• Race Oncology issued certificate for its bisantrene formulation, RC220
  • Immutep completed enrolment for its TACTI-003 Phase IIb trial


Race issued a GLP certificate in the US

Race Oncology (ASX:RAC) said a Certificate of Testing (CoT) has been issued by Societal CDMO (San Diego, USA) for the first engineering batch of Race’s proprietary bisantrene formulation, RC220.

The CoT confirms that the drug meets manufacturing quality specifications for IV (intravenous) drug product, and is good for use in Good Laboratory Practice (GLP) toxicology and safety pharmacology studies.

Race says this is a major milestone to support the progression of RC220 into the first human clinical trials.

RC220 is a bisantrene formulation designed to enable safe administration of bisantrene to patients via peripheral vein (arm or leg) IV infusions.

Bisantrene is a small molecule anthracene-based chemotherapeutic that was originally developed by American Cyanamid (Lederle Laboratories) in the 1980s.

Studies have shown that bisantrene reduces risk of cardiotoxicity and demonstrates cardio-protection when used in conjunction with anthracyclines, a class of drugs used in cancer chemotherapy.

Societal CDMO meanwhile was contracted to produce RC220, with an engineering batch of more than 1,500 vials of RC220 having been manufactured so far.

“Bringing a new IV drug product like RC220 to the clinic is a complex undertaking that requires successful progress through multiple checkpoints,” said Race’s executive director, Dr Pete Smith.

Smith said the recent data confirming that RC220 satisfied all manufacturing quality specifications when produced at scale represents an incredibly important milestone.

“It strongly supports our ability to produce GMP material suitable for human clinical use,” he said.


Immutep to commence Phase IIb trial after completing enrolment

Meanwhile, Immutep (ASX:IMM) announced that it has completed enrolment for its TACTI-003 Phase IIb Trial of Efti and KEYTRUDA in First Line Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma.

A total of 171 head and neck squamous cell carcinoma (HNSCC) patients were enrolled at over 30 centres across the United States, Europe, and Australia.

Of that, 138 patients with recurrent or metastatic HNSCC whose tumours expressed PD-L1 (CPS ≥1) have been enrolled into the 1:1 randomised Cohort A of the trial, which will evaluate the safety and efficacy of 30mg of efti in combination with 400mg of KEYTRUDA.

Additionally, 33 patients with recurrent or metastatic HNSCC were enrolled into Cohort B to determine the efficacy and safety of the same combination therapy in patients with PD-L1 negative tumours (CPS <1). These patients are not expected to respond to KEYTRUDA monotherapy, and therefore were not randomised.

The primary endpoint of the study is Overall Response Rate of evaluable patients.

Secondary endpoints include Overall Survival, Overall Response Rate according to iRECIST, Progression Free Survival, and Duration of Response.

“We are very excited to have completed patient enrolment in this randomised, multi-national trial and look forward to sharing data in the first half of 2024,” said Immutep’s Chief Medical Officer, Dr Florian Vogl.


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