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.
Circle Pharma Inc. has selected CID-078 as its first clinical development candidate. CID-078 is an orally bioavailable macrocycle with dual cyclin A and B inhibitory activity that drives synthetic lethality in multiple tumor types.
B7-H4 is an immune-suppressive protein overexpressed in several tumors, including breast, endometrial and ovarian cancers, that has been successfully targeted with antibody-drug conjugate (ADC) strategies in preclinical testing.
Hillstream Biopharma Inc. has signed an exclusive agreement with Applied Biomedical Science Institute (ABSI) to license technology for human antibodies targeting novel HER2 and HER3 conformational epitopes. The goal is to develop proprietary multiformat biologics, including bispecific antibodies and antibody-drug conjugates (ADCs).
Precision diagnostics company Inoviq Ltd.’s stock soared 44% on the news that its breast cancer diagnostic, SubB2M/CA15-3, detected all stages of breast cancer with 87% accuracy, 81% sensitivity and 93% specificity. The clinical validation study that included 483 samples outperformed the standard of care CAS15-3 test, demonstrating an area under the curve (AUC) of .93 compared to .70.
A new study from Dana Farber Cancer Institute, Brigham and Women’s Hospital and Poland’s Medical University of Lodz suggests a simple blood test could detect ovarian and breast cancer without the need for genetic sequencing, paving the way for broader and less costly screening campaigns.
Researchers from Imperial College of Science, Technology and Medicine have reported results of preclinical evaluation of THEO-260, a novel oncolytic virus for the treatment of stromal-rich tumors. The candidate is currently in development for late-stage relapsed refractory ovarian cancer.
