Epizyme, Blueprint among cancer companies that fit M&A criteria, says Jefferies » 08:3902/2402/24/20
EPZM, BPMC, DCPH, MTRX, IMMU, KPTI, AGIO
Jefferies analysts Michael Yee and Andrew Tsai noted that of the 66 standalone small-to-mid cap companies with an approved oncology drug in the last decade, 22 of those, or 61%, were ultimately acquired. Within that context, they noted that Epizyme (EPZM), Blueprint Medicines (BPMC), Deciphera (DCPH), Matrix Service (MRTX) and Immunomedics (IMMU) are some of the oncology companies that continue to fit the M&A criteria they examined. The analysts also noted that the M&A rate is over 55% for standalone oncology SMIDs with an approved oral, small molecule, adding that it is possible Epizyme, Blueprint, Karyopharm (KPTI) and Agios Pharmaceuticals (AGIO) could be attractive M&A candidates since they have maintained sole U.S. rights. Yee and Tsai additionally noted that with 22 cancer IPOs in 2019 that the M&A "pool is being replenished."
Bristol-Myers advances CytomX's BMS-986249 into randomized cohort expansion » 08:1802/2402/24/20
CytomX Therapeutics announced that its partner, Bristol-Myers Squibb, has initiated a randomized Phase 2 cohort expansion in its ongoing first-in-human Phase 1/2a trial of the anti-CTLA-4 Probody BMS-986249 alone and in combination with Opdivo. BMS-986249 is a peptide masked version of the anti-CTLA-4 antibody Yervoy. The randomized cohort expansion is designed to further evaluate the safety and efficacy of BMS-986249 in combination with Opdivo in patients with metastatic melanoma, as part of the larger clinical trial. The advancement of BMS-986249 into this part of the planned study triggers a milestone payment of $10M from Bristol-Myers Squibb to CytomX. n September 2019, Bristol-Myers Squibb also initiated the dose escalation phase of a Phase 1/2a clinical trial of a second anti-CTLA-4 Probody, BMS-986288, based on a modified version of ipilimumab, administered as monotherapy and in combination with nivolumab in patients with selected advanced solid tumors. These Probody programs, designed to optimize the risk-benefit profile of CTLA-4-directed therapy, arose from the companies' foundational 2014 worldwide oncology license and collaboration agreement.
Bristol-Myers: Japan's MHLW approves Opdivo for treatment of esophageal cancer » 07:1402/2102/21/20
Bristol-Myers Squibb announced Japan's Ministry of Health, Labor and Welfare has approved Opdivo for the treatment of patients with unresectable advanced or recurrent esophageal cancer that has progressed following chemotherapy.
Compugen to initiate Phase 1/2 triple combination study with Bristol-Myers » 07:0702/2002/20/20
Compugen (GEN) announced…
Compugen (GEN) announced its plan to initiate a Phase 1/2 study evaluating a triple combination of Compugen's COM701, an investigational anti-PVRIG antibody, in combination with Bristol-Myers Squibb's (BMY) PD-1 immune checkpoint inhibitor Opdivo and BMS-986207, Bristol-Myers Squibb's investigational anti-TIGIT antibody. The triple combination study is designed to evaluate the blockade of the three immune checkpoint pathways - PVRIG, TIGIT and PD-1, and will accelerate the clinical evaluation of Compugen's science-driven DNAM axis hypothesis in various advanced solid tumors. The study is expected to commence in the second half of 2020, following the clearance of a new Investigational New Drug Application by the U.S. FDA. Compugen will be the study sponsor with Opdivo and BMS-986207 supplied by Bristol-Myers Squibb.
|Over a week ago|
Five Prime downgraded to Neutral at Wedbush as cabiralizumab study flops » 07:4502/1902/19/20
As previously reported,…
As previously reported, Wedbush analyst Robert Driscoll downgraded Five Prime (FPRX) to Neutral from Outperform with a price target of $5, down from $12. The analyst cited the announcement that the Phase 2 cabiralizumab study in pancreatic cancer did not meet its primary endpoint. Driscoll is "disappointed" in this result given the rationale behind CSF1-R antagonism as well as the initial signal efficacy observed in pancreatic cancer patients in the prior Phase 1 study. Given that partner Bristol-Myers Squibb (BMY) will no longer directly support development of cabiralizumab, he now sees little to no value in the asset and are removing the program from his model.
Roth says cabiralizumab contributed $1 to Five Prime price target » 10:5802/1802/18/20
Five Prime Therapeutics…
Five Prime Therapeutics (FPRX) reported that the Phase II trial testing the combination of Bristol-Myers (BMY) anti-PD-1 antibody nivolumab and Five Prime's anti-CSF-1R antibody cabiralizumab with and without chemotherapy did not meet its primary endpoint of median progression-free survival in advanced pancreatic patients. Roth Capital analyst Tony Butler says the royalties from cabiralizumab contributed approximately $1 per share to his price target for Five Prime shares. It was also announced that Bristol-Myers has no near-term plans for additional sponsored development of cabiralizumab, Butler points out. He keeps a Neutral rating on Five Prime shares with a $10 price target. The stock in late morning trading is down 4% to $4.36.
Five Prime says cabiralizumab with Opdivo trial did not meet primary endpoint » 09:2802/1802/18/20
Five Prime (FPRX)…
Five Prime (FPRX) announced that Bristol-Myers (BMY) informed the company that the randomized Phase 2 trial testing the combination of cabiralizumab with Opdivo with and without chemotherapy in patients with advanced pancreatic cancer did not meet its primary endpoint. While Bristol-Myers has no near term plans for additional sponsored development of cabiralizumab, Bristol-Myers will continue to support the evaluation of cabiralizumab in select, ongoing investigator-sponsored trials and may continue to assess future development opportunities for the investigational asset. Bristol-Myers also informed the company that no new safety signals were observed in the Phase 2 trial.
Bristol-Myers announced five-year follow-up results from Phase 3 CheckMate -025 » 15:2502/1602/16/20
Bristol-Myers Squibb announced five-year follow-up results from the Phase 3 CheckMate -025 study, which continue to demonstrate that treatment with Opdivo delivers superior overall survival and objective response rates in patients with previously treated advanced or metastatic renal cell carcinoma compared to those treated with everolimus. With an extended minimum follow-up of 64 months, patients treated with Opdivo continue to demonstrate OS benefit with 26% of patients alive compared to 18% of patients treated with everolimus. Additionally, the percentage of patients experiencing an objective response was 23% for Opdivo versus 4% for everolimus and the median duration of response for Opdivo was also maintained longer than for everolimus. The overall safety profile was consistent with that observed in previously reported analyses from CheckMate -025 in patients with RCC. No new safety signals or drug-related deaths occurred with extended follow-up.
Bristol-Myers announced updated results from Phase 3 CheckMate -214 study » 15:2302/1602/16/20
Bristol-Myers Squibb announced updated results from the Phase 3 CheckMate -214 study evaluating the combination of Opdivo plus Yervoy versus sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma. With a minimum follow-up of 42 months, the combination of Opdivo plus Yervoy continues to show superior overall survival, objective response rates, duration of response and complete response rates. The safety profile for Opdivo plus Yervoy was consistent with prior findings and no new safety signals or drug-related deaths occurred with extended follow-up. A significant OS benefit was observed in both patients from the intermediate- and poor-risk and the intent-to-treat populations treated with Opdivo plus Yervoy compared to those treated with sunitinib alone. Of the patients treated with Opdivo plus Yervoy who experienced a complete response, per independent review, that response was ongoing in 84% and 86% of patients in the IP and ITT populations, respectively.
Mirati Therapeutics announces trial initial data in Renal Cell Carcinoma » 08:4502/1602/16/20
Mirati Therapeutics (MRTX) announced the presentation of initial data from an ongoing investigator sponsored Phase 1/2 clinical trial of sitravatinib in combination with Bristol-Myers' (BMY) nivolumab in patients with advanced clear cell renal cell cancer who have documented progression on a prior VEGF-targeted therapy. As of the data cut-off date of January 1, 2020, 38 out of 40 patients enrolled were evaluable for response at greater than 12 weeks on therapy. 15/38 patients achieved a confirmed partial response including one PR that has improved to an unconfirmed complete response. 35/38 patients achieved clinical benefit. Initial median progression-free survival was 10.3 months. Median overall survival has not yet been reached with 30/38 patients still on study as of the data cut-off date. The combination has been well-tolerated with manageable adverse events.