Nimbus Therapeutics LLC

Dive Brief:Atlas Venture said Thursday that its raised $450 million for its 14th fund, through which the firm will continue to seed and grow new biotechnology companies.Partner Bruce Booth called the fundraising round the smoothest and most efficient hes seen in 20 years at the firm. Given the level of demand, we could have raised several multiples of what we set as our hard cap of $450 million, Booth wrote in a blog post.Booth, Kevin Bitterman, Michael Gladstone, David Grayzel and Jason Rhodes are the investing partners in Atlas new fund. Jean-Franois Formela, who joined Atlas in 1993 to build up its life science franchise and initiated biotech investing at the firm, decided to stop making new investments and instead will focus on his current portfolio and other duties at Atlas.Dive Insight:Investor confidence in biotechnology is recovering after a significant dropoff in recent years. And 2024 has seen a number of multibillion-dollar fundraises from venture capital firms, including Arch Venture Partners, Flagship Pioneering, Bain Capital Life Sciences and Forbion.But Atlas, one of the most prominent early-stage biotech investors, is purposely keeping its funds relatively small, according to Booth. The firm has some scar tissue from growing too fast in the early part of the century, when it invested in tech as well as biotech companies. Atlas is now determined to stay disciplined and focused on the model that we continue to try to perfect: seed-led venture creation, he wrote.A modest fund size better allows the firm to be dynamic and adaptive and gives a better chance of success in early-stage biotech investing, Booth wrote. We want to remain company builders focused on disciplined capital allocation and driving superlative returns, and resist the temptation to become asset aggregators in order to absorb higher fees, he added.The model has worked well for Atlas over the last two years, as the firm launched 16 new biotech companies and saw several startups in its portfolio achieve significant milestones.Versanis, Aiolos Bio, Mariana Oncology and an immune disease drug developed by Nimbus Therapeuticswere all acquired. Four other companies went public and another Day One Biopharmaceuticals got its first regulatory approval for a drug.Atlas has invested in more than 30 fundraising rounds by biotech startups since the beginning of 2022, according to data compiled by BioPharma Dive. All told, Atlas portfolio companies have almost 50 clinical trials underway. The firm last closed one of its own funds in 2022, raising $450 million. '

Novartis will pay $150 million upfront to Schrödinger, in a pact announced Tuesday to work together on several preclinical drug programs. Founded in 1990, Schrödinger has been developing and selling its physics-based R&D software to drugmakers like Novartis for decades, outlasting multiple waves of excitement over AI that have come in and out of its space. This latest deal is centered on multiple drug targets that both companies were researching. Schrödinger is not disclosing the targets beyond saying they are highly validated with compelling genetics or human biological evidence and fall outside oncology. “Schrödinger and Novartis are going to combine our efforts on these targets to finish discovery, to identify development candidates, and then Novartis will take on the further development of these programs,” Karen Akinsanya, Schrödinger’s president of R&D, therapeutics, said in an interview. Beyond $150 million upfront, which Schrödinger expects to recognize as revenue over the course of the research, the deal outlines potential payments of up to $892 million for R&D and regulatory achievements and up to $1.38 billion more for possible commercial milestones. Novartis is also ramping up its broader usage of Schrödinger software through a second agreement that includes an undisclosed increase in how much Novartis pays for the software. That fits a trend Schrödinger CEO Ramy Farid sees in pharma giants shifting from using its software as a way to explore or understand experiments to using it at a greater scale, where calculations are relied on more than traditional methods. He pointed to the success of biotech startups like Nimbus Therapeutics , Morphic Therapeutic , Ajax Therapeutics and Structure Therapeutics — all heavy users of Schrödinger software from the start. “I don’t think that can be ignored, and it looks like the industry is not ignoring it anymore,” Farid said. “So now you have companies like Lilly and BMS and Novartis scaling up their usage in a really meaningful way, but we’re in the early days of it. There are many, many more companies that will, I think, transition in the way that Novartis just did.” Schrödinger’s challenge will be turning that vision into a reality that impacts the top line. The company’s software revenue for the third quarter, also announced Tuesday morning, came in below expectations at $31.9 million, up 10% from a year ago. The $1.4 billion biotech has seen its stock price fall 44% this year, as investors await clinical readouts from its own drug pipeline expected in 2025.

BOSTON--( BUSINESS WIRE )-- Nimbus Therapeutics , LLC ("Nimbus Therapeutics" or "Nimbus"), a biotechnology company that designs and develops breakthrough medicines for patients through its powerful computational drug discovery engine, today announced the presentation of new clinical and translational data from its ongoing Phase 1/2 trial of NDI-101150, a novel, oral, potent and selective small-molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor, for the treatment of advanced solid tumors. Results will be highlighted in two poster presentations at the Society for Immunotherapy of Cancer (SITC) 39 th Annual Meeting, taking place November 6-10, 2024 in Houston, Texas. The Phase 1/2 multicenter, open-label trial ( NCT05128487 ) is designed to assess NDI-101150 as a monotherapy (50-200 mg QD dose) and in combination with pembrolizumab (200 mg Q3W) in the treatment of adults with advanced solid tumors. The clinical results being presented at the SITC Annual Meeting include updated safety data from 53 patients in the dose escalation cohorts (n=41 on monotherapy, n=12 on combination therapy) and additional data from 35 patients in the dose expansion cohorts as well as updated efficacy data from 17 response-evaluable patients with renal cell carcinoma (RCC) who received NDI-101150 monotherapy. Results, as of August 12, 2024, showed: Safety Profile NDI-101150 was generally well-tolerated with immune-related adverse events supporting the proposed mechanism of action of HPK1 inhibition, which results in immune activation. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 14% of all patients exposed to NDI-101150 (n=88). The most common TRAEs were nausea, diarrhea, vomiting and fatigue. Efficacy and Target Engagement Treatment with NDI-101150 monotherapy resulted in objective responses in 18% (3/17) of response-evaluable RCC patients, including one complete response (CR) and two partial responses (PRs). A clinical benefit rate (CR + PR + stable disease [SD] ≥6 months) of 29% (5/17) and a disease control rate of 65% (11/17) were observed in response-evaluable RCC patients treated with NDI-101150 monotherapy. NDI-101150 effectively inhibited its target across multiple dose levels, providing strong pharmacodynamic evidence of the molecule's activity in patients. Supporting Mechanistic Evidence Analysis of tumor biopsies showed a more robust presence of immune cells post-treatment, with increased numbers of tumor-infiltrating lymphocytes and dendritic cells in the tumor microenvironment. Comprehensive gene expression profiling demonstrated broad activation of immune-related pathways, including enhanced interferon response and T cell activation signals. "These clinical results of NDI-101150 are highly encouraging, particularly in the context of renal cell carcinoma patients who have experienced disease progression on prior checkpoint inhibitors," said Nathalie Franchimont, M.D., Ph.D., Chief Medical Officer of Nimbus. "The objective responses and disease control rates seen thus far with NDI-101150 in heavily pretreated patients as well as the current safety profile support further evaluation of NDI-101150 in the clinic." "The clinical and translational data package being presented at SITC demonstrates both the therapeutic potential of NDI-101150 and the power of our computational drug discovery engine to design highly selective molecules against challenging targets like HPK1," said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. "The monotherapy activity we observed is particularly noteworthy, as many second-generation immunotherapy compounds have struggled to show clinical benefit on their own. Together with its safety profile and the immune activation signals we've observed, these data support NDI-101150's potential as a novel oral non-checkpoint immunotherapy option for patients who need new treatment approaches beyond current checkpoint inhibitors." The abstracts are available in the Journal for ImmunoTherapy of Cancer (JITC) , the official journal of SITC, here and the details of the poster presentations are as follows: Title: Ongoing Phase 1/2 Trial of the HPK1 Inhibitor NDI-101150 as Monotherapy and in Combination with Pembrolizumab: Clinical Safety Update and Renal Cell Carcinoma (RCC) Efficacy Analysis Lead Author: David Sommerhalder, M.D., Director of Clinical Research, NEXT Oncology Date: Saturday, November 9, 2024 Time: 9:00 a.m. – 8:30 p.m. CST Category: Clinical Trials in Progress Abstract Number: 682 Title: Tumor Immune Microenvironment Characterization from Pre- and Post-Dose Tumors Collected from a Phase 1/2 Study of NDI-101150, a Hematopoietic Progenitor Kinase 1 (HPK1) inhibitor Lead Author: Scott Daigle, Senior Director, Translational Medicine, Nimbus Therapeutics Date: Friday, November 8, 2024 Time: 9:00 a.m. – 7:00 p.m. CST Category: Biomarkers, Immune Monitoring and Novel Technologies Abstract Number: 83 About Nimbus Therapeutics Nimbus Therapeutics is a clinical-stage, structure-based drug discovery company developing novel small molecule medicines designed to act against well-validated but difficult-to-drug targets implicated in multiple human diseases. The company advances promising research based on a unique strategy that combines leading-edge computational technologies with a tailored array of machine learning-based predictive modeling approaches. Nimbus' pipeline includes a clinical-stage HPK1 inhibitor for the treatment of cancer (NCT05128487), as well as a diverse portfolio of preclinical programs focused on cancer, including a WRN program for MSI-H cancers, autoimmune conditions, and metabolic diseases. The company is headquartered in Boston, Mass. To learn more about Nimbus, please visit www.nimbustx.com .