DermTech coverage transferred at Cowen » 17:2410/1410/14/21
Cowen transferred coverage of DermTech to analyst Max Masucci, who maintained an Outperform rating and $50 price target on the name.
Syros Pharmaceuticals appoints Jason Haas CFO » 08:0310/1210/12/21
Syros Pharmaceuticals announced the appointment of Jason Haas as Chief Financial Officer. Mr. Haas brings more than 25 years of healthcare investment banking and corporate finance experience to Syros. "We are pleased to welcome Jason to Syros, who brings an exceptional depth of financial, strategic, and leadership experience in the life sciences space," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "Jason has a proven track record as a strategic advisor to biotechnology and pharmaceutical companies across all stages of development. He joins Syros at a pivotal time, as we advance towards becoming a commercial-stage company, with a growing portfolio in targeted hematology and selective CDK inhibition."
Achilles Therapeutics joins the NA-ATTC consortium » 08:0210/1210/12/21
Achilles Therapeutics announced that it has joined the Northern Alliance for Advanced Therapies Treatment Centre, or NA-AATC, consortium. The NA-ATTC consortium is funded by Innovate UK, the government's innovation agency, and is one of only three Advanced Therapy Treatment Centres in the UK. NA-ATTC was created to address the challenges of bringing pioneering advanced therapy medicinal products to patients. Specifically, the consortium focuses on all elements of the clinical delivery pathway from procurement of starting materials, through to delivery of clinical trials, and adoption and reimbursement across a range of advanced therapies and indications. As an industry partner, Achilles will contribute its knowledge and expertise in supply chain and operations for cell therapies that has been developed with its precision clonal neoantigen-reactive T cell therapy.
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Achilles Therapeutics management to meet virtually with Oppenheimer » 04:5510/0510/05/21
Virtual Meeting to be…
Virtual Meeting to be held on October 5 hosted by Oppenheimer.
DermTech names L'Oreal executive Keraudy to board of directors » 16:0310/0410/04/21
DermTech (DMTK) announced…
DermTech (DMTK) announced the appointment of Nathalie Gerschtein Keraudy, President of the Consumer Products Division of L'Oreal (LRLCY), to its board of directors. "Nathalie has tremendous experience in building brands that consumers, clinicians, and the world recognize and trust," said Matt Posard, the Chairman of DermTech's board of directors. "Her unique and diverse perspectives will complement our efforts to make DermTech the trusted brand for genomic products that transform dermatologic care."
MannKind announces first patient enrolled in INHALE-1 study of AFREZZA » 07:2810/0410/04/21
MannKind Corporation announced the enrollment of the first pediatric patient in the INHALE-1 study. The multi-center study will evaluate the efficacy and safety of Afrezza in combination with basal insulin vs. multiple daily injections of insulin in children and adolescents aged 4-17 who are living with type 1 or type 2 diabetes. INHALE-1 is a 26-week open-label, randomized clinical trial with a 26-week extension. The primary endpoint is change in HbA1c level after 26 weeks. Secondary endpoints include change in fasting plasma glucose after 26 weeks and rate of hypoglycemic events.Enrollment is underway at several sites, including AM Diabetes & Endocrinology Center in Bartlett, Tenn., where the first patient was enrolled. In all, approximately 260 patients are planned to be enrolled at more than 30 sites across the United States.
MannKind announces first patient enrolled in INHALE-1 study of Afrezza » 07:2310/0410/04/21
MannKind announced the…
MannKind announced the enrollment of the first pediatric patient in the INHALE-1 study. The multi-center study will evaluate the efficacy and safety of Afrezza in combination with basal insulin vs. multiple daily injections of insulin in children and adolescents aged 4-17 who are living with type 1 or type 2 diabetes. INHALE-1 is a 26-week open-label, randomized clinical trial with a 26-week extension. The primary endpoint is change in HbA1c level after 26 weeks. Secondary endpoints include change in fasting plasma glucose after 26 weeks and rate of hypoglycemic events.
Seres Therapeutics presents data from SER-109 Phase 3 ECOSPOR III study » 15:1910/0310/03/21
Seres Therapeutics announced late-breaking data from its Phase 3 ECOSPOR III study evaluating SER-109, an investigational oral microbiome therapeutic for recurrent C. difficile infection. SER-109 was associated with significantly greater reduction of antimicrobial resistance genes compared to placebo, with the reduction observed both rapidly and sustained through Week 8 of the study. These data, presented by Timothy Straub on October 2 at the IDWeek 2021 Virtual Conference, support a potential role for microbiome therapeutics in rapid decolonization of antibiotic resistant bacteria. The SER-109 ECOSPOR III Phase 3 study was a multicenter, randomized, placebo-controlled study. Previously reported topline data indicated that the study achieved its primary endpoint at eight weeks and demonstrated a sustained clinical response rate of approximately 88% at eight weeks post-treatment. SER-109 resulted in a 27% absolute reduction of recurrence of CDI compared to placebo at eight weeks post-treatment, which is a relative risk reduction of 68%. In May 2021, Seres presented 24-week clinical data from the study that demonstrated significantly reduced recurrence rates compared to placebo over 24 weeks. SER-109 was observed to be well tolerated, with no treatment-related serious adverse events observed in the active arm and an adverse event profile comparable to placebo. Seres expects to file a Biologics License Application with the U.S. Food and Drug Administration in mid-2022.
Fate Therapeutics announces presentation at SITC annual meeting » 08:2210/0110/01/21
Fate Therapeutics announced that one oral and four poster presentations for the Company's induced pluripotent stem cell product platform were accepted for presentation at the 36th Annual Meeting of the Society for Immunotherapy of Cancer being held November 10-14, 2021. The oral presentation will highlight preclinical data for FT536, the Company's off-the-shelf, multiplexed-engineered, iPSC-derived, chimeric antigen receptor NK cell product candidate that uniquely targets the alpha3 domain of the MHC class I related proteins A and B. In a recent publication in Cancer Immunology Research, Kai W. Wucherpfennig, M.D., Ph.D., Chair of the Department of Cancer Immunology and Virology at the Dana-Farber Cancer Institute and co-leader of the Cancer Immunology Program at Dana-Farber / Harvard Cancer Center, demonstrated that cancers with loss of MHC Class I expression can be effectively targeted with MICA/B alpha3 domain-specific antibodies to restore NK cell-mediated immunity against solid tumors. The FT536 program is supported by an exclusive license from the Dana-Farber Cancer Institute to intellectual property covering novel antibody fragments binding MICA/B for iPSC-derived cellular therapeutics. The Company expects to submit an Investigational New Drug application for FT536 in the fourth quarter of 2021 for the treatment of advanced solid tumors, including in combination with monoclonal antibody therapy. Poster presentations at SITC will include preclinical data on new functional elements that the Company is evaluating for incorporation into its iPSC-derived cell product candidates for solid tumors. These synthetic features include engineered chemokine receptors, which the Company has demonstrated can enhance the trafficking and homing of iPSC-derived CAR T cells to tumors, and synthetic TGFbeta re-direct receptors, which the Company has shown can exploit immuno-suppressive cytokines found in the tumor microenvironment to potentiate iPSC-derived CAR T cells and improve anti-tumor activity.
Syros Pharmaceuticals management to meet virtually with Piper Sandler » 04:5510/0110/01/21
Virtual Meeting to be…
Virtual Meeting to be held on October 1 hosted by Piper Sandler.