G1 Therapeutics announced that new data from its randomized Phase 2 clinical trial of trilaciclib in combination with etoposide/carboplatin for treatment of first-line small cell lung cancer, or SCLC, will be presented at the European Society for Medical Oncology, or ESMO. The company reported topline data from this trial in March showing myelopreservation benefits. Additional data from this trial have been selected for a poster discussion session on October 21. A second poster with new data focused specifically on the impact of trilaciclib on immune system function, including preservation of T cell subsets such as activated CD8+ T cells and an increased CD8+/regulatory T cell ratio in peripheral blood compared to placebo, will be presented on October 20.
Tuesday, October 9, 2018
Wave Life Sciences plans to develop programs in rare, genetic eye diseases
Wave Life Sciences announced plans to design and advance stereopure oligonucleotide therapeutics for the potential treatment of rare, inherited eye diseases. Wave’s research in ophthalmology will initially focus on the following four inherited retinal diseases which commonly lead to progressive vision loss typically starting in childhood or adolescence: retinitis pigmentosa due to a P23H mutation in the RHO gene, Stargardt disease, Usher syndrome type 2A and Leber congenital amaurosis 10. The company expects to announce its first ophthalmology development candidate in the second half of 2019. Wave’s decision to expand its therapeutic pipeline into ophthalmology is supported by its data presented at the 14th Annual Meeting of the Oligonucleotide Therapeutics Society. The data demonstrate that a single intravitreal injection of stereopure oligonucleotide in the eye of non-human primates resulted in greater than 95% knockdown of a target RNA in the retina for at least four months. Based on these data, the company is working to design development candidates that could achieve a therapeutic effect with only two doses per year. Wave’s research will assess four genetic targets, RHO P23H, USH2A, ABCA4 and CEP290 to address four rare, inherited retinal diseases. The company estimates that approximately 10,000 U.S. patients could potentially be treated by Wave’s approach to addressing these four diseases.
Ziopharm expects to respond to FDA’s request for information in 2H19
Ziopharm updated guidance on the timing of its response to the request for more information from the U.S. Food and Drug Administration regarding the clinical hold placed on the investigational new drug application for its third-generation Phase 1 trial to evaluate CD19-specific CAR-T therapies under P-O-C technology. Ziopharm expects to respond to the FDA’s request for information in the second half of 2019. Ziopharm also affirmed its guidance on the planned Phase 1 trial to evaluate SB-modified TCRs to treat solid tumors. As disclosed in Ziopharm’s second quarter business update, the IND application for this Phase 1 trial, which is being led by and conducted at the National Cancer Institute, remains on track to be submitted in the fourth quarter of 2018 followed by enrollment of patients beginning in 2019, pending regulatory clearance.
Principia Biopharma initiated at Baird
Principia Biopharma initiated with an Outperform at Baird. Baird analyst Brian Skorney started Principia Biopharma (PRNB) with an Outperform rating and $50 price target, stating that its BTK inhibitor partnered with Sanofi (SNY) for multiple sclerosis has blockbuster potential. He also believes PRN1008, which is entering Phase 3, has a worldwide opportunity over $500M in pemphigus that would also open the door for a host of other indications.
Bruker initiated with a Sell at UBS
UBS analyst Daniel Brennan initiated Bruker with a Sell rating and $30 price target.
Exact Sciences initiated at UBS
Exact Sciences initiated with a Buy at UBS. UBS analyst Daniel Brennan initiated Exact Sciences with a Buy rating and $100 price target.
Syneos Health (SYNH) Earns Buy Rating from Analysts at UBS Group
Equities research analysts at UBS Group began coverage on shares of Syneos Health (NASDAQ:SYNH) in a note issued to investors on Tuesday, The Fly reports. The firm set a “buy” rating on the stock.
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