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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EQRx and Absci Announce Partnership to Discover and Develop Next-Generation Protein-Based Drugs

On October 6, 2021 EQRx, a new type of pharmaceutical company committed to developing and delivering important new medicines to patients at radically lower prices, and Absci Corporation (Nasdaq: ABSI), the drug and target discovery company harnessing deep learning AI and synthetic biology to expand the therapeutic potential of proteins, reported a discovery collaboration (Press release, EQRx, OCT 6, 2021, View Source [SID1234590862]).

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The partnership will leverage Absci’s Drug Creation technology for discovery and development activities, along with EQRx’s clinical development expertise and commercial capabilities, to advance next-generation, protein-based therapeutics at more affordable costs for patients. EQRx and Absci will collaborate to jointly engineer and develop several clinical candidates across multiple therapeutic areas, including oncology and immunology. At Absci’s option, it may make additional investments at progressive stages of development in exchange for an increased share of product sales.

"Absci’s technology platform enables rapid discovery and production of well-differentiated protein-based drugs that are elusive to other discovery approaches," said Carlos Garcia-Echeverria, Ph.D., chief of Rx creation at EQRx. "We are excited to work with Absci towards our goal of providing innovative, cost-effective treatment options for patients."

"This collaboration with EQRx expands the reach of our AI-powered target discovery, drug design and development technology," said Sean McClain, founder and CEO of Absci. "Together, we look forward to discovering differentiated next-generation biologics, driving efficiencies, and accelerating timelines so that our future medicines can have the biggest possible impact for patients in need."

Voyager Therapeutics Announces License Option Agreement with Pfizer for Next-Generation TRACERᵀᴹ AAV Capsids to Enable Neurologic and Cardiovascular Gene Therapy Programs

On October 6, 2021 Voyager Therapeutics, Inc. (Nasdaq: VYGR), a gene therapy company developing life-changing treatments and next-generation adeno-associated virus (AAV) platform technologies, reported an agreement through which Pfizer Inc (NYSE: PFE) may exercise options to license novel capsids generated from Voyager’s RNA-driven TRACERTM (Tropism Redirection of AAV by Cell-type-specific Expression of RNA) screening technology as part of Pfizer’s efforts to develop, manufacture, and commercialize gene therapies, utilizing two undisclosed transgenes to treat certain neurologic and cardiovascular diseases (Press release, Voyager Therapeutics, OCT 6, 2021, View Source [SID1234590861]).

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"This transaction highlights the potential of our TRACER platform to identify novel AAV capsids that target desired cells and tissues with greater specificity at lower doses and with fewer off-target risks than conventional AAV serotypes," said Michael Higgins, Interim CEO of Voyager. "We believe that our TRACER platform has the ability to produce not only enhanced blood-brain-barrier penetrant capsids, but also novel capsids with enhanced tropisms across a diversity of tissues and cell types, offering promise to unlock the fullest potential of gene therapies for a wide array of diseases with unmet medical need."

"Our collaboration with Voyager will provide Pfizer with access to additional AAV capsids that may help further advance our industry-leading gene therapy portfolio," said Seng Cheng, Ph.D., Senior Vice President and Chief Scientific Officer of Pfizer’s Rare Disease Research Unit. "We are impressed with Voyager’s results to date and are enthusiastic about the potential to utilize these novel capsids to help accelerate the development of new therapeutic options for patients living with certain neurologic and cardiovascular diseases."

Proprietary AAV capsids derived from Voyager’s TRACER platform have demonstrated superior blood-brain-barrier penetration, enhanced cardiac muscle tropism, and increased transgene expression in target tissues compared to conventional AAV capsids as measured in non-human primates (NHPs). Voyager presented data at the 24th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) for one capsid candidate demonstrating more than 1,000-fold increased transgene expression compared to conventional AAV9 across a wide array of brain regions when dosed intravenously in NHPs. Results presented also included another capsid candidate showing significantly enhanced cardiac muscle transduction and dorsal root ganglia de-targeting compared to conventional AAV9. Voyager is performing further screening with its TRACER platform to identify additional proprietary AAV capsids targeting multiple tissue and cell types for use in gene therapies to treat a broad range of diseases.

Under the terms of the agreement, Pfizer will have the right to evaluate novel capsids selected for central nervous system and cardiac tropisms from Voyager’s TRACER platform and to exercise options to license capsids for exclusive use in Pfizer’s development of AAV gene therapies incorporating two undisclosed transgenes. These transgenes will be distinct from those planned for Voyager’s internal pipeline. Voyager will retain global rights to all licensed capsids for use with other transgenes and to all other applications of its TRACER technology.

Voyager will receive $30 million upfront and is entitled to receive up to $20 million in exercise fees for two options, exercisable by Pfizer within 12 months of signing. In addition, Voyager will be eligible to earn up to $580 million in total development, regulatory, and commercial milestones associated with licensed products incorporating the two undisclosed Pfizer transgenes together with a Voyager licensed capsid. Voyager is also eligible to receive mid- to high-single-digit tiered royalties based on net sales of Pfizer’s products incorporating the licensed capsids.

About the TRACER AAV Capsid Discovery Platform
Voyager’s TRACER system is a broadly applicable, RNA-based functional screening platform that allows for rapid in vivo evolution of AAV capsids with enhanced tropisms and cell- and tissue-specific transduction properties in multiple species, including non-human primates (NHPs). Initial data from the first of many libraries screened in NHPs demonstrated the proprietary capsid variants effectively penetrated the blood-brain barrier and achieved widespread biodistribution and transduction of multiple regions of the brain. Separate results have demonstrated the ability of certain capsids to transduce cardiac muscle and to de-target the dorsal root ganglia. Voyager is proceeding with additional capsid campaigns derived from AAV9 and other capsid serotypes to identify novel AAV vectors optimized for specific therapeutic applications.