On December 20, 2022 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported an expanded clinical development plan for VB10.16, the Company’s wholly-owned cancer vaccine, for the treatment of HPV16-positive cancers with high unmet need (Press release, Nykode Therapeutics, DEC 20, 2022, View Source [SID1234625430]). Nykode Management will host a webcast today, December 20, 2022, to discuss the development plan at 11 a.m. CET (in Norwegian) and 4 p.m. CET/10 a.m. ET (in English).

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VB10.16 is an off-the-shelf therapeutic cancer vaccine specifically designed to treat HPV16-induced malignancies. The drug candidate has reported interim data from VB-C-02, a Phase 2 trial in heavily pre-treated cervical cancer patients. The analysis demonstrated a favorable safety profile, with responses observed in both PD-L1 positive and negative patients (ORR 27% and 17%, respectively). The vaccine-induced significant HPV16-specific T cell responses that were associated with clinical responses.

"Today we announce our expanded VB10.16 development plan underlining our confidence in the product candidate’s potential to treat a broad group of HPV-related cancer patients with significant unmet need. These indications constitute a large potential market opportunity for Nykode. Our potential registrational trial strategy disclosed today in advanced cervical cancer could provide a fast path to making VB10.16 available to patients. I am excited by our ambitious VB10.16 development plans and our recently signed agreements supporting the development. We remain committed to taking full advantage of the potential of VB10.16 and Nykode’s technology platform," said Michael Engsig, Chief Executive Officer of Nykode Therapeutics.

Klaus Edvardsen, Chief Development Officer of Nykode Therapeutics, stated: "The interim results from our C-02 Phase 2 trial show the ability of VB10.16 to improve clinical outcomes in heavily pretreated patients with advanced cervical cancer. Our next trial in advanced cervical cancer will focus on patients who failed first line treatment including checkpoint inhibitor treatment. In this patient group with limited treatment options and a significant unmet need, we aim for a potential registrational trial."

Expanded VB10.16 Clinical Development Plan

Cervical Cancer
Nykode is planning to conduct a single arm trial, VB-C-04, with potential registrational intent in 2 nd line immune checkpoint inhibitor refractory advanced cervical cancer patients. The trial will be conducted in the United States and initiated in the fourth quarter of 2023.

Head and Neck Cancer
Nykode is planning to conduct an open-label, dose-finding, single arm Phase 1b/2a trial of VB10.16 in combination with pembrolizumab in patients with first line HPV16-postive, recurrent or metastatic squamous cell head and neck cancer as described in Nykode’s announcement on December 6, 2022. The trial, VB-C-03, will evaluate the overall response rate, safety, tolerability, and antigen specific immune response of the combination therapies. Nykode expects to enroll patients in Europe during the first half of 2023.

Basket Trial
Nykode expects to collaborate on an investigator-initiated basket trial to evaluate VB10.16 in combination with a PD-L1 inhibitor in patients diagnosed with HPV16-positive anal, penile, vaginal and/or vulvar cancer who are no longer eligible for curative treatments. The trial is expected to enroll patients with both PD-L1 positive and PD-L1 negative tumors. Nykode will continue to study VB10.16 in patients with PD-L1 negative tumors to investigate VB10.16’s potential for a dedicated trial in such a patient population.

Webcast
Investors and analysts are invited to join a webcast presentation of the VB10.16 development plan conducted by Michael Engsig, Chief Executive Officer, and Klaus Edvardsen, Chief Development Officer, today, December 20, 2022 at:

11 a.m. CET / 5 a.m. ET which will be conducted in Norwegian
4 p.m. CET / 10 a.m. ET which will be conducted in English

The slide presentation and live and archived webcast can be accessed in the Investors section of the Company’s website at View Source

41st Annual J.P. Morgan Healthcare Conference

Nykode Management will present at the 41st Annual J.P. Morgan Healthcare Conference, taking place January 9-12, 2023, in San Francisco, California.

About VB10.16

VB10.16 is a potentially first-in-class off-the-shelf therapeutic cancer vaccine candidate in development for the treatment of human papillomavirus type 16 (HPV16)-positive cancers. The cancer vaccine is designed based on Nykode’s Vaccibody technology platform of targeting antigens to antigen presenting cells. VB10.16 has reported positive interim data from a Phase 2 trial in heavily pre-treated cervical cancer patients (NCT04405349). The analysis demonstrated a favorable safety profile, with responses observed in both PD-L1 positive and negative patients (ORR 27% and 17%, respectively). The vaccine-induced significant HPV16-specific T cell responses were associated with
clinical responses. The candidate has also demonstrated favorable clinical data in a Phase 1/2a study in pre-cancerous HPV16-induced high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3) demonstrating a statistically significant correlation of immune responses and clinical responses.