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.

On October 6, 2021 Defence Therapeutics, a biotechnology company working on cancer therapeutics and infectious disease vaccines is finalizing all required steps in preparation to a pre-IND meeting to initiate a phase I trial against melanoma using its DC cancer vaccine candidate AccuVAC-D002 (Press release, Defence Therapeutics, OCT 6, 2021, View Source [SID1234626237]).

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Defence has successfully exploited the use of its AccumTM technology platform to develop a large pipeline of products in immune-oncology and infectious diseases. Amongst its lead products is AccuVAC-D002, a DC-based cancer vaccine engineered to treat melanoma. The AccumTM technology platform is very efficient at enhancing intracellular delivery of proteins of pharmacological interests such as ADCs or vaccine antigens. Defence’s scientific team recently identified a novel function for the use of "free" AccumTM and its recently developed variants as anti-cancer molecules.

"We have successfully moved our product pipeline forward and developed various cancer vaccines including AccuVAC-D002. With the synopsis in hand, we are actively working with a large established CRO in the USA to identify and set-up the site for our Phase I against melanoma in the first half of 2022", says Mr. Plouffe, CEO of Defence Therapeutics.

Defence Therapeutics has antibody-drug conjugates and vaccines in late-stage pre-clinical development and/or undergoing GLP studies. With two DC cancer vaccines (AccuVAC-D001 and D002) undergoing manufacturing in clean rooms, Defence is most likely to initiate its Phase I trials in Q1/Q2 of 2022.

Skin Cancer Treatment Market to reach USD 14.55 Billion with a 7.5% CAGR by 2027, according to a report by Fortune Business InsightsTM.

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).

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
***

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.

On October 6, 2021 Precirix NV, a clinical-stage biotechnology company developing precision radiopharmaceuticals in oncology, reported that it has dosed the first patients in its Phase I/II clinical study of CAM-H2 for the treatment of HER2-positive metastatic cancer (Press release, Precirix, OCT 6, 2021, View Source [SID1234590885]). This is a major milestone in the company’s development of its lead therapeutic asset.

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The Phase I/II trial (NCT04467515) evaluates safety, tumor uptake, tumor retention and early signs of antitumor activity of single-agent CAM-H2 in HER2-positive metastatic breast and gastric/gastro-esophageal cancer patients that have relapsed or are refractory to available anti-HER2 therapies. The trial is a continuous study composed of two parts: a Phase I dose-escalation phase to establish the recommended dose for Phase II in 3+3 dose-ascending cohorts of patients, followed by a Phase II dose-expansion phase. The Phase I/II clinical study will allow inclusion of patients with brain metastases, a population in dire need of effective therapies, and will enroll a total of appr. 70 patients.

Ruth Devenyns, CEO commented: "We are very excited to have dosed the first patients in this clinical study, the result of years of thorough scientific research, collaboration and operational excellence of our entire team and partners. Special thanks to our former CMO Ruggero Della Bitta, for his contribution to our global clinical development strategy and securing regulatory clearance for the Phase I/II trial. We look forward to recruiting additional patients and generating efficacy data to confirm the strong results from our preclinical and first-in-human studies, with the goal of bringing new treatment options to cancer patients."

About CAM-H2

CAM-H2 comprises a single-domain antibody targeting HER2, covalently linked to iodine-131. Single-domain antibodies are ideally suited for targeted delivery of radiation to tumors given their size, specificity and pharmacokinetic characteristics. Imaging studies conducted with the HER2 targeting single-domain antibody labelled with gallium-68 have demonstrated specific uptake and retention in primary, metastatic and brain lesions in HER2-positive breast cancer patients.

About HER2-positive cancer

Worldwide, >1.6 m cases of breast cancer and >1.2m cases of gastric cancer are diagnosed annually, of which >20% are HER2-positive. In breast cancer, some 60% of the patient population develops metastatic disease, with brain metastases occurring in up to 50% of metastatic patients1,2. HER2 is also overexpressed in subsets of patients with other solid tumors including biliary tract, colorectal, non-small-cell lung and bladder cancer3.

HER2 is an established therapeutic target and a variety of agents targeting HER2 have been approved, however none of these cure metastatic disease. Specifically in brain metastases there are limited treatment options. There are no approved HER2 targeting radiopharmaceuticals and CAM-H2 is the lead candidate in therapeutic development, leveraging the advantages of using a single-domain antibody to deliver targeted radiation to the tumor and bringing a new mechanism of action in the current HER2 treatment landscape to address important unmet medical needs, including brain metastases and low HER2 expression.