| Yesterday | ||||
Piper Sandler analyst… Piper Sandler analyst Joseph Catanzaro lowered the firm's price target on Leap Therapeutics to $4 from $6 and keeps an Overweight rating on the shares. While the analyst's investment thesis has not changed, he acknowledges that "biotech valuations have re-rated," and lowers the firm's price targets on companies in the coverage universe to "reflect this recent pullback and current market conditions." | ||||
| Thursday | ||||
Leap Therapeutics… Leap Therapeutics announced that initial clinical data from the investigator-sponsored Phase 1b/2a dose escalation and dose expansion study testing Leap's anti-Dickkopf-1 antibody, DKN-01, as monotherapy or in combination with docetaxel in metastatic castration-resistant prostate cancer will be presented at the upcoming 2022 American Society of Clinical Oncology Annual Meeting on June 3-7. DKN-01, as a monotherapy and in combination with docetaxel, was well tolerated by patients, with partial responses in all of the patients treated with DKN-01 in combination with docetaxel who had measurable disease. Accrual into the Phase 2 portion of this study is ongoing, alongside preclinical and correlative studies aiming to further investigate the mechanism of action of DKN-01 in prostate cancer and to identify the best clinical path forward. Data that will be presented at ASCO is from the completed Phase 1 portion of the study. Thirteen patients were enrolled. The primary endpoint of the Phase 1 dose escalation cohorts was safety, characterized by dose-limiting toxicity. No partial responses were seen in the monotherapy cohort with best overall response of stable disease in 2 out of 5 evaluable patients. In the combination cohort, all 5 evaluable patients had a PR and by PSA50. Confirmed partial responses in the combination cohort were observed in both DKK1 high and low expressing tumors, including in 2 out of 3 patients with aggressive variant prostate cancer. | ||||
BeiGene "will… BeiGene "will present data from its broad solid tumor and hematology portfolios in eight presentations at the upcoming American Society of Cancer Oncology, ASCO, Annual Meeting being held in Chicago from June 3-7, 2022. Highlights include new clinical data for its BTK-inhibitor zanubrutinib, or BRUKINSA: 1) Long-term safety and efficacy results from the Phase 3 ASPEN trial of BRUKINSA versus ibrutinib in patients with Waldenstrom macroglobulinemia, with median follow up of 43 months. 2) Primary analysis from the Phase 2 ROSEWOOD trial of zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy in patients with relapsed or refractory follicular lymphoma. | ||||
| Over a week ago | ||||
BeiGene announced the… BeiGene announced the opening of a new regional office in Basel, Switzerland. BeiGene has built a European organization, including commercial and clinical teams, and this new location will serve as a hub for the company's operations in the region. | ||||
Cash and cash equivalents… Cash and cash equivalents totaled $103.2M at March 31, 2022. Research and development incentive receivables totaled $1.3M at March 31, 2022. "We are making consistent progress in advancing DKN-01 across multiple tumor types and look forward to Dr. David Wise of New York University presenting initial prostate cancer data at the upcoming ASCO conference," said Douglas E. Onsi, President and CEO of Leap. "With compelling response and survival data for DKN-01 in combination with BeiGene's tislelizumab in gastric cancer patients presented in January, and the recent completion of enrollment in our second-line cohort, we are preparing for updated data readouts from our DisTinGuish study in the second half of the year. We are also looking forward to hosting an R&D Day in late June to outline the next phase in the clinical development strategy for DKN-01." | ||||
Reports Q1 revenue… Reports Q1 revenue $306.63M, consensus $288.28M. "I have never been more confident in BeiGene. We made terrific progress in the first quarter with our global commercial performance in the U.S., Europe, and in Asia, and we continue to build on our strategic competitive advantages, including breaking ground on our flagship U.S. manufacturing and clinical R&D campus at Princeton Innovation West in Hopewell, N.J.," said John Oyler, co-founder, chairman, and CEO at BeiGene. "BRUKINSA and tislelizumab continue to validate our ability to run global clinical trials and bring impactful medicines to cancer patients. We announced long-term follow up data from our Phase 3 head-to-head global ALPINE trial in relapsed/refractory CLL, where BRUKINSA demonstrated superiority in overall response rate versus ibrutinib as assessed by an Independent Review Committee and continued to show lower rates of atrial fibrillation and flutter. Our tislelizumab program with Novartis has also progressed with positive data from RATIONALE 306, our global trial in 1L advanced esophageal cancer. We are well positioned to advance our pipeline and expand our global capabilities to meet the needs of patients around the world." | |
BeiGene (BGNE) announced… BeiGene (BGNE) announced that the China National Medical Products Administration, or NMPA, has granted conditional approval of Blincyto for injection for the treatment of pediatric patients with relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia, or ALL. The NMPA granted conditional approval for adult patients in this indication in December 2020. Developed by Amgen (AMGN) and licensed to BeiGene in China under a strategic collaboration commenced in 2020, this is the second approval for Blincyto in China. The pediatric Supplemental Biologic License Application was submitted by BeiGene. | |
BeiGene announced the… BeiGene announced the groundbreaking of its U.S. manufacturing and clinical R&D center at the Princeton West Innovation Campus in Hopewell, New Jersey. The initial phase of construction is expected to include approximately 400,000 square feet of dedicated commercial-stage biologic pharmaceutical manufacturing space, with capacity for up to 16,000 liters of biologics formula. BeiGene intends to recruit hundreds of new hires from the area's attractive talent market to support its continued growth and its commitment to producing life-saving oncology medicines. | |
BeiGene announced that… BeiGene announced that the BTK inhibitor BRUKINSA, zanubrutinib, has been approved in Uruguay for the treatment of adult patients with previously treated mantle cell lymphoma, relapsed or refractory marginal zone lymphoma , and Waldenstrom's macroglobulinemia . BeiGene and Adium entered into an exclusive distribution agreement for Adium to commercialize BRUKINSA in Latin America. "Tolerability of treatments for B-cell malignancies is an important consideration with BTK inhibition, and BRUKINSA was designed with that in mind to maximize BTK occupancy and minimize off-target binding. Today, we have a new treatment option for patients with MCL, MZL and WM in Uruguay, providing hope for improved treatment outcomes," said Dr. Karina Cicinelli, Corporate Medical Director at Adium. "We are proud of the progress BeiGene has made in Latin America over the past year, with this approval in three indications in Uruguay following recent launches in Brazil, Chile and Ecuador. With Adium's established commercial presence in Latin America, we hope patients with MCL, MZL, and WM will soon have access to this important treatment option," commented Eduardo Molinari, Senior Director of New Market Development in Latin America at BeiGene. |
| Over a month ago | ||||
Novartis (NVS) announced… Novartis (NVS) announced positive topline results from an interim analysis of the Phase III RATIONALE 306 study, which showed anti-PD-1 immune checkpoint inhibitor tislelizumab plus chemotherapy significantly improved overall survival, or OS, compared to chemotherapy in patients with previously untreated unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma, or ESCC, regardless of PD-L1 expression. Novartis intends to submit these data to regulatory authorities, and will collaborate with BeiGene (BGNE) to present them at an upcoming medical meeting. Approximately 649 study participants were randomized 1:1 to receive either tislelizumab plus chemotherapy or chemotherapy alone. The primary endpoint is OS. Secondary endpoints include progression-free survival, objective response rate, duration of response, health-related quality of life measures and safety. Tislelizumab is currently under review by the US Food and Drug Administration and the European Medicines Agency for advanced or metastatic ESCC after prior chemotherapy. The EMA is also reviewing tislelizumab for advanced or metastatic non-small cell lung cancer, or NSCLC, after prior chemotherapy, and in combination with chemotherapy for previously untreated advanced or metastatic NSCLC. | ||||
