On February 20, 2018 Dynavax Technologies Corporation (NASDAQ:DVAX) reported that it has closed on a $175 million non-dilutive term loan agreement with CRG LP, a healthcare focused investment firm (Press release, Dynavax Technologies, FEB 20, 2018, View Source [SID1234524052]). Dynavax will receive $100 million in a first tranche and up to an additional $75 million may be borrowed in a second tranche at Dynavax’s option.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"This non-dilutive financing, together with our $192 million in cash at December 31, 2017, will enable us to implement our commercialization plan for HEPLISAV-B in the United States, and expand and advance clinical studies of our immuno-oncology product candidates," said Michael Ostrach, chief financial officer of Dynavax. "Our strong cash position will support the launch of our HEPLISAV-B field sales team next week and the phase 3 clinical trial of SD-101 and additional Phase 2 trials planned to start later this year."
Dynavax will receive $100 million in a first tranche and up to an additional $75 million may be funded at Dynavax’s option in a second tranche at any time upon notice delivered no later than June 30, 2019, in an amount determined by the company in increments of $25 million. Interest on the term loans will accrue at a rate of 9.5% per annum with the principal to be repaid at maturity on December 29, 2023. The principal can be repaid at any time after the second anniversary with no additional prepayment fees. Further information on the loan arrangement is available in the Current Report on Form 8-K to be filed by the Company with the Securities and Exchange Commission.
"With a newly approved product that can help address unmet medical needs and a promising immuno-oncology platform, Dynavax is the archetype of companies we seek to support," said Luke Düster, Managing Director of CRG. "This transaction demonstrates our confidence in HEPLISAV-B and Dynavax’s commercial strategy and ability to continue to translate its innovative technology into important commercial products."
Commercialization of HEPLISAV-B
HEPLISAV-B was approved by the U.S. Food and Drug Administration (FDA) in November 2017 for the prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax commercially launched HEPLISAV-B in the United States in January 2018.
The company is seeking a recommendation from the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) to add HEPLISAV-B to the adult vaccination schedule for the prevention of hepatitis B. The ACIP recommendation is required to obtain access to HEPLISAV-B through medical policies that only offer vaccinations included in the CDC’s schedule. The ACIP meeting is scheduled for February 21, during which the committee will determine its recommendation. The company will deploy its field sales team on February 26, targeting institutions, the largest independent accounts, and influential accounts that are current hepatitis B vaccinators.
Advancement of Immuno-Oncology Pipeline
Dynavax continues to expand its TLR based immuno-oncology platform through the execution of ongoing clinical trials and preclinical work on multiple compounds and combination therapies. The company’s lead program, SD-101, has shown promising initial clinical data with the potential to significantly enhance the immune response against cancer. Data from its Phase 2 trial in melanoma and head and neck squamous cell carcinoma have been submitted in separate abstracts to upcoming medical conferences.
About HEPLISAV-B
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like receptor (TLR) 9 agonist to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.
For more information about HEPLISAV-B, visit View Source
Indication and Use
HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.
Important Safety Information (ISI)
Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.
Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.
The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).
For full Prescribing Information for HEPLISAV-B, click here.
About SD-101
SD-101, the Company’s lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. Dynavax is evaluating this intratumoral TLR9 agonist in several clinical studies to assess its safety and activity, including a Phase 2 study in combination with Keytruda (pembrolizumab), an anti-PD-1 therapy, in patients with metastatic melanoma and in patients with head and neck squamous cell cancer, in a clinical collaboration with Merck. Dynavax maintains all commercial rights to SD-101.