Anticancer Inc., of San Diego, said it plans to test its oral recombinant methioninase for the potential to slow or arrest infection of 2019-nCoV in patients, with and without symptoms. Following tests in cultured lung cells infected with 2019-nCoV in vitro, the firm aims to test the therapy in patients infected with the virus. Work will take place in China, with the appropriate organizations and safety profiles, the company said.
Avacta Group plc, of Cambridge, U.K., signed a collaboration with Affyxell Therapeutics, a recently established joint venture with Daewoong Pharmaceutical Co. Ltd., of Seoul, South Korea, to develop Affimer proteins to be used by Affyxell for the generation of new cell and gene therapies. Under the terms, Avacta and Affyxell will work together to develop Affimer proteins against a range of targets which, when produced by mesenchymal stem cells (MSCs), are intended to inhibit inflammatory and autoimmune pathways and improve the overall efficacy of MSCs, creating a next generation of stem cell therapies. The initial focus will be on inflammatory and autoimmune diseases. In the longer term, there is potential for Affyxell to address oncology uses. Avacta’s research and development costs associated with generation of the Affimer proteins will be funded by Affyxell. In addition, Avacta will retain the rights to commercialize the Affimer proteins outside the field of cell therapies.
Clover Biopharmaceuticals Inc., of Chengdu, China, started development of a recombinant subunit vaccine for 2019-nCoV, the newly identified coronavirus that is believed to have originated from Wuhan, China. Clover is using its Trimer-Tag technology to construct a recombinant 2019-nCoV S protein subunit-trimer vaccine (S-Trimer) and will produce it via a rapid mammalian cell culture-based expression system. Clover expects to obtain a highly purified S-Trimer vaccine for further preclinical safety and analysis within the next six to eight weeks. The company said it could be able to rapidly scale up and produce large quantities of a coronavirus vaccine, if a successful vaccine candidate is able to be identified.
Ares Genetics GmbH, a unit of Curetis NV, of Holzgerlingen, Germany, and BGI Group, of Shenzhen, China, said they plan to collaborate to develop molecular testing in Europe for the coronavirus 2019-nCoV, responsible for the outbreak originating in the Chinese city of Wuhan. BGI said it sequenced the genome of the 2019-nCoV virus and developed a real-time fluorescent PCR kit to detect the virus that can provide results in a few hours, gaining approval from the Chinese NMPA. The DNBSEQ-T7 sequencing platform developed by BGI unit MGI Tech Co. Ltd. also gained emergency approval from the NMPA for surveillance, discovery and identification of unknown infectious diseases in China. In Europe, BGI and MGI will work with Ares to make the 2019-nCoV testing portfolio available to public health institutions and hospitals for outbreak monitoring, infection control and epidemiology. Beginning in February, Ares will provide next-generation sequencing services for 2019-nCoV from its NGS laboratory in Vienna for infection control and tracking of pathogen evolution, based on MGI’s DNBSEQ sequencing platform. Ares and Curetis also will support BGI in the distribution of its PCR and NGS reagent kits to molecular testing laboratories in Europe with the capability for 2019-nCoV testing. Financial terms were not disclosed.
Curevac AG, of Tubingen, Germany, and the Coalition for Epidemic Preparedness Innovations (CEPI) are collaborating to develop an mRNA-based vaccine against coronavirus nCoV-2019. CEPI is contributing $8.3 million for development, manufacturing and clinical trials.
Horizon Therapeutics plc, of Dublin, said it agreed to purchase the three-building campus in Deerfield, Ill., that formerly belonged to Takeda Pharmaceuticals Co. Ltd., of Osaka, Japan. The transaction is expected to close in the first quarter, with additional terms of the purchase not disclosed. Horizon is expected to occupy the campus in the second half of this year.
Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa., and Advaccine Biotechnology Co., of Beijing, plan to advance Inovio's vaccine for the coronavirus 2019-nCoV. Inovio is developing INO-4800 through a phase I to evaluate safety and immunogenicity with the support of an initial grant up to $9 million from the Coalition for Epidemic Preparedness Innovations.
Novartis AG, of Basel, Switzerland, completed the acquisition of the Japanese business of Aspen Global Inc., a unit of Durban, South Africa-based Aspen Pharmacare Holdings Ltd. Novartis' Sandoz unit acquired all of the shares in Aspen Japan K.K. and associated assets held by Aspen for an undisclosed amount. Through the acquisition, Sandoz gains access to approximately 20 products of off-patent medicines.
Outlook Therapeutics Inc., of Cranbury, N.J., said it inked agreements with Biolexis Pte. Ltd., of Singapore, its largest stockholder, and MTTR LLC, its development partner for ONS-5010, an ophthalmic formulation of the VEGF ligand inhibitor bevacizumab, that align the interests of the parties with the company’s common stockholders and support continued development of the lead program. Outlook and MTTR agreed to terminate their strategic partnership, eliminating rights by MTTR to potential future royalty payments from licensing agreements and net sales in exchange for the issuance of approximately 7.2 million common shares of Outlook (NASDAQ:OTLK) to MTTR’s four principals, subject to stockholder approval. Outlook inked consulting agreements with the principals describing terms of their respective compensation arrangements. With termination of the MTTR strategic partnership agreement, Outlook regained full ownership of potential licensing proceeds or net sales from ONS-5010. The company also agreed to seek stockholder approval to amend the terms of its outstanding series A-1 convertible preferred stock in exchange for an agreement by Biolexis to convert its series A-1 preferred outstanding shares once terms are amended. If approved, the proposed amendment will increase the conversion rate to approximately $431.03 per share, resulting in the issuance of approximately 29.4 million shares upon conversion of the 68,112 preferred outstanding shares held by Biolexis. In addition, Outlook and Biolexis agreed to reduce the exercise price to 23.2 cents per share on warrants to acquire approximately 4.7 million common shares held by Biolexis in exchange for its agreement to exercise the warrants promptly for cash, resulting in proceeds to Outlook of approximately $1.1 million. On Jan. 28, OTLK shares closed at 93 cents.
Oxford Gene Technology IP Ltd., a unit of Sysmex Corp., of Kobe, Japan, said Vincente Peg, a pathologist at the Vall d´Hebron University Hospital in Barcelona, and colleagues showed a correlation between the clearance of circulating tumor DNA (ctDNA) in HER2-positive or triple-negative breast cancer patients undergoing neoadjuvant treatment with a clinical/pathologic complete response. The researchers used a Sureseq NGS cancer gene enrichment panel from Oxford to identify driver mutations from breast cancer formalin-fixed paraffin-embedded tissue of 29 individuals with early stage disease and the Safeseq personalized liquid biopsy platform from Sysmex Inostics for patient-specific longitudinal analysis of plasma ctDNA. The plasma analysis, conducted at neoadjuvant treatment midpoint and post-treatment immediately prior to surgery, showed the absence of ctDNA in all patients (12/12) who showed a complete clinical response, but ctDNA was detected in three of five patients who did not achieve complete response. Researchers said the findings suggested ctDNA testing is an important clinical parameter to consider alongside imaging to determine complete response to neoadjuvant treatment. The data were reported at the American Association for Cancer Research Advances in Liquid Biopsies conference in Miami.
Sandoz AG, Holzkirchen, Germany, completed its acquisition of Grand Bay, Mauritius-based Aspen Global Ltd.’s Japanese operations. The $364 million cash deal consists of shares in Aspen Japan K.K. and Aspen Global’s associated assets. Aspen's portfolio in Japan consists of off-patent medicines with a focus on anesthetics and specialty brands. Aspen Global also has a five-year manufacturing and supply agreement, including an additional two-year extension option, with Sandoz for the supply of active pharmaceutical ingredients, semifinished and finished goods related to the portfolio of divested brands. The acquisition enables Sandoz, a unit of Novartis AG, to expand its presence in the third largest worldwide generics marketplace, the company said.
Sorrento Therapeutics Inc., of San Diego, and Celularity Inc., of Warren N.J., created a clinical and manufacturing collaboration to treat and prevent the Wuhan coronavirus, 2019-nCoV, by expanding the use of Celularity’s CYNK-001, an allogeneic, off-the-shelf, placental-derived natural killer cell therapy. Sorrento will use its existing cGMP cell therapy manufacturing facilities in San Diego to supplement Celularity's new cGMP facility in Florham Park, N.J. Sorrento owns 25% of Celularity. No financial details were disclosed.
Veloxis Pharmaceuticals A/S, of Copenhagen, has, upon request from Asahi Kasei Pharma Denmark A/S, requested Nasdaq Copenhagen A/S to remove Veloxis' shares from trading and official listing at Nasdaq Copenhagen. Nasdaq Copenhagen has accepted the request. Asahi Kasei Group, of Tokyo, disclosed plans to acquire Veloxis late last year.
In work that is proving prescient, researchers at the Wuhan Institute of Virology and Duke-National University of Singapore have adapted next-generation sequencing (NGS) for coronavirus surveillance. The emergence of 2019-nCoV as a pandemic threat is the third serious public health threat by coronaviruses, pointing to a need for surveillance. However, coronaviruses are a large and genetically very diverse family, and it is likely that many of its members remain undiscovered. In such a situation, neither targeted PCR nor NGS are good options for surveillance because PCR will miss genomic diversity and NGS will miss low-abundance species, and be very costly. In their work, which was conducted prior to the emergence of 2019-nCoV, the team combined NGS on coronavirus-enriched samples based on eight strains of coronavirus. They demonstrated that “within these data sets, the ratios of viral reads to total number of reads increased by almost 100% for captured samples, in contrast to the ratios of less than 1% for most of the unbiased NGS. The high ratio of viral to total reads in conjunction with decreased data size reduces the sequencing cost and data analysis burden.” The team acknowledged that the method is in need of further improvements, including better capture of diverse spike regions, but concluded that “this methodology could thus greatly facilitate large-scale surveillance studies.” Their work appeared in the Jan. 29, 2020, online issue of mSphere.
Wuxi Biologics, of Hong Kong, created an R&D team of more than 100 people to develop and manufacture multiple neutralizing antibodies to treat the Wuhan coronavirus, 2019-nCoV. The first batch of antibody is expected to be produced in two months, ready for preclinical toxicology studies and initial human clinical studies. Large-scale manufacturing could follow the studies at the company's four GMP facilities with single batch bioreactor capacity ranging from 2,000 liters to 12,000 liters. A single batch at that scale combined is expected to treat up to 80,000 patients.