Olema Pharmaceuticals, Inc. (OLMA) experienced an increase of 6.50% in premarket. However, the last trading session closed at $11.07 with an incline of 5.43%.
First Clinical Data on OP-1250 by OLMA – What’s it all about?
OLMA announced the first clinical data on OP-1250 in Advanced ER+ / HER2- Breast Cancer on 30th November 2021. Firstly, OP-1250 revealed exceptionally appealing pharmacokinetics, excellent tolerability, and compelling effectiveness signs. Secondly, in a strongly pretreated patient group, robust anti-tumor activity was seen. This includes three partial responses and up to 100 percent target lesion reduction.
Thirdly, in the indicated Phase 2 dosage range, there was a 17 percent overall response rate and a 46 percent clinical benefit rate; efficacy data is still maturing, with 32 percent of patients continuing on the trial. Lastly, Phase 2 monotherapy and the first CDK4/6 inhibitor combo trials will begin in Q1 2022.
Now what?
With the expected pharmacokinetics, excellent tolerability, and early but obvious effectiveness signs, OLMA effectively met the objectives for the dose-escalation portion of the current Phase 1/2 study of OP-1250. Moreover, OLMA is particularly motivated by the reactions seen in patients who had previously received multiple lines of treatment and had ESR1 stimulatory genetic changes, illustrating that OP-1250 is an active drug.
These results give the confidence to move forward with the development program in both monotherapy and combination settings as the company works to position OP-1250 as a differentiated, potentially best-in-class CERAN that they believe could become the backbone endocrine therapy of choice for ER+ breast cancer.
Third Quarter 2021 results Revealed by OLMA
OLMA released third-quarter 2021 results on 10th November 2021. The company had $306.0 million in cash, cash equivalents, and marketable securities. The quarter ended with a net loss of $17.7 million, compared to $7.8 million the year before. Furthermore, research and development (R&D) costs were $12.5 million, $4.7 million more than the year before. The rise in R&D spending was principally due to the progress of the ongoing Phase 1/2 clinical study of OP-1250, as well as an increase in nonclinical research activities, higher personnel-related costs, and higher non-cash stock-based compensation costs.
OP-1250 – What’s it?
OP-1250 has the ability to be a distinct, finest complete estrogen receptor (ER) antagonist (CERAN). The company looks forward to obtaining further clinical data in support of the usage of OP-1250 as a monotherapy and in combination with other authorized breast cancer therapies as OLMA recruits more individuals.
