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Humanetics Corporation Announces Investigator-Initiated Phase 2 Trial in Patients with Non-Small Cell Lung Cancer and Underlying Interstitial Lung Disease

On March 31, 2026 Humanetics Corporation (Humanetics) reported the launch of a new investigator-initiated clinical trial (IIT) of BIO 300 Oral Suspension (BIO 300), led by Dr. Narek Shaverdian, Director of Thoracic Radiation Oncology at Memorial Sloan Kettering Cancer Center (MSK). This study is designed to evaluate the efficacy of BIO 300 in reducing the toxicity of thoracic radiation therapy in patients with non-small cell lung cancer (NSCLC) and concomitant interstitial lung disease (ILD), compared to historical results. The trial will enroll approximately 24 participants at MSK in New York.

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BIO 300 is a promising candidate in the development pipeline for Humanetics, aimed at improving quality-of-life outcomes for patients receiving radiation therapy for NSCLC, head and neck cancer, and prostate cancer. The product has shown strong potential across complementary therapeutic areas, including inflammatory lung diseases.

Initial clinical research of BIO 300 in NSCLC found lower rates of hematological, pulmonary, and gastrointestinal toxicities compared to historical controls. In multiple clinical studies, the product has been found to be safe and well-tolerated, with no dose-limiting toxicities reported to date.

"Patients with NSCLC and interstitial lung disease represent a historically high-risk population for standard therapies," said Dr. Shaverdian. "This trial aims to develop a new strategy that would allow us to deliver thoracic radiation more safely and effectively through the use of BIO 300, potentially expanding treatment options and improving outcomes for these patients."

This study is a single-arm, prospective, phase II trial that will evaluate the time to Grade ≥ 3 pneumonitis, defined as the time from completion of radiation therapy to the occurrence of Grade ≥ 3 pneumonitis as the primary endpoint. Secondary endpoints include safety assessments, pulmonary function testing, and patient-reported quality of life. The first participant was enrolled in January 2026.

"As BIO 300 has been shown to be safe, while demonstrating efficacy in patients with NSCLC, we believe the same effect can be shown in patients with NSCLC in the setting of ILD," said Dr. Michael D. Kaytor, Chief Scientific Officer at Humanetics. "We are extremely enthusiastic about this clinical study, and the commitment of Dr. Shaverdian and the team at MSK."

(Press release, Humanetics, MAR 31, 2026, View Source [SID1234664096])

CellCentric Initiates DOMMINO-1, a Pivotal Phase 2 Clinical Trial of Inobrodib in Combination with Pomalidomide and Dexamethasone (InoPd) in Relapsed or Refractory Multiple Myeloma

On March 31, 2026 CellCentric, a clinical-stage biotechnology company developing inobrodib as a first-in-a-class, oral p300/CBP inhibitor for the treatment of multiple myeloma, reported the initiation of DOMMINO-1, a pivotal Phase 2 clinical trial evaluating inobrodib 20 mg in combination with standard doses of pomalidomide (pom) and dexamethasone (dex; InoPd) in heavily pretreated patients with relapsed or refractory multiple myeloma (RRMM). The first patient was dosed at The Royal Marsden NHS Foundation Trust in London. Additional sites are now open in the UK and U.S.

"Dosing the first patient in DOMMINO-1 marks an important milestone as we advance InoPd in registration-enabling studies," said Naseer Qayum M.D., Ph.D., Chief Strategy Officer and Head of R&D at CellCentric. "Inobrodib 20 mg with pom + dex has demonstrated encouraging clinical activity, including a 60% objective response rate, and a tolerability profile consistent with pom-dex alone. Patients who are refractory to pomalidomide and have progressed following bispecifics or other BCMA-directed therapies have very limited options. We believe InoPd may deliver a transformative all-oral treatment for RRMM patients and look forward to further evaluating its potential in this Phase 2 trial."

Care for patients with multiple myeloma has transformed over the last two decades. It is a condition treated with serial therapeutic options. Inobrodib represents a new modality complementary to existing treatments and potentially addresses a major unmet need.

"Advances in multiple myeloma treatment, including bispecific antibodies, have improved patient outcomes. However, many people ultimately relapse or become refractory to these therapies, and new treatment options are urgently needed," said Charlotte Pawlyn, M.D., Honorary Consultant Hematologist at The Royal Marsden NHS Foundation Trust, Group Leader in Myeloma Biology and Therapeutics at The Institute of Cancer Research, London, and Principal Investigator for the DOMMINO‑1 study. "Inobrodib represents a novel mechanism through inhibition of p300/CBP and has demonstrated the ability to be used in combination with established therapies. We look forward to further evaluating InoPd in this trial."

DOMMINO-1 is a Phase 2 open-label, single-arm study enrolling 100 adult patients across clinical sites in the UK and U.S. (NCT07096778). The trial is designed to assess the safety and efficacy of InoPd, with participants receiving inobrodib at a 20 mg dose, as supported by recent dose-optimization work (Project Optimus), shared with the U.S. Food and Drug Administration (FDA) and other regulatory agencies. The primary endpoint is overall response rate, with secondary endpoints including progression-free survival, overall survival and duration of response. Eligible participants in this study, specifically, must have previously received a bispecific antibody and be refractory to at least one proteasome inhibitor, one anti-CD38 monoclonal antibody and pomalidomide.

"InoPd appears to be a promising option in multiple myeloma treatment, not only for its tolerability and efficacy observed to date, but also for the practical benefits it may offer patients," said Nisha Joseph, M.D., Associate Professor, Department of Hematology and Medical Oncology, Emory University School of Medicine in Atlanta and DOMMINO-1 principal investigator at the first U.S. trial site. "More than 70% of patients are treated in the community setting, and an all-oral regimen may facilitate and expand access for those living with this disease, as well as their caregivers and healthcare providers."

About Inobrodib

Inobrodib is a potential new treatment for people with multiple myeloma and other cancers. It has been evaluated in over 450 patients to date. Clinical activity has been seen in both hematologic malignancies and solid tumors. Delivered as an oral capsule, inobrodib is easy for patients to take and designed to be used at home without the need for intensive monitoring.

Alongside InoPd, inobrodib is also being explored in combination with bispecific therapies elranatamab and teclistamab. Proof of concept in a maintenance setting is also being explored. CellCentric maintains all development and commercial rights to inobrodib and is free to expand the program in combination with other agents. The U.S. FDA previously granted Fast Track and Orphan Drug Designations to inobrodib for RRMM.

(Press release, CellCentric, MAR 31, 2026, View Source [SID1234664095])

Ivonescimab Shows Quality of Life Benefits in Chemotherapy-Free First-Line NSCLC: Health-Related Quality of Life Data from the HARMONi-2 Study Presented at ELCC 2026

On March 31, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported the results of health-related quality of life (HRQoL) data (Poster: 107P) from the HARMONi-2 study at the 2026 European Lung Cancer Congress (ELCC). The study evaluated ivonescimab, the company’s first-in-class PD-1/VEGF bispecific antibody, versus pembrolizumab as a first-line treatment for patients with PD-L1–positive non-small cell lung cancer (NSCLC).

In the primary analyses of HARMONi-2, ivonescimab demonstrated a median progression-free survival (PFS) of 11.14 months compared with 5.82 months for pembrolizumab (HR = 0.51; P < 0.0001), representing a 49% reduction in the risk of disease progression or death, with a manageable safety profile. The exploratory analysis presented at ELCC 2026 focuses on the other key pillar of treatment evaluation: HRQoL. The HRQoL analysis was conducted with the QLQ-C30, QLQ-LC13, and EQ-5D-5L instruments, showed that in the chemotherapy-free setting, ivonescimab not only significantly extended PFS but also delivered meaningful improvements in health-related quality of life. These findings provide additional, robust evidence to support the broad clinical use of ivonescimab and reinforce its role as a new standard of care (SOC) in first-line lung cancer treatment.

Key Findings:

Global health and functional status with sustained improvements and delayed deterioration:

In the primary analysis of HARMONi-2, in the ivonescimab group, the median time to deterioration (TTD) in global health status/quality of life (GHS/QoL) was not reached (vs 9.9 months for pembrolizumab), and the 12-month deterioration-free rate was 51% (vs 46%). The results published at ELCC2026, scores for GHS/QoL, physical function, and emotional function improved from baseline in both arms. In the ivonescimab arm, the mean GHS/QoL score increased from 71.8 (SD 17.6) at baseline to 78.5 (SD 15.9) at week 12 and remained stable at 78.5 (SD 16.0) at week 30. In the pembrolizumab arm, the mean score improved from 73.6 (SD 17.5) at baseline to 76.7 (SD 16.6) at week 12 and decreased slightly to 76.5 (SD 16.9) by week 30.

Better control of key lung cancer symptoms, with a sustained advantage in dyspnea:

According to the EORTC QLQ-LC13 lung cancer-specific questionnaire, patients in the ivonescumab group experienced sustained reductions in scores for cough, hemoptysis, and dyspnea.

Cough: Median TTD was not reached; the mean score decreased from 29.9 (SD 23.3) at baseline to 19.0 (SD 18.2) at week 12 and 19.6 (SD 21.7) at week 30.

Hemoptysis: The mean score decreased from 7.2 (SD 14.6) at baseline to 2.9 (SD 9.5) at week 30.

Dyspnea: Ivonescumab showed a trend toward superior long-term control, with the mean score decreasing from 17.5 (SD 16.0) at baseline to 12.1 (SD 14.6) at week 30.

High and stable health utility values:

On the EQ-5D-5L visual analog scale (VAS), the mean health status score increased from 81.9 (SD 13.5) at baseline to 84.3 (SD 10.6) at week 12 and remained high at 83.7 (SD 11.4) at week 30. Health utility values, which reflect overall patient well-being, remained consistently high throughout ivonescimab treatment, with mean values of approximately 0.9 (SD 0.1) at baseline, week 12, and week 30.

Based on the HARMONi-2 results, ivonescimab became the first therapy to show a significant PFS benefit over pembrolizumab in a head-to-head Phase III study. Ivonescimab was approved in 2025 in China as a first-line treatment for patients with PD-L1-positive NSCLC, establishing a novel, more effective, and safer chemotherapy-free option. To date, the breakthrough clinical value of ivonescimab has been demonstrated in dozens of clinical trials and real-world experience involving more than 70,000 patients.

(Press release, Akeso Biopharma, MAR 31, 2026, View Source [SID1234664094])

Hoth Therapeutics Announces Issuance of Chinese Patent for Cancer Cell-Targeting Technology

On March 31, 2026 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company focused on developing innovative therapies for unmet medical needs, reported that the China National Intellectual Property Administration (CNIPA) has granted Chinese Patent, titled "Targeting Kit with Splice Switching Oligonucleotides to Induce Apoptosis of Mast Cells."

The patent, originally filed under PCT Application No. PCT/US2019/048400 and developed by North Carolina State University, strengthens Hoth’s intellectual property portfolio and provides protection in a key global market through August 27, 2039, subject to maintenance requirements.

The granted patent relates to a novel therapeutic platform utilizing splice-switching oligonucleotides designed to selectively induce apoptosis in mast cells, which play a central role in a variety of inflammatory and immunological conditions.

"This patent grant in China represents an important milestone in expanding our global intellectual property protection for this innovative platform," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "We believe this technology has broad potential across multiple indications where mast cell activity contributes to disease, and this issuance further strengthens our position as we advance development."

(Press release, Hoth Therapeutics, MAR 31, 2026, View Source [SID1234664093])

Abbisko Therapeutics’ FGFR4 Inhibitor Irpagratinib Granted Orphan Drug Designation by EMA for Hepatocellular Carcinoma

On March 31, 2026 Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter, HKEX code: 02256) reported that its independently developed, highly selective, oral small-molecule FGFR4 inhibitor irpagratinib (ABSK-011), has been granted Orphan Drug Designation (ODD) by the European Medicines Agency (EMA) for the treatment of hepatocellular carcinoma (HCC). Irpagratinib is currently being evaluated in multiple clinical studies across different regions globally. The ODD granted by the EMA is expected to strongly support the product’s clinical development, regulatory filings, and commercialization in Europe.

Orphan Drug Designation is a key incentive established by the EMA to facilitate the development and authorisation of medicines for rare diseases. The ODD granted to irpagratinib not only reflects regulatory recognition of its potential clinical value and need, but also provides access to a range of incentives, including eligibility for protocol assistance (PA), regulatory fee reductions, and 10 years of market exclusivity after marketing authorisation—thereby providing a strong foundation for future registration and commercialization.

Primary liver cancer ranks as the third leading cause of cancer-related mortality worldwide, with HCC accounting for approximately 75%–85% of cases. Currently, immune checkpoint inhibitors (ICIs) combined with anti-angiogenic therapy have become the standard first-line treatment for advanced HCC. However, effective second-line and later-line options remain limited. Additionally, approximately 30% of HCC patients exhibit FGF19 overexpression, and this subgroup tends to derive limited benefit from first-line targeted immunotherapy combinations. As there are no approved therapies targeting the FGFR4/FGF19 signaling pathway, significant unmet medical needs remain for patients with FGF19 overexpression under the current standard of care.

Irpagratinib is a highly selective, orally administered small-molecule FGFR4 inhibitor independently developed by Abbisko Therapeutics. In prior clinical studies, irpagratinib has demonstrated favorable safety and tolerability along with antitumor activity both as a monotherapy and in combination regimens in patients with FGF19-overexpressing advanced HCC. Currently, multiple clinical trials of irpagratinib are underway globally in patients with FGF19-overexpressing advanced HCC, including studies evaluating irpagratinib in combination with different targeted-immunotherapies in the first-line setting, as well as monotherapy in the second-line and later-line settings. Among these, the pivotal registrational study of irpagratinib monotherapy administered the first patient dose in June 2025 and currently involves more than 50 clinical research centers across China, and is progressing smoothly.

In addition to the EMA ODD, irpagratinib has previously been granted ODD and Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA), as well as Breakthrough Therapy Designation (BTD) by China’s National Medical Products Administration (NMPA). Leveraging the expedited review advantages provided by these regulatory designations, Abbisko Therapeutics will continue to advance the global clinical development and regulatory filings of irpagratinib, with the goal of bringing this innovative therapy to patients with hepatocellular carcinoma worldwide as early as possible and providing a new safe and effective precision treatment option for this challenging disease.

About Irpagratinib (ABSK-011)

Irpagratinib is a highly-selective FGFR4 small molecule inhibitor designed to target overexpression of the FGF19 signaling pathway. Several epidemiological studies indicate that approximately 30% of HCC patients worldwide exhibit FGF19 overexpression. Development of targeted therapies against FGFR4 represent an innovative and novel approach to the treatment of HCC.

To date, no FGFR4 inhibitor has been granted regulatory approval globally. According to Frost & Sullivan, irpagratinib is expected to become the first breakthrough treatment for the treatment of HCC patients with FGF19 overexpression.

In addition to monotherapy, Abbisko Therapeutics is exploring irpagratinib in combination with atezolizumab, an anti-PD-L1 antibody manufactured by F. Hoffmann-La Roche and Roche (China), in a Phase II study. At the the 2025 ESMO (Free ESMO Whitepaper) GI Congress, Abbisko presented clinical data showing that the combination of irpagratinib and atezolizumab achieved an objective response rate (ORR) exceeding 50% and a median progression-free survival (mPFS) of more than 7 months in FGF19-overexpressing HCC patients previously treated with immune checkpoint inhibitors.

(Press release, Abbisko Therapeutics, MAR 31, 2026, View Source [SID1234664092])