Culmination Bio has secured $10m in investment from the Merck Global Health Innovation Fund (venture capital arm of MSD) and Amgen Ventures to develop an intelligence platform to facilitate diagnostic and therapeutic development. The US-based company has a library of multimodal and longitudinal data along with the accompanying biospecimens, Culmination Bio’s CEO Lincoln Nadauld told Pharmaceutical Technology. The data for Culmination’s library consists of de-identified HIPPA-compliant data from Intermountain Health. This allows the company to “identify specific patient cohorts and proactively or prospective rapidly recruit them”, which can accelerate drug discovery and clinical trial recruitment. Nadauld said that having biospecimens is instrumental in validating diagnostic devices, adding: “An example would be a liquid biopsy company validating their novel technology in the liquid biopsy space, for cancer. They often need fresh samples from patients with defined diseases, and we can deliver not only the biospecimens but the accompanying multimodal data that ...
Boston-based start-up Pepper Bio has raised $6.5m in oversubscribed seed funding to develop its Compass drug discovery platform. The financiers included venture capital companies such as NFX, Silverton Partners, Mana Ventures and others. Pepper’s CEO Jon Hu told Pharmaceutical Technology that the Compass platform provides biological maps for insight into different “-omics”- genomics, transcriptomics, proteomics and phosphoproteomics. The success rate of drug development from pre-clinical studies to regulatory approval is 3%-10%, says Hu. If one can improve this success rate, it can bring down the cost of drug approval, he adds. According to Hu, the high cost of development is driven by the cost of failed iterations of the therapy. Pepper sources its database consists of publicly and commercially available data in addition to its proprietary data, which was either generated in-house or acquired through partnerships. Hu added that public and commercial data undergoes a series of transformations including an ...
In a bid to expand its oncology pipeline AbbVie has announced it will acquire ImmunoGen under a definitive agreement. The proposed $10.1bn acquisition will see AbbVie purchase ImmunoGen’s outstanding shares at $31.26 per share. The acquisition is expected to be completed in mid-2024. On an investor call following the announcement this morning (30 November), AbbVie’s executive vice president and chief financial officer Scott Reents, said the funding of the transaction will be driven by a combination of cash and debt. The exact split of cash and debt has not been indicated, but Reents anticipates that AbbVie will spend at least $2bn in cash in the acquisition. Through the transaction, AbbVie will gain an asset in Elahere (mirvetuximab soravtansine-gynx), ImmunoGen’s lead antibody-drug candidate (ADC), which received an accelerated approval to treat folate receptor alpha (FRα)-positive, platinum resistant ovarian, fallopian tube, or primary peritoneal cancer, in November 2022. As per AbbVie’s executive ...
By Tristan Manalac Pictured: Eli Lilly’s Biotechnology Center in California Eli Lilly on Tuesday signed a license and collaboration agreement with Tokyo-based biotech PRISM BioLab to discover and develop small molecule inhibitors of protein-protein interactions. Under the terms of the deal, Lilly will make an upfront payment and pledges up to $660 million in preclinical, clinical and commercial development milestones. The Japanese biotech will also be eligible for royalties on future sales of any pharmaceutical product that emerges from the partnership. In return, Lilly will gain access to PRISM’s proprietary PepMetics platform, which synthesizes small molecule drug candidates that can behave like peptides, according to the biotech’s ...
Eli Lilly is building on its small drug molecule portfolio with a partnership with Prism Biolab to develop and commercialise small molecules that modulate targets picked by Lilly. As part of the agreement, Prism will receive upfront payments and up to $660m based on preclinical, clinical, and commercial development milestone payments, along with royalty payments. This alliance will utilise Prism’s PepMetics technology platform to discover oral protein-protein interaction (PPI) targets. Lilly has made several moves in the last couple of years to develop small-drug molecules. Earlier this month, the company was one of the investors in Alto Neuroscience’s $45m Series C financing round, which will support Alto’s clinical programme of four small-molecule CNS candidates to treat psychiatric disorders including depression and post-traumatic stress disorder. Alto is expecting positive topline data from Phase II studies investigating two of the molecules, ALTO-100 and ALTO-300, in H2 2024 and H1 2025, respectively. In ...
By Kate Goodwin Pictured: Bristol Myers Squibb building in Munich/iStock, Tati Campelo Bristol Myers Squibb is upping the ante in its partnership with Avidity Biosciences. The San Diego-based biopharma announced Tuesday an expansion of its previous collaboration with BMS, with the latter paying $100 million upfront and adding up to five cardiovascular targets. With potential cumulative payments of up to $2.3 billion plus low double-digit royalties, the partnership could be a lucrative one for the RNA biopharma. The deal expansion sent Avidity’s suffering stock soaring around 35% in premarket trading. A welcome reprieve to the 72% tumble it took earlier this year. Avidity will get a $60 million upfront cash payment in addition to BMS scooping up $40 million of its stock to deliver new cardiovascular treatments utilizing the former’s antibody oligonucleotide conjugates (AOCs). Avidity’s AOCs combine the targeting specificity of monoclonal antibodies with the precision of oligonucleotide therapies to ...
Don Tracy, Associate Editor Law aims to mitigate ongoing global drug shortages. US President Joe Biden has announced approximately 30 new actions aimed at strengthening supply chains critical to national interests. According to the White House, these actions aim to help Americans get necessary products when they need them. Furthermore, the president has invoked the Defense Production Act, enabling investment in domestic manufacturing of essential medicines, medical countermeasures, and critical inputs that have been deemed as essential to the national defense.1 “And today, we’re coming together to ask a simple question: What’s next?What can we do? What must we do to keep making progress to keep our supply chain stable and secure in the long term, to keep preserving that breathing room—that little bit of breathing room for American families for the season to come, no matter what challenges we face,” Biden said during a speech delivered yesterday.2 Earlier this ...
The US Food and Drug Administration (FDA) has granted an orphan drug designation to Priothera’s mocravimod for leukaemia patients undergoing a stem cell transplant. The drug is indicated to help improve the outcome of patients with haematologic malignancies following a haematopoietic stem cell transplantation, according to a 27 November press release. Following the designation, the Dublin, Ireland-headquartered biotech will now be in line for tax credits for US-based clinical trials and, if the therapy is approved, have seven years of market exclusivity in the designated indication. Haematopoietic stem cell transplantation, also known as blood and bone marrow transplantation, is used to treat a wide range of blood cancers. There are nearly 60,000 new cases of leukaemia in the US each year. This is the second orphan drug designation for Priothera’s mocravimod. The first, granted in March 2022, was for the treatment of acute myeloid leukaemia (AML) in patients undergoing hematopoietic ...
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to the investigational therapy epcoritamab to treat follicular lymphoma. The European Medicines Agency (EMA) has validated a Type II application for epcoritamab for the same indication. Co-developed by AbbVie and Genmab, the subcutaneous IgG1-bispecific antibody, marketed as Epkinly in the US and Tepkinly in the EU, is being evaluated as a new therapy for follicular lymphoma. It has regulatory approval for treating certain large B-cell lymphomas (LBCL). AbbVie had entered into the $750m cancer therapeutics deal with Genmab to develop and commercialise antibody therapies back in 2020. In May 2023, the FDA granted an accelerated approval to Epkinly to treat relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adult patients. Epkinly has generated $14m in sales so far this year, according to AbbVie’s Q3 2023 financial results. According to GlobalData’s Pharma Intelligence Center, the drug ...
The European Commission has granted marketing authorisation to EirGenix’s Herceptin (trastuzumab) biosimilar for marketing in the European Union. The biosimilar has been approved as a treatment for human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, as per a 22 November press release. Herceptin is a monoclonal antibody that binds to HER2 receptors, thereby priming these receptors for immune system targeting. The drug generated SFr1.26bn ($1.4bn) in year-to-date (YTD) sales in September, as per Roche’s Q3 financials. Sandoz is responsible for the worldwide commercialisation of EirGenix’s Herceptin biosimilar, except in Taiwan, China, Russia, and some Asian countries, based on the 22 November press release. Meanwhile, EirGenix holds the developmental, commercialisation and manufacturing rights for the biosimilar in countries not covered by Sandoz. In September, EirGenix’s Herceptin biosimilar received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines ...
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