On June 7, 2022 To help molecular diagnostic manufacturers and clinical testing laboratories adapt to higher-standard In Vitro Diagnostic Requirements (IVDR) now in effect in the European Union, Thermo Fisher Scientific reported that it is offering an IVDR version of the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System globally (Press release, Thermo Fisher Scientific, JUN 7, 2022, View Source [SID1234615718]). The innovative qPCR system simplifies molecular diagnostic workflows for infectious disease and oncology.

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Molecular diagnostic kit manufacturers and clinical testing labs that develop their own assays need open qPCR platforms that meet IVDR requirements. The IVDR-compliant QuantStudio 5 Dx System will enable molecular diagnostic manufacturers to develop new IVDR-compliant tests under the new regulations. The system will also help clinical labs running diagnostic tests switch to IVDR qPCR testing.

"Molecular diagnostic manufacturers and laboratories that lack appropriately validated and CE-labelled instruments and tests may face delays under the new IVDR regulations," said Marty Murawski, vice president, regulatory and quality assurance, at Thermo Fisher Scientific. "We are committed to helping our customers maintain high patient safety standards, meet new requirements, and obtain proper accreditation to remain competitive in today’s market. By making the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System IVDR-compliant, we can now provide a high-performance, reliable qPCR system to support new testing workflows."

Among the system’s updates, the multi-mode software is now IVDR compliant, providing dual functionality for running diagnostic tests and developing new assays in today’s regulatory environment. The qPCR system comes with an intuitive touchscreen and simplified, efficient workflow that minimizes steps to deliver quality results in as little as 30 minutes. In addition, a security, auditing, e-signature module provides secure operation.

The updated QuantStudio 5 Dx Real-Time PCR System is available in all regions that recognize CE-IVD certification and is also listed with the U.S. Food and Drug Administration (FDA).

On June 7, 2022 Exscientia (Nasdaq: EXAI) reported that Andrew Hopkins, DPhil., Exscientia’s founder and CEO, and Dave Hallett, Chief Operations Officer, will participate in a fireside chat at the Goldman Sachs 43rd Annual Global Healthcare Conference on Tuesday, June 14, 2022 at 9:20 a.m. P.T. (5:20 p.m. BST) (Press release, Exscientia, JUN 7, 2022, View Source [SID1234615716]).

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A live webcast of the fireside chat will be available on the Company’s website, under the "Investors & Media" section at www.investors.exscientia.ai. An archived replay of the webcast will be available for approximately 30 days following the presentation.

On June 7, 2022 CEL-SCI Corporation (NYSE American: CVM) reported that its abstract and poster titled "Leukocyte interleukin injection (LI) immunotherapy extends overall survival (OS) in treatment-naive low-risk (LR) locally advanced primary squamous cell carcinoma of the head and neck: The IT-MATTERS study" was presented on June 6, 2022 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s 2022 ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois (Press release, Cel-Sci, JUN 7, 2022, View Source [SID1234615715]).

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Presented by CEL-SCI’s Chief Scientific Officer, Eyal Talor, Ph.D., to the largest gathering of cancer experts from academia, industry, patient advocacy and policy, the poster provided detailed data on Multikine’s (Leukocyte Interleukin, Inj.)* efficacy in extending overall survival in treatment-naive low-risk (LR) locally advanced primary squamous cell carcinoma of the head and neck. The abstract was selected by ASCO (Free ASCO Whitepaper) for poster presentation and was well received by oncology experts at the conference.

Based on the results of this pivotal Phase 3 study, including data in the ASCO (Free ASCO Whitepaper) poster presentation, CEL-SCI intends to file a Biologic License Application with the U.S. Food and Drug Administration (FDA) for approval of this indication.

Link to poster: View Source

Link to ASCO (Free ASCO Whitepaper) abstract 6032: View Source

The conclusions presented in the poster are as follows:

Safety results were not significantly different between treatment groups.
Leukocyte Interleukin, LI (MK) neoadjuvant immunotherapy did not add excess safety issues or TEAEs.
In the Randomized ITT population, early LI (MK) response decreases mortality and is prognostic/predictive of OS.
ITT Lower Risk LI (MK)+CIZ+SOC absolute OS advantage over SOC alone (Control) increased over time to 14.1% at 5-years; the 0.68 HR corresponds to a 47% prolongation of median survival, having a 46-month median OS advantage over SOC alone. The SCCHN population studied has been without any new therapy options in decades.

On June 7, 2022 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported that members of its senior management team will participate in a fireside chat at the Goldman Sachs 43rd Annual Global Healthcare Conference on Tuesday, June 14, 2022 at 03:20 p.m. Pacific Time/ 6:20 p.m. Eastern Time in Rancho Palos Verdes, CA (Press release, Repare Therapeutics, JUN 7, 2022, View Source [SID1234615714]).

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A live webcast of the fireside chat can be accessed in the Investor section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days.

On June 7, 2022 Genexine (KOSDAQ: 095700) a publicly traded, clinical stage biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, reported top-line results from the KEYNOTE-899 phase 1b/2 clinical trial of GX-I7 (efineptakin alfa) in combination with pembrolizumab (Press release, Genexine, JUN 7, 2022, View Source [SID1234615713]). The results indicated that GX-I7 in combination with pembrolizumab was safe and well tolerated and demonstrated promising early anti-tumor activity in patients with R/R metastatic TNBC. Genexine presented these data in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting taking place from June 3-7, 2022.

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Top-line data showed that GX-17 in combination with pembrolizumab was safe and well tolerated in the overall phase 1b/2 trial. For the phase 2 expansion cohort GX-I7 was administered at a dose of 1,200 µg/kg in nine-week intervals combined with pembrolizumab at 200 mg administered every three weeks.

Observed ORRs with GX-17 in combination pembrolizumab were 15.7% (8/51) for phase 1b and 21.2% (7/33) for phase 2. Of the 25 patients who had an evaluable PD-L1 from a biopsy sample, 40.0% (10/25) were PD-L1 positive (CPS≥10). Notably, the ORR in patients who were PD-L1 positive was 60% (6/10). Absolute lymphocyte count and the number of CD4+ and CD8+ T cells were significantly increased, while NLRs and proportion of Treg in CD4+ T cells were significantly decreased in patients receiving GX-I7 720 µg/kg or higher.

"The results from this study are quite encouraging and indicate that GX-I7 (efineptakin alfa) in combination with a check point inhibitor could become an important therapy for patients with r/r metastatic TNBC." said Professor Sohn Ju-hyuk the primary investigator of the trial and professor of Medical Oncology at Yonsei Severance Hospital. "GX-I7 represents a new class of potential therapy for cancer patients and could become the first therapy to manage lymphopenia in cancer patients. Although this is a retrospective analysis, I am encouraged by the 60% ORR in PD-L1 positive patients especially considering there was no response in the PD-L1-negative group with previous study. I believe further trials with PD-L1 positive TNBC patients are warranted."

"GX-I7 represents a potential first-in-class treatment for cancer patients. We are pleased with the observed safety and tolerability profile and are encouraged by the efficacy shown in these two trials," said Neil Warma, CEO of Genexine. "We plan on carefully analyzing the complete data set but are highly encouraged by the CPS>10 cohort that showed a robust 60% ORR. Although this was observed in a modest sample size, we believe it warrants further review. GX-I7 is one of our flagship products and Genexine has embarked on a global development program in multiple cancers with our partners, NeoImmune Tech in the U.S. and I-Mab in China."

GX-I7 (efineptakin alfa), discovered and developed by Genexine, is a hybrid Fc-fused long-acting recombinant human IL-7 which plays an essential role in the development and homeostasis of T-cells. T-cells play an important role in fighting cancer by recognizing cancer cells and killing them directly or indirectly by communicating with other immune cells. As a T-cell amplifier, GX-I7 may boost the immune system and help eradicate tumor cells more effectively. GX-I7 may modulate multiple steps in the cancer immunity cycle to overcome resistance to current immunotherapy. By working synergistically with leading and emerging immuno-oncology therapeutics, GX-I7 may broaden, deepen, and prolong anti-tumor responses in cancer patients.