On November 7, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported recent operational highlights and financial results for the third quarter ended September 30, 2022 (Press release, Oncolytics Biotech, NOV 7, 2022, View Source [SID1234623267]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

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"Our continued progress in breast cancer and the highly-promising pancreatic cancer data we reported earlier today have pelareorep moving confidently towards pivotal trials in both of these indications for which new treatment options are needed," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "In breast cancer, we remain on track to report an expansive dataset from our randomized BRACELET-1 trial in the first half of next year. This phase 2 trial was carefully designed to validate the statistically significant survival benefit provided by pelareorep in a prior phase 2 study, and its results are expected to inform the optimal design of a subsequent registrational trial. In pancreatic cancer, we plan to discuss our new data with regulators to enable the program’s expeditious advancement into a pivotal study. With these core programs each representing a potential registration opportunity and distinct avenue for value creation, we believe we are entering a new phase in Oncolytics’ evolution."

Third Quarter and Subsequent Highlights

Pancreatic Cancer Program

Reported interim data showing a 70% ORR in phase 1/2 GOBLET trial’s pancreatic cancer cohort

An abstract published as part of the SITC (Free SITC Whitepaper) Meeting, and highlighted in a separate press release issued earlier today, features data from the phase 1/2 GOBLET trial’s cohort in first-line advanced/metastatic pancreatic ductal adenocarcinoma, one of the most difficult-to-treat human cancers. As of the abstract’s data cutoff date (July 28, 2022), seven of ten evaluable patients had achieved a partial response following treatment with pelareorep in combination with atezolizumab and the chemotherapeutic agents gemcitabine and nab-paclitaxel. An additional two patients achieved stable disease, leading to an ORR and clinical benefit rate of 70% and 90%, respectively. The 70% ORR reported as of the cutoff date is nearly triple the average ORR of approximately 25% reported in historical control trials evaluating the combination of gemcitabine and nab-paclitaxel in pancreatic cancer1-4. Together with data from prior clinical studies, these results suggest pelareorep synergizes with checkpoint inhibition and chemotherapy in pancreatic cancer and support Oncolytics’ plan to advance into a registrational pancreatic cancer study pending discussions with regulatory authorities.

Breast Cancer Program

New AWARE-1 data further demonstrate pelareorep’s immune-mediated mechanism of action

An abstract published earlier today as part of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting features new data on the twenty HR+/HER2- breast cancer patients comprising the first two cohorts of the AWARE-1 study. Patients in these cohorts were treated with pelareorep and letrozole without (cohort 1) or with (cohort 2) Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab. Flow cytometry analyses of blood samples from these patients showed a statistically significant increase in anti-cancer NK cells on day 21 post-treatment in cohort 2 compared to cohort 1. In addition, cohort 2 patients showed higher levels of HLA-DR expression (a marker of T cell activation) in anti-cancer CD8+ T cells, and better maintained low levels of T cell exhaustion markers on day 21 compared to cohort 1 patients. Together with prior clinical data, these results further demonstrate pelareorep’s immunologic mechanism of action and its potential to synergistically combine with a variety of drug classes.

Corporate Updates

Elected Jonathan Rigby to the Board of Directors

Mr. Rigby has over thirty years of pharmaceutical and biotechnology industry experience. He is currently the Group Chief Executive Officer of Revolo Biotherapeutics and previously co-founded Zogenix, Inc., a CNS-focused specialty pharmaceutical company that was acquired by UCB earlier this year in a transaction valued at up to approximately U.S. $1.9 billion.

Financial Highlights

As of September 30, 2022, the Company reported $32.4 million in cash and cash equivalents.
General and administrative expenses for the third quarter of 2022 were $2.4 million, compared to $2.9 million for the third quarter of 2021.
Research and development expenses for the third quarter of 2022 were $3.7 million, compared to $3.3 million for the third quarter of 2021.
The net loss for the third quarter of 2022 was $4.4 million, compared to a net loss of $4.9 million in the third quarter of 2021. The basic and diluted loss per share was $0.08 in the third quarter of 2022, compared to a basic and diluted loss per share of $0.09 in the third quarter of 2021.
Net cash used in operating activities for the nine months ended September 30, 2022 was $17.4 million, compared to $16.1 million for the nine months ended September 30, 2021.
Anticipated Milestones and Catalysts

Final AWARE-1 study data: Q4 2022
Clinical data from Adlai Nortye’s bridging trial in HR+/HER2- metastatic breast cancer patients: Q4 2022
Overall response rate, progression-free survival, and evolving overall survival data from phase 2 BRACELET-1 metastatic breast cancer study: H1 2023

Webcast and Conference Call

Management will host a conference call for analysts and institutional investors at 8:30 a.m. ET today, November 7, 2022. To access the call, please dial (888) 664-6383 (North America) or (416) 764-8650 (International) and, if needed, provide confirmation number 4240-6541. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics’ website (LINK) and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 406-541#.

On November 7, 2022 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported results of additional efficacy analysis of the interim results from its Phase 2 trial of VB10.16 in combination with atezolizumab in advanced cervical cancer (Press release, Nykode Therapeutics, NOV 7, 2022, View Source [SID1234623266]).

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"This additional analysis confirms our belief in VB10.16’s competitive strength and its potential to improve outcomes in patients with advanced cervical cancer," said Michael Engsig, Chief Executive Officer of Nykode. "Our C-02 trial enrolled heavily pre-treated patients with about one third having received three or more prior treatments. The additional analysis shows an increased response rate and competitive efficacy in patients receiving up to two prior therapies, which increases our confidence in our vaccine platform’s ability to induce clinically relevant immune responses in patients with recurrent and metastatic diseases. The data will help inform our clinical strategy as we further define the patient population for our next study of VB10.16 in advanced cervical cancer."

Interim data from 39 patients were announced in May 2022. The trial enrolled patients pre-treated with 1-5 lines of prior systemic therapy in recurrent or metastatic setting and showed a 21% Objective Response Rate (ORR) on average across all lines. This new analysis reviewed patient outcomes based on the number of previous lines of systemic therapy and number of extrapelvic metastases, showing a robust clinical benefit with partial and complete responses in 30% of patients treated with up to two prior lines of therapy. The response rate was similarly higher in patients with lower metastatic burden. A high disease control rate (DCR) was observed across all patient groups. Importantly, the T cell responses continue to show association with clinical outcomes. The data were reviewed as part of the Company’s presentation at the Credit Suisse Annual Healthcare Conference on Tuesday, November 8, 2022. The presentation can be accessed in the Investors section of the Company’s website here.

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 November 7, 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 and host 1×1 meetings at two upcoming investor conferences in November (Press release, Nykode Therapeutics, NOV 7, 2022, View Source [SID1234623265]).

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Presentation Details Credit Suisse Annual Healthcare Conference
Jefferies London Healthcare Conference

Slides of both presentations can be accessed in the Investors section of the Company’s website here. A live and archived webcast of the Jefferies presentation will also be available.

On November 7, 2022 Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized immunotherapies, reported interim data from the Phase 1b trial evaluating NOUS-PEV which demonstrated it to be safe, well tolerated, immunogenic and with signs of anti-tumor activity (Press release, NousCom, NOV 7, 2022, View Source [SID1234623264]). These data will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, November 8-12, 2022.

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NOUS-PEV is a personalized cancer immunotherapy being evaluated in a multicenter Phase 1b open-label, dose confirmation and cohort expansion study (NCT04990479). NOUS-PEV is individually designed and manufactured to contain patient-specific neoantigens identified and selected from a patient’s own tumor biopsy. The Phase 1b trial is assessing the safety, feasibility and preliminary efficacy as per RECIST 1.1 criteria in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab in patients with either locally advanced 1L melanoma or 1L non-small cell lung cancer (NSCLC) expressing more than 50% PD-L1.

The key findings to be presented at SITC (Free SITC Whitepaper) are as follows:

Manufacturing Feasibility: >90% of vaccines successfully manufactured, released and delivered to patients on time
Safety: Well tolerated with a favorable safety profile
Immunogenicity: Potent neoantigen specific immune responses were detected in all evaluable subjects with clinical responses
Biomarkers/Immune correlates of clinical efficacy: Deepening of clinical responses coincided with the increase of NOUS-PEV-induced T cells in blood; Increased T cell infiltration in the tumors; NOUS-PEV-induced neoantigen specific T cells identified in tumor biopsies in subjects with clinical responses.
Clinical Efficacy: Clinical responses correlated with biomarker analyses/predictions
Dr Oliver Bechter, MD, Principal Investigator (PI) of the trial and Professor in the Department of General Medical Oncology at the Leuven Cancer Institute (Belgium), said "I am very excited to see this initial data from patients who have received NOUS-PEV. The data demonstrated NOUS-PEV to be well tolerated and to have a good safety profile, comparable to pembrolizumab monotherapy. Nouscom has already demonstrated that its platform promotes the expansion and diversification of neoantigen-specific memory CD8+ T cells that enhance anti-tumor immunity, and the early translational data from the first three melanoma patients receiving NOUS-PEV further supports this. The higher number of relevant neoantigens that can be delivered via this platform compared to other approaches will increase the likelihood of eliciting a response. This can be crucial for patients who do not respond to anti-PD1 therapy. I look forward to seeing further data to build on this immune mechanism of action with potential to provide new effective treatment options for cancer patients."

Dr Sven Gogov, MD, Chief Medical Officer of Nouscom, added: "We are delighted with the initial data from this Phase 1b trial evaluating NOUS-PEV in solid tumors. We have developed a robust and efficient nine-week needle-to-needle GMP manufacturing process that can be scaled up as we progress in clinical development. These data further validate our proprietary platform and mechanism of action in the clinic, demonstrating that viral vector encoding cancer neoantigens drive potent and quality immune responses in metastatic cancer patients, which correlate with significant clinical responses. We look forward to presenting further data during 2023."

Poster Presentation Details:

Title: NOUS-PEV, a Novel Personalized Viral-based Prime/Boost Cancer Immunotherapy Targeting Patient-Specific Neoantigens: Interim Results from the First Subjects in the Phase 1b Study (#706)
Date: 11th November 2022
Time: 11:40-13:10 and 19:30-21:00 EST
Location: Hall C
Presenter: Dr Oliver Bechter, MD, Principal Investigator (PI) of the trial and Professor in the Department of General Medical Oncology at the Leuven Cancer Institute (Belgium)
The abstracts will be publicly available at 8am EST on 7th November 2022, and available in the Journal for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (JITC) supplement.

About NOUS-PEV

NOUS-PEV is a personalized cancer immunotherapy designed for each patient based on selection and prioritization of mutations unique to that patient’s tumor. The strategy is based on Nouscom’s heterologous prime boost platform clinically validated by its lead off-the-shelf clinical development program NOUS-209. The platform is composed of a proprietary non-human adenoviral vector (GAd) and Modified Vaccinia Ankara viral vector (MVA). Each of the two viral vectors have the capacity to encode up to 60 personalized neoantigens selected and prioritized using the VENUS (Vaccine-Encoded Neontigens Unrestricted Selection) 1 proprietary algorithm.

NOUS-PEV is being evaluated in a Phase 1b clinical trial in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab in patients with either locally advanced 1L melanoma or 1L non-small cell lung cancer (NSCLC) expressing more than 50% PD-L1. The trial (NCT04990479) commenced in 2021 and is currently enrolling patients across multiple clinical sites in Europe.

1. Leoni et al. VENUS, a Novel Selection Approach to Improve the Accuracy of Neoantigens’ Prediction. Vaccines 9, 2021

On November 7, 2022 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported the presentation of two preclinical data abstracts focused on its natural killer cell pipeline and proprietary manufacturing technology at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37TH Annual Meeting and Pre-Conference Programs (Press release, Nkarta, NOV 7, 2022, View Source [SID1234623263]).

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"Our presentations at this year’s SITC (Free SITC Whitepaper) meeting illustrate the inherent power and potential of donor-derived NK cells," said James Trager, PhD, Chief Scientific Officer of Nkarta. "Nkarta’s research team has shown that our manufacturing platform technology can expand NK cells by well over a billion-fold, while maintaining their integrity and potency. These findings could prospectively allow us to derive our CAR NK products from a very limited set of stringently selected donors. In a second study, the team has also further built on the considerable potency of our CD19-directed CAR NK candidate, NKX019."

SITC 2022 abstracts will be available on the SITC (Free SITC Whitepaper) website, View Source

Nkarta’s posters will be available for download at View Source after 9:00 a.m. ET on November 10, 2022.

Title: Large-scale expansion and engineering of human NK cells sourced from peripheral blood versus umbilical cord blood
Abstract Number: 381
Poster Presentation Date and Time: November 10, 2022, 9:00 a.m. – 9:00 p.m. ET
This study illustrates a remarkable >250-billion fold expansion of NK cells derived from peripheral blood using Nkarta’s proprietary NKSTIM cell line. NK cells maintained their potency, and showed no signs of chromosomal aberrations over an extended period of expansion. Both the expansion capacity and potency of NK cells derived from adult donors compared favorably to those from cord blood. Phenotypic analysis of expanded cells demonstrated the selective expansion or differentiation of in vivo educated NK cells. These cells could be identified and isolated from pre-expansion NK cells, and demonstrated superior expansion and native activity. These findings point the way toward selection of donors or of a specific cell population with optimal potential for expansion and potency based on straightforward phenotypic profiling.

Title: NKX019, an Off-the-Shelf CD19 CAR-NK Cell, mediates improved anti-tumor activity and persistence in combination with CD20-directed therapeutic mAbs
Abstract Number: 902
Poster Presentation Date and Time: November 11, 2022, 9:00 a.m. – 8:30 p.m. ET
In this preclinical study, the CD19-directed CAR NK, NKX019, was combined with the widely used anti-CD20 monoclonal antibodies (mAb) rituximab or obinutuzumab. These antibodies mediate both direct cell killing of CD20+ B cell malignancies, and can also mediate the antibody-dependent cellular cytotoxicity (ADCC) activity of NK cells through their interaction with CD16. Both the CAR NK cells and the monoclonal antibodies showed high potency against cell lines and primary malignant cells. When NKX019 was used with either mAb, their combined potency was greater than that of the individual agents alone. The potency of these combinations could be attributed in part to NKX019 ADCC activity, as demonstrated using an ADCC-deficient variant of rituximab and by increased degranulation of NKX019 in the presence of obinutuzumab. Results of this study point to a potential to combine these agents clinically to improve product potency and tumor targeting.