Biopharmaceutical firm Chimerix Inc. (CMRX:NASDAQ), which is focused on developing medicines for treatment of cancer and other serious diseases, today announced that it has entered into a definitive agreement to acquire Oncoceutics Inc., a privately held, clinical-stage biotechnology company that is actively developing a novel class of compounds called imipridones.
Chimerix stated that "Oncoceutics' lead product candidate, ONC201, has been shown in clinical testing to selectively induce cell death in multiple cancer types." The firm explained that "ONC201 is an orally administered small molecule dopamine receptor D2 (DRD2) antagonist and caseinolytic protease (ClpP) agonist in late-stage clinical development for recurrent gliomas that harbor the H3 K27M mutation." The company noted that recurrent glioma is a type of deadly brain cancer that typically has an average survival rate of eight months, and in recurrent pediatric patient cases, the rate is around just four months.
Dr. Patrick Wen, director of the Center for Neuro-Oncology at the Dana-Farber Cancer Institute and professor of neurology at Harvard Medical School, remarked, "Patients with H3 K27M-mutant glioma are in desperate need of better therapeutic alternatives...The tumor responses and safety profile we have observed with ONC201 in this devastating disease are compelling and I look forward to the possibility of accelerating its delivery to patients."
Chimerix's CEO Mike Sherman stated, "Glioma remains one of the highest areas of unmet need in oncology where even first-line radiation therapy, as well as temozolomide in eligible patients, is not meaningfully effective and subsequent therapies are considered palliative. Further, there are no molecularly-targeted therapies for patients which harbor the H3 K27M mutation in this life-limiting disease. Given the urgent need and based on discussions with the FDA, there is a potential accelerated path to approval based on overall response. With a registration cohort of patients fully enrolled, treated, and preliminary data in hand, ONC201 offers an exciting near-term opportunity to quickly bring a potentially life-saving therapy and hope to patients with limited or no options."
"Oncoceutics represents a transformative acquisition for Chimerix, positioning the company with five assets across all stages of development and delivering on our goal to focus on oncology opportunities, complementing our Phase 3 study in acute myeloid leukemia with DSTAT. With the upcoming Prescription Drug User Fee Act (PDUFA) date of April 7, 2021 for brincidofovir in smallpox and the confirmatory response rate assessment of ONC201 in 2021, we expect these near-term milestones to accelerate delivery of two new therapies in areas of particularly high unmet need," Sherman added.
Oncoceutics' CEO Lee Schalop, M.D., commented, "We are thrilled to join the Chimerix team to help accelerate ONC201 to glioma patients in urgent need of effective treatments. Chimerix has the leadership and resources to bring this program successfully through to approval and to further develop other promising assets in the Oncoceutics pipeline."
The company advised that ONC201 is presently being studied in a Phase 2 clinical trial of 50 patient subjects that have progressive measurable disease and have received radiation previously and who are two years of age or older and have been diagnosed with recurrent diffuse midline glioma that harbor the H3 K27M mutation.
The firm stated that cohort enrollment is completed and includes patients from multiple clinical trials. The company indicated that it anticipates that a BICR analysis will be undertaken in 2021 and if the results prove to be favorable, may provide the basis for regulatory approval of ONC201 in the U.S. The company pointed out that "a BICR of the first 30 patients treated with ONC201 was completed and that the drug demonstrated a favorable safety profile with a database of over 350 treated patients."
The company stated that under the terms of the purchase transaction, Chimerix will pay Oncoceutics shareholders a total of $78 million, which includes $39 million in cash and $39 million in Chimerix common stock. The cash payment is to be made in two stages with $25 million being paid at closing and the remaining $14 million balance will be payable one year from the closing date. The deal further stipulates that "Oncoceutics shareholders will also potentially earn development, regulatory and sales milestones totaling up to $360 million across three development programs and royalties on combined sales of ONC201 and ONC206 of 15% up to $750 million in annual revenue and 20% above $750 million in annual revenue."
Chimerix advised that both companies' Board of Directors approved the transaction, which closed with the execution of definitive agreements on January 7, 2021.
Chimerix is a development-stage biopharmaceutical company based in Durham, N.C., that is involved in advancing medicines in the areas of cancer and other serious diseases. The company's current clinical programs are evaluating dociparstat sodium (DSTAT), a glycosaminoglycan compound derived from porcine heparin that has low anticoagulant activity, and brincidofovir (BCV), an antiviral drug being developed as a medical countermeasure for smallpox. DSTAT is also now being studied in a Phase 2/3 trial in adults with acute lung injury with underlying COVID-19 and the firm indicated that it plans to commence another separate Phase 3 trial of DSTAT for acute myeloid leukemia in early 2021.
Chimerix began the day with a market capitalization of around $311.9 million with approximately 62.63 million shares outstanding and a short interest of about 1.4%. CMRX shares opened more than 30% higher today at $6.5535 (+$1.5735, +31.60%) over yesterday's $4.98 closing price and reached a new 52-week high this morning of $9.36. The stock has traded today between $6.55 and $9.36 per share and is currently trading at $8.23 (+$3.25, +65.26%).[NLINSERT]
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