On May 8, 2018 Medigene AG (MDG1, Frankfurt, Prime Standard), reported that researchers from Max-Delbrück-Center for Molecular Medicine (MDC) and Charité, both in Berlin, Germany, will present an update on the clinical trial preparations concerning a MAGE-A1-specific T cell receptor clinical investigator-initiated trial (IIT) at the 16th Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) in Mainz, Germany, from 15 – 17 May (Press release, MediGene, MAY 8, 2018, View Source [SID1234526177]). CIMT (Free CIMT Whitepaper) is Europe’s largest meeting focused on cancer immunotherapy research and development.

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!

In the abstract that will be published today, the partners announce that the competent regulatory authority Paul-Ehrlich-Institute, Germany, has granted the clinical trial authorization for the planned Phase I trial and that the manufacturing license for the established GMP-compliant manufacturing process is expected to be issued in Q2 2018. More details on the trial design for the treatment of patients with relapsed or refractory multiple myeloma can be found in the abstract on the CIMT (Free CIMT Whitepaper) website: www.meeting.cimt.eu/program

The academic trial will be conducted under the responsibility of Charité and the Max-Delbrück Center. Medigene has supported both the MDC and Charité in regulatory affairs and other matters related to trial approval. Additionally, Medigene has certain rights of first negotiation for the TCR candidate utilized in this trial.

Independently, Medigene is currently conducting its own, company-sponsored phase I/II clinical trial with its proprietary TCR therapy MDG1011 in various blood cancer indications which commenced at the end of March 2018.

Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard, TecDAX) is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene concentrates on the development of personalized T cell-based therapies, with associated projects currently in pre-clinical and clinical development. For more information, please visit www.medigene.com

This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only.

On May 7, 2018 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS) and CrystalGenomics, Inc. (KOSDAQ:083790) reported that Aptose exercised its option under the 2016 Option Agreement to exclusively license CG-806, a first-in-class, non-covalent pan-inhibitor of the Bruton’s tyrosine kinase (BTK) and FMS-like tyrosine kinase 3 (FLT3) from CrystalGenomics, Inc (Press release, CrystalGenomics, MAY 7, 2018, View Source [SID1234539163]). CG-806 is being developed as a highly potent, oral small molecule for acute myeloid leukemia (AML), B-Cell malignancies and other hematologic malignancies.

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!

With the early exercise of the option, Aptose owns global rights to develop and commercialize CG-806 for all indications outside of Korea and China – the Licensed Territory. The exercise triggers a payment of US $2.0 million to CrystalGenomics. CrystalGenomics is eligible for regulatory and sales milestone payments, as well as royalties on product sales in the Licensed Territory.

Aptose has been conducting Investigational New Drug (IND) enabling studies with CG-806, as well as numerous preclinical studies. When tested against fresh bone marrow samples from patients with AML, CG-806 demonstrated superior potency and range of activity relative to all other FLT3 inhibitors evaluated. Likewise, CG-806 demonstrated superiority over ibrutinib when tested against samples from CLL patients. The superior potency and breadth of activity against patient-derived hematologic malignancy cells is due to the ability of CG-806 to target all wild type (WT) and all known mutant forms of FLT3 and BTK, and to suppress multiple signaling pathways that can rescue hematologic cancers from other agents. Once-daily oral dosing of CG-806 in murine xenograft models of human hematologic malignancies demonstrated tumor eradication in the absence of observable toxicity, and dose range finding studies have shown CG-806 to have a robust safety profile. Aptose expects to submit an IND in late 2018 and initiate clinical trials immediately thereafter.

"CG-806 has the potential to serve as a transformational agent for AML, chronic lymphocytic leukemia (CLL) and other hematologic malignancies," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. "Recent pre-clinical studies, just highlighted at the 2018 AACR (Free AACR Whitepaper) Annual Meeting, demonstrated CG-806’s superior potential to other FLT3 inhibitors on AML patient samples and superior potential to ibrutinib on CLL patient samples."

"Aptose has made the clinical development of CG-806 a priority, and we are pleased to be working with them," said Joong Myung Cho, Ph.D., Chairman and Chief Executive Officer of CrystalGenomics. "Aptose and its clinical advisors clearly recognize the potential of CG-806 as an exciting therapeutic option for patients with AML, CLL and other malignancies."

Cellular Biomedicine Group has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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!

ArQule has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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!

On May 7, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage oncology company, reported financial results for the first quarter ended March 31, 2018 (Press release, Mirati, MAY 7, 2018, View Source [SID1234527095]).

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!

"We have made significant progress in all of our programs and continue to be encouraged by positive clinical results for sitravatinib and mocetinostat with planned data presentations at a fall oncology conference," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer. "Additionally, we are on track to file our planned Investigational New Drug application (IND) for MRTX849, a potent and selective inhibitor for KRAS, in the fourth quarter of 2018."

Financial Results for the First Quarter 2018

Cash, cash equivalents, and short-term investments were $148.7 million at March 31, 2018, compared to $150.8 million at December 31, 2017.

License and collaboration revenues for the first quarter of 2018 were $9.5 million, compared to none in the same period in 2017. License and collaboration revenues relate to the Collaboration and License Agreement between the Company and BeiGene, Ltd. ("BeiGene"), which became effective January 7, 2018, under which the Company granted BeiGene an exclusive license to develop, manufacture and commercialize sitravatinib in Asia (excluding Japan and certain other countries).

Research and development expenses for the first quarter of 2018 were $19.7 million, compared to $14.4 million for the same period in 2017. The increase in research and development expenses is primarily due to an increase in third party research and development expense for sitravatinib due to the continuation and expansion of ongoing clinical trials. The increase is also related to continued development of our KRAS inhibitor program for costs associated with preparing to file a planned IND application for our selected lead clinical compound, MRTX849. These increases are partially offset by a decrease in glesatinib expenses.

General and administrative expenses for the first quarter of 2018 were $5.2 million, compared to $3.7 million for the same period in 2017. The increase is primarily due to an increase in share-based compensation expense due to an increase in the fair value of stock options granted during the three months ended March 31, 2018 compared to the same period in 2017.

Net loss for the first quarter of 2018 was $14.7 million, or $0.51 per share basic and diluted, compared to net loss of $17.8 million, or $0.73 per share basic and diluted for the same period in 2017.