Abbvie Inc., of North Chicago, said it has formed three new collaborative deals. Abbvie and Pur MHC LLC, of Austin, Texas, inked a research and license agreement with peptide targets to use with T-cell receptor therapeutics in various types of cancers. Dong-A-ST Co. Ltd., of Seoul, South Korea, has signed a licensing agreement with Abbvie for MerTK inhibitors that are in preclinical development for immune-oncology therapeutic treatments. Zebra Biologics Inc., of Concord, Mass., is partnering with Abbvie on research to discover agonist antibody therapeutics for inflammatory diseases, using Zebra's antibody discovery platform. Abbvie will be responsible to develop, manufacture and seek regulatory approval for any such clinical candidates.
Ambrx Inc., of San Diego, and Mabspace Biosciences Co. Ltd., of Suzhou, China, said they agreed to collaborate on discovery and development of multiple antibody-drug conjugates (ADCs) in China and around the world for oncology. Mabspace will employ its immune tolerance breaking technology to generate and identify humanized antibodies suitable for ADC development, and Ambrx will employ its Eucode-based site-specific conjugation technology to develop lead ADC molecules. The parties will jointly develop and share the cost and rights of the resulting ADC products.
Aobiome LLC, of Cambridge, Mass., said it partnered with Icarbonx, China's largest health data collection and analysis platform, which has made a $30 million investment in the company. Aobiome is focused on microbiome drug development and has launched a phase II trial employing its bacterial platform for treatment of hypertension. It is the second trial and targets ammonia-oxidizing bacteria (AOB), following the initiation of its acne vulgaris phase IIb trial last year. Once deployed, the company's AOBs are designed to consume ammonia and produce nitrite and nitric oxide, key signaling molecules known to regulate inflammation and vasodilation.
Arena Pharmaceuticals Inc., of San Diego, amended its Belviq (lorcaserin HCl) marketing and supply agreement with Tokyo-based Eisai Co. Ltd. and Eisai Inc., of Woodcliff Lake, N.J. Under the revised deal, Eisai is acquiring global commercialization rights to Belviq, including in the territories retained by Arena under the parties' prior agreement, with control over global development and commercialization decisions, and is responsible for all lorcaserin development expenses going forward. The revised agreement is expected to provide Arena with $23 million of cash payments and over $80 million of potential cost relief on current lorcaserin development obligations. Arena is eligible to receive royalty payments of 9.5 percent on annual global net sales of lorcaserin less than or equal to $175 million, 13.5 percent on annual global net sales greater than $175 million but less than or equal to $500 million and 18.5 percent on annual global net sales greater than $500 million.
Ascentage Pharma Group, of Taizhou, Zhejiang, has raised ¥500 million (US$72 million) from Future Industry Investment Fund, a private equity fund managed by China's State Development & Investment Corporation Fund Management Corp. Ltd. Other investors joining the round include Shiyu Capital, Hidragon Capital and Founder KIP Capital, along with previous investors Yuanming Capital, Oriza Venture Fund and Efung Capital. The proceeds will support the acceleration of pipeline development of small molecules that target apoptosis pathways in clinical development. In December the FDA granted the company's investigational new drug application for to APG-1252, a Bcl-2/Bcl-xL inhibitor for the treatment of cancers including small cell lung cancer. (See BioWorld Today, Jan. 4, 2017.)
Auven Therapeutics Management LLLP, of St. Thomas, U.S. Virgin Islands, closed the sale of its portfolio company, Ocular Technologies Sarl, and said that Seciera (OTX-101), discovered and developed by Ocular, achieved positive top-line results in a confirmatory phase III trial in dry eye disease. Auven sold the exclusive global rights to Ocular, which holds the global rights to Seciera – a nanomicellar formulation of cyclosporine A 0.09 percent – to a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd., of Mumbai, in return for an up-front payment of $40 million at closing. Auven also is eligible for undisclosed development and sales milestones and tiered royalties on global sales of Seciera.
Avidity Biosciences Inc., of La Jolla, Calif., said it completed a $16 million series B financing round to support the development of its antibody-siRNA conjugate (ASC) platform. The round includes an investment of $10 million in new capital and conversion of $6 million in convertible debt. Osaka, Japan-based Takeda Pharmaceuticals Ltd., through its venture group, led the financing, and both new and existing investors participated, including Alethea Capital, Alexandria Real Estate Equities, Brace Pharma, Ecor1 Capital, F-Prime Capital, Moore Venture Partners and Tavistock Life Sciences. ASCs link a monoclonal antibody, designed against a specific molecular target, with a siRNA therapeutic payload, allowing the conjugate to have significant specificity and selectivity. In preclinical models, ASCs have shown potential to knock down messenger RNA levels in multiple important cell types and tissues, including tumor, muscle, heart, lung, liver and B cells. In addition, the company said, ASCs have drug-like properties comparable to antibodies and antibody-drug conjugates. Separately, the company announced that a publication, titled "Targeting Therapeutic Oligonucleotides," authored by Arthur Levin, executive vice president of research and development, has been published in the Jan. 5, 2017, issue of The New England Journal of Medicine.
Bioatla LLC, of San Diego, and West Palm Beach, Fla.-based F1 Oncology Inc., announced a global license agreement to combine Bioatla's Conditionally Active Biologic technology with F1's technologies to develop and commercialize chimeric antigen receptor T-cell therapies and other adoptive cellular therapies for the treatment of cancer. Financial terms of the agreement include technical and regulatory milestone-based equity investments of up to $50 million through 2018, as well as supply-related payments by target and indication. F1 Oncology retains rights to all products outside China, Hong Kong, Macau and Taiwan.
Curis Inc., of Lexington, Mass., exercised its option to extend the exclusivity period with Bangalore, India-based Aurigene Discovery Technologies Ltd. under their January 2015 agreement, which is focused on the discovery, development and commercialization of small molecule candidates in the fields of immune-oncology and selected precision oncology targets. Licensed programs include CA-170, CA-327 and CA-4948. The extension includes a $7.5 million payment to Aurigene, payable in the first and third quarters.
Eisai Inc., a unit of Eisai Co. Ltd., of Tokyo, said it reached an agreement with Arena Pharmaceuticals Inc., of San Diego, to revise its marketing and supply agreement for the chronic weight management treatment, Belviq/Belviq XR (lorcaserin hydrochloride), by acquiring full rights to develop and market the drug. Eisai gained sole responsibility for global development and regulatory submissions as well as global marketing for lorcaserin. Arena remains eligible to earn $26 million in potential and regulatory milestones, including $25 million upon global net sales reaching $250 million in any 12-month period and $1 million for approval in Brazil. Other unearned purchase price adjustments and clinical and commercial milestones were eliminated, and a planned technology transfer will enable Eisai to participate in the manufacture of lorcaserin. Eisai will also assume Arena's exclusive distribution agreements with third parties to develop and market lorcaserin in South Korea, Taiwan and Israel and will serve as exclusive supplier. In separate news, its Eisai GmbH unit reported that the German Institute for Quality and Efficiency in Health Care (IQWiG) has published a report recognizing an additional benefit generated by the administration of Kisplyx (lenvatinib) in combination with everolimus for the treatment of advanced renal cell carcinoma vs. the established comparator therapy. The final decision to implement the report's recommendation lies with the German Federal Joint Committee and is expected for March 2017. (See BioWorld Today, Nov. 11, 2013.)
Glenmark Pharmaceuticals Ltd., of Mumbai, said the FDA cleared the firm's IND for a phase I study of lead candidate GBR 1302-BEAT in patients with HER2-positive cancers. The company plans to expand the ongoing phase I trial to include sites in the U.S. The study is testing the humanized, bispecific monoclonal antibody targeting HER2 and CD3, based on the BEAT (Bi-specific Engagement of Antibodies based on the T-cell receptor) technology platform. The two-part study involves a dose-escalation portion followed by an expansion study to determine early proof of concept.
Iljin SNT Co. Ltd., of Seoul, South Korea, completed its acquisition of 1.33 million units of Vancouver, British Columbia-based Aurinia Pharmaceuticals Inc. at $2.25 per unit. Each unit comprises one common share in the capital of Aurinia and one half of one common share purchase warrant.
Lantern Pharma Inc., of Dallas, is collaborating with India-based Artificial Intelligence (AI) and data analytics company, Intuition Systems LLP, also of India, which will work closely with Lantern's existing computational team to bring additional AI, big data analysis, cloud support and infrastructure to support drug development and biomarker identification.
Macrogenics Inc., of Rockville, Md., gained FDA orphan drug status for MGD006 (also known as S80880), a dual-affinity re-targeting molecule that recognizes both CD123 and CD3, for the investigational treatment of acute myeloid leukemia (AML). The candidate is currently in a phase I dose-escalation study designed to assess the safety and tolerability in patients with relapsed/refractory AML or myelodysplastic syndrome. Macrogenics retains full development and commercialization rights to MGD006 in the U.S., Canada, Mexico, Japan, South Korea and India. The France-based Servier Group has rights to MGD006 in all other countries.
Minomic International Ltd., of Sydney, said it completed enrollment and dosing of the first three patients in its first-in-human trial testing Milga, a chimeric version of the company's MIL-38 anti-glypican 1 antibody conjugated to the radioactive isotope 67Gallium. The study is designed to evaluate the safety and tumor targeting of Milga in patients with advanced prostate, bladder and pancreatic cancers. The primary endpoints are safety and tolerability, while secondary endpoints are to qualitatively evaluate Milga as a diagnostic tool and to perform dosimetry analysis of tumor images to determine relative accumulation of Milga in different organs.
Momenta Pharmaceuticals Inc., of Cambridge, Mass., and CSL Ltd., of Melbourne, Australia, agreed to an exclusive research collaboration and global license to develop and commercialize Fc multimer proteins, including Momenta's M230, a selective Fc receptor immunomodulator that is expected to enter the clinic in 2017. Momenta is set to receive $50 million up front and is eligible for up to $550 million in clinical, regulatory and commercial milestone payments. In addition, the company gained an option to elect a cost- and profit-sharing arrangement, enabling it to fund a portion of global development and commercialization costs in exchange for a share of U.S. profits, along with milestones and royalties outside the U.S. Momenta also retained an option to co-promote M230 and other products from the partnership in the U.S. CSL and Momenta plan to collaborate on R&D for additional Fc multimer proteins that may emerge from either company's research efforts.
Prima Biomed Ltd., of Sydney, said it developed an early stage candidate, IMP761, a humanized IgG4 monoclonal antibody, designed to be an agonist of LAG-3. The company will advance the compound to preclinical development, including in vivo efficacy model studies.
Promethera Biosciences SA, of Mont-Saint-Guibert, Belgium, and Lifeliver, of Seoul, South Korea, formed a strategic alliance to jointly develop Promethera's suite of cell-based liver disease therapies in South Korea. The deal includes a license agreement for Hepastem and H2Stem to develop and commercialize these platforms in liver disease, and a supply agreement to provide Heparesc for Lifeliver's bioartifical liver system. Financial details were not disclosed.
Prometic Life Sciences Inc., of Laval, Quebec, amended its licensing agreement with Hematech Biotherapeutics Inc., of Taipei, Taiwan, in May 2012, and has reacquired the rights initially granted to Hematech to a 50 percent share of the worldwide profits related to plasminogen congenital deficiency sales. The parties had originally entered two separate agreements: the licensing agreement and a further agreement that provided Hematech with the manufacturing rights to supply Prometic with additional plasma-derived biopharmaceuticals on a contract manufacturing basis. Since 2012, Prometic has secured manufacturing capacity.
SCPharmaceuticals Inc., of Lexington, Mass., said it closed a $45.6 million series B investment round, which was co-led by Orbimed and a wholly-owned subsidiary of Sun Pharmaceutical Industries Ltd. In addition existing investors 5AM Ventures and Lundbeckfond Ventures participated in the round. The investment will support the development of the operational and commercial infrastructure to bring Furoscix and the sc2wear infusor to market in the U.S. The company is developing the sc2Wear infusor for subcutaneous administration of products that currently require intravenous or intramuscular administration by a certified health care professional. The drug delivery platform is based on the Sensecore micro-piston pump developed by Sensile Medical, of Hägendorf, Switzerland, to which the company has an exclusive global license for certain therapeutic categories including heart failure and infectious disease. Their initial product, the sc2Wear furosemide infusor for use in patients with heart failure, is anticipated to be submitted for regulatory approval early this year.
Senhwa Biosciences Inc., of Taipei, Taiwan, said the FDA granted orphan drug designation to CX-4945, a small molecule drug that inhibits protein kinase CK2, to treat cholangiocarcinoma.
Sharp Edge Labs Inc., of Pittsburgh, said it inked a drug discovery collaboration with Sumitomo Dainippon Pharma Co. Ltd., of Osaka, Japan, in which the latter will make its compound library available to Sharp Edge for use in its drug discovery platform, with the goal of identifying lead compounds and potential development candidates for neurodegenerative disorders. Financial terms were not disclosed.
Sun Pharmaceuticals Industries Ltd., of Mumbai, India, disclosed successful phase III confirmatory results for Seciera for the treatment of dry eye disease. Seciera is a patented, nanomicellar formulation of cyclosporine A 0.09 percent. It is a clear, preservative-free, aqueous solution. In the 12-week, multicenter, randomized, double-masked, vehicle-controlled confirmatory study, 744 dry eye patients were treated either with Seciera or its vehicle. After 12 weeks of treatment, as compared to vehicle, Seciera showed statistically significant improvement in the primary end point, Schirmer's score (a measurement of tear production) (p<0.0001). The demonstration of efficacy by Seciera at 12 weeks is earlier than other drugs approved for dry eye in the same class, Sun said.
Tot Biopharma Co. Ltd., of Suzhou, China, and Lee's Pharmaceutical Holdings Ltd., of Hong Kong, said Lee's, through its wholly owned subsidiary Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd., acquired the exclusive license of TAB014, a monoclonal antibody developed and manufactured by Tot in China. TAB014 can be used to treat wet age-related macular degeneration and other eye diseases. Lee's will get exclusive rights to carry out the clinical and commercial development of TAB014 in China (including mainland China, Hong Kong and Macau), and make the up-front payment, milestone payment and after-launch sales commission to Tot. Lee's will also pay the costs incurred during the processes of clinical development, regulatory submission and product commercialization in the licensed territory. An IND application of TAB014 has been submitted to CFDA.
Sterility and data problems resulted in an FDA warning letter for a Wockhardt Ltd. plant in Gujarat, India. The Dec. 23 letter, posted to the agency website Tuesday, stems from an inspection that took place more than a year ago. Products from the plant, including finished drugs and APIs, were placed on import alert in August. Among the sterility issues, the FDA cited improper airflow, aseptic equipment design and the use of frayed gowns. Data problems included unreported test results, failure to validate 12 computerized systems in the quality control lab and discrepancies between unofficial notebooks and official data retained by the quality unit. The FDA investigator also found torn and shredded equipment maintenance documents, raw material labels and change control work orders awaiting incineration in a scrap yard.