On April 6, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that, at the 2026 European Lung Cancer Congress (ELCC 2026), it has announced updated results with a median follow-up of 21.45 months from a prospective, open-label, single-arm, multicenter Phase Ib/II study evaluating cadonilimab in combination with anlotinib and docetaxel in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who progressed after prior PD-(L)1 inhibitor-based therapy.

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Cadonilimab is the world’s first approved bispecific antibody for cancer immunotherapy, having received marketing approval in 2022. In extensive real-world clinical practice and multiple Phase III studies, it has demonstrated clinically meaningful benefit across all patient populations regardless of PD-L1 expression status, addressing a significant unmet medical need and earning broad recognition from physicians and patients.

Cadonilimab-based regimens have previously shown promising therapeutic potential in difficult-to-treat tumors, including immunotherapy-refractory hepatocellular carcinoma (HCC) and gastric cancer. The updated data presented at ELCC 2026 now provide further robust evidence of cadonilimab’s important additional value in treating immunotherapy-resistant diseases, beyond its well-established benefit in the all-comer population. Just as importantly, cadonilimab’s consistent safety profile makes it a highly preferable backbone with which other treatments can be combined to create efficacious treatment for a multitude of cancers.

In this difficult-to-treat population of patients with immunotherapy-resistant advanced NSCLC, the cadonilimab combination regimen demonstrated clinically meaningful anti-tumor activity, durable disease control, and a manageable safety profile, supporting its potential as a new second-line treatment option.

Key Findings from the Phase Ib/II Study (Median Follow-Up: 21.45 Months):

Progression-Free Survival (PFS): In the overall population, median PFS was 7.0 months, with a 6-month PFS rate of 55.7%.
Consistent Benefit Across Subgroups: Median PFS was 7.5 months in the squamous NSCLC (sq-NSCLC) subgroup and 7.4 months in the PD-L1 TPS ≥1% subgroup.
Disease Control and Response Durability: The Disease Control Rate (DCR) reached 95.2%; the Objective Response Rate (ORR) was 26.2%, and the median Duration of Response (DoR) was 6.0 months. Patients who achieved circulating tumor DNA (ctDNA) clearance had a median PFS of 9.1 months. After the first treatment cycle (C1), the ctDNA detection rate decreased from 1.5% to 0.5%, demonstrating the regimen’s depth of anti-tumor activity at the molecular level.
Safety Profile: The triple combination of cadonilimab, anlotinib, and docetaxel was well tolerated, with a grade ≥3 treatment-related adverse event (TRAE) rate of 14.0%. No treatment-related deaths were reported.

(Press release, Akeso Biopharma, APR 6, 2026, View Source [SID1234664187])

On April 6, 2026 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, reported that the first patient has been enrolled in its Phase 1 dose escalation trial evaluating IDE574, a potential first-in-class oral small molecule equipotent dual inhibitor of the lysine acetyltransferase (KAT) 6 and 7 paralogs, both of which have been shown to support cancer cell survival. The company is planning to evaluate safety, efficacy and pharmacokinetics of IDE574 as a monotherapy in the Phase 1 dose escalation trial in solid tumor patients, including breast, prostate, colorectal, and lung cancer.

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"Targeting mechanisms of resistance and tumor heterogeneity in cancer are core strategies of our R&D efforts, and we are excited to advance IDE574 in the clinic to evaluate its potential as a monotherapy agent to drive deeper, more durable antitumor responses for patients versus historical clinical data published with KAT6-selective agents," said Michael White, Ph.D., Chief Scientific Officer of IDEAYA Biosciences. "We are thrilled to advance another potential first-in-class agent into the clinic that targets large solid tumor indications of high unmet need, including breast, prostate, CRC, and lung cancer. We believe the novel chromatin remodeling mechanism of the KAT6/7 dual inhibitor IDE574, has the potential for monotherapy efficacy and to treat breast cancer patient’s refractory to hormone-based therapy due to ESR1 mutations, and to evaluate rational combinations with assets in the IDEAYA pipeline," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

IDE574 is a selective, equipotent dual inhibitor of both KAT6 and KAT7 with single-digit to low-teen nanomolar cellular potency in target engagement assays, which spares other structurally similar KAT paralogs with approximately a 350-to-2,000-fold selectivity windows versus KAT5 and KAT8, both of which are required for normal cell function. KAT6 and KAT7 are epigenetic modulators of cell identity and lineage commitment programs that are corrupted by oncogenic transformation. Estrogen-receptor 1 mutations (ESR1) is a common acquired resistance mechanism to endocrine based therapy in breast cancer with prevalence from 10 to 50% (Fuqua, et al., Cancer, July 2019; Zundelevich, et al., Breast Cancer Research, February 2020) highlighting the unmet need for alternative drug mechanisms, such as KAT6/7. IDE574 has shown robust and durable monotherapy anti-tumor activity, superior to KAT6 inhibition alone, in preclinical tumor models with 8p11 amplifications and ESR1 mutations, as well as in selected indications dependent upon lineage-specific transcription factor activity.

(Press release, Ideaya Biosciences, APR 6, 2026, View Source [SID1234664186])

On April 6, 2026 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), reported that it is halting further recruitment in the AMPLICITY clinical trial in advanced pancreatic cancer investigating the Company’s lead drug narmafotinib in combination with the chemotherapy regimen modified FOLFIRINOX (mFOLFIRINOX).

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Eight (8) patients have been dosed with daily narmafotinib in combination with the mFOLFIRINOX regimen administered on its routine cycle and doses. Three (3) events of protocol-defined dose-limiting toxicity (DLT) have been observed at this time, though importantly none have been attributed to narmafotinib and instead relate to the chemotherapy regimen. Five of the 8 patients remain on study and will continue to receive the narmafotinib – mFOLFIRINOX combination with continuing safety monitoring as before.

FOLFIRINOX has been one of the main chemotherapy regimens used in the treatment of pancreatic cancer patients who are generally fitter and have a higher performance status. It is recognized as being more aggressive and less well tolerated by patients compared to gemcitabine and Abraxane, the chemotherapies being investigated in combination with narmafotinib in the ongoing ACCENT study. However, Amplia anticipates an increasing preference for less toxic chemotherapeutic regimens in clinical practice and will therefore halt recruitment in AMPLICITY and focus its resources on exploring combinations other than with FOLFIRINOX.

Dr Chris Burns, CEO and Managing Director of Amplia, commented on the latest results: "The DLTs observed are very disappointing for the patients and their families; however, toxicity with FOLFIRINOX chemotherapy is well documented. Given these effects, and the evolving landscape for pancreatic cancer treatment, we will continue to build on our promising ACCENT trial data, as well as plan for additional studies with new, targeted agents being developed for pancreatic cancer."

While efficacy data from AMPLICITY is early, four of the eight patients in the trial have recorded stable disease at their first (2-month) scan, with one of these patients subsequently recording a partial response at their 4 -month scan. No other efficacy data is available at this time though updates will be reported in due course.

(Press release, Amplia Therapeutics, APR 6, 2026, View Source [SID1234664185])

On April 6, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, an investigational, systemically delivered immunotherapy that has been shown to activate innate immune-sensing pathways, reported that it has scheduled a Type C meeting with the U.S. Food and Drug Administration ("FDA") on April 16, 2026, to discuss a potential registrational development path in anal cancer.

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The meeting will focus on the potential to initiate a single-arm pivotal study evaluating pelareorep in combination with a checkpoint inhibitor in patients being treated with second-line and later therapy for squamous cell anal carcinoma ("SCAC"). Patients will have received a checkpoint inhibitor and chemotherapy in the first-line, which means all patients treated in this study would have no alternative approved therapies available at this stage of treatment. The Company intends to discuss a study design enrolling approximately 60 to 70 patients with objective response rate ("ORR") as the primary endpoint to support a potential full approval.

Pelareorep, in combination with a checkpoint inhibitor, has demonstrated encouraging clinical activity in SCAC. In Cohort 4 of the GOBLET study, the combination achieved approximately 30% ORR with a median duration of response in late-line patients of 17 months. These results compare favorably to real-world outcomes, where response rates are approximately 10-14% with a median duration of response of approximately 9.5 months in this setting.1

"We believe this upcoming FDA meeting is a critical step in advancing pelareorep toward a potential registration pathway in anal cancer," said Jared Kelly, Chief Executive Officer of Oncolytics. "Our goal is to align with the FDA on the statistical analysis plan and sample size for a potential pivotal single-arm study in second-line and later SCAC. In a setting with limited approved therapies, we believe the strength and durability of our data support this approach, and recent regulatory discussions in oncolytic virus development underscore the importance of demonstrating clear, durable clinical benefit with checkpoint inhibition. With few late-line options and no confounding checkpoint inhibitor data, SCAC offers a clearer efficacy signal and a potentially more efficient path to approval for pelareorep."

SCAC is a rare cancer with limited treatment options in the second-line and later setting, and outcomes remain poor following progression on first-line treatment. The World Health Organization estimates that there are approximately 54,000 cases of anal cancer globally each year, and the anal cancer market is expected to double to $2.3 billion from 2025 to 2035.

(Press release, Oncolytics Biotech, APR 6, 2026, View Source [SID1234664184])

On April 6, 2026 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported management will participate in the 25th Annual Needham Virtual Healthcare Conference.

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25th Annual Needham Virtual Healthcare Conference
Fireside Chat: Monday, April 13, 2026, at 3:00 p.m. EDT

The presentation will be webcast live and can be accessed by visiting ‘Events & Presentations’, under ‘Events’, via the ‘Investors’ section of Immunocore’s website at www.immunocore.com. Following the event, a replay of the presentation will be made available for a limited time.

(Press release, Immunocore, APR 6, 2026, View Source [SID1234664183])