On October 20, 2021 TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from solid tumors, reported new programs and provided highlights from its emerging TRuC pipeline programs during its first virtual R&D Day (Press release, TCR2 Therapeutics, OCT 20, 2021, View Source [SID1234591601]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"At TCR2, our mission is to build the next great cell therapy company in solid tumors based on the early success of our mesothelin franchise and an emerging pipeline which will extend our reach into new cancer patient populations and beyond," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "Today we will review our narrowed focus on solid tumors and unveil new strategies to potentially further enhance the persistence and efficacy of our TRuC-T cells. In addition, we will introduce compelling preclinical data for our TRuC Tregs, which could expand our footprint into the autoimmune disease setting. We believe that TCR2 is already helping to change the treatment paradigm for patients with treatment-refractory solid tumors and, through continued innovation, will progress our re-prioritized pipeline to patients with a variety of unmet medical needs."

Pipeline Updates

Gavo-cel:

TCR2 announced today the completion of the 3-patient cohort at the new dose level 3.5A (3×108/m2 following lymphodepletion) using a split dosing approach. Two patients were evaluable for safety. In both cases, gavo-cel was well-tolerated with no patients experiencing on-target, off tumors toxicities or Grade ≥3 cytokine release syndrome (CRS) non-hematologic toxicities.
TCR2 anticipates the identification of the RP2D in 4Q21.
TC-110:

TCR2 announced today that, in alignment with its pipeline prioritization on solid tumors, the Company has deprioritized the development of TC-110 for the treatment of patients with CD19+ non-Hodgkin lymphoma or adult acute lymphoblastic leukemia and plans instead to evaluate business development options.
TC-510:

TCR2 announced today the Company anticipates the IND filing for its first TRuC-T cell enhanced with a PD1xCD28 switch receptor to be in 1Q22.
TC-520:

TCR2 announced today the selection of its lead candidate targeting CD70 co-expressing an IL-15 enhancement as TC-520. In new preclinical data highlighted at the R&D Day, TC-520 enhanced with membrane-bound IL-15 resulted in a significant increase in TC-520 cells with a CD8+ naïve/T memory stem cells phenotyope, improved autonomous persistence as well as increased expansion following repeated stimulation with CD70-expressing cancer cell lines.
The Company anticipates initiating IND-enabling studies for TC-520 with an indication focus on renal cell carcinoma in 2022.
Allogeneic:

TCR2 announced today new preclinical data demonstrating allogeneic (off-the-shelf) TRuC-T cells targeting mesothelin that utilized a CRISPR/Cas9 endonucleases approach and the use of fully human TCRγ/δ domains reduced the risk of immunogenicity and host rejection, lacked alloreactivity while maintaining clearance of tumor cells comparable to autologous TRuC-T cells targeting mesothelin.
TCR2 is currently evaluating the combination of enhancements with allogeneic TRuC-T cells to potentially improve persistence.
The Company anticipates the identification of a lead candidate for its allogeneic program in 2022.
TRuC Tregs:

TCR2 announced today new preclinical data demonstrating proof-of-concept for TRuC Treg cells targeting HLA-A*02 for the prevention of Graft versus Host Disease (GvHD). In in vitro and in vivo experiments, TRuC Tregs utilizing the full TCR signaling complex promoted and stabilized Tregs by suppressing the proliferation of mismatched effector cells and inhibiting the production of cytokines in a dose dependent manner.
TCR2 plans to evaluate business development options to enable the treatment of patients with GvHD and other autoimmune diseases.

On October 20, 2021 Sysmex Inostics reported that it has developed a new CLIA-validated liquid biopsy test for the detection of Minimal Residual Disease (MRD) in Acute Myeloid Leukemia (AML) (Press release, Sysmex Inostics, OCT 20, 2021, View Source [SID1234591600]). A global leader and pioneer in blood-based, ultra-sensitive molecular testing for oncology, the company’s new test uses a targeted Next Generation Sequencing (NGS) panel.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The new test, AML-MRD-SEQ, offers clinical trial sponsors, and eventually physicians and patients, an early signal for the presence of cancer cells following initial therapy. This new liquid biopsy solution is a major step in developing treatment strategies to support the fight against a devastating disease," said Shinichi Sato, CEO of Sysmex Inostics, Inc.

This new test, AML-MRD-SEQ, adds to the portfolio of ultra-sensitive Plasma-Safe-SeqS technology NGS tests available through Sysmex Inostics’ CLIA lab services in Baltimore, Maryland.

Previous generations of AML MRD tests were only able to detect a limited number of mutations that have an established therapeutic indication. AML-MRD-SEQ offers a more expansive panel covering 68 regions across 20 genes, including established MRD markers such as NPM1, and demonstrating significant potential for use as an investigational tool for other markers with prognostic values that are not yet well-established. The new highly sensitive AML-MRD-SEQ test with broader genomic coverage offers the opportunity for early intervention and clinical trial enrollment.

"Sysmex Inostics’ mission is to develop new innovative tools and expand partnerships with top-tier global biopharmaceutical companies to further advance drug development and treatments for the benefit of oncology patients worldwide," Sato concluded.

AML-MRD-SEQ offers reliable detection of molecular MRD with 50 to 100 times greater sensitivity versus other currently available NGS pan-heme tests.1,2 Such ultra-sensitive detection of low-level mutant molecules allows clinical trial sponsors to execute on clinical development timelines more efficiently.

AML is one of the deadliest blood cancers, resulting in more than 10,000 lives lost in the U.S. each year.3 Because AML relapses usually result in a poor prognosis, it is necessary to test patients for MRD after initial treatment as a prognostic indicator of therapeutic effectiveness and relapse risk. Applying Sysmex Inostics’ ultra-sensitive liquid biopsy NGS technology, Plasma-Safe-SeqS, to the detection of gene mutations associated with AML MRD enables accelerated clinical development timelines, cost savings, and improved outcomes throughout the clinical trial process.

A recent market research report states that the liquid biopsy market is estimated to achieve an annual growth rate of more than 35% over the next few years, reaching $4 billion by 2024.4 The analysis notes that an increasing focus on personalized medicine for cancer care is driving the tremendous growth.

On October 20, 2021 Semmelweis University reported that it has improved its position from the 70th rank since last year and is now ranked 33rd among higher education institutes, according to the Times Higher Education (THE) Emerging Economies Rankings (Press release, Semmelweis University, OCT 20, 2021, View Source [SID1234591597]).

The Times Higher Education Emerging University Ranking use 13 calibrated performance indicators to reflect the characteristics of the emerging economy universities. Semmelweis University has once again climbed the ranking and became the best educational institute in Hungary, moving from 70th to the 33th place of the world’s top universities.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Among the other Hungarian universities on the list, Eötvös Loránd University was ranked 150th, University of Debrecen 191th. As for other universities it looks as follows: University of Pécs and University of Szeged (201-250th). Óbuda University, Budapest University of Technology and Economics, Corvinus University of Budapest, Hungarian University of Agriculture and Life Sciences were ranked 401-500th. University of Miskolc finished 501+ on the list.

China continues to dominate the Emerging Economies rankings occupying the top three positions (Beijing University, Tsinghua University and Zhejiang University) of the table.

On October 20, 2021 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, reported that Company’s Management will provide a corporate update and participate in one-on-one investor meetings at the Jefferies Virtual Gene Therapy/Editing Summit to be held October 27-28, 2021 (Press release, Selecta Biosciences, OCT 20, 2021, View Source [SID1234591595]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details on the conference can be found below.

Jefferies Virtual Gene Therapy/Editing Summit
Format: Presentation and one-on-one investor meetings
Date: Wednesday October 27, 2021
Presentation Time: 11:00 a.m. EST
Webcast: Click Here

An archived webcast will also be accessible in the Investors & Media section of the company’s website at www.selectabio.com.

On October 20, 2021 QIAGEN N.V. (NYSE: QGEN) (Frankfurt Stock Exchange: QIA) reported that it plans to release its report on results for the third quarter and first nine months of 2021 on Wednesday, November 3, at approximately 21:05 Central European Time (CET) / 16:05 Eastern Daylight Time (EDT) (Press release, Qiagen, OCT 20, 2021, View Source [SID1234591594]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A conference call is scheduled for Thursday, November 4 at 14:30 Frankfurt time /13:30 London time/ 9:30 New York time. It will be hosted by Thierry Bernard, Chief Executive Officer, and Roland Sackers, Chief Financial Officer. (For Europe: Due to the U.S. time switch, the timing of our investor conference call will be held 30 minutes earlier than usual.)