On April 27, 2026 Secura Bio, Inc. (www.securabio.com), an integrated pharmaceutical company maximizing commercial outcomes for oncology medicines, reported the publication in the Journal of Clinical Oncology of the Phase 2 PRIMO data indicating that duvelisib, an oral dual inhibitor of PI3K-delta and PI3K-gamma, demonstrated significant clinical activity and tolerability in patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL).

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The PRIMO Phase 2 study was a global open-label, multi-center, single-arm trial investigating the safety and efficacy of duvelisib monotherapy in 123 adult R/R PTCL patients from the US, EU, UK, and Japan. The trial was conducted in two phases (dose optimization phase and dose expansion phase [PRIMO-EP]). The Journal of Clinical Oncology paper presents outcomes for 123 patients in the PRIMO-EP population. The trial demonstrated an overall response rate (ORR) of 48.0%, a complete response rate (CRR) of 33.3%, median progression-free survival (mPFS) of 3.4 months, and median overall survival (mOS) of 12.4 months. Currently available single agents have been observed to provide ORRs of less than 30% and CRRs below 15%.1-3

"PTCL is a rare, aggressive type of non-Hodgkin lymphoma, and relapsed and refractory PTCL is an area of tremendous unmet need. Currently, there are only limited treatments, and the treatments we have are effective for just a minority of patients and lack durability," said one of the lead authors Neha Mehta-Shah, MD, MSCI, Associate Professor of Medicine at Washington University in St. Louis. "Duvelisib has demonstrated potential for this difficult-to-treat population, with rapid and clinically meaningful responses overall, including a substantial proportion of patients achieving complete remission and durable responses among patients with the angioimmunoblastic T-cell lymphoma form of the disease. At the same time, in this population, duvelisib’s safety profile was manageable with appropriate prophylaxis and monitoring."

Duvelisib was dosed at 75 mg twice daily for two 28-day cycles, followed by 25 mg twice daily until progressive disease or unacceptable toxicity. Patients in the trial were heavily pretreated with a median (range) of two (1-9) prior anticancer therapies.

The safety profile observed in PRIMO was consistent with that seen in the previous duvelisib interim analyses of PRIMO, and adverse events were generally manageable with per-protocol dose modifications. The most frequently occurring treatment-emergent adverse events (TEAEs) occurring in ≥15% of patients were alanine aminotransferase increased (37.4%), aspartate aminotransferase increased (35.8%), neutrophil count decreased (33.3%), diarrhea (33.3%), platelet count decreased (26.0%), and fatigue (26.0%).

Deeper and more durable response in AITL subgroup

As reported in the Journal of Clinical Oncology, ORRs by baseline histology were highest in the AITL subgroup (62.2%), followed by the PTCL-NOS (49.1%) and ALCL (15.0%) subgroups. While not powered for subgroup comparisons, the AITL subgroup also differed meaningfully from the overall population as measured by CRR (51.4% vs. 33.3%), mPFS (8.3 vs. 3.4 months) and OS (18.1 vs. 12.4 months).

Based on these results, Secura Bio is conducting TERZO, a Phase 3 multicenter, open-label, randomized controlled clinical trial to evaluate duvelisib in R/R nodal T-follicular helper (TFH) cell lymphoma, in the European Union and the United Kingdom. The activity of duvelisib was particularly encouraging in the AITL subgroup of PRIMO (now classified as a subgroup of nodal TFH lymphoma). Click here for more information about the TERZO trial.

"The PRIMO data in AITL are especially promising because they provide a compelling biological rationale for duvelisib in TFH-derived lymphomas," said Christiane Langer, MD, Senior Vice President, Head of Clinical and Medical Affairs at Secura Bio. "The TERZO trial is designed to confirm that rationale, and we are excited to have already surpassed the 50% enrollment mark. We are looking forward to its completion next year."

Transplant subgroup outcomes

The Journal of Clinical Oncology paper also provides outcomes data on 19 patients who went on to receive stem cell transplant (SCT) at the time of treatment discontinuation (11 had a planned SCT, and 8 additional patients received unplanned SCT). Notably, the estimated 4-year overall survival in this cohort was 75%, supporting the potential role of duvelisib as an effective bridge to transplant in some patients with PTCL.

"We are encouraged by the fact that a significant number of patients went on to receive a transplant", said Dr. Langer. "For some patients, duvelisib may allow reconsideration of stem cell transplant by achieving disease control quickly enough to make this a realistic next step in their treatment journey."

Earlier PRIMO trial outcome data have supported duvelisib’s listing as a preferred treatment option for R/R PTCL within the National Comprehensive Cancer Network guidelines.4 In addition to Secura Bio’s Phase 3 TERZO trial, duvelisib is being studied in combination with CHOP as part of an intensive approach for patients with untreated PTCL in an ongoing US intergroup trial (A051902, NCT04803201).

About Peripheral T-cell Lymphoma
Peripheral T-cell lymphoma (PTCL) is a rare, aggressive type of non-Hodgkin lymphoma that develops in mature white blood cells that circulate through the bloodstream and lymphatic system. PTCL accounts for between 10-15% of all non-Hodgkin lymphomas and generally affects people aged 60 years and older. Although there are many different subtypes of PTCL, they often present in a similar way, with widespread, enlarged, typically painless lymph nodes in the neck, armpit, and/or groin. There are currently no well-established standards of care for patients with relapsed or refractory disease.5,6

About COPIKTRA (duvelisib)
COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K) and the first US approved dual inhibitor of PI3K-delta and PI3K-gamma pathways, two enzymes known to help support the growth and survival of malignant cells. PI3K signaling may lead to the proliferation of malignant cells and is thought to play a role in the formation and maintenance of a supportive tumor microenvironment. COPIKTRA is indicated in the United States for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior lines of systemic therapy.7 COPIKTRA is also being developed for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status in the United States and is being investigated in combination with other agents through investigator-sponsored studies. Treatment of T-cell lymphomas is a disease category for which COPIKTRA is not currently indicated. For more information on COPIKTRA, please visit www.COPIKTRA.com.

INDICATIONS AND USAGE

COPIKTRA (duvelisib) is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of systemic therapy.

Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality.

IMPORTANT SAFETY INFORMATION

Treatment-related mortality occurred in 15% of COPIKTRA treated patients.
Fatal and/or serious infections occurred in 31% (4% fatal) of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected.
Fatal and/or serious diarrhea or colitis occurred in 18% (<1% fatal) of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.
Fatal and/or serious cutaneous reactions occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Withhold COPIKTRA.
Fatal and/or serious pneumonitis occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA.

WARNINGS AND PRECAUTIONS

Treatment-related Mortality: In a randomized controlled trial in patients with relapsed or refractory CLL or SLL, treatment with COPIKTRA caused increased treatment-related mortality. With extended follow-up with a median of 63 months, treatment-related deaths occurred in 15% (23/158) of those patients in the overall population. In the indicated patient population, patients with relapsed or refractory CLL or SLL after at least two prior lines of systemic therapy. Treatment related deaths following treatment with COPIKTRA occurred in 14% (13/93) of patients. The most common cause of the treatment-related deaths were infections, which occurred in 9% and 11% of patients with relapsed or refractory CLL following at least one or two prior systemic therapies, respectively. COPIKTRA is not indicated and is not recommended for any patients in the initial or second-line treatment setting.

Infections: Serious, including fatal (18/442, 4%), infections occurred in 31% of patients receiving COPIKTRA. The most common serious infections were pneumonia, sepsis, and lower respiratory infections. Median time to onset of any grade infection was 3 months, with 75% of cases occurring within 6 months. Treat infections prior to initiation of COPIKTRA. Advise patients to report new or worsening signs and symptoms of infection. Cases of Pneumocystis jirovecii pneumonia (PJP) (1%) and cytomegalovirus (CMV) reactivation/infection (1%) occurred in patients taking COPIKTRA. Provide prophylaxis for PJP during treatment and following completion of treatment until the absolute CD4+ T cell count is greater than 200 cells/μL. Consider prophylactic antivirals during COPIKTRA treatment to prevent CMV infection, including CMV reactivation.

Diarrhea or Colitis: Serious, including fatal (1/442; 0.2%); diarrhea or colitis occurred in 18% of patients receiving COPIKTRA. Median time to onset of any grade diarrhea or colitis was 4 months, with 75% of cases occurring by 8 months. The median event duration was 0.5 months. Advise patients to report any new or worsening diarrhea.

Cutaneous Reactions: Serious, including fatal (2/442; 0.5%); cutaneous reactions occurred in 5% of patients receiving COPIKTRA. Fatal cases included drug reactions with eosinophilia and systemic symptoms (DRESS) and toxic epidermal necrolysis (TEN). Median time to onset of any grade cutaneous reaction was 3 months with a median event duration of 1 month. Presenting features for serious events were primarily described as pruritic, erythematous, or maculo-papular. Less common presenting features include exanthem, desquamation, erythroderma, skin exfoliation, keratinocyte necrosis, and papular rash. Advise patients to report new or worsening cutaneous reactions.

Pneumonitis: Serious, including fatal (1/442; 0.2%), pneumonitis without an apparent infectious cause occurred in 5% of patients receiving COPIKTRA. Median time to onset of any grade pneumonitis was 4 months with 75% of cases occurring within 9 months. The median event duration was 1 month with 75% of cases resolving by 2 months.

Hepatotoxicity: Grade 3 and 4 ALT and/or AST elevation developed in 8% and 2%, respectively, of patients receiving COPIKTRA (N=442). Two percent of patients had both an ALT or AST > 3 X ULN and total bilirubin > 2 X ULN. Median time to onset of any grade transaminase elevation was 2 months with a median event duration of 1 month. Monitor hepatic function during treatment with COPIKTRA.

Neutropenia: Grade 3 or 4 neutropenia occurred in 42% of patients receiving COPIKTRA (N=442), with Grade 4 neutropenia occurring in 24% of all patients. Median time to onset of grade ≥3 neutropenia was 2 months. Monitor neutrophil counts at least every 2 weeks for the first 2 months of COPIKTRA therapy, and at least weekly in patients with neutrophil counts < 1.0 Gi/L (Grade 3-4).

Embryo-Fetal Toxicity: COPIKTRA can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus and conduct pregnancy testing before initiating COPIKTRA treatment. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for 1 month after the last dose.

ADVERSE REACTIONS

B-cell Malignancies Summary

Fatal adverse reactions within 30 days of the last dose occurred in 8% (36/442) of patients treated with COPIKTRA 25 mg BID. Serious adverse reactions were reported in 289 patients (65%). The most frequent serious adverse reactions that occurred were infection (31%), diarrhea or colitis (18%), pneumonia (17%), rash (5%), and pneumonitis (5%). The most common adverse reactions (reported in ≥20% of patients) were diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.

CLL/SLL

Fatal adverse reactions within 30 days of the last dose occurred in 12% (19/158) of patients treated with COPIKTRA and in 4% (7/155) of patients treated with ofatumumab. Serious adverse reactions were reported in 73% (115/158) of patients treated with COPIKTRA and most often involved infection (38%; 60/158) and diarrhea or colitis (23%; 36/158). The most common adverse reactions with COPIKTRA (reported in ≥20% of patients) were diarrhea or colitis, neutropenia, pyrexia, upper respiratory tract infection, pneumonia, rash, fatigue, nausea, anemia, and cough.

For specific information on the management of the adverse reactions above, please review Dose Modifications for Adverse Reactions within the full Prescribing Information.

DRUG INTERACTIONS

CYP3A4 Inducers: Coadministration with a strong or moderate CYP3A4 inducer may reduce COPIKTRA efficacy. Avoid coadministration with strong or moderate CYP3A4 inducers.

CYP3A4 Inhibitors: Coadministration with a strong CYP3A4 inhibitor may increase the risk of COPIKTRA toxicities. Reduce COPIKTRA dose when co-administered with a strong CYP3A4 inhibitor.

CYP3A4 Substrates: Coadministration of COPIKTRA with sensitive CYP3A4 substrates may increase the risk of toxicities of these drugs. Consider reducing the dose of the sensitive CYP3A4 substrate and monitoring signs of toxicities of the co-administered sensitive CYP3A4 substrate.

Please see the Prescribing Information, including Boxed Warning.

(Press release, Secura Bio, APR 27, 2026, View Source [SID1234664831])

On April 27, 2026 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported that the Company will host a key opinion leader (KOL) webinar to discuss data from an investigator-initiated trial on onvansertib’s single-agent clinical activity in chronic myelomonocytic leukemia (CMML). The webinar will take place on Thursday, April 30th, 2026, at 11:00 a.m. ET.

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The webinar will feature KOL Mrinal Patnaik, MBBS, a physician scientist with the Division of Hematology, Department of Internal Medicine at Mayo Clinic, Minnesota. He is the Chair of the Acute Leukemia and Myeloid Neoplasms group at Mayo Clinic, Rochester and is also the Scientific Director of the Epigenetics Developmental Laboratory and the Epigenomics Program. His main clinical and research interests lie in precision genomics and epigenetics and the application of the same to myeloid neoplasms and bone marrow failure syndromes. He directs the Mayo Clinic Clonal hematopoiesis Clinic (CHIP), bone marrow failure syndrome clinic and the short telomere clinic.

KOL Webinar Information

Interested parties can register for and access the live webcast by visiting the "Events" section of the Cardiff Oncology website. The webcast replay will be available after the conclusion of the discussion.

(Press release, Cardiff Oncology, APR 27, 2026, View Source [SID1234664830])

On April 27, 2026 Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics, reported that it met the key secondary endpoint of PFS and showed additional compelling results in the randomized COMPANION-002 study, which evaluated tovecimig plus paclitaxel versus paclitaxel alone in patients with unresectable advanced, metastatic or recurrent biliary tract cancer (BTC) treated in the second-line setting. The complete dataset, including Duration of Response (DoR), will be presented at a medical conference later this year.

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"In this study, tovecimig showed an impressive overall response rate which translated into a clinically meaningful and highly statistically significant improvement in PFS for patients with previously treated BTC. The remarkable 56% reduction in the risk of disease progression is unprecedented in this patient population without an actionable mutation in their tumor," said Thomas Schuetz, MD, PhD, Chief Executive Officer of Compass. "It is also notable that the 31 crossover patients survived a median of 12.8 months, similar to the median OS seen in front-line studies in this setting. Including crossover, 85% of patients in the study received tovecimig in combination with paclitaxel and the pooled median OS for all patients in the study was 8.9 months, which is also substantially longer than chemotherapy benchmarks of approximately 6 months."

"These findings reinforce our belief that tovecimig can address a significant unmet need for patients with limited and insufficient treatment options. We are immensely grateful to the patients, investigators, and clinical teams who made this study possible, and we look forward to presenting the full dataset at an upcoming medical meeting. We are now focused on engaging with the FDA to bring this much needed therapy to the cholangiocarcinoma community as quickly as possible."

"Patients with advanced biliary tract cancer have an urgent need for better treatment options," said Juan Valle, MD, Chief Medical Officer of the Cholangiocarcinoma Foundation. "These results are a significant step forward and I anticipate that, if approved, it will meaningfully change the way physicians care for these patients. I also applaud Compass for putting patients first in the design of this study by allowing patients to crossover to receive treatment with tovecimig. These patients clearly benefited from this innovative therapy. I look forward to supporting Compass as they work to bring tovecimig to patients with cholangiocarcinoma."

COMPANION-002 Data Summary:

Primary Endpoint (previously announced in April 2025):

Overall Response Rate: 17.1% ORR for tovecimig in combination with paclitaxel (19 of 111 patients) including one complete response, compared to 5.3% for paclitaxel alone (3 of 57 patients), in patients with BTC in the second line setting. This 11.8% improvement in ORR for those receiving tovecimig was statistically significant (p=0.031). All responses were assessed by blinded independent central review (BICR).
Key Secondary Endpoints:

Progression-Free Survival (PFS): Tovecimig in combination with paclitaxel demonstrated a statistically significant improvement in median PFS of 4.7 months compared to 2.6 months for paclitaxel alone (HR=0.44, p<0.0001). Progression was confirmed in each case by BICR.
Overall Survival (OS): Tovecimig did not meet the OS secondary endpoint due to high crossover from the control arm (31 of 57 patients, or 54%) and prolonged survival of those crossover patients after receiving tovecimig, as further described below. As a result of this crossover, 85% (142 of 168) of patients in the study received tovecimig plus paclitaxel with a pooled OS in the study of 8.9 months.

In the ITT OS analysis, tovecimig in combination with paclitaxel had a median OS of 8.9 months compared to 9.4 months for the control arm, which included 26 patients (46%) who received paclitaxel alone and 31 patients (54%) who crossed over to receive tovecimig in combination with paclitaxel (HR=1.05, p=0.78). In the rank-preserving structural failure time (RPSFT) OS analysis, the combination also had a median OS of 8.9 months compared to 9.4 months for paclitaxel alone (HR=1.13, p=0.65). Though the RPSFT analysis is intended to adjust for crossover, its validity depends on certain assumptions that were not met in this study and thus its results here are largely uninterpretable.
Progression-Free Survival of Crossover Patients (PFS2): An additional, pre-specified secondary endpoint analyzed PFS in the patients in the paclitaxel arm who crossed over to receive tovecimig plus paclitaxel. In this analysis, the pre-crossover PFS (PFS1) on paclitaxel alone was compared to PFS with tovecimig post-crossover (PFS2) in the same crossover patients (n=31). In this subset, tovecimig demonstrated a statistically significant improvement with median PFS2 of 3.5 months after treatment with tovecimig compared to median PFS1 of 1.9 months for paclitaxel (HR=0.36, p=0.0016).
Post Hoc Subset Analyses:

OS of Paclitaxel Control Arm (Crossover vs. Non-Crossover): In an analysis of OS in all patients randomized to the paclitaxel control arm (n=57), crossover patients who subsequently received tovecimig demonstrated a statistically significant improvement in median OS of 12.8 months compared to 6.1 months for non-crossover patients who received only paclitaxel (HR=0.54, p=0.04).
PFS of Paclitaxel Control Arm (Crossover vs. Non-Crossover): Another analysis of these same patients randomized to the paclitaxel control arm (n=57) demonstrated that the crossover patients initially progressed faster on paclitaxel monotherapy compared to the non-crossover patients, with a median PFS of 1.9 months versus 3.6 months (HR=2.31, p=0.007). Thus, notably, despite progressing more quickly on initial paclitaxel monotherapy, crossover patients still demonstrated a statistically significant median 12.8 months OS after being treated with tovecimig.
Safety:

Tovecimig was generally well tolerated and the safety profile was consistent with previously reported data from prior studies, with no new safety signals. The most commonly reported treatment emergent adverse events in the tovecimig combination arm were hypertension (69%) and fatigue (67%). The most common related treatment-emergent adverse events of Grade 3 or higher included hypertension (44%) and neutropenia (36%).
BTC is estimated to affect approximately 26,500 patients annually in the United States. For the vast majority of patients with BTC whose tumors do not harbor an actionable mutation with an approved targeted therapy, there is currently no FDA-approved treatment in the second line setting. The therapeutics most commonly used in this setting, which are not labeled or approved by the FDA for the treatment of patients with BTC, generally have an ORR of ~5% or less and patients face a median OS of approximately six months.

In the coming months, Compass intends to meet with the U.S. Food and Drug Administration (FDA) to discuss these data in advance of a planned BLA submission.

Webcast Information
Compass will host a webcast today, Monday, April 27, 2026 at 8:00 a.m. ET to provide a review of the tovecimig secondary endpoints COMPANION-002 data. Interested parties may register for the call-in advance via View Source;tp_key=efc315f5a6.

A replay of the webcast will be available via the Investors section of the Compass website at investors.compasstherapeutics.com.

About COMPANION-002
COMPANION-002 is a Phase 2/3 randomized, controlled study of tovecimig in patients with unresectable advanced, metastatic or recurrent biliary tract cancers who have received one prior systemic chemotherapy regimen (clinical trial information: NCT05506943). The study enrolled 168 adult patients, randomized in a 2:1 ratio to receive tovecimig plus paclitaxel (n=111) or paclitaxel alone (n=57). All patients were dosed with 80 mg/m2 of paclitaxel on days 1, 8 and 15 of every 28-day cycle. Patients in the tovecimig arm were also dosed with 10 mg/kg of tovecimig on days 1 and 15 of each 28-day cycle. The primary endpoint of the trial is ORR as confirmed by blinded independent central radiology review and secondary endpoints include PFS, OS, and DoR, among others. Patients in the paclitaxel-only arm who progressed could cross over to the tovecimig plus paclitaxel arm after centrally confirmed progression if they also still met the enrollment criteria for the study.

About Tovecimig (CTX-009)
Tovecimig is an investigational bispecific antibody that is designed to simultaneously block Delta-like ligand 4 (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization. Preclinical and clinical data of tovecimig suggest that blockade of both pathways provides robust anti-tumor activity across several solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic and non-small cell lung cancer.

(Press release, Compass Therapeutics, APR 27, 2026, View Source [SID1234664829])

On April 27, 2026 Apollomics Inc. (Nasdaq: APLM), a clinical-stage biopharmaceutical company advancing innovative oncology therapies to transform the treatment landscape for patients with few or no options, reported financial results for the full year ended December 31, 2025.

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"Our primary focus is to advance the global development of vebreltinib for the treatment of patients with c-MET alterations across different tumors," said Hung-wen (Howard) Chen, Chief Executive Officer of Apollomics. "Based on guidance from the U.S. Food and Drug Administration (FDA), we anticipate submitting an Investigational New Drug Application for accelerated approval of vebreltinib for second-line treatment for non-small cell lung cancer (NSCLC) patients with c-MET amplification in the first half of 2027."

Pipeline Update

Vebreltinib (APL-101) – a highly specific, CNS-penetrant c-MET inhibitor for treating NSCLC, brain tumors, and other solid tumors with MET dysregulation. It also shows significant potential in combination regimens, particularly with EGFR inhibitors.
The China rights of APL-101 were out-licensed to Apollomics’ partner, Beijing Avistone Biotechnology Co., Ltd., while Apollomics retains the global (ex-China) rights.
Vebreltinib has been approved by China’s National Medical Products Administration (NMPA) for three distinct indications: METex14 skipping NSCLC, MET-amplified NSCLC, and PTPRZ1-MET fusion high-grade gliomas. Notably, it is the first c-MET inhibitor approved for the latter two conditions.
The Company is advancing global development of vebreltinib, prioritizing NSCLC with c-MET amplification while expanding its application across diverse MET alterations and tumor types. Simultaneously, the Company is investigating strategic combinations with other tumor inhibitors to fully maximize vebreltinib’s therapeutic potential.
The Phase 2 component of the SPARTA clinical study, APL-101-01, is an ongoing open-label multi-cohort study for evaluation of efficacy and safety of vebreltinib for the treatment of a number of solid tumors, including NSCLC with MET Exon 14 skipping, NSCLC with c-MET amplification, brain tumors with MET fusion or MET amplification and other solid tumors with MET amplification or MET fusion. Apollomics is currently conducting the ongoing Phase 2 portion of the global SPARTA study at approximately 25 study sites in over 10 countries in North America, Europe and Asia-Pacific. As of April 2026, over 282 subjects have enrolled in the SPARTA study.
Interim efficacy and safety data from the global multi-cohort Phase 2 SPARTA trial and from the multi-cohort Phase 2 KUNPENG trial demonstrated that vebreltinib appeared efficacious in NSCLC patients with MET Exon14 skipping mutation with or without co-occurring MET amplification.
In March 2025, the Company announced a development and commercialization agreement for vebreltinib with LaunXP International Co., Ltd., an affiliate of LaunXP Biomedical Co., Ltd (Collectively, "LaunXP"). LaunXP will receive exclusive development and commercialization rights for vebreltinib in combination with an EGFR inhibitor in Asia (excluding mainland China, Hong Kong and Macau) for the treatment of NSCLC.
Apollomics is committed to expanding its clinical pipeline through ongoing collaborations with global partners. These efforts will focus on investigating new combination therapies that maximize vebreltinib’s efficacy, ensuring the asset’s potential is fully realized across diverse patient populations.

Immuno-Oncology Product Candidates
APL-501 (Anti-PD-1 antibody): APL-501 is an investigational, humanized, IgG4 monoclonal antibody that selectively binds to PD-1 on T lymphocytes and other immune cells. The China rights of APL-501 were out-licensed to Apollomics’ partner, Edding Genor Group Holdings Ltd., while Apollomics retains the global (ex-China) rights. Data from a Phase 1 study in advanced or relapsed/refractory solid tumors in Australia are currently being analyzed.
APL-502 (benmelstobart, anti-PD-L1 antibody): APL-502 is a novel IgG1 humanized monoclonal antibody against PD-L1. The China rights of APL-502 were out-licensed to Apollomics’ partner, Chia Tai-Tianqing Pharmaceutical Holdings Co., Ltd. (CTTQ), while Apollomics retains the global (ex-China) rights.
APL-502 (also known as TQB-2450 in China) has been approved by China’s NMPA for three distinct indications: extensive-stage small cell lung cancer, recurrent/metastatic endometrial cancer, and late-stage unresectable or metastatic renal cell carcinoma. Ongoing clinical trials include the following tumor types: NSCLC, esophageal cancer, ovarian cancer, hepatocellular carcinoma, cholangiocarcinoma, primary mediastinal large B cell lymphoma, and alveolar soft part sarcoma.

Business Highlights

New senior management team: In September 2025, Apollomics appointed a new management team, led by Hung-wen (Howard) Chen, Chief Executive Officer, and Yi-kuei (Alex) Chen, Chief Operating Officer, and Peter Lin, Chief Financial Officer.
Positive Turnaround Developments: With the appointment of a new board of directors and management team, the Company has made meaningful progress executing its strategic turnaround plan. In 2025, the Company successfully implemented significant cost reduction initiatives to streamline operations and enhance financial discipline. In parallel, Apollomics has strengthened its financial and legal position through the resolution of legacy matters, including the settlement of the Cayman litigation in November 2025, and the clearance of substantial outstanding legal and clinical program-related obligations. Furthermore, Apollomics has a renewed commitment to advancing its pipeline, including the relaunch of a previously paused clinical program for vebreltinib.
Full Year 2025 Financial Results

Cash, cash equivalents, bank deposits and money market funds as of December 31, 2025, were approximately $3.3 million, compared with $9.8 million as of December 31, 2024. In September 2025, the Company raised $4.1 million in a private investment in public equity (PIPE) financing, before transaction expenses.
Revenue for the full year 2025 was $8.5 million compared to $0 for full year 2024. Revenue in 2025 is a result of the upfront payment related to the LaunXP licensing agreement for the development and commercialization in Asia (excluding mainland China, Hong Kong and Macau) of vebreltinib.
Research and development expenses were approximately $5.5 million for full year 2025, compared to approximately $24.6 million for full year 2024.
General and administrative expenses were approximately $12.4 million for full year 2025, compared to approximately $17.8 million for full year 2024.
Net loss for the full year 2025 was $(10.9) million, or $(7.57) per diluted share, compared with a net loss of $(53.9) million, or $(52.80) per diluted share, for the full year 2024.
As part of its strategic turnaround plan, Apollomics significantly reduced costs and expenses in 2025 compared to the previous year. For the full year 2025, operating expenses were $19.8 million compared to $55.7 million for the prior year, representing a 64% decrease year-over-year.

(Press release, Apollomics, APR 27, 2026, View Source [SID1234664828])

On April 27, 2026 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including metastatic triple-negative breast cancer ("mTNBC") and colorectal cancer ("mCRC"), reported the successful enrollment and initial dosing of the first participant in its Expanded Access Program (EAP) for patients with triple-negative breast cancer (TNBC).

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The EAP is designed to provide eligible patients access to leronlimab outside of a clinical study setting. The program is intended for patients who have exhausted available treatment options and are not eligible for ongoing or planned clinical studies, in accordance with U.S. Food and Drug Administration (FDA) guidelines.

"Dosing the first patient in our EAP marks an important step in making leronlimab available to individuals with urgent unmet medical needs, while also advancing our understanding of CCR5 biology in the treatment of aggressive cancers," said Jacob Lalezari, M.D., CEO of CytoDyn. "Data generated through this program may further inform how CCR5 inhibition influences the tumor microenvironment, including its potential role in modulating PD-L1 expression and supporting combination approaches with immune checkpoint inhibitors."

"For patients with advanced triple-negative breast cancer who have exhausted standard treatment options, expanded access programs can provide additional avenues for care," said Namita Chittoria, M.D., Assistant Professor at the Huntsman Cancer Institute and the University of Utah, and a member of CytoDyn’s Scientific Advisory Board. "Leronlimab is an investigational therapy being evaluated in this difficult-to-treat setting, and access outside of a clinical study may offer a meaningful option for select patients – both as an additional treatment opportunity and as a way to preserve valuable time with family. Beyond individual use, these programs also inform our understanding of emerging therapies."

In addition to providing compassionate access, the EAP is expected to generate real-world insights into the biological activity of leronlimab in heavily pretreated patients. Recent data, presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, highlight the potential role of CCR5 inhibition in modulating the tumor microenvironment in metastatic triple-negative breast cancer, with observed associations in PD-L1 expression and broader immune signaling pathways. Together, these findings provide a scientific foundation for the EAP and support continued exploration of leronlimab as a strategy to enhance responses to immune checkpoint inhibitor (ICI) therapies.

To support execution of the program, the Company has engaged With Every Patient (WEP Clinical) as the clinical research organization to support program execution, including patient identification, site coordination, and regulatory compliance. The EAP is now open for physician referrals, and CytoDyn expects to expand participation as additional sites are activated. The program will operate under applicable U.S. Food and Drug Administration (FDA) guidelines, and additional information for physicians and eligible patients, including referral details, is available on the Company’s website at www.cytodyn.com.

(Press release, CytoDyn, APR 27, 2026, View Source [SID1234664827])