Two More Cancer Drug Candidates Hit the Fast Track

Two experimental cancer drugs, one for ovarian cancer and one for a form of breast cancer, received Fast Track designation from the U.S. Food and Drug Administration (FDA), which will speed up the regulatory process for these medications.

The first Fast Track designation was awarded to China-based InxMed’s IN10018, which is being developed for the treatment of platinum-resistant ovarian cancer patients. The experimental drug is a potent and selective ATP-competitive focal adhesion kinase (FAK) small molecule inhibitor. Early clinical data has shown that IN10018 is not only safe, but also yielded positive efficacy signals against a number of tumor types, according to the company. Preclinical and supporting clinical data have demonstrated IN10018’s “promising efficacy” when combined with standard chemotherapy to treat platinum-resistant ovarian cancer patients, the company added.

“This is an important milestone for InxMed. IN10018 is one of our critical assets to fulfill our “Best-in-Disease Combination” development strategy. We will leverage the advantage of [the] Fast Track status and work closely with U.S. FDA to speed up further clinical development,” Zaiqi Wang, InxMed’s chairman and chief executive officer, said in a statement.

FAK inhibitors have the potential to overcome fibrotic barrier and immune tolerance in some patients. FAK activation is closely related to drug resistance of chemotherapies and targeted therapies. Additionally, it is thought this drug class will be able to boost multiple modalities, including targeted therapy, chemotherapy, immunotherapy and radiation therapy. In June, InxMed researchers published a paper demonstrating the potential of FAK inhibitors alongside KRAS G12C inhibitors.

The paper showed that a combination of the two drug types can reduce the extent of drug resistance in order to improve treatment outcomes in patients. Additionally, the two drug types achieved “synergistic anticancer effects with multiple in vitro and in vivo models,” the researchers said.

Ireland’s Carrick Therapeutics also snagged the Fast Track designation for its experimental breast cancer drug. Carrick is developing samuraciclib in combination with fulvestrant for CDK4/6i resistant HR+, HER2- advanced breast cancer. This combination is currently being assessed in a Phase IIa study. New data is expected to be presented at the European Society for Medical Oncology Congress in September. Also, the company is exploring the combination of samuraciclib with chemotherapy as a potential treatment for locally advanced or metastatic triple negative breast cancer (TNBC). Samuraciclib in combination with chemotherapy for the treatment of TNBC is currently undergoing IND-enabling studies.

Carrick bills samuraciclib as the “most advanced oral CDK7 inhibitor in clinical development.” The company said, inhibiting CDK7 regulates the transcription of cancer-causing genes and promotes uncontrolled cell cycle progression and resistance to anti-hormone therapy. Earlier this month, Carrick and Swiss pharma giant Roche partnered to evaluate samuraciclib and Roche’s giredestrant in CDK4/6i resistant HR+, HER2- metastatic breast cancer. Additionally, Carrick is assessing samuraciclib in prostate cancer, a cancer type where CDK7 has been shown to play an important role. 

Carrick CEO Tim Pearson said the FDA’s decision to award the Fast Track designation to both combination approaches with samuraciclib emphasizes the necessity for “innovative therapies” that can improve the treatment for patients with HR+, HER2- advanced breast cancer and locally advanced or metastatic TNBC.

“This is a meaningful milestone for our development in samuraciclib as we work to advance innovative combination treatment approaches for patients who have few treatment options available today,” Pearson said in a statement.