ImmunoGen announced positive results from its pivotal trial of mirvetuximab in ovarian cancer. Immunogen announced positive top-line data from the pivotal SORAYA trial.
The trial evaluates the safety and efficacy of mirvetuximab soravtansine monotherapy in patients with FRα-high platinum-resistant ovarian cancer who have been previously treated with Avastin.
Data from SORAYA have the potential to redefine the standard of care for patients with FRα-high platinum-resistant ovarian cancer, as this trial has demonstrated that mirvetuximab delivers clinically meaningful benefit in this setting, with significant and durable responses and a favorable tolerability profile. SORAYA is a single-arm study of mirvetuximab in patients with platinum-resistant ovarian cancer whose tumors express high levels of FRα and who have been treated with up to three prior regimens – at least one of which included bevacizumab.
The primary endpoint for the study is confirmed ORR as assessed by investigator, including complete and partial responses, and the key secondary endpoint is DOR. ORR was also assessed by blinded independent central review. The study is designed to rule out a 12% ORR, based on expected outcomes with available single agent chemotherapy from the AURELIA study in patients with platinum-resistant ovarian cancer and one to two prior lines of therapy.
Ambrx Biopharma released its Phase 1 data for ARX788 in HER2-positive metastatic breast cancer patients. The ADC demonstrated disease control in 29 patients, all refractory to HER2 targeted agents including trastuzumab, ADCs, TKIs and bispecific antibodies, with overall response rates of 65-80% depending on prior therapy. ARX788 comprises a Herceptin trastuzumab-based antibody conjugated to two cytotoxic tubulin inhibitor payloads. Ambrx licensed the China rights to ARX788 to its partner NovoCodex Pharmaceuticals, which presented the data at San Antonio Breast Cancer Symposium.
Tot Biopharm’s self-developed Pusintin, a biosimilar to Roche’s Avastin, has won marketing approval from China’s NMPA. It was approved for treatment of patients with advanced, metastatic, or recurrent non-squamous NSCLC and those with metastatic colorectal cancer.
CytomX Therapeutics announced preliminary Phase 2 results in patients with either advanced squamous NSCLC or head and neck squamous cell carcinoma, who were treated with CX-2029, a CD71-directed conditionally activated ADC being co-developed by CytomX and AbbVie. The compound demonstrated ORR of 18.8% and disease control rate of 87.5% in unselected advanced squamous NSCLC. The enrollment was completed in advanced head and neck squamous cell carcinoma with objective response rate of 4% and disease control rate of 56%.
German start-up Emergence is launching with a large series A to develop an ADC platform that aims to generate compounds with better therapeutic indexes than competitors’ programs, which could enable the start-up to compete on either efficacy or safety, or to go into a broader set of indications. The round was led by Pontifax and includes RA Capital, OrbiMed, Surveyor Capital and Hadean Ventures as new investors as well as existing investors Kurma Partners, NRW.BANK, High-Tech Gründerfonds, Gründerfonds Ruhr and Bpifrance.
Proceeds from this funding round will be used to advance the company’s next-generation ADC targeting Nectin-4 to clinical proof-of-concept as well as the development of additional ADC programs. Emergence’s lead asset, ETx-22, is a next-generation Nectin-4 ADC which has been optimized to increase efficacy and minimize toxicity.
Mythic Therapeutics announced its launch to develop smarter and safer ADCs with an oversubscribed Series B financing round of $103 million. Viking Global Investors led the round, along with new investors including Venrock, Foresite, Perceptive Advisors, and Highside Capital. Existing investors participating in the round include Venrock, First Round Capital, OMX Ventures, Lifeforce Capital, and Refactor Capital.
The proceeds from Mythic’s Series B will finance the lead program through first-in-human clinical studies in lung cancer and fund pipeline development.
