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New funds will go toward advancing BBI-355, supporting Boundless Bio’s other preclinical candidates and the biotech’s clinical trial assay called ECHO. Boundless Bio, the precision oncology company working on treatments for oncogene-amplified cancers, is amping up its fundraising with a new $100 million series C round backed by Leaps by Bayer and RA Capital Management. Bayer’s investment arm will join more than a dozen other investors, which include Arch Venture Partners, Vertex Ventures, Alexandria Venture Investments and many more, in supporting the fundraising. Boundless launched in 2019 with a $49 million series A round, followed by a $105 million series B round in April 2021. Now, the company has a clinical candidate called BBI-355 working its way through a phase 1/2 study in patients with oncogene-amplified cancers. These cancers have managed to evade targeted therapies and immunotherapies, and Boundless has set out to change that, estimating that about 400,000 patients lack treatment options. The new funds will go toward advancing BBI-355, supporting Boundless’ other preclinical candidates and the biotech’s clinical trial assay called ECHO. BBI-355 is a checkpoint kinase 1 (CHK1) inhibitor being tested alone and in combination with other therapies in several cancer indications, including non-small cell lung cancer, breast cancer, head and neck squamous cell carcinoma and others, according to the POTENTIATE trial’s clinical record. Boundless just announced that the first patient had been dosed last week.

- Collaboration joins MD Anderson's expertise and capabilities with Fed Bio's proprietary ACT bacterial cell therapy platform to design and manufacture a complex, synthetic microbiome-based therapy – HOUSTON and SOUTH SAN FRANCISCO, Calif., Feb. 1, 2023 /PRNewswire/ -- The University of Texas MD Anderson Cancer Center and Federation Bio, a biotechnology company pioneering bacterial cell therapies, today announced a strategic collaboration to design and manufacture a complex, synthetic microbial consortium with the goal of expanding the number of cancer patients who respond to immunotherapy. The agreement pairs Federation Bio's proprietary ACT™ (anerobic co-culture technology) platform with the expertise and capabilities of MD Anderson's Platform for Innovative Microbiome and Translational Research (PRIME-TR). Immune checkpoint inhibitors and other forms of immunotherapy have dramatically improved outcomes for many with cancer, but many patients do not benefit from these treatments.i Previous work, including research led by MD Anderson, demonstrates the gut microbiome is a key mediator of individual response to checkpoint inhibitors.ii Further, early findings suggest that fecal microbiota transplants (FMT) from individuals who respond to checkpoint inhibitors may improve outcomes for those who did not previously benefit.iii,iv Unfortunately, the application of FMT in this setting has been hindered by the inability to scale up manufacturing or modify FMT for enhanced therapeutic benefit. Under the agreement, MD Anderson and Federation Bio intend to rationally design a complex consortium of bacteria derived from a donor fecal sample that has a demonstrated ability to improve immunotherapy responses in cancer patients via FMT in a clinical trial. Federation Bio will use its proprietary ACT™ platform to manufacture the consortium from purified cell lines, generating a therapy that comprises the full metabolic complexity of the identified microbiome and is optimized for therapeutic benefit. "Federation Bio's demonstrated ability to engineer complex, synthetic bacterial consortia and produce them at scale offers an exciting avenue to potentially improve cancer immunotherapy responses," said Jennifer Wargo, M.D., professor of Genomic Medicine and Surgical Oncology and director of PRIME-TR at MD Anderson. "Published evidence supports the potential of this approach, and we believe this collaboration will enable us to accelerate the development and evaluation of microbial cell therapies for our patients." Federation Bio's ACT™ platform uniquely enables the production of highly controlled bacterial consortia that have been rationally designed to address a broad range of diseases and disorders. The company already has used the platform to design and manufacture FB-001, an investigational oral therapy consisting of 148 bacterial strains isolated from multiple healthy donors. Federation Bio currently is evaluating FB-001 in a Phase I clinical trial; it is the first rationally designed complex consortium at this scale to enter clinical studies. "We are proud to be collaborating with MD Anderson, an institution that is leading the charge globally to advance microbiome-based approaches that could dramatically improve outcomes for cancer patients," said Emily Drabant Conley, Ph.D., chief executive officer at Federation Bio. "We've demonstrated that our ACT™ platform enables the manufacture of complex, rationally designed microbial consortia at scale through the manufacture of FB-001, and this collaboration enables us to explore its potential in oncology, where there is both high unmet need and evidence supporting the critical role of the microbiome in driving therapeutic response." PRIME-TR is a novel institutional platform that aims to transform the landscape of cancer treatment, diagnosis and prevention through studying and targeting the microbiome at multiple different niches. Supported by MD Anderson's Moon Shots Program®, PRIME-TR works to advance microbiome-based applications as a complement to other foundational discoveries and cancer treatments, including immune-based strategies and other therapeutic approaches. About Federation Bio Federation Bio is a biopharmaceutical company pioneering novel bacterial cell therapies to treat a wide range of intractable diseases – from metabolic disorders to metastatic cancers. The company's first-in-class ACT™ (anerobic co-culture technology) platform allows rapid manufacturing of rationally designed complex bacterial consortia. This approach enables stable engraftment and targeting of multiple mechanisms of action within a single therapeutic. The company's first-in-class bacterial engineering platform generates microbial cell therapies to drive potent T-cell mediated anti-tumor effects. The company is based in South San Francisco. Additional information can be found at About MD Anderson The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world's most respected centers focused on cancer patient care, research, education and prevention. The institution's sole mission is to end cancer for patients and their families around the world. MD Anderson is one of only 53 comprehensive cancer centers designated by the National Cancer Institute (NCI). MD Anderson is No. 1 for cancer in U.S. News & World Report's "Best Hospitals" rankings and has been named one of the nation's top two hospitals for cancer since the rankings began in 1990. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672). Media Contacts: MD Anderson Clayton Boldt, Ph.D. 713-792-9518 [email protected] Federation Bio Michele Parisi 925-864-5028 [email protected] i Sharma P, Hu-Lieskovan S, Wargo JA, Ribas A. Primary, Adaptive, and Acquired Resistance to Cancer Immunotherapy. Cell. 2017 Feb 9;168(4):707-723. ii Khan MAW, Ologun G, Arora R, McQuade JL, Wargo JA. Gut Microbiome Modulates Response to Cancer Immunotherapy. Dig Dis Sci. 2020 Mar;65(3):885-896. iii Baruch EN, et al. Fecal microbiota transplant promotes response in immunotherapy-refractory melanoma patients. Science. 2021 Feb 5;371(6529):602-609. iv Davar D, et al. Fecal microbiota transplant overcomes resistance to anti-PD-1 therapy in melanoma patients. Science. 2021 Feb 5;371(6529):595-602. SOURCE Federation Bio