press release, MiNK Therapeutics, APR 17, 2026, View Source [SID1234664517])

Evaxion’s AI-Immunology™ platform demonstrates 86% vaccine target precision in phase 2 personalized cancer vaccine trial

On April 17, 2026 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology platform, reported new data demonstrating that AI-Immunology identifies and selects the most therapeutically relevant vaccine targets. The data will be presented at the AACR (Free AACR Whitepaper) Annual Meeting in San Diego, California, on April 22, 2026.

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86% of the vaccine targets included in Evaxion’s personalized cancer vaccine EVX-01 trigger a tumor-specific immune response. This is a success rate much higher than what has been reported for other methods. The high number reflects a broad yet specific immune response, increasing the likelihood of strong anti-tumor effect and positive clinical outcomes.

"We are delighted with the data demonstrating again the unique capabilities of AI-Immunology in identifying and selecting relevant vaccine targets. This is a further validation of the platform as an effective tool for developing potentially transformational treatments of cancer and other diseases," says Bigitte Rønø, CSO of Evaxion.

Encouraging data
In addition to the 86% success rate, the new data set includes two-year analysis showing durable vaccine-specific immune responses following EVX-01 administration. Notably, high de novo responses (86%) were observed, meaning the vaccine gives rise to a high number of novel tumor specific T cells. This potentially increases the vaccine’s tumor killing ability.

Further, a positive correlation between vaccine target AI-prediction scores and the magnitude of the immune responses was demonstrated, underlining the predictive power of AI-Immunology.

The new data stems from the phase 2 trial investigating EVX-01 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced melanoma. Each patient enrolled in the trial received a unique vaccine designed and manufactured based on their individual biology. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

The trial has already yielded encouraging two-year clinical data, including a 75% Objective Response Rate. Its one-year extension was successfully completed earlier this month with three-year clinical data expected to be presented in the second half of 2026.

AACR presentation details
Abstract title: AI-designed personalized neoantigen vaccine, EVX-01, induces durable de novo T-cell responses in advanced melanoma patients
Poster#: 7741
Session category: Clinical research
Session title: Immune response to therapies
Location: Poster section 42
Date/Time: April 22, 2026, at 9am-12pm CST/16-19 CET
Presenter: Mads Lausen Nielsen, PhD, Project Manager at Evaxion

About EVX-01
EVX-01 is a personalized peptide-based cancer vaccine intended for first-line treatment of multiple advanced solid cancers. It is Evaxion’s lead clinical asset.

Designed with our AI-Immunology platform, EVX-01 and is tailored to target the unique tumor profile and immune characteristics of each patient. It engages the patient’s immune system to fight off cancer by mounting a targeted response against tumors.

(Press release, Evaxion, APR 17, 2026, View Source [SID1234664516])