On March 4, 2021 Eucure Biopharma, as a biopharmaceutical company dedicated to the development of tumor and immune antibody drugs with independent intellectual property rights, reported encouraging anti-tumor activity as demonstrated in the dose escalation phase of the Phase I clinical study of CTLA-4 antibody (YH001) in combination with Junshi Biosciences’ anti-PD-1 monoclonal antibody Toripalimab Injection (Brand Name: TuoYi ) in Australia (Press release, Eucure, MAR 4, 2021, View Source [SID1234577206]).

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A 64-year-old male subject with gastroesophageal junction tumor with liver/lung metastases, Subject Number 10104, who progressed after prior third-line chemotherapy, was enrolled in the 0.3 mg/kg dose group of YH001 in this study on September 17, 2020.

The subject received one-cycle (21 days/cycle) YH001 monotherapy, followed by combination therapy with Toripalimab 240 mg. As of March 1, 2021, the subject had received 7 cycles (21 weeks) of study drug. The first imaging assessment at Week 8 post-treatment indicated stable disease (SD), with a 12.7% reduction from baseline in the total diameter of all target lesions. The second imaging assessment at Week 15 post-treatment indicated a partial response (PR), with a 60.9% reduction from baseline in the total diameter of all target lesions. During the study, no dose-limiting toxicity (DLT) events were observed, study drug-related adverse events were only Grade 1 fatigue, and no Grade 2 or above adverse events occurred. The clinical study YH001002 is intended to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of CTLA-4 (YH001) in combination with toripalimab in patients with solid tumors.

YH001, a monoclonal antibody targeting CTLA-4, can enhance the removal of regulatory T cells (Treg cells) in the tumor microenvironment by improving the immune response against tumor cells in order to treat multiple tumors. Enhancing patients’ immune responses to tumors by blocking inhibitory signals of human anti-tumor responses is considered the most promising tumor immunotherapy at present. Guided by this theory, CTLA-4 and PD-1 are considered as two significant checkpoints of the immune system, as well as cornerstone targets for tumor immunotherapy as they initiate anti-tumor immune attacks by affecting different types of T cells, respectively. As the first approved tumor immunotherapy antibody drug, Ipilimumab targeting CTLA-4 demonstrated good efficacy in the treatment of advanced metastatic melanoma and other tumors, and showed strong potential in combination with the PD-1 antibody. However, the clinical toxicity of Ipilimumab has been always the biggest worry limiting its clinical manifestation, and also prompted the scientific community to reexamine and investigate the mechanism of action of CTLA-4. YH001 is a recombinant humanized anti-CTLA-4 IgG1 monoclonal antibody injection developed by Eucure (Beijing) Biopharma Co., Ltd. Preclinical data demonstrated that binding and ADCC activity of YH001 were higher than that of Ipilimumab under the same conditions; YH001 also can block the binding of CTLA-4 to CD80/CD86, so YH001 is predicted to have a good anti-tumor effect.

In response, Dr. Yuelei Shen, the President of Biocytogen and CEO of Eucure Biopharma, commented, "We are very pleased to see a partial response of target tumor lesions in this clinical study, which is going fast and smoothly in Australia. We will accelerate the development to initiate trials in combination with PD-1 monoclonal antibody drug in China as soon as possible in order to provide effective innovative products for Chinese patients. Our three independently developed products have advanced to the clinical phase and the first patient has been screened in Australia successively since May 2020. The first patient screening was completed and the first administration was received in the Phase I clinical study of YH001 (CTLA4) in combination with PD-1 in Australia in May 2020; the first patient screening was completed and the first administration was received in the second clinical trial of YH002 (OX40) in Australia in June 2020. In July 2020, the first patient screening was completed and the first administration was received for YH003, an important cornerstone of the tumor immunotherapy. The Phase I clinical studies of these three products have been moved smoothly and have escalated to the effective dose. This also marks a successful transition of Biocytogen/Eucure Biopharma from a preclinical company to an innovative drug company in the clinical phase."

About TuoYi (Toripalimab Injection)

Toripalimab Injection (TuoYi ) was the first domestic monoclonal antibody drug targeting PD-1 approved for marketing in China, and received the support as a National Science and Technology Major Project. The first approved indication for TuoYi is the treatment of patients with unresectable or metastatic melanoma who have failed in prior systemic therapy, and TuoYi is recommended in Guidelines of Chinese Society of Clinical Oncology (CSCO) – Melanoma (2019, 2020). In December 2020, TuoYi passed the negotiation procedure for national health insurance successfully and was included in the new version of National Reimbursement Drug List. In February 2021, TuoYi was approved by NMPA for the treatment of patients with recurrent/metastatic nasopharyngeal cancer who have failed in prior second-line or above systemic therapies. An application for NDA approval of toripalimab for a new indication of treatment of patients with locally advanced or metastatic urothelial carcinoma who have failed in or intolerable to systemic therapy was accepted by NMPA in May 2020, and was included in the priority review procedure by the NMPA in July 2020. In September 2020, Toripalimab received Breakthrough Therapy Designation for the treatment of nasopharyngeal carcinoma from FDA. An application for NDA approval for a new indication of toripalimab in combination with chemotherapy for advanced recurrent and metastatic nasopharyngeal cancer without prior first-line systemic therapy was accepted by NMPA in February 2021. Toripalimab has received 1 Breakthrough Therapy Designation, 1 Fast Track Designation, and 3 Orphan Drug Designations from FDA in the treatment of mucosal melanoma, nasopharyngeal carcinoma, and soft tissue sarcoma by now. Over 30 clinical studies has been conducted worldwide since toripalimab was clinically developed at the beginning of 2016 to actively explore the efficacy and safety of TuoYi in indications such as melanoma, nasopharyngeal cancer, urothelial cancer, lung cancer, gastric cancer, esophageal cancer, liver cancer, bile duct cancer, breast cancer, renal cancer, etc. Collaboration with domestic and foreign first-in-class innovative pharmaceutical companies in combination therapies is also ongoing, and more patients in China and other countries are expected to receive the most advanced tumor immunotherapy in the world.

About Biocytogen

Biocytogen is an international biotechnology company that develops new drugs based on innovative technology. Biocytogen is committed to becoming the birthplace of global new drugs with the mission of focusing on technological innovation, continuous new drug production, and safeguarding of human health. Biocytogen has established a unique new drug development system covering the whole drug development process by organically integrating the single-cell antibody discovery technology platform, efficient gene editing model development platform, large-scale animal model supply platform, and rapid animal in vivo and in vitro drug efficacy evaluation platform with powerful clinical development capabilities based on the fully human antibody RenMab , RenLite, and RenNano mice independently developed by Biocytogen with completely independent intellectual property rights. Therefore, Biocytogen successfully transformed into Biotech, and will focus more on development of innovative antibody drugs in the future. As implementation of the large-scale antibody drug development – "Project Integrum", Biocytogen will work with global partners to jointly accelerate the new drug development. Biocytogen is headquartered in Beijing, with branches in Haimen (Jiangsu), Boston, Shanghai. Eucure Biopharma, a wholly-owned subsidiary of Biocytogen, focuses on clinical development.

On March 4, 2021 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new medicines for patients with pediatric cancers, solid tumors, and other cancers, reported the pricing of an underwritten public offering of 14,614,541 shares of its common stock at a price to the public of $1.3685 per share (Press release, Salarius Pharmaceuticals, MAR 4, 2021, View Source [SID1234576211]). The gross proceeds to Salarius from the offering, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be approximately $20 million. The closing of the offering is expected to take place on or about March 8, 2021, subject to the satisfaction or waiver of customary closing conditions. In addition, Salarius has granted the underwriter a 45-day option to purchase up to 2,192,181 additional shares of common stock at the public offering price per share, less underwriting discounts and commissions.

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Ladenburg Thalmann & Co. Inc. is acting as sole book-running manager in connection with the public offering.

The securities were offered pursuant to a registration statement on Form S-3 (File No. 333-231010), which was declared effective by the United States Securities and Exchange Commission (the "SEC") on May 17, 2019. When available, copies of the final prospectus supplement and accompanying prospectus relating to the offering can be obtained at the SEC’s website at www.sec.gov or from Ladenburg Thalmann & Co. Inc., Attn: Prospectus Department, 640 Fifth Avenue, New York, NY 10019 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.

On March 4, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported its financial results and operational highlights for the quarter and year ended December 31, 2020 (Press release, , MAR 4, 2021, View Source [SID1234576155]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

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"We are beginning 2021 with strong momentum, bolstered by a robust clinical data set that demonstrates the potential of pelareorep to boost the effectiveness of immuno-oncology agents and address major unmet medical needs across multiple indications," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "Interim AWARE-1 results highlight pelareorep’s ability to train the immune system to target tumors and its potential to synergistically combine with checkpoint blockade therapy in HR+/HER2- breast cancer patients. These findings reinforce the survival benefit observed in our prior phase 2 study and are suggestive of a successful outcome with our phase 2 BRACELET-1 trial, which evaluates pelareorep-checkpoint inhibitor therapy in the same breast cancer subtype. We look forward to reporting additional biomarker and safety data from our lead breast cancer program later this year and to the program’s continued advancement towards a registrational study."

Dr. Coffey continued, "Beyond our lead program, we continue to leverage our compelling data and collaborations with industry leaders to expand pelareorep’s commercial and business development potential. Pelareorep promotes tumor inflammation and upregulates PD-L1 expression in the clinic, positioning it to address unmet needs in triple-negative breast cancer (TNBC) and gastrointestinal (GI) cancers. In each of these indications, checkpoint inhibitors have had commercial success, but immunosuppressive tumor microenvironments (TMEs) and low PD-L1 expression severely limit their efficacy and the number of patients who can be successfully treated. Through our IRENE and GOBLET trials, we are collaborating with industry leaders to show that we can increase the percentage of TNBC and GI cancer patients responding to checkpoint blockade by taking advantage of pelareorep’s immunotherapeutic effects. Excitingly, pelareorep’s synergistic benefits appear to extend to immunomodulatory agents beyond checkpoint inhibitors, as recent preclinical results show that pelareorep may broaden the applicability of CAR T cells to solid tumors by improving their persistence and efficacy. Looking ahead, we will explore a partnership strategy to develop pelareorep as an enabling technology for CAR T cells and other immunotherapies while keeping our primary focus on our lead breast cancer program. We believe this strategy will drive and expand our sustained growth by allowing for the efficient development of pelareorep in a variety of difficult-to-treat indications. Finally, with our strengthened financial position, we look forward to accelerating these activities and delivering on our catalysts."

Select highlights from 2020 and early 2021

Breast Cancer Program

Reported AWARE-1 Data Demonstrating Pelareorep’s Ability to Reverse Immunosuppressive TMEs and Potential to Boost the Effectiveness of Checkpoint Inhibitors

AWARE-1 data presented at the 2020 San Antonio Breast Cancer Symposium (SABCS) showed that systemic pelareorep treatment increased tumor PD-L1 expression by an average of 105-fold in early-stage breast cancer patients, thereby making tumors more amenable to checkpoint inhibitor therapy. Data also showed that 72% of patients saw an increase in CelTIL (the study’s primary endpoint), a measure of tumor-associated cellularity and tumor-infiltrating lymphocytes that is associated with favorable clinical response. These data add to prior AWARE-1 results showing that systemic pelareorep treatment led to the generation of new anti-viral and anti-tumor T cell clones and an average 14-fold increase in intratumoral CD8+ T cells. Together, these data support the results of a prior successful phase 2 trial (IND-213) that showed a near doubling of overall survival with pelareorep treatment by demonstrating pelareorep’s ability to induce robust and potentially long-lasting anti-tumor immune responses in HR+/HER2- breast cancer patients (link to PR, link to poster).

Initiated Dosing in Phase 2 BRACELET-1 Study and Successfully Completed Safety Run-in

Oncolytics advanced its lead breast cancer program with the initiation of dosing in BRACELET-1, a randomized phase 2 study being conducted under a co-development agreement with Merck KGaA (Darmstadt, Germany) and Pfizer. BRACELET-1 is designed to generate mechanistic data supporting the results of IND-213 and to evaluate pelareorep’s ability to synergistically combine with anti-PD-L1 therapy. The study also seeks to validate peripheral T cell clonality as a biomarker of pelareorep response in HR+/HER2- metastatic breast cancer, which may improve the patient selection process in future registration studies and increase their likelihood of success. The trial’s safety run-in has been successfully completed, with the Data and Safety Monitoring Board verifying pelareorep’s outstanding safety profile.

Initiated Dosing in Phase 2 IRENE Study

Oncolytics expanded its lead breast cancer program into a new disease subtype through the initiation of dosing in IRENE, a phase 2 investigator-sponsored study investigating the use of pelareorep in combination with Incyte’s anti-PD-1 checkpoint inhibitor retifanlimab (INCMGA00012) in patients with unresectable locally advanced or metastatic TNBC. In addition to investigating the safety and efficacy of pelareorep-anti-PD-1 combination treatment in TNBC patients, the study also evaluates changes in PD-L1 expression and correlations between treatment outcomes and peripheral T cell clonality.

Gastrointestinal Cancer Program

Announced Phase 1/2 GOBLET Study in Collaboration with Roche and AIO

GOBLET is a phase 1/2 multi-center trial designed to investigate the use of pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab (Tecentriq) in patients with metastatic pancreatic, metastatic colorectal and advanced anal cancers. The trial is being managed by AIO, a leading academic cooperative medical oncology group based in Germany. GOBLET builds on previously reported early clinical data showing that pelareorep-based combination treatments stimulated an adaptive immune response and led to a greater than 90% clinical benefit rate in KRAS mutated colorectal cancer patients (link to PR, link to study), as well as a greater than 80% increase in progression-free survival (PFS) in pancreatic cancer patients with low levels of CEACAM6 expression (link to PR, link to poster). In addition to evaluating the safety and efficacy of pelareorep-atezolizumab treatment, the trial also seeks to validate CEACAM6 and T cell clonality as predictive biomarkers, which may improve the patient selection process in future registration studies and increase their likelihood of success.

Hematologic Malignancies Program

Announced Clinical Proof-of-Concept Data at the ASCO (Free ASCO Whitepaper) Virtual Meeting

Phase 1b data presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting showed that pelareorep, when combined with carfilzomib, activated a profound inflammatory response accompanied by a 50% overall response rate and an 83% clinical benefit rate in patients with challenging-to-treat carfilzomib-refractory multiple myeloma (link to the PR, link to the poster). The data also showed the first reported incidence of cytokine stimulation associated with tumor response in multiple myeloma, highlighting the ability of pelareorep to induce robust immune cell activation and tumor lysis. Together with earlier trial data showing pelareorep-induced upregulation of PD-L1 expression, these data highlight the potential of pelareorep to synergistically combine with checkpoint inhibitors in hematologic cancers.

Opportunities to Further Expand the Clinical Benefits of Pelareorep to Additional Indications

Reported Positive Clinical Results Against Glioblastoma Multiforme

Oncolytics announced positive results from ReoGlio, an investigator-sponsored phase 1b trial evaluating the combination of pelareorep and granulocyte-macrophage colony-stimulating factor (GM-CSF) alongside standard chemoradiotherapy and adjuvant temozolomide for the treatment of glioblastoma multiforme (GBM) at the 2020 Society of Neuro-Oncology Annual Meeting (link to the PR). The results showed a compelling signal of efficacy and demonstrated the safety and tolerability of the pelareorep-based combination therapy in newly diagnosed GBM patients. Notably, observed improvements in median PFS correlated with the dose of pelareorep administered. Oncolytics thanks the University of Leeds, Cancer Research UK, and The Brain Tumor Charity for designing, managing, and funding the ReoGlio trial.

Demonstrated the Potential of Pelareorep to Broaden the Applicability of CAR T Cells to Solid Tumors

A recent preclinical study from the Mayo Clinic showed that loading chimeric antigen receptor (CAR) T cells with pelareorep vastly improved their persistence and efficacy in a murine solid tumor model, in stark contrast to preclinical studies using intratumoral infection with the VSV oncolytic virus that weakened CAR T cells (link to the PR, link to the poster). The efficacy of pelareorep-loaded CAR T cell ("CAR/Pela") therapy was further enhanced by boosting mice 8 days later with a single intravenous dose of pelareorep, which led to the generation of highly persistent CAR T cells, the inhibition of recurrent tumor growth, and ultimately tumor cures. These synergistic immune effects were specific to pelareorep, as intravenous boosting with VSV did not augment CAR/Pela therapy or prevent the growth of recurrent tumors. Together, these data demonstrate the potential of pelareorep to broaden the applicability of CAR T cells to solid tumors, an area where CAR T cell efficacy is currently limited due to immunosuppressive TMEs that promote T cell exhaustion and exclusion.

Corporate Highlights

Appointed Richard Vile, Ph.D., to Scientific Advisory Board

Dr. Vile, a Professor of Immunology at the Mayo Clinic, is a world-renowned scientist and long-time collaborator of Oncolytics with extensive experience studying pelareorep, and led the Mayo Clinic CAR T preclinical study mentioned above. Dr. Vile is a recognized key opinion leader whose research focuses on several areas of immuno-oncology, including oncolytic viruses, adoptive cell therapies (ACTs) such as CAR T cells, and potential synergistic interactions between oncolytic viruses and ACTs. In addition to his role as a professor at the Mayo Clinic ("Mayo"), Dr. Vile is the Director of Mayo’s Immuno-oncology and Gene and Virus Therapy programs and Co-Director of the Cancer Immunology and Immunotherapy program. He also serves on the editorial board of several prestigious scientific journals, including Molecular Therapy, Gene Therapy, The Journal of Gene Medicine, and OncoImmunology.

Financial Highlights

As at December 31, 2020, the Company reported $31.2 million in cash and cash equivalents. The Company raised gross proceeds of $40.0 million during 2020 through the issuing of common stock through our ATM facility.

Operating expense was $4.0 million for the fourth quarter of 2020 and $12.5 million for the full year 2020, compared to $4.1 million in the fourth quarter of 2019 and $9.6 million for the full year 2019.

R&D expense was $4.1 million for the fourth quarter of 2020 and $12.9 million for the full year 2020, compared to $2.7 million in the fourth quarter of 2019 and $10.8 million for the full year 2019.

Net cash used in operating activities was $5.7 million for the fourth quarter of 2020 and $22.1 million for the full year 2020, compared to $7.3 million in the fourth quarter of 2019 and $19.9 million for the full year 2019.

The net loss for the fourth quarter of 2020 was $9.3 million, compared to a net loss of $19.4 million in the fourth quarter of 2019. The basic and diluted loss per share was $0.21 in the fourth quarter of 2020, compared to a basic and diluted loss per share of $0.71 in the fourth quarter of 2019. The net loss for the full year 2020 was $22.5 million, compared to a net loss of $33.1 million for the full year 2019. The basic and diluted loss per share was $0.56 for the full year 2020, compared to a basic and diluted loss per share of $1.50 for the full year 2019.

As at March 4, 2021, the Company had approximately $50 million in cash and cash
equivalents, an unlimited number of authorized common shares with 52,083,924 common shares issued and outstanding, 16,443,500 warrants (exercisable into 1,730,894 common shares) issued in 2017 with a $9.025 strike price, 110,572 warrants issued in 2020 with a US$0.90 strike price and 3,878,852 options and share units.
Anticipated Milestones & Catalysts

Announcement of final data from phase 2 NU 18I01 second-line pancreatic cancer study*: H1 2021

Dosing of the first patient in GOBLET study in gastrointestinal cancer: H1 2021

Interim data for AWARE-1 breast cancer study: H1 2021

Final biomarker data for AWARE-1 breast cancer study in the intended target population for a registrational study: H2 2021

Interim safety update from Phase 2 BRACELET-1 metastatic breast cancer study: H2 2021

Completion of enrollment in BRACELET-1 metastatic breast cancer study: Q4 2021

Interim safety update from IRENE study in TNBC: Q4 2021

Interim safety data from phase 1 WINSHIP 4398-18 multiple myeloma study: Q4 2021
*Guidance provided by clinical investigators

Oncolytics expects to provide updates on the timing of the following milestones over the coming months:

Phase 2 BRACELET-1 metastatic breast cancer study: final data
Update on COVID-19

Oncolytics continues to collaborate with its investigators to ensure the safety of patients and employees, as well as the productivity of its clinical programs. We expect these measures will allow us to build on the positive momentum of the past year, despite any COVID-19-related challenges that may arise. Moving forward, we plan to remain in contact with relevant stakeholders and keep the market apprised of any new information that may impact clinical timelines.

Webcast and Conference Call

Management will host a conference call for analysts and institutional investors at 8:30 am ET today, March 5, 2021. To access the call, please dial (888) 231-8191 (North America) or (647) 427-7450 (International) and, if needed, provide confirmation number 569-6653. 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 (855) 859-2056 (North America) or (416) 849-0833 (International) and using reference code 569-6653.

About AWARE-1
AWARE-1 is an open label window-of-opportunity study in early-stage breast cancer enrolling 38 patients into five cohorts:

Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)

Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)

Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)

Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)

Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)
The study combines pelareorep, with or without atezolizumab, and the standard of care according to breast cancer subtype. Patients are biopsied as part of their initial breast cancer evaluation, then again on day three following initial treatment, and a final tissue sample after three weeks, on the day of their mastectomy. Data generated from this study are intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive biomarker data by breast cancer subtype. The primary endpoint of the study is overall CelTIL (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety, and tumor and blood-based biomarkers.

For more information about the AWARE-1 study, refer to View Source

About BRACELET-1
The BRACELET-1(BReast cAnCEr with the Oncolytic Reovirus PeLareorEp in CombinaTion with anti- PD-L1 and Paclitaxel) study is an open-label, phase 2, randomized study in patients with HR+/HER2-, endocrine-refractory metastatic breast cancer being conducted under a co-development agreement with Merck KGaA, Darmstadt, Germany and Pfizer. PrECOG LLC, a leading cancer research network, is managing the study. The study will take place at 20 trial sites and enroll 45 patients randomized into three cohorts. A three patient safety run-in will be conducted with patients receiving pelareorep, paclitaxel, and avelumab prior to randomization. The three cohorts will be treated as follows:

Cohort 1 (n=15): paclitaxel

Cohort 2 (n=15): paclitaxel + pelareorep

Cohort 3 (n=18): paclitaxel + pelareorep + avelumab (Bavencio)
Patients in cohort 1 will receive paclitaxel on days 1, 8, and 15 of a 28-day cycle. Patients in cohort 2 will receive the same paclitaxel regimen as cohort 1, plus pelareorep on days 1, 2, 8, 9, 15 and 16 of the 28-day cycle. Patients in cohort 3 will receive the same combination and dosing regimen as cohort 2, plus avelumab on days 3 and 17 of the 28-day cycle. The primary endpoint of the study is overall response rate. Exploratory endpoints include peripheral and tumor T cell clonality, inflammatory markers, and safety and tolerability assessments.

For more information about the BRACELET-1 study, refer to View Source

About IRENE
The IRENE (INCMGA00012 and the oncolytic virus pelareorep in metastatic triple-negative breast cancer) study is a single-arm, open-label, phase 2 study evaluating the combination of pelareorep and INCMGA00012 for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer. The study will enroll 25 patients and will be conducted at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center.

Study participants will receive pelareorep intravenously on days 1, 2, 15, and 16 of 28-day treatment cycles. INCMGA00012 will be administered on day 3 of each cycle, with treatment cycles continuing until disease progression is observed. The co-primary endpoints of the study are safety and objective response rate. Secondary endpoints include progression-free survival, overall survival, and duration of response. Exploratory endpoints include peripheral T cell clonality and pre- vs. post-treatment change in tumor PD-L1 expression.

For more information on the IRENE study, refer to View Source

About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication biomarker, safety, and efficacy study in advanced or metastatic GI tumors. The study will be conducted at 25 centers in Germany. The primary endpoint of the study is safety, with overall response rate and blood-based biomarkers (T cell clonality and CEACAM6) as exploratory endpoints. Approximately 55 patients are planned for enrollment across four separate cohorts:

Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line metastatic Pancreatic cancer patients (n=12);

Pelareorep in combination with atezolizumab in 2nd and 3rd line metastatic colorectal cancer patients that are diagnosed as MSI (microsatellite instability) high (n=19);

Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients (n=14); and

Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients (n=10).
About ReoGlio
The ReoGlio trial was an investigator-sponsored phase 1b, open-label trial evaluating the combination of pelareorep and GM-CSF, alongside standard chemoradiotherapy and adjuvant temozolomide, for the treatment of newly diagnosed GBM. Fifteen patients were treated in the trial, twelve of which were evaluable for efficacy analyses. The primary objective of the study was to determine the maximum tolerated dose of pelareorep and GM-CSF with standard chemoradiotherapy. Secondary objectives were to gain a preliminary assessment of the activity of the pelareorep-GM-CSF combination and to assess treatment compliance. The trial was designed and managed by the University of Leeds and funded through grants provided by Cancer Research UK and The Brain Tumor Charity.

About Breast Cancer
Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. It is the second leading cause of death from cancer in women in America, with an estimated 42,000 deaths in the US in 2020.1

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

About Gastrointestinal Cancer
Excluding skin cancers, colorectal cancer is the third most common cancer, with an estimated 104,610 new cases of colon cancer and 43,340 new cases of rectal cancer diagnosed in the U.S. in 20202. Also, for the 2020 year, the American Cancer Society estimates there will be 57,600 new cases of pancreatic cancer3 and 8,590 new cases of anal cancer 4 in the U.S.

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On March 4, 2021 KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, reported that Travis C. Mickle, Ph.D., President and CEO of KemPharm, will present at the 33rd Annual Roth Conference being held virtually from March 15-17, 2021 (Press release, KemPharm, MAR 4, 2021, View Source [SID1234576154]). The presentation will be available on demand during the virtual event for all registered attendees.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Details regarding KemPharm’s presentations are as follows:

Event:   33rd Annual Roth Conference
Date:    Monday, March 15, 2021 to Wednesday, March 17, 2021
Time: Available on Demand
Registration:   View Source
During the pre-recorded virtual presentation, Dr. Mickle will provide an overview of KemPharm’s corporate achievements and potential milestones, including the U.S. Food and Drug Administration’s (FDA) recent approval of AZSTARYS (formerly known as KP415), a once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years and older. AZSTARYS consists of serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH.

The complete label for AZSTARYS, including prescribing information and important safety information, may be found at View Source

On March 4, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported that the Company will release its year-end 2020 financial results on Thursday, March 11, 2021, after the market closes (Press release, Onconova, MAR 4, 2021, View Source [SID1234576153]). Management will host a conference call and live webcast at 4:30 p.m. ET on the same day to discuss these results and provide an update on its pipeline programs.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Interested parties who wish to participate in the conference call may do so by dialing (855) 428-5741 for domestic and (210) 229-8823 for international callers and using conference ID 3863774. Those interested in listening to the conference call live via the internet may do so by visiting the investors’ page of the company’s website at www.onconova.com and clicking on the webcast link.

A webcast replay will be available on the Onconova website for 90 days following the call by visiting the investor page of the company’s website at www.onconova.com