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 OREGA Biotech reported that interim results from the Phase 2 MATISSE trial evaluating IPH5201, a first-in-class CD39 blocking monoclonal antibody, in combination with durvalumab and platinum-based chemotherapy in patients with resectable early-stage non-small cell lung cancer (NSCLC) were presented on April 21st during a plenary session at AACR (Free AACR Whitepaper) 2026 by Professor Fabrice Barlesi (Gustave Roussy) and discussed by Professor Tina Cascone (MD Anderson).

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Presentation highlights:
Perioperative PD-(L)1 inhibitors combined with chemotherapy are now a standard of care in resectable early-stage NSCLC. However, further improvements in pathological complete response (pCR) and survival outcomes are still needed. IPH5201, a humanized anti-CD39 neutralizing antibody, is designed to enhance antitumor immunity by reducing immunosuppressive adenosine and increasing immuno-activating ATP levels, as demonstrated in preclinical models.

In the ongoing Phase 2 MATISSE study:

40 patients with stage II–IIIA NSCLC were treated
The regimen demonstrated a safety profile comparable to preoperative platinium-based chemo+durvalumab
The observed pathological Complete Response (pCR) rates were:
5% in the overall population
7% in patients with PD-L1 ≥1%
50% in patients with PD-L1 ≥50%
These results compare favorably with historical data from the AEGEAN Phase 3 study.

Biomarker analyses confirmed CD39 target engagement and suggested a correlation between CD39+ tumor cell density and treatment response.

These findings support the continuation of the study, including ongoing recruitment of patients with PD-L1 ≥1%.

About IPH5201 antibody
IPH5201 is a first-in-class-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.

(Press release, OREGA BIOTECH, APR 22, 2026, View Source [SID1234664684])

On April 22, 2026 Hengrui Pharma reported steady growth in the first quarter of 2026. In Q1 2026, the Company recorded revenue of RMB 8.14 billion, up 12.98% year-over-year, while net profit attributable to shareholders increased by 21.78% to RMB 2.28 billion. Innovative drugs remained the key growth driver, generating RMB 4.53 billion in revenue, up 25.75% year-over-year and accounting for 61.69% of total pharmaceutical sales.

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The Company continued to advance its innovation-driven strategy with sustained R&D investment and solid pipeline progress. R&D investments in Q1 2026 totaled RMB 2.22 billion, representing for approximately 27.32% of revenue.

During the period, three innovative products and new indications were approved in China, which included an anti-PD-L1/TGF-βRII bi-functional fusion protein and an indication expansion for HER2-targeting ADC.

In terms of pipeline advancement, the Company obtained 26 clinical trial approvals and had 8 new drug applications accepted in China across key therapeutic areas including oncology, metabolic, cardiovascular, and immunological diseases.

Business development has become a recurring and increasingly important growth driver, with RMB 787 million in out-licensing revenue recognized during the quarter, primarily from the collaboration with GSK. Since 2023, Hengrui Pharma has completed 12 overseas business development transactions, including out-licensing, NewCo structures, and strategic alliance models.

A key milestone during the period was the successful Nasdaq listing of Kailera Therapeutics (NASDAQ: KLRA), a NewCo company built around Hengrui Pharma’s GLP-1-based assets. This milestone reflects continued progress in executing the Company’s NewCo strategy, with Hengrui and Kailera working together to advance the global development of the GLP-1 portfolio.

Looking ahead, Hengrui Pharma will remain committed to innovation and globalization, strengthening its pipeline and advancing the development and commercialization of innovative therapies to benefit patients worldwide.

(Press release, Hengrui Pharmaceuticals, APR 22, 2026, View Source [SID1234664700])

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 21, 2026 Convergent Therapeutics Inc., a clinical-stage biotechnology company developing next-generation alpha-emitting radioantibodies for the treatment of advanced prostate cancer, reported that results from its ongoing Phase 2 CONVERGE-01 trial of CONV01-α will be presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting. The oral presentation, scheduled for June 1 in Chicago, will highlight data from patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with Lu-177 PSMA radioligand therapy.

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"We appreciate the opportunity to share these data at ASCO (Free ASCO Whitepaper) and to contribute to the discussion around how prostate cancer treatment is evolving," said Philip Kantoff, MD, Chief Executive Officer and Co-Founder of Convergent Therapeutics. "As targeted radiotherapies become more integrated into care, there is growing focus on how to extend benefit for patients who have already received Lu-177 PSMA radioligand therapy and need further options. This is an important emerging challenge in mCRPC, and one that will help define the next phase of progress in the field."

Abstract Title: CONVERGE-01 part 3: Ac-225 rosopatamab tetraxetan (CONV01-a) in Lu-PSMA pretreated metastatic castration-resistant prostate cancer (mCRPC).
Abstract Number: 5011
Format: Oral Presentation
Session Type/Title: Clinical Science Symposium – Radiation Re-Imagined: Radioligand Innovation in Prostate Cancer
Date and Time: June 1, 3:00 PM-4:30 PM CDT
Presenter: Michael J. Morris, MD, Prostate Cancer Section Head, Memorial Sloan Kettering Cancer Center

About the CONVERGE-01 Trial
The CONVERGE-01 trial is a Phase II, randomized, open-label, multicenter three-part study designed to assess the safety and efficacy of CONV01-α in patients with mCRPC. In Part 1, patients received rosopatamab tetraxetan to characterize the biodistribution of the radioantibody to target organs and prostate cancer lesions. Participants were then enrolled in either Part 2 (dose optimization) or Part 3 (dose escalation) depending on their prior treatment history. Part 2 enrolled Lu-177-PSMA-radioligand therapy-naïve participants and Part 3 enrolled participants who received prior Lu-177-PSMA-radioligand therapy. All patients will receive Ac-225 rosopatamab tetraxetan in a single fractionated two-week cycle. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT06549465.

About CONV01-α
CONV01-α is a PSMA-targeted Ac-225 radioantibody that pairs antibody precision with the localized potency of alpha radiation. CONV01-α, which is being developed to improve the treatment of metastatic castration-resistant prostate cancer (mCRPC), uses a humanized monoclonal antibody directed at prostate-specific membrane antigen (PSMA), a well-established and highly expressed antigen in prostate cancer. CONV01-α is differentiated by its ability to precisely deliver actinium-225 (Ac-225) through this PSMA-targeting antibody, enabling short-range, high-energy alpha particle radiation that creates focused DNA damage within tumor cells while limiting exposure to surrounding tissues. Initial studies in more than 120 patients have established clinical proof-of-concept for CONV01-α, showing consistent antitumor activity and a differentiated safety profile. This selectivity, combined with strong tumor retention and minimal salivary and renal uptake, supports the potential of CONV01-α to be a clinically impactful therapy for PSMA-positive cancers.

(Press release, Convergent Therapeutics, APR 21, 2026, View Source;in-Lu-PSMA-pretreated-Metastatic-Castration-Resistant-Prostate-Cancer-Patients-at-the-2026-ASCO-Annual-Meeting [SID1234664604])