Led · Series E · Nov 2022

CG Oncology is an oncolytic immunotherapy company focused on developing bladder-saving therapeutics for patients with urologic cancer and is based in Irvine, Calif. Its lead asset, cretostimogene grenadenorepvec, is an intravesically delivered oncolytic immunotherapy in a Phase 3 trial for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Cretostimogene grenadenorepvec is also in a Phase 2 study in combination with pembrolizumab for the same indication and is being evaluated with nivolumab in other bladder cancer types. The company reports that the asset has shown clear signals of activity as a single agent and in combination. CG Oncology says it aims to advance its clinical programs toward FDA approval, emphasizing potential to address resistance mechanisms to approved immunotherapies and improve outcomes for bladder cancer patients. The recently announced financing will support continued development and regulatory advancement of its lead programs. CG Oncology develops oncolytic immunotherapies focused on urologic cancers, with an emphasis on bladder‑sparing approaches. Its lead candidate, CG0070, is an intravesically delivered oncolytic agent in a Phase 3 BOND3 monotherapy trial for BCG‑unresponsive NMIBC and a fully enrolled Phase 2 CORE1 combination study with pembrolizumab. The company has a clinical collaboration with Merck/MSD to evaluate the CG0070‑pembrolizumab combination. Interim Phase 2 data presented at SITC 2022 showed strong anti‑tumor activity and tolerability for the combination. CG0070 has been administered to over 200 patients and has demonstrated potential best‑in‑class efficacy and safety in monotherapy and strong response rates with checkpoint inhibitors. CG Oncology plans to use the new proceeds to advance its lead bladder cancer programs toward FDA approval and to expand development into first‑line BCG‑naïve intermediate‑risk NMIBC. The company has secured more than $200 million in total funding to date following the Series E close. CG Oncology, based in Irvine, Calif., is a clinical-stage biotechnology company focused on developing next-generation oncolytic immunotherapies. Its lead candidate, CG0070, is a selective oncolytic immunotherapy that completed a Phase 2 trial for high-grade NMIBC after BCG failure. The company is advancing multiple late-stage programs including a global Phase 3 trial (BOND3) of CG0070 monotherapy and a Phase 2 combination trial (CORE1) with pembrolizumab in BCG-unresponsive NMIBC. A Phase 1b study (CORE2) is also ongoing combining CG0070 with nivolumab as a neoadjuvant therapy for MIBC in cisplatin-ineligible patients. Management says the lead monotherapy program is advancing to a BLA. The company recently closed financing to support these clinical development programs. Cold Genesys is a clinical-stage biopharmaceutical company developing oncolytic immunotherapies, with lead candidate CG0070 targeting non-muscle invasive bladder cancer (NMIBC). CG0070 completed a Phase 2 single-arm, open-label, multicenter study (BOND2) and has demonstrated clinical safety and efficacy in over 100 patients to date for NMIBC. The company is also exploring CG0070 in combination with immune checkpoint modulators across different solid tumors and has a partnership with Merck to evaluate pembrolizumab (KEYTRUDA) plus CG0070 in a Phase 2 study. Cold Genesys recently closed a $22 million Series C preferred stock financing to accelerate its ongoing clinical programs and further advance CG0070. The round was led by ORI Healthcare Fund with participation from Perseverance Capital Management, reflecting investor confidence in the company's platform and leadership. The company is headquartered in Santa Ana, California. Cold Genesys is a clinical-stage immuno-oncology company focused on developing oncolytic immunotherapies, principally CG0070. CG0070 is an investigational oncolytic immunotherapy based on a modified common cold virus backbone that contains a cancer-specific promoter and a GM-CSF transgene and is designed to selectively replicate in tumors and elicit an immune response. The agent is intended to lyse tumor cells and induce immunogenic cell death, releasing tumor-derived antigens and GM-CSF to stimulate a systemic anti-tumor immune response. CG0070 is being evaluated in a pivotal Phase II single-arm, open-label BOND II study enrolling 122 high-risk non-muscle invasive bladder cancer patients who have failed BCG therapy and refused cystectomy. Cold Genesys plans to use financing proceeds to develop CG0070 in combination with immune checkpoint modulators across multiple Phase I/II studies for different solid tumor indications. The company acquired exclusive worldwide rights to CG0070 from BioSante Pharmaceuticals in 2010. The recent financing will support the pivotal trial and the company's combination-development programs.

Led · Series A · Oct 2021

Affylmmune Therapeutics, based in Natik, MA, develops cancer immunotherapies that extend CAR T cell activity to solid tumors using its “Tune & Track” platform. The platform tunes CAR T cell affinity to reduce toxicity and increase CAR T cell longevity while enabling in vivo monitoring via a proprietary tracking system. Its lead asset, AIC1000, is in a Phase 1 study for anaplastic thyroid cancer and refractory poorly differentiated thyroid cancer. The company plans IND-enabling work for two additional pipeline candidates and to fund select drug discovery activities. Management includes Co-Founder & CEO Moonsoo Jin, Ph.D., and President & COO Eric von Hofe. Affylmmune intends to double headcount over the next nine months, focusing on expanding in-house discovery and leadership teams.

Led · Series C · May 2020

Pillar Biosciences develops next‑generation sequencing (NGS) testing solutions for precision oncology under its Decision Medicine™ approach. Its proprietary SLIMamp® and PiVAT® technologies power rapid targeted sequencing panels and distributable clinical testing kits. The company offers more than 20 NGS testing kits in IVD or RUO formats and has multiple panels in development. Pillar says it has seen strong commercial growth and is focused on expanding adoption of its kits and biopharma partnerships. Proceeds from the recent financing will be used to grow headcount and infrastructure to support commercial activities and partnerships. The company has operations in Natick, Massachusetts, and says the new capital will help it move closer to profitability. Pillar Biosciences develops NGS-based clinical cancer diagnostics using its SLIMamp®- and PiVAT®-based products to serve high-throughput reference and clinical oncology laboratories. Its panels are compatible with Illumina®, Ion Torrent™, and MGI™ sequencing platforms. The company recently received New York State Department of Health approval for a custom product and CE approval for its first in vitro diagnostic panel, the Pillar® ONCO/Reveal® Lung and Colon Cancer Assay. That assay guides prescription of six therapies simultaneously, reduces repeat testing, and enables treatment decisions in four days. Pillar has secured distributors in Israel, Hong Kong, Macau, South Korea, and ASEAN countries. The company intends to use new funding to accelerate expansion of its IVD and research-use-only panels and advance global commercial outreach. Pillar Biosciences develops NGS-based clinical oncology tests using a patent-pending targeted sequencing technology platform and a proprietary data analysis toolkit. The company has released beta versions of a Lung & Colon Cancer Somatic Mutation Panel and a BRCA1 & BRCA2 Germline Mutation Panel to cancer centers and clinical testing companies in the US and China for validation studies. It intends to use recent funding to continue R&D in tumor tissue genotyping and to integrate back-end information analytics capabilities. Pillar also plans to add liquid biopsy products for cancer therapeutic decision-making and treatment monitoring. The company received an $18M venture capital investment to support these efforts.

Participated · Series B · Nov 2017

Semma Therapeutics develops stem cell-derived, insulin-producing beta cells combined with a protective delivery device aimed at providing a functional cure for insulin-dependent diabetes. The company’s proprietary processes generate billions of functional SC-beta cells that in preclinical studies were comparable to human islet beta cells and effectively controlled diabetes. Semma’s state-of-the-art cell delivery technology is designed to protect SC-beta cells from the patient’s immune system and to be surgically practical. The company plans to use proceeds from its recent financing to bring its lead encapsulated stem cell-derived islet program through clinical proof-of-concept and to explore additional regenerative medicine therapeutics. Semma was founded in 2014 and is headquartered in Cambridge, MA, with operations in Providence, RI. The company has strategic partnerships and investor relationships with Novartis, Medtronic and the JDRF T1D Fund. Semma Therapeutics is developing Stem Cell-derived Islet (SC-Islet) therapy to treat patients with type 1 diabetes who currently depend on insulin. Its core approach pairs proprietary SC-Islets with a cell delivery and immune protection strategy intended to shield transplanted cells from the patient’s immune system. The goal is to enable the beta cells to function as they do in non-diabetic individuals. The company is led by CEO Robert Millman and was founded in 2014. Semma is based in Cambridge, Massachusetts. Financially, the company has support from strategic and venture investors and recently received an additional undisclosed investment. Semma Therapeutics is a biopharmaceutical company developing cellular therapy for diabetes by generating stem-cell derived pancreatic islets (SC-islets). The company uses technology developed in Douglas Melton’s Harvard lab, which has been licensed to Semma, to create large supplies of insulin-producing islet cells from pluripotent stem cells. Semma’s program aims to derive pluripotent stem cells from a patient’s blood or skin, differentiate them into SC-islets, and transplant them back to circumvent allogeneic immune rejection and lifelong immunosuppression. Clinical evaluation and patient selection will be performed at UCLA, pluripotent stem-cell derivation and analysis at Cedars-Sinai, and manufacturing for Phase 1/2 clinical trials at City of Hope. Semma accepted a $5 million grant from the California Institute of Regenerative Medicine (CIRM) to fund development of this personalized cell therapy. The company is headquartered in Cambridge, Massachusetts, and is also working to combine its proprietary cells with a device to provide an islet replacement without immunosuppression. Semma Therapeutics is developing a cell-based therapy for Type 1 diabetes that uses lab-grown, glucose-responsive human pancreatic beta cells. The company is commercializing a procedure reported by Doug Melton's lab in Cell that can generate large numbers of functional insulin-producing beta cells. Semma has an exclusive license to this breakthrough technology from Harvard and is focused on combining the proprietary cells with a device to provide beta cell replacement without immunosuppression. The company aims to bring this therapeutic option to the clinic to reduce or eliminate patients' reliance on daily insulin injections. Semma recently closed a $44 million Series A (equity and strategic funding) and signed an agreement with Novartis to advance the program through clinical proof-of-concept. The company is headquartered in Cambridge, MA, and Robert Millman is joining as CEO.

Participated · Series B · Nov 2017

Arterys is a San Francisco, CA-based global medical imaging platform that delivers clinical AI products over the internet. Led by co-founder and acting CEO John Axerio-Cilies, the company provides a web-based, AI-powered, FDA-cleared cloud-native viewer and platform. It operates a marketplace and ecosystem of partners to develop and deliver clinical applications built on its platform. The company raised $28m in a Series C to broaden that ecosystem and accelerate partner efforts. Arterys plans to extend its proprietary technology to application partners to make it easier for clinicians to integrate AI into their workflows from a single interface. The company emphasizes accelerating partners’ efforts to bring new clinical-grade AI applications to providers through its platform. Arterys is a San Francisco-based provider of a web-based AI platform for medical image analytics that enables physicians to process patient imaging cases with embedded AI algorithms. The cloud platform supports MRI and CT and offers image interpretation, case sharing, and automated reporting. Its proprietary technology protects patient information and complies with U.S. and EU data privacy regulations. Arterys' Cardiac MRI suite was the first product of its kind to obtain FDA clearance for use as a diagnostic support tool and is also cleared in Canada and the EU. The platform and cardiac MRI suite have been used to help diagnose more than 15,000 patients worldwide. The company plans to use the new funding to expand its web-based AI platform, launch oncology and neurology products, and accelerate commercialization of its cardiac offering. Arterys develops deep-learning diagnostic software for medical imaging that connects to standard MRI machines to enable non-invasive, precise quantitation of blood flow. The cloud-based platform uploads 10-minute chest MRI scans to a HIPAA-compliant server for computation and presents results in a web browser for clinician interaction and rapid approval of quantitative analyses. The solution targets cardiovascular applications including structural heart disease, congenital heart disease, carotid/neurovascular and renal vascular disease. The company plans to expand commercial operations for its visualization and quantification algorithm using proceeds from its recent Series A. The platform has regulatory clearances—CE Mark and U.S. FDA market clearance (March 2014)—and is already used for research at leading hospitals in the U.S. and Europe. Arterys anticipates broader distribution through ViosWorks in up to 7,000 GE MRI machines in H2 2016; the company is led by founder and CEO Fabien Beckers.