Alnylam Pharmaceuticals Inc., of Cambridge, Mass., said its Zug, Switzerland-based unit has signed an exclusive distribution agreement with Ankara, Turkey-based Gen İlaç ve Sağlık Ürünleri A.Ş for the hereditary transthyretin-mediated amyloidosis (ATTR) therapy Onpattro (patisiran). Terms were not disclosed.
Aytu Bioscience Inc., of Englewood, Colo., said it has received notice from Nasdaq that it has regained compliance with the minimum bid price requirement for continued listing on the exchange's Capital Market. Company shares (NASDAQ:AYTU) fell 31 cents on March 25 to $1.68.
Beigene Ltd., of New York, said the China National Medical Products Administration suspended the importation, sales and use of Abraxane (nanoparticle albumin-bound paclitaxel) in China supplied to Beigene by Celgene Corp., part of Bristol Myers Squibb Co., of New York. The suspension is based on inspection findings at BMS’s U.S. contract manufacturing facility, though the nature of that finding wasn't disclosed. As a result, Beigene expects a disruption in Abraxane supply in China and is working with BMS to restore supply as soon as possible, it said, including through BMS’s remediation efforts at the current manufacturing site and application to qualify an alternative manufacturing site for China supply.
Biosig Technologies Inc., of Westport, Conn., said its majority-owned subsidiary, Neuroclear Technologies Inc., acquired the rights to develop a pharmaceutical to treat COVID-19. In a preliminary internal review, the orally administered, broad-spectrum antiviral agent Vicromax demonstrated strong activity against COVID-19 in cell cultures in laboratory testing. In the analysis, Vicromax was added to a tissue culture assay for SARS-CoV-2 coronavirus and an antiviral effect was observed, which led to a reduction of more than 90% of infectious viruses. The company said it intends to pursue development of the agent for the treatment of COVID-19 through FDA-approved clinical trials.
Brightinsight Inc., of San Jose, Calif., said Astrazeneca plc of Cambridge, U.K. has agreed to work with it to develop apps, algorithms, software and connected devices on top of the Brightinsight Platform. The first major program the companies are collaborating on is in the chronic disease management space.
Bristol Myers Squibb Co., of New York, has posted a letter to clinical investigators on the company’s website regarding the impact of the COVID-19 pandemic on its clinical trials. Among its actions, BMS said it will suspend new site activations for ongoing trials, as of March 20 through April 13, with the timeframe possibly extending beyond April 13. Sites for new studies will not be activated globally until April 13, again with that timeframe extending further if deemed necessary. Studies involving healthy volunteers (HVs) should not initiate and new sites should not be activated until April 13. If an HV study has not yet begun enrolling, it should be paused until at least April 13, as should an HV study that is at a natural break point (e.g. in between cohorts, between study parts, etc.).
Cannabics Pharmaceuticals Inc., of Tel Aviv, Israel, said its R&D team in Israel studied the combinatorial effects of purified cannabinoids and has recently revealed complex relations between cannabinoid compounds, some of which bear synergistic effects and some antagonistic effects on the viability of gastrointestinal cancer cells. Natural cannabinoid extracts have been shown to have an entourage effect in various studies in different disease models and clinical studies, the company noted. The overall view is that the entourage effect leads to better outcomes and purified cannabinoids are more toxic and less effective. However, the underlying combinatorial map of cannabinoids and their effects on cancer cell death remains undiscovered.
Cansino Biologics Inc., of Tianjin, China, said Sartorius, its life science research partner, has provided support and the Institute of Bioengineering at the Academy of Military Medical Sciences in China in their development of the first vaccine candidate against COVID-19. Cansino and the institute used Sartorius’ Biostat STR single-use bioreactor system for the upstream preparation of the recombinant vaccine, thus ensuring the rapid linear amplification of the adenovirus vector (Ad5-nCoV) and ultimately saving time during development, the company said.
Cold Genesys Inc., of Irvine, Calif., disclosed its name change to CG Oncology Inc., effective immediately. The change reflects the company’s overall vision and mission to treat a variety of oncology conditions. CG is a clinical-stage immuno-oncology company developing an oncolytic immunotherapy to combat bladder cancer and other solid tumors.
Debiopharm International SA, of Lausanne, Switzerland, signed a worldwide, exclusive license and research agreement with 3B Pharmaceuticals GmbH, of Berlin, to further the development of its radioligand program, Debio-0228, which targets the CAIX (carbonic anhydrase 9) enzyme to fight the progression of cancer. The agreement extends the radio-oncology portfolio of Debiopharm, which currently includes another clinical-stage radiotherapeutic and the radiotherapy-enhancing antagonist of inhibitors of apoptosis proteins, Debio-1143. The collaboration with 3B is projected to advance the program into clinical development phases of development within two years.
Forge Therapeutics Inc., of San Diego, has begun a research collaboration and option agreement with F. Hoffmann-La Roche Ltd., of Basel, Switzerland, to license FG-LpxC LUNG, an antibiotic for treating serious lung infections attributed to antibiotic-resistant gram-negative bacteria, including Pseudomonas aeruginosa. The FG-LpxC LUNG program is being developed to treat hospital-based infections, including those cited on the CDC's most urgent threats list, which commonly occur in people with weakened immune systems and chronic lung diseases. Roche has an exclusive option to license the FG-LpxC LUNG program from Forge. Forge will retain control of the program prior to Roche exercising its option, at which time Roche will take over the further development. Forge could receive up to $190.5 million, including sales-based payments and commercialization royalties.
Lack of travel in the wake of COVID-19 forced some changes Immuron Ltd., of Melbourne, Australia. Gary S. Jacob resigned as CEO and board member, and the company is deeply cutting its external consultant costs. The changes are expected to reduce cash operating expenses by more than $2 million effective from April. In Australia, Immuron’s one commercial, revenue-generating asset is Travelan for treating traveler’s diarrhea and to reduce the risk of minor gastrointestinal disorders.
Laekna Therapeutics Shanghai Co. Ltd., of Shanghai, said it inked an agreement with Basel, Switzerland-based Novartis AG, gaining exclusive global rights to the latter’s anti-PD-L1 antibody, FAZ-053. The antibody has been involved in a phase I trial in patients with advanced cancer and has demonstrated proof-of-concept results for a tolerable safety profile and clinical efficacy in diverse solid tumors. Laekna said it plans to start trials on combination therapies as soon as possible. The deal marks the third in a recent series of agreements between Laekna and Novartis. Under the terms, Novartis will receive an up-front payment, with additional payments at key development milestones as well as royalties on future sales. Specific financial terms were not disclosed.
Preclinical studies from Lidds AB, of Uppsala, Sweden, show that a TLR9 agonist formulated with Nanozolid (NZ-TLR9) reveal a single injection reduces tumor growth and improves survival rate. The in vivo efficacy is as good as with repeated injections of the standard TLR9 agonist, the company said. Lidds’ preclinical trials in a syngeneic mouse model where LIDDS NZ-TLR9 was intratumorally injected with the Nanozolid technology show the antitumoral immune responses were enhanced as well as showed strong antitumoral efficacy data, the company said. NZ-TLR9 injection is similar in antitumoral efficacy as repeated injections with a standard non-formulated TLR9 agonist, the company noted.
Mateon Therapeutics Inc., of Agoura Hills, Calif., reported that OT-101, its antisense drug candidate targeting COVID-19, showed significant activity against coronaviruses and in the new testing results, two additional therapeutic oligonucleotides designed to target COVID-19 also demonstrated “potent” antiviral activity. OT-101 and the other candidates inhibit virus binding to its target, stopping the virus from replicating and stopping viral-induced pneumonia. The results are from a collaboration between Mateon and Golden Mountain Partners LLC, of Los Angeles.
COVID-19 impact at PCI Biotech AS, of Oslo, Norway, has affected opening new trial sites and new patient enrollment in its RELEASE study of bile duct cancer. The company said it expects short-term delays and increased costs. The company said 34 of its planned 40 sites in the U.S. and Europe are activated and it expects to add sites in Asia. It added there are no major short-term shortages of supplies of products and devices for the trial.
Redhill Biopharma Ltd., of Tel Aviv, Israel, said due to the COVID-19 virus outbreak the initiation of the pivotal phase III study evaluating RHB-204 as a first-line, standalone treatment for pulmonary nontuberculous mycobacteria infections caused by Mycobacterium avium complex is planned to be deferred by one quarter, to the third quarter of this year. The company also reported progress with its previously announced development program with opaganib (Yeliva, ABC-294640), individually and in combination with other compounds, for the treatment of COVID-19, and the company expects to provide more detailed updates in the near future.
Repertoire Immune Medicines, of Cambridge, Mass., said it received an investment from the JDRF T1D Fund, a venture philanthropy vehicle focused on accelerating product development in type 1 diabetes (T1D). The investment will enable the company to utilize its core platforms to discover new antigens and T-cell receptors in hopes of advancing the development of treatments and cures for T1D. Terms of the financing were not disclosed.
Sorrento Therapeutics Inc., of San Diego, said it has been working on a decoy cellular vaccine for COVID-19 (STI-6991) and is in active discussions with the FDA’s Center for Biologics Evaluation and Research regarding the required IND-enabling studies, CMC, clinical protocol and endpoints for potential accelerated approval. Upon receiving guidance from the FDA, Sorrento intends to submit a full package for an IND filing that would enable human clinical trials to start as soon as possible. The decoy cell strategy (I-Cell, which means immune-training cells) was developed by Sorrento scientists utilizing expertise acquired in the fight against cancer. Sorrento expects to utilize a well-known replicating cell line (human erythroleukemia, K562) to incorporate SARS-CoV-2’s spike protein or its S1 domain onto the cellular membrane so that the viral antigen is presented on a decoy cell surface to elicit both T-cell and B-cell immunities.
Stemcell Technologies Inc., of Vancouver, British Columbia, said its human tissue culture systems were used by researchers at China’s Center for Disease Control to grow lung airway cells that could successfully propagate the novel coronavirus SARS-CoV-2. Scientists were then able to isolate the virus, obtain the viral gene sequence, and make the data available to researchers globally.
Turn Biotechnologies Inc., of Mountain View, Calif., said a study by researchers at the Stanford University School of Medicine, published in Nature Communications, highlights the promise of technology being developed by the company to treat age-related health conditions. The study found that old human cells can be induced into a more youthful and vigorous state when they are exposed to a rejuvenating treatment that triggers the limited expression of a group of proteins known as Yamanaka factors, which are important to embryonic development. For the first time, researchers have used Yamanaka factors to undo many of the effects of aging on cells without eliminating their DNA of the molecular tags that differentiate, for example, skin cells from heart muscle cells. The company’s mRNA technology combats the effects of aging in the epigenome, thus restoring optimal gene expression and enabling cells to function as vigorously as when they were young.
Vir Biotechnology Inc., of San Francisco, said it has identified multiple human monoclonal antibody development candidates that neutralize SARS-CoV-2. In order to speed development, its lead development candidate was transferred at-risk to Wuxi Biologics Co. Ltd., of Shanghai, and Cambridge, Mass.-based Biogen Inc. several weeks ago, and Vir anticipates that human trials will begin within the next three to five months. The ability of this antibody to neutralize the SARS-CoV-2 live virus has been confirmed in two separate laboratories. It binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved. Vir said it believes that the conservation of that epitope will make it more difficult for escape mutants to develop. The company is continuing its search for additional antibodies from survivors of SARS-CoV-2, SARS-CoV-1 and other coronaviruses. Those antibodies may also be candidates to address the ongoing COVID-19 pandemic as well as coronavirus outbreaks that may occur in the future.