Aclaris Therapeutics Inc., of Wayne, Pa., said that, in conjunction with Allergan plc, of Dublin, it filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware against Taro Pharmaceuticals Inc., a unit of Taro Pharmaceutical Industries Ltd., of Hawthorne, N.Y., related to Taro's filing of an abbreviated new drug application with the FDA to market a generic version of Rhofade (oxymetazoline hydrochloride) cream 1%, approved to treat rosacea and erythema, prior to the expiration of Orange Book-listed patents.
Adaptimmune Therapeutics plc, of Oxfordshire, U.K., said it inked a three-year agreement with Cryoport Inc., of Irvine, Calif., covering transport of Adaptimmune's cell therapies. Cryoport, which specializes in temperature-controlled logistics, will use its Smartpak II monitoring system to provide near real-time information on location, temperature, orientation, humidity, shock and other factors associated with transport of the temperature-sensitive cell therapies. The agreement follows a previous relationship between the companies supporting research-based shipments. Financial terms were not disclosed.
Bayer AG, of Leverkusen, Germany, and Riken Innovation Co. Ltd., an affiliate of Japan's Riken Institute, said they formed a strategic collaboration to explore drug discovery opportunities across multiple indications by combining Riken Innovation's expertise in academic research with Bayer's drug discovery and development experience. The partners plan to explore potential drug targets and assess disease mechanisms. When a path for a potential drug target is identified, Riken Innovation will coordinate advancement of the project for partnering opportunities. The collaboration will be facilitated by Bayer's Open Innovation Center in Osaka, Japan, and Riken Innovation, recently formed to advance industry-academic partnerships and translate discoveries from Riken researchers.
Insilico Medicine, of Hong Kong, said it entered a two-program artificial intelligence (AI) drug discovery collaboration with Jiangsu Chia Tai Fenghai Pharmaceutical Co. Ltd., of Yancheng, China, focusing on previously undruggable targets, beginning with an AI-enabled platform for triple-negative breast cancer. Insilico is eligible to receive up to $200 million in milestone payments and royalties based on net product sales from the collaboration. Additional terms were not disclosed.
Cure Pharmaceutical Holding Corp., of Oxnard, Calif., said it expanded its oral drug delivery line by creating Cureform, which includes its Curefilm oral thin film. Cureform solutions are intended to increase drug bioavailability, protect against degradation and offer better palatability through taste-masking. The new line adds Curepods chewables and nano and microemulsions to serve as alternative dosage forms that may improve solubility and absorption. The company's combined technologies offer the potential for immediate and controlled-release drug delivery, Cure said.
Datar Cancer Genetics Ltd., of Mumbai, India, said its phase II/III prospective precision oncology trial, RESILIENT, intended to validate the benefit of approved drugs to treat advanced cancer, achieved its primary and secondary endpoints of objective response rate (42.9%) and disease control rate (90.5%), respectively. The RESILIENT protocol was designed to analyze all functional layers of a cancer cell, including DNA, RNA, proteins and germline genetics, as well as the chemoresistance of live tumor cells. Drug combinations tested in the trial were selected based on multi-analyte integration. Of 143 individuals who started treatment, 126 were evaluable per study criteria. No serious treatment-related adverse events or deaths were seen, and most participants reported stable to improved quality of life. The data were published in Oncotarget. The company said the precision oncology trial testing various regimens showed that individuals who previously failed multiple lines of treatment can benefit from a personalized combination of approved cancer drugs when comprehensive tumor analysis is used to guide treatment.
Evotec SE, of Hamburg, Germany, and Celmatix Inc., of New York, said they formed a partnership to develop preclinical programs in prevalent but underserved conditions affecting women's reproductive health, including polycystic ovary syndrome, endometriosis and infertility. Evotec will be responsible for medicinal chemistry, in vitro and in vivo pharmacology in addition to broad development capabilities, while Celmatix will contribute drug target discovery powered by its multiomics Reproductive Atlas platform. Financial terms were not disclosed.
Fauna Bio Inc., of Berkeley, Calif., was awarded a Small Business Innovation Research grant from the NIH for the development of its integrated genomics platform and testing of repurposed drug candidates. The grant allows Fauna to extend its discovery platform with sequencing data from its biobank of 13-lined ground-squirrel tissues, which is the species that has emerged as the model hibernator. The company will then integrate existing publicly available genomic, transcriptomic and proteomic data for the species.
Galderma Pharma SA, of Lausanne, Switzerland, received a manufacturing license from the Swedish Medical Products Agency for a facility in Uppsala, Sweden. The facility will manufacture Galderma's QM-1114, a botulinum toxin derived from a strain of Clostridium botulinum.
GE Healthcare Inc., of Princeton, N.J., and Theragnostics Inc., of Boston, signed a global commercial partnership for a new prostate-specific membrane antigen PET/CT imaging agent. Theragnostics will lead the development of the tracer, called Galliprost, while GE will lead all pre-approval commercial preparations and, as and when approval is received, all subsequent commercial and distribution activities. Theragnostics has reported data from a phase II study that met its primary and secondary endpoints, demonstrating that one-third of newly diagnosed prostate cancer patients, and more than 50% of patients with biochemically recurrent disease, had their treatment plans modified as a result of a Galliprost scan.
Gensight Biologics SA, of Paris, reported proof of GS-010 DNA transfer from one eye to the other eye following unilateral intravitreal injection of primates. In a study to investigate the local biodistribution of GS-010, tissue samples from the non-injected eye of monkeys that had been unilaterally injected with GS-010 were found to contain GS-010 DNA three months after injection, indicating the expression of the therapeutic gene in the contralateral eye. The results join a growing body of evidence suggesting the two eyes communicate not only in disease, but also in response to treatment, the company said.
Glaxosmithkline plc (GSK), of London, disclosed a five-year collaboration with Lyell Immunopharma Inc., of South San Francisco, to develop new technologies to improve cell therapies for cancer patients. The pact will apply Lyell's technologies to further strengthen GSK's cell therapy pipeline, including GSK-3377794, which targets the NY-ESO-1 antigen that is expressed across multiple cancer types. Improving the "fitness" of T cells and delaying the onset of T-cell exhaustion could help engineered T-cell therapies become more effective in solid tumors, the companies said. Terms were not disclosed.
Ionis Pharmaceuticals Inc., of Carlsbad, Calif., said it was notified by partner Bayer AG, of Leverkusen, Germany, about the decision to advance IONIS-FXI-LRx following positive clinical results. IONIS-FXI-LRx is an antisense medicine being developed to treat patients with clotting disorders. IONIS-FXI-LRx utilizes Ionis' platform called LIgand Conjugated Antisense, or LICA, and is designed to reduce the production of factor XI, a clotting factor produced in the liver. Under the companies' agreement, Ionis has generated more than $185 million to date, including a $10 million milestone payment Ionis earned with Bayer's continuation decision. Ionis is eligible to receive additional milestone payments as the medicine advances toward the market, as well as tiered royalties in the low to high 20% range on gross margins. Bayer will now assume all development, regulatory and commercialization activities and costs.
In its drive to the clinic, Nanoviricides Inc., of Shelton, Conn., began bioanalytical studies for its IND-enabling preclinical safety and toxicology studies of NV-HHV-101. Northeast Biolab, of Hamden, Ct., will conduct the safety and toxicokinetic analyses. The broad-spectrum drug candidate, and its variations, are being evaluated for treating difficult and life-threatening viral illnesses.
Novartis Pharmaceuticals Canada Inc., of Dorval, Quebec, part of Novartis AG, may now treat patients in the province with relapsed/refractory (r/r) pediatric and young adult B-cell acute lymphoblastic leukemia and adult r/r diffuse large B-cell lymphoma using Kymriah (tisagenlecleucel), the country's first approved CAR T-cell therapy. Kymriah is a CD19-directed genetically modified autologous T-cell immunocellular therapy.
Nasdaq delisted the company stock of Novelion Therapeutics Inc., of Vancouver, British Columbia, on Oct. 9. Novelion had previously received written notice from Nasdaq that the company was not in compliance with the continued listing requirement to maintain minimum market value of publicly held shares of $15 million. The company had also previously received a second notice from Nasdaq that it was out of compliance with the minimum bid price of $1 per share. Novelion officials said they will not ask for a review or an appeal of Nasdaq's decision.
To recover from its failed phase II bryostatin-1 for Alzheimer's disease in September, Neurotrope Inc., of New York, formed a strategic alternatives committee to evaluate the company's future opportunities. Bryostatin-1, Neurotrope's lead candidate, failed to outperform a placebo in helping people with moderate to severe Alzheimer's achieve improvement on a standardized measure of cognition. (See BioWorld, Sept. 10, 2019.)
Ocugen Inc., of Malvern, Pa., said it entered a second amendment to the asset purchase agreement with Medavate Corp. relating to the sale of Ocugen’s autologous chondrocyte cartilage implant, Neocart. The amendment increases the purchase price to $7 million, from $6.5 million, to be paid on the earlier of Oct. 31 or when Medavate obtains financing. Medavate also will now pay Ocugen royalties in the low single digits for net sales of Neocart.
Parexel International, of Waltham, Mass., and Datavant, of San Francisco, said they established a multiyear strategic partnership to enable the connection of real-world data across all clinical trials conducted by Parexel. By default, Datavant's connectivity technology will be integrated into Parexel's standard data workflow for all studies, allowing sponsors to optimize the evidence generation process by connecting real-world data to their clinical trial data, whether in the trial protocol or retroactively after a study is complete. The technology enables linking of de-identified data from electronic health records, claims and diagnostics, as well as emerging sources such as genomics, wearable devices, socioeconomic and behavioral data.
Prevail Therapeutics Inc., of New York, which is developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative disorders, and Lonza Group Ltd., of Basel, Switzerland, said they entered a strategic collaboration. The companies have been working together since 2018, with an initial focus on process development, toward the GMP manufacturing of Prevail's two lead programs, PR-001, an AAV9-based gene therapy delivering GBA1, in development for Parkinson's disease patients with GBA1 mutations and neuronopathic Gaucher disease patients, and PR-006, an AAV9-based gene therapy delivering GRN, for frontotemporal dementia patients with a GRN mutation. Under this collaboration, focused on the baculovirus/Sf9 production system for gene therapies, Lonza will manufacture the company's pipeline of AAV-based gene therapy programs at its gene therapy center in Houston. Prevail plans to initiate a phase I/II trial of PR-001 in PD-GBA in 2019, and PR-006 will enter the clinic next year.
Promis Neurosciences Inc., of Toronto, said it identified several antibody candidates for multiple system atrophy (MSA), a severe, Parkinson's-like disease caused by toxic, misfolded forms of the protein alpha-synuclein. The new antibody candidates now become part of the company's pipeline of antibodies that demonstrate high selectivity for toxic misfolded proteins, implicated as a root cause of several neurodegenerative diseases. Its preclinical in vitro studies indicate that antibody candidates targeting toxic forms of alpha-synuclein bind strongly to toxic alpha-synuclein aggregates derived from MSA-affected brain. The same antibodies protect cultured neurons from alpha-synuclein toxicity and propagation.
Relmada Therapeutics Inc., of New York, said its shares been approved for listing on Nasdaq and they will trade under their existing symbol, RLMD. To accomplish the uplisting, the company's board approved 1-for-4 reverse stock split in September.
Ritter Pharmaceuticals Inc., of Los Angeles, which is focused on developing therapeutic products that modulate the gut microbiome to treat gastrointestinal diseases, said it has engaged A.G.P./Alliance Global Partners as financial advisor to explore and evaluate strategic alternatives to enhance shareholder value.
Samsung Bioepis Co. Ltd., of Incheon, Korea, said real-world data of Benepali, a biosimilar referencing Thousand Oaks, Calif.-based Amgen Inc.'s Enbrel, in patients with moderate to severe psoriasis from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR), will be presented at the European Academy of Dermatology and Venereology congress in Madrid. BADBIR is a U.K. and Ireland observational study that assesses the long-term safety of biologic treatments for psoriasis, in which Samsung Bioepis has participated since May 2016. The study included BADBIR-registered patients treated from Jan. 1, 2016, to Sept. 1, 2018, with 189 patients included in the analysis. At baseline enrollment, the mean disease duration was 22.6 years and the mean Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) scores were 11.6 and 13.1, respectively. The median treatment period was 14.1 months and the recorded discontinuation rate was 26.3%. Of the 48 patients who had their PASI score available both at baseline and at six months, disease activity of 20 patients with baseline PASI < 10 (mean PASI 3.2) did not increase after six months (mean PASI 3.2). Disease activity of 28 patients with baseline PASI ≥ 10 (mean PASI 15.7) was reduced after six months (mean PASI 5).
Sosei Group Corp., of Tokyo, said its partner, Genentech Inc., a member of the Roche Group, of Basel, Switzerland, plans to select a new G protein-coupled receptor, or GPCR, disease target, which triggered a $3 million payment to Sosei Heptares. Under the collaboration and license agreement, signed in July, Genentech will be responsible for developing and commercializing potential new medicines for each novel target and will have exclusive global rights to those agents. Sosei Heptares is also eligible to receive future milestone payments from Genentech that may exceed $1 billion for achieving prespecified research, development and commercialization events. In addition, the company is eligible to receive royalty payments on the net sales of potential future medicines resulting from the collaboration. (See BioWorld, July 17, 2019.)
Sutro Biopharma Inc., of South San Francisco, said it achieved a milestone under its collaboration and license deal with Merck KGaA, of Darmstadt, Germany, and is entitled to a milestone payment. The milestone was linked to the designation by Merck of an undisclosed bispecific antibody-drug conjugate (ADC) as a clinical candidate with approval to advance to IND-enabling studies. The candidate was discovered using Sutro's XpressCF+ discovery and manufacturing technology and includes a linker-warhead also discovered by Sutro. As part of the agreement, Sutro will manufacture the ADC for the early clinical supply of the candidate and is eligible for further milestones and royalties. Merck will be responsible for drug product, clinical development and commercialization. (See BioWorld, July 25, 2018.)
Trillium Therapeutics Inc., of Toronto, said it received notification from Nasdaq notifying the firm it is eligible for an additional 180 calendar days, or until March 30, 2020, to regain compliance with the minimum bid price requirements for continued listing.
Virtrial, a Scottsdale, Ariz.-based telehealth company, said it was awarded an FDA-approved hybrid centralized clinical trial with stem cell company Hope Biosciences Inc., of Sugar Land, Texas, which will provide the latter's autologous, adipose-derived culture expanded mesenchymal stem cells to treat spinal cord injury/disorder. Study protocol incorporates remote visits via Virtrial's telehealth platform.