On April 14, 2021 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX) (Paris:ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported the completion of patient recruitment in its Phase 1/2 brain cancer study with lead candidate, NOX-A12 plus radiotherapy (Press release, NOXXON, APR 14, 2021, View Source [SID1234578050]). All three patients participating in the third and final dose cohort have been successfully enrolled and received initial treatment. NOXXON’s Phase 1/2 clinical study is investigating three dose regimens of CXCL12 inhibitor, NOX-A12 (200, 400 and 600 mg/week), each combined with external beam radiotherapy in newly diagnosed brain cancer patients.

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Once the last patient in the third cohort completes four weeks of therapy with NOX-A12 combined with radiotherapy, the independent Data Safety Monitoring Board (DSMB) will convene to assess the safety and tolerability of 600 mg NOX-A12 per week, the highest dose planned in the study. As outlined in the approved study protocol, it is planned for each patient to be treated with NOX-A12 for up to six months. Top-line data from this arm is planned to be available in November 2021.

"The combination of NOX-A12 and radiotherapy has been well tolerated by the participating patients so far. In the upcoming and final planned DSMB meeting, the safety of the highest dose tested will be assessed. Once patients have received treatment over a longer time period, the clinical investigators will analyze all available trial data to define the recommended dose for a Phase 2 glioblastoma study," said Prof. Frank Giordano, Director and Chair of the Department of Radiation Oncology at the University Hospital Bonn.

"Completing patient recruitment for this dose escalation study is an important step in the continued clinical assessment of our novel therapy for patients with difficult-to-treat and highly aggressive brain cancer. We are currently preparing the submission of a protocol amendment to allow the inclusion of additional patients with the goal of expanding the data base for the recommended Phase 2 dose. In addition, our expansion aims to create a basis for enrolling a broader group of patients in future studies, in particular brain cancer patients who would also receive chemotherapy in addition to NOX-A12. Notably, this would allow NOX-A12 to be tested in all first line glioblastoma patients," commented Aram Mangasarian, CEO of NOXXON.

On April 14, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported data from an independent, prospective study published in the American Journal of Surgery demonstrating DecisionDx-Melanoma’s utility for prediction of outcomes in patients with cutaneous melanoma (Press release, Castle Biosciences, APR 14, 2021, View Source [SID1234578049]). DecisionDx-Melanoma is Castle’s gene expression profile test that uses an individual patient’s tumor biology to predict risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors.

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The publication, titled "Utility of a 31-gene expression profile for predicting outcomes in patients with primary cutaneous melanoma referred for sentinel node biopsy," describes a study comparing tumor features, sentinel node biopsy (SLNB) results, and patient outcomes from a prospective database of 383 patients with cutaneous melanoma who both underwent SLNB and had their primary tumor assayed with DecisionDx-Melanoma. Groups were compared by univariate and multivariate analyses, and relapse-free and distant metastasis-free survival (RFS, DMFS) were estimated by Kaplan-Meier method.

The study’s results demonstrated that a Class 2 (high-risk) DecisionDx-Melanoma result was significantly associated with higher rates of SLNB positivity compared to Class 1 (low risk). With respect to risk prognoses, patients who received a Class 2B DecisionDx-Melanoma result and were SLNB-positive experienced the highest recurrence rates (38%), compared to only a 2% recurrence rate for patients who were Class 1A and SLNB-negative. DecisionDx-Melanoma Class 2 results were significantly associated with poorer RFS and DMFS rates compared to Class 1 results, both in the entire cohort of 383 cases and in patients staged as "low risk" (IA-IIA) according to American Joint Committee on Cancer (AJCC) staging criteria.

"We sought to study the utility of this 31 gene expression profile (31-GEP) test in the largest, independent, prospective study to date," said corresponding author John T. Vetto, M.D., FACS, Professor of Surgery, Division of Surgical Oncology, Oregon Health & Science University, Portland. "Current staging parameters in melanoma are invaluable but also imperfect. We were encouraged to find that, like AJCC stage, the 31-GEP results were independently associated with patient outcomes, including recurrence and distant metastasis, and that the 31-GEP results added prognostic information when incorporated with existing features to evaluate patient risk."

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. To predict likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithm, i31-GEP, to produce an integrated test result. i31-GEP is an artificial intelligence-based neural network algorithm (independently validated in a cohort of 1,674 prospective, consecutively tested patients with T1-T4 cutaneous melanoma) that integrates the DecisionDx-Melanoma test result with the patient’s traditional clinicopathologic features. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through December 31, 2020, DecisionDx-Melanoma has been ordered more than 68,920 times for use in patients with cutaneous melanoma.

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.