Olema Pharmaceuticals

Olema's KAT6 Inhibitor OP-3136 Shows Promising Anti-Tumor Activity Across Multiple Cancer Types

a month ago

• Olema Oncology's novel KAT6 inhibitor OP-3136 demonstrated potent anti-tumor activity in preclinical models of ovarian, prostate, and non-small cell lung cancer, expanding its potential beyond breast cancer. • In ovarian cancer models, OP-3136 achieved sustained tumor regression over 28 days, while showing comparable efficacy to ribociclib in lung cancer models and dose-dependent tumor inhibition in prostate cancer. • The compound exhibited enhanced anti-tumor activity when combined with standard therapies like ribociclib and docetaxel, with patient recruitment currently ongoing in Phase 1 clinical trials.

Olema Oncology Advances Pivotal Phase 3 Trials for Palazestrant in Metastatic Breast Cancer

2 months ago

• Olema Oncology is progressing its pivotal Phase 3 OPERA-01 trial of palazestrant monotherapy in second/third-line metastatic breast cancer, with top-line data anticipated in 2026. • The company is preparing to initiate the Phase 3 OPERA-02 trial of palazestrant in combination with ribociclib for frontline metastatic breast cancer in 2025, supported by promising efficacy data showing 13.8 months median progression-free survival. • With $392.7 million in cash reserves as of Q1 2025, Olema is well-positioned to advance its clinical pipeline, including the ongoing Phase 1 trial of KAT6 inhibitor OP-3136 for multiple solid tumor applications.

Novartis' Intrathecal Zolgensma Shows Positive Phase III Results for SMA Type 2

5 months ago

• Novartis' intrathecal onasemnogene abeparvovec (OAV101 IT) met its primary endpoint in the Phase III STEER study for SMA Type 2. • The STEER trial demonstrated a statistically significant increase in motor function, as measured by HFMSE scores, in treatment-naïve patients. • OAV101 IT showed a favorable safety profile, with adverse events similar to the control arm, potentially expanding treatment options for SMA. • Novartis plans to submit the data to regulatory agencies in 2025, seeking approval to broaden the availability of this one-time gene therapy.

Olema Oncology's KAT6 Inhibitor OP-3136 Receives FDA IND Clearance, Phase 1 Trial Planned for 2025

5 months ago

• Olema Oncology has received FDA clearance for its Investigational New Drug (IND) application for OP-3136, a novel KAT6 inhibitor, marking a key regulatory milestone. • OP-3136, a small molecule, has demonstrated compelling preclinical activity as a monotherapy and in combination with palazestrant for breast cancer. • A Phase 1 clinical trial is scheduled to begin in early 2025 to assess the safety and initial efficacy of OP-3136 in patients with breast and other cancers. • This regulatory advancement diversifies Olema's oncology pipeline and strengthens its focus on targeted therapies for endocrine-driven cancers.

Novartis' Fabhalta Shows Promise in PNH Patients Switching from Anti-C5 Therapies

6 months ago

• Novartis' Fabhalta (iptacopan) demonstrates improved hemoglobin levels in PNH patients switched from anti-C5 therapies in a Phase IIIB trial. • The APPULSE-PNH study evaluated Fabhalta as a twice-daily oral monotherapy, showing a consistent safety profile with previous data. • Fabhalta, a Factor B inhibitor, has received approvals for PNH and is being studied for other complement-mediated diseases. • The Max Foundation expands collaboration with Novartis to provide access to iptacopan for treating PNH in low-resource countries.

Palazestrant Plus Ribociclib Shows Promise in Advanced Breast Cancer

6 months ago

• Palazestrant combined with ribociclib demonstrates encouraging clinical activity in ER+/HER2- advanced or metastatic breast cancer patients, including those with ESR1 mutations. • The combination therapy shows a favorable safety profile, consistent with ribociclib, and is well-tolerated, supporting its potential as a first-line treatment option. • Interim Phase 1b/2 data reveals a 73% 6-month progression-free survival rate across all patients, with median PFS not yet reached after a 12-month follow-up. • Olema Oncology plans to initiate a pivotal Phase 3 trial (OPERA-02) of palazestrant with ribociclib as a first-line treatment based on these promising results.