On April 14, 2021 HTL, the worldwide leader in biotechnology solutions using hyaluronic acid (HA) and other biopolymers, and Echelon Biosciences Inc., a U.S.-based global supplier of biochemical reagents, assays, and services to research and development laboratories, reported their new distribution and product development partnership (Press release, HTL Biotechnology, APR 14, 2021, View Source [SID1234578048]). The partnership will enable distribution of high-quality HA and glycosaminoglycan (GAG), and the co-development of novel GAG products.

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The partnership provides academic research and pharmaceutical development laboratories’ expanded access to Good Manufacturing Practices (GMP)-grade, kit-packaged hyaluronic acid and glycosaminoglycan (GAG) products. By offering premium, clinical grade products to early-stage research investigators, the partnership seeks to bridge the gap between lab-based research, development and commercialization, and accelerate innovation worldwide.

"Innovation is at the heart of HTL’s DNA," said HTL CEO Yvon Bastard. "This growth opportunity reinforces our mission and vision to apply science for increased bio-compatibility and improved health outcomes around the world."

"This new partnership offers scientists and researchers the key technologies to develop innovative biopolymer solutions for new medical applications in aesthetics, ophthalmology, rheumatology, tissue engineering and drug delivery," said Charles Ruban, HTL deputy CEO. "This is the true meaning of HTL’s tagline of ‘Beyond, together.’ HTL’s ambition is not only to grow its lead position in producing and distributing hyaluronic acid worldwide, but also to build tomorrow’s glycosaminoglycan-based solutions."

"Echelon has been granted the opportunity to expand its market-leading HA assays and extra cellular matrix product line with the supply of HTL’s hyaluronic acid and other GAG-derived products. HTL is recognized internationally for producing biopolymers of premium quality," says Bert Israelsen, president of Echelon Biosciences. "Echelon offers our customers access to the latest innovative tools with unparalleled technical support, thereby fully enabling maximized creativity in basic and applied research. With its fermentation and organic synthesis platforms, HTL creates functionality and added value by developing chemically modified biopolymers tailored to specific needs."

"This new partnership is a milestone in HTL’s expanding footprint in the North American market and with the U.S. medical community," said Glenn Prestwich, Ph.D., one of Echelon’s founders and now HTL’s exclusive science and innovation advisor for this market. By entrusting Echelon with the distribution of HTL’s hyaluronic acid and glycosaminoglycan products for research use, HTL aims to significantly increase its support and involvement in biopolymer research in the U.S. and worldwide, but also its research and development capacity.

"This new initiative demonstrates HTL’s commitment to invest in innovation in healthcare," said Humberto C. Antunes, strategic advisor to HTL and former CEO of Galderma. "In the fields of health and wellness, the biotechnology ecosystem of innovation, incubators, and established and emerging companies are incredibly dynamic in the United States, Mexico and Canada. It means a huge growth potential for HTL products," added Antunes.

On April 14, 2021 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported the dosing of the first cancer patient with agenT-797, an allogeneic iNKT cell therapy, in a Phase 1 clinical trial through its subsidiary, AgenTus Therapeutics (Press release, Agenus, APR 14, 2021, View Source [SID1234578047]).

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"Our proprietary iNKT cell therapy has been advancing in the clinic in patients with acute respiratory distress syndrome (ARDS) secondary to COVID-19; we are now expanding our iNKT cell therapy to treat patients with cancer," said Jennifer Buell, PhD, President and COO of Agenus. "iNKT cells penetrate tissues, demonstrate potent tumor killing, and show compelling curative potential in solid tumor models with activating iNKT cell therapies and checkpoint antibodies. We are thrilled to advance this cell therapy for broader benefit in patients with solid tumors and in combination with antibodies."

The Phase 1 trial has been initiated in hematologic cancers, with expansion into solid tumors expected to begin shortly. Led by Clifton Mo, MD, Director of Autologous Stem Cell Transplantation for Multiple Myeloma at the Dana-Farber Cancer Institute, the Phase I dose-escalation trial will explore the safety, tolerability, and preliminary clinical activity of agenT-797 in patients with relapsed/refractory multiple myeloma. Agenus anticipates initial data readouts for the Phase 1 study in the fourth quarter of 2021.

A Phase 1 trial of agenT-797 for intubated patients with moderate to severe symptoms of COVID-19 was initiated in late 2020. Preliminary data show no adverse events attributable to agenT-797 and suggest early signals of activity. Dose escalation is expected to be completed in the first half of 2021 with expansion into a Phase 2 trial with data readouts expected this year.

iNKT cell therapy is expected to eliminate graft-versus-host disease, may not require genetic manipulation, and can be manufactured to treat large numbers of patients from a single dose. These attributes support the possibility of a safer and more affordable and accessible therapy than currently approved cell therapies.

As a subsidiary of Agenus, AgenTus currently has unique access to Agenus’ portfolio of checkpoint antibodies and cancer vaccines which allows for optimal combinations with its cell therapies. This gives the company enormous flexibility to develop effective combinations with curative potential for patients with cancer and infectious disease.

On April 14, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, and Lonza reported that the companies have entered into an agreement for the manufacture of ATYR2810, aTyr’s monoclonal antibody targeting Neuropilin-2 (NRP2) that is currently in preclinical development for cancer (Press release, aTyr Pharma, APR 14, 2021, View Source [SID1234578046]).

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Under the terms of the agreement, Lonza will utilize its Ibex Design, a fully integrated end-to-end program, to manufacture cGMP material for ATYR2810. The agreement will cover the early stages from gene to Investigational New Drug (IND) and will provide both drug substance (DS) and drug product (DP) to support toxicological studies in animals and early clinical development in humans.

The scope will include process support, including cell line development, process development, and supply chain simplification, to DS and DP manufacturing at Lonza’s Visp and Stein (CH) sites.

"As we prepare to advance ATYR2810 to clinical stage development, we are pleased to work with Lonza, a partner with extensive and proven capability in antibody manufacturing, for the production of our first anti-NRP2 antibody," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "Having recently initiated IND-enabling activities for ATYR2810 following some compelling preclinical data in triple-negative breast cancer, strengthened by additional data in lung cancer, this agreement with Lonza reflects our commitment to this program and will support our efforts to eventually advance ATYR2810 to in-patient trials in cancer, including certain aggressive tumors where NRP2 is implicated."

"We look forward to supporting aTyr as they advance their novel therapeutic antibody from preclinical stages into the clinic. This collaboration signifies our commitment and flexibility in accommodating the specific and unique needs of small biotech companies," said Jennifer Cannon, Senior Vice President, Global Head of Mammalian Biologics, Lonza.

About ATYR2810

aTyr is developing ATYR2810 as a potential therapeutic for certain aggressive tumors where Neuropilin-2 (NRP2) is implicated. ATYR2810 is a fully humanized monoclonal antibody that is designed to specifically and functionally block the interaction between NRP2 and one of its primary ligands, VEGF. ATYR2810 is the first Investigational New Drug (IND) candidate to arise from aTyr’s in-house research program designing monoclonal antibodies to selectively target the NRP2 receptor and its associated signaling pathways. NRP2 is a cell surface receptor that is highly expressed in certain tumors, in the lymphatic system and on key immune cells implicated in cancer progression. Increased NRP2 expression is associated with worse outcomes in many cancers. Preclinical data suggest that ATYR2810 could be effective against certain types of solid tumors. ATYR2810 is currently undergoing IND-enabling studies.

On April 14, 2021 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), a biotechnology company focused on cytokine-based intratumoral immunotherapies, reported that it has received authorization to CE mark its proprietary next generation go-to-market gene delivery device, GenPulse, a part of the OncoSec Medical System (OMS) electroporation device platform for use in solid tumors (Press release, OncoSec Medical, APR 14, 2021, View Source [SID1234578041]). The CE mark certification augments the Notified Body certification to the International Organization for Standardization’s (ISO) 13485 standard for the design, development, manufacture and distribution of electroporation devices, which is renewed annually, subject to a successful audit. The GenPulse is the gene electrotransfer device which OncoSec plans to deploy commercially, both in the U.S. and the European Union (EU).

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"This CE certification is an essential regulatory milestone on OncoSec’s road to commercialization in Europe," said Robert Ashworth, Senior Vice President, Regulatory Quality and CMC at OncoSec. "The CE mark on our proprietary GenPulse generator represents the culmination of years of work and demonstrates that OncoSec has the capability to manufacture and develop a device that meets performance, quality and safety requirements in the EU."

A CE mark indicates the OMS electroporation device complies with Directives of the European Commission (EC) and therefore can be marketed within the 31-nation European Economic Area (EEA) and Switzerland. This OMS electroporation device applies short electric impulses to a tumor, causing pores to open in the membrane of cancer cells, significantly increasing the uptake of anti-cancer agents into these cells. The CE mark certification involved a comprehensive audit of the company’s quality system, as well as thorough evaluation and testing of the OMS electroporation device to assure it performs safely and as designed.

On April 14, 2021 Veracyte (Nasdaq: VCYT) reported a key milestone in its companion diagnostics program with Acerta Pharma, the hematology research and development arm of AstraZeneca (LSE/STO/NYSE: AZN) (Press release, Veracyte, APR 14, 2021, View Source [SID1234578040]). The first patient has been enrolled and randomized in Acerta Pharma’s Phase 3 ESCALADE trial, which is using Veracyte’s LymphMark lymphoma subtyping test to identify patients with untreated diffuse large B-cell lymphoma (DLBCL) who may benefit from Acerta and AstraZeneca’s acalabrutinib (Calquence) in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) therapy.

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The randomized, double-blind, placebo-controlled ESCALADE study is designed to evaluate the efficacy and safety of acalabrutinib with R-CHOP therapy as compared to placebo plus R-CHOP in patients aged 18-65. The study is expected to enroll up to 600 participants at centers around the world. Study investigators are using the investigational LymphMark genomic test to select patients with non-germinal center B-cell (non-GCB) subtype DLBCL, an aggressive form of the disease that is associated with worse outcomes following the traditional chemoimmunotherapy regimen (R-CHOP).

"The initiation of this global study marks an important step in our multi-year companion diagnostics program with Acerta Pharma," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "By distinguishing DLBCL patients based on the genomic underpinning of their disease, we believe the LymphMark test will help identify patients early on who are more likely to respond to targeted therapies such as Calquence that may improve outcomes."

DLBCL patients respond to treatment differently based on the molecular subtype of their tumors. The LymphMark test uses gene-expression profiling of RNA extracted from surgical tissue to classify the "cell of origin" subtype of DLBCL tumors. The World Health Organization recommends gene-expression profiling for patients with DLBCL, which may potentially be mitigated by more specific treatments that are under development.i By identifying the specific subtypes in individual patients’ tumors, physicians can help ensure the right patients are included in clinical trials evaluating these therapies.

Non-Hodgkin lymphoma (NHL) ranks among the top-10 common cancers worldwide, with over 500,000 new cases estimated in 2018.ii DLBCL is the most common type of NHL, accounting for approximately 30 percent of lymphomas.iii

The LymphMark test is intended for use on the nCounter Analysis System. Veracyte acquired the LymphMark test, as well as the exclusive global diagnostic rights to the nCounter system, in December 2019.