3Sbio Inc., of Shanghai, said its subsidiary, Sunshine Guojian Pharmaceutical Co. Ltd., selected a monoclonal antibody targeting VSIG4, as a licensed program under the partnership agreement with Verseau Therapeutics Inc., of Bedford, Mass., focused on the development and commercialization of antibodies in the field of immuno-oncology for a broad range of cancers. By targeting VSIG4, a type-I receptor from the B7-like family that is highly expressed on tumor-associated macrophages and dendritic cells across most tumor types, the antibody is designed to reprogram macrophages and dendritic cells to a pro-inflammatory state, activate T cells and attract other immune cells to generate a coordinated and powerful antitumor response. This is the second compound selected from the companies’ 2019 deal.
ADC Therapeutics SA, of Lausanne, Switzerland, and Overland Pharmaceuticals Inc., of Shanghai and Boston, said they formed a new company, Overland ADCT Biopharma Ltd., to develop and commercialize four of ADC Therapeutics’ antibody-drug conjugate product candidates for difficult-to-treat hematologic and solid tumors – loncastuximab tesirine (lonca), ADCT-601, ADCT-602 and ADCT-901 – in greater China and Singapore. Overland Pharmaceuticals has invested $50 million in Overland ADCT Biopharma to fund operations, including development plans for approval of lonca for the treatment of relapsed or refractory diffuse large B-cell lymphoma in the licensed territory. Overland Pharmaceuticals will have a 51% stake and ADC Therapeutics a 49% stake. As part of the strategic business plan, Overland ADCT Biopharma may consider additional private investors and/or a potential public offering in the future. Both parties will appoint an equal number of nominees to the board and a search is underway for a CEO for the new company. ADC Therapeutics can also earn milestone payments and royalties from the regional license agreement with Overland ADCT Biopharma.
Allarity Therapeutics A/S, of Horsholm, Denmark, said it amended its license agreement with Eisai Co. Ltd., of Tokyo, to expand Allarity’s field-of-use to include antiviral uses of stenoparib (formerly E-7449). Allarity already holds global, exclusive rights to the PARP inhibitor, stenoparib, under an existing license with Eisai, in the field of cancer therapeutics and treatment. The expansion will support Allarity in its advancement of stenoparib as a potential antiviral therapy for COVID-19. The company previously announced preclinical studies showing the drug has inhibitory activity against coronavirus as a single agent, and in combination with remdesivir. Based on those results, Allarity submitted a phase II/III protocol through the U.S. Biomedical Advanced Research and Development Authority portal to be an arm in the NIH ACTIV clinical trials, a part of the Operation Warp Speed.
Alzecure Pharma AB, of Stockholm, said it started preclinical development of ACD-857, part of the company’s Neurorestore platform, with the aim of developing symptom-relieving drugs for the treatment of diseases with cognitive disorders. ACD-857 may play a significant role in the treatment of indications in which cognitive functions are impaired, such as Alzheimer's disease, the company said.
Anixa Biosciences Inc., of San Jose, Calif., said it and its partner, Ontochem GmbH, of Halle, Germany, verified that one of recently discovered compounds is similar in potency to remdesivir, the only approved antiviral drug against SARS-Cov-2. As previously announced, Anixa and Ontochem had identified multiple compounds that could disrupt the function of a viral enzyme called an endoribonuclease (also known as non-structural protein-15, or NSP-15). The company plans to test the compound in animal studies in coming months.
Ashvattha Therapeutics Inc., of Redwood City, Calif., said it started a preclinical proof-of-concept study for OP-801 imaging of neuroinflammation. Ashvattha is developing OP-801 as a neuroimaging agent to diagnose patients with neuroinflammation due to Alzheimer’s disease, amyotrophic lateral sclerosis and other neurodegenerative diseases. It is being developed as a companion diagnostic and also a pharmacodynamic tool for therapeutics to treat neuroinflammation.
Brainstorm Cell Therapeutics Inc., of New York, said it initiated a Nurown expanded access program for patients with amyotrophic lateral sclerosis who completed the company’s pivotal phase III trial and meet specific eligibility requirements.
Crispr Therapeutics AG, of Zug, Switzerland, said it received a grant from the Bill & Melinda Gates Foundation to research in vivo gene editing therapies for the treatment of HIV. The grant builds upon the company’s CRISPR/Cas9 gene editing technology and expertise in editing hematopoietic stem cells and contributes to efforts to accelerate transformative medicines for global health.
Cybin Inc., of Toronto, said it closed its acquisition of 100% of the shares in Adelia Therapeutics Inc., of Boston, for up to CA$20.2 million (US$15.75 million). The deal brings Cybin psychedelic molecules and a range of technologies related to novel therapeutics, delivery methods and therapeutic regimens, as well as six patent applications. Adelia also adds a library of psychedelic derivative drug development candidates. The first lead compounds are expected to enter clinical studies in 2021, subject to receipt of approvals.
Enzolytics Inc., of Plano, Texas, said it engaged Samm Solutions Inc., through a master services agreement, to conduct a toxicity study on ITV-1 (immune therapeutic vaccine-1), a suspension of inactivated pepsin fraction, which studies have shown is effective in treating HIV/AIDS.
Eureka Therapeutics Inc., of Emeryville, Calif., reported preclinical results from its Invisimask human antibody nasal spray in mice, which offers protection against SARS-CoV-2 S pseudotyped virus infection for up to 10 hours. Invisimask is an intranasal application of a proprietary human monoclonal antibody that is intended to be used as a prophylactic against contracting SARS-CoV-2 infection. Results of the study, which has not been peer reviewed, are available on preprint server Biorxiv.
Havn Life Sciences Inc., of Vancouver, British Columbia, disclosed the first preclinical study to focus on the effects of psilocybin on the immune system. The study, expected to start in the first quarter of 2021, is designed to determine if a single dose of psilocybin extract can impact the body's inflammatory response and regulate the human immune system. It is the first step required to file an application for development of psilocybin delivery methods that could address inflammatory and immune diseases such as arthritis.
Hummingbird Biosciences Pte Ltd., of Singapore, said it is collaborating with artificial intelligence and precision medicine firm Tempus to drive development of Hummingbird’s lead clinical program, HMBD-001, as it advances into clinical trials in HER3-driven cancers, including those that harbor neuregulin 1 (NRG1) fusions. As part of the collaboration, Hummingbird will use Tempus’ AI-enabled platform and data, as well as joining its TIME Trial Network, for rapid identification, site activation and efficient enrollment of cancer patients who have NRG1 fusions and meet eligibility criteria.
Immunoprecise Antibodies Ltd. (IPA), of Victoria, British Columbia, and Litevax BV, of Oss, the Netherlands, said they nominated a lead vaccine for further preclinical and clinical evaluation and development based on results from their collaborative preclinical immunogenicity study. The companies selected the vaccine candidate following an assessment of the immunogenicity profiles of multiple SARS-CoV-2 vaccine candidates, each having an empirically designed, single SARS-CoV-2 spike protein segment, in non-rodent species. Using IPA's extensive datasets, candidates were screened and optimized to maximize the inclusion of functional, antigenic epitopes while simultaneously minimizing the total foreign epitope exposure, thereby potentially reducing long-term, negative side effects. Immunization of swine with a low dose of the selected candidate resulted in significant serum reactivities toward the SARS-CoV-2 spike protein segment.
Intellia Therapeutics Inc., of Cambridge, Mass., presented data showing physiological protein levels of human alpha-1 antitrypsin (AAT) in nonhuman primates (NHPs) following a single administration. Compared to traditional adeno-associated virus gene therapy, Intellia’s targeted liver gene insertion technology has the ability to achieve therapeutic levels of protein expression, in a stable and durable manner, after a single course of treatment. The normal human AAT protein levels Intellia achieved following targeted insertion of the human SERPINA1 gene remained stable through 11 weeks in an ongoing NHP study. The observed levels of human AAT protein produced from the liver may be therapeutically sufficient to restore protease inhibition to protect the lungs and liver from improperly regulated neutrophil elastase activity. The NHP data build on previous results showing that consecutive in vivo genome editing (knockout plus insertion) achieved therapeutically relevant results in an AATD mouse model.
Mosaic Immunoengineering Inc., of Novato, Calif., said it is advancing immuno-oncology candidate MI-O-101 to an IND or equivalent that would support a phase I trial in multiple cancer types. The company plans to initiate discussions with regulatory agencies in early 2021 in order to review its regulatory strategy for advancing the program for the treatment of cancer in humans while it continues to evaluate options for advancing the technology for veterinary applications in companion animals. MI-O-101 is an intratumoral immunotherapy agent designed to stimulate innate immune cell receptors to turn immunologically "cold" tumors "hot," thus making tumors more susceptible to attack by additional cells of the immune system.
Neuraxpharm Group, of Dusseldorf, Germany, said it expanded its operations in northwestern Europe with the launch of Neuraxpharm Ireland, and the acquisition of Medinutrix Ltd. (trading as Aribamed), a privately owned specialty pharmaceutical distribution company.
Neurorx Inc., of Radnor, Pa., has entered an agreement with special purpose acquisition company Big Rock Partners Acquisition Corp, in which the firms will merge, with shares trading on Nasdaq under the ticker NRXP. Under the terms, Big Rock will issue to Neurorx's current equity holders an aggregate of 50 million shares of Big Rock common stock for their interests in Neurorx, representing $500 million of equity consideration, assuming a value of $10 per common share. Subject to certain conditions, an aggregate of 25 million additional shares of Big Rock common stock will be issued to Neurorx pre-merger equity holders if, prior to Dec. 31, 2022, (1) RLF-100 receives emergency use authorization by the FDA and (2) the FDA accepts the company's filing of its application to approve RLF-100. In addition, subject to certain conditions, a $100 million cash earnout may be payable to Neurorx pre-merger equity holders if, prior to Dec. 31, 2022, either (1) FDA approval of the company's COVID-19 drug is obtained and the company's COVID-19 drug is listed in the FDA's Orange Book or (2) FDA approval of the company's antidepressant drug regimen is obtained and the company's antidepressant drug regimen is listed in the FDA's Orange Book. The transaction is expected to occur in the first or second quarter of 2021.
Novo Seeds, the early stage investment and company creation team of Novo Holdings, of Copenhagen, said it invested in a new portfolio company, Hemab ApS, which is focused on developing bispecific antibodies for the treatment of rare bleeding disorders. Hemab was co-founded by Johan Faber and Søren Bjørn, who until 2018, held leadership positions within hemophilia drug research and development at Bagsvaerd, Denmark-based Novo Nordisk A/S. Hemab has secured an exclusive license to certain intellectual property to develop a product within hemophilia and other rare bleeding disorders from Novo Nordisk and an exclusive license to Copenhagen-based Genmab A/S’s bispecific Duobody platform technology, which enables the company to further develop novel therapies for ultra-rare bleeding disorders.
Pharmablock Sciences Inc., of Nanjing, China, said it signed a partnership agreement with Ascentage Pharma Group International, of Suzhou, China, aimed at strengthening the cooperation between the two companies in drug development and manufacturing. Under the terms, Pharmablock becomes the preferred CDMO partners of Ascentage, and the two will continue to advance and expand CDMO cooperation for current and future projects.
Pharmacyte Biotech Inc., of Laguna Hills, Calif., said it commenced additional physical parameter testing of its Cypcaps product for pancreatic cancer, in line with the recommendations provided by the FDA, which asked that two additional methods be developed to determine the strength of the encapsulated cells to be used in the planned clinical trial in locally advanced, inoperable pancreatic cancer.
Phathom Pharmaceuticals Inc., of Florham Park, N.J., said it plans to expand its vonoprazan development program into non-erosive reflux disease (NERD), a major subcategory of gastroesophageal reflux disease characterized by reflux-related symptoms in the absence of esophageal mucosal erosions. The vonoprazan NERD development program is expected to evaluate vonoprazan in clinical trials that have the potential to offer patients increased dosing regimen flexibility in the management of their NERD symptoms as compared to many current U.S. treatments. The NERD development program plan is expected to include the evaluation of both vonoprazan continuous and on-demand dosing regimens. Phathom anticipates initiating a phase II trial in mid-2021.
Reviva Pharmaceuticals Holdings Inc., of New York, as the successor to Tenzing Acquisition Corp., a special purpose acquisition company incorporated in the British Virgin Islands (NASDAQ:TZAC), and Reviva Pharmaceuticals Inc., a California-based clinical-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system, cardiovascular, metabolic and inflammatory diseases, completed their merger agreement, in which Reviva has become a wholly owned subsidiary of Reviva Holdings, and Reviva Holdings, as the successor to Tenzing, will continue trading on Nasdaq under the new ticker RVPH for its common stock and RVPHW for its warrants, effective Dec. 15.
Teon Therapeutics Inc., of San Francisco, said Cancer Research UK formally approved Teon's TT-702 program to enter a clinical collaboration. TT-702, a A2BR-specific antagonist being pursued in prostate cancer and other tumor types, is expected to enter a phase Ib/IIa study in early 2021. In a collaboration, Cancer Research UK would sponsor and oversee the clinical trial, which will be run through the Centre for Drug Development. Future considerations would be contingent upon achievement of TT-702 development milestones by Teon.
Unicycive Therapeutics Inc., of Los Altos, Calif., said it entered a licensing agreement with Spectrum Pharmaceuticals Inc., of Henderson, Nev., for Renazorb (lanthanum dioxycarbonate), a late-stage asset for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). Under the terms of the asset purchase agreement, Unicycive has acquired global rights for Renazorb and all its trademark and associated patents, and Spectrum has received an equity interest in Unicycive along with milestone and royalty payments. Specific terms were not disclosed.
Vivus Inc., of Campbell, Calif., said it received approval from the U.S. Bankruptcy Court for the District of Delaware on its second amended joint prepackaged chapter 11 plan of reorganization. The Bankruptcy Court approved the disclosure statement and solicitation procedures and confirmed the second amended chapter 11 plan of reorganization, which implements the mediated settlement among the company, Icahn Enterprises Holdings LP (dba IEH Biopharma LLC) and the Equity Committee. Vivus will emerge from chapter 11 as a wholly owned subsidiary of Icahn Enterprises LP and will continue to manufacture, sell and provide physician and patient support for its commercial products, Qsymia (phentermine and topiramate extended-release) for weight management in adults and Pancreaze (pancrelipase) for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.