On March 20, 2018 Crescendo Biologics Limited (Crescendo), the drug developer of novel,targeted T-cell engaging therapeutics, reported Dr Brian McGuinness, Head of New Product andBusiness Development, Phil Bland-Ward (CSO) and James Legg (VP R&D) will be presenting a poster at AACR (Free AACR Whitepaper) (American Association for Cancer Research) Annual Meeting in Chicago, USA on 18 April 2018 (Press release, Crescendo Biologics, MAR 20, 2018, View Source [SID1234525091]).

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The Crescendo team will be available to discuss the poster entitled "Multifunctional biologics fortargeted T-cell therapy based on in vivo matured fully human VH domains" within the "Antibodies,Fusion Proteins and Related Biologics session". This will cover the beneficial characteristics of Humabodies and their enhanced therapeutic potential over traditional monoclonal antibodies.

Poster details
Title: Multifunctional biologics for targeted T-cell therapy based on in vivo matured fully human VHdomains
Authors: J. Legg, B. McGuinness, P. Bland-Ward, P. Pack
Session Category: Experimental and Molecular Therapeutics
Session Title: Antibodies, Fusion Proteins, and Related BiologicsSession Date and Time: Wednesday Apr 18, 2018 8:00 AM – 12:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 35

Poster Board Number: 11
Permanent Abstract Number: 5766

There will also be a poster by Eleven Biotherapeutics in the same session which includes data fromCrescendo. This poster, entitled ‘Engineering and characterization of anti-PSMA humabody-deBouganinfusion proteins’, will be at Board Number 15.

AACR’s Annual Meeting is being held in Chicago, Illinois from 14 – 18 April. The theme is ‘DrivingInnovative Cancer Science to Patient Care’. Presentations at the Annual Meeting will cover the latestbasic, translational, clinical, and prevention-focused research in the field, including important areas suchas early detection, cancer interception, and survivorship in all populations.

AC Immune has filed a 20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 20-F, AC Immune, 2018, MAR 20, 2018, View Source [SID1234526042]).

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On March 20, 2018 Cotinga Pharmaceuticals Inc. (TSX Venture:COT) (OTCQB:COTQF) ("Cotinga" or the "Company"), a clinical-stage pharmaceutical company advancing a pipeline of targeted therapies for the treatment of cancer, reported that the Company submitted an updated clinical package to regulatory authorities to expand its ongoing Phase 1 trial of COTI-2 (Press release, Cotinga, MAR 20, 2018, View Source [SID1234533158]). The protocol amendment will expand the clinical trial to evaluate COTI-2 as a combination therapy in a wide spectrum of cancers.

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"Based on the strength of encouraging interim data from our ongoing Phase 1 trial, as well as preclinical studies demonstrating that COTI-2 was efficacious and synergistic when administered alongside standard of care chemotherapeutics, we are excited to push forward the development of COTI-2 as part of a combination therapy regimen," said Alison Silva, President and Chief Executive Officer. "After close consultation with our academic collaborators and investigators, we submitted a substantially updated regulatory package to the FDA seeking approval to evaluate COTI-2 as a combination therapy in our ongoing trial. In addition to evaluating our lead asset as a combination therapy for gynecological malignancies and head and neck squamous cell carcinoma (HNSCC), the protocol amendment will also broaden the trial to include other solid tumors. We look forward to implementing this amendment and dosing the first patient with a combination therapy regimen in the months ahead."

Phase 1 Trial of COTI-2

The ongoing Phase 1 trial of COTI-2 is currently evaluating COTI-2 as a monotherapy for the potential treatment of gynecological malignancies and HNSCC. In 2017, the Company announced top-line data from the gynecological malignancies arm of the trial demonstrating COTI-2 was generally safe and well-tolerated. COTI-2 also exhibited an encouraging pharmacokinetic/pharmacodynamic profile and signals of efficacy.

The protocol amendment submitted by the Company in March 2018 aims to expand the ongoing Phase 1 trial to evaluate COTI-2 in combination with various standard of care chemotherapy regimens in a wide spectrum of cancers. The current gynecological malignancies arm will be expanded to evaluate COTI-2 in combination with bevacizumab and paclitaxel/doxorubicin. The current dose-escalation HNSCC arm will be expanded to evaluate COTI-2 in combination with cisplatin in HNSCC and other solid tumors. Primary outcome measures will evaluate safety and tolerability and determine the maximum tolerated dose and recommended Phase 2 dose for COTI-2 as a combination therapy. Secondary and exploratory outcome measures will evaluate pharmacodynamics and various signals of efficacy. Pending regulatory approval and subject to sufficient financing, the Company expects to implement this protocol amendment for the ongoing Phase 1 trial of COTI-2 in May 2018.

On March 19, 2018 Oncoceutics, Inc. reported that multiple abstracts from the company and its commercial and academic collaborators will be presented at the 2018 annual meeting of the American Association of Cancer Research (AACR) (Free AACR Whitepaper) in Chicago, Illinois, on April 14th to April 18th (Press release, Oncoceutics, MAR 19, 2018, View Source [SID1234558371]).

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These abstracts highlight the unique way that ONC201 engages the dopamine receptor, leading to downstream direct anti-tumor and immune oncology effects, which are especially pronounced in tumors with dopamine pathway dysregulation. These tumors include H3 K27M mutant high grade gliomas and other cancers, where ONC201 is now in advanced clinical trials.

Additionally, the abstracts showcase the continued preclinical advancement of other members of the imipridone family. ONC212 will be featured in an oral presentation highlighting its ability to treat aggressive leukemias as a single agent, and effectively synergize with other anti-leukemic agents, specifically BCL-2 inhibitors, due to its unique GPCR target. ONC206 demonstrates parallel characteristics with ONC201, while also being differentiated by a unique binding profile.

The abstracts are listed below and categorized by topic: ONC201 clinical translation; ONC201 preclinical single agent and combinatorial activity; and analogs (ONC206 and ONC212). All poster presentations will be in McCormick Place South, Exhibit Hall A, and the oral presentation of ONC212 will take place in Room S102 – McCormick Place South (Level 1) at the times described below.

ONC201 Clinical Translation:

Selective targeting of dopamine receptor dysregulation in high grade gliomas with imipridone ONC201
April 17, 2018, 8:00 AM

ONC201 induction of apoptosis in hPheo1 cell line supports use of this oral agent in ongoing phase 2 clinical trial against neuroendocrine tumors
April 17, 2018, 1:00 PM

Clinical immunostimulatory activity of imipridone ONC201, a selective DRD2 antagonist, in advanced solid tumor patients
April 18, 2018, 8:00 AM

ONC201 Preclinical Single Agent and Combinatorial Activity

Treatment and signaling contexts for the application of the imipridone ONC201 to prostate cancer cells
April 15, 2018, 1:00 PM

LB-082. ONC201 sensitizes resistant breast cancer cells to TRAIL through death receptor 5 upregulation

April 16, 2018, 8:00 AM – 12:00 PM

Synergistic antitumor effect of ONC201 in combination with radiation therapy
April 16, 2018, 1:00 PM

Combination ONC201 and radiation therapy in the treatment of breast cancer
April 16, 2018, 1:00 PM

Analogs (ONC206 and ONC212):

Receptor pharmacology and anti-cancer activity of selective DRD2/3 antagonist imipridone ONC206
April 17, 2018, 1:00 PM

The novel imipridone ONC212 highly synergizes with the BCL-2 inhibitor ABT-199 in AML and activates orphan receptor GPR132
April 17, 2018, 3:35 PM – Oral Presentation

On March 19, 2018 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported dosing of the first patient in a Phase 1 study of AG-270, a first-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor (Press release, Agios Pharmaceuticals, MAR 19, 2018, View Source [SID1234524881]). This open-label, dose-escalation and expansion study investigates AG-270 in patients with solid tumors or lymphoma with deletion of the metabolic gene methylthioadenosine phosphorylase (MTAP).

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"In addition to significant milestones for our late-stage portfolio this year, we are pleased to demonstrate the continued productivity of our research engine by advancing our sixth internally discovered molecule into the clinic," said Scott Biller, M.D., chief scientific officer of Agios. "As a first-in-class MAT2A inhibitor, AG-270 has the potential to benefit the large number of patients whose cancer is characterized by the loss of MTAP. We look forward to conducting the early clinical work that will explore the pharmacology and clinical activity of MAT2A inhibition in tumors carrying this deletion."

"We are excited to participate in the development of this novel and targeted approach to cancer treatment," said Howard (Skip) Burris, M.D., chief medical officer and president of clinical operations at Sarah Cannon. "Bringing AG-270 into the clinic represents an opportunity for Sarah Cannon and Agios to continue a partnership that began with the IDH inhibitors and remains focused on transforming cancer care and personalizing treatment."

AG-270 Phase 1 Study Design

The purpose of this Phase 1 multi-center, open-label study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-270 in approximately 50 patients with advanced solid tumors or lymphoma with MTAP deletion. AG-270 will be administered as a single agent dosed orally once daily in 28-day cycles. The first part of the study is a dose-escalation phase in which cohorts of patients will receive ascending doses of AG-270 to determine the maximum tolerated dose (MTD) or optimal dose. The second part of the study is a dose expansion phase where additional patients will receive AG-270 at the MTD or optimal dose to further evaluate its safety, tolerability and clinical activity as a potential dose for future studies. Patients must have evidence of loss of the MTAP protein from their tumor tissue, or evidence of loss of the CDKN2A tumor suppressor gene (commonly co-deleted with the MTAP gene), in order to be eligible for the study. Please refer to www.clinicaltrials.gov for additional clinical trial information.

About the MAT2A Inhibitor AG-270
AG-270 is part of a 2016 global research collaboration agreement with Celgene Corporation. Through Phase 1 dose escalation, Celgene has the option, for a fee of at least $30 million, to participate in a worldwide cost and profit share with Agios. Upon exercise of the option the parties will share all development costs, subject to specified exceptions, and any profits on net sales and Agios will be eligible for up to $169 million in clinical and regulatory milestone payments for the program. As described in a 2016 Cell Reports publication, Agios discovered that MAT2A is a component of a novel pathway in MTAP-deleted tumors which, when inhibited, results in robust anti-tumor activity. Preclinical data presented at the 2017 Keystone Tumor Metabolism meeting demonstrated that small molecule inhibitors of MAT2A are efficacious in MTAP-deleted tumor xenograft models.