Nevia Bio Ltd. (formerly Gina Life Ltd.) completed a $3.1 million seed round that will allow the company, which has developed a platform that can decode biomarkers data from vaginal secretions for the early detection of ovarian cancer, to conduct clinical trials. With ovarian cancer the leading cause of death in women diagnosed with gynecological cancers, Nevia is hoping that its platform will save many lives.
Harbour Biomed Ltd. has received FDA clearance of its IND application to commence a phase I trial of HBM-9033 in advanced solid tumors. Developed in collaboration with Medilink Therapeutics (Suzhou) Co. Ltd., HBM-9033 is an antibody-drug conjugate that specifically targets human mesothelin (MSLN), an upregulated tumor-associated antigen in various solid tumors, including mesothelioma, ovarian cancer, lung cancer, breast cancer and pancreatic cancers. The fully human monoclonal antibody in HBM-9033, generated from the Harbour Mice platform, binds preferably to membrane bond MSLN over soluble MSLN, which minimizes the interference of the shedding MSLN on the binding and internalization of the membrane bond MSLN.
Novarock Biotherapeutics Ltd., a subsidiary of CSPC Pharmaceutical Group Ltd., has received FDA approval of its IND application for NBL-028, a CLDN6-CD137 bispecific antibody.
Oncusp Therapeutics Inc. has received IND clearance from the FDA to begin clinical trials with CUSP-06, a cadherin-6 (CDH6)-targeting antibody-drug conjugate designed for the treatment of multiple solid tumors. CDH6 is overexpressed in cancers including ovarian, renal, uterine, thyroid, lung, and cholangiocarcinoma. A phase I trial will pave the way for expansion in patients with platinum-refractory/resistant ovarian cancer and other advanced solid tumors.
Despite continual investment in research focused on high-grade serous ovarian cancer (HGSOC), the 5-year survival rate of ∼30% for most patients has remained unchanged for decades. While ≤20% of HGSOC patients present with treatment-refractory disease, therapeutic strategies have not changed outcomes for these patients in 40 years.
Aravive Inc.’s sole asset missed a phase III primary endpoint in ovarian cancer but the company still has studies planned for treating renal cell carcinoma and pancreatic cancer. Aravive’s stock (NASDAQ:ARAV) dwindled dramatically on Aug. 3, with shares closing 77.2% lower at 28 cents each. That’s a massive drop from heights seen in the past 12 months, as shares hit $2.46 each in March 2023 and $2.09 each in November 2022. The company plans to study the data and make a decision about whether to proceed with the other studies.
Mersana Therapeutics Inc. followed grim June news with an even worse headline as the phase Ib/II study called Uplift with upifitamab rilsodotin (upri) did not meet its primary endpoint in platinum-resistant ovarian cancer (prOC). The antibody-drug conjugate (ADC) targets the sodium-dependent phosphate transport protein NaPi2b and was developed via the company’s platform called Dolaflexin. Shares of Mersana (NASDAQ:MRSN) tumbled 73%, or $2.84, to close July 27 at $1.07 on word of the failure of the trial.
