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PharmaMar’s Zepzelca® (lurbinectedin) and atezolizumab (Tecentriq®) has obtained another three approvals as first-line maintenance therapy for small cell lung cancer

On April 20, 2026 PharmaMar (MSE:PHM) reported that the Australian Therapeutic Goods Administration (TGA) and the Health Sciences Authority (HSA) in Singapore have granted approval for Zepzelca (lurbinectedin) in combination with atezolizumab (Tecentriq) as a first line maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC), whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.

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The approvals are based on the results from the Phase 3 IMforte[i]trial.

PharmaMar’s partner in Australia and Singapore, Specialised Therapeutics Asia Pte, Ltd (STA), will market and commercialize the product.

These approvals were obtained under the Orbis Project, an initiative of the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence, designed to provide a framework for concurrent submission and review of oncology products among international partners. As of today, this treatment is approved in a total of 13 countries: the US, Switzerland, the United Arab Emirates, Oman, Uruguay, Peru, Paraguay, Ecuador, Israel, Taiwan, Australia, Singapore and Dominican Republic.

PharmaMar also received a recommendation for approval from the European Medicines Agency in March. The European Commission will now decide on the marketing authorization in accordance with the established procedure.

(Press release, PharmaMar, APR 20, 2026, View Source [SID1234664549])

Pasithea Therapeutics Announces Grant of Rare Pediatric Disease Designation (RPDD) by FDA to PAS-004 for Treatment of Neurofibromatosis Type 1 (NF1)

On April 20, 2026 Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, reported that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to PAS-004 for treatment of Neurofibromatosis type-1 (NF1).

The FDA grants RPDD for serious or life-threatening diseases in which the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years and affect fewer than 200,000 people in the U.S. There are approximately 115,000 individuals in the U.S living with NF1.

Under the FDA’s Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives an approval of a new drug application (NDA) or biologics license application (BLA) for a rare pediatric disease may be eligible for a Priority Review Voucher ("PRV") which can be redeemed to obtain priority review for a subsequent marketing application for a different product. The PRV may be sold or transferred to another sponsor. In the last 12 months, disclosed PRV sales have ranged from $150–$205 million.

"We are pleased to have received rare pediatric disease designation from the U.S. FDA for our PAS-004 program for patients with NF1," said Dr. Tiago Reis Marques, chief executive officer of Pasithea. "This designation for PAS-004 reinforces the potential of PAS-004 to address this serious condition."

PAS-004 has so far been granted the following FDA regulatory designations: Orphan Drug Designation, Fast Track Designation and Rare Pediatric Disease Designation.

The Company is currently conducting a Phase 1/1b multicenter, open-label, dose escalation trial of PAS-004 in adult participants with symptomatic, inoperable, incompletely resected, or recurrent NF1-PN (NCT06961565).

About NF1- PN
Plexiform neurofibromas (PN) are tumors originating from the nerve sheath that grow through and around nerves and may involve multiple nerve branches. Thirty to fifty percent (30-50%) of patients with NF1 will harbor PNs, which can undergo malignant transformation. PN-related morbidities are primarily caused by the direct impact of the tumor on surrounding structures and can be life-threatening when they compress vital organs or when they become malignant.

(Press release, Pasithea Therapeutics, APR 20, 2026, View Source [SID1234664548])

OXC-101 as a novel therapy in canine blood cancer will be presented at AACR

On April 20, 2026 Oxcia in a collaboration with SLU and Karolinska Institutet, reported that mitotic MTH1 inhibitor OXC-101 is investigated in a pilot clinical study in canine lymphoma and hemangiosarcoma. The early clinical results are presented by Dr. Kumar Sanjiv at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting 19-22 April, 2026. The title of the presentation is: "OXC-2101 (karonudib) in canine lymphoma and hemangiosarcoma: Safety, early efficacy and translational potential" (Poster Number 7913) and will be presented Wed 22 April 2026.

(Press release, Oxcia, APR 20, 2026, View Source;utm_medium=rss&utm_campaign=oxc-101-as-a-novel-therapy-in-canine-blood-cancer-will-be-presented-at-aacr [SID1234664547])

Nykode Therapeutics Presents Additional Immunogenicity Data from VB-C-03 Trial at the 2026 American Association for Cancer Research (AACR) Annual Meeting

On April 20, 2026 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported the poster presentation of additional immunogenicity data from the VB-C-03 clinical trial at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

The data build on results initially presented at the 10th International Congress on Innovative Approaches in Head & Neck Oncology (ICHNO) in March 2026, which demonstrated a confirmed objective response rate of 38.5% and strong immunogenicity signals. The current results support an even more robust immunogenicity, with now 11 evaluable patients, where all 10 patients (100%) in the 6 and 9 mg dose groups showed HPV16-specific vaccine-induced immune responses. The responses were both rapid and durable, with a demonstrated persistence into the last analyzed timepoint at the completed end-of-treatment.

"The consistency and strength of the T-cell responses we are observing across patients underscore that abi-suva has the makings of a best-in-class vaccine for HPV16-positive cancers. For patients with recurrent or metastatic head and neck cancer, where current treatments offer a response rate of only around 19%, a therapy that can generate this quality of immune response alongside meaningful clinical activity could represent a real step forward. We enter the Abili-T trial with a well-defined dose, a strong immune response profile, and a competitive data package that sets abi-suva apart from other approaches in this indication and we are deeply motivated by the opportunity to make a difference for these patients," said Agnete Fredriksen, CSO and Co-founder of Nykode Therapeutics.

The poster will be available after the session at the Company’s Webpage: View Source

(Press release, Nykode Therapeutics, APR 20, 2026, View Source [SID1234664545])

Nanobiotix Announces New Preclinical Data Supporting Improved Systemic Bioavailability and Reduced Toxicity for LNP-Delivered DNA Immunotherapy After Pre-Treatment With Nanoprimer Technology

On April 20, 2026 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the "Company"), a late-clinical stage biotechnology company pioneering nanotherapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, reported the presentation of new preclinical data evaluating its Nanoprimer platform in sequence with lipid nanoparticle-delivered recombinant DNA ("LNP-DNA") at the 2026 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

POSTER #6389: Maximizing systemic LNP-DNA delivery for cancer-activated expression of Immunotherapy agents using Nanoprimer technology

Background

A key limitation common to LNP-DNA is rapid hepatic clearance via the mononuclear phagocyte system ("MPS"), which can reduce systemic bioavailability and tumor accumulation, as well as increase hepatic toxicity. In addition, LNP-DNA may trigger transient acute inflammation through activation of the cGAS/STING pathway.

In this evaluation, LNP-DNA vehicles designed for anti-tumor immunotherapy were administered with or without Nanobiotix Nanoprimer pre-treatment in a mouse model. Nanoprimer is designed to transiently occupy hepatic clearance pathways such as MPS to increase bioavailability and target accumulation, while reducing hepatic toxicity. Both agents were administered intravenously (IV).

Key Observations

Reduced hepatic exposure and toxicity:
Decreased liver uptake of LNP-DNA and improved hepatic tolerability
Improved systemic bioavailability:
Increase in circulating levels of LNP-DNA
Mitigation of inflammatory response:
Attenuated activation of cGAS-STING pathway downstream targets
Potentially broad applicability across LNP designs:
Notably, these LNP-DNA formulations were specifically engineered for extrahepatic delivery, supporting the potential of the Nanoprimer to further optimize advanced delivery systems

Conclusions

These data support further evaluation of Nanoprimer in sequence with innovative LNP-delivered therapies
Advanced LNP systems designed for extrahepatic delivery could potentially be further optimized to improve systemic bioavailability and reduce toxicity through sequencing with the Nanoprimer

"We continue our dual path approach to the development of our next-wave Nanoprimer platform in which we are both pursuing external collaborations with partners developing innovative therapeutic candidates that are challenged by liver accumulation, as well as our own proprietary internal pipeline," said Laurent Levy Nanobiotix Chief Executive Officer and Chairman of the Executive Board. "We are encouraged by these preclinical results, generated in collaboration with Earli, which further support our hypothesis that the Nanoprimer may improve therapeutic efficacy while mitigating toxicity when sequenced prior to the administration of advanced therapeutics such as LNP-DNA and an additional layer of proof of concept."

About NANOPRIMER

The Nanoprimer is an early-stage nanotherapeutic platform designed to disrupt the design and development of innovative therapeutics and improve outcomes for patients. The Nanoprimer potentially increases drug bioavailability or decreases unintended off-target effects in the liver, specifically hepatic toxicity. The platform is designed for use in combination with advanced therapeutics across multiple drug classes. The Nanoprimer is being developed through external collaborations and an internal proprietary pipeline.

Nanoprimer is an early-stage nanotherapeutic platform designed to unleash the potential of advanced therapeutics by addressing one of the most common structural limitations in modern medicine: liver uptake and extrahepatic delivery. As therapies become more complex—such as RNA, gene therapies, and advanced biologics—they are increasingly captured by the liver, limiting their ability to reach target tissues and reducing their effectiveness.

Nanoprimer transiently modulates this natural clearance, allowing more drug to circulate longer, reach its intended target, and reduce off-target liver exposure.This approach can both enhance the performance of existing therapies and unlock new therapeutic pathways that were previously not achievable.

Developed as a therapeutic companion platform, Nanobiotix is advancing this technology through strategic external collaborations alongside a proprietary internal pipeline of Nanoprimer-enabled assets.

(Press release, Nanobiotix, APR 20, 2026, View Source [SID1234664544])