On March 25, 2019 Ascentage Pharma, globally-focused, clinical-stage biopharmaceutical company developing novel small molecule therapies for cancers, hepatitis B and age-related diseases, reported that research results of its pipeline of small molecule therapeutics will be presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in Atlanta, March 29-April 3, 2019 (Press release, Ascentage Pharma, MAR 25, 2019, View Source [SID1234534612]).

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AACR abstracts include:

Title: Predicting Drug Sensitivity to A Novel BCL-2 and BCL-xL Dual Inhibitor In Solid Tumor PDX TrialsSession Title: BCL-2 Family ProteinsSession Date and Time: Monday, April 1, 2019 1:00 PM – 5:00 PM EDTPoster Number: 2503
Title: MDM2 Inhibitor APG-115 Synergizes With CDK4/6 Inhibitors In A Patient Derived Xenograft Model of Dedifferentiated LiposarcomaSession Title: Credentialing of Molecular TargetsSession Date and Time: Monday, April 1, 2019 8:00 AM – 12:00 PM EDTPoster Number: 1253
Title: Activation of P53 In the Tumor Microenvironment by MDM2 Inhibitor APG-115 Synergizes With PD-1 Blockade Independently of P53 Status of Tumor CellsSession Title: Combination Immunotherapies 2 Session Date and Time: Tuesday, April 2, 2019 8:00 AM – 12:00 PM EDTPoster Number: 3192
Title: BCL-2 Selective Inhibitor APG-2575 Synergizes with BTK Inhibitor in Preclinical Xenograft Models of Follicular Lymphoma and diffuse Large B-cell LymphomaSession Title: Apoptosis, Necrosis, and Cancer Cell SurvivalSession Date and Time: Monday, April 1, 2019 1:00 PM – 5:00 PM EDTPoster Number: 2058
Title: Synergistic Effect of BCL-2 Inhibitor APG-2575 and CDK9 Inhibitor in Acute Myeloid Leukemia and DLBCL Preclinical Tumor ModelsSession Title: Novel Antitumor Agents 1Session Date and Time: Tuesday, April 2, 2019 8:00 AM – 12:00 PM EDTPoster Number: 3068
Title: FAK Blockade Enhances Antitumor Effect of BTK Inhibitor In Esophageal Squamous Cell Carcinoma via EGFR-ERK-Akt Pathway InhibitionSession Title: Combination Approaches to Novel TherapiesSession Date and Time: Sunday, March 31, 2019 1:00 PM – 5:00 PM EDTPoster Number: 309
Title: A Novel Bcl-2/Bcl-XL Inhibitor APG-1252-12A as A Potential Therapeutic Strategy for Gastric CarcinomaSession Title: Apoptosis, Necrosis, and Cancer Cell SurvivalSession Date and Time: Monday, April 1, 2019 1:00 PM – 5:00 PM EDTPoster Number:2054
Title: FAK Inhibition Reduces Tumor Infiltration of Tregs Via Restricting CCL5 Release and Boosts the Present Therapeutic Regimen for BRAFV600E -mutated Colorectal CarcinomaSession Title: Immunomodulation by Chemotherapy and Targeted AgentsSession Date and Time: Tuesday, April 2, 2019 1:00 PM – 5:00 PM EDTPoster Number: 3958
Title: Novel FAK/ALK/ROS1 Inhibitor APG-2449 Synergizes with Osimertinib in Preclinical Xenograft Models of EGFR-mutant NSCLCSession Title: Tyrosine Kinase and Phosphatase Inhibitors 2Session Date and Time: Monday, April 1 2019 1:00 PM – 5:00 PM EDTPoster Number: 2204

On March 25, 2019 H3 Biomedicine Inc., a U.S.-based precision medicine research & development subsidiary of Eisai Co., Ltd., reported multiple presentations at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held March 29 through April 3, 2019 at the Georgia World Congress Center in Atlanta, GA (Press release, H3 Biomedicine, MAR 25, 2019, View Source [SID1234534597]).

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Leveraging its integrated data science, human biology and precision chemistry discovery engine, H3 is advancing a pipeline of highly targeted, investigational breakthrough medicines to address critical unmet needs in the treatment of hematologic and solid tumor cancers. The company currently has three precision medicine therapeutic programs in clinical study with several additional research programs advancing toward the development stage.

H3’s presentations at this year’s AACR (Free AACR Whitepaper) Annual Meeting showcase the company’s breadth of expertise in oncology research and the molecular insights enabled by its unique discovery engine.

The schedule for H3’s presentations is as follows (in chronological order):

Oral Presentation/Education Session:

Title:Targeting the spliceosome; perspectives from structural biology

Session:Chemistry to the Clinic: Part 2: Novel Chemical Tools and Leads for Unprecedented Targets

Date and Time: Saturday, March 30, 2019; 10:15 a.m. – 12:15 p.m. EDT

Location: Room A311-312

Presenter: Nicholas Larsen, Ph.D., Director, H3 Biomedicine

Poster Presentations:

Abstract Number: 281

Title: Sensitivity to splicing modulation of BCL2 family genes reveals cancer therapeutic strategies for splicing modulators

Session: Combination Approaches to Novel Therapies

Date and Time: Sunday March 31, 2019; 1:00 p.m. – 5:00 p.m. EDT

Location: Exhibit Hall B; Poster Section 12; Poster Board Number 2

Abstract Number:498

Title: Integrating bulk and spatial profiling technologies for the discovery of RNA and protein biomarkers in muscle invasive bladder cancer

Session: Imaging the Tumor Microenvironment

Date and Time: Sunday, March 31, 2019; 1:00 p.m. – 5:00 p.m. EDT

Location:Exhibit Hall B; Poster Section 20; Poster Board Number 11

Abstract Number: 2467

Title: Heme-CMap: Generation and characterization of ~20K L1000 profiles across 11 hematologic malignant lines

Session: Databases and Computational Tools for Cancer Discovery

Date and Time: Monday April 1, 2019; 1:00 p.m. – 5:00 p.m. EDT

Location: Exhibit Hall B; Poster Section 31; Poster Board Number 7

** In collaboration with the Broad Institute

On March 25, 2019 EpiVax Oncology, Inc., a precision cancer immunotherapy company, reported that its abstract has been selected for an oral presentation, at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, taking place on March 29th – April 3rd in Atlanta, Georgia (Press release, EpiVax, MAR 25, 2019, View Source [SID1234534613]). It will present data highlighting how inhibitory neoepitopes uncovered using advanced computational tools affect immune responses to therapeutic cancer vaccines.

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Ancer is a Superior Neoantigen Prediction Platform, Powered by Machine Learning Based Algorithms.

Self-like Treg Cancer Neoepitopes Uncovered Using Ancer.

"While it is extremely important to select both Class I and Class II neoantigens in order to induce an effective anti-tumor response, we have shown that including computationally predicted inhibitory Class II T cell neoepitopes in neoantigen-based vaccines, can significantly suppress the immune response," said EpiVax Oncology CEO, Gad Berdugo, MSc Eng., MBA. "Current neoantigen selection methods are non-validated and may select neoantigens that are non-immunogenic, that potentially trigger immune-related adverse events, or that lead to immunosuppression via the induction of regulatory T cells. Our neoantigen discovery platform, Ancer, is powered by machine-learning based algorithms that have been used commercially for 20 years and have shown superior accuracy at predicting not only CD8 T cell neoepitopes, but also the much more challenging CD4 T cell neoepitopes. Furthermore, we are thrilled to bring to the immuno-oncology field advanced algorithms that have been able to predict inhibitory T cell epitopes since 2013. We will show at AACR (Free AACR Whitepaper) that it is critical to identify and filter out these inhibitory Class II neoepitopes in order to improve the immune response generated by cancer vaccines."

ORAL PRESENTATION:
Abstract: 943
Presenter: Guilhem Richard, PhD, Lead Computational Immunologist, EpiVax Oncology Inc.
Title: "Filtering out self-like neoantigens improves immune response to cancer vaccines"
Date: Sunday, March 31, 2019
Session: MS.IM02.03 – Cancer Vaccines and Intratumoral Immunomodulation
Time: 3:00 PM – 5:00 PM Eastern Time
Location: Georgia Ballroom 3 – Building C – GWCC
Session Link: View Source!/6812/session/830

On March 25, 2019 AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, reported financial results for the fourth quarter and full year ended December 31, 2018 (Press release, AmpliPhi Biosciences, MAR 25, 2019, View Source [SID1234534598]). AmpliPhi Biosciences will not be conducting a conference call in conjunction with this financial results release.

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"I am pleased with the strong progress AmpliPhi achieved in 2018, capped off by the announcement of the pending merger with C3J at the beginning of 2019," said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. "Leading up to the closing of the merger, which is expected in May 2019, we remain on track to initiate a clinical trial of AB-SA01 for the treatment of S. aureus bacteremia later in 2019. The increasing prevalence of antibiotic-resistant infections has become a global public health crisis, and we believe precisely targeted bacteriophage therapeutics, with their novel mechanism of action, could be an important therapeutic option where currently-available antibiotic treatments have become ineffective."

Recent Business Highlights

In January 2019, AmpliPhi and C3J Therapeutics, Inc., a private clinical stage biotechnology company focused on the development of novel synthetically engineered bacteriophage products, announced they had entered into a definitive agreement under which a wholly owned subsidiary of AmpliPhi will merge with C3J in an all-stock transaction, subject to shareholder approval. Certain existing C3J shareholders have agreed to purchase $10.0 million of common stock of the combined company immediately following the closing of the merger, subject to customary conditions. The financing will help fund further development of the combined company’s preclinical and clinical programs, and is expected to close immediately following the completion of the merger. Management expects the merger will close in May 2019.
Presented clinical case data from the expanded access program at the ID Week 2018 Conference in October 2018. Thirteen patients with serious and life-threatening S. aureus infections were treated with AB-SA01 at the Westmead Hospital in Sydney. Eighty-three percent (10 out of 12) patients in the modified intent-to-treat (mITT) population achieved treatment success at the end of therapy as reported by treating physicians. Bacteriophage treatment was well tolerated, with no adverse events attributable to the therapy.
Completed treatment of 21 patients at 7 hospitals with serious or life-threatening infections not responding to antibiotics with AmpliPhi’s bacteriophage product candidates, AB-SA01 and AB-PA01. Following administration of 1,000+ doses, a treatment success rate of 84% was observed at the end of therapy, and treatment was generally well tolerated.
Completed an underwritten public offering in October 2018 generating net proceeds of $5.8 million.
Fourth Quarter and Full Year Ended December 31, 2018 Financial Results

Research and development (R&D) expenses for the fourth quarter of 2018 were $1.4 million compared to $1.1 million for the fourth quarter of 2017. The increase of $0.3 million was primarily attributable to an increase in clinical costs and related professional services.
R&D expenses for the year ended December 31, 2018 were $4.9 million compared to $2.9 million for the year ended December 31, 2017. The increase in 2018 was impacted by a $1.2 million tax incentive payment received in 2018 from the Australian tax authority, compared to a $2.0 million tax incentive payment from the Australian tax authority received in 2017. Excluding any benefit from tax incentive payments, R&D expenses were $6.1 million and $4.9 million, respectively. The increase of $1.2 million in 2018 was primarily related to an increase in clinical activities and related professional and consulting expenses.
General and administrative (G&A) expenses were $1.5 million for the fourth quarter of 2018 compared to $1.3 million for the fourth quarter of 2017. The increase of $0.2 million was primarily due to higher legal and professional fees in the fourth quarter of 2018.
G&A expenses for the year ended December 31, 2018 were $5.7 million compared to $7.6 million for the year ended December 31, 2017. The $1.9 million decrease was primarily attributable to a decrease in severance costs, legal and professional fees and lower non-cash charges in 2018.
Operating expenses in the fourth quarter of 2018 included a non-cash charge of $1.9 million for the impairment of intangible assets for the excess of book value over the computed fair value of those assets as of December 31, 2018. The impaired assets were recorded in connection with acquisitions of a predecessor company in 2011.
Net cash used in operating activities for the year ended December 31, 2018 was $9.4 million, as compared to $9.2 million for the year ended December 31, 2017.
Cash and cash equivalents as of December 31, 2018 totaled $8.2 million.
As of March 8, 2019, there were approximately 32.3 million shares of common stock outstanding.
The audit opinion included in the company’s Annual Report on Form 10-K for the year ended December 31, 2018 contains a going concern explanatory paragraph.

On March 25, 2019 Epic Sciences, Inc. (Epic) reported that Lloyd Sanders has joined the company as president and chief executive officer (Press release, Epic Sciences, MAR 25, 2019, View Source [SID1234534614]). After serving nearly six years in the role, Murali Prahalad, Ph.D., has stepped down to pursue new opportunities and has been appointed to Epic’s board of directors.

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"Under Murali’s leadership, the Epic team has made substantial progress in advancing our proprietary Functional Cell Profiling platform and successfully launching and obtaining Medicare coverage for the world’s first predictive test for metastatic prostate cancer," said Gregory T. Lucier, chairman of Epic Sciences. "As Murali continues to advise the company in his role as a director, we welcome Lloyd to the team to capitalize on our solid foundation. The trajectory has been set for significant commercial growth through Epic’s portfolio of high-value liquid biopsy tests and expansion into breast cancer, immuno-oncology and global markets. Lloyd and the leadership team, board, investors and Epic employees are highly motivated to take Epic to the next level."

Mr. Sanders joins Epic with 20 years of diagnostics and pharmaceutical industry experience, much of it focused on oncology. Prior to Epic, he served as president of the oncology segment of the molecular diagnostics company Myriad Genetics, overseeing the oncology, urology and dermatology commercial organizations. While at Myriad, he was responsible for the sales, marketing and laboratory operations of numerous commercial products. Previously, Mr. Sanders served as chief operating officer at Dey Pharma, a division of Mylan, overseeing sales, marketing and medical affairs, including the EpiPen flagship brand. Prior to Dey Pharma, he ascended from vice president of marketing to chief operating officer of oncology biotech Genta. He also held several leadership positions and was responsible for the commercial success of several oncology products at Sanofi-Synthelabo, subsequently Sanofi-Aventis, and Pharmacia (now Pfizer).

"Epic has established an impressive position in the prostate cancer liquid biopsy market and I am eager to work with the team to advance the mission of providing very powerful predictive, actionable information to physicians and patients that can extend lives," said Mr. Sanders. "By expanding the breadth and depth of Epic’s portfolio of reimbursed products, and building our thriving biopharma solutions business that supports our pharmaceutical partners’ development of next-generation immunotherapies and targeted cancer agents, we can play an important role in changing cancer from a lethal to a chronic, manageable disease."