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.

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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]).

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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).

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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.

On May 16, 2018 Moleculin Biotech, Inc., (Nasdaq:MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported that a second U.S. site, located in Lubbock, Texas, has qualified for its clinical trial to study Annamycin for the treatment of relapsed or refractory acute myeloid leukemia ("AML") (Press release, Moleculin, MAY 16, 2018, View Source [SID1234526711]).

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UMC Southwest Cancer Center has now qualified as the second U.S. site for Moleculin’s clinical trial of Annamycin. Dr. Sanjay Awasthi, Division Chief of Hematology/Oncology at Texas Tech University will serve as the site’s Principal Investigator.

"We are extremely pleased to announce our second site, as every new site opened for this clinical trial expands our ability to recruit patients and moves us one step closer to generating the data we are all eager to see," commented Walter Klemp, Moleculin’s Chairman and CEO. "Annamycin represents a unique treatment opportunity to address a critical unmet need in relapsed/refractory AML. Currently approved first-line therapy fails to help a majority of AML patients because of multidrug resistance and the limitations presented by the inherent damage those drugs can do to a patient’s heart ("cardiotoxicity"). Unfortunately, there is no effective second-line therapy for a majority of those patients. Preclinical studies have shown that Annamycin has an ability to avoid the multidrug resistance mechanisms that defeat currently approved AML drugs and is designed to have little to no cardiotoxicity. We hope to reproduce this data in our current Phase I/II clinical study and that Annamycin can finally provide a second-line treatment option for the majority of AML patients."

UMC Southwest Cancer Center

The UMC Southwest Cancer Center in Lubbock, Texas is a nationally recognized leader in the fight against cancer. Their multi-disciplinary approach combines the expertise of Texas Tech Physicians with UMC’s compassionate care and technological advancements. Comprehensive cancer treatment and care is available in one facility, close to home.

On May 16, 2018 Molecular Templates, Inc., (Nasdaq:MTEM) a clinical stage biopharmaceutical company focused on the discovery and development of Engineered Toxin Bodies, a new class of targeted biologic therapies that possess unique mechanisms of action in oncology, reported that data on two of its pipeline programs will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2018, to be held June 1-5 in Chicago, Illinois (Press release, Molecular Templates, MAY 16, 2018, View Source [SID1234526710]).

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Date: Monday, June 4
Time: 8:00am – 11:30am Central Time
Location: Hall A, Poster Board #217
Abstract #:
7580
Session:
Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Poster Title: Safety and Efficacy of Anti-CD20 Immunotoxin MT-3724 in Relapsed/Refractory B-cell non-Hodgkin Lymphoma (NHL) in a Phase 1 Study
First Author: Paul A. Hamlin, MD, Memorial Sloan Kettering Cancer Center
The poster summarizes interim results from a Phase I study of B-cell non-Hodgkin’s lymphoma (NHL) patients treated with MT-3724 who had previously relapsed after prior response to anti-CD20 Mab and chemotherapy. The results showed that MT-3724 has clinical anti-tumor activity in heavily pre-treated patients with relapsed or refractory B-cell NHL. Consistent with the mechanism of action, the best activity is observed in patients with rapidly growing diffuse large B-cell lymphoma (DLBCL).

Date: Monday, June 4
Time: 8:00am – 11:30am Central Time
Location: Hall A, Poster Board #394
Abstract #: 2568
Session: Developmental Therapeutics – Clinical Pharmacology & Experimental Therapeutics
Poster Title: Unexpected Pharmacokinetics of Evofosfamide Observed in Phase III MAESTRO Study
First Author: Jack P. Higgins, Ph.D., Molecular Templates, Inc.
This study compares the pharmacokinetic (PK) profile of Evofosfamide from the Phase II and Phase III trials completed in patients with pancreatic ductal adenocarcinoma (PDAC). A new ethanol-based formulation of Evofosfamide was introduced following Phase 2, with the goal of improving drug product solubility. The resultant decrease in drug exposure may explain why the efficacy seen in the Phase 2 study was not replicated in Phase 3.