Agenus Inc., of Lexington, Mass., said it received a milestone payment of $10 million from Kenilworth, N.J.-based Merck & Co. Inc., triggered with the advancement of an ILT4 antibody MK-4830 into a phase II trial. The checkpoint antibody, discovered by Agenus, is designed to target immune-suppressive myeloid cells in the tumor microenvironment for the treatment of advanced solid tumors. Merck is evaluating MK-4830 in combination with Keytruda (pembrolizumab) in a phase II study in patients with PD-L1-positive advanced non-small-cell lung cancer. Under the terms of the agreement, Merck is responsible for all product development expenses for MK-4830 and Agenus is eligible to receive up to $85 million in additional potential milestone payments, as well as royalties on worldwide product sales.
Altimmune Inc., of Gaithersburg, Md., said it entered an agreement with Lonza Ltd., of Basel, Switzerland, for the manufacturing of AdCOVID, its next-generation, single-dose intranasal vaccine candidate for COVID-19. In preclinical studies, AdCOVID produced a 29-fold increase in mucosal IgA, well above the level associated with protection observed in several clinical studies from influenza.
American Museum of Natural History researchers have discovered a new “hidden” gene in SARS-CoV-2 that they speculate may have contributed to its unique biology and pandemic potential. The research team identified ORF3d, a new overlapping gene in SARS-CoV-2 that has the potential to encode a protein that is longer than expected by chance alone. They found that this gene is also present in a previously discovered pangolin coronavirus, perhaps reflecting repeated loss or gain of this gene during the evolution of SARS-CoV-2 and related viruses. The new gene is described in eLife.
Antibe Therapeutics Inc., of Toronto, said it received final approval from the Toronto Stock Exchange to list its common shares on the exchange under existing ticker symbol ATE.
Applied Molecular Transport Inc., of South San Francisco, said the mechanism of action of AMT-101 and preclinical data supporting its potential as a treatment for ulcerative colitis and other inflammatory diseases have been published in The Journal of Immunology. The research highlights how the company’s technology platform exploits existing natural cellular trafficking pathways to transport therapeutics through the intestinal barrier directly into the underlying immune-rich milieu of the lamina propria. In models of induced colitis, AMT-101 was able to rectify pathologic changes by suppressing pro-inflammatory markers of disease while inducing anti-inflammatory cytokines, both locally in the intestinal tissue as well as in plasma.
Aravive Inc., of Houston, and Shanghai-based 3D Medicines Inc., said they entered a collaboration and exclusive license agreement for the development and commercialization of AVB-500 across all oncology indications in mainland China, Hong Kong, Macau and Taiwan (greater China). AVB-500 is an ultra-high affinity decoy protein that targets the GAS6-AXL signaling pathway associated with tumor cell growth. Aravive will receive a signing payment of $12 million and be eligible to receive up to $207 million in development and commercial milestone payments with the potential for near-term milestone payments of $6 million. In addition, 3D Medicines will pay Aravive tiered royalties ranging from the low double-digits to midteens as a percentage of annual net sales of AVB-500 in greater China. 3D Medicines will be responsible for all costs associated with development and commercialization activities for AVB-500 in greater China. Aravive will retain all rights to the compound in the rest of the world.
Armis Biopharma Inc., of Fort Collins, Colo., said it has been awarded a grant of $423,048 from the U.S. NIH to support development of Veriox Decon, to provide first responders working on mass-casualty decontamination, an FDA-approved field-deployable skin decontamination kit.
Atyr Pharma Inc., of San Diego, said it identified receptor targets for two tRNA synthetases from its pipeline that may have utility in the development of new therapeutics to treat cancer and fibrosis. The company expects to present findings from that research at a scientific conference. The discovery work was completed as part of a research collaboration with CSL Behring, a unit of CSL Ltd., of Melbourne, Australia.
Axovant Gene Therapies Ltd., of New York, is changing its name to Sio Gene Therapies Inc., effective Nov. 13. The company’s ticker on Nasdaq will be SIOX.
Azurrx Biopharma Inc., of Delray Beach, Fla., signed a binding letter of intent with Asymchem Inc., of Morrisville, N.C., for the development and production of recombinant lipase MS-1819 for the treatment of exocrine pancreatic insufficiency. Asymchem will implement fermentation, verify protein expression and ultimately fine-tune the technology suitable for production, and will be responsible for sourcing all materials required for the program under cGMP regulatory conditions.
Bone Therapeutics SA, of Gosselies, Belgium, and its collaborators started a new research program with expert industry and academic partners. The 28-month collaboration has been formed to develop biologically active, patient-tailored, 3D-printed, bioresorbable implants enriched with Bone Therapeutics’ allogeneic bone-forming cells, Allob. The consortium has been established under the Competitiveness Clusters framework of the Walloon Health Association, Biowin, and has received €3 million (US$3.5 million) in funding.
Boston Children’s Hospital and Deerfield Management Co. in New York disclosed a research collaboration to advance promising therapeutics that will address unsolved medical needs and find cures for disease. Deerfield pledged up to $65 million, with the goal of translating more of the work of Boston Children’s biomedical researchers and accelerating innovation for potential commercial biopharmaceutical uses. Physician-scientists from Boston Children’s Hospital will have the opportunity to submit proposals for review, effective immediately, to a committee composed of scientific leadership from both Boston Children’s and Deerfield.
Briacell Therapeutics Corp., of Berkeley, Calif., disclosed a Cooperative Research and Development Agreement with the U.S. National Cancer Institute to develop novel off-the-shelf personalized therapeutics for cancer. The company and the institute will conduct preclinical studies to develop and test Bria-OTS, Briacell’s off-the-shelf personalized immunotherapy, as a treatment for cancer to improve upon and broaden applicability of that therapeutic approach.
Brickbio Inc., of Boston, expanded on three therapeutic programs and received positive data on its first preclinical antibody-drug conjugate, BRKB-28, for breast cancer and gastric cancer. The data from a leading contract research organization that conducted in vitro testing showed that BRKB-28 did not target nor adversely affect healthy cells, and at the same time eradicated the cancerous targets. Brickbio's platform has the ability to precisely control the drug-to-antibody ratio while producing a homogenous product, the company said, which contributed to a significantly improved performance profile of BRKB-28.
Cancer Research UK said scientists have invented a new experimental drug that aims to harness the full power of the body’s own immune system, launching a two-pronged response against cancer, according to a study published in Nature Cancer. Partly funded by Cancer Research UK, the new drug, which targets suppressive “regulatory” immune cells inside a tumor, significantly improved long-term survival in animal models even when used without other drugs. Roche Holding AG, of Basel, Switzerland, also is a sponsor of the study.
Caris Life Sciences Inc., of Irving, Texas, said that Huntsman Cancer Institute at the University of Utah has joined Caris' Precision Oncology Alliance. The alliance is a collaborative network of leading cancer centers that work together to advance comprehensive cancer profiling and establish standards of care for molecular testing in oncology through research focused on predictive and prognostic markers that improve the clinical outcomes of patients with cancer, Caris said.
Cevec Pharmaceuticals GmbH, of Cologne, Germany, signed an option and license agreement with Roche Holding AG, of Basel, Switzerland, for the use of its newly launched Elevecta technology for large-scale manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications. Cevec will grant Roche, and Spark Therapeutics, a member of the Roche Group, an option for a nonexclusive license for the development of AAV producer cell lines based on Cevec’s Elevecta. Cevec will be eligible for payments based on achievement of certain milestones for products, as well as royalties on sales of potential products using the technology. Financial details were not disclosed.
Collplant Biotechnologies Ltd., of Rehovot, Israel, said it is developing an antiviral for treating COVID-19. In vitro early results from the company showed significant inhibition of avian coronavirus infectivity. The formulations are based on Collplant's recombinant human type I collagen imbedded with silver nanoparticles. The potential efficacy was assessed by the ability of the formulations to protect epithelial cells from lethal doses of the virus. The company said it intends to develop an antiviral inhalation formulation to limit the spread of coronavirus in the upper and lower respiratory systems.
Helix Biopharma Corp., of Richmond Hill, Ontario, said it signed a definitive share purchase agreement for Helix's remaining holdings in its Polish subsidiary, Helix Immuno-Oncology SA, of Warsaw, for gross proceeds of PLN6.7 million (US$1.76 million). The transaction is expected to close in November. Helix specializes in researching and developing cancer therapies.
Hitgen Inc., of Chengdu, China, said it entered a collaboration and licensing agreement with Guangzhou Baiyunshan Pharmaceutical Holdings Co. Ltd., of Guangzhou, China, to develop and commercialize HG-030 in mainland China. HG-030 is a Trk/ROS1 inhibitor that received IND approval from China’s National Medical Products Administration in March. It is entering a phase I trial in China for patients with NTRK/ ROS1 gene fusion-positive cancers.
Insilico Medicine, of Rockville, Md., said it will collaborate on a multitarget AI-powered drug discovery collaboration with Janssen Pharmaceutica NV, of Beerse, Belgium. Insilico said it will design small-molecule hits with defined properties for several targets nominated by Janssen and will receive up-front and milestone payments. Insilico develops software leveraging generative models, reinforcement learning and other machine learning techniques to generate new molecular structures.
KBL Merger Corp. IV, a special purpose acquisition company, said it completed acquisition of 180 Life Sciences Corp., of Menlo Park, Calif., which has a lead candidate in a phase IIb/III trial for treating Dupuytren's contracture, a fibrotic disease of the hand. Following the merger, 180 Life Sciences will be a wholly owned subsidiary of the acquisition company.
Locus Biosciences Inc., of Morrisville, N.C., said it signed a contract with the global nonprofit Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) to fund up to $12.5 million of a $14.8 million program for developing LBP-KP01, a CRISPR/Cas3-enhanced bacteriophage product targeting the bacterial pathogen Klebsiella pneumoniae. The initial target indication will be recurrent urinary tract infections. Locus said it intends to develop the product for infections of other body sites, such as lung infections, intra-abdominal infections and bacteremia.
Mallinckrodt plc, of Dublin, said it initiated a retrospective chart review study, Nitric Oxide Treatment In COVID-19 Evaluation (NOTICE), to collect real-world data on the use of Inomax (nitric oxide) gas as inhalation therapy in patients with respiratory complications associated with SARS-CoV-2. Inomax is indicated for treating term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension. Mallinckrodt said it will collect data from approximately 200 hospitalized adult patients with a confirmed diagnosis of COVID-19 who were treated with Inomax for pulmonary complications associated with COVID-19 for at least 24 hours between Jan. 1, 2020, and July 31, 2020.
CureDuchenne Ventures said it is investing in Mesentech Inc., of Vancouver, British Columbia, to support early stage research into lead program MES-1007 for treating muscular dystrophy patients. MES-1007 is a bone-targeted prodrug of a prostaglandin mimetic designed to reverse bone loss caused by diseases such as Duchenne muscular dystrophy and osteoporosis.
Point Biopharma Inc., of Toronto, licensed the Canseek tumor targeting technology from Bach Biosciences LLC, of Boston. Point plans to use the technology in PNT-2004, a pan-tumor radioligand treatment. Financial terms of the deal weren't disclosed.
Prestige Biopharma Ltd., of Singapore, licensed the Israeli rights to Tuznue, a biosimilar of Herceptin (trastuzumab, Roche Holding AG), to Abic Marketing Ltd., a subsidiary of Teva Pharmaceutical Industries Ltd., of Tel Aviv, Israel. Prestige will be responsible for providing commercial supply of the drug, while Teva will be responsible for local registration, sales and marketing in Israel. Financial terms of the deal weren't disclosed.
Recce Pharmaceuticals Ltd., of Sydney, said new preliminary research of R-327 showed the synthetic anti-infective inhibited the SARS-CoV-2 virus. Next up for the drug is stage Ib confirmatory in vitro testing and cytotoxicity assessment. The company added that parallel U.S. in vivo studies are on track to show data before the end of 2020.
Renew Biopharma Inc., of San Diego, licensed its engineered enzymes for the use of biosynthesis of cannabinoids in microalgae to Algae-C Inc., of Caledon, Ontario. Renew will receive an undisclosed up-front payment and is eligible for milestone payments and royalties on future product sales.
Replicel Life Sciences Inc., of Vancouver, British Colombia, signed a binding term sheet to license the U.S. rights to the Replicel Injector Product Line to Mainpointe Pharmaceuticals LLC, of Louisville, Ky. Replicel will receive a CA$2.7 million (US$2.1 million) investment over the next 10 months from Mainpointe, which will receive 4 million shares in Replicel. Mainpointe will pay for all costs to obtain FDA approval and has the right to participate in Replicel’s royalty revenue stream up to a defined ceiling. The U.S. license expires four years after FDA approval of the product line or when Mainpointe has earned $2 million in gross income from the products. The deal is subject to the companies entering a definitive agreement.
TCR2 Therapeutics Inc., of Cambridge, Mass., is partnering with Elevatebio LLC, of Cambridge, Mass., to manufacture TCR2's TC-210, a TRuC-T cell targeting advanced mesothelin-expressing cancer, for use in the upcoming phase II trial. Financial terms of the deal weren't disclosed.
Tscan Therapeutics Inc., of Waltham, Mass., issued an option to license several immunodominant T-cell targets, associated sequences and relevant data to Qiagen NV, of Venlo, the Netherlands. Qiagen plans to use the data to develop T-cell-based laboratory tests for detecting prior exposure to SARS-CoV-2, the coronavirus that causes COVID-19. Financial terms of the collaboration were not disclosed.
Valirx plc, of London, established an evaluation and option agreement with Kalos Therapeutics Inc., of San Francisco, for Kalos' peptide, KTH-222. Valirx has six months to evaluate the peptide in preclinical studies in combination with standard-of-care treatment, paclitaxel, at which point Valirx has the option to enter a full licensing agreement. As part of the evaluation agreement, Valirx pledged 10,000 shares to Kalos, which is subject to approval by shareholders at the Valirx's 2021 annual general meeting.
Xphyto Therapeutics Corp., of Vancouver, British Columbia, expanded its development agreement with Raimar Löbenberg, a professor at the University of Alberta, to test different psychedelic compounds. The previous agreement covered development rights under Löbenberg's cannabis licenses and to related intellectual property.