On April 23, 2026 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that Shanghai Henlius Biotech, Inc. has presented preclinical data for HLX49, a HER2 biparatopic antibody–drug conjugate (ADC), at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, held in San Diego, USA, from 17-22 April 2026.

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HLX49 is a HER2 biparatopic antibody–drug conjugate (ADC) that incorporates HER2 binding domains from HLX22, a HER2-specific monoclonal antibody. HLX22 is developed in several oncology indications by Henlius under a license from AbClon, Inc., following a discovery collaboration which grants Alligator the right to participate in potential future revenues from both HLX22 and HLX49, and future derivatives. According to Henlius’ official communication, HLX49 is being developed based on Henlius’ proprietary ADC platform. Preclinical HLX49 data was presented in poster format as part of Henlius’ broader early‑stage innovation portfolio at AACR (Free AACR Whitepaper) 2026.

"We view Henlius’ continued expansion of HER2‑directed research, including the presentation of HLX49 at AACR (Free AACR Whitepaper), as a sign of their sustained faith in the underlying biology of HLX22," said Søren Bregenholt, CEO of Alligator Bioscience. "It is encouraging to see Henlius advancing a broad and coherent HER2 strategy while progressing HLX22 in late-stage clinical development."
Under the terms of Alligator’s agreement with AbClon, Alligator is entitled to 35% of AbClon’s revenue from its sublicense to Henlius, including potential milestone payments and royalty revenues. This entitlement applies to HLX22 as well as to products developed by Henlius that are based on, derived from, or incorporate HLX22‑related antibody binding characteristics, which, if such products are successfully developed and approved, could represent a meaningful long‑term revenue opportunity for Alligator.

(Press release, Alligator Bioscience, APR 23, 2026, View Source [SID1234664717])

On April 23, 2026 Orion Corporation (Orion Pharma) reported the initiation of a Phase 1b/2 basket trial evaluating ODM-212, a potential best-in-class, oral pan-TEAD inhibitor, in combination with standard of care treatments in advanced mesothelioma, KRAS G12C mutated non-small cell lung cancer (NSCLC) and pancreatic cancer. The TEADCO trial is a multi-centre, open-label basket trial designed to evaluate the efficacy, safety, dose and tolerability of ODM-212 in combination with standard of care in these indications.

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The first cohort of the TEADCO trial evaluates ODM-212 in combination with ipilimumab and nivolumab as a first-line treatment for patients with advanced malignant pleural mesothelioma. ODM-212 has the potential to both exert direct anti-tumour activity and prevent emergence of treatment resistance to standard of care therapies in this indication.

The second cohort evaluates ODM-212 in combination with sotorasib, a targeted KRAS inhibitor, for the treatment of NSCLC in patients with KRAS G12C mutation. This arm has two sub-cohorts: patients who have been previously treated with KRAS G12C inhibitor and patients who have not received KRAS G12C inhibitor as a prior treatment. ODM-212 has the potential to prevent or overcome treatment resistance to approved KRAS inhibitors in this setting.

The third cohort evaluates ODM-212 in combination with chemotherapy (nab-paclitaxel/gemcitabine) for the treatment of metastatic adenocarcinoma of the pancreas aiming to improve treatment efficacy through combination therapy.

"Initiation of the TEADCO Phase 1b/2 basket trial is another important milestone for the ODM-212 clinical development program and reflects our commitment to patients with difficult-to-treat cancers," said Professor Outi Vaarala, Executive Vice President, Research & Development at Orion. "Together with the ongoing TEADES study, TEADCO highlights the versatility of ODM-212 both as monotherapy and in combination with other treatments. We believe ODM-212 has the potential to deliver meaningful clinical benefit, including by addressing treatment resistance to current standard of care therapies. We remain focused on advancing and expanding ODM-212 clinical development program."

About ODM-212
ODM-212 is an oral small-molecule pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor developed by Orion Pharma. It targets the Hippo signaling pathway, which regulates cell growth and organ size. Dysregulation of this pathway—particularly through YAP/TAZ activation—can lead to uncontrolled tumour growth and resistance to cancer therapies. ODM-212 works by blocking TEAD transcription factors, disrupting YAP-TEAD protein-protein interactions, and inhibiting TEAD auto-palmitoylation, which is essential for TEAD activity.

About Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma (MPM) is a rare and aggressive cancer that originates in the pleura—the thin membrane lining the lungs and chest wall. It accounts for about 80–90% of all mesothelioma cases and is strongly linked to asbestos exposure. Current treatments mainly include chemotherapy and immunotherapy.

About NSCLC
Non-small cell lung cancer ("NSCLC") encompasses all epithelial lung cancers other than small cell lung cancer. The three main types are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. NSCLC is the most common type of lung cancer, accounting for up to 85% of cases, with risk factors ranging from smoking to asbestos exposure and pulmonary fibrosis. Approximately 13% of NSCLC patients have KRAS G12C mutation.

About Pancreatic Cancer
Pancreatic cancer has a poor prognosis and remains one of the deadliest types of cancer. Treatment options are limited, chemotherapy being often the only option.

(Press release, Orion, APR 23, 2026, View Source [SID1234664697])

On April 22, 2026 Rakovina Therapeutics Inc. (TSX-V: RKV; FSE: 7JO0), a biopharmaceutical company advancing innovative cancer therapies through artificial intelligence (AI)-powered drug discovery, reported the presentation of new preclinical data from two of its lead programs at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held April 17–22 in San Diego, California.

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The data, presented across two poster sessions at the world’s premier cancer research forum, advance Rakovina’s AI-driven pipeline targeting DNA damage response (DDR) vulnerabilities in hard-to-treat solid tumors. Both programs leverage generative AI platforms to address longstanding limitations of existing cancer therapies, including poor central nervous system (CNS) penetrance and the toxicity burden of drug combination regimens.

Novel Brain-Penetrant Dual ATR-mTOR Inhibitor Demonstrates In Vivo Efficacy in PTEN-Deficient Cancers

The first poster, titled A Novel Brain-Penetrant Dual ATR-mTOR Inhibitor for PTEN-Deficient Cancers (Presentation #1743, DNA Damage and Repair 2 session, April 20), presented preclinical data from Rakovina’s program to develop first-in-class CNS-penetrating molecules that simultaneously inhibit ATR and mTOR, two key drivers of survival in PTEN-deficient cancer cells. The program was developed in collaboration with Variational AI (Vancouver, BC) using the Enki generative AI platform.

PTEN deficiency is found in up to 40% of gliomas and 63% of breast cancers, which frequently metastasize to the brain. Simultaneous inhibition of ATR and mTOR is a rational therapeutic strategy in PTEN-deficient tumors, as PTEN loss activates both ATR-dependent DNA damage signaling and mTOR-driven cell survival pathways. However, no approved therapy directly addresses this dual vulnerability with effective CNS penetrance.

Using the Enki latent diffusion model to simultaneously optimize potency, selectivity, CNS penetrance, and ADMET properties, Rakovina generated and synthesized a curated set of novel small-molecule dual ATR-mTOR inhibitor candidates. Key findings presented at AACR (Free AACR Whitepaper) 2026 include:

Enzymatic potency: Candidate compounds demonstrated equal or greater inhibition of recombinant ATR and mTOR enzymes compared to reference compounds ceralasertib and tuvusertib.
Selectivity: Candidates are equally or more selective against PIKK family enzymes than the reference compounds ceralasertib and tuvusertib.
Cell viability inhibition: Candidates inhibit cell viability of D283 medulloblastoma cells equally or more than reference compounds. A prototype lead candidate inhibited cell viability of both PTEN wild-type and PTEN-deficient cancer cell lines.
Metabolic stability: After 45 minutes of incubation with human liver microsomes, candidate compounds demonstrated strong metabolic stability.
CNS penetrance: Pharmacokinetic profiling following intraperitoneal administration in mice confirmed varying but measurable levels of CNS penetrance across candidates, with brain-to-plasma ratios broadly consistent with Enki AI predictions.
In vivo efficacy: In a subcutaneous LNCaP prostate tumor model, a prototype lead candidate significantly prolonged tumor doubling time compared to vehicle control, with equal potency to reference compound ceralasertib. Critically, the Rakovina candidate was better tolerated than ceralasertib, demonstrating less weight loss with daily dosing and no signs of hematological toxicity at terminal complete blood count analysis.
Optimization of candidate inhibitors is ongoing.

Novel AI-Designed Lipid Nanoparticle Formulation of kt-3283 Successfully Characterized

The second poster, titled Development of a Lipid Nanoparticle Formulation of the Bifunctional PARP and HDAC Inhibitor Kt-3283 (Presentation #6373, Drug Delivery session, April 21), presented preclinical formulation data on pLNP/kt-3283, developed in collaboration with NanoPalm (Riyadh, Saudi Arabia) using the EnsaliX AI platform.

kt-3283 integrates PARP inhibition and HDAC-mediated chromatin remodeling into a single compound, thereby improving the PARP efficacy, and eliminating the need for combination drug regimens and their associated toxicity risks. While kt-3283 has demonstrated potent anti-tumor activity across multiple tumor types in prior in vitro studies, its clinical viability has been limited by bioavailability and metabolic stability challenges. The pLNP formulation has been specifically designed to address these limitations.

Data presented confirm the successful assembly of the EnsaliX-designed patterned lipid nanoparticles. Physicochemical characterization confirmed uniform particle size, stable colloidal behavior, and a structured surface texture predicted to enhance cellular uptake. The pLNP/kt-3283 formulation demonstrated structure and particle size consistency supporting further biological evaluation.

Next steps include in vitro and in vivo characterization to confirm activity against PARP and HDAC enzymes, determine ADME properties, and evaluate efficacy in tumor models.

"Presenting at AACR (Free AACR Whitepaper) is a meaningful milestone for our team, and these results represent a genuine step forward for both programs," said Kim Oishi, Chief Executive Officer of Rakovina Therapeutics. "The in vivo efficacy data for our ATR-mTOR inhibitor are particularly encouraging. The compound demonstrated potency comparable to an established reference compound while exhibiting a meaningfully improved tolerability profile. That is exactly the differentiation we are building toward. Combined with the initial characterization of our LNP formulation for kt-3283, we believe these results reinforce the potential of our AI-driven pipeline and support a path toward IND-enabling studies."

Rakovina’s AI-powered discovery approach leverages generative AI platforms to evaluate billions of potential drug candidates at a pace not achievable through traditional methods. These capabilities are supported by the company’s access to the University of British Columbia’s lab infrastructure, enabling rapid in-house testing of lead compounds.

"These results demonstrate that our strategy of integrating AI-guided design with biological validation, is working as intended," said Dr. Mads Daugaard, President and Chief Scientific Officer of Rakovina Therapeutics. "For the ATR-mTOR program, our candidate inhibitors are tracking closely with the AI predictions for potency, selectivity, and CNS penetrance and our in vivo results give confidence in the direction of this program. For kt-3283, we have demonstrated that the EnsaliX-designed LNP formulation produces a well-characterized nanoparticle. The structured surface and organized phospholipid assembly we observed are precisely the properties expected to enhance nanoparticle stability and cellular uptake of kt-3283. Both programs have clear next steps, and we are moving forward with purpose."

The data presented at AACR (Free AACR Whitepaper) 2026 reinforce the progress of Rakovina’s AI-enabled DDR inhibitor pipeline and inform the next phase of preclinical development for both programs. For the ATR-mTOR program, further optimization of candidate inhibitors is ongoing. For the kt-3283 LNP program, the company will advance in vitro and in vivo studies to further characterize biological activity prior to evaluating efficacy in tumor models.

Rakovina intends to use these findings to advance best-in-class lead candidates toward IND-enabling studies in collaboration with pharmaceutical partners.

(Press release, Rakovina Therapeutics, APR 22, 2026, View Source [SID1234664716])

On April 22, 2026 BeyondSpring Inc. (NASDAQ: BYSI) reported new preclinical data at the 2026 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) demonstrating that Plinabulin has the potential to enhance both the efficacy and tolerability of ADC therapy — potentially boosting anticancer responses while keeping patients on treatment long enough to benefit.

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Antibody-drug conjugates — a form of targeted chemotherapy that delivers cancer-killing agents directly to tumor cells, known as ADCs — have emerged as one of oncology’s most important new treatment classes. But two persistent clinical barriers limit their full potential: they do not always produce durable responses, and neutropenia (a dangerous drop in white blood cell counts) can force dose reductions or treatment delays that cut treatment short. New AACR (Free AACR Whitepaper) data show that Plinabulin directly and simultaneously addresses both.

Three Key Findings from AACR (Free AACR Whitepaper) 2026

The data show why the combination works. Plinabulin, when added to two leading approved ADCs — T-DXd (trastuzumab deruxtecan) and Dato-DXd (datopotamab deruxtecan) — produced three significant results that neither drug achieved alone:

Stronger anticancer activity: Complete tumor regressions were more frequent and animals survived significantly longer — in both two-drug (ADC+ Plinabulin) and three-drug (ADC+ Plinabulin + PD-1 inhibitor) combinations (PD-1 inhibitors are immunotherapies that activate the body’s own immune system to fight cancer).
Better tolerability to potentially keep patients on therapy: Plinabulin reduced animal death in both two-drug and three-drug combinations. In 6 prior clinical studies, Plinabulin measurably reduced chemotherapy-induced neutropenia, the white blood cell toxicity that commonly forces ADC dose reductions or treatment delays — potentially allowing patients to remain on treatment long enough to benefit from the drug’s anticancer activity.
Immune system activation: Analysis showed that Plinabulin enhanced the body’s own cancer-fighting T-cells, significantly increasing CD8+ T cell/Treg ratio — providing a biological explanation for why the combination outperforms either drug alone.

Plinabulin is Mechanistically Complementary, Not Merely Additive

Plinabulin activates a protein called GEF-H1 that simultaneously matures immune cells (dendritic cells) to attack tumors, signals the body to replenish cancer-fighting blood cells, and disrupts the blood supply feeding tumors. These are precisely the biological pathways that ADCs do not activate — which is why the two work better together than either does alone.

In BeyondSpring’s pivotal Phase 3 DUBLIN-3 study (The Lancet Respiratory Medicine, 2024), Plinabulin combined with docetaxel chemotherapy doubled two- and three-year survival rates in second- and third-line EGFR wild-type NSCLC patients — and simultaneously reduced docetaxel-limiting grade 4 neutropenia from 33% to 5%, keeping patients on therapy longer for the drug to work. The new AACR (Free AACR Whitepaper) data extend that same combination logic into the ADC setting, broadening Plinabulin’s reach across the treatment landscape.

BeyondSpring’s planned DUBLIN-4 program — a 442-patient FDA-aligned confirmatory Phase 3 trial building directly on the DUBLIN-3 results — is the defined next clinical step. Today’s AACR (Free AACR Whitepaper) data further strengthen the scientific rationale for Plinabulin’s combination potential and point toward future ADC combination studies beyond the confirmatory program.

Plinabulin as a Potential Backbone Drug Across Multiple ADC Combinations

ADCs are increasingly being tested in earlier lines of cancer treatment and in combination with immunotherapy. However, recent large Phase 3 studies — TROPION-Lung01 and EVOKE-01 — showed that leading ADCs failed to outperform older chemotherapy, such as docetaxel, in certain lung cancer settings, underscoring the need for an agent that can improve the efficacy and tolerability of ADC-based combinations.

Plinabulin’s ability to simultaneously boost efficacy and reduce toxicity positions it as a potential backbone agent across the ADC landscape — a role no other drug currently fills. Today’s AACR (Free AACR Whitepaper) data open the door to ADC combination studies as a natural next chapter in Plinabulin’s clinical development, alongside the ongoing DUBLIN-4 confirmatory program.

"Plinabulin has the potential to enable ADC therapy to deliver on its full promise — producing more complete responses, extending survival, and keeping patients on treatment. These AACR (Free AACR Whitepaper) data further strengthen our conviction in Plinabulin’s combination potential, as we advance the DUBLIN-4 confirmatory Phase 3 program in NSCLC post immune checkpoint inhibitors and explore the broader opportunity in ADC-based regimens."
— Dr. Lan Huang, Co-Founder, Chairman, and CEO, BeyondSpring Inc.

BeyondSpring’s China operations have been a strategic engine in building the ADC partnerships that support Plinabulin’s global development.

"China’s ADC research ecosystem is among the most active in the world, and BeyondSpring is well-positioned to leverage those capabilities. Our collaboration with Shanghai Chest Hospital demonstrated the value of strategic partnerships in advancing Plinabulin’s preclinical and clinical development in ADC combination, and we see continued opportunity to build on that model as the ADC combination landscape evolves."
— Min Qiu, Deputy General Manager, BeyondSpring China

BeyondSpring’s AACR (Free AACR Whitepaper) 2026 Presentation

Title: Plinabulin Boosts Antitumor Efficacy of Topoisomerase Inhibitor-Based Antibody-Drug Conjugates Without or With Immune Checkpoint Inhibitor

Presenters: Yingjuan June Lu, Xiaoyan He, Weiwei Cheng, Zhengyan Zhang, James Tonra, Lan Huang

Session: T Cell Engagers 2 / Antibody-Drug Conjugates 1 (Immunology Track)

Poster Number: 5597

About Plinabulin

Plinabulin is a late-stage Phase 3 anticancer agent and first-in-class GEF-H1 (guanine nucleotide exchange factor H1) agonist. Its multifunctional mechanism — encompassing dendritic cell maturation, tumor microenvironment modulation, anti-angiogenesis, and chemotherapy-induced neutropenia (CIN) mitigation — activates biological pathways that standard chemotherapy and ADCs do not. Over 700 cancer patients have been treated with good tolerability and durable anticancer benefit in rational combination settings. DUBLIN-3 Phase 3 results in NSCLC were published in The Lancet Respiratory Medicine in 2024.

About DUBLIN-3 and the Path to DUBLIN-4

In the DUBLIN-3 Phase 3 study of 2L/3L EGFR wild-type NSCLC (Lancet Respiratory Medicine, 2024), Plinabulin plus docetaxel significantly outperformed docetaxel monotherapy (n=559, 1:1 randomization), with improvements in OS, PFS, and ORR; doubling of 2- and 3-year survival rates; and reduction of docetaxel-induced grade 4 neutropenia from 33% to 5% (p<0.0001).

DUBLIN-4 is BeyondSpring’s planned FDA-aligned confirmatory Phase 3 program (n=442, 1:1 randomization), designed to validate the DUBLIN-3 results in a prospective confirmatory setting in a patient population selected based on Plinabulin’s mechanism of action: non-squamous NSCLC patients who have progressed on PD-1/L1 inhibitors. The ADC preclinical data presented at AACR (Free AACR Whitepaper) 2026 broaden the scientific case for Plinabulin’s combination potential.

(Press release, BeyondSpring Pharmaceuticals, APR 22, 2026, View Source [SID1234664715])

On April 22, 2026 The US Food and Drug Administration (FDA) reported that it has extended by up to three months the target action date for its review of the biologics license application for Sarclisa (isatuximab-irfc) subcutaneous (SC) in combination with approved standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all currently approved US indications of Sarclisa intravenous (IV) formulation. The revised target action date for the FDA decision is July 23, 2026.

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Sanofi is committed to working closely with the FDA to bring this new advancement to patients and providers as quickly as possible. If approved, Sarclisa would be the first anticancer treatment to be administered through an on-body injector (OBI).

On March 26, 2026, the European Medicine Agency Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Sarclisa SC administered via both an OBI and manual injection for the treatment of MM patients across all currently approved indications and combinations for Sarclisa IV formulation in the EU. A final decision is expected in the coming months.

About Sarclisa
Sarclisa (isatuximab-irfc) has been approved in almost 60 countries across four indications for certain patients with newly diagnosed MM and relapsed or refractory MM. Sarclisa-based regimens have been prescribed to treat more than 60,000 patients worldwide.

At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need.

For more information on Sarclisa clinical studies, please visit www.clinicaltrials.gov.

(Press release, Sanofi, APR 22, 2026, View Source [SID1234664714])