On June 1, 2023 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported that it has expanded the clinical collaboration and supply agreement with Roche to cover evaluation of VB10.16, Nykode’s wholly owned off-the-shelf therapeutic cancer vaccine candidate, in combination with Roche’s cancer immunotherapy atezolizumab in patients with advanced cervical cancer who have progressed on pembrolizumab plus chemotherapy +/-bevacizumab as first line treatment (Press release, Nykode Therapeutics, JUN 1, 2023, View Source [SID1234632286]). The VB-C-04 trial is expected to be initiated in the U.S. in the fourth quarter of 2023 with registrational intent, which provides a potential fast-to-market path.
Under the terms of the agreement, Nykode will sponsor and fund the planned clinical trial, and Roche will provide atezolizumab. Nykode retains all commercial rights to VB10.16 worldwide.

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Nykode has recently reported positive safety and efficacy results from the Phase 2 VB-C-02 trial in Europe in advanced cervical cancer patients with VB10.16 in combination with atezolizumab. The results showed an overall response rate (ORR) of 29%, median overall survival (mOS) not reached but greater than 25 months at the time of analysis, and 6.3 months median progression free survival (mPFS) in PD-L1+ patients. In the patient population most relevant for the upcoming VB-C-04 trial, PD-L1+ patients with one prior line of systemic treatment, ORR was 40% and disease control rate was 80% with mPFS of 16.9 months and mOS not reached but greater than 25 months at the time of analysis.

"We look forward to expanding our collaboration with Roche to bring the combination of VB10.16 and atezolizumab to cervical cancer patients with limited treatment options. Cervical cancer has a poor prognosis, and the recent positive clinical data from VB-C-02 has strengthened our commitment to contribute with a well-tolerated treatment that can potentially prolong the life of these women. The trial provides a potential fast path to market for VB10.16." said Michael Engsig, CEO of Nykode Therapeutics. "Overall, the collaboration speaks to our shared confidence in the unique potential of VB10.16, the platform, and the synergy between our vaccine candidates and atezolizumab.

In addition to the existing VB-C-02 and the new VB-C-04 collaboration, Roche continues to be a valuable partner under our collaboration agreement covering development of individualized vaccines for a broad range of cancers." The VB-C-04 trial will be conducted together with GOG Foundation, a U.S.-based not-for-profit organization with expertise in bringing best-in-class new treatments to patients.

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 data from a Phase 2 trial in advanced cervical cancer patients (NCT04405349) in combination with atezolizumab with mOS not reached but greater than 25 months at the time of analysis in PD-L1+ patients. The vaccine-induced significant HPV16-specific T cell responses were correlated 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.

About Cervical Cancer

Cervical cancer is the fourth leading cause of cancer death in women worldwide and is most frequently diagnosed between the ages of 35 and 44. Each year around 600,000 women are diagnosed with cervical cancer worldwide. Almost all cases are caused by human papillomavirus (HPV) infection and HPV16 accounts for more than half of all cervical cancer cases. Approximately 80% of patients with cervical cancer have squamous cell carcinoma (arising from cells lining the bottom of the cervix) and most other patients have adenocarcinomas (arising from glandular cells in the upper cervix). Cervical cancer is often curable when detected early and effectively managed, but treatment options are more limited in advanced disease stages or when the cancer has spread.

On May 31, 2023 HOOKIPA Pharma Inc. (Nasdaq: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported the pricing of an underwritten public offering of 22,900,768 shares of its common stock and 15,268 shares of its non-voting Series A-2 convertible preferred stock (the "Offering") (Press release, Hookipa Pharma, JUN 1, 2023, View Source [SID1234632274]). The public offering price of each share of common stock is $1.31 and the public offering price of each share of non-voting Series A-2 preferred stock is $1,310.00 (each share of non-voting Series A-2 preferred stock is convertible into 1,000 shares of common stock). The gross proceeds to HOOKIPA from this offering are expected to be approximately $50.0 million, before deducting underwriting discounts and commissions and other offering expenses. All of the securities in the Offering are to be sold by HOOKIPA. The Offering is expected to close on June 5, 2023, subject to customary closing conditions.

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SVB Securities and RBC Capital Markets are acting as joint book-running managers for the Offering. H.C. Wainwright & Co. and JMP Securities, a Citizens Company, are acting as lead managers for the Offering.

The securities described above are being offered by HOOKIPA pursuant to a shelf registration statement on Form S-3 (No. 333-266104), including a base prospectus filed with the Securities and Exchange Commission (the "SEC"), which was declared effective on July 21, 2022. A final prospectus supplement and accompanying prospectus relating to the Offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may also be obtained, when available, from SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston Massachusetts 02109, by telephone at 1-800-808-7525 ext. 6105, or by email at [email protected]; RBC Capital Markets, LLC, Attention: Equity Capital Markets, 200 Vesey Street, 8th Floor, New York, NY 10281, by telephone at 877-822-4089, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.