On May 20, 2021 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune T-cell activating technology, reported publication of abstract #2501 by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, PDS Biotechnology, MAY 20, 2021, View Source [SID1234580369]). The abstract summarizing interim data from the National Cancer Institute (NCI)-led phase 2 trial has been accepted for oral presentation at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting taking place June 4-8. The presentation, scheduled for June 7, is expected to include results from a larger sample than the 14 patients included in the abstract.

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Additional data highlights from abstract #2501 include:

An overall objective response rate of 71% (10/14) in patients with refractory HPV16-associated cancers
1 complete response (anal cancer)
9 partial responses (3 cervical cancer, 2 vulvar/vaginal cancer, 2 anal cancer, 2 oropharyngeal cancer)
90% of these of these responses are ongoing after a median 5 months of follow up (9/10)
The NCI Center for Cancer Research’s Laboratory of Tumor Immunology and Biology (LTIB) and Genitourinary Malignancies Branch (GMB) are jointly leading this Phase 2 trial (NCT04287868), which studies PDS0101 in combination with two investigational immune-modulating agents: bintrafusp alfa (M7824), a bifunctional "trap" fusion protein targeting TGF-β and PD-L1, and NHS-IL12 (M9241), a tumor-targeting immunocytokine. Bintrafusp alfa is being jointly developed by Merck KGaA, Darmstadt, Germany, and GlaxoSmithKline; NHS-IL12 is being developed by Merck KGaA, Darmstadt, Germany.

The trial is evaluating the treatment combination in both checkpoint inhibitor naïve and refractory patients with advanced human papillomavirus (HPV)-associated cancers that have progressed or returned after treatment. Objective response is measured by radiographic tumor responses according to RECIST 1.1. These reported data validate the preclinical studies published by the NCI demonstrating that the complementary mechanisms of action of the three immunotherapies which involve potent in-vivo HPV16-specific killer and helper T-cell induction with effective T-cell tumor infiltration, blocking of immune checkpoints as well as targeting of TGF-β resulted in superior tumor regression.

"The achievement of a 71% objective response rate in a difficult to treat patient population continues to strengthen the evidence of our novel Versamune platform’s potential ability to induce high levels of tumor-specific CD8+ killer T-cells that attack the cancer resulting in strong synergy with Bintrafusp alfa and NHS-IL12, thus leading to effective tumor regression," commented Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. "The initial data solidifies our belief that PDS0101’s published preclinical efficacy, when combined with these two immune-modulating agents, demonstrates the potential to significantly improve clinical outcomes for patients with advanced, refractory HPV-associated cancers who have limited treatment options."

There are more than 630,000 cases of HPV-associated malignancies including cervical, oropharyngeal and anal cancer worldwide annually. HPV 16 is responsible for most of these cases. About 15-20% of HPV-associated malignancies respond to PD-(L)1 inhibitors. However, for the overwhelming majority of patients who progress on these immunotherapies there is no effective standard of care therapy.

The abstract is now available online on the ASCO (Free ASCO Whitepaper) conference website: View Source

Abstract Number: 2501
Abstract Title: Phase II evaluation of the triple combination of PDS0101, M9241, and bintrafusp alfa in patients with HPV 16 positive malignancies.

Presenting Author: Julius Strauss, MD, National Cancer Institute
Session: Developmental Therapeutics—Immunotherapy
Date: June 7, 2021
Time: 3:00 PM-6:00 PM EDT

Dr. Julius Strauss, Staff Clinician, LTIB, is serving as the Principal Investigator of this phase 2 clinical trial in advanced HPV-associated cancers. For patients interested in enrolling in this clinical study, please call NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email [email protected], and/or visit the website: View Source

On May 20, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported clinical and biomarker data demonstrating clinical proof-of-concept for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer (Press release, Oncolytics Biotech, MAY 20, 2021, View Source [SID1234580368]). The data will be featured in an upcoming electronic poster presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is taking place virtually from June 4 – 8, 2021.

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The newly announced data are from a phase 2 trial evaluating pelareorep in combination with the PD-1 inhibitor pembrolizumab (KEYTRUDA) in pancreatic adenocarcinoma patients who progressed after first-line treatment. Findings from the trial indicate that pelareorep and pembrolizumab synergize and show anti-cancer activity in these difficult-to-treat patients, which is mediated through the complementary immunotherapeutic effects of the two agents.

"These results are very promising, particularly considering the extremely challenging patient population enrolled in the trial. That we saw a response signal in select patients, despite the absence of chemotherapy, provides evidence of the considerable anti-cancer activity of pelareorep-pembrolizumab combination therapy," said Principal Investigator, Devalingam Mahalingam, M.D., Ph.D., Associate Professor of Medicine at The Northwestern University Feinberg School of Medicine and a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. "We notably observed an association between treatment-induced anti-cancer immune responses and improved tumor control in some patients, which demonstrates pelareorep’s underlying immunologic mechanism of action and validates the strategy of combining it with checkpoint inhibition. I look forward to discussing these data with the scientific community at the upcoming ASCO (Free ASCO Whitepaper) conference and to the continued evaluation of pelareorep-checkpoint inhibitor combination therapy in select patients with pancreatic and other gastrointestinal cancers."

The data presented in the upcoming ASCO (Free ASCO Whitepaper) poster represent an update based on additional data that was collected after the cutoff date used for the poster’s corresponding abstract. Key data and conclusions that will be featured in this upcoming poster include:

Disease control was achieved in 42% (5/12) of patients, with one patient achieving a partial response and four patients achieving stable disease
On-treatment tumor biopsies showed pelareorep replication and increased infiltration of CD8+ T cells and PD-L1+ cells relative to pre-treatment samples
Patients achieving disease control showed reductions in pro-tumor regulatory T (T­reg) cells in the peripheral blood and tumor tissue compared to those with progressive disease
Patients achieving disease control showed increased activation of anti-cancer CD8+ T cells in the peripheral blood compared to those with progressive disease
Pelareorep-pembrolizumab combination therapy was found to be well tolerated, with most treatment-related adverse events being grade 1 or 2
Bin Zhang, M.D., Ph.D., Professor at The Northwestern University Feinberg School of Medicine, commented, "These data show that pelareorep can train the immune system to target pancreatic cancer while simultaneously promoting the infiltration of T cells into the tumor and remodeling the tumor microenvironments (TMEs) to be less immunosuppressive. This positions pelareorep to synergistically combine with both checkpoint inhibitors as well as a broad range of other immuno-oncology agents."

"The findings from this study highlight the broad applicability of pelareorep’s immunotherapeutic mechanism of action as they are consistent with what has been seen in clinical trials in other indications such as breast cancer," added Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics. "The compelling findings from this phase 2 study highlight the potential of pelareorep to address the critical unmet need in pancreatic cancer by reversing the immunosuppressive TMEs that often limit the efficacy of checkpoint inhibitors. The anti-cancer activity demonstrated in this study bodes well for a successful outcome in our GOBLET trial, which includes a cohort evaluating pelareorep and the PD-L1 inhibitor atezolizumab in combination with chemotherapy as first-line therapy in metastatic pancreatic cancer patients."

The electronic poster, titled, "Treatment with pembrolizumab in combination with the oncolytic virus pelareorep promotes anti-tumor immunity in patients with advanced pancreatic adenocarcinoma" will be made available on the ASCO (Free ASCO Whitepaper) Annual Meeting website at 9:00 a.m. ET on June 4, 2021. A copy of the poster will also be posted on the Posters & Publications page of Oncolytics’ website (LINK).

Oncolytics plans to further develop pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer in collaboration with Roche and AIO-Studien-gGmbH (AIO) through the GOBLET study, a phase 1/2 multi-center trial designed to investigate the use of pelareorep in combination with Roche’s anti-PD-L1 inhibitor atezolizumab (Tecentriq) in patients with metastatic pancreatic, metastatic colorectal and advanced anal cancers (link to the GOBLET announcement PR). Oncolytics expects the first patient to be dosed in GOBLET in mid-2021.

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 biomarker evaluation (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 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 20201. Also, for the 2020 year, the American Cancer Society estimates there will be 57,600 new cases of pancreatic cancer2 and 8,590 new cases of anal cancer 3 in the U.S.

On May 20, 2021 Istari Oncology, Inc., a clinical-stage biotechnology company focused on novel immunotherapies for the treatment of solid tumors, reported that it was just awarded "Best Early Stage Product Development Company" within the Life Sciences award category by the Triangle Business Journal (Press release, Istari Oncology, MAY 20, 2021, View Source [SID1234580367]).

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The Triangle Business Journal (TBJ) Life Sciences Awards recognize both individuals and research organizations in the Research Triangle region of North Carolina that are blazing trails and breaking ground in this field. The life sciences award category includes biotechnology, pharmaceuticals, clinical research, human health, medical devices and diagnostics, and many others. This year TBJ honored 16 winners – three individuals and 13 organizations – including Istari, in a ceremony held virtually earlier today.

"I’m really grateful for this award and for the Istari team to be honored by the Triangle Business Journal for all of their contributions," stated President and CEO, Matt Stober. "It serves as recognition of the hardworking team we have here at Istari Oncology and the unique immunotherapy we believe will change the treatment paradigm for cancer patients."

Istari’s lead immunotherapy candidate, PVSRIPO, is based on an attenuated version of the polio vaccine, originally developed through research at the Preston Robert Tisch Brain Tumor Center at Duke University Medical Center. The therapy is currently being evaluated in multiple clinical trials across a range of solid tumors including glioblastoma and melanoma. PVSRIPO will also be evaluated in a "basket trial" that includes other solid tumors such as bladder cancer.

On May 20, 2021 Invitae Corporation (NYSE: NVTA), a leading medical genetics company, reported that members of its management team will present at the William Blair 41st Annual Growth Stock Conference on Thursday, June 3, 2021 at 3:20 p.m. Central / 4:20 p.m. Eastern / 1:20 p.m. Pacific (Press release, Invitae, MAY 20, 2021, View Source [SID1234580366]).

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

The live webcast of the fireside chat may be accessed by visiting the investors section of the company website at ir.invitae.com. A replay of the webcast will be available shortly after the conclusion of the fireside chat.

On May 20, 2021 Incyte (Nasdaq:INCY) reported that it will present at the following investor conferences during the month of June (Press release, Incyte, MAY 20, 2021, View Source [SID1234580365]):

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William Blair 41st Annual Growth Stock Conference (Virtual) on Thursday, June 3, 2021 at 1:00 pm (EDT)
BioPharma Sustainability Roundtable’s CEO Investor Forum on Monday, June 7, 2021 at 1:35 pm (EDT)
Goldman Sachs 42nd Annual Global Healthcare Conference (Virtual) on Tuesday, June 8, 2021 at 8:00 am (EDT)
Guggenheim’s "Biopharma’s Next Decade: Views from the Top on Global Strategy and Innovation" Series on Monday, June 28, 2021 at 11:00 am (EDT)
The presentations will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay.