- Clinical-stage biotech Cardiff Oncology Inc announced new preclinical and clinical data from its lead program in KRAS-mutated metastatic colorectal carcinoma (mCRC) in a second-line setup.
- The data featured in a presentation at the European Society for Medical Oncology (ESMO) Congress 2022 included updated data and biomarker analyses from Phase 1b/2 trial for onvansertib plus chemotherapy FOLFIRI and cancer therapy bevacizumab.
- As of July 26 data cutoff, overall response rate (ORR) and median progression-free survival (mPFS) significantly surpassed those in historical control studies.
- In an analysis of clinical responses, the KRAS responder group had greater ORR and mPFS than non-responders.
- Another ESMO presentation discussed a comparison between KRAS responders and non-responders in CRDF’s Expanded Access Program, which included patients who were ineligible to participate in the Phase 1b/2 trial.
- As of August 5, EAP patients who had received colorectal cancer therapy irinotecan demonstrated clinical benefit in response to onvansertib plus FOLFIRI/bevacizumab.
- HC Wainwright initiated coverage on Rain Therapeutics Inc , with a price target of $10 with a Buy rating.
- With an upside of almost 60%, the analyst believes Rain's lead asset, milademetan, has the potential to become a tumor-agnostic therapy for MDM2 amplified cancers.
- Milademetan, in-licensed from Daiichi Sankyo
DSNKY
in 2020, is an oral MDM2 inhibitor that reactivates the tumor suppressor gene, p53. - P53 is a key regulator of various cellular processes, including the cell cycle, DNA repair, and apoptosis.
- Milademetan could address p53 inactivation across multiple p53 wild-type (WT) tumor types, representing about 50% of all cancers.
- Rain is conducting a Phase 3 MANTRA trial in patients with well-differentiated / de-differentiated liposarcoma.
- Since the primary endpoint is based on a doubling of PFS, we believe Rain's Phase 1 data de-risks the upcoming Phase 3 data, slated for release in 1H23, writes HC Wainwright.
- The analyst conservatively projects that milademetan could have a peak annual sales potential of nearly $1 billion from liposarcoma, non-small cell lung cancer (NSCLC), and breast cancer indications.
