On April 18, 2026 Moderna, Inc. (NASDAQ:MRNA) reported that the Company will present data from a Phase 1/2 study of mRNA-4359, an investigational cancer antigen therapy, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in San Diego, CA, on April 17-22, 2026. The presentation reports safety, efficacy and translational data from a Phase 2 dose-expansion cohort of the Phase 1/2 study (NCT05533697), which evaluated mRNA-4359 + pembrolizumab as a first-line therapy in patients with locally advanced or metastatic melanoma.

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Among 12 participants, mRNA-4359 + pembrolizumab resulted in an overall response rate (ORR) of 83% (95% CI: 52%-98%), with two patients achieving a complete response and eight achieving a partial response, as well as a disease control rate (DCR) of 92% (95% CI: 62%-100%). The median time to response was six weeks (range, 5.6-24.0). Responses occurred across baseline tumor PD-L1 expression categories, with an ORR of 88% (95%CI: 47%-100%) among patients with PD-L1+ (TPS≥1%) tumors, and 67% (95%CI: 9%-99%) among patients with PD-L1- (TPS<1%) tumors. Consistent with mRNA-4359’s mechanistic rationale, antigen-specific T-cell responses and novel expanded T-cell receptor (TCR) clonality was observed in all patients (n=7) with evaluable samples. mRNA-4359 + pembrolizumab demonstrated a manageable safety profile, with no new immune-related adverse events (AEs).

"This study evaluating mRNA-4359 + pembrolizumab as a first-line treatment option reflects our ambition to demonstrate the potential of mRNA technology throughout a cancer patient’s journey. While conducted among a small patient population, we are encouraged by the high response rates and mechanistic translational results," said David Berman, M.D., Ph.D., Chief Development Officer of Moderna. "We look forward to further evaluating the potential of mRNA-4359 in patients with melanoma."

"This early data supports the potential activity of the mRNA-4359 + pembrolizumab combination, with promising anti-tumor activity," Dr. Pavlina Spiliopoulou, School of Cancer Sciences, University of Glasgow, the abstract’s lead author and presenter. "The consistent activation of antigen-specific T-cell responses provides important early evidence that mRNA technology could be used to help direct the immune system against melanoma in a multi-targeted manner."

This presentation builds on promising early data presented at the 2025 European Society for Medical Oncology Congress, in which mRNA-4359 + pembrolizumab achieved an ORR of 24% and DCR of 60% among 29 evaluable patients with checkpoint inhibitor-resistant/refractory (CPI-R/R) melanoma. Among those with response-evaluable disease and PD-L1+ (TPS≥1%) tumors, the ORR was 67%.

The U.S. FDA has granted Fast Track designation for mRNA-4359 in combination with pembrolizumab for the treatment of CPI refractory unresectable or metastatic melanoma with PD-L1+ (TPS>1%). Fast Track is designed to facilitate the development and expedite the review of therapies and vaccines for serious conditions and that fill an unmet medical need. Programs with Fast Track designation may benefit from early and frequent communication with the FDA, in addition to a rolling submission of the marketing application.

The details of the presentation are as follows:

Abstract Presentation #CT106: First-Line mRNA-4359 Plus Pembrolizumab (Pembro) in Locally Advanced or Metastatic Melanoma: Results from the Phase 1/2 mRNA-4359-P101 Study

Session Title: Clinical Trials Plenary 3: Cellular Therapies and Complex Immunotherapies

Session Date/Time: Monday, April 20, 10:15AM – 12:15PM PT

Presenter: Dr. Pavlina Spiliopoulou, School of Cancer Sciences, University of Glasgow, UK

About mRNA-4359

mRNA-4359 is an investigational, immune-evasion targeted cancer antigen therapy that encodes broad epitopes of PD-L1 and IDO1. With its dual mechanism of action, it is designed to elicit antigen-specific T-cell responses to simultaneously: (1) kill tumor cells expressing PD-L1 and IDO1, and (2) deplete immunosuppressive cells that shield the tumor from attack. This is hypothesized to rebalance the tumor microenvironment into an immune-permissive state, supporting sustained and durable anti-tumor activity with a manageable safety profile.

(Press release, Moderna Therapeutics, APR 18, 2026, https://feeds.issuerdirect.com/news-release.html?newsid=8054079664924385&symbol=MRNA [SID1234664479])

On April 17, 2026 Orum Therapeutics ("Orum" or the "Company") (KRX: 475830), a biotechnology company pioneering the field of degrader-antibody conjugates (DACs), reported the presentation of new preclinical data for ORM-1153, a CD123-targeting DAC designed to selectively deliver a proprietary GSPT1-degrading payload, in development for the treatment of AML and other CD123-positive hematological malignancies. The data were presented in two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026.

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"These data show strong preclinical activity and the potential for a differentiated safety and tolerability profile, supporting the advancement of ORM-1153 as a next-generation CD123-targeting degrader-antibody conjugate for acute myeloid leukemia," said Chad May, Ph.D., Chief Scientific Officer of Orum. "Our approach combines a proprietary CD123-antibody and novel GSPT1-targeted protein degrader with the goal of achieving greater selectivity than conventional cytotoxic antibody-drug conjugates. We believe this strategy can enable more effective and better-tolerated therapies for patients with AML."

The first poster (Abstract Number: 1824) highlights how ORM-1153 was engineered with a proprietary CD123-antibody designed for enhanced internalization and reduced Fc-gamma receptor interactions, together with a linker optimized for plasma stability, an approach intended to improve delivery, reduce off-target and immune cell engagement, and support favorable pharmacologic properties. Consistent with that design, ORM-1153 showed strong preclinical anti-leukemia activity at low doses, along with prolonged accumulation in tumors, undetectable systemic free payload, and favorable repeat-dose non-human primate findings supporting a manageable safety and tolerability profile.

Data from the second poster (Abstract Number: 1710) extend Orum’s previously presented findings by showing activity across primary AML patient samples and in models with relevant tumor mutations, including TP53. Taken together, the findings support the potential for broad activity in AML, including in patients with TP53 mutations.

"These AACR (Free AACR Whitepaper) data are particularly encouraging in the context of AML, where many patients, especially those with TP53 mutations, continue to have limited treatment options and poor outcomes," said Olaf Christensen, M.D., Chief Medical Officer of Orum. "The activity we are seeing across primary patient samples and TP53-relevant models, together with a consistent pharmacologic and tolerability profile, supports the continued advancement of ORM-1153 toward clinical development."

Both posters are available on Orum’s website and will be presented at AACR (Free AACR Whitepaper) on Monday, April 20, from 9 am to 12 pm PDT.

About ORM-1153

ORM-1153 is a CD123-targeting degrader-antibody conjugate developed using Orum’s Dual-Precision TPD² approach. The molecule is built from two proprietary elements, a GSPT1-degrading payload and an anti-CD123 antibody engineered for high internalization efficiency, conjugated with a cleavable β-glucuronide linker. By combining tumor-selective antibody delivery with targeted protein degradation, ORM-1153 is designed to induce cancer cell death through degradation of GSPT1, a protein implicated in cell survival, including in TP53-mutant AML, while minimizing effects on normal tissues.

About Orum’s TPD² Approach

Orum’s unique Dual-Precision Targeted Protein Degradation (TPD²) approach builds novel targeted protein degraders combined with the precise cell delivery mechanisms of antibodies to generate innovative, first-in-class, cell-selective TPDs for the treatment of cancer and other serious diseases. Orum has developed new targeted protein degrader payloads to specifically degrade an intracellular target protein within cancer cells via the E3 ubiquitin ligase pathway. Conjugated to antibodies, the payloads are designed to be delivered specifically to target cells and precisely degrade the intracellular target protein of interest.

(Press release, Orum Therapeutics, APR 17, 2026, View Source [SID1234664797])

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])

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])

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])