On April 6, 2022 C2i Genomics, a cancer intelligence company, reported it has launched its C2inform minimal residual disease (MRD) test across Europe after obtaining CE-IVD marking in the EU and UK (Press release, C2i Genomics, APR 6, 2022, View Source [SID1234611639]). The company also announced the completion of several clinical trials across the globe, including leading cancer centers in Europe, U.S. and Singapore.

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The new clinical data will be presented at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in New Orleans, Louisiana. C2inform is the first CE Marked software-as-a-medical-device MRD test and will be available in countries accepting the CE Mark. The test provides a streamlined process for in-house use by any pathology lab and genomic cancer lab to offer testing closer to the patient.

C2inform test works by applying whole-genome sequencing and artificial intelligence to just a 3-4mL blood sample to support rapid and accurate detection of cancer, monitor disease progression, and evaluate therapeutic efficacy. The test enables informed and timely personalized treatment decisions and supports the development of more effective cancer treatments through pharma drug development partnerships. The test requires significantly reduced lab operation complexity, eliminates the need to develop a patient-specific assay, and offers a rapid and high throughput solution for cancer patients across the EU.

This European regulatory certification indicates C2inform’s conformity with high safety, health, and environmental protection standards and allows for commercial sale to cancer diagnostic labs that require CE Marking. The CE Mark is a prerequisite for reimbursement of diagnostic tests by health authorities, and in some European countries, it is required before laboratories can use a new testing method. Early adopters include multiple leading cancer centers in Denmark, Switzerland, France and UK, and an industry partnership with OncoDNA, a genomic and theranostic company, that was announced as a strategic partner of C2i Genomics in early 2022.

"The last year has been incredibly exciting as we’ve solidified multiple global partnerships to expand our distributed diagnostic model. With several strategic partnerships throughout Europe and now with the CE Mark registration, we’re eager to scale our C2inform test to bring whole genome cancer detection and monitoring across Europe," said Asaf Zviran, CEO and Co-Founder of C2i Genomics. "As C2i continues to expand commercial availability our goal at our core is to continue advancing better patient outcomes and more precise oncology treatments."

At the AACR (Free AACR Whitepaper) 2022, C2i will present exciting new clinical performance results of C2inform from clinical studies that include over 200 patients and 3,000 plasma samples from the EU, U.S. and Singapore. The studies have validated the C2inform assay performance on multiple early-stage cancer types including colorectal, bladder, glioblastoma multiforme (GBM) and lung cancer. More than half of these results were established in clinical studies in Europe.

The C2inform test is the first product released through the C2intelligence cloud-based platform. A globally deployed and highly scalable software-as-a-service (SaaS) platform for whole-genome data management, analytics and clinical interpretation. The platform is compatible with analyzed sequences received from any Illumina NovaSeq sequencer, increasing worldwide accessibility and reducing turnaround times and logistic barriers.

This CE Mark comes shortly after the company announced a strategic partnership with OncoDNA and the initiation of a first-of-its-kind interventional clinical trial in France led by Gustave Roussy. Outside of Europe, the company has multiple global alliances, including a partnership with NovogeneAIT Genomics in Southeast Asia and in China with a strategic partnership with NuProbe Global. The company also has a technology development partnership with Twist Bioscience and clinical data and genomics data integration with Premier Inc.

For companies interested in deploying the platform, please visit www.c2i-genomics.com.

On April 6, 2022 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported the results from the NOPHO sponsored Phase 2 trial of eryaspase in ALL patients are now published in the British Journal of Haematology (Press release, ERYtech Pharma, APR 6, 2022, View Source [SID1234611600]).

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The Phase 2 NOR-GRASPALL-2016 trial evaluated the safety and pharmacological profile of eryaspase in ALL patients who had previously experienced hypersensitivity reactions to pegylated asparaginase therapy. The trial was conducted by the Nordic Society of Pediatric Haematology and Oncology (NOPHO) at 21 clinical sites in the Nordic and Baltic countries of Europe and enrolled 55 patients. Primary objectives of the trial were asparaginase enzyme activity and safety. Both endpoints were met.

Eryaspase demonstrated sustained asparaginase enzyme activity above the threshold of >100 U/L at trough levels 14 days after first infusion in 92.5% of patients. Eryaspase was generally well tolerated when added to chemotherapy and almost all patients were able to receive the intended courses of asparaginase (median of 5 doses per patient). Of the 55 patients, only 2 patients had severe allergic reaction and withdrew eryaspase treatment.

The Principal Investigator, Dr. Birgitte Klug Albertsen, Associate Professor at Aarhus University Hospital, Denmark, commented, "I am grateful that the editors of the British Journal of Haematology selected our study for publication. The study demonstrated that eryaspase, given as a convenient schedule every two weeks, provides a sustained asparaginase enzyme activity level above the recommended threshold for other Asparaginase treatments, few hypersensitivity reactions and is generally well tolerated in combination with chemotherapy. We conclude that eryaspase seems to be a promising treatment alternative for ALL patients with hypersensitivity to PEG-asparaginase."

"We are proud to be working with the NOPHO group in conducting this study in ALL, and hopeful that study results provide the possibility of an alternative treatment for ALL patients with hypersensitivity to PEG-asparaginase." said Dr. Iman El-Hariry, ERYTECH’s Chief Medical Officer. "We have an ongoing dialogue with the U.S. FDA regarding a potential regulatory approval in this indication based on the NOPHO-sponsored trial."

The paper: "Asparaginase Encapsulated in Erythrocytes as Second-line Treatment in Hypersensitive Patients with Acute Lymphoblastic Leukaemia" by Line Stensig Lynggaard, Goda Vaitkeviciene, Cecilia Langenskiöld, Anne Kristine Lehmann, Päivi M. Lähteenmäki, Kristi Lepik, Iman El Hariry, Kjeld Schmiegelow, and Birgitte Klug Albertsen, can be viewed online at View Source, appearing in British Journal of Haematology, 2022;00:1– 10, published by Wiley.
For additional information and copies of the paper, please contact Wiley at View Source
About Acute Lymphoblastic Leukemia

Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that is the most common type of cancer in children in the US and Europe. More than 13,000 cases are diagnosed in the US and Europe each year with the majority of patients diagnosed
before age 20. Asparaginase has been an integral component of ALL treatment for several years but is associated with treatment- limiting hypersensitivity in up to 30% of patients. Discontinuation of asparaginase therapy in ALL patients has been associated with
inferior event free survival highlighting the need for additional asparaginase based treatment options.

On April 6, 2022 Selecta Biosciences, Inc. (Nasdaq: SELB) ("Selecta" or the "Company"), a biotechnology company focused on developing tolerogenic therapies to mitigate unwanted immune responses, reported that it has agreed to sell 27,428,572 shares of its common stock and accompanying warrants to purchase up to 20,571,429 shares of common stock at a combined offering price of $1.41 per share and accompanying warrant (Press release, Selecta Biosciences, APR 6, 2022, View Source [SID1234611564]). The warrants to purchase shares of common stock have an exercise price of $1.55 per share, are immediately exercisable and will expire five years from the date of issuance. All of the securities in the offering will be sold by Selecta. The gross proceeds to Selecta from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be approximately $38.7 million. The offering is expected to close on April 11, 2022, subject to the satisfaction of customary closing conditions.

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SVB Leerink is acting as sole bookrunning manager for the offering. Canaccord Genuity is acting as lead manager for the offering.

The offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-241692) that was previously filed with the Securities and Exchange Commission (the "SEC") on August 6, 2020 and declared effective on August 14, 2020. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source When available, copies of the final prospectus supplement and accompanying prospectus may also be obtained by contacting SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of Selecta’s securities, nor shall there be any sale of Selecta’s securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On April 6, 2022 Geron Corporation (Nasdaq: GERN), a late-stage biopharmaceutical company focused on the development and commercialization of treatments for hematologic malignancies, reported that John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer, plans to present a company overview at the 21st Annual Needham Virtual Healthcare Conference on Wednesday, April 13, 2022 at 3:45 p.m. ET (Press release, Geron, APR 6, 2022, View Source [SID1234611563]).

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A live webcast of the presentation will be available through the Investor Relations section of Geron’s website under Events. Following the presentation, the webcast will be archived and available for replay for a period of 30 days.

On April 6, 2022 BiOneCure Therapeutics, Inc. reported that the U.S. Food and Drug Administration (FDA) has cleared the IND for BIO-106, an antibody-drug conjugate (ADC) designed to target TROP-2 to treat a broad range of advanced solid tumors (Press release, BiOneCure Therapeutics, APR 6, 2022, View Source [SID1234611556]).

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The clinical study cleared by the FDA, known as StarBridge-1, is a Phase I/II, multicenter, open-label study to evaluate the safety, pharmacokinetics and preliminary anti-tumor activity of BIO-106 as monotherapy and in combination with pembrolizumab in patients with advanced cancers

This IND approval is a significant milestone for both our team and the patients we hope to serve.

"This is the first IND approval for BiOneCure. It is a significant milestone for both our team and the patients we hope to serve." said Haifeng Bao, Ph.D., Co-founder and Chief Executive Officer at BiOneCure. "BiOneCure has complete intellectual property rights of the product, covering the payload, antibody and the ADC drug product, The introduction of our innovatively developed ADC candidate BIO-106 validated our approach to the next generation of ADC. We are very excited to bring the new molecule to the clinical stage and look forward to advancing this trial"

About BIO-106
BIO-106 is an anti-Trop-2 ADC to target cancer cells expressing Trop-2, a protein overexpressed in a broad range of tumors including TNBC, HR+/HER2 mBC, NSCLC, and others. BIOneCure has developed BIO-106 using its proprietary TAMTM payload technology to enable homogenous high drug load. In the pre-clinical study, BIO-106 has demonstrated broad anti-tumor activities with excellent safety profile and wide therapeutic window.