ADC Therapeutics announced that the European Commission has granted Orphan Drug designation to Zynlonta, a CD19-targeted ADC, for the treatment of DLBCL. Separately, the company announced the first patient has been dosed in the Phase 1 trial evaluating ADCT-901, targeting kidney associated antigen 1 (KAAG1), in patients with selected advanced solid tumors with high unmet medical needs.
Immunogen announced the appointment of Helen M. Thackray to its Board of Directors. Currently, Dr. Thackray is the Chief Research and Development Officer for BioCryst Pharmaceuticals, where she oversees research and development activities from discovery through registration and defines the strategic direction of the company's pipeline.
Mersana’s members of management presented at three investor conferences, including Baird Global Healthcare Conference, Morgan Stanley Annual Global Healthcare Conference and Cantor Global Healthcare Conference.
FDA has granted accelerated approval to Tivdak (tisotumab vedotin-tftv), the first and only approved ADC for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Seagen also announced that Japan's MHLW has approved Padcev (enfortumab vedotin) for radically unresectable urothelial carcinoma that has progressed after anti-cancer chemotherapy.
Alkermes held two poster presentations related to nemvaleukin alfa, the company's engineered IL-2 variant immunotherapy, at ESMO Congress. The presentations included a trial-in-progress poster for ARTISTRY-6, a global Phase 2 trial of nemvaleukin monotherapy in patients with melanoma who have been previously treated with anti-PD-(L)1 therapy, with or without anti-CTLA-4 therapy, and a poster showing data from a preclinical study that evaluated the anti-tumor efficacy of a mouse ortholog of nemvaleukin as monotherapy and in combination with chemotherapy in a murine model of small cell lung cancer.
ImmunityBio announced positive durable responses in BCG unresponsive bladder cancer patients with a complete response rate of 72%, median duration of complete response of 19.9 months, and 85% remaining cystectomy-free in Phase 2/3 trial.
Nektar has entered a new oncology clinical collaboration with Merck KGaA, and Pfizer to evaluate the maintenance regimen of NKTR-255, Nektar's IL-15 receptor agonist, in combination with avelumab, a PD-L1 inhibitor, in patients with locally advanced or metastatic urothelial carcinoma in the Phase 2 JAVELIN Bladder Medley study.
Xencor presented at the Cantor Virtual Global Healthcare Conference.
Allogene‘s management participated in two virtual investor conferences, including H.C. Wainwright Conference and BofA Healthcare Conference.
Autolus announced that planning approval has been granted to build the company’s new manufacturing facility in Stevenage, UK. The 70,000 square foot facility is being built by Merit Holdings Limited as general contractor for the Reef Group, who will lease the facility to Autolus. Global commercial launch capacity for obe-cel will initially be provided by the existing clinical trial manufacturing facility at The Cell and Gene Therapy Catapult facility.
The short interest of Bellicum increased in September by 32% to 1,049,113 on September 15, compared to 792,820 on August 13.
The short interest of Bellicum decreased in September by 33% to 3,062,786 on September 15, compared to 4,550,930 on August 13.
Arcus’ management participated in two investor conferences, including Citi’s Annual Biopharma Conference and Cantor Global Healthcare Conference.
Immutep reported final OS data from its Phase 2b AIPAC trial evaluating eftilagimod alpha in metastatic breast cancer at SITC 2021.
Clovis announced that it has paid off in full at maturity the remaining $64 million in principal amount outstanding of its 2.5% convertible senior notes due 2021. In addition, Clovis sold during 3Q 2021 to date an aggregate of approximately 9.4 million shares of its common stock for gross proceeds of approximately $43 million.