Aclaris Therapeutics provided updated data from three clinical trials for ATI-502, an investigational topical Janus kinase, or JAK, 1/3 inhibitor, an update on the expected release of topline data for one clinical trial for ATI-502, and an enrollment update for a clinical trial for ATI-501, an investigational oral JAK 1/3 inhibitor. AA-202 Topical and AUATB-201 Topical are ongoing Phase 2 clinical trials of ATI-502 for the treatment of alopecia areata, or AA, in the United States and Australia, respectively. In AA-202 Topical, 11 patients with the more severe forms of AA, alopecia universalis, or AU, and alopecia totalis, or AT, were treated with ATI-502 in an initial double-blind pharmacokinetic and pharmacodynamic study for 28 days before entering a 12-month open-label extension. In AUATB-201 Topical, an open-label clinical trial, 12 patients with eyebrow loss due to AA, including patients with AU or AT, had their eyebrows treated with ATI-502 for 6 months. VITI-201 Topical is an open-label pilot clinical trial of ATI-502 administered twice daily in 34 patients with non-segmental facial vitiligo. As announced in November, Aclaris completed enrollment of AA-201 Topical, a randomized, double-blinded, parallel-group, placebo-controlled trial to evaluate the safety, efficacy and dose response of two concentrations of ATI-502 for the treatment of AA. This trial enrolled 129 patients with patchy AA, who were randomized to receive either ATI-502 or placebo. The primary efficacy endpoint is the mean change from baseline in the severity of Alopecia tool, or SALT, score at Week 24. Topline data from the AA-201 Topical trial are now expected in Q2 of 2019. In addition, Aclaris announced that it has completed enrollment of AUAT-201 Oral, a randomized, double-blinded, parallel-group, placebo-controlled trial to evaluate the safety, efficacy and dose response of three concentrations of ATI-501 oral suspension for the treatment of AA. This trial enrolled 87 patients with AA, including AT and AU, who were randomized to receive either ATI-501 or placebo. The primary efficacy endpoint is the mean change from baseline in the SALT score at Week 24. Topline data from the AUAT-201 Oral trial are now expected in Q3 of 2019.
Monday, December 17, 2018
Ligand acquires milestone, royalty rights to PTX-022 from Palvella
Ligand Pharmaceuticals Incorporated announced the acquisition of economic rights to PTX-022 from Palvella Therapeutics. PTX-022 is a novel, topical formulation of rapamycin currently in Phase 2/3 development for the treatment of pachyonychia congenita, a rare skin disorder for which no FDA-approved treatment exists. Ligand will pay $10M to Palvella Therapeutics and in return will receive a tiered royalty on net sales in the mid-to-upper single digits, as well as regulatory and financing milestones. Ligand will not incur any expenses to develop or commercialize PTX-022. “This transaction provides Palvella Therapeutics with capital to complete its planned clinical trials that could be the basis for registration and approval of a novel and important new medicine,” said John Higgins, Chief Executive Officer of Ligand. “The PTX-022 program is being managed by a team of distinguished and capable scientists who have identified a novel way to treat PC. This deal has the potential to provide lucrative economics to Ligand for a drug that could launch in 2022, should its development be successful and if it is approved by the FDA. Ligand is assembling a large collection of significant royalty-bearing assets and partnerships for drugs, many of which could launch over the next several years. Ligand expects to continue entering into license agreements from its existing technologies and will continue to explore ways to acquire new revenue streams through product investments, such as this deal with Palvella, or through company acquisitions.”
https://thefly.com/landingPageNews.php?id=2838179
Imugene ‘encouraged’ by data for HER2 vaccine in gastric cancer
Australian biotech Imugene says its HER2 vaccine hit the mark in a phase 1b trial, setting up a phase 2 study that will start recruiting patients in the new year.
The first tranche of data from the 14-patient trial comes from the first 10 evaluable subjects who were given the HER-Vaxx vaccine at three doses on top of standard chemotherapy with cisplatin and fluorouracil or capecitabine.
Of these, five had a partial response—with a 30% decrease or more in tumor size from baseline scans—while four showed disease stabilization. Imugene CEO Leslie Chong said (PDF) she is “cautiously encouraged” by the data, although the phase 1b study is only really intended to give a safety readout. On that score, HER-Vaxx also seemed to be well-tolerated.
“With these early results from the HER-Vaxx clinical study, Imugene’s B-cell active immunotherapy approach is showing positive signs which provides us with further confidence in our … pipeline,” she added. The vaccine performed best at the highest dose (50 mcg), which will be taken forward into phase 2.
HER-Vaxx grew out of work at the Medical University of Vienna in Austria and is designed to induce a patient’s own immune system to produce antibodies that can attack tumor cells. Imugene’s hope is that vaccination will be an alternative to regular use of monoclonal antibodies such as Roche’s Herceptin, which made sales of almost $7.5 billion last year.
The vaccine is based on B-cell epitope peptides, which when injected cause patients’ B cells to generate antibodies against HER2 receptors, slowing the growth of HER2-positive cancer cells and causing them to be destroyed by the immune system. HER-Vaxx has previously been shown to stimulate a polyclonal antibody response—based on multiple antibody types—in preclinical studies as well as a phase 1 trial in HER2-positive breast cancer.
The phase 2 gastric cancer study, which is expected to enroll 68 HER2-positive gastric cancer patients, will compare HER-Vaxx plus chemo to chemo alone and be carried out in sites across Asia, Eastern Europe and India, where HER2 treatments such as Herceptin and Roche’s follow-up drug Perjeta are not readily available to patients. Imugene’s HER2 vaccine is seen as the key to showing proof of concept for its B-cell epitope platform, but analysts at Edison think the programs at the company with the greatest potential rewards are its PD-1 (KEY-Vaxx) and combined PD-1/HER2 vaccines.
Imugene has in-house PD-1 candidates in early-stage development but cut two years off its timelines in June after licensing technology from the Ohio State University Wexner Medical Center and Mayo Clinic, according to Edison, which says that deal could be “transformational” for the biotech. Clinical trials of KEY-Vaxx are due next year and if successful could make the vaccine a rival to blockbuster checkpoint inhibitors such as Merck & Co.’s Keytruda and Bristol-Myers Squibb’s Opdivo.
“One of the key appeals of KEY-Vaxx is that if it demonstrates efficacy in clinical studies with acceptable tolerability, then the convenient sub-cutaneous dosing schedule and low cost of goods could make it well suited for use in combination with other therapies in a wide range of cancers,” said Edison in a recent research note.
Repligen upgraded to Buy on valuation at CL King
CL King upgraded to Buy from Neutral with a $65 price target. Analyst David Westenberg said shares are now trading at a “reasonable” valuation with near-term drivers looking positive.
https://thefly.com/landingPageNews.php?id=2838163
Roche treatment of follicular lymphoma granted FDA orphan status
Genentech, a Roche company, received FDA orphan designation for its treatment of follicular lymphoma, according to a post to the agency’s website.
https://thefly.com/landingPageNews.php?id=2838167
White House blocks tax break for alcohol companies, WSJ says
The White House finalized a regulation limiting the ability of U.S. wineries and global alcohol companies to cut import taxes, the Wall Street Journal reports. In the government’s mind, the new rules stop wine and liquor companies from double-dipping on tax breaks, with the government arguing that the companies are getting or seeking a tax advantage for imports over domestic production, the report notes. Publicly traded alcohol companies include Diageo (DEO), Constellation Brands (STZ) and Brown-Forman (BFA).
https://thefly.com/landingPageNews.php?id=2838149
Bristol-Myers treatment of idiopathic pulmonary fibrosis gets orphan status
The FDA granted orphan designation to Bristol-Myers’ treatment of idiopathic pulmonary fibrosis, according to a post to the agency’s website.
https://thefly.com/landingPageNews.php?id=2838157
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