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Phio Pharmaceuticals Announces Acceptance of Six Abstracts at The 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC)

On September 12, 2022 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company developing the next generation of therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported that six abstracts have been accepted for poster presentations at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), which will be held in Boston, MA from November 10 – 12, 2022 (Press release, Phio Pharmaceuticals, SEP 12, 2022, View Source [SID1234619429]).

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"We are pleased to announce the acceptance of six posters for presentation at the annual SITC (Free SITC Whitepaper) meeting. These posters will highlight in vitro as well as, in vivo tumor efficacy, and clinical work with our INTASYL compounds targeting PD-1, CTLA-4, CTGF, TIGIT, and BRD4, as well as the manufacturing, in collaboration with our partner AgonOx, Inc., of clinical scale batches of TIL with and without PH-762, our PD-1 gene silencing INTASYL compound," said Dr Simon Fricker, Vice President of Research and Development at Phio Pharmaceuticals. "We have worked intensely over the past year to advance our programs evaluating the potential of INTASYL treatment in immuno-oncology and adoptive cell therapy in vitro and in well-established animal models. The team is excited to share the results of these programs during these upcoming posters at SITC (Free SITC Whitepaper)."

Details on the Company’s poster presentations and related presentation schedules will be forthcoming.

Nykode Therapeutics to present at H.C. Wainwright 24th Annual Global Investment Conference

On September 9, 2022 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported that its Chief Executive Officer, Michael Engsig, and Chief Business Officer & Cofounder, Agnete Fredriksen, will present at the H.C. Wainwright 24th Annual Global Investment Conference on Tuesday, September 13, 2022 at 11:00 a.m. ET / 5:00 p.m. CET and are available for 1:1 investor meetings (Press release, Nykode Therapeutics, SEP 9, 2022, View Source [SID1234619428]).

The live and archived webcast of the presentation can be accessed in the Investors section of the Company’s website here.

NuCana Presents Promising Data on NUC-7738 at the European Society of Medical Oncology (ESMO) Annual Meeting 2022

On September 12, 2022 NuCana plc (NASDAQ: NCNA) reported that data from the ongoing NuTide:701 study of NUC-7738 in an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting (Press release, Nucana BioPharmaceuticals, SEP 12, 2022, View Source [SID1234619427]).

Oral 455MO: NUC-7738 in Patients with Advanced Solid Tumors- Phase 1 results from the NuTide:701 Phase 1 / 2 Study

Data on NUC-7738 from the Phase 1 part of NuTide:701 showed encouraging signals of anti-tumor activity across a range of tumor types, particularly melanoma. Promising data were observed in a variety of solid tumors with numerous patients staying on treatment for extended periods, including one patient with metastatic melanoma who became eligible for complete surgical resection following eleven months of treatment with NUC-7738. NUC-7738 also had a favorable safety profile with low rates of treatment-related AEs (TRAEs), very few Grade 3 TRAEs and no patients experiencing Grade 4 or 5 TRAEs.

Dr. Stefan Symeonides, Senior Lecturer in Experimental Cancer Medicine at the Edinburgh Cancer Research Centre and lead author of the ESMO (Free ESMO Whitepaper) presentation, said: "NUC-7738 has shown an excellent safety profile and encouraging signals of anti-tumor activity in this study which is enrolling patients who have exhausted all standard therapies. We are excited to further investigate the activity of NUC-7738 in melanoma and other tumor types."

"We remain very encouraged by what we have observed with NUC-7738," said Hugh S. Griffith. "NUC-7738’s precise mode of action of disrupting RNA polyadenylation in cancer cells thereby altering the expression of genes associated with key cellular processes is very exciting. The positive signals observed in Part 1 of the NuTide:701 study, combined with NUC-7738’s differentiated mode of action, provide a strong scientific rationale to expedite its development and enrich the Phase 2 part of the study for patients with melanoma. This part of the study will also include a cohort combining NUC-7738 with pembrolizumab, which is a standard of care for melanoma patients. We have begun enrolling patients into the Phase 2 part of the study and look forward to sharing these data."

About NUC-7738
NUC-7738 is a phosphoramidate transformation of 3′-deoxyadenosine (3′-dA), also known as cordycepin. 3’-dA has demonstrated potent anti-cancer activity in non-clinical studies, but has not been successfully developed as an anti-cancer agent due to its rapid breakdown by adenosine deaminase (ADA). NUC-7738 is designed to generate the active anti-cancer metabolite of 3’-dA directly inside cancer cells, thus overcoming 3’-dA’s key limitations of breakdown, transportation and activation. The cytotoxic effect of NUC-7738 is largely attributed to the generation of the main active anti-cancer metabolite, 3′-dATP which interferes with RNA polyadenylation, causing changes in the expression of genes involved in various cellular processes, leading to cancer cell death.

Nanobiotix Announces Agreement in Principle to Restructure Existing Loan Agreement With European Investment Bank, Extending Operating Runway Into Q1 2024

On September 12, 2022 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported reaching an agreement in principle to restructure €30.7 million in outstanding debt obligations related to the Company’s 2018 loan agreement with the European Investment Bank ("EIB") (Press release, Nanobiotix, SEP 12, 2022, View Source [SID1234619426]).

"The European Investment Bank has shown an unwavering commitment to supporting potentially disruptive healthcare innovation in the European Union and this agreement in principle is a testament to their strength as a strategic partner," said Bart Van Rhijn, chief financial officer, Nanobiotix. "In view of macroeconomic volatility and the impact on the overall biotechnology industry, Nanobiotix continues to prioritize lead registrational programs for NBTXR3 as a single agent activated by radiotherapy and in combination with checkpoint inhibitors for the treatment of head and neck cancer. Restructuring existing debt obligations to extend the maturity date of the loan will enable Nanobiotix to drive priority development programs in 2023 by extending operating runway an additional quarter. Combined with the committed access to capital available through our existing equity line, this provides Nanobiotix with the ability to extend its operating runway into the first quarter of 2024."

The finance contract and royalty agreement established with the EIB in July 2018 consisted of an initial tranche of €16.0 million drawn in October 2018 and repayable in a single installment at maturity in 2023 and a second tranche of €14.0 million granted in March 2019 and repayable in semi-annual installments of principal and interest after a two-year grace period. The 2018 agreement also included a commitment to pay low single-digit royalties annually over a six-year period beginning in January 2021.

The agreement in principle is structured around Nanobiotix expected cash inflow from future non-dilutive value drivers including planned commercialization1 of NBTXR3 and potential partnerships. The agreement in principle allows for deferment of approximately €25.3 million in principal repayments up to June 2029 and approximately €5.4 million in payment-in-kind (PIK) interest payments up to October 2024. It also includes an additional €20.0 million payment with a due date in 2029 which could be accelerated based on potential cash inflow. The outstanding debt obligations will continue to accrue interest until the new maturity dates. The six-year royalty period included in the 2018 agreement is also being revised to commence upon commercialization.

Execution by the Company and EIB of a definitive amendment, expected in Q4 2022, is subject to finalization of the necessary documents and agreements.

Mersana Therapeutics Announces FDA Fast Track Designation Granted to XMT-1660 for the Treatment of Triple-Negative Breast Cancer

On September 12, 2022 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to XMT-1660 for the treatment of adult patients with advanced or metastatic triple-negative breast cancer (TNBC) (Press release, Mersana Therapeutics, SEP 12, 2022, View Source [SID1234619425]). XMT-1660 is a B7-H4-directed Dolasynthen antibody drug conjugate with a precise, target-optimized drug-to-antibody ratio (DAR 6) and Mersana’s clinically validated DolaLock microtubule inhibitor payload with controlled bystander effect.

"While breast cancer remains an area of high unmet need, TNBC is associated with particularly poor outcomes and very limited treatment options," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "XMT-1660 has demonstrated promising anti-tumor effects in preclinical studies, and we are excited to have recently initiated our Phase 1 trial to investigate its safety and clinical activity. This Fast Track designation allows for a potentially accelerated regulatory review of XMT-1660 as we seek to offer a new therapy for patients living with a range of B7-H4 expressing tumors."

Mersana’s ongoing multicenter Phase 1 trial is investigating the safety, tolerability and anti-tumor activity of XMT-1660 in patients with solid tumors, including in breast, endometrial and ovarian cancers. The initial dose escalation portion of this trial will evaluate the safety and tolerability of XMT-1660. The dose expansion portion of the trial will evaluate the safety, tolerability and efficacy of XMT-1660.

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fill an unmet medical need. A product candidate that is granted Fast Track designation may be eligible for several benefits, including more frequent meetings and communications with the FDA and, if certain criteria are met, the potential for Accelerated Approval, Priority Review or Rolling Review of a Biologics License Application (BLA) by the FDA.