Stocks had a lousy start to the year, and even though January is considered as the whole year’s barometer, Wall Street expects good times ahead.
Stocks had a lousy start to the year, and even though January is considered as the whole year’s barometer, Wall Street expects good times ahead.
Monthly market moves of selected competitors compared to NASDAQ Biotechnology Index (NBI)
ADCT has entered an exclusive license agreement with Mitsubishi Tanabe for development and commercialization of Zynlonta for all hematologic and solid tumor indications in Japan. ADC Therapeutics will receive upfront of $30 million and up to additional $205 million in milestones and royalties ranging from high teens to low twenties.
ImmunoGen announced that Mimi Huizinga, MD, MPH, FACP has been appointed Senior Vice President and Head of Medical Affairs.
Mersana announced during JP Morgan conference its 2022 strategic priorities. The UPLIFT registrational trial of UpRi in platinum-resistant ovarian cancer is expected to complete enrollment in Q3 2022. The company plans to initiate a Phase 3 UP-NEXT maintenance in platinum-sensitive ovarian cancer in Q2 2022.
Seagen announced partial results in 61 patients with untreated metastatic PDAC from the ongoing phase 1 trial combining SEA-CD40 with chemotherapy and pembrolizumab. In. Activity of SEA-CD40 combination was observed in both doses of SEA-CD40 tested. The overall confirmed ORR was 44 %, median PFS was 7.4 months, and median OS was 15 months.
Alkermes presented a poster related to IL-2 variant immunotherapy nemvaleukin alfa at ASCO Gastrointestinal Cancers Symposium. The poster highlighted data related to advanced GI cancers from Phase 1/2 ARTISTRY-1 of nemvaleukin as monotherapy and in combination with Keytruda, and preclinical data from the study of nemvaleukin in combination with novel agents in GI cancers.
ImmunityBio announced interim results from 63 patients in its metastatic pancreatic cancer trial (QUILT 88) showing that the OS rate for patients doubled compared to historical survival rate of three months after two prior lines of therapy. The treatment-related serious adverse events were uncommon (8%) and no treatment-related deaths were reported. ImmunityBio plans to meet with FDA in 2022 to discuss the path for the approval of combination therapies for pancreatic cancer.
Nektar's President and CEO Howard Robin presented at JP Morgan Healthcare Conference.
Xencor announced its 2022 strategic priorities. The company plans to initiate a second Phase 2 study, evaluating vudalimab in patients with advanced pelvic tumors, including clinically defined high-risk mCRPC and certain gynecologic malignancies. Xencor will also present initial data from the Phase 2 study in mCRPC, in the second half of 2022.
Allogene announced that FDA has removed the clinical hold on all of the AlloCAR T clinical trials. FDA had placed a hold on all five of the trials based on a report of a chromosomal abnormality detected post-AlloCAR T administration in a single patient treated with ALLO-501A in the ALPHA2 study. Investigation confirmed the chromosomal abnormality in a single patient was not observed in any AlloCAR T product and not related to Allogene manufacturing process or TALEN gene editing.
Autolus announced its 2022 corporate priorities and provided guidance. Updates on the FELIX trial, where Autolus is evaluating obe-cel in r/r adult ALL patients. The trial is currently enrolling patients into the Phase 2 portion. Autolus expects data from the Phase 2 trial to be available in 2022.
Bellicum’s President and CEO Rick Fair participated in the B. Riley Securities 2022 Virtual Oncology Conference.
Mustang said FDA has issued a hold, pending CMC clearance, on the IND application. Submitted in December 2021, the IND is to initiate a pivotal Phase 2 multicenter study to assess MB-207, lentiviral gene therapy for the bubble boy disease. FDA has previously granted MB-207 Orphan Drug and Rare Pediatric Disease Designations.
Arcus provided update on key milestones anticipated in 2022. Multiple datasets are expected, including presentations planned for domvanalimab and etrumadenant in first line PD-L1 high NSCLC (ARC-7), quemliclustat in pancreatic cancer (ARC-8), and PK/PD data for AB521, Arcus’s HIF-2a inhibitor.
Immutep announced it will participate in SVB Leerink Global Healthcare Conference and BIO CEO & Investor Conference during February.
Clovis announced it estimates sales of $35 – $36 million in Rubraca rucaparib global sales for Q4 2021 and $148 – $149 million for the whole fiscal year 2021.