Abbvie Inc., of North Chicago, disclosed the creation of a new global business, Allergan Aesthetics, and the proposed leadership team for the combined company, effective upon the expected first-quarter 2020 close of the buyout of Dublin-based Allergan plc. Allergan Aesthetics will operate as a new global dedicated business with its own research and development function under the Abbvie umbrella and will include leading aesthetic products, including, Botox (onabotulinumtoxinA injection) cosmetic, the Juvederm collection of dermal fillers and Coolsculpting body contouring, among others. The global business, located in Irvine, Calif., will be led by Carrie Strom, currently senior vice president of U.S. medical aesthetics for Allergan. Upon completion of the acquisition, Strom will be named senior vice president of Abbvie and president of global Allergan aesthetics. The eyecare and specialty businesses will be integrated into the existing Abbvie organization. Several Allergan leaders have accepted leadership positions in the future company across those franchises.
Adaptive Phage Therapeutics Inc., of Gaithersburg, Md., said the U.S. Department of Defense awarded the firm a contract of $10.2 million for the development of Phagebank, a personalized bacteriophage therapeutic, for the treatment of bacterial infections. The award is designated to conduct a clinical trial, with the goal of making Phagebank phage therapy available to treat multidrug-resistant and complicated infections.
Altavant Sciences Inc., of Cary, N.C., signed a definitive agreement to acquire Onspira Therapeutics Inc., of Basel, Switzerland. The acquisition expands Altavant's pipeline to include OSP-101, an inhaled interleukin-1 receptor antagonist with orphan drug designation from the FDA. OSP-101 is in preclinical development for the treatment of bronchiolitis obliterans syndrome, the leading non-infectious complication following lung transplantation and a major cause of death in those patients. Terms were not disclosed.
Avacta Group plc, of Cambridge, U.K., and Daewoong Pharmaceutical Co. Ltd., of Seoul, South Korea, agreed to establish a joint venture in South Korea, and to enter a collaboration and license agreement for the joint venture to develop the next generation of cell and gene therapies incorporating Affimer proteins. The joint venture will develop a new class of mesenchymal stem cells (MSCs) that are primed to produce Affimer proteins, which are designed to enhance the immune-modulatory effect when administered to patients, by reducing inflammatory or autoimmune responses. Daewoong will provide the joint venture with access to its technology for generating allogeneic MSCs from a single donor to treat a large number of patients, the companies said.
Axim Biotechnologies Inc., of New York, signed a binding term sheet to acquire oncology research and development company Sapphire Biotech Inc., of San Diego, as a wholly owned subsidiary. Sapphire has discovered a lead compound that inhibits and suppresses invasion in vitro and metastasis in vivo. The company intends to begin testing its new drug in mouse models and then in a subsequent phase I application. Sapphire is also developing a line of diagnostics for early cancer detection, response to treatment and recurrence monitoring, one of which is currently being evaluated in a clinical trial for its potential to diagnose pancreatic cancer.
Candel Therapeutics Inc., of Needham, Mass., acquired all oncolytic and other herpes simplex virus (HSV)-based assets from Periphagen Inc., of Pittsburgh, Pa., bringing its vector engineering, production expertise and next-generation HSV drug development platform in-house. This acquisition supports further development of Candel's rQNestin34.5, currently in a phase I study for recurrent malignant gliomas. Terms of the transaction were not disclosed.
Catabasis Pharmaceuticals Inc., of Boston, and Duchenne UK, a charity that seeks to fund and accelerate treatments and a cure for Duchenne muscular dystrophy (DMD), have entered a partnership for a phase II trial of edasalonexent, described as a NF-kB inhibitor, in non-ambulatory DMD patients. The exploratory trial, which is subject to the receipt of adequate funding, is designed to assess safety, pharmacokinetics and exploratory measures of function, including cardiac, skeletal muscle and pulmonary function, in non-ambulatory DMD patients, the company said.
Certara Inc., of Princeton, N.J., said its Simcyp population-based simulator was used to support Lausanne, Switzerland-based Galderma SA’s successful NDA with the FDA for Aklief (trifarotene) cream 0.005% for the topical treatment of acne. Trifarotene is the first new retinoid molecule to receive FDA approval to treat acne in more than 20 years, the company noted. Simcyp allowed Galderma to expedite and inform its drug development program, while also providing safety label claim and pediatric dosing information without the need for testing in clinical patients.
Cohbar Inc., of Menlo Park, Calif., disclosed the discovery of a series of mitochondrial peptide analogues with potent in vitro activity as selective inhibitors of C-X-C chemokine receptor type 4 (CXCR4) and with preliminary in vivo efficacy in a mouse model of melanoma, including substantial reduction in tumor growth as compared to control animals. CXCR4 is a key regulatory receptor involved in tumor growth, invasion, angiogenesis, metastasis and resistance to therapy, the company said.
Debiopharm SA, of Lausanne, Switzerland, granted Knight Therapeutics Inc., of Montreal, rights to commercialize Trelstar (triptorelin) in Canada. Knight takes over commercial activities from Debiopharm's current partner, Dublin-based Allergan plc, and expects to begin recording revenues sometime in early 2020. Previously, Trelstar, an agonist analogue of the gonadotropin-releasing hormone, was launched and commercialized in Canada by Paladin Labs Inc. between 2006 to 2014.
Enterprise Therapeutics Ltd., of Brighton, U.K., disclosed the publication of its first peer-reviewed paper. Published in the American Journal of Respiratory and Critical Care Medicine, the paper describes TMEM16A potentiation via ETX-001 as an approach for the treatment of cystic fibrosis. The research was conducted in collaboration with University of Sussex, University of North Carolina and University of Miami. The paper demonstrates the ability of ETX-001, to enhance the activity of TMEM16A in human bronchial epithelial cells from patients, increasing epithelial fluid secretion and mucus clearance, providing the first preclinical proof of principle for that approach.
Entrada Therapeutics Inc., of Boston, said it is developing ENTR-501, a thymidine phosphorylase enzyme replacement therapy, for the treatment of mitochondrial neurogastrointestinal encephalomyopathy (MNGIE), a rare, autosomal recessive disorder that results in a clinically distinct combination of severe gastrointestinal and neurological manifestations caused by the systemic accumulation of toxic metabolites in the affected tissues. ENTR-501 is a recombinant form of the thymidine phosphorylase enzyme engineered using Entrada's Endosomal Escape Vehicle technology and is designed to replace deficient thymidine phosphorylase in MNGIE patients.
New data from Hepion Pharmaceuticals Inc., of Edison, N.J., show pharmacologic inhibition of cyclophilins with compounds such as Hepion's CRV-431 could help resolve multiple pathophysiological activities occurring in nonalcoholic steatohepatitis (NASH), including mitochondrial dysfunction, liver cell death, inflammation and fibrotic liver scarring. Cyclophilins are a family of modulatory enzymes. CRV-431 has reduced liver fibrosis and hepatocellular carcinoma tumor burden in experimental NASH models. The new data were published in Expert Opinion on Investigational Drugs.
Preclinical data for HMBD-001, an anti-HER3 antibody from Hummingbird Bioscience Pte Ltd., of Singapore, show the antibody is superior at tumor growth inhibition, regardless of how HER3 is activated, compared to previous anti-HER3 drugs with different binding sites and mechanisms of action. HMBD-001 demonstrated efficacy in a panel of in vitro and in vivo tumor models with high HER3 activity and oncogenic downstream signaling, the company said. HER3 is in the EGFR tyrosine kinase receptor family, which drives cancer cell division and growth, and is expressed in more than half of colorectal and gastric cancers, at least a third of breast cancers as well as significant subpopulations of many other indications. The data were published in Molecular Cancer Therapeutics.
Immunic AG, a subsidiary of Immunic Inc., of New York, exercised an exclusive global option to license a group of compounds designated by Immunic as IMU-856 from Tokyo-based Daiichi Sankyo Co. Ltd. Immunic plans to begin phase I studies for the program in the first half of 2020. IMU-856 is an oral, small-molecule modulator targeting an undisclosed protein serving as a transcriptional regulator of intestinal barrier function. The option and license agreement gave Immunic exclusive rights to commercialization of IMU-856 in all countries, including the U.S., Europe and Japan. The option also includes exclusivity on a patent application filed by Daiichi Sankyo covering IMU-856's composition. Concurrent with the option exercise, Immunic will pay Daiichi Sankyo a one-time up-front licensing fee. Daiichi Sankyo could receive certain future development, approval and sales milestone payments, as well as royalties. Financial terms were not disclosed.
Innovent Biologics Inc., of Suzhou, China, and Sirnaomics Inc., of Gaithersburg, Md., will collaborate on clinical studies using Innovent's injectable antibody drug, Tyvyt (sintilimab), and Sirnaomics' RNAi candidate, STP-705 (cotsiranib), for combination treatment in advanced cancers, including hepatocellular carcinomas. Tyvyt, developed in China by Innovent and Indianapolis-based Eli Lilly and Co., was granted marketing approval by the National Medical Products Administration of China for relapsed/refractory classical Hodgkin lymphoma in 2018. Tyvyt is an immunoglobulin G4 monoclonal antibody that binds to PD-1 molecules on the surface of T cells, blocks the PD-1/ PD-1 ligand-1 pathway and reactivates T cells to kill cancer cells.
Nanovalent Pharmaceuticals Inc., of San Francisco, published patent No. 10,369,104 from the U.S. Patent and Trademark Office regarding its application of targeted polymerized nanoparticles in cancer, supporting the company’s goal of a 2020 financing to accelerate its pre-IND work on its lead drug candidate, NV-103 (irinotecan), in Ewing sarcoma, hepatocellular carcinoma, neuroendocrine tumors, acute myeloid leukemia and acute lymphoblastic leukemia. Funding comes from direct management investment, angel investors and grants from the National Science Foundation, the National Cancer Institute and the Montana Chamber of Commerce.
Nanoviricides Inc., of Shelton, Conn., contracted and initiated genetic toxicology testing required to support an IND for its lead candidate, NV-HHV-101. Studies include the Ames test using bacterial cells to determine if the candidate causes mutations and the standardized micronucleus test to determine if it damages chromosomes in human cells. Nanoviricides plans filing an IND with the FDA to advance NV-HHV-101 into the clinic for treating shingles rash.
Nuprobe Global, of Boston, and Carriergene Biotech Co. Ltd., of Suzhou, China, completed their merger and integration.
Preveceutical Medical Inc., of Vancouver, British Columbia, completed a preliminary safety evaluation of selected water-based cannabis extract-infused soluble gel formulations in freshly explanted human nasal mucosal tissue. The data show no elevation in what the company called “clinically accepted" biomarkers of tissue toxicity. The company has five research and development programs, including dual gene therapy for curative and prevention therapies for diabetes and obesity, and non-addictive analgesic peptides to replace addictive analgesics such as morphine, fentanyl and oxycodone.
Probiogen AG, of Berlin, signed a commercial license agreement with Basel, Switzerland-based Roche Holding AG for applying Probiogen’s Glymaxx technology to boost antibody-dependent cellular cytotoxicity antitumor activity. One Glymaxx-modified cell line can produce fucosylated or afucosylated antibodies and those with an intermediate defined fucosylation level. In September, Leverkusen, Germany-based Bayer AG agreed to use Glymaxx to develop undisclosed antibody candidate for oncology.
Schrödinger LLC, of New York, and Leverkusen, Germany-based Bayer AG announced a five-year technology alliance to develop a way to accelerate the discovery of innovative new drugs. Schrödinger said the technology "is expected to be capable of enumerating, screening and scoring billions of synthetically feasible, virtual compounds, supporting the identification and optimization of potential new therapeutic candidates." Under the terms of the agreement, Schrödinger is expected to receive about €10 million (US$11.2 million).
Taxis Pharmaceuticals Inc., a Monmouth Junction, N.J.-based company developing efflux pump inhibitors to destroy a major mechanism of multidrug-resistant Pseudomonas aeruginosa bacteria, has been awarded up to $3.2 million to support its work by CARB-X, a global nonprofit partnership dedicated to accelerating antibacterial research. Taxis is eligible for an additional funding of up to $11.4 million if the project achieves certain milestones. To date, CARB-X has invested $179.3 million in 54 projects.
TMAccelerator Co. LLC, a Boston-based company also known as Translational Medicine Accelerator (TMA), and Toronto-based Cyclica Inc. have formed the Rare Diseases Medicine Accelerator, a joint venture (JV) focused on accelerating the discovery of patient-driven therapies for rare and ultra-rare diseases. The pairing will combine Cyclica's AI-augmented drug discovery platform with TMA’s precision health care platform to support development of new therapies addressing rare and ultra-rare diseases through the creation of early stage biotechnology companies, they said. Initially, the JV will focus on patient populations in regions that include Latin America as well as East and Sub-Saharan Africa.
Veracyte Inc., of South San Francisco, announced a multiyear partnership with Acerta Pharma, the hematology research and development arm of Cambridge, U.K.-based Astrazeneca plc. Veracyte will provide genomic information that will support Acerta's development of new cancer drugs, it said. Financial and other terms of the collaboration were not disclosed.
Verastem Inc., of Boston, said it has obtained global development and commercialization rights to the RAF/MEK inhibitor CH-5126766 from Tokyo-based Chugai Pharmaceutical Co. Ltd. The asset is currently under development for the treatment of KRAS-mutant solid tumors and is the subject of a phase I study combining it with focal adhesion kinase inhibitor defactinib. Based on single-agent defactinib results in KRAS-mutant non-small-cell lung cancer, Verastem conducted an internal preclinical effort to identify drug classes that were synergistic with defactinib "and saw the highest level of synergy in combination with MEK inhibitors and, specifically, with CH-5126766,” said Dan Paterson, Verastem Oncology's president and chief operating officer. Under the terms of the agreement, Verastem is responsible for the development and worldwide commercialization of CH-5126766. It will also make an up-front payment of $3 million and pay royalties to Chugai.
Xencor Inc., of Monrovia, Calif. said Foster City, Calif.-based Gilead Sciences Inc. will leverage its Xtend extended half-life and cytotoxic XmAb Fc technologies for developing and commercializing GS-9722, Gilead’s effector-enhanced HIV antibody, currently in phase I development. Under the terms of the agreement, Xencor granted Gilead an exclusive license for GS-9722 and up to three additional HIV antibodies. Xencor retained the right to grant licenses for other antibodies directed to the target. Gilead will be responsible for the activities and costs related to R&D, regulatory and commercial activities. Xencor will receive an up-front payment of undisclosed value and is eligible to receive milestones and royalties for the successful development and commercialization of products covered by the partnership.