Alimera Sciences Inc., of Atlanta, said Ocumension Therapeutics Ltd., of Shanghai, acquired an exclusive license to develop and commercialize Alimera’s 0.19-mg fluocinolone acetonide intravitreal implant, marketed by Alimera as Iluvien, to treat diabetic macular edema and other retina diseases, excluding uveitis, in greater China and other western Pacific countries. Alimera is entitled to receive up to $99 million, including an up-front payment of $10 million and up to $89 million in sales-based milestone payments. Ocumension was granted exclusive rights to develop and commercialize the product under its own brand in mainland China, Hong Kong, Macau, Taiwan, South Korea, Brunei, Cambodia, East Timor, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam. Alimera will serve as exclusive product supplier to Ocumension for commercial sale at a predetermined transfer price. In conjunction with the transaction, Ocumension made a $10 million equity investment in Alimera through a private offering, purchasing about 1.14 million shares of Alimera’s common stock (NASDAQ:ALIM) at approximately $8.73 apiece. Ocumension also agreed to issue 1 million non-transferable warrants granting Alimera the right for four years to subscribe to up to 1 million shares of Ocumension stock at the subscription price of HK$23.88 (US$3.07) per warrant share, subject to certain conditions. On April 14, Alimera shares gained 65 cents, or about 6%, to close at $10.97. Ocumension, which trades on the Stock Exchange of Hong Kong as 1477.HK, closed even on April 14 at HKD 19.90 (US$2.56).
Aquavit Holdings LLC, of New York, said it acquired an exclusive license to register, market and commercialize botulinum toxin DTX-021 in the U.S. and Canada. The licensed asset, manufactured by Huons Bio Pharma, a unit of Huons Global Co. Ltd., of Seongnam, Gyeonggi-do, South Korea, was said to show equivalency on glabellar lines and improvement on periorbital rhytids vs. onabotulinumtoxinA (Botox, Abbvie Inc.) when assessed in a phase III trial. Huons is set to receive milestone payments and royalties in addition to an up-front payment, all undisclosed, and become exclusive supplier of the botulinum toxin to Aquavit, which plans to file an IND with the FDA to initiate the U.S. registration process.
Ardelyx Inc., of Fremont, Calif., will receive a $5 million milestone payment from its partner, Kyowa Kirin Co. Ltd., of Tokyo, for the start of four phase III studies in Japan by Kyowa.
Atyr Pharma Inc., of San Diego, and Lonza Group AG, of Basel, Switzerland, said they agreed to a manufacturing pact for ATYR-2810, Atyr’s monoclonal antibody targeting neuropilin-2, in preclinical development to treat cancer. Lonza will use Ibex Design, a fully integrated end-to-end program, to manufacture cGMP material for the asset. The agreement covers the provision of drug substance and product to support animal toxicological studies and early development in humans, including cell line development, process development and supply chain simplification at Lonza’s manufacturing sites in Visp and Stein, Switzerland.
Aura Biosciences Inc., of Cambridge, Mass., said Cancer Immunology Research, a journal of the American Association for Cancer Research, published a report online describing long-term antitumor activity of AU-011 (belzupacap sarotalocan), the company’s lead virus-like drug conjugate (VDC) candidate, as a monotherapy and in combination with checkpoint inhibitors in preclinical studies conducted in collaboration with the NCI’s Center for Cancer Research. In vitro and in vivo studies in immunocompetent murine tumor models showed a dose-dependent cytotoxic response of AU-011, with up-regulation of the markers of immunogenic cell death like caspase-1 and calreticulin surface expression. A single in vivo dose administration caused rapid cell death, leading to long-term complete responses (CRs) in 50% of animals. Combination with immune checkpoint inhibitors resulted in a 70% to 100% CR rate that was durable 100 days following treatment, with 50% to 80% of the animals showing protection from secondary tumor re-challenge. In March 2021, Aura raised $80 million in an oversubscribed financing to support pivotal testing of AU-011 for first-line treatment of choroidal melanoma and expansion of the company's VDC platform to additional ocular oncology indications and solid tumors.
Auris Medical Holding Ltd., of Hamilton, Bermuda, said affiliate Altamira Medica Ltd. reported initial data from testing of the nasal spray AM-301 after the start of infection of human nasal epithelium cells with SARS-CoV-2. In saline and vehicle-treated control cultures, SARS-CoV-2 replicated efficiently over four days, resulting in increased viral titer. Daily treatment with AM-301 resulted in a statistically significant deceleration of viral titer growth vs. the controls (p<0.01, linear mixed-effects model). At day four of the experiment, viral titers were 73.7% to 94.5% lower than the controls.
Bioage Labs Inc., of Richmond, Calif., said it inked an exclusive global license with Amgen Inc., of Thousand Oaks, Calif., covering development and commercialization of Amgen’s clinical-stage APJ agonist, BGE-105 (previously AMG-986), to ameliorate muscle aging across all indications. Bioage assumed responsibility for global development, manufacturing and commercialization in exchange for an up-front payment to Amgen, which also is entitled to development and regulatory milestone payments and sales royalties. Amgen also will receive an undisclosed number of shares in privately held Bioage.
Biocryst Pharmaceuticals Inc., of Research Triangle Park, N.C., said the Japanese National Health Insurance System (NHI) approved the addition of Orladeyo (berotralstat) to its drug price list for prophylactic treatment of hereditary angioedema in adults and children 12 and older. Biocryst’s partner, Torii Pharmaceutical Co. Ltd., of Tokyo, plans to launch Orladeyo in Japan following the NHI drug price listing. The kallikrein inhibitor was approved in February 2021 by Japan’s MHLW. The NHI price listing triggered a $15 million milestone payment from Torii to Biocryst, which also is set to receive tiered royalties ranging from 20% to 40% of Japanese net sales.
Bio-Techne Corp., of Minneapolis, said it struck a license agreement for use of one of its antibodies by Monrovia, Calif.-based Xencor Inc. This is Bio-Techne's third licensing agreement with Xencor, which is developing engineered monoclonal antibodies for treating cancer and autoimmune diseases.
Boehringer Ingelheim GmbH (BI), of Ingelheim, Germany, and The University of Texas MD Anderson Cancer Center, Houston, said they extended and expanded their joint Virtual Research and Development Center to explore new molecules from BI’s KRAS and TNF-related apoptosis-inducing ligand receptor 2 portfolios to treat lung cancer, particularly non-small-cell lung cancer. Under the new agreement, joint research will continue for five additional years. The collaboration began in 2019.
New preclinical data from Genome Protection Inc., of Buffalo, N.Y., demonstrated the efficacy of a deimmunized and pharmacologically optimized Toll-like receptor (TLR5) agonist, GP-532, for prophylaxis and acute radiation syndrome treatment. GP-532’s potency is expected by the company to not be affected by neutralizing antibodies developing in humans following administration of the first-generation TLR5 agonist entolimod, which has been an obstacle for broadening medical applications of TLR5 agonists beyond radiation countermeasure. The company said that GP-532 could be projected for disease indications requiring long-term repeat administration. Genome Protection is a collaboration between Cleveland Biolabs Inc. and Everon Biosciences LLC, both of Buffalo, N.Y.
Hemogenyx Pharmaceuticals plc, of London, said an unnamed global pharmaceutical company it has been working with will not exercise its option to license Hemogenyx’s CDX bispecific antibody for treating acute myeloid leukemia and other potential applications. Hemogenyx said it gave notice to the unnamed company that it intends to exercise its option to license the unnamed company’s intellectual property on an exclusive, worldwide basis. Hemogenyx said the two are working to determine the exact terms of the license and the unnamed company’s continued involvement in the progression of CDX toward clinical trials.
Immunicum AB, of Stockholm, said it began a research collaboration with the Icahn School of Medicine at Mount Sinai in New York to investigate Immunicum’s allogeneic dendritic cell therapy candidates to understand their interactions with and activation of tumor specific T cells. Immunicum is developing off-the-shelf, cell-based therapies for treating solid and blood-borne tumors.
Innovation Pharmaceuticals Inc., of Wakefield, Mass., said brilacidin, its defensin-mimetic drug candidate, was featured in George Mason University’s science series Rising to the National and International COVID-19 Challenge. The company’s ongoing research assessing brilacidin’s broad-spectrum antiviral potential and preliminary in vitro data showed that brilacidin potently inhibits both coronaviruses and alphaviruses, according to Innovation.
Organicell Regenerative Medicine Inc., of Miami, entered an agreement with Oklahoma State University to study Zofin, an acellular material derived from human amniotic fluid, for the treatment of respiratory diseases caused by virus infections of pandemic potential.
Polyneuron Pharmaceuticals AG, of Basel, Switzerland, and collaborators at the University of Basel received a CHF1.2 million (US$1.3 million) grant from the Swiss Innovation Agency Innosuisse to study glycopolymers to improve outcomes in ABO-incompatible transplants. The company hopes to be able to use the glycopolymers to mimic blood group antigens and remove the relevant antibodies in vitro in a preclinical proof-of-concept model.
Protokinetix Inc., of Marietta, Ohio, engaged an undisclosed global pharmaceutical company to develop a topical ocular formulation of its anti-aging glycopeptide, AAGP, for the treatment of dry eye disease and ocular inflammation.
Rubryc Therapeutics Inc., of San Carlos, Calif., and Zai Labs Inc., of Shanghai, are collaborating to use Rubryc’s meso-scale engineered molecules platform to identify monoclonal antibodies that bind an undisclosed oncology target. Zai Labs has an option to license any products that result from the project. Rubryc will receive an undisclosed up-front payment and is eligible to receive future research, development and commercialization milestone payments for each candidate, as well as royalties on worldwide net sales of each product.
Stridebio Inc., of Research Triangle Park, N.C., licensed AAV vectors from Duke University that were developed by Duke researcher and Stridebio co-founder, Aravind Asokan. Stridebio also obtained a license to use IgG-degrading enzyme IdeZ to clear neutralizing antibodies and a license for a gene therapy approach for the treatment of alternating hemiplegia of childhood. Stridebio and Duke plan to collaborate on other gene therapy treatments; an undisclosed program targeting the central nervous system vasculature has already started.
Taysha Gene Therapies Inc., of Dallas, reported preclinical data for its various gene therapy candidates. TSHA-113 significantly reduced tau mRNA and protein levels in mouse models of human tauopathies. TSHA-105 significantly reduced plasma citrate levels, normalized EEG brain activity and reduced the number of seizures and seizure susceptibility in SLC13A5 knockout mice. TSHA-106, which facilitates shRNA-mediated knockdown of UBE3A-ATS for the treatment of Angelman disease, increased UBE3A expression in cell lines across 26 distinct shRNA candidates. TSHA-112 produced significant reductions in GYS1 protein, abnormal glycogen accumulation and polyglucosan bodies in the APBD knockout mouse model. TSHA-111-LAFORIN and TSHA-111-MALIN generated knockdown of GYS1 expression and insoluble glycogen and decreased Lafora body formation in laforin and malin mouse models. TSHA-110 produced a dose-dependent reduction of GM2 accumulation at 20 weeks in GM2A knockout mice. The company expected to file an IND/CTA for SLC13A5 deficiency, APBD, Lafora disease or GM2 AB variant by the end of 2021.
Tilt Biotherapeutics Ltd., of Helsinki, Finland, and Merck & Co. Inc., of Kenilworth, N.J., are collaborating to test TILT-123, a dual cytokine armed oncolytic adenovirus, in combination with Merck’s Keytruda (pembrolizumab) in a phase I dose-escalation trial in patients with platinum-resistant or refractory ovarian cancer. The study is expected to enroll 15 to 30 patients.