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Monday, April 1, 2019

Pfizer Spinout SpringWorks Nabs $125M to Move Candidates to Late-Stage Trials

SpringWorks Therapeutics snagged $125 million in a Series B funding round that will help it accelerate its two late-stage cancer treatments into late-stage trials and toward potential regulatory approval, as well as support the continued expansion of the company’s emerging targeted oncology programs.
The Series B round was backed by stalwart investors in the pharma arena, including ArrowMark Partners, Samsara BioCapital, GlaxoSmithKline and Laurion Capital Management. SpringWorks also saw continued financial support from long-time investors that includes Pfizer, OrbiMed, Bain Capital and LifeArc.
SpringWorks is driving toward potential approval with nirogacestat, a gamma-secretase inhibitor for the treatment of desmoid tumors and PD-0325901, a MEK inhibitor for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas. Both of these late-stage drugs were part of Pfizer’s pipeline when SpringWorks was spun out of that company in 2017. When SpringWorks was launched, the company secured $103 million in a Series A. The company was launched in order to provide some hope for the development of medicines across therapeutic areas where there is an urgent need.
Saqib Islam, SpringWorks chief executive officer, said the latest financing round “underscores the progress” the company has made in advancing its late-stage programs toward pivotal studies.

We are well positioned to continue to execute on our strategy to build a leading rare disease and targeted oncology company that brings promising science to underserved patient communities,” he said in a statement.
In November, SpringWorks received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for PD-0325901. PD-0325901 inhibits MEK, a key signaling protein for cellular survival and proliferation. The investigational therapeutics has been shown to block MEK phosphorylation in clinical biopsies. That blocking causes the cells to die. Neurofibromatosis type 1, or NF1, is a rare genetic disorder that is caused by mutations in the NF1 gene, and that affects both children and adults. The company is currently evaluating PD-0325901 as a monotherapy for NF1. But, the company said that given the critical role that the MAPK pathway plays in the growth and proliferation of a large number of tumor types, SpringWorks is also pursuing PD-0325901 in combination with other rational anti-cancer agents across a range of solid tumors. The company anticipates initiating Phase III trial this year. In September, just ahead of the Orphan Drug Designation approval, SpringWorks and Beigene teamed up to develop treatments with PD-0325901. The two companies will pair PD-0325901 with BeiGene’s investigational RAF dimer inhibitor, lifirafenib (BGB-283) in patients with advanced solid tumors.
Also in November, SpringWorks received Fast Track designation from the FDA for nirogacestat, for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis. Desmoid tumors are rare and debilitating soft-tissue tumors that can occur in both children and adults. Depending on their size and location, desmoid tumors can cause severe morbidities such as pain, internal bleeding, disfigurement, and limited range-of-motion. In June 2018, the U.S. FDA granted Orphan Drug designation for nirogacestat for the treatment of desmoid tumors. SpringWorks will launch a Phase III trial for nirogacestat this year.

Lonza to Launch H2OBioEV™ Bioactive Functional for Skin Rejuvenation

At in-cosmetics Global 2019, Lonza today launches the newest in its portfolio of bioactives, H2OBioEV™ Bioactive, a multifunctional cosmetic ingredient that revitalizes, rejuvenates and moisturizes skin. In-cosmetics Global 2019 takes place 2-4 April in Paris (FR). Lonza will be at Stand L88.
‘H2OBioEV™ Bioactive moisturizes by replenishing essential humectants, which provide an optimal environment for epidermal proteins to form and maintain a strong barrier, thus restoring a smooth and radiant appearance,’ said Vanessa Arruda, PhD, Global Market Development Manager, Bioactives. ‘It is an evolution in moisturization, to refresh and revitalize skin.’
H2OBioEV™ BioActive is unique because it offers three different biophysical and biochemical approaches to address dry skin from a single ingredient. H2OBioEV™ bioactive rejuvenates skin by:
  • Depositing an invisible film that locks moisture in the skin
  • Replenishing essential humectants and providing a stabilizing environment for functional skin proteins
  • Stimulating the expression of proteins essential to forming and maintaining an optimal skin barrier function
‘The modern consumer has different needs and expectations, which change the way she or he chooses products,’ Dr. Arruda said, referring to a recent Euromonitor survey.1‘Rather than looking for a specific type of product, consumers are looking for cutting-edge technologies that provide particular functionalities. They recognize five categories of functionality in cosmetic products: rejuvenating, age defying, age reversing, beauty enhancing and imperfection correcting.’

Syndax updates findings from melanoma, NSCLC cohorts of ENCORE 601 trial

Syndax Pharmaceuticals (SNDX) announced the presentation of updated findings from the melanoma and non-small cell lung cancer, or NSCLC, cohorts of ENCORE 601, the company’s Phase 1b/2 trial evaluating the efficacy and safety of entinostat, its once-weekly, oral, small molecule, class I HDAC inhibitor, in combination with Keytruda, Merck’s (MRK) anti-PD-1 therapy. The data were presented during oral presentations at the American Association of Cancer Research Annual Meeting. The company presented results from the ENCORE 601 melanoma cohort that enrolled patients whose disease had progressed on or after anti-PD-1 therapy. Of 53 patients treated, a confirmed objective response was observed in 19% of patients per irRECIST criteria, with a clinical benefit rate of 36%. Median duration of response is 13 months. Four responders, all of whom have been on study therapy for over a year, currently remain on treatment. Efficacy results in patients who also received prior Yervoy therapy were consistent with the overall population. The entinostat-pembrolizumab combination was well tolerated with a manageable toxicity profile. Briggs Morrison, M.D., CEO of Syndax, said, “Both indications represent areas of high unmet need and we believe that available data warrant consideration to move the entinostat-pembrolizumab combination into one or more registration trials. As previously communicated, we look forward to determining next steps for the combination program following availability of overall survival results from E2112, our Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer, the next interim readout of which is expected in the second quarter of this year.”

Bayer resumed with a Hold from Buy at Berenberg

Berenberg transferred coverage of Bayer to analyst Sebastian Bray and downgraded the stock to Hold from an under review designation. The analyst sees downside from legal settlements following the unfavorable glyphosate verdicts. He has a price target of EUR 67 for the shares.

Teladoc oversold on Aetna contract confusion, says Piper Jaffray

Piper Jaffray analyst Sean Wieland believes some confusion over Aetna’s intentions have pressured the shares of Teladoc (TDOC). The confusion lies in the fact that this was a “Request for Price” and not a “Request for Proposal,” Wieland tells investors in a research note. However, his channel checks indicate there isn’t any intention of CVS Health’s (CVS) Aetna switching vendors. To the contrary, we’ve seen companies do this in front of a contract expansion, when they need to provide the board with benchmark pricing data to prove they are not overpaying, says the analyst. As such, he believes potential risk related to Teladoc’s Aetna contract is minimal. Further, Wieland sees upside to Teladoc’s initial guidance on stronger utilization trends as “telemedicine continues to go mainstream.” He views the stock as oversold and reiterates an Overweight rating with an $86 price target.

Autolus Therapeutics to host conference call

Conference call to discuss the ALLCAR19 data presented at AACR will be held on April 2 at 8 am.

AngioDynamics granted FDA approval to initiate NanoKnife DIRECT study

AngioDynamics announced that the United States FDA approved the company’s investigational device exemption application for its NanoKnife Irreversible Electroporation “Direct IRE Cancer Treatment” clinical study. The DIRECT Study supports a proposed expanded indication for the NanoKnife System in the treatment of Stage III pancreatic cancer. In January 2018, the FDA granted the company’s NanoKnife System a Breakthrough Device Designation under the 21st Century Cures Act.