Pharmaceutical Industry 29 June – 5 July: Ft Agomab Therapeutics and Racura Oncology
- Agomab Therapeutics is preparing to begin dosing patients in its phase 2b NOV-ERA study of ontunisertib for fibrostenosing Crohn’s disease in the second half of 2026.
- Racura Oncology has treated the first patient in its phase 1 HARNESS-1 trial of RC220 for EGFR-mutant non-small cell lung cancer.
Two Clinical Programmes Signal Progress in Difficult-to-Treat Diseases
Agomab Therapeutics and Racura Oncology have each announced important progress in their clinical development programmes, with new studies targeting two very different, but highly challenging, areas of medicine: fibrostenosing Crohn’s disease and EGFR-mutant non-small cell lung cancer.
For Agomab, the focus is on ontunisertib, an investigational oral, GI-restricted ALK5 inhibitor being developed for fibrostenosing Crohn’s disease, also known as FSCD.
The company has confirmed the design of its phase 2b NOV-ERA study following alignment with the US Food and Drug Administration on key elements of the trial. Dosing is expected to begin in the second half of 2026.
For Racura Oncology, the milestone is the first patient treated in its phase 1 HARNESS-1 clinical trial of RC220, also known as E,E-bisantrene, in patients with EGFR-mutant non-small cell lung cancer, or NSCLC.
The first participant received RC220 at 50mg/m² in combination with the standard-of-care tyrosine kinase inhibitor osimertinib, marketed by AstraZeneca as Tagrisso, with no adverse events observed during or after infusion.
Together, the updates underline the steady, careful work that sits behind late-stage and early-stage drug development. They also reflect the pharmaceutical sector’s growing focus on disease areas where existing treatment options remain limited, incomplete or vulnerable to resistance.
Agomab Targets a Major Unmet Need in Crohn’s Disease
Agomab’s NOV-ERA study is being positioned as a landmark trial in fibrostenosing Crohn’s disease, a complication that affects around 46% of Crohn’s disease patients. The condition is marked by fibrotic strictures in the intestinal tract, which can lead to obstructive symptoms, dietary changes, malnutrition and, in many cases, surgery.
Despite the scale of the problem, Agomab said there are currently no approved pharmacological therapies for FSCD. That gives the NOV-ERA study particular significance, not only for the company’s own pipeline, but for a patient population that has long had few non-surgical options.
The company has agreed the study’s primary efficacy endpoint with the FDA. The endpoint will focus on endoscopic passability at Week 24, assessed using the SES-CD narrowing score.
In practical terms, the study will examine whether treatment can improve the ability to pass through strictures endoscopically, an important marker in a disease where narrowing of the intestine can be clinically serious.
The trial protocol has already been submitted to the FDA and has cleared central IRB approval in the United States. It has also received approval from Health Canada.
Clinical Trial Applications have additionally been filed across several territories, including the European Union and Asia Pacific, showing that Agomab is preparing for a broad clinical development footprint.
NOV-ERA Study Design Sets Out Dose-Ranging Pathway
The NOV-ERA study will be a randomised, double-blind, placebo-controlled, dose-ranging phase 2b trial. It is expected to enrol up to 320 adults with symptomatic fibrostenosing Crohn’s disease.
Eligible participants must have at least one naive or anastomotic, endoscopically non-passable ileal stricture, confirmed by centrally read SES-CD.
Following a six-week screening period, patients will be randomised on a 1:1:1:1 basis to receive one of three doses of ontunisertib or placebo twice daily over a 52-week treatment period.
The primary endpoint will measure the proportion of patients achieving endoscopic passability at Week 24. Secondary endpoints will include changes on magnetic resonance enterography, changes in SES-CD, endoscopic response and remission, patient-reported outcomes and time to FSCD-related events.
Agomab’s Chief Medical Officer described NOV-ERA as breaking new ground as the first phase 2b study in FSCD. They said the trial will help inform dose selection and pivotal endpoints, while the protocol submissions to key regulatory agencies represent a crucial milestone in the late-stage development of ontunisertib.
The company is now focused on completing operational preparations and moving towards patient enrolment in the coming months.
Ontunisertib remains investigational and has not been approved by any regulatory authority.
Racura Oncology Begins First-in-Patient Dosing for RC220
Racura Oncology has also moved its clinical programme forward, treating the first patient in the phase 1 HARNESS-1 trial of RC220 for EGFR-mutant non-small cell lung cancer.
The first patient was treated by Principal Investigator Associate Professor Surein Arulananda and his team at Monash Health in Victoria. The participant received RC220 at 50mg/m², with no adverse events observed during or after infusion.
HARNESS-1 is designed to assess whether RC220 can be safely combined with osimertinib, a standard-of-care targeted therapy used in EGFR-mutant NSCLC.
While osimertinib has become an important treatment option for this patient group, resistance to targeted therapies remains a major clinical challenge. That resistance can limit long-term disease control and creates a need for new combinations that may improve outcomes or extend response.
Racura’s Chief Executive Officer and Managing Director said the treatment of the first patient marks an important step in the clinical development of RC220 and reflects broader progress across the company’s oncology pipeline.
They also highlighted the importance of the patient group being studied, noting the continuing challenge of resistance to current targeted therapies. The company thanked A/Prof Arulananda and the Monash Health team, along with the patients and families supporting the research.
HARNESS-1 Takes a Careful Dose-Escalation Approach
HARNESS-1 is a multi-centre phase 1a/b study that uses circulating tumour DNA to help identify eligible patients. This approach supports more precise patient selection and reflects the growing role of molecular monitoring in oncology trial design.
The study will use single-patient cohorts for the first three dose escalations, beginning at 50mg/m² before moving to 100mg/m² and 150mg/m². After these initial stages, the trial will progress into larger groups to identify the maximum tolerated dose of RC220 in combination with osimertinib.
Between 12 and 40 participants are expected to be enrolled in the dose-escalation stage. This will be followed by a randomised phase 1b expansion stage involving 40 patients. The study will evaluate safety, pharmacokinetics and early measures of clinical activity, including progression-free survival and overall survival.
The staged structure is designed to provide a cautious but informative development pathway. Early oncology trials must balance urgency with patient safety, particularly when testing novel combinations in populations that may have already undergone significant treatment.
Impact on Pharmaceutical Manufacturing and Production
These clinical updates also have implications beyond the clinic, particularly for pharmaceutical manufacturing and production planning.
As Agomab moves ontunisertib towards a sizeable phase 2b trial across multiple territories, the company will need reliable production systems capable of supporting consistent oral drug supply, quality control and regulatory documentation across jurisdictions.
For Racura Oncology, the early-stage combination trial with RC220 creates a different but equally important manufacturing challenge, where small-batch production, sterility, stability and dose accuracy must support careful escalation in a cancer setting.
More broadly, both programmes show how pharmaceutical production is increasingly shaped by precision trial design, international regulatory engagement and the need for scalable processes long before a medicine reaches potential approval.
Manufacturers are not simply producing trial material; they are building the operational foundation that can support later-stage development, regulatory inspection and, if successful, future commercial supply.
Clinical Development Momentum Builds Across Two Frontiers
Although Agomab and Racura are operating in different therapeutic areas, their announcements share a common theme: the pursuit of better options for patients facing difficult disease pathways.
Agomab’s ontunisertib programme is targeting a serious complication of Crohn’s disease where surgery often remains a central part of care and approved pharmacological options are absent.
Racura’s HARNESS-1 study is testing a potential new combination strategy in EGFR-mutant NSCLC, where resistance to existing targeted therapies continues to challenge clinicians and patients.
Neither programme is without risk. Ontunisertib remains investigational, and NOV-ERA will need to show meaningful benefit against carefully selected endpoints. RC220 is still at an early stage of human clinical evaluation in this setting, with safety, dosing and activity all still to be established.
However, both developments represent important forward movement. They show companies attempting to address not just common disease labels, but specific clinical problems within them: stricturing disease in Crohn’s and resistance in EGFR-mutant lung cancer.
Conclusion
Agomab Therapeutics’ NOV-ERA study and Racura Oncology’s HARNESS-1 trial highlight the complex, incremental nature of pharmaceutical innovation.
One programme is preparing to test a GI-restricted investigational therapy in the first phase 2b study for fibrostenosing Crohn’s disease, while the other has begun patient dosing in an early-stage oncology trial exploring a combination approach for EGFR-mutant non-small cell lung cancer.
For patients, clinicians and the pharmaceutical industry, the significance lies in the direction of travel. Both companies are advancing programmes in areas where current care remains imperfect and where new therapeutic strategies are urgently needed.
The coming stages will determine whether these investigational treatments can translate early promise into clinical progress, but for now, both announcements mark meaningful steps in the long route from scientific rationale to potential patient impact.
News Credits:
Agomab outlines design of phase 2b NOV‑ERA study in fibrostenosing Crohn’s disease
Racura treats first patient in phase 1 HARNESS‑1 lung cancer trial
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