On February 15, 2021 Elicio Therapeutics, a private biotechnology company developing a pipeline of potent immunotherapies based on its proprietary lymph node targeting technology, reported Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development, and Chief Medical Officer, will co-lead a workshop, "Improving Efficacy and Solid Tumor Infiltration with Combination Strategies," at the upcoming CAR-TCR Digital Summit Europe, February 16 – 18, 2021 (Press release, Elicio Therapeutics, FEB 15, 2021, View Source [SID1234575073]).

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 Elicio Amphiphile platform enables precise targeting and delivery of immunogens directly to the lymphatic system, orchestrating the immune response, to significantly amplify and enhance the body’s own system of defenses to defeat cancer and stop its recurrence. When combined with CAR-T therapy, AMP-CAR-T amplifiersspecifically designed to bind to the CAR receptor are presented on the cell surface of immune cells in the lymph nodes. CAR-T cells passing through the lymph nodes en route to the tumor see these AMP-CAR-T amplifiers on the surface of specialized antigen presenting cells (APCs), which then deliver potent activating signals to T cells to coordinate their expansion, development of anti-tumor functions, and mobilization against tumors.

"Through published studies in mice, Amphiphile activation of the chimeric antigen receptor when CAR-T cells entered the native micro-environment of lymph nodes, enhanced treatment of multiple solid tumors," said Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development, and Chief Medical Officer. "We have seen that this combination approach enhances trafficking, infiltration and persistence. Such potent amplification of the engineered T cell immune responses were critical, enabling prolonged survival and durable cures in solid tumor models where CAR-T alone had no effect."

At the summit Dr. Haqq will discuss:

Activation of CAR-T cells with Amphiphiles delivered to the lymph nodes to induce massive CAR-T expansion.
Lymph node activation to improve CAR-T function.
Ten-fold improvement in CAR-T trafficking into the solid tumors.
Durable complete responses observed for solid tumors across cancer types.
Persistence of CAR-T cells enabling rejection of additional cancer cells in rechallenge experiments that used doses lethal to untreated mice.
Induction of antigen spreading using the Amphiphile technology to recruit antitumor T cells to participate in a broad tumor attack.
Elicio is developing the AMP-CAR-T platform for combination with CAR-T cell therapies in a variety of settings including those targeting CD19, BCMA, and several solid tumor indications.

On February 15, 2021 Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) reported that on February 1, 2021, it received approval for a partial change to the manufacturing and marketing approval for the OncoGuide NCC Oncopanel System,1 a gene mutation analysis set for use in cancer genome profiling (the "System"), which was made as a result of an enhancement of the System’s functions, including an expanded scope of detectable gene mutations (Press release, Sysmex, FEB 15, 2021, View Source [SID1234575070]). With this change, it has become possible to detect mutations and copy number alterations of 124 genes, fusions 2 of 13 genes, and microsatellite instability3 (MSI), up from the mutations and copy number alterations of 114 genes before. These enhancements allow for more detailed gene information that aids in cancer diagnosis and treatment and selection of anti-cancer drugs. The System also detects germline variants4 of all 124 genes for reference purposes and provides them as part of the results.

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!

Since receiving manufacturing and marketing approval in December 2018, the System has been introduced into clinical settings to perform tests that provide information useful in determining treatment methods, including diagnosis and the selection of anti-cancer drugs. Capable of obtaining comprehensive cancer genome profiles by measuring 114 cancer-related genes in tumor tissues for analysis of all solid tumors, the System has been instrumental in analyzing mutations of cancerspecific genes. Meanwhile, there is a pressing need for a technique that more accurately monitors gene mutations associated with existing cancers and expands the number of detectable genes in pursuit of more comprehensive cancer genome profiling. This would allow for greater diagnostic accuracy and the selection of anti-cancer drugs with higher efficacy.

On February 1, 2021, Sysmex received approval for a partial change to the manufacturing and marketing approval of the System, regarding the enhancement of its functions, including greater scope of detectable gene mutations. With this enhancement, it has become possible to detect the fusions of 13 genes, including the NTRK3 gene,5 which is detected in a tumor-agnostic manner, as well as mutations of 124 genes, regardless of fusion partners. Detection of MSI has also been made possible, as it appears to be related to abnormalities in the ability to repair DNA and thus serves as evidence that cancer is likely to occur. The System also detects germline variants of all 124 genes for reference purposes and provides them as part of the results of the matched-pairs test6 that the System performs using tumor and nontumor tissues (blood). It is expected that these additional functions will make it easier to select drugs targeting patientspecific mutations and improve treatment outcomes.

RIKEN Genesis Co., Ltd., a subsidiary of Sysmex that provides cancer genome profiling lab-assay services, aims to promptly commence genetic testing using the System with the additional functions included in this approval.

Sysmex remains committed to contributing to the development and advancement of personalized healthcare by working to increase testing opportunities for patients and creating high-value-added testing and diagnosis technologies.

Product Overview Generic name: Gene mutation analysis set (for use in cancer genome profiling)
Name: OncoGuide NCC Oncopanel System (In vitro diagnostic medical device registration number: 23000BZX00398000 / Obtained on: December 25, 2018)
Manufacturer and seller: Sysmex Corporation
Target market: Japan
Target institutions: Medical institutions that have in place diagnostic systems appropriate for cancer genome profiling

Overview of the application for approval of partial change-Addition of a gene panel for analysis (from 114 genes to 124 genes)
-Addition of a function to detect microsatellite instability (MSI)
-Version upgrade of software as a result of the improvement to the OncoGuide NCC Oncopanel Analysis Program
-Partial change to the composition of the OncoGuide NCC Oncopanel Kit
-Extension of expiry dates of the OncoGuide NCC Oncopanel Kit (from nine months to 12 months) Approval obtained: February 1, 2021.

Reference
Press release dated December 25, 2018: "Sysmex Receives Manufacturing and Marketing Approval to Use the OncoGuide NCC Oncopanel System in Cancer Genome Profiling" View Source

Press release dated February 21, 2019: "Commencement of Assay Service Using the OncoGuide NCC Oncopanel System in Cancer Genome Profiling" View Source

Press release dated May 31, 2019: "The OncoGuide NCC Oncopanel System Receives Insurance Coverage for Use in Cancer Genome Profiling" View Source Press release dated April 1, 2020: "Advanced Medical Care Approval for Cancer Gene Panel Testing at the Time of Initial Treatment" View Source

Terminology
1 OncoGuide NCC Oncopanel System: On December 25, 2018, Sysmex received manufacturing and marketing approval for the System as Japan’s first medical device for cancer genome profiling under the Ministry of Health, Labour and Welfare’s Sakigake Designation system. This combination medical device was subsequently covered under the NHI as of June 1, 2019. NHI coverage for D006-19 cancer genome profiling using the System includes patients with solid tumors for which no standard treatment exists and patients with solid tumors confirmed to have spread locally or metastasized (including patients for whom treatment is expected to conclude). Coverage is limited to cases in which the attending physician determines the potential for applying chemotherapy following this testing is high, based on chemotherapy guidelines from related societies and the patient’s general status and organ function. Its utility at the time of initial treatment was assessed in the study which was applied as Advanced Medical Care as described in the press release dated April 1, 2020.

2 Gene fusion: A type of mutation where one gene (Gene A) fuses with another to behave as a single gene. Gene A fuses with various genes, but the System can detect the fusion of Gene A, regardless of the types of genes that fuse with Gene A.

3 Microsatellite instability (MSI): A phenomenon where repeated sequences called "microsatellites", short nucleotide repeats (from one to several bases per unit) in genomic DNA display a different number of repetitions in tumor tissues than in non-tumor (normal) tissues, due to malfunctions of the mismatch repair system that may occur during DNA replication.

4 Germline variants: Natural genetic variants involved in cancer risk or hereditary disorders.

5 NTRK3 gene: A gene that produces the protein involved in the differentiation and maintenance of neurons. It is believed that cancer is likely to occur when unnecessary cells multiply as abnormal proteins are produced by the NTRK fusion gene (the NTRK gene fusing with various other genes).
6 Matched-pairs test: A test that simultaneously sequences DNA from tumor tissues of a patient with solid cancer and non-tumor tissues (blood) of the same patient. Performed to confirm (for secondary findings) genetic mutations (variants) that may be determined as pathological, and unrelated to the primary purpose for testing.

On February 15, 2021 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, reported that Aoife Brennan, M.B. Ch.B., Synlogic’s President and Chief Executive Officer, and other members of the executive team will present at the following virtual banking and industry conferences (Press release, Synlogic, FEB 15, 2021, View Source [SID1234575069]):

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!

BIO CEO & Investor Digital Conference: Dr. Brennan will have an on-demand presentation starting on Tuesday, February 16, 2021.
Cantor Fitzgerald Industry Panel: Dr. Brennan will present at 10:00 am on Thursday, February 18, 2021.
SVB Leerink 10th Annual Global Healthcare Conference: The Company will present at 5:00 pm on Thursday, February 25, 2021.
Cowen 41st Annual Health Care Conference: The Company will present at 9:10 am on Thursday, March 4, 2021.
H.C. Wainwright Global Life Sciences Conference: The Company will present at 4:00 pm on Tuesday, March 2, 2021.
Chardan’s 3rd Annual Microbiome Medicines Summit: The Company will present at 1:30 pm on Monday, March 8, 2021.
These are virtual events. A live webcast of the presentations, if available, can be accessed under "Event Calendar" in the Investors & Media section of the Company’s website. An archived copy of the webcast will be available on the Synlogic website for approximately 30 days after the event.

On February 15, 2021 Kuraray Co., Ltd. (hereinafter "Kuraray" or "the Company") reported details of outstanding items in connection with the Company’s decision to issue share purchase warrants as part of a stock-linked compensation plan (Press release, Kuraray, FEB 15, 2021, https://pdf.irpocket.com/C3405/ng2K/nikM/NTCq.pdf [SID1234575067]). The decision to offer share purchase warrants, identified as "Kuraray Co., Ltd. Share Purchase Warrants issued in February 2021" was first made at a Board of Directors’ meeting held on January 20, 2021. Brief details of outstanding items are provided as follows.

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!

1. Total number of allotted share purchase warrants 197 units (the number of shares to be granted per share purchase warrant is 500)

2. Parties eligible for allotment (hereinafter "Rights Holders") and number of allotted
share purchase warrants

3. Type and number of shares to be issued upon the exercise of share purchase warrants 98,500 shares of Kuraray common stock 4. Total payment due upon exercise of share purchase warrants Payment per share purchase warrant ¥587,000 (Payment per share ¥1,174)

On February 15, 2021 Targovax ASA (OSE: TRVX), a clinical stage immune-oncology company developing immune activators to target hard-to-treat solid tumor, reported that its lead clinical candidate ONCOS-102 has received Fast-Track designation in malignant pleural mesothelioma from the US FDA (Press release, Targovax, FEB 15 , 2021, View Source [SID1234575061]).

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 US FDA granted Fast-Track designation to ONCOS-102 based on encouraging pre-clinical and clinical efficacy associated with broad immune activation observed to date. Receiving this designation is an endorsement by the US FDA of the strength of the ONCOS-102 data package.

The FDA Fast Track-designation is awarded to therapies with potential to address unmet medical needs in serious medical conditions and allows for more frequent interactions with the FDA to expedite clinical development, as well as the regulatory review processes. Fast-Track products have improved likelihood of receiving Priority Review for a future Biologics License Application (BLA) and may be allowed to submit parts of the application early to shorten review time.

The Fast-Track approval comes in addition to ONCOS-102’s existing Orphan Drug Designation (ODD) with both the US FDA and European EMA in the mesothelioma indication, which provides ONCOS-102 market exclusivity for 7 and 10 years in the USA and EU, respectively, from the date of BLA grant.

Dr. Ingunn Munch Lindvig, VP Regulatory Affairs, said: "Securing this Fast-Track designation is a very important milestone for the ONCOS-102 program. Most importantly Fast-Track validates the strong potential of ONCOS-102 as a future treatment option for solid tumors with high unmet medical need".