• Imagion announced positive results from Phase 1 breast cancer study
  • Microba also announced positive results from Phase 1 bowel disease study
  • Little Green Pharma to capitalise as France integrates medicinal cannabis into healthcare system


Imagion’s positive Phase 1 study in breast cancer

Imagion Biosystems (ASX:IBX) jumped 7% this morning after announcing positive results from its IBI10103 Phase 1 Study, which evaluated the potential of the world’s first molecularly targeted MRI contrast agent, MSH2IA (MagSense HER2 Imaging Agent).

The trial, which assessed patients diagnosed with HER2+ primary breast cancer, demonstrated safety and clinical feasibility of molecular MRI (Magnetic Resonance Imaging) with IBX’s MSH2IA.

The trial has met its endpoint of safety and tolerability, and showed that blinded radiologists may be able to distinguish suspicious lymph nodes that are infiltrated with metastatic HER2+ cancer from those involved in a healthy immune response, or otherwise normally reactive.

Thirteen women definitively diagnosed with HER2+ breast cancer were enrolled and treated with the drug without any safety issues, toxicity or drug-related adverse events reported.

Dr Isaac Bright,CEO of Imagion, said patients with HER2 positive breast cancer need better staging options that are safe, reliable, comprehensive, and less invasive than today’s standard of care.

“Too many of these women endure unnecessary interventions that provide incomplete information and impose unnecessary costs on global healthcare systems,” said Dr Bright.

“We are encouraged by MSH2IA’s potential to increase the accuracy of disease staging, and thus improve treatment decisions.”


Microba’s positive Phase 1 trial in bowel disease

Microba Life Sciences (ASX:MAP) also announced a successful Phase 1 Clinical Trial of lead drug candidate, MAP 315, on Inflammatory Bowel Disease (IBD).

Results demonstrated a strong safety and tolerability profile for MAP 315, and supported the continued clinical development of this lead drug candidate.

This is an important clinical development milestone for MAP 315 as a potential new treatment option for the millions of people suffering from ulcerative colitis, a form of bowel disease that causes inflammation and ulcers (sores) in the digestive tract.

The Phase 1 study had enrolled two cohorts of 16 participants each, who were randomised 3:1 to receive MAP 315 or its matching placebo for 14 consecutive days.

Unblinded analysis of trial data demonstrated no clinically significant safety signals from assessments. These assessments include ECGs (electrocardiogram), laboratory analysis of haematology, coagulation, clinical chemistry, urinalysis parameters, and impact on inflammatory biomarkers.

Data from this trial is expected to be formulated and submitted for peer review publication.

“We are very pleased with the results from this clinical study, which provide the foundation for further clinical development of MAP 315 in patients with ulcerative colitis,” said Professor Trent Munro, SVP of Therapeutics at Microba.


Little Green Pharma’s first mover advantage in France

Meanwhile, cannabis stock Little Green Pharma (ASX:LGP) is poised to significantly capitalise on a major amendment to the French health security bill.

The bill relates to new laws governing a two-stage post-French Pilot medicinal cannabis supply in France, as the country moves to integrate medicinal cannabis into its healthcare system.

The first stage will be a nine-month transitional period covered by a €10m budget, during which LGP and two other suppliers have an exclusive right to supply medicinal cannabis oil.

The second stage is a bespoke, subsidised public access regime for medicinal cannabis products meeting certain product registration requirements.

As a quick background, in 2021, LGP and leading French pharmaceutical distributors, Intsel Chimos and Centre Lab, were appointed as primary supplier and distributor of LGP’s 1:20 THC:CBD and CBD50 medicinal cannabis oil for a two-year French pilot program of medicinal cannabis products.

Both of these oil products were produced at LGP’s Australian operations.

Following its initial success, the pilot was extended for a third year until March 2024, with LGP and Intsel Chimos re-appointed as primary CBD oil supplier for both products.

With the program nearing the end of the extension period, the French Government has now signed into law an amendment to the Projet de loi de financement de la Sécurité sociale (Social Security Financing Order), which supports the post-Pilot supply of medicinal cannabis from March 2024 onwards.

LGP says this legislation could pave the way for a substantial transformation in how medicinal cannabis is integrated into the French healthcare system.

LGP and its distribution partners are now set to capitalise on their first mover advantage, after forging long-established relationships with existing patient, hospital prescriber, and pharmacy networks.

France is one of the largest potential medicinal cannabis markets in Europe, with a Total Addressable Market of €5.6 billion.

“Our continuing strategy to break into a number of highly lucrative European markets really sets LGP apart from our Australian peers,” said Little Green Pharma CEO, Paul Long.

“From early in our infancy, we recognised that real growth potential lies in Europem where stringent standards and regulations offer companies like LGP a remarkable competitive advantage over our counterparts.”


Share prices today: