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DiaMedica to Present at the MicroCap Conference on April 10th in New York City at the Essex House

On April 4, 2018 DiaMedica Therapeutics Inc. ("DiaMedica") (TSX VENTURE:DMA) (OTCQB:DMCAF), reported that Mr. Rick Pauls, President and CEO, will present at The MicroCap Conference at the Essex House, 160 Central Park South New York on Tuesday April 10th at 12:30pm ET (Press release, DiaMedica, APR 4, 2018, View Source [SID1234525174]).

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AstraZeneca’s early and late-stage oncology portfolio showcased at AACR annual meeting and ELCC

On April 4, 2018 AstraZeneca and MedImmune, its global biologics research and development arm, reported it will present updates from their early and late stage oncology pipelines at two major congresses this month. In total, 98 abstracts were accepted for the European Lung Cancer Conference (ELCC) in Geneva,11-14 April, and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in Chicago,14-18 April (Press release, AstraZeneca, APR 4, 2018, View Source [SID1234525172]). The abstracts cover key data updates from the Phase III FLAURA and PACIFIC trials in non-small cell lung cancer (NSCLC), and the Phase III OlympiAD trial in BRCA-mutated metastatic breast cancer. They also highlight promising next-generation research from the company’s extensive pipeline in DNA damage response, Immuno-Oncology and Tumour Drivers & Resistance.

Dave Fredrickson, Executive Vice President, Head of Oncology Business Unit said: "Building on major regulatory approvals in the first quarter of 2018, AstraZeneca continues to deliver strong results from our innovative science and accelerated development programmes in oncology. At ELCC, we are sharing new data from two pivotal trials in lung cancer that will help inform treatment strategies for patients who, until now, have had very few options. At the AACR (Free AACR Whitepaper) meeting, we will share pioneering early science across multiple tumour types."

ELCC

As part of the ‘Best of ELCC’ sessions, AstraZeneca will present post-progression outcomes from the FLAURA trial of Tagrisso versus the epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) erlotinib or gefitinib in 1st-line EGFR mutation-positive NSCLC (Abstract #128O). In addition, patient-reported outcomes data will also be presented from the FLAURA trial, showing improvements in key symptoms, supporting the potential use of Tagrisso in this setting (Abstract #139PD).

Patient-reported outcomes will be presented from the PACIFIC trial of Imfinzi in unresectable, Stage III NSCLC (Abstract #703), following its approval in the US for this indication.

AACR annual meeting

DNA Damage Response (DDR)

AstraZeneca will present data on its expanded portfolio of potential medicines which exploit DDR dependencies to selectively kill cancer cells across multiple tumour types. The first-in-class PARP inhibitor, Lynparza, will report final overall survival data from the pivotal OlympiAD trial in BRCA-mutated metastatic breast cancer (Abstract #CT038). Data exploring the clinical properties of Lynparza and four other PARP inhibitors will illustrate clinical efficacy and safety profiles (Abstract #LB-273/17).

New data will also be presented on AZD6738, an Ataxia Telangiectasia and Rad3-related (ATR) inhibitor (Abstracts #CT026/19, #LB-263/7 and #337/18) and AZD0156, a first-in-class inhibitor of Ataxia telangiectasia mutated (ATM) (Abstract #4909/5).

Immuno-Oncology (IO)

A series of presentations will share new insights into the science of Imfinzi, including IO-IO combination data from Study 006 (Abstract #CT113) and Study 10 (Abstract #CT113) in 2nd-line NSCLC patient populations.

Beyond Imfinzi, MedImmune will feature progress in its early IO pipeline, including the novel bispecific antibody MEDI5752, designed to target dual checkpoints on immune cells and leverage the synergistic potential of combined mechanisms in immunotherapy (Abstract #2776/9).

Tumour Drivers & Resistance

Data on AZD4573, a CDK9 inhibitor, will demonstrate rapid cell-death induction in haematological tumour models through depletion of MCL1 (Abstract #310/17). And early monotherapy and combination data on the novel ERK inhibitor AZD0364, (Abstract #1647/2) will show its effect on KRAS-mutated tumours when used in combination with MEK inhibitor, selumetinib (Abstract #1856/14).

Crowd-sourcing combinations

AstraZeneca is presenting the results of the DREAM challenge, an open competition combining crowd-sourcing and the application of machine learning to generate new algorithms that predict the best therapeutic combinations for treating different types of cancer (Abstract #3886/5).

AstraZeneca/MedImmune key presentations at ELCC 2018

Lead author

Abstract title

Presentation details

Tagrisso (osimertinib)

Planchard D et al.

Osimertinib vs standard of care (SoC) EGFR-TKI as first-line therapy in patients (pts) with untreated EGFRm advanced NSCLC: FLAURA post-progression outcomes

ORAL

Abstract #128O

ESMO-IASLC Best Abstracts

Friday, 13 April

5:30-5:45pm

Room B

Leighl N et al.

Patient-reported outcomes from FLAURA: osimertinib versus standard of care (SoC) epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) in patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC)

POSTER DISCUSSION

Abstract #139PD

Thursday, 12 April

8:07am

Room A

Imfinzi

Hui R et al.

Time to deterioration of symptoms with durvalumab in Stage III, locally advanced, unresectable NSCLC: post-hoc analysis of PACIFIC patient-reported outcomes

ORAL

Abstract #703

ESMO-IASLC Best Abstracts

Friday, 13 April

3:00-5:00pm TBD

AstraZeneca/MedImmune key presentations at AACR (Free AACR Whitepaper) 2018 Annual Meeting

Lead author

Abstract title

Presentation details

DNA Damage Response

Robson M et al.

Lynparza

OlympiAD final overall survival: Olaparib versus chemotherapy treatment of physician’s choice (TPC) in patients with HER2-negative metastatic breast cancer (mBC) and a germline BRCA mutation (gBRCAm)

ORAL

Abstract #CT038

Session CTMS01 – New Treatment Approaches for Breast and Ovarian Cancer

Sunday, 15 April

3:50-4:05pm

Room N427 (North, Level 4)

Chen Y et al.

Lynparza + ATM inhibitor

Adaptive oncology phase 1 study of first-in-class inhibitor of ataxia telangiectasia mutated protein kinase (ATM), in combination with olaparib

POSTER

Abstract #4909/5

Session PO.ET05.02 – Pharmacokinetics and Pharmacodynamics

Tuesday, 17 April

1:00-5:00pm

Hall A, Section 41

Krebs M et al.

Lynparza or Imfinzi + ATR inhibitor

Phase I study of AZD6738, an inhibitor of ataxia telangiectasia Rad3-related (ATR), in combination with olaparib or durvalumab in patients (pts) with advanced solid cancers

POSTER

Abstract #CT026/19

Session PO.CT01 – Phase I Clinical Trials 1

Sunday, 15 April

1:00-5:00pm

Hall A, Section 42

Leo E et al.

Lynparza

A head-to-head comparison of the properties of five clinical PARP inhibitors identifies new insights that can explain both the observed clinical efficacy and safety profiles

POSTER

Abstract #LB-273/17

Session LBPO.ET03 – Late-Breaking Research: Experimental and Molecular Therapeutics 3

Tuesday, 17 April

1:00-5:00pm

Hall A, Section 43

Lloyd R et al.

Lynparza + ATR inhibitor

The PARP inhibitor olaparib is synergistic with the ATR inhibitor AZD6738 in ATM deficient cancer cells

POSTER

Abstract #337/18

Session PO.MCB07.03 – Cancer Predisposition and Synthetic Lethality

Sunday, 15 April

1:00-5:00pm

Hall A, Section 15

Young LA et al.

Calquence + ATR inhibitor

Pre-clinical efficacy of AZD6738 in combination with the Bruton’s tyrosine kinase inhibitor, Calquence (acalabrutinib), in models of activated B-cell like diffuse large B-cell lymphoma (DLBCL)

POSTER

Abstract #LB-263/7

Session LBPO.ET03 – Late-Breaking Research: Experimental and Molecular Therapeutics 3

Tuesday, 17 April

1:00-5:00pm

Hall A, Section 43

Immuno-Oncology

Balar A et al.

Durvalumab + tremelimumab in patients with metastatic urothelial cancer

ORAL

Abstract #CT112

Session CTMS02 – Updates in Immuno-oncology Trials

Monday, 16 April

3:35-3:50pm

N Hall C

Chaft J et al.

Phase 1b dose-expansion study of the safety and antitumor activity of durvalumab plus tremelimumab in pretreated advanced NSCLC

ORAL

Abstract #CT113

Session CTMS02 – Updates in Immuno-oncology Trials

Monday, 16 April

3:50-4:05pm

N Hall C

Dovedi SJ et al.

MEDI5752: A novel bispecific antibody that preferentially targets CTLA-4 on PD-1 expressing T-cells

POSTER

Abstract #2776/9

PO.IM02.11 – Therapeutic Antibodies, Including Engineered Antibodies 2

Monday, 16 April

1:00-5:00pm

Hall A, Section 34

O’Donnell P et al.

Updated efficacy and safety profile of durvalumab monotherapy in urothelial carcinoma

POSTER

Abstract #CT031/24

Session PO.CT01 – Phase I Clinical Trials 1

Sunday, 15 April

1:00-5:00pm

Hall A, Section 42

Tumour Drivers & Resistance

Ortiz-Cuaran S et al.

Longitudinal circulating-tumour DNA profiling of EGFR-mutated non-small cell lung cancer patients treated with EGFR-tyrosine kinase inhibitors

ORAL

Abstract #937

Session MS.CL10.01 – Liquid Biopsy 1

Sunday, 15 April

3:20-3:35pm

McCormick Place South (Level 1), Room S105

Cidado J et al.

AZD4573, a novel CDK9 inhibitor, rapidly induces cell death in haematological tumour models through depletion of Mcl1

POSTER

Abstract #310/17

Session PO.MCB02.01 – BCL-2 Family and Mitochondrial Apoptosis

Sunday, 15 April

1:00-5:00pm

Hall A, Section 14

Flemington V et al.

Combination of the novel ERK inhibitor AZD0364 with the MEK inhibitor selumetinib significantly enhances antitumour activity in KRAS mutant tumour models

POSTER

Session PO.ET02.03 – Cell Cycle, Drug Resistance, and Combinations

Abstract #1856/14

Monday, 16 April

8:00am-12:00pm

Hall A, Section 37

Simpson I et al.

Discovery of AZD0364, a potent and selective oral inhibitor of ERK1/2 that is efficacious in both monotherapy and combination therapy in models of NSCLC

POSTER

Abstract (#1647/2)

Session PO.CH01.01 – Target Based Drug Discovery

Monday, 16 April

8:00am-12:00pm

Hall A, Section 30

Innovative Methodologies

Dry JR et al.

A large cancer pharmacogenomics combination screen powering crowd-sourced advancement of computational drug synergy predictions

ORAL

Abstract #3886/5

Session PO.ET05.01 – Pharmacogenetics and Pharmacogenomics

Tuesday, 17 April

8:00am-12:00pm

Hall A, Section 37*

*part of official press programme

Cotinga Pharmaceuticals Announces Presentation on COTI-2 at the American Association for Cancer Research (AACR) Annual Meeting 2018

On April 3, 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 and its collaborators from MD Anderson Cancer Center and Northwestern Medicine will present data on COTI-2, Cotinga’s lead compound currently in a Phase 1 trial, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018 taking place April 14-18, 2018 in Chicago, Illinois (Press release, Cotinga, APR 3, 2018, View Source [SID1234533157]).

Presentation Title: Safety and early efficacy signals for COTI-2, an orally available small molecule targeting p53, in a phase I trial of recurrent gynecologic cancer
Presentation Date and Time: Sunday April 15th, 2018 1:00 PM – 5:00 PM Central Time
Presentation Location: McCormick Place South, Hall A, Poster Section 42

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. In March 2018, the Company submitted a protocol amendment to expand the trial to evaluate COTI-2 in combination with various standard of care chemotherapy regimens in a wide spectrum of cancers. 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 the protocol amendment mid-calendar year 2018.

Cotinga Pharmaceuticals Reports Fiscal 2018 Third Quarter Financial and Operating Results

On April 3, 2019 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 its financial and operating results today for the three- and nine-month periods ended January 31, 2018 (Press release, Cotinga, APR 3, 2018, View Source [SID1234533156]). Recent highlights include:

Advanced the clinical development of COTI-2:

In November 2017, Cotinga announced pharmacokinetic (PK) data from its ongoing Phase 1 trial of COTI-2, which showed that COTI-2 exhibited rapid absorption, long half-life and lack of long-term drug accumulation, which support the potential for daily oral dosing and the continued development of COTI-2 as a potential treatment for patients;
In December 2017, Cotinga announced pharmacodynamic (PD) data and positive signals of efficacy from its ongoing Phase 1 trial of COTI-2, which suggest COTI-2 may be a potentially efficacious treatment for patients;
In January 2018, Cotinga announced publication of positive data from a preclinical study demonstrating that combining COTI-2 with commonly used chemotherapeutic agents improves efficacy and exhibits favorable drug resistance and toxicity profile in human cancer cell lines, which suggest COTI-2 may be potentially efficacious as a combination therapy;
Subsequent to the reporting quarter, in March 2018, Cotinga announced that the Company submitted an updated clinical package to regulatory authorities to expand its ongoing Phase 1 trial of COTI-2. The protocol amendment will expand the clinical trial to evaluate COTI-2 as a combination therapy in a wide spectrum of solid tumor cancers.
Solidified identity as a clinical-stage pharmaceutical company:

In January 2018, the Company changed its name to Cotinga Pharmaceuticals Inc. The new brand signified the Company’s evolution from a technology-driven company to a clinical-stage pharmaceutical company. The name is derived from the Cotingas, one of the world’s largest and most diverse bird species, and symbolizes the Company’s focus on developing innovative therapies to treat a wide spectrum of cancers.
"We were excited to announce multiple meaningful clinical and corporate developments in the third fiscal quarter," said Alison Silva, President & Chief Executive Officer. "The encouraging interim clinical data we announced over the past several months, along with the positive preclinical data we published earlier this year, facilitated a thorough assessment of our clinical development strategy for COTI-2. Based on the findings of that assessment, we submitted a regulatory package to the FDA to expand our ongoing Phase 1 trial to evaluate COTI-2 as a combination therapy in a broad patient population. We are eager to explore the potential of combination therapy with COTI-2 in the clinic, and look forward to implementing this new trial design in the months ahead. Working towards securing sufficient funds to support this clinical development strategy was a top priority during the fiscal quarter and remains so in the fourth quarter. We will report on our progress as those financing efforts advance."

Financing
In December 2017, Cotinga announced it had entered into an agreement with a U.S. investment bank to act as exclusive placement agents on a best-efforts basis for a cross-border private placement equity financing. The objectives of the financing include broadening the investor base to include institutional and other sophisticated investors in the life sciences sector. The Company’s ability to advance its programs is highly dependent upon the outcome of its financing efforts, which are targeted to close in April 2018. The proceeds from the equity financing are intended to primarily support the continued clinical development of COTI-2. The results of the equity financing may require the Company to reprioritize or alter its strategies in respect of its programs.

Upcoming Milestones
COTI-2:

Implementation of protocol amendment to expand ongoing Phase 1 trial of COTI-2 to evaluate COTI-2 as a combination therapy in an expanded patient population expected to commence mid-calendar year 2018.
Readout of additional exploratory endpoint data from the dose escalation portion of the Phase 1 trial in gynecological malignancies expected mid-calendar year 2018;
Initiation of additional combination studies with standard of care chemo- and radiotherapeutics in multiple oncology indications expected in calendar year 2018.
COTI-219:

Continuation of GMP manufacturing work and further mechanism of action preclinical studies to enable an IND filing.
Financial Results
The Company’s operational activities during the quarter were primarily focused on advancing the Phase 1 clinical trial of COTI-2 in gynecological malignancies and HNSCC.

For the three-months ended January 31, 2018, the Company incurred a net loss of $1.279 million, or $0.08 per share, compared to a net loss of $1.238 million, or $0.08 per share, for the three-months ended January 31, 2017. The comparable net loss during the three-month period is primarily due to a decrease in Research and Development ("R&D") expense and General and Administration ("G&A") expense, offset by a lower favorable swing in the valuation of the warrant liability.

For the nine-months ended January 31, 2018, the Company incurred a net loss of $3.301 million, or $0.21 per share, compared to a net loss of $4.302 million, or $0.29 per share, for the nine-months ended January 31, 2017. The decrease in net loss during the nine-month period is primarily due to a decrease in G&A expense and a favorable swing in the valuation of the warrant liability, partially offset by an increase in R&D expense.

There was no revenue for the three- and nine-month periods ended January 31, 2018 or in the comparative periods in the year prior.

Operating expenses in the three- and nine-month periods ended January 31, 2018 decreased by $0.632 million and $0.408 million respectively over the same periods in the year prior, primarily due to a decrease in G&A expense and Sales and Marketing ("S&M") expense, partially offset by an increase in R&D expense and lower investment tax credits.

R&D expense in the three- and nine-month periods ended January 31, 2018 decreased by $0.123 million and increased by $0.182 million respectively over the same periods in the year prior. The decrease in R&D expense in the three-month period is primarily due to a decrease in clinical trial expenses, synthesis and miscellaneous R&D expenses and share-based compensation, partially offset by an increase in in vivo/in vitro testing and salaries and benefits. The increase in R&D expense in the nine-month period is primarily due to an increase in synthesis and miscellaneous R&D expenses, in vivo/in vitro testing, and salaries and benefits, partially offset by a decrease in clinical trial expenses and share-based compensation.

G&A expense in the three- and nine-month periods ended January 31, 2018 decreased $0.519 million and $0.572 million respectively over the same period in the year prior due to a reduction in salaries and benefits, share-based compensation expense, and marketing and travel. These decreases were partially offset by an increase in professional fees, corporate governance, rent and insurance.

S&M expense in the three- and nine-month periods ended January 31, 2018 decreased by $0.026 million and $0.116 million respectively compared to the same periods in the year prior due to a decrease in professional fees and marketing and travel. These decreases were partially offset by an increase in other S&M expenses.

ITC income for the three- and nine-month periods ended January 31, 2018 decreased by $0.037 million and $0.098 million respectively compared to the same periods in the year prior due to a decrease in eligible R&D expenditures.

Detailed operating and financial results can be found in the Company’s Unaudited Condensed Interim Financial Statements and Management Discussion and Analysis for the three- and nine-month periods ended January 31, 2018, which can be found on SEDAR at www.sedar.com or on the Company’s website at www.cotingapharma.com.

20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

BeyondSpring Pharmaceuticals 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, BeyondSpring Pharmaceuticals, 2018, APR 3, 2018, View Source [SID1234527561]).