Targovax ASA: Two abstracts accepted at the SITC Congress

On October 6, 2021 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that two abstracts has been accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.
The abstracts will be released on the SITC (Free SITC Whitepaper) website 9 November 14:00 CEST (www.sitcancer.org/2021/home). The posters are scheduled for presentation during the SITC (Free SITC Whitepaper) congress 12-14 November 2021.

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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
Lead author: 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
Lead author: Lukasz Kuryk, PhD, Director Clinical Science, Targovax
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About SITC (Free SITC Whitepaper)

The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting & Pre-Conference Programs brings together stakeholders across the cancer immunotherapy field to advance the science, discover breakthroughs and educate the world on cancer immunotherapy.

As the largest conference solely focused on cancer immunotherapy, the Annual Meeting & Pre-Conference Programs provides international leaders from academia, regulatory and government agencies, as well as industry representatives with a multidisciplinary educational and interactive environment focused on improving outcomes for all cancer patients.

Viracta Therapeutics Initiates Phase 1b/2 Trial in Epstein-Barr Virus-Positive (EBV+) Solid Tumors

On October 6, 2021 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, reported the initiation of a multinational Phase 1b/2 trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) and other EBV+ solid tumors (Press release, Sunesis, OCT 6, 2021, View Source [SID1234590868]). The trial is designed to evaluate the safety and preliminary efficacy of nanatinostat in combination with valganciclovir (Nana-val) alone and in combination with the PD-1 checkpoint inhibitor pembrolizumab.

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"The initiation of this Phase 1b/2 trial is a key step towards expanding the development of our unique therapeutic approach beyond EBV+ lymphoproliferative disorders. Nasopharyngeal carcinoma is highly associated with EBV, and treatment options for patients with advanced or recurrent EBV+ solid tumors are limited," said Lisa Rojkjaer, M.D., Chief Medical Officer of Viracta. "We are encouraged by the preliminary data that Nana-val has demonstrated in relapsed/refractory EBV+ lymphoma and look forward to evaluating the activity of our novel oral combination regimen in patients with EBV+ solid tumors."

The Phase 1b/2 trial is an open-label, multicenter trial evaluating Nana-val alone and in combination with pembrolizumab. The Phase 1b dose escalation portion is designed to evaluate safety and to determine the recommended Phase 2 dose (RP2D) of Nana-val in patients with EBV+ RM-NPC. In Phase 2, up to sixty patients with EBV+ RM-NPC will be randomized to receive Nana-val at the RP2D with or without pembrolizumab, to evaluate safety, overall response rate, and potential pharmacodynamic markers. Additionally, patients with other EBV+ solid tumors will be enrolled to receive Nana-val at the RP2D in a Phase 1b dose expansion cohort.

About Nanatinostat

Nanatinostat (VRx-3996) is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing viral genes that are epigenetically silenced in EBV-associated malignancies. Nana-val (nanatinostat and valganciclovir) is being investigated in multiple subtypes of relapsed/refractory EBV+ lymphoma and in advanced EBV+ solid tumors in three ongoing trials, one of which is a registration-enabling global, multicenter, open-label Phase 2 basket trial in relapsed/refractory EBV+ lymphoma (NAVAL-1).

Pancreatic cancer: a new treatment available for Argentine patients

On October 6, 2021 Servier reported the launch in Argentina of a new treatment for patients suffering from pancreatic cancer (Press release, Servier, OCT 6, 2021, View Source;utm_medium=rss&utm_campaign=pancreatic-cancer-a-new-treatment-available-for-argentine-patients [SID1234590866]).

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Argentina is the first Latin American country in which Servier has launched a treatment for this type of cancer. This is the third medicine launched by Servier in Argentina in oncology.

Pancreatic cancer in Argentina has an incidence of 4,900 new cases per year, with high mortality rates. It is the 4th cause of death by cancer and accounts for 6.9% of all deaths from cancer in Argentina.1

"The arrival of this new treatment in Argentina is excellent news for patients," said Nelson Da Conceicao, General Manager of Servier Argentina. "The medical need for the treatment to fight pancreatic cancer is particularly strong, with limited therapeutic alternatives."

To meet the growing need for therapeutic solutions, Servier has made oncology one of its top priorities, investing 50% of its annual R&D budget in this field starting in 2020/2021.2 These investments in R&D are complemented by major acquisitions, in order to increase the Group’s arsenal in oncology. In the past four years, Servier has acquired Shire’s oncology business (2018), Symphogen (2020), a Danish company specialized in monoclonal antibodies, and the oncology division of Agios Pharmaceuticals (2021).

"The availability of this medicine in Argentina marks an important step forward in Servier’s ambition to become a renowned player in oncology. The Group’s major involvement in the fight against cancer is now reflected in seven treatments available to patients worldwide,″ said Emmanuel Pradère, Director of the Oncology Franchise at Servier.

NANOBIOTIX to Present First Survival Data From Priority Head and Neck Cancer Program Among Five Presentations at the 2021 Annual Meeting of the American Society for Radiation Oncology

On October 6, 2021 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported two oral presentations and three poster presentations at the 2021 Annual Meeting of the American Society for Radiation Oncology (ASTRO) (Press release, Nanobiotix, OCT 6, 2021, View Source [SID1234590864]). The meeting will be held from October 24-27, 2021.

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"Bringing disruptive therapeutic solutions that expand treatment possibilities for patients with cancer starts with making a meaningful impact on survival," said Laurent Levy, co-founder and chairman of the executive board of Nanobiotix. "Delivering the first look at these exploratory endpoints in our phase I head and neck cancer study will provide useful insight into the potential of our innovation in our priority indication as we prepare to launch our global phase III. While we continue to develop NBTXR3 as a broadly applicable potential therapy across solid tumor types and therapeutic combinations in parallel, we also look forward to presenting updates in immunotherapy and soft tissue sarcoma as well."

Oral and Poster Presentation Details:

Local Control with NBTXR3 as a Single-Agent for Patients with Head and Neck Cancer

Poster presentation #2805: Phase I Study of Novel Radioenhancer NBTXR3 Activated by Radiotherapy in Cisplatin-Ineligible Locally Advanced HNSCC Patients by Christophe Le Tourneau, MD, PhD, on October 26 at 1:15 PM CDT / 8:15 PM CET
NBTXR3 Tumor-Agnostic, Therapeutic Combination-Agnostic Development Potential

Oral presentation #132: Overcoming Resistance to Anti-PD-1 With Tumor Agnostic NBTXR3: From Bench to Bedside by Tanguy Y. Seiwert, MD, on October 26 at 4:20 PM CDT / 11:20 PM CET
Priming Immune Response with NBTXR3 plus Anti-PD-1 in Advanced Cancers

Poster presentation #2739: NBTXR3 Activated by Radiotherapy in Combination with Nivolumab or Pembrolizumab in Patients with Advanced Cancers: A Phase I Trial by Colette Shen, MD, PhD, on October 25 at 4:00 PM CDT / 11:00 PM CET
Local Control with NBTXR3 as a Single-Agent for Patients with Soft Tissue Sarcoma

Oral presentation #77: Study of Novel Radioenhancer NBTXR3 Plus Radiotherapy in Patients with Locally Advanced Soft Tissue Sarcoma: Results of the Long-Term Evaluation in the Phase II/III Act.In.Sarc Trial by Sylvie Bonvalot, MD, PhD, on October 26 at 5:15 PM CDT / 12:15 AM CET
Preclinical Data on NBTXR3 plus Anti-PD-1 in Lung Cancer Model

Poster presentation #2865: NBTXR3 Nanoparticle with ImmunoRadiation Might Reshape Metastatic Tumor-Infiltrating T Cell Repertoire in Murine Lung Cancer Model by Chike O. Abana, MD, PhD, on October 26 3:30 PM CDT / 10:30 PM CET
About NBTXR3

NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as the primary development pathway. The company-sponsored phase I dose escalation and dose expansion study has produced favorable safety data and early signs of efficacy; and a phase III global registrational study is planned to launch in 2021. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the planned phase III study.

Nanobiotix has also prioritized an Immuno-Oncology development program—beginning with a Company sponsored phase I clinical study evaluating NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors for patients with locoregional recurrent or recurrent/metastatic HNSCC and lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3 , Nanobiotix has engaged in a strategic collaboration strategy with world class partners to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several phase I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations.

World Vaccine Congress Europe, 19-21 October 2021

On October 6, 2021 Gerben Zondag, Founder & COO of Immunetune, reported that it will be attending the World Vaccine Congress Europe, taking place October 19-21, 2021, in Barcelona, Spain (Press release, ImmuneTune, OCT 6, 2021, View Source [SID1234590863]). Feel free to reach out to us to set up a meeting and explore collaboration opportunities.

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