AC Immune SA, of Lausanne, Switzerland, said it received a grant from Target ALS supporting a collaboration between AC Immune and the Healey Center for ALS at Massachusetts General Hospital to accelerate development of AC Immune’s immuno-assays to detect disease-associated forms of TAR DNA-binding protein 43 (TDP-43) in cerebrospinal fluid and blood samples. The pathological aggregation of TDP-43 is associated with motor and cognitive decline plus episodic memory loss in several neurodegenerative diseases, including amyotrophic lateral sclerosis, frontotemporal lobar degeneration with TDP-43 pathology and limbic-predominant age-related TDP-43 encephalopathy. Target ALS is a medical research foundation.
Aditum Bio, of Oakland, Calif., said it formed a new portfolio company, Anteris Bio, to develop renal disease therapies. Anteris is the third independent company launched by Aditum, which was created by former Novartis AG CEO Joe Jimenez and the former president of the Novartis Institutes for Biomedical Research, Mark Fishman. Anteris was formed after the in-licensing of ANT-401, an Nrf2 activator compound, from Vtv Therapeutics Inc., of High Point, N.C. Anteris will pay Vtv an up-front fee of $2 million, and Vtv may be eligible for up to $151 million in future development, regulatory and commercial milestones, as well as royalties on annual net sales at a low double-digit rate in exchange for worldwide development and commercialization rights. Vtv will also receive a minority equity interest in Anteris.
Alume Biosciences Inc., of La Jolla, Calif., said it was awarded a $2.5 million phase II Small Business Innovation Research (SBIR) grant from the U.S. NIH’s National Institute of Neurological Disorders and Stroke. Alume received a phase I SBIR grant in 2019 from the NIH to develop nerve illumination agents for surgical use. The phase II grant will support testing of Alume's fluorescent nerve targeting agent in an ongoing phase I/II trial in patients undergoing head and neck surgery.
Anchiano Therapeutics Ltd., of Cambridge, Mass., and Chemomab Ltd., of Tel-Aviv, Israel, agreed to merge and focus on advancing Chemomab’s lead product, CM-101. Shareholders from both companies support the transaction. Chemomab also is aiming to complete a PIPE financing to advance CM-101 into phase II trials in rare fibrotic indications, as well as to further develop Chemomab’s earlier-stage pipeline. Current Chemomab shareholders and holders of Chemomab equity awards will convert 100% of their existing equity interests into securities of the combined company. Current shareholders of Chemomab will own approximately 90% of the combined company upon closing. Oppenheimer & Co. Inc. is acting as financial advisor to Anchiano and Goldfarb Seligman and Cooley LLP are serving as legal counsel to Anchiano. The company’s new name will be Chemomab Therapeutics Ltd.
Annovis Bio Inc., of Berwyn, Pa., presented a paper at the New York Academy of Sciences’ Alzheimer's Disease Therapeutics: Alternatives to Amyloid 2020 Virtual Conference that highlights data which demonstrate that by lowering amyloid, tau and alpha-synuclein, its lead candidate, ANVS-401, restores axonal transport and nerve cell health. To test that hypothesis, trisomic Down syndrome mice were treated with ANVS-401, an orally available small molecule shown to reduce amyloid precursor protein (APP), tau and alpha-synuclein. ANVS-401 lowered APP and phospho-tau, reversed Rab5 hyperactivation and restored retrograde transport. Annovis is conducting two double-blind, placebo-controlled phase IIa studies designed to measure the toxic cascade that leads to nerve cell death and expects preliminary data in both Alzheimer’s and Parkinson’s disease patients in the first quarter of 2021.
Assertio Holdings Inc., of Lake Forest, Ill., announced a comprehensive restructuring plan designed to further reduce its cost base and right size its organization based on near-term impacts from the COVID-19 pandemic and changes in the company’s product payer mix. The restructuring plan is expected to reduce Assertio’s total annual cost base by approximately $45 million after one-time restructuring costs. Those reductions are in addition to the previously announced $40 million in synergies associated with the Zyla Life Sciences Inc. merger. The company expects to recognize approximately $8 million to $10 million in severance and restructuring charges in the fourth quarter of 2020 and throughout 2021.
Berg LLC, of Framingham, Mass., is collaborating with Adventhealth to conduct a comprehensive study of various age-related metabolic, neurological and musculoskeletal disorders, including sarcopenia and nonalcoholic steatohepatitis. The research is being conducted in partnership with Adventhealth's Translational Research and comprises separate investigations that employ Berg's Interrogative Biology platform to examine potential biomarker signatures of age-related disease. Among other efforts, the research will investigate integration of multi-omics and deep phenotyping to define signatures of aging skeletal muscle and response to exercise; a phase II trial to study the impact of BPM-31510 on platelet and skeletal muscle mitochondrial energetics in healthy adults; and investigate the mechanism of action of BPM-51545, a biologically active recombinant Enolase-1 protein, in skeletal muscle.
Emendobio Inc., of New York, said that Anges Inc., of Osaka, Japan, completed the acquisition of Emendobio at a valuation of $250 million. Emendobio is now an independent wholly owned subsidiary of Anges, and will continue to maintain its business operations at its facilities in New York and Tel Aviv, Israel. The acquisition was completed on Dec. 15.
Etherna Immunotherapies NV, of Niel, Belgium, and Frame Therapeutics, of Amsterdam, the Netherlands, have been awarded a €1.9 million (US$2.3 million) Eurostars grant to develop a therapeutic vaccine to treat kidney cancer. The companies began collaborating early in 2020, deploying mRNA technologies to develop cancer vaccines based on genetic mutations in patient tumors to stimulate a patient’s immune system against the tumor.
Greenwich Lifesciences Inc., of Stafford, Texas, entered an option agreement with Westport Bio, exercisable at the sole discretion of the company, to in-license a preclinical coronavirus vaccine program. The company has agreed to sponsor research at up to $250,000 plus additional license and assignment fees. Westport Bio’s coronavirus vaccine program includes up to seven vaccine candidates which are designed to complement or improve upon the DNA/RNA-based coronavirus vaccines that are in advanced phase III trials or that have recently been approved by the FDA for emergency use.
GT Gain Therapeutics SA, of Lugano, Switzerland, received CHF850,000 (US$959,531) from Innosuisse, the Swiss Innovation Agency, to support further investigation of the mechanisms of action of Gain’s Star small-molecule therapeutic candidates on lysosomal dysfunction and prion-like transmission of toxic forms of protein aggregates associated with neurodegenerative diseases.
Harbour Biomed, also known as HBM Holdings Ltd., of Suzhou, China, and Utrecht University (UU), of Utrecht, the Netherlands, licensed to Abbvie Inc., of North Chicago, its fully human, SARS-CoV-2 neutralizing antibody, ABBV-47D11, and program, for the prevention and treatment of COVID-19 and related coronaviruses. Abbvie has initiated a phase I trial of the antibody in the U.S. and will expand it into Europe. Under the agreement, Abbvie will conduct clinical development of ABBV-47D11, and if successful, will manufacture and commercialize the product worldwide. Abbvie will pay HBM and UU a one-time license fee; payments upon achievement of certain development, regulatory and sales-based milestones; and tiered royalties on commercial net sales of the antibody. Additional terms were not disclosed.
Immunogen Inc., of Waltham, Mass., disclosed in a Dec. 10 SEC filing that Jazz Pharmaceuticals plc, of Dublin, exercised its opt-out rights with respect to IMGN-632, following an internal portfolio review. As a result, Immunogen retains all rights to the compound, which has received FDA breakthrough therapy designation for relapsed or refractory blastic plasmacytoid dendritic cell neoplasm. Jazz will continue to provide a predetermined amount of research funding for the IMGN-632 program over the next 12 months; however, due to the timing of the Jazz opt out, Immunogen said it will not owe royalty payments to Jazz on commercial sales of IMGN-632 if it is approved. IMGN-632 was included in the firms’ collaboration and option agreement in August 2017.
Immuron Ltd., of Melbourne, Australia, said it executed a new research agreement with Monash University to advance SARS-CoV-2 findings and to further research and identify inhibitory substances in Immuron’s marketed products.
Inovio Inc., of Plymouth Meeting, Pa., and a team of scientists from the Wistar Institute, Cambridge, U.K.-based Astrazeneca plc, the University of Pennsylvania and Indiana University said they received a $37.6 million grant from the U.S. Defense Advanced Research Projects Agency (DARPA), a research and development agency of the U.S. Department of Defense and the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, to use Inovio's iDNA-encoded monoclonal antibody (dMAb) technology to develop anti-SARS-CoV-2-specific dMAbs which could offer versatile capabilities to function as both a therapeutic and preventive treatment for COVID-19. As part of DARPA's two-year grant, Inovio and Wistar will construct COVID-19 dMAb candidates mirroring Astrazeneca's traditional recombinant monoclonal antibody candidates currently being tested in clinical trials to treat COVID-19. The dMAb candidates will then be advanced into preclinical studies and then into rigorous, first-in-human clinical trials within one year of funding.
Lantern Pharma Inc., of Dallas, reported new data that substantiates blood-brain barrier permeability for its drug candidate, LP-184, which is being targeted for treating glioblastoma multiforme (GBM). LP-184 works by causing DNA damage in cancer cells that can be repaired exclusively by the nucleotide excision repair pathway, while current treatment temozolomide (TMZ) causes damage that can be repaired exclusively by the base excision repair pathway. Those approaches to killing tumor cells may be complementary and represent the potential for future combination therapy applications. Using in silico tools, and also generating further in vitro data from both neuronal cell-plates, and neurospheres, LP-184 demonstrated permeability that was in line with TMZ and other therapies being used in GBM today, while also demonstrating nanomolar potency.
Nervgen Pharma Corp., of Vancouver, British Columbia, said it engaged Novotech (Australia) Pty Ltd., a CRO in Asia-Pacific, for its upcoming phase I trial testing NVG-291. The study is expected to begin in Australia in the first quarter of 2021.
Oncimmune Holdings plc, of Nottingham, U.K., said a study published in PLOS One, which analyzed autoantibodies in patients with newly diagnosed rheumatoid arthritis (RA) who were treated with either Actemra (tocilizumab, Roche Holding AG) or methotrexate monotherapy, significantly expanded the biomarkers commonly measured in RA patients to develop a detailed picture of the immune response to the disease and its treatment.
Opiant Pharmaceuticals Inc., of Santa Monica, Calif., disclosed an additional commitment of up to $3.5 million from the Biomedical Advanced Research and Development Authority (BARDA) part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, to advance the clinical development of OPNT-003, nasal nalmefene, for opioid overdose. The contract modification increases the total potential value of the BARDA contract to $8.1 million.
Quantum Genomics SA, of Paris, said it entered an exclusive licensing and collaboration with Faran SA, of Athens, Greece, to develop and commercialize firibastat in Greece. Under the terms, Faran will receive exclusive commercialization rights to firibastat for the treatment of difficult-to-treat resistant hypertension in Greece. Additionally, Faran may join the global study in Greece. Quantum Genomics will receive up-front and milestone payments amounting up to $12.1 million, plus double-digit royalties on sales.
Redhill Biopharma Ltd., of Tel Aviv, Israel, reported preclinical data showing opaganib, an orally administered sphingosine kinase 2 selective inhibitor, demonstrated a reduction of thrombosis in an acute respiratory distress syndrome (ARDS) preclinical animal model designed to measure thrombotic risks. The latest finding points toward another potential benefit of opaganib to COVID-19 patients – in addition to the already established inhibition of SARS-CoV-2 replication and the potential reduction in hyperimmune response by opaganib, the company said. Following those preliminary findings, additional work is being planned to evaluate the range of potential physiologically and pharmacologically relevant opaganib doses with respect to thrombosis reduction.
Sanofi SA, of Paris, said it renewed a partnership agreement with the World Health Organization (WHO), consolidating a 20-year collaboration targeting neglected tropical diseases and supporting the WHO in its commitment to sustainably eliminate sleeping sickness before 2030. With the new five-year commitment, Sanofi will provide a consistent financial support with $25 million ($5 million/year) dedicated to disease management, including screening of populations, disease awareness campaign, capacity building and drug donation.
Seelos Therapeutics Inc., of New York, said the company’s phase IIb/III study of SLS-005 (trehalose) was selected for inclusion in the Healey ALS Platform Trial in amyotrophic lateral sclerosis. Trehalose is a low molecular weight disaccharide (0.342 kDa) designed to cross the blood-brain barrier, stabilize proteins and activate autophagy.
Seneca Biopharma Inc., of Germantown, Md., said it received notice that Nasdaq granted the firm’s request for a 180-day extension to regain compliance with the minimum bid price requirement. The company now has until June 9, 2021, to meet the bid price requirement.
Sensorion SA, of Montpellier, France, said Sonova Holding AG, a Swiss provider of hearing solutions, will acquire a 3.7% ownership stake in Sensorion by way of subscription to a reserved share capital increase for total gross proceeds of €5 million (US$6.1 million). Sensorion and Sonova plan a strategic collaboration in the field of innovative diagnostic and therapeutic solutions for certain types of hearing loss. To that effect, they signed a letter of intent dated Dec. 14, providing for an exclusive period of negotiation of a co-development agreement.