CURE’s Clinical Trial Corner: March 2021

As the cancer treatment landscape continues to expand, patients and their caregivers should be aware of the various clinical trials currently being conducted — including studies they can possibly join.

Pan Tumor

Compugen Ltd. recently announced the expansion of a collaboration agreement with Bristol Myers Squibb. The expanded agreement allows Compugen to add Bristol Myers Squibb’s Opdivo (nivolumab) to COM701 — a first-in-class anti-PVRIG antibody — in patients with select cancer indications enrolled onto a phase 1b combination study.

“We are excited to further expand our clinical program evaluating COM701,” Compugen’s president and CEO Anat Cohen-Dayag said in a news release. "While our triple checkpoint blockade study of COM701 combined with Bristol Myers Squibb's PD-1 and TIGIT inhibitors currently advancing in the clinic offers the ultimate test of our science-driven hypothesis, translational research at Compugen suggests that certain patients may not require a triple therapy combination. With the enrollment in the dose escalation arm of COM701 in combination with Opdivo completed and preliminary signs of antitumor activity previously disclosed, we are ready to continue our evaluation of this dual combination and move to the cohort expansion phase of the study.”

The phase 1b study (NCT03667716) is expected to analyze fixed doses of COM701 and Opdivo in patients with ovarian, breast, endometrial and microsatellite-stable colorectal cancers.

Lung Cancer

Aileron Therapeutics recently announced it plans to expand the enrollment target for an upcoming phase 1b trial of a novel therapy in patients with non-small cell lung cancer.

The trial, which had an original target enrollment of 40 patients, is now expected to enroll 60 patients with advanced p53-mutated non-small cell lung cancer who are undergoing treatment with first-line chemotherapies carboplatin plus pemetrexed. The aim of the study is to assess if ALRN-6924 — a chemoprotective agent — can reduce or eliminate chemotherapy-induced side effects without diminishing the chemotherapy’s ability to kill the cancer cells.

“Last month, the field of chemoprotection took a giant step forward with the approval of the industry’s first chemoprotection agent, which is approved to decrease the incidence of chemotherapy-induced myelosuppression in patients with extensive small-cell lung cancer,” Dr. Manuel Aivado, president and CEO of Aileron, said in a news release. “With this milestone, the regulatory path for chemoprotective agents like ALRN-6924 has now been clarified. ALRN-6924 is the first and only reported chemoprotective agent in clinical development to employ a biomarker strategy, in which we exclusively focus on treating patients with p53-mutated cancers. This strategy is designed to selectively protect healthy cells in the body from chemotherapy while ensuring we do not protect cancer cells. As a result, healthy cells are spared from chemotherapeutic destruction while chemotherapy continues to kill cancer cells.”

Aileron announced it expects to enroll patients onto the trial in the second quarter of 2021.

Solid Tumors

The first patient has been dosed in a phase 1/2 trial of KB-0742 — an oral bioavailable cyclin dependent kinase 9 (CDK9) inhibitor — to treat MYC-amplified solid tumors, Kronos Bio announced.

Kronos expects to enroll approximately 100 patients with advanced solid tumors or non-Hodgkin lymphoma onto to open-label trial. The trial is expected to consist of a dose-escalation stage — to review safety and set a recommended dose. The expansion stage, according to Kronos, is then expected to study that dose further in patients.

“KB-0742 represents a promising new approach to treating cancers that are transcriptionally addicted to MYC. We are excited to have initiated our clinical development program for KB-0742, which emerged from our internal discovery research efforts and moved quickly into clinical testing in under two years,” Norbert Bischofberger, president and CEO of Kronos, said in a news release. “We believe KB-0742 has the potential to be a meaningful advance in the treatment of MYC-amplified cancers, which represent approximately 30% of solid tumors.”

The company expects to report initial data from the dose-escalation study in the fourth quarter of 2021.

COVID-19

The institutional review board of Roswell Park Comprehensive Cancer Center in Buffalo, New York has approved an amendment which called for the randomization of an additional 20 patients into a phase 1/2a study evaluating a two-drug combination for the treatment of patients with cancer and mild-to-moderate COVID-19 infection.

In November 2020, AIM ImmunoTech announced that the first patient had been enrolled and received treatment with Ampligen (rintatolimod) and interferon alpha-2b to combat mild-to-moderate COVID-19.

“We are excited to see Ampligen tested not only as part of an antiviral treatment combination for COVID-19 among cancer patients, but also as a possible standalone therapy for this terrible virus,” AIM president and CEO Thomas K. Equels said in a news release. “An early-onset treatment is especially critical for cancer patients, who face significantly increased risk of severe symptoms or death.”

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