• Imugene reports positive early signs from Phase 1 CF33-hNIS Study
  • Amplia says first patient dosed in Phase 2a portion of the ACCENT trial 


Imugene jumps on positive study results

Immuno-oncology company, Imugene (ASX:IMU), jumped 7% this morning after reporting positive early signals from its Phase 1 MAST (Metastatic Advanced Solid Tumours) trial evaluating its novel cancer-killing virus, CF33-hNIS (VAXINIA).

As of 12 January, 38 patients have been dosed with VAXINIA, comprised of 19 patients dosed intra-tumourally (IT), and 19 patients dosed intravenously (IV)  – as either monotherapy or in combination with pembrolizumab.

In the IT cohort, 47% had a reduction in tumour burden, and 3 lesions were completely eradicated, while three patients had an objective response.

In the IV cohort, 53% of patients achieved stable disease as their best response.

Further, the data shows that patients who received prior checkpoint blockade therapy derived better clinical benefit with and without pembrolizumab.

Earlier, Imugene had also shown that 7 patients with gastrointestinal cancers who received CF33-hNIS alone showed positive treatment effects, with a disease control rate of 86%. These results were already presented at this week’s annual ASCO-GI Symposium in San Francisco.

“This latest data reinforces the early positive responses we’ve seen in gastrointestinal cancers and in particular for cholangiocarcinoma (bile duct cancer),” said Imugene CEO, Leslie Chong.

“It provides an excellent platform to investigate the impact of VAXINIA at higher dose levels, as we also expand the trial to additional patients with hard-to-treat biliary tract cancers.”

The clinical trial commenced in May 2022, and is anticipated to run for approximately 24 months while being funded from Imugene’s existing budgets and resources.


Amplia doses first patient in Phase 2a trial

Amplia Therapeutics (ASX:ATX) meanwhile said the first patient in the Phase 2a portion of the ACCENT trial has begun dosing.

The ACCENT trial is examining the combination of Amplia’s FAK inhibitor narmafotinib, in combination with standard-of-care chemotherapy in first-line patients with advanced pancreatic cancer.

In November, the company announced completion of the Phase 1b stage of the ACCENT trial where ascending doses of narmafotinib, in combination with the standard-of-care chemotherapy regime of gemcitabine and Abraxane, were dosed to patients.

That Phase 1b stage identified a safe and well-tolerated dose of narmafotinib that provides sufficient circulating drug levels to significantly block the activity of the FAK enzyme.

The identified dose of narmafotinib is now being tested in patients, in combination with gemcitabine and Abraxane, in the current Phase 2a stage of the trial.

The study is being conducted at six trial sites open in Melbourne, Sydney and Brisbane, with five additional sites opened in Korea.

“The trial in advanced pancreatic patients will determine whether narmafotinib, in combination with gemcitabine and Abraxane, provides improved efficacy forthe treatment of this devastating cancer,” said Amplia’s CEO, Dr Chris Burns.

“Patients and clinicians are desperate for improved treatment options given the current five-year survival for newly diagnosed patients is only 12%.”

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