On November 3, 2023 Oncolytics Biotech, a clinical-stage immunotherapeutics company focused on oncology, reported recent operational highlights and financial results for the third quarter ended September 30, 2023 (Press release, Oncolytics Biotech, NOV 3, 2023, View Source [SID1234639000]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

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"We continue to build our case for pelareorep to be an important immunotherapy in multiple large and in-need cancer indications," said Dr. Matt Coffey, President and Chief Executive Officer. "The ESMO (Free ESMO Whitepaper) presentations show the first batch of survival data from first-line metastatic pancreatic cancer patients exceeds the historical averages recorded in control trials, aligning with the positive response data we first reported at SITC (Free SITC Whitepaper) last year. They also reveal that pelareorep can generate an immune response in heavily pre-treated metastatic colorectal cancer patients. I’m pleased to note that GOBLET has now reported consecutive indications where pelareorep-based therapy has met the success criteria for efficacy, validating our decision to explore pelareorep in gastrointestinal indications in combination with the checkpoint inhibitor atezolizumab. The compelling GOBLET results were instrumental in obtaining a US$5 million grant from PanCAN to explore pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with and without atezolizumab in pancreatic cancer patients."

Dr. Coffey continued, "Having already observed efficacy signals in pancreatic cancer from the combination of pelareorep and atezolizumab plus the standard of care regimen gemcitabine and nab-paclitaxel, we believe that with encouraging efficacy signals from a pelareorep and mFOLFIRINOX combination, we have the potential to become the go-to treatment option for a substantial number of pancreatic cancer patients."

Third Quarter and Subsequent Highlights

Pancreatic Cancer Program

Updated data reported at ESMO (Free ESMO Whitepaper) shows robust survival and translational data

A poster with data from the pancreatic cancer cohort of the Phase 1/2 GOBLET study was presented at the European Society for Medical Oncology (EMSO) Congress 2023 (link to the PR, link to the poster). This study cohort was designed to evaluate pelareorep in combination with atezolizumab and the chemotherapeutic agents gemcitabine and nab-paclitaxel in patients with advanced or metastatic pancreatic cancer. The efficacy results presented exceeded those from earlier studies, including a 62% objective response rate, a median progression-free survival of 7.2 months, an interim median overall survival of 10.6 months, and a 46% interim 12-month survival rate. These data also demonstrated the ability of pelareorep-based combination therapy to induce the expansion of both pre-existing and new T-cell clones from the tumor. This combination therapy has already been selected for inclusion in the Precision PromiseSM Pivotal Phase 3 Platform Trial (link to the PR).

Pancreatic Cancer Action Network (PanCAN) award and grant

Oncolytics was awarded the Therapeutic Accelerator Award, which includes a US$5 million grant from PanCAN, to initiate a Phase 1/2 randomized clinical trial of pelareorep combined with modified FOLFIRINOX, with or without the checkpoint inhibitor atezolizumab (link to the PR). We anticipate that the combination therapy that performs best will be further evaluated in a licensure-enabling study, such as the Precision PromiseSM Pivotal Phase 3 Platform Trial. The combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab has already been selected for inclusion in Precision Promise, with the trial expected to open in the first half of 2024.

Colorectal Cancer Data

ESMO presentation shows the third-line colorectal cancer cohort met its success criteria for efficacy

A poster presentation at ESMO (Free ESMO Whitepaper) announced interim results from the third-line metastatic colorectal cancer cohort of the Phase 1/2 GOBLET study (link to the PR, link to the poster). In a patient population that failed two prior lines of treatment, six of 15 patients recorded stable disease as their best response, and four had stable disease at week 16 or later, thereby meeting the prespecified success criteria for stage 1 of the study. The disease control rate was 40%, the median progression-free survival was 2.8 months, the median overall survival was 8.0 months, and the 12-month survival rate was 33%.

Breast Cancer Program

AWARE-1 abstract data reported at SITC (Free SITC Whitepaper) reinforces pelareorep’s ability to remodel the tumor microenvironment, poster to be available later today

Additional data from the AWARE-1 breast cancer study was reported in an abstract at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting. AWARE-1 evaluated early-stage breast cancer patients in two cohorts who received pelareorep and letrozole with and without atezolizumab. The study met its primary endpoint of CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes), with the arm that included atezolizumab showing enhanced outcomes. Further analysis of the tumor microenvironment of patient tissue samples was performed using imaging mass cytometry (IMC). The data show increased PD-L1 positive cells and an increase in cytotoxic T cells, amongst other benefits, which make the tumor microenvironment more amenable to treatment. The SITC (Free SITC Whitepaper) poster embargo lifts at 9 a.m. Pacific Time today, November 3, 2023, and the poster will be available on the Oncolytics website shortly after that.

Financial Highlights

As of September 30, 2023, the Company reported $40.0 million in cash and cash equivalents, with a projected cash runway for at least 12 months.
Net cash used in operating activities for the nine months ended September 30, 2023 was $22.3 million, compared to $17.4 million for the nine months ended September 30, 2022. The change reflected higher net operating activities.
General and administrative expenses for the third quarter of 2023 were $5.2 million, compared to $2.4 million for the third quarter of 2022. The increase was primarily due to higher investor relations activities and the portion of the public offering transaction costs allocated to general and administrative expenses.
Research and development expenses for the third quarter of 2023 were $5.8 million, compared to $3.7 million for the third quarter of 2022. The increase was primarily due to higher manufacturing expenses as we completed a scaled-up engineering production run and the associated batch testing. The increase was partly offset by lower clinical trial expenses related to clinical and safety data management.
The net loss for the third quarter of 2023 was $9.9 million, compared to a net loss of $4.4 million for the third quarter of 2022. The basic and diluted loss per share was $0.14 in the third quarter of 2023, compared to a basic and diluted loss per share of $0.08 in the third quarter of 2022.
Anticipated Milestones and Catalysts

Interim data from the GOBLET study’s anal cancer cohort: Q4 2023
Initiation of the Precision PromiseSM Pivotal Phase 3 Platform Trial in first-line metastatic pancreatic ductal adenocarcinoma (PDAC) patients: H1 2024
Initiation of the PanCAN supported Phase 1/2 combination study of pelareorep and modified FOLFIRINOX in newly diagnosed metastatic PDAC patients: H1 2024
BRACELET-1 Phase 2 metastatic breast cancer study overall survival data
Webcast and Conference Call

Management will host a conference call for analysts and investors at 8:30 a.m. ET today, November 3, 2023. To access the call, please dial (888) 664-6383 (North America) or (416) 764-8650 (International) and, if needed, provide Conference ID: 6026-0546. To join the conference call without operator assistance, please click here. 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: 260-546#.

On November 3, 2023 Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, reported new preclinical data on its drug-Fc conjugate (DFC) candidate, CBO421, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 38th Annual Meeting (Press release, Cidara Therapeutics, NOV 3, 2023, View Source [SID1234638369]). The conference is taking place November 1-5, 2023, both virtually and in-person in San Diego, CA.

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"We look forward to sharing data that demonstrate the potential for CBO421 to potently inhibit tumor growth as both a monotherapy and in combination with PD-1 therapies," said Jeffrey Stein, Ph.D. president and chief executive officer of Cidara. "CD73 plays a significant role in contributing to immune evasion in solid tumors. CBO421, our CD73-targeting DFC, combines the strengths of small molecule inhibitors and monoclonal antibodies against CD73 and demonstrates the potential for best-in-class activity to fully exploit the CD73 target to inhibit immune evasion by cancer cells in-vivo. Based on these data, we’re excited to advance this candidate into clinical trials for the treatment of solid tumors."

Presentation details are summarized below:

Title: Discovery of CBO421, a first-in-class drug Fc-conjugate (DFC), targeting CD73 in cancer
Presenter: Simon Döhrmann, Ph.D., Cidara Therapeutics
Session Location: Ground Level Exhibit Halls A and B1
Date and Time: Friday, November 3, 2023, 12:00-1:30 PDT

On November 3, 2023 Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, reported new preclinical data on its drug-Fc conjugate (DFC) candidate, CBO421, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 38th Annual Meeting (Press release, Cidara Therapeutics, NOV 3, 2023, View Source [SID1234637014]). The conference is taking place November 1-5, 2023, both virtually and in-person in San Diego, CA.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We look forward to sharing data that demonstrate the potential for CBO421 to potently inhibit tumor growth as both a monotherapy and in combination with PD-1 therapies," said Jeffrey Stein, Ph.D. president and chief executive officer of Cidara. "CD73 plays a significant role in contributing to immune evasion in solid tumors. CBO421, our CD73-targeting DFC, combines the strengths of small molecule inhibitors and monoclonal antibodies against CD73 and demonstrates the potential for best-in-class activity to fully exploit the CD73 target to inhibit immune evasion by cancer cells in-vivo. Based on these data, we’re excited to advance this candidate into clinical trials for the treatment of solid tumors."

Presentation details are summarized below:

Title: Discovery of CBO421, a first-in-class drug Fc-conjugate (DFC), targeting CD73 in cancer
Presenter: Simon Döhrmann, Ph.D., Cidara Therapeutics
Session Location: Ground Level Exhibit Halls A and B1
Date and Time: Friday, November 3, 2023, 12:00-1:30 PDT

On November 6, 2023 Orano Med, a pioneer in targeted alpha therapy, and 48Hour Discovery, a novel peptide discovery platform company, reported their strategic collaboration to advance cancer treatment through radioligand discovery and development (Press release, 48Hour Discovery, NOV 3, 2023, View Source;utm_medium=rss&utm_campaign=orano-med-and-48hour-discovery-to-develop-innovative-peptide-receptor-radionuclide-therapy-for-targeted-cancer-treatment [SID1234637006]). This partnership aims to harness the potent properties of lead-212 (212Pb), a rare alpha-emitting radioisotope, in conjunction with 48Hour Discovery’s innovative peptide discovery technology and expertise.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Orano Med is advancing precision medicine in oncology by capitalizing on the unique properties of lead-212 and its proprietary platform to develop new radioligand therapies. Their commitment to innovation and therapeutic excellence aligns with 48Hour Discovery’s dedication to redefining drug discovery through novel peptides.

The core of the collaboration is the development of a novel peptide receptor radionuclide therapy (PRRT) capable of selectively targeting cancer cells with unparalleled precision. Lead-212, renowned for its potent alpha-emitting properties, holds the potential to deliver therapeutic payloads directly to cancer cells, minimizing collateral damage to healthy tissues. The expertise of Orano Med in harnessing the therapeutic potential of 212Pb, combined with 48Hour Discovery’s cutting-edge peptide design platform, is driving the development of novel cancer treatment modalities.

48Hour Discovery’s innovative platform has garnered significant attention for its transformative approach to peptide-based drug discovery. Their methodology, encompassing state-of-the-art phage display libraries, high-throughput screening, and chemical modifications, has enabled the identification of peptides with enhanced affinity, specificity, and therapeutic potential. The partnership with Orano Med opens doors to leverage this expertise in crafting peptides that will deliver highly cytotoxic 212Pb on cancer cells with unparalleled effectiveness.

"Uniting Orano Med’s expertise in targeted alpha therapy with 48Hour Discovery’s innovative approach to drug discovery creates a powerful synergy," says Julien Dodet, CEO at Orano Med. "We are excited about the potential to reshape the landscape of cancer therapy and deliver transformative treatments to patients."

Rick Finnegan, CEO of 48Hour Discovery, shares, "Our collaboration with Orano Med represents a testament to the value of cross-disciplinary partnerships. Together, we embark on a journey that can redefine the paradigms of cancer treatment, offering new hope to patients worldwide."

On November 3, 2023 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of oncolytic immunotherapies, reported updated interim results from ARTACUS, a Phase 1/2 clinical trial evaluating RP1 monotherapy for the treatment of skin cancers in patients who have had solid organ or hematopoietic cell transplants (Press release, Replimune, NOV 3, 2023, View Source [SID1234636972]). The data were presented today by Dr. Michael R. Midgen of the University of Texas MD Anderson Cancer Center during an oral session (Abstract #777) at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in San Diego.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Treatment with RP1 monotherapy led to an overall response rate (ORR) of 34.8 percent (8 of 23 evaluable patients, including 5 complete responses and 3 partial responses). Of the 23 evaluable patients, 20 had cutaneous squamous cell carcinoma (CSCC) and 3 had merkel cell carcinoma (MCC) with responses observed in 6 CSCC patients and 2 patients with MCC. One patient treated for CSCC also had a complete response of a new primary basal cell carcinoma which appeared post baseline that was treated with RP1. Most responses were ongoing as of the data cutoff date of September 18, 2023. There was no evidence of allograft rejection including of hepatic and lung allografts. RP1 monotherapy was well tolerated, and the safety profile was similar to the profile in non-immunocompromised patients with advanced skin cancers. The slides are available on the Replimune website under presentations.

"These data demonstrating an overall response rate of nearly 35 percent with good durability of benefit to date show that RP1 monotherapy has clinically meaningful anti-tumor activity in a difficult to treat patient population receiving chronic immunosuppressive treatment and where systemic immunotherapy may not be a viable option," said Robert Coffin, President and Chief Research and Development Officer of Replimune. "Patients receiving organ transplants are highly susceptible to skin cancer at a rate which is far higher than in the general population. Based on the data to date, we believe that RP1 monotherapy may potentially provide a safe and effective option for patients that currently have a limited number of treatments available."

About ARTACUS
ARTACUS is a multicenter, open-label, two-part Phase 1b/2 study evaluating RP1 as monotherapy for the treatment of locally advanced or metastatic cutaneous malignancies in patients who underwent a kidney, liver, heart, lung, or other solid organ transplant, or hematopoietic cell transplantation, who are on chronic immunosuppressive treatment, in whom systemic immunotherapy is typically contra-indicated. Researchers will assess the safety of RP1 and also evaluate its ability to shrink tumors.

About RP1
RP1 is Replimune’s lead product candidate and is based on a proprietary new strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response.