• Sierra Oncology

  Participated · Equity · Apr 2012

  ProNAi Therapeutics, founded in 2004 in Michigan, develops DNA interference (DNAi®) therapeutics using single‑stranded, unmodified DNA oligonucleotides delivered via a differentiated lipid delivery system (SMARTICLES®). Its lead candidate, PNT2258, is a 24‑base single‑stranded DNA oligonucleotide encapsulated in a pH‑tunable anionic liposome that targets the BCL2 gene; preclinical studies demonstrated activity both as a single agent and in combination with other therapies. Clinically, PNT2258 has shown early evidence of systemic anti‑tumor effect and has been administered to 35 patients across a Phase I study and a pilot Phase II study. The company plans to use new financing to advance PNT2258 into multiple Phase II studies in relapsed or treatment‑refractory non‑Hodgkin’s lymphoma (including DLBCL, Richter’s transformation, and follicular lymphoma), support manufacturing, advance preclinical candidates, and build its organization in Michigan. ProNAi reports a broad pipeline of DNAi leads against over 40 oncology and non‑cancer targets (including CMYC, KRAS, PD‑1 and Hep B) and pursues a strategy of establishing multiple partnerships across its portfolio. The company emphasizes that combining genetic specificity with effective IV delivery addresses nucleic acid delivery challenges faced by competitive programs. ProNAi Therapeutics develops nucleic acid therapeutics using proprietary DNA interference (DNAi) technology. Its lead candidate, PNT2258, is a first-in-class DNAi agent that targets the oncogene BCL2 and is in Phase II trials for BCL2-driven lymphomas. The company reports clinical activity to date — 3 complete responses and 1 partial response among 8 diffuse large B‑cell and follicular lymphoma patients, with additional tumor shrinkage and disease stabilization in the remainder. ProNAi plans to expand single-agent Phase II studies to refractory or relapsed DLBCL and FL and to initiate front-line combination studies later in the year. Management emphasizes a capital-efficient clinical strategy and intends to pursue multiple partnerships across a pipeline of DNAi leads for over 30 cancer and non-cancer targets, including CMYC and KRAS. The company is headquartered in Plymouth, Mich. ProNAi Therapeutics develops nucleic acid-based DNA-interference therapies designed to silence disease-causing genes. Its lead candidate, PNT2258, uses pieces of DNA and liposomal delivery technology licensed from Marina Biotech to block target gene activity inside cells. PNT2258 entered a phase 1 trial in September 2010 to evaluate safety and tolerable dosing in patients with tumors lacking effective treatments; results were expected later in the year, with a planned phase 1/2 to follow. The company is exploring additional targets in inflammation and genetic diseases. Financially, ProNAi was reported to be on its way to raising $1 million according to a recent U.S. SEC filing, and lists investors including Sigvion Capital, Apjohn Ventures, Amherst Fund, Grand Angels, Bioscience Research Commercialization Center, Michigan Technology Tri-Corridor and the 21st Century Jobs Fund. Founded in 2004, ProNAi is headquartered in Kalamazoo, Michigan. ProNAI Therapeutics develops DNA-driven gene-silencing cancer therapeutics, notably PNT2258. PNT2258 entered a Phase I study in September that is scheduled to run through next year. The company says the proceeds from its current fundraising will likely pay for this trial and other studies. Regulatory filings report the company has raised nearly $1.7 million toward a potential $12 million fundraise. COO Robert Forgey previously said the company had raised nearly $1 million to pay for the trial. ProNAI has raised about $17 million to date from investors including Apjohn Ventures and Sigvion Capital. ProNAi is a Kalamazoo, Mich.-based biotechnology company focused on intravenous cancer therapeutics. The company develops drugs based on "nucleic acid interference" to fight cancer. Its lead candidate, PNT2258, could enter early-stage clinical trials against skin and prostate cancer later this year. Financially, ProNAi has raised $2 million toward a $4 million bridge round and aims to raise a $25 million second round later this year. The bridge financing includes investors such as Apjohn Ventures, Sigvion Capital, Amherst Fund, Grand Angels, the Michigan Economic Development Corp., the Biosciences Research Commercialization Center and the Michigan Technology Tri-Corridor. The article discloses no operating metrics or prior funding rounds.

• Akebia Therapeutics

  Participated · Series B · Jan 2012

  Akebia Therapeutics is a fully integrated biopharmaceutical company focused on developing vadadustat, an investigational therapy for anemia in patients on dialysis. The company says vadadustat is under FDA review, with a potential decision noted for March 27, 2024. Akebia secured a $55 million term loan facility to strengthen liquidity around that regulatory milestone. The arrangement provides $37.0 million immediately and an additional $18.0 million contingent on FDA approval of vadadustat. The financing includes an extended interest-only period and deferred principal repayment, which reduces near-term cash outflows. Management frames the facility as enabling the company to navigate pre- and post-approval activities, including potential commercialization efforts. The deal increases financial leverage and creates eventual repayment obligations tied to the company’s future regulatory and commercial outcomes. Akebia Therapeutics is developing AKB-6548, an orally available hypoxia‑inducible factor prolyl hydroxylase (HIF‑PH) inhibitor intended to treat anemias secondary to chronic kidney disease (CKD) and end‑stage renal disease. The compound is positioned as a potentially safer, orally dosed alternative to injectable erythropoiesis stimulating agents (ESAs) by stimulating endogenous EPO via HIF2α stabilization. In a 93‑patient, 42‑day Phase 2a CKD trial AKB-6548 produced a statistically significant, dose‑related increase in hemoglobin with a safety profile comparable to placebo and low iron requirements. Akebia plans a 140‑day Phase 2b CKD trial expected to begin in the third quarter and intends to use new financing over the next 18 months to complete studies and prepare AKB-6548 for Phase 3. The company was spun out of Procter & Gamble Pharmaceuticals in 2007 and is based in Cincinnati, Ohio. No revenue or user metrics were disclosed in the article. Akebia Therapeutics is a discovery and development company focused on treatments for chronic anemia. Its lead program, AKB-6548, is an orally bioavailable HIF-prolyl hydroxylase (HIF-PH) inhibitor currently in Phase 2 clinical trials. AKB-6548 is described as potentially best-in-class, offering potential advantages including an improved safety profile, once-daily oral dosing, and lower cost of goods versus traditional erythropoiesis stimulating agents. The company drew down a $4.1 million tranche of a previously announced Series B financing to enable completion of the Phase 2 study and to continue the process of selecting a partner for Phase 3 pivotal studies. The tranche was provided by a syndicate of life-science investors. Separately, Akebia spun out two programs—AKB-9778 (Tie-2 activator) and AKB-4924 (HIF-1α stabilizer)—to form a new stand-alone company, Aerpio Therapeutics. Akebia Therapeutics is a Cincinnati, OH–based pharmaceutical discovery and development company focused on anemia and vascular disorders. Its lead anemia program is AKB-6548, which the company says offers potential advantages over traditional erythropoiesis-stimulating agents, including an improved safety profile, oral dosing and lower cost of goods. The financing announced enables Akebia to complete two Phase 2b studies of AKB-6548 and to position that program for pivotal studies. Akebia also plans to advance AKB-9778, a novel Tie-2 activator for diabetic macular edema and vascular leak, into the clinic. The company closed a $22m Series B with a $14m first closing and the right to access an additional $8m through the end of 2011, which funds these near-term clinical plans. Akebia Therapeutics was formed by Joseph Gardner and John Rice to commercialize therapies acquired from Procter & Gamble and focuses on small-molecule drug discovery and development. Its lead candidate is AKB-6548, an oral erythropoietin-stimulating drug intended to treat chronic anemia. The company reported positive Phase 1 results in 33 healthy volunteers, showing increased erythropoietin and reticulocytes and good tolerability. Akebia plans to move into Phase 2 clinical trials for AKB-6548 and is evaluating partnering with a large pharmaceutical company or pursuing additional fundraising to complete development. Financially, the company recently completed a second closing that boosted a previously announced financing to $17 million. Management expects market opportunities due to safety concerns with existing injectable ESAs and potential expansion of the treated patient population if oral agents prove safer and easier to use.

No current team members are available.