Hoffmann-La Roche Ltd.

SAN DIEGO, April 3, 2024 /PRNewswire/ -- Blacksmith Medicines, Inc. (Blacksmith), a leading biopharma dedicated to discovering and developing medicines targeting metalloenzymes, today announced that it will present a company overview and participate in 1x1 meetings at the 23rd Annual Needham Healthcare Conference on Thursday, April 11, 2024 at 11:00 am ET. "At Blacksmith Medicines, we are developing a pipeline of novel small molecule medicines targeting metalloenzymes of significant unmet need and high pharma interest, but chemistry limitations have hampered previous efforts that we can solve using our technology platform," said Zachary A. Zimmerman, Ph.D., CEO of Blacksmith. "We look forward to presenting our story at the Needham conference and showcasing the vast number of important metalloenzyme targets, the broad therapeutic application of our technology, and our compelling preclinical data." About metalloenzymes and the Blacksmith platform Metalloenzymes utilize a metal ion cofactor in the enzyme active site to perform essential biological functions. This diverse class of targets has historically been difficult to drug due to small molecule chemistry limitations that have plagued the industry. The Blacksmith metalloenzyme platform has solved this problem by leveraging the following: A large proprietary fragment library of metal-binding pharmacophores (MBPs); A comprehensive database containing a full characterization of the metalloenzyme genome including functions, metal cofactors, and associations to disease; A first-of-its-kind metallo-CRISPR library of custom single guide RNAs; An industry-leading metalloenzyme computational toolkit for docking, modeling and structure-based drug design; and A robust and blocking intellectual property estate covering bioinorganic, medicinal, and computational chemistry approaches for metalloenzyme-targeted medicines. About Blacksmith Medicines At Blacksmith Medicines, we are developing medicines targeting metal-dependent enzymes. Over 30% of known enzymes are metalloenzymes, covering all major enzyme classes: oxidoreductases, transferases, hydrolases, lyases, isomerases, and ligases. Metal ions, including magnesium, zinc, iron, manganese and copper, are the essential ingredient in these metalloenzymes. We recognized a large unmet need for new chemical matter and innovative approaches to drug this important class of enzymes. Our purpose-built platform for metalloenzyme-targeted medicines combines, for the first time in industry, a focused library of metal-binding pharmacophores with proprietary computational modeling approaches to rapidly and rationally design small molecule inhibitors that interact with key metal ions in the enzyme's active site. Our comprehensive knowledge of the metal environment and key active site interactions enables Blacksmith to rapidly build potent and selective inhibitors in a stepwise and predictable manner. Blacksmith has executed strategic drug discovery collaborations with Basilea Pharmaceutica International Ltd., Cyteir Therapeutics Inc., Eli Lilly and Company (Lilly), Hoffmann-La Roche Ltd., and Zoetis LLC., and has been awarded non-dilutive Federal funding agreements with CARB-X and NIH/NIAID. Blacksmith investors include Lilly, Evotec A.G., MP Healthcare Partners, MagnaSci Ventures, and Alexandria Venture Investments. For further information, please visit the company's website and LinkedIn Media Contact: Amy Conrad Juniper Point [email protected] 858-366-3243 SOURCE Blacksmith Medicines

SAN DIEGO, March 19, 2024 /PRNewswire/ -- Blacksmith Medicines, Inc. (Blacksmith), a leading biopharma dedicated to discovering and developing medicines targeting metalloenzymes, announced today that it will present a talk and poster highlighting its novel chemistry technology platform for metalloenzyme inhibitors of LpxC for the treatment of infections caused by multidrug-resistant Gram-negative bacteria at the New Antibacterial Discovery and Development Gordon Research Conference (GRC): Innovative Approaches in Antibacterial Research and Development to Fight the Antibiotic Resistance Crisis being held March 17-22, 2024, in Ventura, CA. "We are looking forward to attending the GRC and presenting an overview of Blacksmith's discovery platform along with a progress update on our novel class small-molecule antibacterial targeting LpxC," said Andrew Tomaras, Ph.D., Senior Vice President of Blacksmith. "Our lead candidate, currently undergoing IND-enabling studies, has demonstrated activity against susceptible and multidrug-resistant Gram-negative organisms included on the WHO and CDC bacterial threat lists, and is currently being pursued using both IV and oral routes of administration for indications such as UTI." Talk Presentation Details: Title: "Anti-Infective Candidates with Novel Targets Using the Blacksmith Discovery Platform" Category: Discovery Pipelines, Hits, Leads and Candidates Date and Time: Tuesday, March 19 at 11:05am – 11:25am Pacific Poster Presentation Details: Title: "Advanced preclinical in vitro and in vivo characterization of a novel, non-hydroxamate-based LpxC inhibitor for the intravenous and oral treatment of multidrug-resistant Enterobacterales" Date and Time: Thursday, March 21 at 4:00pm – 6:00pm Pacific Poster Board Number: 13 More information can be found on the meeting website at 2024 New Antibacterial Discovery and Development GRC and, following the presentation, a version of the poster will be made available on the Blacksmith Medicines website About LpxC LpxC, a zinc hydrolase, is an attractive and highly sought-after antibiotic target – it is conserved across Gram-negative bacteria and not found in Gram-positive bacteria or human cells. Inhibiting LpxC results in potent killing of Gram-negative bacteria with the benefit of sparing Gram-positive bacteria such as those residing in the protective microbiome of the gut which help to deter opportunistic C. difficile infections. Other LpxC inhibitors have been evaluated by biopharma in the past but chemistry limitations (e.g. hydroxamic acid) have yielded ineffective compounds that suffer from poor drug-like properties. Thus, there are no approved therapeutics targeting LpxC. Blacksmith, using its proprietary chemistry platform, has developed novel non-hydroxamate inhibitors of LpxC that are safe and effective in animal models of Gram-negative infection and are able to kill Gram-negative 'superbugs' where other antibiotics are ineffective. About metalloenzymes and the Blacksmith platform Metalloenzymes utilize a metal ion cofactor in the enzyme active site to perform essential biological functions. This diverse class of targets has historically been difficult to drug due to small molecule chemistry limitations that have plagued the industry. The Blacksmith metalloenzyme platform has solved this problem by leveraging the following: A large proprietary fragment library of metal-binding pharmacophores (MBPs); A comprehensive database containing a full characterization of the metalloenzyme genome including functions, metal cofactors, and associations to disease; A first-of-its-kind metallo-CRISPR library of custom single guide RNAs; An industry-leading metalloenzyme computational toolkit for docking, modeling and structure-based drug design; and A robust and blocking intellectual property estate covering bioinorganic, medicinal, and computational chemistry approaches for metalloenzyme-targeted medicines. About Blacksmith Medicines At Blacksmith Medicines, we are developing medicines targeting metal-dependent enzymes. Over 30% of known enzymes are metalloenzymes, covering all major enzyme classes: oxidoreductases, transferases, hydrolases, lyases, isomerases, and ligases. Metal ions, including magnesium, zinc, iron, manganese and copper, are the essential ingredient in these metalloenzymes. We recognized a large unmet need for new chemical matter and innovative approaches to drug this important class of enzymes. Our purpose-built platform for metalloenzyme-targeted medicines combines, for the first time in industry, a focused library of metal-binding pharmacophores with proprietary computational modeling approaches to rapidly and rationally design small molecule inhibitors that interact with key metal ions in the enzyme's active site. Our comprehensive knowledge of the metal environment and key active site interactions enables Blacksmith to rapidly build potent and selective inhibitors in a stepwise and predictable manner. Blacksmith has executed strategic drug discovery collaborations with Basilea Pharmaceutica International Ltd., Cyteir Therapeutics Inc., Eli Lilly and Company (Lilly), Hoffmann-La Roche Ltd., and Zoetis LLC., and has been awarded non-dilutive Federal funding agreements with CARB-X and NIH/NIAID. Blacksmith investors include Lilly, Evotec A.G., MP Healthcare Partners, MagnaSci Ventures, and Alexandria Venture Investments. For further information, please visit the company's website and LinkedIn. Media Contact: Amy Conrad Juniper Point [email protected] 858-366-3243 SOURCE Blacksmith Medicines

The process for Canadians to access new medicines is complex and involves several different federal, provincial, and territorial agencies. As Roche Canada, we stand ready to work collaboratively to bring Columvi to Canadian patients who need it, as soon as possible. Positive recommendations from CADTH and INESSS are important steps towards public access to Columvi® (glofitamab for injection); provincial and territorial governments will make the final decision on public reimbursement.1,2 MISSISSAUGA, ON, March 7, 2024 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that on March 5, 2024, the Institut National d'Excellence en Santé et en Services Sociaux (INESSS) recommended Columvi® (glofitamab for injection) for public reimbursement. This recommendation follows the recent positive recommendation from the Canadian Agency for Drugs and Technologies in Health (CADTH) Canadian Drug Expert Committee (CDEC) issued on February 21, 2024. Reaching these important milestones is the result of close collaboration with both CADTH and INESSS and further emphasizes the need to move quickly through the subsequent steps to public reimbursement. Roche Canada now looks forward to working together with the pan-Canadian Pharmaceutical Alliance (pCPA), as well as the provincial and territorial governments, to achieve sustainable, equitable access for Canadian patients. Columvi is the only fixed treatment duration bispecific antibody authorized in Canada to treat diffuse large B-cell lymphoma.3,4,5 It received the first global marketing authorization when it was authorized by Health Canada almost one year ago on March 24, 2023. Since then, it has been authorized and publicly reimbursed in five other countries, and our aim is to ensure swift access to Columvi in Canada, as well. This recommendation shows that both CADTH and INESSS recognize the clinical evidence and benefit shown by Columvi for use in Canadians living with relapsed or refractory DLBCL. In Canada, it is estimated that in 2023, 4,000 Canadians were diagnosed with diffuse large B-cell lymphoma.6,7,8 "It is exciting to see our continued progress towards public access to glofitamab, a targeted bispecific antibody treatment for Canadians living with relapsed or refractory DLBCL," said Dr. John Kuruvilla, Hematologist in the Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre. "This treatment is an important option to have available for patients that have received multiple prior treatments." "I am pleased to see INESSS and CADTH issue positive recommendations for glofitamab." said Dr. Nathalie Johnson, Hematologist at the Jewish General Hospital and Associate Professor at McGill University. "It is a fixed-duration treatment that could benefit patients with relapsed or refractory DLBCL in Quebec and the rest of Canada." "The positive recommendations for this therapy are wonderful news for relapsed or refractory diffuse large B-cell lymphoma patients as we are one step closer to having public access to this treatment option." said Antonella Rizza, CEO, Lymphoma Canada. Columvi is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from follicular lymphoma (trFL), or primary mediastinal B-cell lymphoma (PMBCL), who have received two or more lines of systemic therapy and are ineligible to receive or cannot receive CAR-T cell therapy or have previously received CAR-T cell therapy.9 Full details on the recommendation, including conditions for reimbursement, are available on the CADTH and INESSS websites. About Columvi (glofitamab for injection)9 COLUMVI (glofitamab for injection) is a bispecific monoclonal antibody that binds bivalently (with high avidity) to CD20 expressed on the surface of B cells and monovalently to CD3 in the T-cell receptor complex expressed on the surface of T cells. By simultaneous binding to CD20 on the B cell and CD3 on the T cell, COLUMVI mediates the formation of an immunological synapse with subsequent potent T-cell activation and proliferation, secretion of cytokines, and release of cytolytic proteins that results in the lysis of CD20-expressing B cells. COLUMVI comes as a concentrate for solution for infusion, with each vial containing either 2.5 mg (in 2.5 mL) or 10 mg (in 10 mL) of COLUMVI. Each mL contains 1 mg of COLUMVI. About Diffuse Large B-cell Lymphoma (DLBCL) Lymphoma is the name for a group of blood cancers that develop in your lymphatic system.10 Lymphomas occur in two main types: Hodgkin lymphoma and non-Hodgkin lymphoma. In particular, diffuse large B-cell lymphoma (DLBCL) is an aggressive (fast-growing) blood cancer and the most common form of non-Hodgkin lymphoma (NHL).11 While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, where options may not offer optimal outcomes for patients and managing the disease can become complex.12 About Roche Canada At Roche Canada, patients and science are at the heart of everything we do. Our passion for science and our commitment to relentlessly pursuing the impossible for patients have made us one of the world's leading pharmaceutical, in-vitro diagnostics, and diabetes care management companies. With our combined strength in diagnostics and pharmaceuticals, we're driving personalized healthcare (PHC) forward, while ensuring we deliver meaningful benefits for patients and a sustainable healthcare system. Because we're committed to making quality healthcare accessible to everyone. And we're adding our expertise in new areas, such as artificial intelligence, real world data collection and analysis and collaborating with many different sectors and industries. Having the courage to reinvent ourselves and question the status quo is what patients and the healthcare system expect from Roche - and our commitment is as strong today as it was on the first day of our Canadian journey in 1931. Today, Roche Canada employs more than 1,800 people across the country through its Pharmaceuticals division in Mississauga, Ontario as well as its Diagnostics and Diabetes Care divisions in Laval, Quebec. For more information, please visit or follow Roche Canada on LinkedIn, or on X / Twitter @RocheCanada. SOURCE Roche Canada