On January 09, 2023 Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative vaccines, reported preliminary, unaudited financial highlights for the fourth quarter and full year ending December 31, 2022 and Phase 1 shingles topline results (Press release, Dynavax Technologies, JAN 9, 2023, View Source [SID1234626052]).

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"We are pleased with the relentless execution of our strategy throughout 2022, delivering transformative progress across our commercial and development portfolio including revenue at the top end of our guidance, achievement of all of our stated clinical milestones and the strengthening of our balance sheet," said Ryan Spencer, Chief Executive Officer of Dynavax. "In 2023, we anticipate building on the strong foundation laid in 2022, with continued product revenue growth for HEPLISAV-B, advancement of our clinical development pipeline leveraging our versatile CpG 1018 adjuvant technology and execution of our corporate development objectives to help drive long-term value."

2022 Preliminary Unaudited Commercial and Financial Highlights:
Preliminary HEPLISAV-B Net Product Revenue for the fourth quarter and full year 2022 were approximately $35 million and $126 million, respectively, representing quarterly and annual growth of 105% and 104% compared to Q4 2021 and full year 2021, respectively.
Preliminary CpG 1018 adjuvant Net Product Revenue for the fourth quarter and full year 2022 were approximately $147 million and $588 million, respectively, representing the successful completion of all pandemic adjuvant delivery obligations under existing commercial supply agreements.
Approximately $624 million in estimated Cash and Cash Equivalents, and Marketable Securities as of December 31, 2022.
The preliminary selected financial results contained herein are unaudited, subject to adjustment, and provided as an estimate in advance of the Company’s announcement of complete financial results for the three and twelve months ended December 31, 2022.

Phase 1 Topline Results from Shingles Program
The Phase 1 clinical trial (DV2-ZOS-01) was designed to evaluate an investigational shingles vaccine Z-1018, utilizing different regimens of CpG 1018 adjuvant, with or without aluminum hydroxide (alum). The trial compared Z-1018 arms versus the active comparator Shingrix. The Company reported the following topline results, assessed at Week 12, and plans to submit an abstract for presentation at an upcoming medical meeting in the first half of 2023.

Z-1018 demonstrated high antibody and CD4 positive T-cell vaccine response rates in all arms, which were similar to the comparator;
Robust increases in CD4 positive T-cells were observed in all Z-1018 arms, although lower than the comparator;
Total frequency of solicited systemic adverse events and local post-injection reactions were similar across the Z-1018 arms and lower than the comparator,
The frequency of moderate and severe local post-injection reactions was 9% for Z-1018 arms compared to 37% for the comparator and the frequency of moderate and severe solicited systemic adverse events was 26% for Z-1018 arms and 43% for the comparator;
"With these promising data, we have a better understanding of the potential for a CpG 1018 adjuvanted shingles vaccine to reduce post-injection reactions to improve patients’ experience compared with the currently commercialized shingles vaccine," said Dr. Robert Janssen, Chief Medical Officer of Dynavax. "With the high vaccine response rate, and in comparison with immunologic and efficacy data from previous shingles vaccine studies, we believe our vaccine candidate has the potential to be highly efficacious."

Based on these initial data, the Company intends to advance its shingles vaccine candidate with CpG 1018 adjuvant into a Phase 1-2 study in early 2024 to expand on these results and to evaluate various dose levels of Dynavax-manufactured gE protein.

About DV2-ZOS-01 Clinical Trial
DV2-ZOS-01 is a randomized, active-controlled, dose-escalation, multi-center Phase 1 clinical trial to evaluate the safety, tolerability, and immunogenicity of investigational herpes zoster (shingles) vaccine utilizing a commercially available gE plus CpG 1018 adjuvant (Z-1018) with and without alum compared to Shingrix in approximately 150 healthy volunteers between the ages of 50 and 69 years of age.

For additional information about this trial, please visit www.clinicaltrials.gov using the identifier
NCT05245838.

Shingrix is a registered trademark of GlaxoSmithKline, PLC.

About HEPLISAV-B
Important U.S. Product Information
HEPLISAV-B is indicated for the prevention of infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older.

For full U.S. Prescribing Information for HEPLISAV-B, click here.

Important U.S. Safety Information (ISI)
Do not administer HEPLISAV-B to individuals with a history of a 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%).
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The median duration of tovorafenib treatment was 8.4 months, with 77% (n=59) of patients on treatment at the time of the data cutoff

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Nearly 60% (n=46) of patients had already received at least one prior MAPK inhibitor prior to study participation

"The responses we’ve observed in the FIREFLY-1 study with weekly monotherapy tovorafenib in children with recurrent or progressive low-grade gliomas are very encouraging," said Samuel Blackman, M.D., Ph.D., co-founder and chief medical officer of Day One. "As tovorafenib progresses in the clinic, we want to thank the patients, their families, the clinical investigators, and the advocates who have chosen to participate in the FIREFLY-1 clinical trial and support the development of a potential new treatment for children in need of new therapeutic options."

FIREFLY-1 is evaluating tovorafenib as once-weekly monotherapy in patients aged 6 months to 25 years with recurrent or progressive pLGG. The trial is being conducted in collaboration with the Pacific Pediatric Neuro-Oncology Consortium (PNOC) and is designed to support the potential regulatory approval of tovorafenib.

"Based on the efficacy and safety profile of tovorafenib observed to date from the FIREFLY-1 trial population, we plan to submit a New Drug Application in the first half of this year that will include additional follow up from the full study population," said Jeremy Bender, Ph.D., chief executive officer of Day One. "We look forward to continuing our discussions with regulatory authorities with the hope of bringing this therapy to children in need of new options as soon as possible."

In addition to FIREFLY-1, Day One is expanding the development of tovorafenib as a front-line therapy for patients newly diagnosed with pLGG. The global, Phase 3, registrational FIREFLY-2/LOGGIC clinical trial is evaluating once-weekly monotherapy tovorafenib in newly-diagnosed patients with pLGG harboring a known activating RAF alteration.

About Pediatric Low-Grade Glioma

Pediatric low-grade glioma (pLGG) is the most common brain tumor diagnosed in children, accounting for 30% – 50% of all central nervous system tumors. BRAF wild-type fusions are the most common cancer-causing genomic alterations in pediatric low-grade gliomas. These genomic alterations are also found in several adult and pediatric solid tumors.

Pediatric low-grade glioma can impact a child’s health in many ways depending on tumor size and location, including vision loss and motor dysfunction. There are no approved therapies for pLGG, and current treatment approaches are associated with potential acute and life-long adverse effects. While most children with pLGG survive their cancer, children who do not achieve remission following surgery may face years of increasingly aggressive therapies. Due to the indolent nature of pLGG, patients generally receive multiple years of systemic therapy.

About Tovorafenib

Tovorafenib is an investigational, oral, brain-penetrant, highly-selective type II pan-RAF kinase inhibitor designed to target a key enzyme in the MAPK signaling pathway, which is being investigated in primary brain tumors or brain metastases of solid tumors. Tovorafenib has been studied in over 325 patients to date. Currently tovorafenib is under evaluation in a pivotal Phase 2 clinical trial (FIREFLY-1) among pediatric, adolescent and young adult patients with recurrent or progressive pLGG, which is an area of considerable unmet need with no approved therapies. Tovorafenib is also being evaluated alone or as a combination therapy for adolescent and adult patient populations with recurrent or progressive solid tumors with MAPK pathway aberrations (FIRELIGHT-1).

Tovorafenib has been granted Breakthrough Therapy and Rare Pediatric Disease designations by the U.S. Food and Drug Administration (FDA) for the treatment of patients with pLGG harboring an activating RAF alteration. Tovorafenib has also received Orphan Drug designation from the FDA for the treatment of malignant glioma, and from the European Commission (EC) for the treatment of glioma.

About the Pacific Pediatric Neuro-Oncology Consortium

The Pacific Pediatric Neuro-Oncology Consortium (PNOC) is an international consortium with study sites within the United States, Canada, Europe and Australia dedicated to bringing new therapies to children and young adults with brain tumors.