Preclinical Data Supporting Therapeutic Potential of Surface Oncology’s Lead Clinical Programs, SRF617 and SRF388, Presented at the Society for Immunotherapy of Cancer 2021 Annual Meeting

On November 9, 2021 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that two scientific posters sharing updated preclinical data from Surface Oncology’s two lead clinical-stage antibody therapies, SRF617 (targeting CD39) and SRF388 (targeting IL-27), will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2021 Annual Meeting, to be held virtually and at the Walter E. Washington Convention Center in Washington, D.C. November 10-14, 2021 (Press release, Surface Oncology, NOV 9, 2021, View Source [SID1234594832]).

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"The data to be presented highlight SRF617’s potent CD39 inhibition in preclinical models, and its effect on promoting proinflammatory therapeutic activity," said Vito Palombella, Ph.D., chief scientific officer at Surface Oncology. "Additionally, we will provide evidence that the IL-27 gene signature is highly expressed in patients with lung cancer that have treatment-resistant disease, supporting our continued development of SRF388, our first-in-class IL-27 antibody, across numerous tumor types."

Highlights of the posters are provided below. Full posters will be placed on Surface Oncology’s website following the presentations.

SRF617 Highlights
In a poster entitled "The fully human antibody SRF617 is a potent inhibitor of ecto-enzyme CD39 in vivo," Surface researchers describe preclinical studies demonstrating the therapeutic potential of targeting CD39 for cancer treatment:

SRF617 is an inhibitor of CD39 enzymatic activity in vivo.
Anti-CD39 therapy promotes a pro-inflammatory tumor microenvironment by increasing CD8+ T cell accumulation and downregulating CD39 protein on immune cells.
In combination with gemcitabine, anti-CD39 therapy promotes an increase in tumor macrophages while reducing CD39 expression and activity.
SRF388 Highlights
In a poster entitled "IL-27 signaling drives a type 1 interferon-like gene expression program of immunoregulatory pathways associated with cancer progression," Surface researchers demonstrate that blockade of IL-27 alleviates an immunosuppressive gene transcriptional program implicated in treatment resistance in cancer:

IL-27 induces robust gene expression in human immune cells and cancer cell lines that include several inhibitory receptors and canonical interferon-regulated genes.
Both IL-27 and IFNβ can counteract some of the immune stimulatory properties of PD-1 blockade.
IL-27 is expressed by a macrophage population associated with progressive disease in patients with non-small cell lung cancer (NSCLC).
These studies elucidate the transcriptional networks engaged after IL-27 signaling in immune and cancer cells and highlight the parallels with interferon-associated immune regulation.

Ziopharm Oncology Presents Preclinical Data Supporting TCR-T Library Approach at the Society for Immunotherapy of Cancer 2021 Annual Meeting

On November 9, 2021 Ziopharm Oncology, Inc. ("Ziopharm" or the "Company") (Nasdaq: ZIOP), reported the presentation of preclinical data highlighting the potential of neoantigen-specific TCR-T cells for the treatment of solid tumors at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2021 Annual Meeting (Press release, Ziopharm, NOV 9, 2021, View Source [SID1234594831]).

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"We are pleased to share preclinical data demonstrating the versatility of our Sleeping Beauty technology to develop neoantigen-specific TCR-T cells with the potential to address a wide range of solid tumor indications," commented Raffaele Baffa, M.D., Ph.D., Chief Medical Officer & EVP, Research & Development. "Our TCR-T library approach allows us to develop safe, effective and durable therapies for any patient with a matching neoantigen/HLA combination within our library. We are working diligently to initiate our Phase 1/2 TCR-T Library trial in the first half of 2022 as well as continue to expand our library of TCRs in order to increase the pool of eligible patients who could benefit from these therapies."

Details of Ziopharm’s SITC (Free SITC Whitepaper) 2021 presentation are as follows:

Title: Neoantigen-specific TCR-T cells targeting shared hotspot mutations for adoptive cell therapy in common epithelial cancers
Presenter: Drew Deniger, Ph.D., Ziopharm Oncology
Date/Time: Saturday, Nov. 13, 2021 from 7:00 a.m. – 8:30 p.m. ET
Location: Walter E. Washington Convention Center, Hall E
Abstract Number: 226

In the study presented at SITC (Free SITC Whitepaper), Ziopharm’s non-viral gene transfer technology, Sleeping Beauty, was used to develop TCR-T cells targeting EGFR, KRAS and p53 neoantigens, which are present in cancer cells but not in normal tissue, and are presented by a variety of human leukocyte antigen (HLA) molecules on the cancer cell surface. Ziopharm’s Sleeping Beauty technology exhibited greater than 60% expression of the introduced neoantigen-specific TCRs in the generated TCR-T cells. The study demonstrated that the neoantigen-specific TCR-T cells successfully targeted tumor cells expressing EGFR, KRAS and p53 neoantigens in conjunction with the matching HLA restriction. Importantly, these TCR’s did not recognize cells lacking the matching mutations and HLA restrictions.

Istari Oncology Presents Data on Its PVSRIPO Immunotherapy at the Annual November Meetings for the Society for Immunology of Cancer (SITC) and the Society for Neuro-Oncology (SNO)

On November 9, 2021 Istari Oncology, Inc., a clinical-stage biotechnology company developing novel immunotherapies for the treatment of solid tumors, reported it will be presenting data on its investigative immunotherapy PVSRIPO for the potential treatment of solid tumors at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC; Washington D.C.; November 10-14) and the 26th Annual Meeting of the Society for Neuro-Oncology (SNO; Boston; November 18 – 21) (Press release, Istari Oncology, NOV 9, 2021, View Source [SID1234594830]).

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PVSRIPO is an investigational immunotherapy based on the live–attenuated Sabin type 1 poliovirus vaccine that has been genetically modified for safety. PVSRIPO has been shown to activate a patient’s innate and adaptive immune system to facilitate a systemic anti-tumor immune response. Because PVSRIPO utilizes CD155 (the poliovirus receptor) to enter both solid tumor cells and antigen–presenting cells (APCs) in the tumor microenvironment, PVSRIPO has the potential to treat a variety of cancers.

Details of Istari Oncology’s SITC (Free SITC Whitepaper) Presentations – Focusing on PVSRIPO’s recall MOA and recent expansion into head and neck cancer
Title: Poster Presentation: (517) LUMINOS-103: A basket trial evaluating the safety and efficacy of PVSRIPO and PVSRIPO in combination with anti-PD-1/L1 checkpoint inhibitors in patients with advanced solid tumors
Presenter: Brant A. Inman MD, MS
Presentation time: 11/12/2021 from 7:00 – 8:30 p.m. EST
Location: Poster Hall, Walter E. Washington Convention Center, Washington D.C.

Title: Poster Presentation: (739) Intratumor childhood vaccine-specific CD4+ T cell recall helps antitumor CD8 T cells
Presenter: Michael Brown, PhD
Presentation time: 11/12/2021 from 7:00 a.m. – 8:30 p.m. EST
Location: Poster Hall, Walter E. Washington Convention Center, Washington D.C.

Details of Istari Oncology’s SNO Presentations – Focusing on preclinical and clinical safety data supporting the company’s work in glioblastoma
Title: Poster Presentation: (CTIM-18) LUMINOS-101: Initial safety and tolerability of PVSRIPO and pembrolizumab combination therapy in recurrent glioblastoma
Presenter: Andrew Sloan, MD
Presentation time: 11/18 – 11/21 from 7:30 – 9:30 p.m. EST
Location: Exhibit Hall D, Hynes Convention Center, Boston, MA

Title: Poster Presentation: (BIOM-20) Tumor-intrinsic and peripheral features associate with survival after polio virotherapy in recurrent GBM
Presenter: Michael Brown, PhD
Presentation time: 11/18 – 11/21 from 7:30 – 9:30 p.m. EST
Location: Exhibit Hall D, Hynes Convention Center, Boston, MA

Title: Abstract Presentation: (IMMU-26) Safety and efficacy of PVSRIPO in recurrent glioblastoma: long-term follow-up and initial multicenter results
Presenter: Annick Desjardins, MD, FRCPC
Presentation time: 11/19 from 4:50 – 4:55 p.m. EST
Location: Room 207, Hynes Convention Center, Boston, MA

Title: Abstract Presentation: (EXTH-77) Polio virotherapy of murine brain tumors includes microglia proliferation and inflammation that is potentiated by immune checkpoint blockade
Presenter: Yuanfan Yang, MD
Presentation time: 11/21 from 11:50 – 11:55 a.m. EST
Location: Room 208, Hynes Convention Center, Boston, MA

For more information about Istari Oncology and its ongoing clinical trials, visit www.istarioncology.com.

About PVSRIPO
PVSRIPO is an investigational immunotherapy based on the live-attenuated Sabin type 1 poliovirus vaccine that has been genetically modified for safety. PVSRIPO targets cells using the poliovirus receptor CD155, which is widely expressed on both the malignant cells of most solid tumors and key antigen-presenting cells (APCs) within the tumor microenvironment. PVSRIPO targets tumors using three key mechanisms: 1) engagement and activation of APCs, leading to T cell priming and sustained, systemic anticancer immunity; 2) direct tumor cell killing and antigen release; and 3) amplification of the immune response via recall of poliovirus vaccine-specific T cells. PVSRIPO has been granted Breakthrough Therapy and Orphan Drug Designation status by the U.S. Food and Drug Administration in recurrent glioblastoma, and Fast Track and Orphan Drug Designation status in refractory melanoma.

Pacira BioSciences Reports Preliminary Net Product Sales of $44.3 Million for October 2021

On November 9, 2021 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported preliminary unaudited net product sales (Press release, Pacira Pharmaceuticals, NOV 9, 2021, View Source [SID1234594829]). EXPAREL (bupivacaine liposome injectable suspension) net product sales of $42.5 million for the month of October 2021, compared with $40.7 million for the prior year. Net product sales of iovera° were $1.2 million for the month of October 2021, compared with $1.0 million for the prior year. EXPAREL average daily sales for the month of October 2021 were 109 percent of October 2020. The company reports average daily growth rates for EXPAREL to account for differences in the number of selling days per reporting period. EXPAREL selling days were 21 in October 2021 and 22 in October 2020.

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"EXPAREL utilization continues to significantly outperform the elective surgery market with October sales trends showing a reduction in pandemic-related challenges and giving us further confidence in our outlook for strong growth in the fourth quarter," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "Integration planning continues to progress, and we look forward to adding ZILRETTA to our commercial offering after our previously announced acquisition of Flexion closes. ZILRETTA is expected to provide significant operational synergies, accretion, and growth potential that we believe will be further fueled by our complementary call points and extensive commercial infrastructure. Looking ahead, we believe we are well positioned to deliver topline annual growth in the high teens with operating margins that exceed 50 percent by the end of our 5-year planning period."

The company’s net product sales were negatively impacted by the COVID-19 pandemic in 2020 due to the significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020, allowing EXPAREL sales to return to year-over-year growth in June 2020. However, while many restrictions have since eased and COVID-19 vaccines have become more widely available and administered to the general public, it is still unclear how long it will take the elective surgery market to normalize, or if restrictions on elective procedures will recur due to COVID-19 variant strains or otherwise.

To provide greater transparency, the company is reporting monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. The financial information included in this press release is preliminary, unaudited, and subject to adjustment. It does not present all information necessary for an understanding of the company’s financial results for the fourth quarter or full year 2021.

Incyte to Present at Upcoming Investor Conference

On November 9, 2021 Incyte (Nasdaq:INCY) reported that it will present at the Evercore ISI 4th Annual HealthCONx Conference (Virtual) on Tuesday, November 30, 2021 at 2:15 p.m. ET (Press release, Incyte, NOV 9, 2021, View Source [SID1234594828]).

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The presentation will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 30 days.