| Yesterday | ||||
Piper Sandler analyst… Piper Sandler analyst Joseph Catanzaro lowered the firm's price target on I-Mab to $35 from $80 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." | ||||
Needham analyst Mike… Needham analyst Mike Matson upgraded Boston Scientific (BSX) to Buy from Hold with a $48 price target. The company could likely sustain high single digit growth even assuming a moderate WATCHMAN slowdown as it has numerous new products across most of its businesses that could serve as an offset, the analyst tells investors in a research note. With Johnson & Johnson's (JNJ) M&A plans coming into focus as it spins off its consumer business, Boston Scientific could be its target and a "good fit", Matson adds. | ||||
| Thursday | ||||
Eli Lilly announced that… Eli Lilly announced that data from its oncology portfolio will be presented at the 2022 ASCO Annual Meeting. The data include new analyses from studies of Verzenio - abemaciclib, a CDK4/6 inhibitor -, Retevmo - selpercatinib, a selective RET inhibitor -, and imlunestrant - an investigational, oral selective estrogen receptor degrader. Lilly will present analyses from the Verzenio Phase 3 monarchE study in high-risk HR+, HER2- early breast cancer assessing factors associated with increasing risk of treatment discontinuation, an update on the tumor agnostic efficacy of Retevmo in patients with RET fusion-positive solid tumors other than lung and thyroid cancer treated on the global, multicenter registrational LIBRETTO-001 trial, and updated monotherapy results from the ongoing, first-in-human, Phase 1 EMBER trial of imlunestrant in patients with estrogen receptor positive advanced breast cancer and endometrioid endometrial cancer. | ||||
4D pharma (LBPS)… 4D pharma (LBPS) announced the presentation of a trial in progress poster from the Phase II clinical trial of MRx0518 in combination with Bavencio - avelumab -, a PD-L1 blocking antibody, as a first-line maintenance therapy for patients with unresectable locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy, at the 2022 ASCO Annual Meeting. Highlights from the trial in progress poster include: the multi-center study will enroll 30 patients with unresectable locally advanced or metastatic urothelial carcinoma. Patients will receive intravenous Bavencio - avelumab - every two weeks, in combination with one oral capsule of MRx0518 twice daily, until disease progression, patient withdrawal, or unacceptable toxicity. In addition to assessing the safety of the combination of MRx0518 with Bavencio, the study will assess the effect of the combination on progression-free survival at 6 months. The study is being conducted in collaboration with Merck (MRK), Darmstadt, Germany and Pfizer (PFE). Study sites are open for patient enrolment. | ||||
I-Mab announced… I-Mab announced preliminary data of its ongoing Phase 2 clinical trial with uliledlimab, a differentiated CD73 antibody, and its global clinical development plan. Preliminary results through December 2021 from an ongoing Phase 2 clinical study of uliledlimab in combination with toripalimab in patients with non-small cell lung cancer -NSCLC - were largely consistent with those observed in Phase 1 clinical trial in relation to favorable drug safety and pharmacokinetics and pharmacodynamic profile of ulilelimab. Uliledlimab appears safe and well-tolerated up to the highest doses tested, as a monotherapy and a combination therapy. Among three NSCLC patient cohorts who were under different treatment settings, clinical response varied. The highest response rates were observed in the patient cohort with advanced NSCLC who were previously ineligible for standard of care, while the other two cohorts with advanced NSCLC who were heavily treated showed a lower clinical response. The clinical response observed in this patient cohort displayed a correlation with CD73 expression in tumors. This Phase 2 clinical trial is still ongoing. The company plans to expand the study to focus on the selected NSCLC patient cohort. The future clinical development plan of uliledlimab includes a Phase 3 registrational clinical trial in patients with NSCLC to be expected next year if approved by the China National Medical Products Administration and another clinical trial in the U.S. in other selected cancer types and beyond combination with PD-1/PD-L1 therapy in the next 12 months. | ||||
The FDA granted Johnson… The FDA granted Johnson & Johnson's Janssen Research & Development orphan status for its treatment of patients undergoing myeloablative hematopoietic stem cell transplant conditioning to improve platelet recovery and reduce myeloablative bone marrow conditioning-related toxicities. Reference Link | |
SELLAS Life Sciences… SELLAS Life Sciences announced top-line clinical data from its Phase 1/2 trial of galinpepimut-S, the Company's Wilms Tumor-1-targeting peptide immunotherapeutic, in combination with Merck's anti-PD-1 therapy, KEYTRUDA(R) (pembrolizumab), in patients diagnosed with WT1 relapsed or refractory platinum resistant advanced metastatic ovarian cancer. Data from 15 patients enrolled in the study, conducted under a Clinical Trial Collaboration and Supply Agreement with Merck & Co., has been preliminarily analyzed with final data for all 17 patients enrolled in the clinical trial expected by the end of 2022. All enrolled patients were resistant to standard of care platinum-based therapy and 78.5 percent of evaluable patients were refractory to or had failed their first- or second-line therapies with 21.5 percent having failed three or more lines of therapy, including one patient who failed five previous lines of therapy. Of the 15 patients, 13 received at least three doses of GPS, the last of which was in combination with pembrolizumab, and were evaluable for response outcomes. Summary of Top-Line Clinical Data: The overall response rate of the trial is, similar to the response to checkpoint inhibitors. An ad hoc analysis of clinical outcomes in this cohort shows a disease control rate, the sum of overall response rate and rate of stable disease, of 53.9 percent at a median follow-up of 43.1 weeks. In a checkpoint inhibitor single agent study in a similar platinum-resistant ovarian cancer patient population treated with a checkpoint inhibitor alone, the observed DCR was 37.2 percent, consistent with a DCR rate increase of 45 percent in the GPS combination with pembrolizumab over that seen for checkpoint inhibitors alone. Median progression-free survival was 12 weeks compared to 8.4 weeks for checkpoint inhibitors alone seen in studies with similar patient populations, a 43 percent increase in the GPS combination with pembrolizumab. Patients with fewer previous lines of chemotherapy experienced a more favorable median PFS than those with more than two previous lines: for patients with two or fewer previous lines of therapy treated with GPS in combination with pembrolizumab, median PFS was 24 weeks. With 43.1 weeks of follow-up the median overall survival has not been reached. The safety profile of GPS in combination with pembrolizumab was similar to pembrolizumab alone, with the only addition of low-grade rapidly resolving local reactions at the GPS injection site, consistent with observations from other GPS clinical studies. | |
Novocure (NVCR) announced… Novocure (NVCR) announced it has entered into a clinical trial collaboration agreement with Merck (MRK), to study the use of Tumor Treating Fields, or TTFields, concomitant with MSD's anti-PD-1 therapy Keytruda for the treatment of patients with newly diagnosed glioblastoma. This is the second clinical collaboration between Novocure and MSD. |
| Wednesday | ||||
Eli Lilly and Company… Eli Lilly and Company announced plans to expand its manufacturing footprint in Indiana by investing $2.1B in two new manufacturing sites at Indiana's LEAP Lebanon Innovation and Research District in Boone County. David Ricks, Lilly's chair and CEO, said, "These new sites will add capacity in support of our growing pipeline of innovative medicines, while also creating more high-tech jobs for Hoosiers. We are pleased to be a founding investor at the LEAP Lebanon Innovation District." The investment in Boone County is contingent upon local zoning and annexation approvals, the company noted. | ||||
| Tuesday | ||||
According to a post on… According to a post on the FDA's website, Janssen's treatment of primary failure of platelet recovery or secondary failure of platelet recovery in patients who have undergone allogeneic hematopoietic stem cell transplant, received FDA orphan designation. Reference Link | ||||
