On May 16, 2018 The first positive Phase 1 clinical data assessing cemiplimab as a potiential treatment for advanced non-small cell lung cancer (NSCLC) will be shared at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Sanofi Genzyme, MAY 16, 2018, View Source [SID1234526716]). Cemiplimab is an investigational human monoclonal antibody targeting the immune checkpoint PD-1 (programmed cell death protein 1).

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!

As published online in advance of ASCO (Free ASCO Whitepaper), interim results from the Phase 1 dose-escalation phase and expansion cohort of patients with advanced NSCLC showed that cemiplimab monotherapy resulted in an overall response rate (ORR) of 29 percent (six of 21 patients, all of which were partial responses or non-complete responses or non-progressive disease) and a disease control rate of 57 percent (12 of 21 patients, including ORR and six stable disease or non-complete responses or non-progressive disease) as of the data cut-off date. The duration of response exceeded eight months in five of six patients. In the trial, patients received either a 1 mg/kg dose (one patient) or 200 mg flat dose (20 patients) of cemiplimab, each given every two weeks. The most common treatment-related adverse events were asthenia, pneumonitis and rash (three patients each, 14 percent).

The NSCLC expansion cohort enrolled patients whose disease had worsened after initial improvement (relapsed) or not responded (refractory) after at least one course of chemotherapy. NSCLC patients in the Phase 1 trial had failed, on average, 2.14 previous chemotherapy regimens.

"Cemiplimab is the foundation of our broader immuno-oncology program and the clinical profile we’ve seen to date has encouraged us to explore the potential of this anti-PD-1 in multiple malignancies," said Israel Lowy, M.D., Ph.D, Vice President of Global Clinical Development and Head of Translational Science and Clinical Oncology, Regeneron. "In NSCLC, there remains a high unmet need despite recent advances. The positive Phase 1 results in advanced NSCLC support our strategy to advance cemiplimab in multiple Phase 3 trials exploring a number of treatment settings for this disease."

Cemiplimab being investigated in patients with NSCLC in different settings

The Sanofi and Regeneron clinical development program in NSCLC encompasses several Phase 2 and 3 trials investigating cemiplimab treatment of tumors with different PD-L1 (programmed death-ligand 1) expression levels and as a monotherapy or part of doublet or triplet combinations in the first- and second-line treatment settings. This includes a Phase 3 NSCLC trial investigating cemiplimab combination therapy versus pembrolizumab in certain first-line patients.

"The cemiplimab development program is an example of our ability to rapidly translate scientific innovation into potential treatment breakthroughs in oncology," added Joanne Lager, M.D., Head of Oncology Development, Sanofi. "The data shared at ASCO (Free ASCO Whitepaper) will provide an important foundation for evaluating cemiplimab in new combination regimens, with the goal of helping patients who may not benefit from existing therapies."

Additional results for cemiplimab will also be presented at ASCO (Free ASCO Whitepaper)

In addition to the Phase 1 advanced NSCLC data, updated results from pivotal clinical trials investigating cemiplimab in advanced cutaneous squamous cell carcinoma (CSCC) will be presented at ASCO (Free ASCO Whitepaper). Additional accepted abstracts include an assessment of treatment patterns and costs in CSCC as well as overviews of clinical trials in progress for cemiplimab in cervical cancer and for REGN3767, an investigational human monoclonal antibody targeting the immune checkpoint LAG-3 (lymphocyte-activation gene 3), as either a monotherapy or in combination with cemiplimab in solid tumors and lymphoma.

Cemiplimab is currently being reviewed by the U.S. Food and Drug Administration and European Medicines Agency as a potential new treatment for patients with metastatic CSCC or patients with locally advanced CSCC who are not candidates for surgery. In addition to CSCC and NSCLC, cemiplimab is also being investigated in potentially pivotal/pivotal trials as a monotherapy for basal cell carcinoma and cervical cancer alongside exploratory trials in squamous cell carcinoma of the head and neck, melanoma, colorectal cancer, prostate cancer, multiple myeloma, Hodgkin lymphoma and non-Hodgkin lymphoma.

Cemiplimab and REGN3767 are being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

Cemiplimab and REGN3767 are currently under clinical development, and their safety and efficacy have not been fully evaluated by any regulatory authority.

On May 16, 2018 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi reported that the first positive Phase 1 clinical data assessing cemiplimab as a potential treatment for advanced non-small cell lung cancer (NSCLC) will be shared at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Regeneron, MAY 16, 2018, View Source [SID1234526715]). Cemiplimab is an investigational human monoclonal antibody targeting the immune checkpoint PD-1 (programmed cell death protein 1).

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!

As published online in advance of ASCO (Free ASCO Whitepaper), interim results from the Phase 1 dose-escalation phase and expansion cohort of patients with advanced NSCLC showed that cemiplimab monotherapy resulted in an overall response rate (ORR) of 29 percent (six of 21 patients, all of which were partial responses or non-complete responses or non-progressive disease) and a disease control rate of 57 percent (12 of 21 patients, including ORR and six stable disease or non-complete responses or non-progressive disease) as of the data cut-off date. The duration of response exceeded eight months in five of six patients. In the trial, patients received either a 1 mg/kg dose (one patient) or 200 mg flat dose (20 patients) of cemiplimab, each given every two weeks. The most common treatment-related adverse events were asthenia, pneumonitis and rash (three patients each, 14 percent).

The NSCLC expansion cohort enrolled patients whose disease had worsened after initial improvement (relapsed) or not responded (refractory) after at least one course of chemotherapy. NSCLC patients in the Phase 1 trial had failed, on average, 2.14 previous chemotherapy regimens.

"Cemiplimab is the foundation of our broader immuno-oncology program, and the clinical profile we’ve seen to date has encouraged us to explore the potential of this anti-PD-1 in multiple malignancies," said Israel Lowy, M.D., Ph.D., Vice President of Global Clinical Development and Head of Translational Science and Clinical Oncology, Regeneron. "In NSCLC, there remains a high unmet need despite recent advances. The positive Phase 1 results in advanced NSCLC support our strategy to advance cemiplimab in multiple Phase 3 trials exploring a number of treatment settings for this disease."

Cemiplimab being investigated in patients with NSCLC in different settings
The Regeneron and Sanofi clinical development program in NSCLC encompasses several Phase 2 and 3 trials investigating cemiplimab treatment of tumors with different PD-L1 (programmed death-ligand 1) expression levels and as a monotherapy or part of doublet or triplet combinations in the first- and second-line treatment settings. This includes a Phase 3 NSCLC trial investigating cemiplimab combination therapy versus pembrolizumab in certain first-line patients.

"The cemiplimab development program is an example of our ability to rapidly translate scientific innovation into potential treatment breakthroughs in oncology," added Joanne Lager, M.D., Head of Oncology Development, Sanofi. "The data shared at ASCO (Free ASCO Whitepaper) will provide an important foundation for evaluating cemiplimab in new combination regimens, with the goal of helping patients who may not benefit from existing therapies."

Additional results for cemiplimab will also be presented at ASCO (Free ASCO Whitepaper)
In addition to the Phase 1 advanced NSCLC data, updated results from pivotal clinical trials investigating cemiplimab in advanced cutaneous squamous cell carcinoma (CSCC) will be presented at ASCO (Free ASCO Whitepaper). Additional accepted abstracts include an assessment of treatment patterns and costs in CSCC as well as overviews of clinical trials in progress for cemiplimab in cervical cancer and for REGN3767, an investigational human monoclonal antibody targeting the immune checkpoint LAG-3 (lymphocyte-activation gene 3), as either a monotherapy or in combination with cemiplimab in solid tumors and lymphoma.

Cemiplimab is currently being reviewed by the U.S. Food and Drug Administration and European Medicines Agency as a potential new treatment for patients with metastatic CSCC or patients with locally advanced CSCC who are not candidates for surgery. In addition to CSCC and NSCLC, cemiplimab is also being investigated in potentially pivotal/pivotal trials as a monotherapy for basal cell carcinoma and cervical cancer alongside exploratory trials in squamous cell carcinoma of the head and neck, melanoma, colorectal cancer, prostate cancer, multiple myeloma, Hodgkin lymphoma and non-Hodgkin lymphoma.

Cemiplimab and REGN3767 are being jointly developed by Regeneron and Sanofi under a global collaboration agreement and were invented by Regeneron using the company’s proprietary VelocImmune technology that yields optimized fully-human antibodies.

Cemiplimab and REGN3767 are currently under clinical development, and their safety and efficacy have not been fully evaluated by any regulatory authority.

On May 16, 2018 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that the cells it will encapsulate and then use in its planned clinical trial in patients with locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC) have successfully passed all 29 tests required by the U.S. Food and Drug Administration (FDA) (Press release, PharmaCyte Biotech, MAY 16, 2018, View Source [SID1234526714]). Most of the tests were conducted by PharmaCyte’s contractor, Eurofins Lancaster Laboratories, Inc. (Eurofins). The rest of the tests were conducted by third party laboratories subcontracted by Eurofins.

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!

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, "We are pleased that the cells being used in our LAPC trial have now successfully passed all of the rigorous and extensive testing done on them by Eurofins and its subcontractors. The nature of the various tests was quite varied and some of the tests were more complex than others, so we’re excited that the cells, which are at the heart of our pancreatic cancer therapy, could endure such a wide range of testing and pass each and every one. Now that testing is complete and all results are positive, we have been advised by Eurofins that we will have a final Certificate of Analysis next week. With this document in hand, the cell encapsulation process can begin."

Before any tests could be started, cells from the Master Cell Bank had to be thawed from frozen storage and then cultured to obtain enough cells for all of the planned tests. This was completed on January 24, 2018. In all, the cells underwent 29 different tests. Because of processes involved at Eurofins pertaining to the tests, not all tests could begin at the same time.

Once each test was completed, the test results had to be analysed and a report written by Eurofins. Then the conduct and results of each test had to examined and approved by Eurofins’ Quality Assurance/Quality Control department. Now that all the tests have been successfully completed, Eurofins is preparing the necessary Certificate of Analysis to be sent to Austrianova in Thailand where encapsulation will be performed using PharmaCyte’s signature live-cell encapsulation technology. Having the Certificate of Analysis is a cGMP requirement before encapsulation can begin.

On May 16, 2018 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO FR0010095596), a biotechnology company specializing in the development of innovative drugs in oncology, notably against rare or resistant forms of cancer, reported its consolidated revenues and cash position at March 31, 2018 (Press release, Onxeo, MAY 16, 2018, View Source [SID1234526713]).

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!

Judith Greciet, Chief Executive Officer of Onxeo, said: "The first quarter of 2018 was highlighted by strong momentum in the development of AsiDNA, our lead product candidate. Following the significant efforts of our R&D team over the previous months, we recently initiated the DRIIV phase I clinical trial in order to evaluate the potential of AsiDNA, our first-in-class DNA repair inhibitor, administered intravenously, in patients with advanced solid tumors. We expect interim data from this study to be available in the second half of 2018. If these results confirm both the safety profile of AsiDNA and its activity, we will have achieved a key milestone in our AsiDNA development program. Importantly, we continue to advance our core R&D programs according to plan while maintaining strict cost control. As such, we expect that our current cash position of €9.2 million will support our currently planned activities until mid-2019, including through multiple potentially value-creating inflection points for our company.

On May 16, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) reported that abstracts from two Phase 2 studies of indoximod, used in combination with other agents, are now available on the website of the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, NewLink Genetics, MAY 16, 2018, View Source [SID1234526712]). Presentation sessions and times are noted below. Additional data will be presented at ASCO (Free ASCO Whitepaper).

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!

Abstract 9512, Phase 2 trial of the IDO pathway inhibitor indoximod plus checkpoint inhibition for the treatment of patients with advanced melanoma, presented by Yousef Zakharia, MD, University of Iowa Hospitals and Clinics, Holden Comprehensive Cancer Center

Poster Session "Melanoma/Skin Cancers" – Poster Board #339 – Mon, Jun 4, 1:15PM – 4:45PM, McCormick Place, Hall A

Poster Discussion Session – Mon, Jun 4, 4:45PM – 6:00PM, McCormick Place, Rm E451

Abstract 4015, Phase 2 trial of the IDO pathway inhibitor indoximod plus gemcitabine / nab-paclitaxel for the treatment of patients with metastatic pancreas cancer, presented by Nathan Bahary, MD, PhD, University of Pittsburgh Medical Center Cancer Center Pavilion

Poster Session "Gastrointestinal (Noncolorectal) Cancer" – Poster Board #204 – Sun, Jun 3, 8:00AM – 11:30AM, McCormick Place, Hall A

Poster Discussion Session – Sun, Jun 3, 4:45PM – 6:00PM, McCormick Place, Hall D2

About Indoximod
Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target involved in regulating the tumor microenvironment and immune escape. Indoximod is being evaluated in combination with treatment regimens including chemotherapy, radiation, checkpoint blockade and cancer vaccines across multiple indications such as AML, DIPG and melanoma.