Author: Park, Hyo-Jin ; Lee, Do-Geon ; Kim, Eun-Young ; Oh, Seung-Hwan ; Park, Se-Pill ; Pyeon, Da-Bin ; Kim, So-Hee ; Yoon, Jae-Wook ; Lee, Seung-Eun ; Park, Chan-Oh

Summary:

Our previous studies have already revealed that β-cryptoxanthin (BCX), hesperetin (HES), and icariin (ICA) antioxidants are effective for in vitro maturation (IVM) of porcine oocytes. In this study, we investigated which of BCX, HES, or ICA was more effective for IVM of porcine oocytes. The antioxidant properties were assessed with aged porcine oocytes and embryos by comparing 2,2-diphenyl-1-(2,4,6-trinitrophenyl)hydrazyl (DPPH), reducing power, and H2O2 scavenging activity assays. The chemical assay results demonstrated that BCX had a greater DPPH scavenging activity and reducing power than HES and ICA, compared with controls. However, the H2O2 scavenging activity of the antioxidants was similar when tested at the optimal concentrations of 1 μM BCX (BCX-1), 100 μM HES (HES-100), and 5 μM ICA (ICA-5). The biological assay results showed that BCX-1 treatment was more effective in inducing a significant reduction in reactive oxygen species (ROS), improving glutathione levels, and increasing the expression of antioxidant genes. In addition, BCX-1 inhibited apoptosis by increasing the expression of anti-apoptotic genes and decreasing pro-apoptotic genes in porcine parthenogenetic blastocysts. BCX-1 also significantly increased the blastocyst formation rate compared with the ageing control group, HES-100 and ICA-5. This study demonstrates that damage from ROS produced during oocyte ageing can be prevented by supplementing antioxidants into the IVM medium, and BCX may be a potential candidate to improve assisted reproductive technologies.

12 Jun 2020·Journal of biomaterials science. Polymer editionQ3 · ENGINEERING & TECHNOLOGY

A microfluidic system based on the monoclonal antibody BCMab1 specifically captures circulating tumor cells from bladder cancer patients

Q3 · ENGINEERING & TECHNOLOGY

Article

Author: Men, Tongyi ; Wang, Yunchao ; Liu, Qing ; Liang, Ye ; Wang, Jianning ; Niu, Haitao

Circulating bladder tumor cells provide significant information for cancer diagnosis, tumor staging and personalized cancer therapy. Previous studies have reported various methods for capturing circulating tumor cells; however, capturing circulating tumor cells remain a challenge. Here, we present a microfluidic chip with high specificity and capture yields that we refer to as a bladder cancer diagnosis chip. We show that this chip can be used to effectively capture circulating bladder cancer cells based on antibody-BCMab1, a monoclonal antibody that binds to aberrantly glycosylated integrin a3b1. This capture platform is composed of a polydimethylsiloxane (PDMS) chip, whose microchannels are functionalized with biotinylated BCMab1. To change the direction of flow to increase cell-substrate contact, we also introduced a herringbone or chevron channel pattern into the chip. Using this system, we were able to capture bladder cancer cells with high specificity. The capture rates of the bladder cancer diagnosis chip were evaluated at different flow rates and cell concentrations. We found that 90% of the cancer cells were successfully captured at flow rates of 10 μL/min and at various cell concentrations. This highly specific microfluidic chip is a novel tool for bladder cancer diagnosis and offers an opportunity for personalized treatment.

11 Jul 2017·Oncotarget

BCMab1-Ra, a novel immunotoxin that BCMab1 antibody coupled to Ricin A chain, can eliminate bladder tumor

Article

Author: Yan, Ruping ; Chen, Haige ; Li, Chong ; Wang, Jiansong ; Wang, Haifeng ; Zhang, Ruiyun ; Yang, Zhao

Bladder cancer is one of the most common malignancies. However, there is no ideal therapy to cure bladder cancer so far, especially invasive carcinoma. Here, we developed a new antibody-based drug BCMab1-Ra, which was generated by conjugation of BCMab1 (a new monoclonal antibody that specifically recognized the aberrantly glycosylated Integrin a3b1 in bladder cancer) with the ricin A chain (Ra). A patient with multiple bladder cancer received intravescical administration of BCMab1-Ra treatment as a volunteer. After 30 weeks of treatment, no tumor was observed by cystoscope examination. We did not observe any local or systemic side effects. Human anti-mouse antibody (HAMA) was not detectable in the circulation. Results follow-up showed no tumor had been found in every half year review in 3 years.

News (Medical) associated with BCMab-1

14 Aug 2023

·www.prnewswire.com

Oncolytics Biotech® Reports Second Quarter 2023 Financial Results and Operational Highlights

Phase 2 data from randomized BRACELET-1 trial in HR+/HER2- metastatic breast cancer showed a near tripling of confirmed ORR, >50% improvement in PFS, and 71% reduction in risk of disease progression Pelareorep selected for inclusion in the Precision PromiseSM phase 3 platform trial in pancreatic cancer, designed to accelerate registration path and reduce by ~50% phase 3 costs compared to traditional trial $24.4 million in cash, cash equivalents and marketable securities as of June 30, 2023 provides projected runway into H2 2024 Strengthened financial position with a successful US$15 million public offering on August 8, 2023 Management hosting conference call and webcast today at 8:30 a.m. ET SAN DIEGO and CALGARY, AB, Aug. 14, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced recent operational highlights and financial results for the second quarter ended June 30, 2023. All dollar amounts are expressed in Canadian currency unless otherwise noted. "Our core programs in pancreatic and breast cancer are both progressing rapidly towards registrational studies on the back of the impressive clinical data showing the potential of pelareorep as a backbone immunotherapy," said Dr. Matt Coffey, President and Chief Executive Officer. "Data reported at the American Society of Clinical Oncology (ASCO) Annual Meeting from our BRACELET-1 randomized phase 2 trial demonstrated robust improvements in objective response rate (ORR) and progression-free survival (PFS) with a hazard ratio of 0.29 (95% CI: 0.09, 0.98). This has unlocked the potential for including PFS as a dual endpoint in our registrational trial, which could considerably reduce the time to a pivotal readout. At the same time, pelareorep was selected for inclusion in the ongoing Precision Promise pancreatic cancer platform trial. Precision Promise, created by the Pancreatic Cancer Action Network, provides us with the opportunity to reduce the time and costs needed for a potential approval, and we are honored to have been selected for participation in this novel and exclusive trial." Second Quarter and Subsequent Highlights Breast Cancer Program BRACELET-1 data demonstrated a >50% improvement in progression-free survival and a nearly three-fold increase in confirmed overall response rate An oral presentation at the ASCO Annual Meeting featured results from a randomized trial of pelareorep in HR+/HER2- metastatic breast cancer. As of a March 3, 2023 cut-off date, BRACELET-1 data in the paclitaxel plus pelareorep cohort showed median PFS of 9.5 months, compared to 6.3 months in the paclitaxel monotherapy cohort. This resulted in a hazard ratio of 0.29 (95% CI: 0.09, 0.98), indicating the pelareorep-paclitaxel combination reduced the risk of disease progression by 71%. Confirmed ORR in these cohorts was 37.5% for paclitaxel plus pelareorep and 13.3% for paclitaxel. Overall survival data continues to mature as several patients are still on study. With these data, the HR+/HER2- metastatic breast cancer program is now phase 3-ready, and, with two randomized phase 2 trials showing meaningful benefits to patients, the focus is now on progressing to a registrational trial evaluating pelareorep-paclitaxel compared to paclitaxel alone. Oncolytics hosted a key opinion leader (KOL) webinar on June 5, 2023 where breast cancer experts and the management team discussed recent data from the BRACELET-1 study. A link to the replay is available by clicking here. Pancreatic Cancer Program Pelareorep selected for inclusion in Precision Promise Pivotal Phase 3 Platform Trial Pelareorep has been selected for inclusion as a new investigational treatment in Precision Promise. Created by the Pancreatic Cancer Action Network (PanCAN), Precision Promise is an innovative adaptive phase 3 clinical trial designed to streamline registration pathways for promising pancreatic cancer therapies. Inclusion is expected to accelerate the registrational pathway and reduce by half the phase 3 costs compared to a traditional trial. The study is designed to evaluate pelareorep in combination with a checkpoint inhibitor and the chemotherapeutic agents gemcitabine and nab-paclitaxel in comparison to gemcitabine and nab-paclitaxel standard of care therapy. This clinical study is expected to support the approval of the pelareorep combination therapy as a treatment for first-line metastatic pancreatic ductal adenocarcinoma. Additional Immunotherapeutic Opportunity Preclinical pelareorep-chimeric antigen receptor (CAR) T cell therapy combination program A poster presentation at ASCO showed preclinical results of pelareorep synergistically enhancing CAR T cell therapy efficacy in murine solid tumor models (link to the poster). The results suggest pelareorep could substantially expand the commercial potential of CAR T cell therapy beyond hematologic malignancies to include solid tumors, which represent the vast majority of cancer cases. Oncolytics is currently advancing preclinical research collaborations evaluating pelareorep-CAR T cell combination therapies. Financial Highlights As of June 30, 2023, the Company reported $24.4 million in cash, cash equivalents, and marketable securities, then successfully closed a US$15 million public offering on August 8, 2023. On a pro forma basis, including the estimated US$13.6 million in net proceeds from the public offering, the Company's cash, cash equivalents and marketable securities would have been approximately $42.7 million. The net loss for the second quarter of 2023 was $7.4 million, compared to a net loss of $5.1 million for the second quarter of 2022. The basic and diluted loss per share was $0.12 in the second quarter of 2023, compared to a basic and diluted loss per share of $0.09 in the second quarter of 2022. Net cash used in operating activities for the six months ended June 30, 2023 was $16.3 million, compared to $13.2 million for the six months ended June 30, 2022. The change reflected higher net operating activities and non-cash working capital changes. General and administrative expenses for the second quarter of 2023 were $3.5 million, compared to $2.8 million for the second quarter of 2022. The increase was primarily due to higher investor relations activities and annual general meeting of shareholders costs. Research and development expenses for the second quarter of 2023 were $3.7 million, compared to $3.2 million for the second quarter of 2022. The increase was primarily due to higher manufacturing expenses associated with an engineering production run along with process and analytical development activities and higher personnel-related expenses. The increase was partly offset by lower BRACELET-1 study costs. Anticipated Milestones and Catalysts Updated GOBLET study data in advanced/metastatic pancreatic ductal adenocarcinoma (PDAC): H2 2023 Update on GOBLET study's metastatic colorectal and anal cancer cohorts: H2 2023 Guidance on both the HR+/HER2- metastatic breast cancer and advanced/metastatic PDAC registration paths: H2 2023 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, August 14, 2023. To access the call, please dial (888) 664-6383 (North America) or (416) 764-8650 (International) and, if needed, provide confirmation number 5411-4798. 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: 114-798#. ONCOLYTICS BIOTECH INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (unaudited) (in thousands of Canadian dollars, except share amounts) ONCOLYTICS BIOTECH INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS (unaudited) (in thousands of Canadian dollars, except share amounts) ONCOLYTICS BIOTECH INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY (unaudited) (in thousands of Canadian dollars) ONCOLYTICS BIOTECH INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) (in thousands of Canadian dollars) About the Pancreatic Cancer Action Network The Pancreatic Cancer Action Network (PanCAN) leads the way in accelerating critical progress for pancreatic cancer patients. PanCAN takes bold action by funding life-saving research, providing personalized patient services and creating a community of supporters and volunteers who will stop at nothing to create a world in which all pancreatic cancer patients will thrive. For 18 years in a row, PanCAN has earned a Four-Star Rating from Charity Navigator – the highest rating an organization can receive. This rating designates PanCAN as an official "Give with Confidence" charity, indicating strong financial health, ongoing accountability and transparency. About Oncolytics Biotech Inc. Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: . This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; our belief that our core programs in pancreatic and breast cancer are both progressing rapidly towards registrational studies; our belief that recent data has unlocked the potential for including PFS as a dual endpoint in our registrational trial, which could considerably reduce the time to a pivotal readout; our plans and expectations regarding the inclusion of pelareorep in the Precision Promise pancreatic cancer platform trial; our anticipated milestones and catalysts; our plans to advance towards a registrational study in metastatic breast cancer and pancreatic cancer; our belief that our combined cash resources provide a runway into H2 2024; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. Logo: SOURCE Oncolytics Biotech® Inc.

Clinical ResultPhase 3ImmunotherapyASCOPhase 2

08 Dec 2022

·www.biospace.com

Oncolytics Biotech's® Chinese Development Partner Adlai Nortye Presents Interim Clinical Data Further Demonstrating the Anti-Cancer Activity of Pelareorep-Paclitaxel Combination Therapy in HR+/HER2- Metastatic Breast Cancer at the SABCS

Thirteen of fourteen (93%) evaluable patients achieved disease control, with twelve (86%) showing tumor shrinkage SAN DIEGO and CALGARY, AB, Dec. 8, 2022 /PRNewswire/ -- Oncolytics Biotech® Inc.'s (NASDAQ: ONCY) (TSX: ONC) Chinese partner Adlai Nortye today announced interim results from a multicenter, single-arm bridging clinical trial to evaluate the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced/metastatic HR+/HER2- breast cancer. The data were featured in a poster presented yesterday at the San Antonio Breast Cancer Symposium (SABCS), which is being held at the Henry B. González Convention Center in San Antonio, Texas through December 10, 2022. Fifteen patients were treated in the trial as of the data cut-off date (September 26, 2022), with fourteen having had at least one post-baseline tumor assessment (i.e., evaluable for efficacy). All patients enrolled into the trial were previously treated with at least one endocrine therapy and no more than one line of chemotherapy for recurrent/metastatic disease. Data and conclusions presented in the poster are summarized below. Disease control, partial response (PR) or stable disease (SD), was achieved in thirteen of fourteen evaluable patients (93%), with twelve (86%) showing tumor shrinkage from baseline. Seven of fourteen evaluable patients achieved a PR (50%). Three of these patients achieved a confirmed PR (20%), while two patients are awaiting potential confirmatory scans. One patient achieving a PR at week 8 has maintained the PR through week 48 and remains on study. Evolving median progression-free survival (PFS) for trial participants as of the data cut-off date was 9.1 months (95% confidence interval: 3.8 - NA). The studied combination has been well tolerated, with no dose-limiting toxicities or serious adverse events (SAEs) reported to date. "These impressive results have us well-positioned to leverage Oncolytics' prior positive data and join pelareorep's global development program," said Lars Birgerson, M.D., Ph.D., Adlai Nortye President and Chief Medical Officer. "With no SAEs reported, the data suggests the favorable safety and potent anti-cancer activity displayed by the studied combination in North American HR+/HER2- breast cancer patients extends to the Chinese population. There are also promising signs of pelareorep-paclitaxel combination therapy driving durable clinical benefit, with one patient notably still on study for nearly a year while maintaining a PR. We look forward to further characterizing the efficacy and durability of the studied combination as data from the trial mature and to continuing our collaboration with Oncolytics." Data from the bridging trial are expected to accelerate Adlai Nortye's development of pelareorep in China by allowing future regulatory submissions to include data from Oncolytics' North American metastatic breast cancer trials, IND-213 and BRACELET-1. IND-213 is a previously completed randomized phase 2 trial that showed a statistically significant near doubling of median overall survival when HR+/HER2- metastatic breast cancer patients were treated with paclitaxel plus pelareorep vs. paclitaxel alone. BRACELET-1 is an ongoing randomized phase 2 trial in HR+/HER2- metastatic breast cancer patients with cohorts evaluating: (1) paclitaxel monotherapy; (2) paclitaxel plus pelareorep; and (3) paclitaxel plus pelareorep in combination with the anti-PD-L1 inhibitor avelumab. Oncolytics expects to report overall response rate, PFS, and evolving overall survival data from BRACELET-1 at a major medical meeting in the first half of 2023. Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc., commented, "BRACELET-1's upcoming readout represents a crucial catalyst for Oncolytics, as data from the trial are expected to pave the way for pelareorep's advancement to a registrational breast cancer study. We believe Adlai Nortye's latest data significantly de-risk this upcoming readout as they validate IND-213's positive results by confirming the ability of pelareorep plus paclitaxel to drive durable clinical responses in HR+/HER2- breast cancer patients. I'd like to thank Adlai Nortye for the productive partnership that led to these results, providing us with added enthusiasm for the outlook of our breast cancer program." A copy of the SABCS poster (P3-07-04), entitled, A Multicenter, Single-Arm, Open-Label Phase I Study of AN1004 (Pelareorep) Oncolytic Virus Plus Paclitaxel in Chinese Patients with Hormone Receptor-Positive and HER2-Negative Advanced/Metastatic Breast Cancer (REO 026-1), will be available on the Posters & Publications page of Oncolytics' website (LINK) following the conclusion of the symposium. About Adlai Nortye Adlai Nortye is a clinical-stage biopharmaceutical company focused on the development of innovative cancer therapies, with its R&D centers in both China and the U.S. With a strategic emphasis on oncology, the Company has built a global pipeline through collaborations and internal discovery with seven drug candidates in development, including (i) Buparlisib (AN2025), which was in a global Phase III clinical trial in combination with paclitaxel for the treatment of patients with recurrent or metastatic HNSCC after anti-PD-1/PD-L1 treatment; (ii) Palupiprant (AN0025), an oral EP4 antagonist which is undergoing Phase Ib trial in combination with Keytruda® in patients with multiple solid tumors; and (iii) AN4005, an oral small molecule PD-L1 inhibitor which was currently in Phase Ia trial. Adlai Nortye is also conducting a Phase I clinical trial in collaboration with Roche to evaluate the triple combination of AN2025, AN0025 and atezolizumab (a PD-L1 inhibitor) for a variety of PIK3CA mutant solid tumors in the U.S. In addition, Adlai Nortye owns the exclusive rights to Pelareorep (AN1004) in greater China, Singapore, and South Korea, and is conducting a bridging trial in China to assess the safety and tolerability of AN1004 in combination with paclitaxel for the Chinese patient population with metastatic HR+/HER2- breast cancer. Adlai Nortye has assembled an experienced management team, built its proprietary immuno-oncology platforms and partnered with multiple top pharmaceutical companies to promote innovation. Adlai Nortye is committed to becoming an innovative biopharmaceutical company with global vision and strives to benefit patients worldwide. The mission of the Company is to transform deadly cancer into a chronic and eventually a curable disease. For more information, please visit: . About Oncolytics Biotech Inc. Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards registration studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: . This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding the timing and anticipated content of upcoming poster presentations involving pelareorep; Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our expectation that data from the Adlai Nortye bridging trial will accelerate Adlai Nortye's development of pelareorep in China; our expectation that data from the Adlai Nortye bridging trial will pave the way for pelareorep's advancement to a registrational breast cancer study; our plans for clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid hematological malignancies; our plans to advance towards a registration study in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. View original content: SOURCE Oncolytics Biotech® Inc. Company Codes: NASDAQ-NMS:ONCY, Toronto:ONC

Clinical ResultPhase 2Phase 1ImmunotherapyPhase 3

07 Nov 2022

·www.biospace.com

A2 Bio Identifying Solid Tumor Patients for Possible Inclusion in Phase 1 Studies Targeting CEA and Mesothelin Expected to Begin in 2023: Update at SITC 2022

Pre-screening study BASECAMP-1, is actively enrolling patients whose tumors have permanently lost HLA-A*02 AGOURA HILLS, Calif.--(BUSINESS WIRE)-- A2 Biotherapeutics , Inc., “A2 Bio”, is a biotechnology company focused on the development of first-in-class T cell therapeutics to tackle the fundamental challenge in solid tumor treatment—the ability of cancer medicines to selectively kill tumor cells while protecting normal cells. A2 Bio today announced four poster presentations showcasing: (1) BASECAMP-1, a master pre-screening trial to identify patients whose tumors have permanently lost HLA-A*02 (NCT04981119); (2) use of the Tempus xT Next Generation Sequencing (NGS) diagnostic to identify such patients; (3) data for A2 Bio’s lead program, A2B530, targeting CEA Cell Adhesion Molecule 5 (CEA); and (4) data for A2 Bio’s second program, A2B694, targeting mesothelin (MSLN). A2 Bio’s logic‑gated cell therapy utilizes dual receptors (an activator and blocker) and has demonstrated in vitro and in vivo the ability to kill tumor cells via the activator while protecting healthy cells via the blocker. Patients who may benefit from this therapy can be identified by using the Tempus diagnostic to pre-screen patients whose tumors have lost HLA-A*02. Once patients are identified, their T cells may be banked early in their disease course for potential utilization in a Phase 1 study in the event of relapse. “The unmet medical need in lung, colorectal and particularly pancreatic cancer remains extremely high. BASECAMP-1 is a non-interventional pre-screening trial that identifies eligible patients and banks their T cells. If the patients have the misfortune to relapse or progress, A2 Bio will have their cells ready to be manufactured and dosed in our upcoming Phase 1 studies targeting CEA and MSLN,” said William Go, MD, PhD, Chief Medical Officer of A2 Bio. Diane Simeone, MD, Director of the Pancreatic Cancer Center, Perlmutter Professor of Surgery at NYU and Principal Investigator on the study, stated, “BASECAMP-1 is an exciting trial that identifies patients with limited treatment options for a new and unique logic-gated CAR-T immunotherapy approach. We are thrilled to enroll patients at BASECAMP-1 and get them prepped for potential inclusion in Phase 1 studies in 2023.” The four poster presentations will be given on November 10, 2022 at the Society for Immunotherapy of Cancer's (SITC) 37th Annual Meeting in Boston, MA. Details of the posters being presented on November 10, 2022 from 9am-9pm EST at the Poster Hall: Title: BASECAMP-1: Leveraging HLA loss of heterozygosity in solid tumors by NGS to identify patients with relapsed solid tumors for future CEA and MSLN logic-gated Tmod CAR T-cell therapy Poster Number: 639 Presenter: Diane Simeone, MD, Director of the Pancreatic Cancer Center, Perlmutter Professor of Surgery at NYU and Chair of the Pancreatic Cancer Action Network’s (PanCAN) National Scientific and Medical Advisory Board Title: An NGS assay to identify HLA loss of heterozygosity for future CEA and MSLN logic-gated CAR-T solid tumor protocols designed for reduced on-target, off-tumor toxicity Poster Number: 77 Presenter: Scott Kopetz, MD, PhD – Deputy Chair and Professor, Department of Gastrointestinal Medical Oncology, MD Anderson Cancer Center Title: A2B530, an autologous CEA-directed Tmod T-cell therapy with an inhibitory receptor gated by HLA-A*02 to target colorectal, pancreatic, and lung cancer Poster Number: 229 Presenter: J. Randolph Hecht, MD, Carol and Saul Rosenzweig Chair for Cancer Therapies Development, the Director of the UCLA Gastrointestinal Oncology Program and Professor of Clinical Medicine in the David Geffen School of Medicine at UCLA Title: A2B694, an autologous logic-gated cell therapy targeting mesothelin Poster Number: 263 Presenter: Julian Molina, MD, PhD – Professor of Oncology and Consultant, Division of Medical Oncology at Mayo Clinic, Rochester ePosters will be released for viewing on November 10 at 7:00 am ET and can be viewed from the A2 Bio website ( ) About A2 Biotherapeutics A2 Biotherapeutics has invented the Tmod™ cell therapy platform to tackle the fundamental challenge in solid tumor treatment—the ability of cancer medicines to distinguish between tumor and normal cells. The Tmod™ mechanism utilizes two receptors to exploit common, specific gene losses in tumors that distinguish tumor from normal cells. A2 is positioned to deliver a broad pipeline of both autologous and allogeneic cell products, with in-house cGMP manufacturing, a leadership team with 90+ years combined experience in biotech and cell therapy, and a world-class scientific advisory board. A2 is backed by investors that include The Column Group, Vida Ventures, Samsara BioCapital, Nextech Invest, Casdin Capital, Euclidean Capital, UC Investments (Office of the Chief Investment Officer of the Regents), Hartford HealthCare Endowment, StepStone Group, Schroders, Section 32 and Merck. For more information, please visit and linkedin.com/a2-biotherapeutics.

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