On March 15, 2018 MabVax Therapeutics Holdings, Inc. (NASDAQ: MBVX), a clinical-stage oncology drug development company, reported that it will present three posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held April 14-18, 2018 in Chicago, Illinois at McCormick Place (Press release, MabVax, MAR 15, 2018, View Source [SID1234524812]). The first poster session features MVT-1075 (177Lu-CHX-A″-DTPA-HuMab5B1), the Company’s novel fully human antibody-based radioimmunotherapy (RIT) currently being evaluated in clinical development for the treatment of pancreatic cancer and other CA19-9 positive malignancies. The second presentation will feature preclinical investigations on the novel fully human antibody targeting the Thomsen-nouveau (Tn) and the sialyl Tn (sTn) cancer antigens which are highly overexpressed on ovarian and breast cancer tissues. The third poster features the Company’s immunoPET imaging agent MVT-2163 (89Zr-DFO-HuMab5B1), as a companion diagnostic for use in pancreatic cancer and CA19-9 positive malignancies.

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MabVax Therapeutics Logo (PRNewsfoto/MabVax Therapeutics Holdings, I)

Paul Maffuid, Ph.D., Executive Vice President of Research and Development of MabVax, stated, "We look forward to sharing the significant progress we have made through these clinical and preclinical studies that continue to establish our growing body of data supporting the development of MVT-1075 for the treatment of pancreatic cancer and other CA19-9 cancers, and our most advanced research program focused on the Tn and sTn cancer antigens."

Dr. Maffuid continued, "MVT-1075 potentially represents a more potent analog of our fully human HuMab-5B1 therapeutic antibody and establishing these safety and early response data bring us an important step closer in providing a much-needed treatment option for patients who have these devastating cancers. Equally important, our anti-Tn/sTn antibody program has made significant progress over the last few months and these data are the subject of partnering interest."

MabVax Abstracts and Poster Presentations

Sunday April 15, 2018 from 1:00 PM – 5:00 PM CDT:
Title: A fully human antibody binds Tn and sTn carbohydrate antigens specifically on serine residues, without need for polypeptide interaction
Session Location: Poster Section 43
Abstract Number: LB-002, Poster Board Number 2
Presenting Author: Jonah Rainey, Ph.D., Executive Director, Antibody Research MabVax Therapeutics

Tuesday April 17, 2018 from 8:00 AM – 12:00 PM CDT:
Title: Phase I dose escalation study of 177Lu-HuMab-5B1 (MVT-1075) in combination with MVT-5873 as radioimmunotherapy (RIT) in subjects with relapsed / refractory pancreatic cancer or other CA19-9+ malignancies
Session Location: McCormick Place South, Hall A, Poster Section 42
Abstract Number: CT140, Poster Board Number 23
Presenting Author: Paul Maffuid, Ph.D., Executive Vice President, Research & Development MabVax Therapeutics

Tuesday April 17, 2018 from 8:00 AM – 12:00 PM CDT:
Title: PEGylated Hyaluronidase Increases Tumor Uptake of 89Zr-DFO-HuMab-5B1 (MVT-2163) in a CA19-9 Positive Hyaluronan-Accumulating Pancreatic Cancer Model
Session Location: McCormick Place South, Hall A, Poster Section 1
Abstract Number: 3036, Poster Board Number 9
Co-presenting Authors: Paul Maffuid, Ph.D., Executive Vice President, Research & Development and Jonah Rainey, MabVax Therapeutics Executive Director, Antibody Research MabVax Therapeutics

About MVT-1075

MVT-1075 is a radioimmunotherapy product that combines established efficacy of radiation therapy with tumor specific targeting. It has the potential to deliver a more potent HuMab-5B1 based product. MVT-1075 uses small doses of the Company’s MVT-5873 antibody, coupled to a radioisotope to target pancreatic cancer cells and kill them.

About the HuMab-Tn Antibody Targeting Tn and sTn

HuMab-Tn is a fully human antibody derived from a patient vaccinated with a pool of cancer glycans, including Tn. The antibody has been affinity-matured and demonstrates highly selective Tn/sTn glycan binding. Further, the antibody recognizes a wide array of cancers, particularly ovarian and breast including approximately 90% of triple negative breast cancers tested.

About MVT-2163

MVT-1075 is an immunoPET imaging agent product that combines the established PET imaging capabilities of 89Zr with 5B1 tumor specific targeting. It has the potential to aid in identifying the best surgical treatment options for patients with pancreatic cancer and as a potential companion diagnostic with treatment options.

On March 15, 2017 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its fourth quarter 2017 financial results and provided an update on the company, including its progress with IPI-549, a first-in-class oral immuno-oncology product candidate that selectively inhibits phosphoinositide-3-kinase-gamma (PI3K-gamma) and targets immune-suppressive tumor microphages (Press release, Infinity Pharmaceuticals, MAR 15, 2018, View Source [SID1234524810]). Infinity is evaluating IPI-549 as a monotherapy and in combination with Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor, in a Phase 1/1b study in approximately 200 patients with advanced solid tumors.

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"We made significant progress with IPI-549 over the past year, and 2018 will be an important year for us as we report data from the monotherapy expansion and combination dose escalation components of our study and from seven combination expansion cohorts, which will help define our development and regulatory strategy for this first-in-class product candidate. Based on our initial clinical data, IPI-549 has a favorable tolerability profile and has demonstrated clinical and biological activity, both as a monotherapy and in combination with nivolumab. We believe that IPI-549 has the potential to increase the number of patients who respond to immunotherapies as well as to increase the duration of those responses," said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. "In addition, we’ve continued to position Infinity for success by expanding our board and clinical leadership team and establishing a scientific advisory board with thought leaders in the field of immuno-oncology."

Recent developments include the following:

IPI-549

Advanced and expanded clinical development of IPI-549: The Phase 1/1b monotherapy and combination dose escalation components of the study have been completed, and the monotherapy expansion component has been fully enrolled. In addition, six disease-specific combination expansion cohorts are enrolling at the recommended Phase 2 dose of 40 mg once daily of IPI-549 plus Opdivo (nivolumab) at 240 mg every two weeks in patients with non-small cell lung cancer, melanoma, head and neck cancer, triple-negative breast cancer, mesothelioma, and adrenocortical carcinoma. An additional combination expansion cohort of patients pre-selected for having high baseline blood levels of myeloid derived suppressor cells (MDSCs) is expected to open for enrollment in the next few weeks. Studies have shown that poor response to checkpoint inhibitor therapy is correlated with the presence of high baseline blood levels of MDSCs in cancer patients.1,2,3 Preliminary translational data from the study demonstrated an association between high baseline blood levels of MDSCs and clinical responses. Preselecting patients with high blood MDSCs could lead to improved clinical activity for patients treated with the combination of IPI-549 and anti-PD1.
Presented Phase 1/1b clinical and translational data at SITC (Free SITC Whitepaper): In November, Infinity announced updated data from the monotherapy dose-escalation component of the Phase 1/1b study of IPI-549 in a late-breaking presentation at the SITC (Free SITC Whitepaper) Annual Meeting 2017. These data demonstrated that IPI-549 dosed once daily was well tolerated and clinically active. Among 18 patients evaluable for activity, there was a 44 percent clinical benefit rate, defined as patients who had remained on treatment for at least 16 weeks, including one partial response in a patient with advanced peritoneal mesothelioma. Initial translational data from patient blood samples demonstrated that IPI-549 treatment results in a reduction in immune suppression and increased immune stimulation, with upregulation of interferon-gamma responsive factors and reinvigoration/proliferation of exhausted T cells across multiple tumor types and dose levels. Additionally, those patients who showed a clinical benefit had increased numbers of activated monocytes, suggesting a biologic correlate can be identified in patients who remain on treatment longer.
Corporate

David Beier appointed to Board of Directors: David Beier, J.D., is a Managing Director of Bay City Capital and brings a wealth of experience to the Infinity Board. David serves as an advisor to the Parker Institute for Cancer Immunotherapy, as a Senior Fellow at the USC Schaeffer Center for Health Policy & Economics and as a member of the Board of Directors of Arcus Biosciences, UCSF Benioff Children’s Hospitals and the California Life Sciences Association. He also serves as an appointee of Governor Brown on the California State Government Organization and the Economy Commission. Having spent two decades as part of the senior management teams for Amgen and Genentech, he brings invaluable perspective regarding strategy for entrepreneurial biotechnology firms and the industry in general as a globally recognized leader in health care policy, regulatory affairs, healthcare economics, and pricing. Mr. Beier also previously served in the White House during the Clinton Administration as a Chief Domestic Policy Advisor to the Vice President.
Clinical leadership team expanded: Marie-Louise Fjällskog M.D., Ph.D., has been appointed as Vice President of Clinical Development and will play an integral role in the expanded clinical development of IPI-549. Dr. Fjällskog is an Associate Professor of Oncology at Uppsala University, Sweden, and has over twenty-five years of experience in clinical oncology, translational research, and drug development. She joins Infinity from the Novartis Institute for Biomedical Research, where she served as a Clinical Program Leader, Translational Clinical Oncology, and as the global lead for several immuno-oncology programs, including those targeting CSF-1 and PD-1.

In addition, Suresh Mahabhashyam, M.D., M.P.H., was promoted to Vice President of Safety and Risk Management. Dr. Mahabhashyam has over 20 years of experience in medical practice and epidemiology with the last decade focused on drug development at Infinity, Alexion and Allergan.
Scientific Advisory Board established with four thought leaders in immuno-oncology:
Dmitry Gabrilovich, M.D., PhD., a leader in myeloid cell biology and the Christopher M. Davis Professor in Cancer Research and Program Leader, Immunology, Microenvironment, and Metastasis at the Wistar Institute in Philadelphia and Wistar Professor at the Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania;
Roy Herbst, M.D., Ph.D., a leader in lung cancer treatment and research and the Ensign Professor of Medicine (Medical Oncology) and Professor of Pharmacology; Chief of Medical Oncology, Yale Cancer Center and Smilow Cancer Hospital;
Stephen Hodi, M.D., a leader in developing immune therapy and melanoma therapeutics and the Director of the Melanoma Center and the Center for Immuno-Oncology at Dana-Farber/Brigham and Women’s Cancer Center, the Sharon Crowley Martin Chair in Melanoma at Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School; and
David H. Munn, M.D., a pioneer in T cell activation and indoleamine 2,3-dioxygenase (IDO) research and a Professor of Pediatric Hematology-Oncology at the Medical College of Georgia, Augusta University.
2018 Program Goals for IPI-549

Report data from the monotherapy expansion component of the study in the second quarter of 2018
Report data from the combination dose-escalation component of the study in the second quarter of 2018
Report initial data from six disease-specific combination expansion cohorts in the second quarter of 2018
Report more mature clinical and translational data (including insights from paired tumor biopsies) from the six disease-specific cohorts and initial data from the cohort of patients pre-selected for having high baseline blood levels of myeloid derived suppressor cells (MDSCs) in the combination expansion component of the study in the second half of 2018
Full Year 2017 Financial Results

At December 31, 2017, Infinity had total cash, cash equivalents and available-for-sale securities of $57.6 million, compared to $92.1 million at December 31, 2016.
Revenue during 2017 was $6.0 million, all of which related to the amount received from Verastem for the DUO study meeting the pre-specified criteria at completion. Revenue during 2016 was $18.7 million related to Infinity’s previous collaboration agreement with AbbVie Inc.
R&D expense for 2017 was $20.8 million, compared to $119.6 million for 2016. The decrease in R&D expense was primarily related to the company’s 2016 restructuring activities and out-licensing of duvelisib to Verastem.
General and administrative expense was $21.6 million for 2017, compared to $42.2 million for 2016. The decrease in G&A expense was primarily due to the company’s 2016 restructuring activities.
Net loss for 2017 was $41.8 million, or a basic and diluted loss per common share of $0.83, compared to a net loss of $30.1 million, or a basic and diluted loss per common share of $0.61 for 2016.
Financial Outlook
Infinity’s updated 2018 financial guidance is as follows:

Net Loss: Infinity expects net loss for 2018 to range from $35 million to $45 million.
Cash and Investments: Infinity expects to end 2018 with a year-end cash, cash equivalents and available-for-sale securities balance ranging from $15 million to $25 million.
Cash Runway: Based on its current operational plans, Infinity expects that its existing cash, cash equivalents and available-for-sale securities will be adequate to satisfy the company’s capital needs into the third quarter of 2019. Infinity’s financial guidance excludes additional funding or business development activities and does not include the potential $22 million payment from Verastem upon the first regulatory approval of duvelisib, or a potential $2 million milestone payment from PellePharm, a private company, upon initiation of a Phase 3 study for the hedgehog inhibitor program, which Infinity licensed to PellePharm in 2013. Verastem announced that it submitted a New Drug Application for duvelisib to the U.S. Food and Drug Administration on February 7, 2018. With the potential Verastem milestone payment, Infinity expects to extend its cash runway into 2020.
Conference Call Information
Infinity will host a conference call today, March 15, 2018, at 4:30pm EDT to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors/Media" section of Infinity’s website at www.infi.com. To participate in the conference call, please dial 1-877-316-5293 (domestic) and 1-631-291-4526 (international) five minutes prior to start time. The conference ID number is 5558799. An archived version of the webcast will be available on Infinity’s website for 30 days.

About IPI-549 and the Ongoing Phase 1b Study
IPI-549 is an investigational first-in-class, oral, immuno-oncology product candidate targeting tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition, thereby reducing pro-tumor macrophage function and increasing anti-tumor macrophage function. In preclinical studies, IPI-549 reprograms macrophages from a pro-tumor (M2), immune suppressive function, to an anti-tumor (M1) immune activating function and can enhance the activity of, and overcome resistance to, checkpoint inhibitors. 4,5 As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially additive or synergistic approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.

The ongoing Phase 1b study being conducted by Infinity is designed to evaluate the safety, tolerability, activity, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with Opdivo in approximately 200 patients with advanced solid tumors.6 The study includes monotherapy and combination dose-escalation components, in addition to monotherapy expansion and combination expansion components. The monotherapy dose-escalation component is complete, and the monotherapy expansion component has been fully enrolled. The combination dose-escalation component is also complete, and combination expansion cohorts are enrolling.

The combination expansion component of the study includes multiple cohorts designed to evaluate IPI-549 in patients with specific types of cancer, including patients with non-small cell lung cancer (NSCLC), melanoma and head and neck squamous cell carcinoma (HNSCC) whose tumors show initial resistance or initially respond to but subsequently develop resistance to immune checkpoint blockade therapy. The combination expansion component also includes a cohort of patients with triple negative breast cancer (TNBC) who have not been previously treated with immune checkpoint blockade therapy, a cohort of patients with mesothelioma, a cohort of patients with adrenocortical carcinoma and a cohort of patients with high baseline blood levels of MDSCs.

IPI-549 is an investigational compound and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On March 15, 2018 Incyte Corporation (Nasdaq:INCY) reported that 15 abstracts from its research and development portfolio will be presented at the upcoming 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in Chicago, Illinois from April 14-18, 2018 (Press release, Incyte, MAR 15, 2018, View Source;p=RssLanding&cat=news&id=2338255 [SID1234524809]). These abstracts include the first pre-clinical data from the Company’s recently announced AXL/MER, TIM-3 and LAG-3 antibody programs in patients with advanced solid tumors.

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"We are excited to present a broad collection of abstracts from our robust development portfolio at this year’s AACR (Free AACR Whitepaper) Annual Meeting," said Reid Huber, Ph.D., Incyte’s Chief Scientific Officer. "The acceptance of these abstracts and their results represent the progress Incyte continues to make in the pursuit of R&D excellence and ultimately innovation in the treatment of cancer and other serious diseases."

Key abstracts include:

Immuno-Therapy

Combination of a T Cell Activating Immunotherapy with Immune Modulators Alters the Tumor Microenvironment and Promotes More Effective Tumor Control in Preclinical Models (Abstract #1761, Immunology – Modifiers of the Tumor Microenvironment 2)

Monday, April 16, 2018, 8:00 a.m. – 12:00 p.m. CDT, Chicago, Poster Section 33
Identification of p-AKT as a PD marker for MER Kinase in Human G361 Cells (Abstract #2367, Molecular and Cellular Biology/Genetics – Kinases and Phosphatases)

Monday, April 16, 2018, 1:00 p.m. – 5:00 p.m. CDT, Chicago, Poster Section 17
Characterization of INCB081776, a Potent and Selective Dual AXL/MER Kinase Inhibitor (Abstract #3759, Immunology – Immunomodulatory Agents and Interventions 1)

Tuesday, April 17, 2018, 8:00 a.m. – 12:00 p.m. CDT, Chicago, Poster Section 32
INCAGN02390, a Novel Antagonist Antibody that Targets the Co-Inhibitory Receptor TIM-3 (Abstract #3825, Immunology – Therapeutic Antibodies, Including Engineered Antibodies 3)

Tuesday, April 17, 2018, 8:00 a.m. – 12:00 p.m. CDT, Chicago, Poster Section 34
INCAGN02385 is an Antagonist Antibody Targeting the Co-Inhibitory Receptor LAG-3 for the Treatment of Human Malignancies (Abstract #3819, Immunology – Therapeutic Antibodies, Including Engineered Antibodies 3)

Tuesday, April 17, 2018, 8:00 a.m. – 12:00 p.m. CDT, Chicago, Poster Section 34
Epacadostat plus Durvalumab in Patients with Advanced Solid Tumors: Preliminary Results of the Ongoing, Open-Label, Phase 1/2 ECHO-203 Study (Abstract #CT177, Session CTMS03 – Biomarkers in Immuno-Oncology [minisymposium])

Tuesday, April 17, 2018, 2:45 p.m. – 5:00 p.m. CDT, Chicago, N Hall C – McCormick Place North (Level 1)
Targeted Therapy

INCB052793, a JAK1 Selective Inhibitor, is Highly Efficacious in PDX and Xenograft Models of Acute Myeloid Leukemia (AML) Expressing Elevated Endogenous pSTAT3/pSTAT5 (Abstract #1867, Experimental and Molecular Therapeutics – Experimental Agents and Combinations for Hematologic Malignancies 2)

Monday, April 16, 2018, 8:00 a.m. – 12:00 p.m. CDT, Chicago, Poster Section 38
The Evaluation of INCB059872, an FAD-directed Inhibitor of LSD1, in Preclinical Models of T-ALL (Abstract #1893, Experimental and Molecular Therapeutics – Experimental Agents and Combinations for Hematologic Malignancies 2)

Monday, April 16, 2018, 8:00 a.m. – 12:00 p.m. CDT, Chicago, Poster Section 38
The FAD-directed LSD1 Specific Inhibitor, INCB059872, is a Promising Epigenetic Agent for AML Therapy by Inducing Differentiation of Leukemic Stem/Progenitor Cells (Abstract #1888, Experimental and Molecular Therapeutics – Experimental Agents and Combinations for Hematologic Malignancies 2)

Monday, April 16, 2018, 8:00 a.m. – 12:00 p.m. CDT, Chicago, Poster Section 38
INCB059872, a Novel FAD-directed LSD1 Inhibitor, is Active in Prostate Cancer Models and Impacts Prostate Cancer Stem-like Cells (Abstract #1379, Molecular and Cellular Biology/Genetics – Epigenetic Therapy)

Monday, April 16, 2018, 8:00 a.m. – 12:00 p.m. CDT, Chicago, Poster Section 16
In Vivo Assessment of the Combination of the JAK1-Selective Inhibitor Itacitinib with First- and Second-Generation EGFR Inhibitors in Models of Non-Small Cell Lung Cancer (Abstract #2938, Experimental and Molecular Therapeutics – Novel Experimental Combinations)

Monday, April 16, 2018, 1:00 p.m. – 5:00 p.m. CDT, Chicago, Poster Section 41
The FAD-Directed LSD1 Specific Inhibitor, INCB059872, Inhibits Cell Migration and Metastasis by Suppressing Premetastatic Niche Formation in a Spontaneous Metastasis Mouse Model (Abstract #3929, Experimental and Molecular Therapeutics – Resistance and Biology)

Tuesday, April 17, 2018, 8:00 a.m. – 12:00 p.m. CDT, Chicago, Poster Section 39
The BET Inhibitor INCB057643 Suppresses ALDH Activity by Targeting the ALDH1A1 Super-Enhancer in High-Grade Serous Ovarian Cancer (Abstract #3685, Clinical Research – Molecular Classification of Tumors 1: Epigenetic Therapy, Functional and Molecular Imaging, and Tumor Heterogeneity)

Tuesday, April 17, 2018, 8:00 a.m. – 12:00 p.m. CDT, Chicago, Poster Section 28
Effect of JAK/STAT or PI3Kδ Plus PD-1 Inhibition on the Tumor Microenvironment: Biomarker Results From a Phase 1b Study in Patients with Advanced Solid Tumors (Abstract #CT176, Session CTMS03 – Biomarkers in Immuno-oncology [minisymposium])

Tuesday, April 17, 2018, 2:45 p.m. – 5:00 p.m. CDT, Chicago, N Hall C – McCormick Place North (Level 1)
Anti-Tumor Efficacy of INCB057643, a Novel BET Bromodomain Inhibitor, in Castration-Resistant Prostate Cancer as Single Agent and in Combination Therapy (Abstract #5793, Experimental and Molecular Therapeutics – Canonical Targets 2)

Wednesday, April 18, 2018, 8:00 a.m. – 12:00 p.m. CDT, Chicago, Poster Section 36
Full session details and data presentation listings for AACR (Free AACR Whitepaper) 2018 can be found at: View Source!/4562

On March 15, 2018 Cellectar Biosciences (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that results from two preclinical studies highlighting the potential benefits of fractionated dosing regimens of CLR 131 and the ability of the company’s phospholipid drug conjugates (PDCs) to provide improved targeting of tumor cells have been selected for late-breaking poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018 (AACR 2018), April 14-18, 2018 in Chicago (Press release, Cellectar Biosciences, MAR 15, 2018, View Source [SID1234524807]).

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The following research will be presented:

Poster Title: Phospholipid drug conjugates show specificity for a broad range of tumor cells and provides a novel approach for targeted or precision therapy

Poster Number: 10957

Session Title: Late-Breaking Research: Cancer Chemistry

Session Date and Time: Monday, April 16, 2018, 8:00 am – 12:00 pm (CT)

Session Location: Poster Section 43

Presenter: Jarrod Longcor, chief business officer of Cellectar Biosciences

Poster Title: Efficacy of fractionated injections of CLR 131 in an OPM-2 SCID nude mouse model

Poster Number: 10770

Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 3

Session Date and Time: Tuesday, April 17, 2018 1:00 pm – 5:00 pm (CT)

Session Location: Poster Section 43

Presenter: Jarrod Longcor, chief business officer of Cellectar Biosciences

CLR 131 is Cellectar’s investigational radioiodinated PDC therapy that exploits the tumor-targeting properties of the company’s proprietary phospholipid ether (PLE) and PLE analogs to selectively deliver radiation to malignant tumor cells, thus minimizing radiation exposure to normal tissues. Poster 10770 compares bolus dosing to fractionated dosing of CLR 131 in a preclinical mouse model.

Various PDC molecules have been shown to provide specificity in targeting tumor cells versus normal cells both in vitro and in vivo irrespective of the payload. Poster 10957 will further elaborate upon the mechanism of targeting and uptake as well as the cellular trafficking of these molecules.

"Over the past year, we have greatly enhanced our understanding of both our lead asset CLR 131, and our proprietary delivery platform," said James Caruso, chief executive officer of Cellectar Biosciences. "Our data suggest a more optimized dosing scheme that we have recently incorporated into our current Phase 1 trial and also speak to the broad potential of the delivery technology itself."

On March 15, 2018 Asterias Biotherapeutics, Inc. (NYSE American:AST), a biotechnology company dedicated to developing cell-based therapeutics to treat neurological conditions associated with demyelination and cellular immunotherapies to treat cancer, reported financial and operational results for the quarter and full year ended December 31, 2017, as well as recent corporate progress (Press release, BioTime, MAR 15, 2018, View Source;p=RssLanding&cat=news&id=2338386 [SID1234524806]).

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"We have continued to make significant progress in our spinal cord injury clinical program," commented Michael Mulroy, President and Chief Executive Officer. "The additional results from the SCiStar study that we recently reported further support AST-OPC1’s positive safety profile and its potential to durably engraft and help restore upper extremity motor function improvement to individuals with severe cervical spinal cord injuries. Currently, these severely injured patients have no approved treatment options. We look forward to providing additional data readouts from the SCiStar study in 2018 into the first quarter of 2019."

Mulroy continued, "We are equally excited for the planned start of the first-in-human clinical trial of AST-VAC2, our cancer immunotherapy product candidate, in non-small cell lung cancer (NSCLC). Upon this achievement, Asterias will have two product candidates in clinical trials that are aimed at addressing substantial unmet medical needs."

"On the corporate side, Asterias completed a capital raise in 2017 and significantly improved its cost structure heading into 2018," said Ryan Chavez, Chief Financial Officer. "The more focused allocation of capital in 2018 allows the company to reduce its cash burn during a period of additional data readouts from the SCiStar study and the start of the AST-VAC2 clinical trial."

Anticipated 2018 Milestones

The company intends to report the following AST-OPC1 data readouts later this year:

Six-month update for the entire SCiStar study, including Cohort 5, late in the second quarter or early third quarter of 2018.
12-month update for Cohorts 3 and 4 in the third quarter of 2018.
24-month update for Cohort 2 in the third or fourth quarter of 2018.
12-month update for the entire SCiStar study, including Cohort 5, late in the fourth quarter of 2018 or early in the first quarter of 2019.
The company anticipates achieving the following AST-VAC2 milestones in 2018:

Open two sites for the AST-VAC2 study in NSCLC and enroll the first subject in the randomized trial in second quarter of 2018. The study will enroll up to 24 subjects into one of two cohorts, depending on the stage of each subject’s NSCLC.
Assuming the first subject is dosed in the second quarter, the company plans to provide initial safety and immunogenicity data readouts in the second half of 2018.
Asterias plans to host a conference call to discuss the AST-VAC2 program and its potential as a ready-to-administer, off-the-shelf cancer immunotherapy after the first subject is dosed in the study.

2017 and Recent Key Achievements

AST-OPC1:

During 2017 and in February 2018, Asterias continued to provide updates with promising data from the ongoing SCiStar study on recovery of arm, hand, and finger function in subjects who have been administered AST-OPC1.
Reported MRI data from the SCiStar study that indicates AST-OPC1 cells have durably engrafted in patients post-implantation, demonstrating the potential for AST-OPC1 to prevent lesion cavity formation and possibly reducing spinal cord tissue deterioration after spinal cord injury.
Reported continued positive safety profile for AST-OPC1 based on trial results to date. In September 2017, an independent Data Monitoring Committee (DMC) recommended the SCiStar study continue as planned after it completed a regularly scheduled review of the accumulated safety data to date from the study.
Completed enrollment and dosing in all five of the planned cohorts in the SCiStar study, positioning the company for additional anticipated data readouts in 2018 and into the first quarter of 2019.
Obtained U.S. Food and Drug Administration (FDA) designation as a Regenerative Medicine Advanced Therapy (RMAT) under the 21st Century Cures Act, which is intended to facilitate expedited development, review, and approval for important new regenerative medicine therapies for which preliminary clinical evidence indicates the potential to address a serious or life-threatening disease or condition.
Published new efficacy and safety data from preclinical studies of AST-OPC1 in the peer-reviewed journal "Stem Cells Translational Medicine."
AST-VAC2:

Received regulatory clearance in the United Kingdom to initiate a first-in-human clinical trial of Asterias’ cancer immunotherapy product AST-VAC2. This trial is being sponsored and managed by Cancer Research UK, and will examine the safety, tolerability, immunogenicity and activity of AST-VAC2 in subjects with early and late stage NSCLC.
Cancer Research UK, supported by Asterias technical personnel, successfully completed the manufacture of the first cGMP (current Good Manufacturing Practice) clinical grade lot of AST-VAC2. This lot will provide initial clinical trial material for subjects enrolling in the upcoming Phase 1 study evaluating AST-VAC2 in NSCLC.
Published positive AST-VAC1 Phase 2 clinical data in Acute Myeloid Leukemia in ‘Cancer,’ a leading peer-reviewed journal of the American Cancer Society.
Corporate:

Asterias closed the sale of shares of its common stock in a registered direct offering which raised approximately $10.4 million in gross proceeds.
Asterias expanded its operating expense reduction efforts and reduced staffing allocated to non-clinical activities as part of a broader effort to more closely align operating expenses with the company’s primary goal of continuing to generate clinical data in its key clinical stage programs.
Financial Results

As of December 31, 2017, the combined total of cash, cash equivalents, and available-for-sale securities totaled $21.6 million. In October 2017, Asterias closed the sale of shares of its common stock in a registered direct offering which raised approximately $10.4 million in gross proceeds.

Revenue was $4.0 million for the year ended December 31, 2017, comprised of grant income as well as royalty revenue on product sales by licensees. Research and development expenses were $6.4 million in the fourth quarter and $26.6 million in the year ended December 31, 2017. General and administrative expenses were $2.1 million in the fourth quarter and $10.5 million in the year ended December 31, 2017. As a result of the operating cost saving initiatives implemented in 2017, the company expects to reduce its operating costs by approximately 40% in 2018. Asterias believes that its reduced operating costs and cash and cash equivalents as of December 31, 2017 will be sufficient to fund its operations through at least the first quarter of 2019.

Net loss was $6.5 million, or $0.12 per share, for the fourth quarter and $28.4 million, or $0.56 per share, for the year ended December 31, 2017. For the year ended December 31, 2017, net cash used in operating activities was $24.4 million and net cash provided from financing activities was $17.2 million.

Conference Call and Webcast Details

Asterias will host a conference call and webcast today, March 15, 2018, at 5:00 p.m. Eastern / 2:00 p.m. Pacific to discuss the results and corporate developments. For both "listen-only" participants and those participants who wish to take part in the question-and-answer portion of the call, the dial-in number in the U.S./Canada is 888-503-8163. For international participants outside the U.S./Canada, the dial-in number is 719-325-4857. For all callers, refer to Conference ID 9547064. To access the live webcast, go to View Source

A replay of the conference call will be available for one month beginning about two hours after the conclusion of the live call, by calling toll-free (from U.S./Canada) 888-203-1112; international callers dial 719-457-0820. Use the Conference ID 9547064. Additionally, the archived webcast will be available at View Source