Allarity Therapeutics (NASDAQ:ALLR) dosed its first patient in Phase 1b of its clinical trial for the novel combination therapy of two drugs, stenoparib and dovitinib. The company is evaluating the safety, dosing, and potential therapeutic benefit of this combination therapy on advanced solid tumors, including ovarian cancer.

One in 78 women will reportedly develop ovarian cancer during their lifetime, though the disease normally affects older women. It is expected that over 19,000 women will be diagnosed with ovarian cancer in 2023, and this form of cancer is the fifth most common cause of cancer deaths for women. The ovarian cancer treatment market was worth $3.2 billion in 2022 and is expected to reach $6.36 billion by 2027, growing at a compound annual growth rate (CAGR) of 14.4% during the forecast period. However, there continues to be a need for new and more effective treatments for ovarian cancer.

Both stenoparib and dovitinib have shown promising results for cancer treatment in the past. Stenoparib is a poly-ADP ribose polymerase (PARP) inhibitor, which blocks the repair of single-stranded DNA within cancerous cells. Dovitinib is a pan-tyrosine kinase inhibitor (TKI) with an anti-angiogenic activity that cuts off the blood supply to the cancerous region, resulting in an increase in tumor DNA damage, the repair of which can then be blocked by Stenoparib. Now, Allarity Therapeutics is exploring the potential for a combination therapy that uses these two drugs to tackle solid tumors.

Dr. Mansoor Raza Mirza, a leading expert in oncology and Chief Oncologist in the Department of Oncology at Copenhagen University Hospital, is a member of the Scientific Advisory Board of Allarity. Speaking to Benzinga, he shared his excitement in following the results of this trial. Though combination therapy is not unusual, according to Dr. Mirza, this unique combination could be particularly efficacious and serve a major unmet need in cancer patients. The science and rationale supporting this combination therapy are strong, and Dr. Mirza is looking forward to the clinical evidence forthcoming from the trial.

The first stage of the trial will dose patients with stenoparib twice daily to examine the maximum tolerated dose (MTD) of the drug in patients with advanced solid tumors. The second stage of the trial will determine the MTD of dovitinib when given in conjunction with the MTD of stenoparib. The trial will also use Allarity Therapeutics’ DRP companion diagnostics to retrospectively identify responders to the treatment. The study is also designed to assess early signals of a therapeutic benefit of the combination of drugs.

According to Dr. Mirza, this combination has the potential to be particularly efficacious, and the study will be looking at whether these drugs cause synthetic lethality for the tumor. If these trials are safe and effective, then there is the potential for holding comparative trials that measure this combination therapy against traditional treatments like chemotherapy, which can be highly toxic.

Dr. Mirza stated, "In the battle against cancer, we must relentlessly seek innovative and effective therapies. New unique combination therapies have the potential to significantly alter the landscape of cancer treatment. The combination study of stenoparib and dovitinib is interesting because of a variety of reasons, but one I personally find very appealing with such novel combinations is that they could offer a chemotherapy-free treatment option, for example, in our treatment of ovarian cancer patients. Avoiding the side effects typically associated with chemotherapy would be a very welcomed treatment option.”

The Principal Investigator for Allarity’s Phase 1b study, Kathleen N. Moore, MD, MS, commented: “I look forward to working with patients and the clinical team at Allarity to determine if the particular combination of dovitinib and stenoparib can provide synergistic therapeutic benefits and improve outcomes for patients, including those with ovarian cancer.” Dr. Moore is a Gynecologic Oncology faculty member at the University of Oklahoma College of Medicine and Associate Director of Clinical Research at the Stephenson Cancer Center.

Allarity Therapeutics also has two ongoing, phase two monotherapy trials for its drugs Dovinitinb and Stenoparib. The company anticipates interim data readouts from these trials to come in late 2023. Other companies investigating treatments for hard-to-treat cancers include Soligenix (NASDAQ:SNGX) and Salarius Pharmaceuticals (NASDAQ:SLRX).