On March 27, 2026 Senti Biosciences, Inc. (Nasdaq: SNTI) ("Senti Bio"), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, reported financial results for the fourth quarter of 2025 and full year 2025 and provided a summary of recent pipeline and corporate highlights.

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"2025 was a year of important progress for Senti as we continued to advance our mission of developing next-generation cell and gene therapies powered by our synthetic biology platform. Over the past year, we have strengthened the clinical and translational foundation of our pipeline, with SENTI-202 as the lead program generating positive clinical data, while continuing to refine and expand the capabilities of our Gene Circuit platform. We remain focused on disciplined execution, advancing our key programs toward critical development milestones and positioning Senti to deliver smarter, more selective medicines for patients with serious diseases. I am proud of our team’s commitment and believe the progress we made in 2025 positions us well for the opportunities ahead," commented Timothy Lu, MD, PhD, Co-Founder and CEO of Senti Biosciences.

RECENT PIPELINE AND CORPORATE UPDATES

Reported updated positive preliminary clinical data from the ongoing Phase 1 trial of SENTI-202 in relapsed/refractory acute myeloid leukemia (AML), demonstrating encouraging response rates, durability, and a favorable safety profile;
Received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration for SENTI-202 for the treatment of adults with relapsed or refractory AML;
Continued advancement of the Company’s pipeline and synthetic biology platform, including progress across its Gene Circuit–engineered cell therapy programs; and
Maintained focus on disciplined capital management to support pipeline execution and key development milestones.

YEAR 2025 FINANCIAL RESULTS

Cash and Cash Equivalents: As of December 31, 2025, Senti Bio held cash and cash equivalents of approximately $16.4 million.
R&D Expenses: Research and development expenses were $7.8 million for both of the three months ended December 31, 2025 and 2024, respectively. For the full year of 2025, research and development expenses were $37.6 million.
G&A Expenses: General and administrative expenses were $5.8 million and $8.4 million for the quarter ended December 31, 2025 and 2024, respectively. The decrease of $2.6 million was primarily due to a decrease of $2.3 million in external services and supplies cost and a decrease of $0.7 million in facilities and other costs, partially offset by an increase of $0.4 million in personnel-related expenses. For the full year of 2025, general and administrative expenses were $26.2 million.
Net Loss: Net loss was $14.5 million, or $0.53 per basic and diluted share, for the three months ended December 31, 2025. Net loss for the full-year 2025 was $61.4 million, or $2.73 per share. Net loss for the year ended December 31, 2025 included a non-recurring $5.1 million impairment of long-lived assets as well as non-cash stock-based compensation expense of $5.7 million.

(Press release, Senti Biosciences, MAR 27, 2026, View Source [SID1234663989])

On March 27, 2026 Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported its fourth quarter and full-year 2025 operating and financial results and reviewed recent business highlights.

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"We are extremely excited about the continued progress at Calidi," said Eric Poma, PhD, CEO of Calidi Biotherapeutics. "We continue to advance CLD-401, the first lead from our RedTail platform, towards the clinic and have built a world-class scientific advisory board to aid those efforts. We have also expanded what the RedTail platform can do with our new approach of in situ T-cell engagers."

Fourth Quarter 2025 and Recent Corporate Developments

Partnered with Avance Clinical, a full-service contract research organization (CRO) with a proven track record and experience in obtaining regulatory approval and clinical trial initiation in Australia. The partnership is focused on rapidly initiating a first-in-human clinical trial for CLD-401 in Australia. CLD-401, the Company’s lead asset, is a systemically delivered oncolytic virus that replicates only in tumor cells. CLD-401 induces high concentrations of IL-15 superagonist (IL15 SA) expression in the tumor microenvironment while limiting peripheral exposure.

In parallel, Calidi is pursuing an IND filing with the FDA by the end of 2026. Calidi has interacted with the FDA around the Company’s manufacturing and analytical approaches through its Type D meeting request process. The feedback it has received from the agency supports the use of this process for the clinical development of CLD-401.

Partnered with Matica Bio, a leading CDMO in the field of oncolytic virus manufacturing, for the GMP manufacturing of CLD-401. Matica has successfully executed multiple oncolytic virus programs at its state-of-the-art, purpose-built GMP facility in College Station, Texas. That facility was designed specifically to support complex viral vector modalities like CLD-401.

Presented data demonstrating the expression of an in situ T-cell engagers (TCEs) for solid tumors and the simultaneous expression of a T-cell activating agent (e.g., IL-15 SA) through its systemically delivered RedTail platform at the AACR (Free AACR Whitepaper) Immuno-Oncology (AACR-IO) conference. High expression of in situ TCE coincident with expression of a T-cell activator in the TME may overcome the traditional limitations of TCEs in solid tumor.

Raised $6.0 million in gross proceeds from an underwritten public offering with new and existing investors in Q1-2026 and $0.5 million in gross proceeds from the sale of stock under our ATM in Q4-2025, strengthening the balance sheet and extending Calidi’s cash runway.

Fourth Quarter 2025 Financial Results

The company reported a net loss attributable to common stockholders of $4.1 million, or $0.57 per share, for the three months ended December 31, 2025, compared to a net loss attributable to common stockholders of $4.1 million, or $3.23 per share, for the same period in 2024.

Research and development expenses were $2.4 million for the three months ended December 31, 2025, compared to $1.8 million for the comparable period in 2024, respectively.

General and administrative expenses were $2.1 million for the three months ended December 31, 2025, compared to $2.2 million for the comparable period in 2024, respectively.

Full Year 2025 Financial Results

The company reported a net loss attributable to common stockholders of $25.6 million, or $5.95 per share, for the year ended December 31, 2025, compared to a net loss attributable to common stockholders of $23.8 million, or $35.70 per share, for the year ended December 31, 2024.

Research and development expenses were $9.7 million for the year ended December 31, 2025, compared to $8.9 million for the year ended December 31, 2024, respectively.

General and administrative expenses were $10.5 million for the year ended December 31, 2025, compared to $12.9 million for the year ended December 31, 2024, respectively.

The company had approximately $5.6 million in cash and $0.2 million in restricted cash as of December 31, 2025, compared to $9.6 million in cash and $0.2 million in restricted cash as of December 31, 2024.

(Press release, Calidi Biotherapeutics, MAR 27, 2026, View Source [SID1234663988])

On March 27, 2026 Lantern Pharma Inc. (NASDAQ: LTRN) and its CNS-oncology focused wholly owned subsidiary Starlight Therapeutics reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for STAR-001 in a planned Phase 1 pediatric clinical trial (IND No. 179145).

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STAR-001 is a precision oncology compound whose CNS and pediatric CNS indications were initially identified using Lantern’s proprietary RADR AI platform. The planned trial will evaluate STAR-001 as a single agent and in combination with spironolactone in pediatric patients with relapsed or refractory central nervous system (CNS) malignancies.

The trial is planned to be conducted in collaboration with POETIC — the Pediatric Oncology Experimental Therapeutics Investigators’ Consortium — a multicenter network of 14 leading academic children’s cancer centers across the United States, Canada, and Israel. The study protocol, as reviewed and cleared by the FDA, is titled:

"A PHASE 1, MULTICENTER, OPEN-LABEL, DOSE ESCALATION STUDY OF STAR-001 (LP-184) AS A SINGLE AGENT AND IN COMBINATION WITH SPIRONOLACTONE IN PEDIATRIC PATIENTS WITH RELAPSED OR REFRACTORY CENTRAL NERVOUS SYSTEM MALIGNANCIES."

ADDRESSING A CRITICAL UNMET NEED IN PEDIATRIC NEURO-ONCOLOGY

Pediatric CNS tumors represent one of the most devastating and treatment-resistant categories of childhood cancer. In the United States, an estimated 4,975 new cases of primary brain tumors will be diagnosed in children and adolescents in 2026 alone — making brain tumors the leading cause of cancer-related death among children and adolescents ages 0 to 19. The burden extends far beyond U.S. borders: globally, approximately 47,600 new pediatric CNS tumor cases are diagnosed each year, resulting in an estimated 23,500 deaths annually. Across Europe, the disease is similarly pervasive, with wide disparities in survival outcomes for children facing high-grade or relapsed cancers.

Despite significant advances in molecular profiling and surgical technique over the past two decades, survival outcomes for children with relapsed or refractory high-grade CNS tumors have improved only marginally. For certain diagnoses, the prognosis remains catastrophic. Diffuse Intrinsic Pontine Glioma (DIPG), for instance, carries a median survival of less than 12 months from diagnosis with no approved curative option. For children with relapsed ATRT, GBM, medulloblastoma, and ependymoma, current therapeutic options are equally limited and often associated with severe long-term toxicity.

The trial design provides for STAR-001 (LP-184) to be evaluated across a range of these aggressive pediatric CNS malignancies, including:

Atypical Teratoid/Rhabdoid Tumor (ATRT) — for which Lantern Pharma holds FDA Rare Pediatric Disease Designation
Diffuse Intrinsic Pontine Glioma (DIPG) — a brainstem tumor with virtually no long-term survivors under current standard of care
Glioblastoma (GBM)
Medulloblastoma
Ependymoma
"This IND clearance is a defining milestone for Starlight Therapeutics and a meaningful step forward for pediatric neuro-oncology. For children with relapsed or refractory CNS tumors, the options are desperately limited — and the science behind this planned trial was built to change that. CNS and pediatric CNS cancers were initially identified as priority indications by our team in support from our RADR AI platform, and that same analysis led us to ERCC3, a DNA repair enzyme that high-grade CNS tumors rely on to survive. Our modeling, analysis and subsequent in-vivo and animal studies showed that spironolactone could dismantle that pathway by degrading ERCC3 before STAR-001 even enters the cancer cell. In ATRT models, the combination extended median survival by 181% compared to the control. We believe this represents a genuinely new way to attack these brain cancers, and we are proud to be advancing it through a network of some of the world’s most respected pediatric oncology centers."
— Panna Sharma, CEO & President, Lantern Pharma Inc.; Founder & Chairman, Starlight Therapeutics

NOVEL BIOLOGY: TARGETING ERCC3 TO AMPLIFY DNA DAMAGE — A FIRST-IN-CLASS COMBINATION STRATEGY

A scientifically distinctive and potentially first-in-class feature of the planned trial is a dedicated combination cohort evaluating STAR-001 alongside spironolactone — exploiting a biological vulnerability in CNS tumor cells that Lantern’s RADR AI platform, helped in part to identify as a novel approach to creating synthetic lethality in these brain tumors.

STAR-001 operates through a precision bioactivation mechanism: selectively converted into a potent DNA-crosslinking agent within tumor cells that overexpress PTGR1 (Prostaglandin Reductase 1), it induces DNA double-strand breaks that are lethal to the cancer cell — if left unrepaired. By degrading ERCC3, spironolactone removes that option.

Lantern’s RADR AI platform identified ERCC3 (Excision Repair Cross-Complementation Group 3) — a key helicase in the nucleotide excision repair (NER) pathway — as a central repair mechanism that could be exploited in high-grade pediatric CNS malignancies including ATRT, medulloblastoma, and diffuse midline glioma, compared to low-grade gliomas. Spironolactone — a brain-penetrant, orally administered agent with a long safety record in pediatric patients — degrades ERCC3 through targeted proteasomal degradation, reducing ERCC3 protein levels by at least 50% across tumor models and confirming direct target engagement. With this repair pathway dismantled, STAR-001-induced DNA damage accumulates unrepaired, driving dramatically enhanced tumor cell death based on preclinical observations. In ATRT orthotopic xenograft models, the combination extended median survival from 27 to 76 days — a 181% improvement over control (p = 0.0018) — with comparable results across medulloblastoma and DMG models showing up to a 3- to 5-fold increase in apoptotic cells versus monotherapy (p < 0.0001).

This two-pronged strategy — AI-guided identification of a DNA repair vulnerability, precision bioactivation of a DNA-damaging agent, and pharmacological elimination of the tumor cell’s repair escape route — represents a mechanistically coherent and potentially transformative approach to pediatric CNS cancers where conventional chemotherapy has reached its limits.

"High-grade pediatric brain tumors represent a significant unmet medical need, with few effective options for children whose disease has relapsed or become refractory to standard therapy. STAR-001 is a novel, precision brain-penetrant alkylator, bioactivated by PTGR1, that has demonstrated meaningful activity across multiple malignant pediatric brain tumor types in preclinical models. In collaboration with the POETIC consortium, we have developed a Phase 1 pediatric protocol — reviewed and cleared by the FDA — to assess the safety, tolerability, and preliminary activity of STAR-001, both as a single agent and in combination with spironolactone, in children with recurrent malignant brain tumors. We look forward to initiating this planned trial and to the possibility of delivering a new therapeutic option to children who need it most."
— Marc Chamberlain, M.D., Chief Medical Officer, Starlight Therapeutics

MULTICENTER PEDIATRIC CLINICAL TRIAL DESIGN

The planned trial will be conducted across approximately 15 leading academic pediatric oncology centers in collaboration with POETIC (Pediatric Oncology Experimental Therapeutics Investigators’ Consortium), a multicenter network of 14 institutions — including MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, and Lucile Packard Children’s Hospital at Stanford — spanning the United States, Canada, and Israel. The planned trial is subject to obtaining additional funding and it is designed to enroll approximately 18 to 42 pediatric patients aged 1 to 17 years. POETIC’s established clinical infrastructure provides Starlight with the reach to enroll a geographically and demographically diverse patient population across North America and internationally.

ABOUT STAR-001 (LP-184)

STAR-001 is Starlight Therapeutics’ CNS oncology compound, co-developed with Lantern Pharma as LP-184. CNS and pediatric CNS cancers were initially identified as priority indications for STAR-001 through Lantern’s proprietary RADR AI platform, which analyzed genomic and molecular data across tumor types to pinpoint the PTGR1 overexpression signature that makes these malignancies particularly susceptible to STAR-001’s mechanism of action. STAR-001 is a precision acylfulvene-based agent engineered to exploit elevated PTGR1 (Prostaglandin Reductase 1) expression in tumor cells. Laboratory observations have demonstrated that PTGR1-mediated bioactivation selectively converts STAR-001 into a highly reactive DNA-crosslinking species within cancer cells, while normal tissues with lower PTGR1 activity are largely spared. LP-184/STAR-001 has received multiple FDA orphan and rare pediatric disease designations and has demonstrated encouraging activity in early-stage clinical and preclinical studies. In pediatric CNS cancers — where PTGR1 overexpression has been identified across ATRT, GBM, DIPG, medulloblastoma, and ependymoma — we believe STAR-001 represents a scientifically grounded precision approach to a historically intractable disease.

(Press release, Lantern Pharma, MAR 27, 2026, View Source [SID1234663987])

On March 27, 2026 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported that data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, will be presented at the 2026 European Lung Cancer Congress (ELCC 2026) in Copenhagen, Denmark. Three posters featuring updated ivonescimab data will be displayed on Friday, March 27 from 1:00 to 2:00 pm Central European Time. Data for HARMONi was generated and analyzed by Summit and for HARMONi-2 by our collaboration and licensing partner, Akeso Inc. (HKEX Code: 9926.HK).

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The first poster, "Intracranial Efficacy of Ivonescimab Plus Chemotherapy in Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI)-Resistant, EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) in the HARMONi Study" includes outcome data from patients with and without asymptomatic brain metastases at baseline enrolled in HARMONi (NCT06396065). These patients received either ivonescimab delivered in combination with chemotherapy, or chemotherapy alone in this global Phase III trial for patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with an EGFR TKI. Ivonescimab plus chemotherapy demonstrated an improvement in intracranial progression free survival (PFS) in patients with baseline brain metastases of 10.1 months compared to 6.5 months for chemotherapy (HR 0.53 (0.33-0.84); nominal p=0.0068). In patients who did not have baseline CNS metastases, the addition of ivonescimab also showed an improvement in intracranial PFS over control arm with 15.7 months compared to 11.6 months (HR 0.72 (0.55-0.94); nominal p=0.0172). No new safety signals were identified across baseline brain metastasis subgroups.

The second poster, "Health-Related Quality of Life in Patients Previously Treated with an EGFR-TKI from HARMONi: A Phase 3 Trial of Ivonescimab vs Placebo Plus Chemotherapy" includes data from patients enrolled in HARMONi (NCT06396065). These patients received either ivonescimab delivered in combination with chemotherapy, or chemotherapy alone in this global Phase III trial for patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with an EGFR TKI.

The third poster, "Health-Related Quality of Life with Ivonescimab Versus Pembrolizumab for PD-L1 Positive, NSCLC (HARMONi-2): a Randomised, Double-Blind, Phase 3 Study in China" includes data from patients enrolled in HARMONi-2 or AK112-303 (NCT05499390). These patients received either ivonescimab delivered as monotherapy, or pembrolizumab delivered as monotherapy in this Phase III study conducted exclusively in China for patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression with all data collected and analyzed by Akeso.

About the ELCC 2026 Posters

Poster Title: Intracranial Efficacy of Ivonescimab Plus Chemotherapy in EGFR TKI-Resistant, EGFR-Mutated NSCLC in the HARMONi Study
ELCC Presentation No.: 15P
Session Date & Time: Friday, March 27, 1:00 to 2:00pm CET

Poster Title: Health-Related Quality of Life in Patients Previously Treated with an EGFR-TKI from HARMONi: A Phase 3 Trial of Ivonescimab vs Placebo Plus Chemotherapy
ELCC Presentation No.: 20P
Session Date & Time: Friday, March 27, 1:00 to 2:00pm CET

Poster Title: Health-Related Quality of Life with Ivonescimab Versus Pembrolizumab for PD-L1 Positive, NSCLC (HARMONi-2): A Randomised, Double-Blind, Phase 3 Study in China
ELCC Presentation No.: 107P
Session Date & Time: Friday, March 27, 1:00 to 2:00pm CET

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF.

This is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. We believe ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, iScience, 2025). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, iScience, 2025) increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets.

Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 4,000 patients have been treated with ivonescimab in clinical studies globally, and over 60,000 patients when considering those treated in a commercial setting in China, as noted by Akeso.

There are currently 15 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, four of which are Summit-sponsored global studies, one of which is a multiregional study sponsored by a cooperative group, and ten of which are being or have been conducted in China by Akeso. Summit began its clinical development of ivonescimab in NSCLC, commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In 2025, the Company began enrolling patients in HARMONi-7. Summit expanded its Phase III clinical development program into CRC in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3.

HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI (e.g., osimertinib). Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization, which the FDA accepted for filing in January 2026; the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026.

HARMONi-3 is a Phase III clinical trial, which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous or non-squamous NSCLC, irrespective of PD-L1 expression.

HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

HARMONi-GI3 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy in patients with first-line unresectable metastatic CRC.

Also including Summit’s license territories, a Phase III study is planned to be conducted by GORTEC, a cooperative group dedicated to Head and Neck Oncology, in recurrent / metastatic head and neck squamous cell carcinoma (r/m HNSCC). ILLUMINE is a three-arm Phase III clinical trial which is intended to evaluate ivonescimab monotherapy, as well as ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, compared to monotherapy pembrolizumab in patients with PD-L1 positive r/m HNSCC.

In addition, Akeso has recently had positive read-outs in three single-region (China), randomized Phase III clinical trials, HARMONi-A, HARMONi-2, and HARMONi-6, for ivonescimab in NSCLC, including a statistically significant overall survival benefit in HARMONi-A with a manageable safety profile in each study.

HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI.

HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression.

HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression.

Akeso is actively conducting multiple Phase III clinical studies in settings outside of NSCLC, including biliary-tract cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, small cell lung cancer, colorectal cancer, and pancreatic cancer.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US FDA for the HARMONi clinical trial setting.

(Press release, Summit Therapeutics, MAR 27, 2026, View Source [SID1234663986])

On March 27, 2026 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for cancer and immunological diseases, reported the presentation of new clinical data for ZEGFROVY (sunvozertinib) as a first-line treatment in patients with advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) P-Loop and αC-helix compressing (PACC) or other uncommon mutations. The data were presented at the 2026 European Lung Cancer Congress (ELCC), held in Copenhagen, Denmark from March 25 to 28 (#44P).

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PACC mutations account for approximately 12.5% of all EGFR mutations. Approved EGFR kinase inhibitors may have clinical activities to certain types of mutations, but overall, their clinical benefits are rather limited, and chemo doublet are the only option. Multiple studies have shown that patients with these mutations exhibit poorer prognosis than those with classical EGFR common mutations (exon 19 deletions and L858R), underscoring a significant unmet medical need for effective, well-tolerated therapies with broader activity cross the EGFR mutation spectrum.

ZEGFROVY, a rationally designed oral EGFR TKI, has demonstrated robust clinical efficacy in advanced NSCLC and potent antitumor activity in preclinical models of EGFR PACC-mutant tumors. At the recommended phase 3 dose (RP3D) of 300 mg, ZEGFROVY monotherapy demonstrated promising antitumor activity and a manageable safety profile in treatment-naïve patients with advanced NSCLC harboring EGFR PACC or other uncommon mutations.

Per investigator assessment, tumor lesion shrinkage was observed in 100% of patients, with an overall response rate (ORR) of 81.3%, and a disease control rate (DCR) of 100%.
Tumor response was also observed in 11 out of 15 patients with previously-untreated baseline brain metastasis (BM), including 6 patients with confirmed partial response (PR).
The antitumor activity was durable. As of the data-cut-off (DCO) date, median duration of response (DoR) had not been reached, with 81.3% of patients remaining on ZEGFROVY treatment. The estimated 6-month durable response rate was 87.5%.
Progression-free survival (PFS) was not mature. The estimated 9-month PFS rate was 83.9%.
The safety profile was consistent with previous studies of ZEGFROVY. No new safety signals were observed.
Dr. Xiaolin Zhang, CEO of Dizal, said: "NSCLC patients with EGFR PACC and other uncommon mutations represent a population with substantial unmet medical need, given the limited availability of effective and well-tolerated target therapies, compared to those available for classical EGFR mutations. The data presented at ELCC further reinforces the potential of ZEGFROVY to address this gap. We are committed to advancing our clinical development programs, with the goal of bringing transformative treatment options to the global lung cancer community as quickly as possible."

ZEGFROVY is approved in the U.S. and China for the treatment of relapsed or refractory NSCLC with EGFR exon20ins. Recently, Dizal reported the results from the randomized Phase 3 WU-KONG28 study, comparing ZEGFROVY monotherapy with platinum containing chemo doublet. ZEGFROVY showed a statistically significant and clinically meaningful improvement in PFS in newly diagnosed patients with EGFR exon20ins. Detailed results will be presented at the upcoming scientific conference.

About ZEGFROVY(sunvozertinib)

ZEGFROVY is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. ZEGFROVY is approved in the U.S. and China for the treatment the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), whose disease has progressed on or after platinum-based chemotherapy. The approval in China is based on the results of the pivotal WU-KONG6 study in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The U.S. approval is supported by WU-KONG1 Part B, a multinational pivotal study investigating the efficacy and safety of ZEGFROVY in the same indication.

In addition, ZEGFROVY also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations, as well as HER2 exon20ins.

ZEGFROVY showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable.

WU-KONG28, a multinational, randomized Phase 3 study conducted across 16 countries and regions evaluating ZEGFROVY as first-line treatment for patients with EGFR exon20ins NSCLC, met its primary endpoint.

Pre-clinical and clinical results of ZEGFROVY were published in peer-reviewed journals Cancer Discovery, The Lancet Respiratory Medicine and Journal of Clinical Oncology.

(Press release, Dizal Pharma, MAR 27, 2026, View Source [SID1234663985])