Currency in PLN
Last close As at 17/03/2023
PLN21.90
▲ 1.15 (5.54%)
Market capitalisation
PLN285m
Research: Healthcare
As presented at its R&D day in December 2022, Molecure has now initiated the clinical trial for its second candidate, OATD-02. This Phase I trial is an open-label, multi-centre, first-in-human, dose-escalation study. The company will target cancers where immune checkpoint inhibitors (ICIs) have had limited success, an area where we believe OATD-02/ICI combinations could have an impact. In our view, this milestone supports Molecure’s development strategy and we expect an update on this trial in H223. The company also has pre-clinical animal model data for OATD-01 for the treatment of sarcoidosis, which suggests potential use in non-alcoholic steatohepatitis, a fibrotic disease with unmet need.
Molecure |
Clinical trials initiated for second asset
Pharma and biotech |
Spotlight – Flash
10 March 2023 |
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Molecure is a research client of Edison Investment Research Limited |
As presented at its R&D day in December 2022, Molecure has now initiated the clinical trial for its second candidate, OATD-02. This Phase I trial is an open-label, multi-centre, first-in-human, dose-escalation study. The company will target cancers where immune checkpoint inhibitors (ICIs) have had limited success, an area where we believe OATD-02/ICI combinations could have an impact. In our view, this milestone supports Molecure’s development strategy and we expect an update on this trial in H223. The company also has pre-clinical animal model data for OATD-01 for the treatment of sarcoidosis, which suggests potential use in non-alcoholic steatohepatitis, a fibrotic disease with unmet need.
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Source: Company accounts. Note: *Diluted EPS |
OATD-02 is being developed as a potential new oral drug for the treatment of a range of solid tumours. It is the first and only dual-acting arginase inhibitor addressing both tumour immunity and metabolism. Arginases 1 and 2 are validated therapeutic targets associated with a variety of tumour types and OATD-02 is designed to help restore antitumour immune responses by overcoming the immunosuppressive tumour environment. Following approval from the Polish authorities in November 2022, Molecure has now initiated its Phase I trial for OATD-02 as a monotherapy.
This Phase I trial will primarily focus on evaluating the safety and tolerability of the drug. Additional objectives include assessing preliminary efficacy (response and survival), measuring pharmacokinetic/pharmacodynamic biomarker data and establishing a maximum tolerated dose. A Bayesian optimal interval design is being used; management believes this may accelerate the identification of the recommended Phase II dose. The study is based across three sites in Poland and aims to recruit c 40 patients with advanced and/or metastatic solid tumours. Management intends to target indications where ICIs have low response rates, namely, colorectal cancer, platinum-resistant ovarian cancer, pancreatic cancer, or renal cell carcinoma.
We view the first patient dosing in this trial as a key milestone for Molecure, with OATD-02 being the second candidate from the company’s proprietary pipeline to enter clinical development. Management expects to see the initial data from this study in H223, which, if positive, would support the further clinical progression of the asset. We also expect that results from this trial will inform the design of further Phase I/II trials in combination with ICIs.
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Research: Healthcare
Immix Biopharma has expanded both its clinical and technology portfolio with the in-licensing of its first CAR-T cell therapy, NXC-201. The treatment is being investigated in a Phase Ib/II open-label study for multiple myeloma (MM) and light chain amyloidosis (ALA). The trial intends to recruit up to 100 patients and management believes positive results may potentially support early regulatory approval. In our view, NXC-201 may provide Immix with the scope to expand into new indications within oncology, particularly among hematological malignancies. NXC-201’s clinical development is being independently financed under a subsidiary of Immix (Nexcella, of which Immix owns 98%). Our valuation of Immix is US$61.5m or US$4.4 per share (previously US$55.4m or US$4.0 per share). We await further NXC-201 clinical data and communication on its development plan before including it in our valuation.
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