On April 12, 2018 ERYTECH Pharma (Euronext Paris: ERYP—Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that it will present full results from its U.S. Phase I trial evaluating eryaspase (GRASPA) in combination with chemotherapy for the treatment of acute lymphoblastic leukemia (ALL) and pre-clinical data on the erymethionase program at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held April 14-18, 2018 in Chicago, Illinois (Press release, ERYtech Pharma, APR 12, 2018, View Source [SID1234525277]).

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The U.S. Phase I ALL data will be presented during the poster session of the Phase I clinical trials by the lead author of the abstract, Dr. Alison Walker. The data from the dose-escalating Phase I clinical study demonstrate that eryaspase, L-asparaginase encapsulated in red blood cells, was well-tolerated when combined with CALGB 8811 protocol for frontline treatment of adults with ALL. Based on the PK data and the safety findings, the recommended dose for further clinical development is determined at 100 U/kg.

ERYTECH will also present pre-clinical data on the combination of eryaspase and erymethionase, methionine-gamma-lyase encapsulated in red blood cells, at a poster session on Wednesday, April 18, which show promising in vitro and in vivo bi-therapy therapeutic efficacy in different cancer models.

Poster Session: A Phase I study of eryaspase (L-asparaginase encapsulated in red blood cells) in combination with induction and consolidation chemotherapy for adult patients with newly diagnosed acute lymphoblastic leukemia (ALL)

Poster: #CT023 / 16
Lead Author:Dr. Alison Walker
Poster Session/Section: PO.CT01 – Phase I Clinical Trials 1
Date: Sunday, April 15
Time: 1:00 p.m. – 5:00 p.m.
Poster Session: Enzymatic combination investigation in cancer therapy

Poster: #5827 / 23
Lead Author Karine Aguera
Poster Session/Section: PO.ET01.04 – Combination Chemotherapy 2
Date: Wednesday, April 18
Time: 8:00 AM – 12:00 PM
Abstracts are available on the AACR (Free AACR Whitepaper) website. The two posters are to be presented at the 2018 AACR (Free AACR Whitepaper) Annual Meeting and will be available on the Erytech website after April 18, 2018.

On April 12, 2018 Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a late-stage clinical company developing next-generation antibody-drug conjugate (ADC) therapies for the treatment of cancer, reported that preclinical data from the company’s novel, next-generation ADC program using an innovative deBouganin cytotoxic protein payload will be presented during two poster sessions at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Eleven Biotherapeutics, APR 12, 2018, View Source [SID1234525276]). The meeting is taking place April 14-18, 2018 in Chicago.

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"We have uniquely designed our deBouganin payload to address tumor indications that can only be reached through systemic delivery. Our data show that deBouganin exhibits certain advantages over first-generation ADCs, which use more conventional small molecule cytotoxins, with respect to cell killing power, including the ability to kill cancer stem cells, circumvent multi-drug resistance and avoid cross-resistance mechanisms," said Gregory P. Adams, Ph.D., chief scientific officer of Eleven Biotherapeutics. "We are pleased to be presenting these promising data highlighting the potential activity and differentiation of our approach compared to first-generation ADCs."

DeBouganin is a proprietary de-immunized variant of bouganin, a ribosome inactivating protein that when internalized blocks protein synthesis, thereby leading to cell death. Eleven Biotherapeutics will present data from its VB6-845d program, a next-generation ADC comprised of a Fab fragment specific for the epithelial cell adhesion molecule (EpCAM) genetically linked to deBouganin via a furin protease sensitive peptide. Data being presented suggest that VB6-845d mediates tumor cell killing by an immunogenic cell death (ICD) pathway. The potential cross-priming effect initiated by VB6-845d-induced ICD suggests that VB6-845d in combination with immune checkpoint inhibitors may enhance their effectiveness in EpCAM-positive epithelial cancers.

Poster Title: VB6-845d Tumor Cell Killing Elicits Biologic Features of Immunogenic Cell Death
Date and Time:April 16, 2018 from 1:00 to 5:00 p.m. CT

In addition, in collaboration with Crescendo Biologics, the company will present data demonstrating that a fusion protein comprised of the company’s deBouganin payload and Crescendo’s Humabody are expressible as a soluble protein in E. coli supernatant. Crescendo’s Humabody products are a novel class of small, robust and potent protein therapeutics based on fully human VH domain building blocks. In vitro data support the potential of Humabody-deBouganin fusion constructs as anti-cancer therapeutics.

Poster Title: Engineering and Characterization of Anti-PSMA Humabody-DeBouganin Fusion Proteins

Date and Time:April 18, 2018 from 8:00 a.m. to 12:00 p.m. C

On April 11, 2018 Percans Oncology reported that it has developed i-CR, a personalized drug susceptibility testing platform for the precise treatment of colon cancer, to provide clinicians and patients with the most valuable medical plan for reference (Press release, Cothera Bioscience, APR 11, 2018, View Source [SID1234618854]).

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Features of i-CR in vitro drug susceptibility testing platform

i-CR drug susceptibility testing technology focuses on the functionality of tumor cells. It investigates the response of tumor cells under the action of drugs instead of exploring the relationship between drug susceptibility and changes in genes and proteins. The i-CR results are more practical and correspondence to clinical outcomes. This technology takes small samples of patients’ tumors, and performs rapid and high-throughput, drug susceptibility tests for drugs that have been marketed or entered clinical trials, thus providing a strong basis for clinicians to make optmized medical plans for each individual patient.

Target Patients

l Patients newly diagnosed as stage III or IV colorectal cancer;

l Patients who have failed the standard first-line treatment plan and hope to choose the best plan;

l Patients who have local or distant metastases and cannot benefit from genetic testing;

l Patients who are resistant to targeted drugs and need to find effective multiple targeted drugs and targeted combinations.

On April 11, 2018 Aileron Therapeutics (NASDAQ:ALRN), the clinical stage leader in the field of stapled peptide therapeutics for cancers and other diseases, reported the publication of nonclinical results in Science Translational Medicine demonstrating the anti-cancer potential of ALRN-6924 in models of Acute Myeloid Leukemia (AML) (Press release, Aileron Therapeutics, APR 11, 2018, View Source;p=RssLanding&cat=news&id=2342163 [SID1234525472]). ALRN-6924 is designed to reactivate p53-mediated tumor suppression by targeting the two primary p53 suppressor proteins, MDM2 and MDMX. ALRN-6924 is being evaluated in Phase 1 and Phase 2 clinical trials in patients with AML, myelodysplastic syndrome (MDS) and peripheral T-cell lymphoma (PTCL).

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In AML, blood-forming stem cells in the bone marrow produce abnormal red and white blood cells as a result of damage to DNA. P53, a natural tumor suppressor, is inactive in AML, allowing cancer cells to grow unimpeded. Reactivating p53 with ALRN-6924 appears to slow or stop the growth of both mature and immature cancer cells. As demonstrated by the researchers at Albert Einstein in their nonclinical studies, treatment with ALRN-6924 increased the median survival rate in an animal model of human AML (mice transplanted with human leukemia cells) from 50 to about 150 days. In addition, about 40% of the animals were cured, meaning they were tumor-free at one year.

"These data further support our belief that p53’s function may be more effectively restored when both MDMX and MDM2 are blocked. ALRN-6924, a stapled peptide therapeutic shown to inhibit both protein targets, has the potential to deliver on the long-held promise that restoring apoptosis through the p53 pathway may be critical in treating certain cancers," said Manuel Aivado, M.D., Ph.D., Chief Medical and Scientific Officer of Aileron.

"This is a very striking response. Most experimental drugs for leukemia in our experience achieve an increase in survival of only a few days in these preclinical models. Even more importantly, ALRN-6924 effectively cured about 40 percent of the treated mice," said study leader Ulrich Steidl, M.D., Ph.D., Professor of the Departments of Cell Biology and of Medicine and the Diane and Arthur B. Belfer Faculty Scholar in Cancer Research at Albert Einstein College of Medicine, and Associate Chair for Translational Research in Oncology at Montefiore.

The study in Science Translational Medicine is titled, "Dual inhibition of MDMX and MDM2 as a Therapeutic Strategy in Leukemia."

About ALRN-6924
ALRN-6924 is a first-in-class product candidate designed to reactivate wild type p53 tumor suppression by disrupting the interactions between the two primary p53 suppressor proteins, MDMX and MDM2. Aileron believes ALRN-6924 is the first and only product candidate in clinical development that can equipotently bind to and disrupt the interaction of MDMX and MDM2 with p53. Based on preclinical data and preliminary evidence of safety and anti-tumor activity in its ongoing clinical trials, there may be a significant opportunity to develop ALRN-6924 as a monotherapy or combination therapy for a wide variety of solid and liquid tumors. ALRN-6924 is currently being evaluated in multiple clinical trials for the treatment of acute myeloid leukemia (AML), advanced myelodysplastic syndrome (MDS) and peripheral T-cell lymphoma (PTCL). For information about its clinical trials, please visit www.clinicaltrials.gov.

On April 11, 2018 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported that the U.S. Food and Drug Administration has lifted the clinical hold on studies of BPX-501 in the U.S (Press release, Bellicum Pharmaceuticals, APR 11, 2018, View Source [SID1234525332]). The decision follows consultation with the FDA and agreement on amendments to the study protocols including guidance on monitoring and management of neurologic adverse events. Bellicum will be working with U.S. clinical sites to resume patient recruitment based on the amended protocols. The FDA clinical hold did not affect the BP-004 registrational trial in Europe, which is fully enrolled.

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About BPX-501
BPX-501 is an adjunct T-cell therapy administered after allogeneic HSCT, comprising genetically modified donor T cells incorporating Bellicum’s CaspaCIDe safety switch. It is designed to provide a safety net to eliminate alloreactive BPX-501 T cells (via administration of activator agent rimiducid) should uncontrollable GvHD or other T-cell mediated transplant complications occur. This may enable physicians to more safely perform stem cell transplants by administering BPX-501 engineered T cells to speed immune reconstitution, provide control over viral infections, and enhance graft-versus-leukemic activity while minimizing GvHD side effects.