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.

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.

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.

On November 9, 2021 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that the posters being presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting now are available at the Company’s website (Press release, Targovax, NOV 9, 2021, View Source [SID1234594805]).

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Both posters are scheduled for presentation 13 November 2021 at the SITC (Free SITC Whitepaper) congress.

Poster title: A randomised open-label phase I/II study adding ONCOS-102 to pemetrexed/cisplatin in patients with unresectable malignant pleural mesothelioma – 24-month survival data
E-poster number: 462
Presenter: Dr Luis Paz-Ares, Medical Oncology, Hospital Universitario 12 Octubre, Madrid, Spain
Poster title: Consistent pattern of immune activation induced by oncolytic adenovirus ONCOS-102 across diverse types of solid tumors
E-poster number: 368
Presenter: Dr Lone Ottesen, Chief Development Officer, Targovax

On November 9, 2021 Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company developing transformative, targeted therapeutics to treat life-threatening cancers, reported that positive new data from the Phase 1b portion of its open-label Phase 1b/2 trial evaluating batiraxcept (AVB-500) in combination with cabozantinib in patients with clear cell renal cell carcinoma (ccRCC) will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting on November 13, 2021 (Press release, Aravive, NOV 9, 2021, View Source [SID1234594804]). The presentation will highlight interim safety, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity data.

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"We are encouraged by the preliminary performance of batiraxcept in combination with cabozantinib in patients with clear cell renal cell carcinoma," said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. "These results highlight the potential of batiraxcept to improve outcomes for patients with advanced kidney cancer. We look forward to sharing these new clinical data with the research and medical community at this year’s SITC (Free SITC Whitepaper) Annual Meeting."

As of July 21, 2021, seven patients received at least one dose of batiraxcept 15 mg/kg in combination with cabozantinib, six patients were ongoing treatment, and five patients were evaluable for efficacy. No dose-limiting toxicities were observed. Trough levels at cycle 1 day 15 were above the minimal efficacious concentration identified from the Company’s model informed drug development approach, and serum GAS6 levels were suppressed prior to cycle 2 day 1. A best overall response of partial response was observed in 3 of 5 patients (60%, unconfirmed as of July 21, 2021), based on investigator assessment, RECIST v 1.1 criteria. In addition, all patients demonstrated tumor decrease from baseline.

Aravive’s presentation at the SITC (Free SITC Whitepaper) Annual Meeting will include updated safety, PK, PD, and clinical activity data from a larger set of patients treated with batiraxcept 15 mg/kg in combination with cabozantinib as of October 16, 2021.

Poster Presentation Details

Title: A Phase 1b/2 randomized study of AVB-S6-500 in combination with cabozantinib versus cabozantinib alone in patients with advanced clear cell renal cell carcinoma who have received front-line treatment

Presenter: Reshma Rangwala, M.D., Ph.D., Chief Medical Officer of Aravive

Date: November 13, 2021

Time: 7:00 AM – 8:30 PM ET

Location: Hall E

For additional information, please visit the SITC (Free SITC Whitepaper) 36th Annual Meeting website: View Source

Conference Call Information
Aravive will host a conference call and webcast on November 12, 2021 at 8:30 a.m. ET to discuss these clinical data. The conference call may be accessed by dialing (877) 423-9813 (domestic) and (201) 689-8573 (international) and referring to conference ID 13724115. A webcast of the conference call will be available in the Investors section of the Aravive website at View Source The archived webcast will be available on Aravive’s website after the conference call.

About the Batiraxcept (AVB-500) Phase 1b/2 ccRCC Trial
Aravive initiated the Phase 1b portion of the Phase 1b/2 trial of batiraxcept in ccRCC in March 2021. The Phase 1b portion of the clinical trial, a dose escalation study, is expected to enroll approximately 18 patients in three dosing arms (15 mg/kg, 20 mg/kg and 25 mg/kg) to evaluate tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of batiraxcept in combination with cabozantinib. The controlled, randomized, open-label Phase 2 portion of the clinical trial is expected to enroll approximately 45 patients and investigate the recommended batiraxcept dose identified during the Phase 1b portion of the clinical trial in combination with cabozantinib versus cabozantinib alone. The primary endpoint is progression-free survival. The trial is enrolling patients with advanced ccRCC who have progressed on front-line treatment. The Phase 1b/2 trial is listed on clinicaltrials.gov NCT04300140.

About Batiraxcept (AVB-500)
Batiraxcept is a therapeutic recombinant fusion protein that has been shown to neutralize GAS6 activity by binding to GAS6 with very high affinity in preclinical models. In doing so, batiraxcept selectively inhibits the GAS6-AXL signaling pathway, which is upregulated in multiple cancer types including ovarian, renal and pancreatic cancer. In preclinical studies, GAS6-AXL inhibition has shown anti-tumor activity in combination with a variety of anticancer therapies, including radiation therapy, immuno-oncology agents, and chemotherapeutic drugs that affect DNA replication and repair. Increased expression of AXL and GAS6 in tumors has been correlated with poor prognosis and decreased survival and has been implicated in therapeutic resistance to conventional chemotherapeutics and targeted therapies. Batiraxcept is currently being evaluated in multiple clinical trials and has been granted Fast Track designation by the U.S. Food and Drug Administration and orphan drug designation by the European Commission in platinum resistant recurrent ovarian cancer.