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FibroGen Reports Fiscal 2016 Financial Results

On March 1, 2017 FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical company, reported financial results for the year ended December 31, 2016, and provided an update on the company’s recent developments (Press release, FibroGen, MAR 1, 2017, View Source [SID1234517929]).

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"We are pleased with the topline results reported from our two China Phase 3 trials, which are the first Phase 3 readouts for roxadustat, and bring us closer to completing our new drug application submission in China. With our partners AstraZeneca and Astellas, we are making steady progress in Phase 3 clinical development worldwide for roxadustat in CKD anemia, and continue to expect filing of our U.S. NDA in 2018," said Thomas B. Neff, FibroGen’s Chief Executive Officer. "This year, we are expanding development activities for roxadustat into oncology-related anemias. We are also anticipating important clinical milestones for pamrevlumab, or FG-3019. We began the year with the presentation and publication of promising clinical results in pancreatic cancer, and expect to report data from our placebo-controlled Phase 2 trial in idiopathic pulmonary fibrosis in the third quarter of this year."

Recent Developments
U.S. and Europe Roxadustat (FG-4592) Anemia in Chronic Kidney Disease (CKD)

Met initial target enrollment for three FibroGen-sponsored Phase 3 trials supporting U.S. and EU approvals and are continuing to enroll patients to meet overall enrollment goals among the partners
The independent data safety monitoring board (DSMB), which reviews the U.S. and European Phase 3 program quarterly, recommended in February that trials continue without modification to current protocols
China Roxadustat Anemia in Chronic Kidney Disease

Completed the controlled portion of our two Phase 3 trials in 2016
These studies met their primary endpoints for the treatment of anemia in non-dialysis and dialysis patients
— In non-dialysis patients, roxadustat achieved a significantly greater increase in mean Hb and a significantly greater Hb response rate, as compared to patients in the placebo arm
— In dialysis patients, roxadustat met the predefined non-inferiority criteria for the primary efficacy endpoint. In the pre-specified sequential analysis, roxadustat was also shown to be superior to 利血宝 (Li Xue Bao) epoetin alfa (Kirin EPO) in mean Hb increase
Japan Roxadustat Anemia in Chronic Kidney Disease

All six Phase 3 trials are now underway
Presented Phase 2 study results in non-dialysis-dependent patients in a clinical late-breaker session of the November 2016 American Society of Nephrology (ASN) Kidney Week
U.S. Roxadustat Oncology-Related Anemias

Phase 3 investigational new drug application was approved by the FDA for the treatment of anemia in myelodysplastic syndromes (MDS) in the fourth quarter of 2016
China Roxadustat Oncology-Related Anemias

Submitted a clinical trial application (CTA), which is under review by the China Food and Drug Administration (CFDA), for a Phase 2/3 clinical study of anemia in MDS
Pamrevlumab in Idiopathic Pulmonary Fibrosis (IPF)

Completed enrollment of the Phase 2 double-blind, placebo-controlled -067 study
Results from Study -049 were published in the European Respiratory Journal, accompanied by an editorial, and the corresponding open-label extension results were presented at the 19th International Colloquium on Lung and Airway Fibrosis (ICLAF)
— No safety issues reported with long-term treatment
— Trend towards improved or stable pulmonary function and stable fibrosis continued in second year of treatment
Pamrevlumab in Pancreatic Cancer

Presented findings at the 2017 Gastrointestinal Cancers Symposium (ASCO-GI) from an ongoing open-label, randomized Phase 1/2 study in locally advanced pancreatic cancer -069 showing improvement in survival among patients in the combination arm, as compared to chemotherapy alone
Published Phase 1/2 trial results in the Journal of Cancer Clinical Trials reporting statistically significant dose-related increase in survival and that pamrevlumab can be safely combined with chemotherapy standard-of-care in advanced pancreatic cancer
Corporate and Financial Highlights

Net loss per basic and diluted share for the year ended December 31, 2016 was $0.98, as compared to $1.42 a year ago
At December 31, 2016, FibroGen had $342.2 million of cash, restricted time deposits, cash equivalents, investments, and receivables
Outlook

Report pamrevlumab topline Phase 2 IPF data, placebo-controlled and combination treatment sub-study results, in the third quarter
Submit new drug application in China in the third quarter
Expect to complete enrollment of pamrevlumab open-label, randomized Phase 2 trial in locally advanced pancreatic cancer patients in the first half of the year, and to complete the patient treatment period by year-end
On track to submit the NDA for roxadustat in the U.S. in 2018

Puma Biotechnology Announces Publication of Abstracts on Neratinib for the AACR Annual Meeting 2017

On March 1, 2017 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported publication of abstracts on neratinib for the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2017 (Press release, Puma Biotechnology, MAR 1, 2017, View Source [SID1234517928]). The AACR (Free AACR Whitepaper) Annual Meeting will be held at the Walter E. Washington Convention Center in Washington, D.C. from April 1 to April 5.

Full abstracts of the following presentations are available online at www.aacr.org :

Apr. 4, 2017, 1:00 – 5:00 p.m. EDT – Abstract 4818 (Poster): Neratinib/fulvestrant but not fulvestrant alone maintain complete tumor responses after treatment with trastuzumab + paclitaxel of mice bearing ER+/HER2+ xenografts.
L.J. Schwarz et al, Vanderbilt University Medical Center.

April 4, 2017, 1:00 – 5:00 p.m. EDT – Abstract 4157 (Poster): Co-blockade of mTORC1, ERBB and estrogen receptor signaling pathways in endocrine resistant breast cancer: combating tumour plasticity.
R. Ribas et al, Institute of Cancer Research.

April 4, 2017, 1:00 – 5:00 p.m. EDT – Abstract 4038 (Poster): Exploring optimal targeted combination therapies with neratinib for HER2+ breast cancer.
M. Zhao et al, MD Anderson Cancer Center.

April 5, 2017, 8:00 – 12:00 p.m. EDT – Abstract 5167 (Poster): Stem-like colorectal cancer cell lines show response to the ERK1/2 inhibitor, SCH772984, alone and in combination with neratinib while the combination of MEK-162 and neratinib work to decrease tumor growth in inflammatory colorectal cancer subtypes.
R. Pal et al, NSABP.

April 5, 2017, 8:00 – 12:00 p.m. EDT – Abstract 5684 (Poster): NSABP FC-7 Correlative Study: HER2 amplification in circulating cell-free DNA (cfDNA) in metastatic colorectal cancer (mCRC) resistant to anti-EGFR therapy.
S. Rim Kim et al, NSABP.

Full abstracts of the following presentations are expected to be available online March 31, 2017, after 4:00 p.m. EDT:

April 2, 2017, 12:45 – 3:00 p.m. EDT – Abstract CT001 (Oral, Clinical Trials Plenary Session): Neratinib in HER2 or HER3 mutant solid tumors: SUMMIT, a global, multi-histology, open-label, phase 2 ‘basket’ study.
D. Hyman et al, Memorial Sloan Kettering Cancer Center.

April 2, 2017, 3:00 – 5:00 p.m. EDT – Abstract CT011 (Oral, Minisymposium): Circulating tumor DNA (ctDNA) sequencing for HER2 mutation (HER2mut) screening and response monitoring to neratinib in metastatic breast cancer (MBC).
C. Ma et al, Washington University School of Medicine.

April 2, 2017, 3:00 – 5:00 p.m. EDT – Abstract CT013 (Oral, Minisymposium): NSABP FB-10: Phase Ib dose-escalation trial evaluating trastuzumab emtansine (T-DM1) with neratinib (N) in women with metastatic HER2+ breast cancer (MBC).
J. Abraham et al, NSABP.

April 3, 2017, 10:30 a.m. – 12:45 p.m. EDT – Abstract LB103 (Oral, Major Symposium): Landscape of Somatic ERBB2 Mutations – Findings from AACR (Free AACR Whitepaper) GENIE and Comparison to Ongoing ERBB2 Mutant Basket Study.
A. Schram et al, Memorial Sloan Kettering Cancer Center.

April 4, 2017, 1:00 – 5:00 p.m. EDT – Abstract CT128 (Poster): Effects of adding budesonide or colestipol to loperamide prophylaxis on neratinib-associated diarrhea in patients (pts) with HER2+ early-stage breast cancer (eBC): the CONTROL trial.
E. Ibrahim et al, Beaver Medical Group LP.

NewLink Genetics Announces Presentation of Two Abstracts at AACR

On March 1, 2017 NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical company focused on bringing novel immuno-oncology therapies to patients with cancer, reported that two abstracts on the company’s indoximod program will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2017 Annual Meeting in Washington, D.C (Press release, NewLink Genetics, MAR 1, 2017, View Source [SID1234517927]).

Clinical Trials Plenary Session: Abstract CT117 – Interim analysis of the Phase 2 clinical trial of the IDO pathway inhibitor indoximod in combination with pembrolizumab for patients with advanced melanoma, to be presented during the Novel Immuno-Oncology Agent Clinical Trials session, Tuesday April 4, 2017 10:30 a.m. – 12:45 p.m. ET.

Poster Session: Abstract 4076 – A novel prodrug of indoximod with enhanced pharmacokinetic properties, to be presented during poster session PO.ET05.01 – Mechanistic Understanding of Novel Anticancer Therapies, April 4, 2017 1 p.m. – 5 p.m. ET .
The complete text of Clinical Plenary Session abstracts that have not been selected for the press program will be posted online at 4:30 p.m. ET on Friday, March 31. The text of clinical trials abstracts that have been selected for inclusion in the press program will not be posted online until the date and time of presentation.

"We are honored to have been selected by the AACR (Free AACR Whitepaper) review committee for the Clinical Trials Plenary Session at the upcoming AACR (Free AACR Whitepaper) meeting," said Nicholas Vahanian, M.D., President and Chief Medical Officer. "We look forward to sharing the data from both of these abstracts."

Clinical and preclinical data on monalizumab to be presented at AACR annual meeting 2017

On March 2, 2017 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that data on monalizumab will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 1 – 5, 2017, in Washington, D.C (Press release, Innate Pharma, MAR 1, 2017, View Source [SID1234517926]). Abstracts are available on the AACR (Free AACR Whitepaper) website. Monalizumab is Innate Pharma’s investigational first-in-class anti-NKG2A antibody partnered with AstraZeneca.

These data support the rationale for the development of monalizumab:

Preclinical data will be presented in a mini-symposium and show NKG2A expression on tumor-infiltrating CD8+ T cells in patients with head and neck cancer as well as synergy between treatment with a HPV vaccine and NKG2A blockade in a mouse tumor model;
During a poster session, safety data from the dose-escalation part of a Phase Ib/II study evaluating monalizumab in combination with cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck will be presented. In this study, monalizumab plus cetuximab were well tolerated with no additional safety concerns compared to monalizumab or cetuximab alone.
Monalizumab is currently being tested in five Phase I and I/II clinical trials in various cancer as a single agent and in combination with other therapies.

Presentation and poster details:

NKG2A checkpoint receptor expression on tumor-infiltrating CD8+ T cells restrains efficacy of immunotherapy
Abstract Number: 2999
Session Type: Mini-symposium, webcast
Session Title: Innate Immune Mechanisms in Cancer Treatment
Session Date and Time: Monday April 3, 2017 4:35 – 4:50 PM EST
Location: Washington Convention Center, Room 152, Level 1
Presented by Thorbald van Hall, Department of Clinical Oncology, Leiden University Medical Centre, The Netherlands
Safety of the first-in-class anti-NKG2A monoclonal antibody monalizumab in combination with cetuximab: a phase Ib/II study in recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN)
Abstract Number: 5666/20
Session Type: Poster Session
Session Title: Innate Immunity to Generate Adaptive Immunity
Session Date and Time: Wednesday April 5, 2017 8:00 AM – 12:00 PM EST
Location: Washington Convention Center, Halls A-C, Poster Section 28
Presented by Roger B. Cohen M.D., Abramson Cancer Center, Philadelphia, USA

Immune Design to Present New Tumor Eradication Data for Systemic Plus Intratumoral Immunization at the American Association for Cancer Research (AACR) Annual Meeting 2017

On March 1, 2017 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported that new preclinical data showing the broad anti-tumor activity on its "prime-pull" approach, as well as the ability of its ZVex vectors to activate dendritic cells potently, will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2017 Annual Meeting, being held from April 1-5, 2017 in Washington D.C (Press release, Immune Design, MAR 1, 2017, View Source [SID1234517925]).

"These AACR (Free AACR Whitepaper) data illustrate the significant local and systemic immune responses that the combination of ZVex vectors with G100 may generate. We observed complete eradication of large, established B16 tumors in animal models, which previously has been achieved only with complex regimens," said Jan ter Meulen, MD, PhD, Chief Scientific Officer at Immune Design. "In addition, we will present additional data supporting the ability of ZVex vectors to generate potent activation of human dendritic cells."

Immune Design will present data showing the "Prime-Pull" concept that involves the (i) intradermal administration of the dendritic cell (DC)-targeting ZVex vector expressing a tumor-associated antigen and (ii) intratumoral injection of G100, a formulated, potent synthetic toll-like receptor-4 (TLR-4) agonist, in the difficult to treat B16 melanoma model. Antigen-specific CD8 T-cells are induced ("primed") by a ZVex vector, and subsequent injection of G100 leads to pro-inflammatory changes in the tumor microenvironment (TME), which induces the trafficking of T-cells into the tumor (the "pull"). This inflamed TME and recruitment of ZVex-induced CD8 T cells eradicated large, established B16 tumors. Also importantly, treated mice rejected re-challenge with a tumor lacking the antigen used for immunization, indicating antigen spreading induced by the immunotherapeutic regimen. Immune Design is evaluating this immunotherapy approach in an ongoing Phase 1 trial in patients with soft tissue sarcoma who are receiving G100 and CMB305, its prime-boost approach that is being evaluated in multiple clinical trials as both a monotherapy and in combination with atezolizumab, Genentech’s anti-PD-L1 antibody.

In addition, Immune Design will present separate data highlighting the ability of its ZVex vectors to induce potent, innate immune activation in human DCs. Company researchers studied the effect of human DC transduction with ZVex vectors by gene expression profiling. Human DCs transduced with ZVex vectors displayed statistically significant up-regulation of genes involved in antigen presentation and anti-viral defense pathways, highlighting that ZVex is sufficient to activate transduced DCs and facilitate antigen presentation to T cells.

The details for the poster presentations are as follows:

Large established B16 tumors in mice are eradicated by ZVex (dendritic cell-targeting lentiviral vector) and G100 (TLR4 agonist) combination immunotherapy through increasing tumor-infiltrating effector T cells and inducing antigen spreading

Abstract #: 5673

Session Category: Clinical Research

Session Title: Innate Immunity to Generate Adaptive Immunity

Date and Time: Wednesday, April 5, 2017, 8:00 a.m. — 12:00 p.m.

Location: Convention Center, Halls A-C, Poster Section 28

Poster Board: 27

Authors: Tina C. Albershardt, Andrea J. Parsons, Jardin Leleux, Peter Berglund, Jan ter Meulen. Immune Design

The poster presentation will be made available at Immune Design’s website on or after April 5, 2017.

ZVex lentiviral vector strongly activates pro-inflammatory, antigen processing, and anti-viral defense response pathways in monocyte-derived dendritic cells

Abstract #: 5092

Session Category: Experimental and Molecular Therapeutics

Session Title: Gene- and Vector-based Therapy

Date and Time: Wednesday, April 5, 2017, 8 a.m. — 12 p.m.

Location: Convention Center, Halls A-C, Poster Section 3

Poster Board: 8

Authors: Anshika Bajaj, Lisa Y. Ngo, Peter Berglund, Jan ter Meulen. Immune Design

The poster presentation will be made available at Immune Design’s website on or after April 5, 2017.

About ZVex

ZVex is Immune Design’s discovery platform designed to activate and expand the immune system’s natural ability to create tumor-specific cytotoxic T cells (CTLs) in vivo. ZVex uses a re-engineered virus to carry genetic information of a tumor antigen selectively to dendritic cells in the skin or lymph nodes. This ultimately results in the creation of CTLs designed to kill tumor cells bearing that same specific tumor antigen. ZVex is also designed to carry the genetic information for, and therefore potentially cause dendritic cells to express, multiple antigens and/or selected epitopes of interest (including neoantigens), as well as cytokines or other immunomodulatory molecules.

About G100

G100 is a product candidate from Immune Design’s GLAAS discovery platform. It contains a potent synthetic small molecule toll-like receptor-4 (TLR-4) agonist, Glucopyranosyl Lipid A (GLA), and is the lead product candidate in Immune Design’s Antigen Agnostic approach. It leverages the activation of both innate and adaptive immunity, including Dendritic Cells, in the tumor microenvironment to create an immune response against the tumor’s preexisting diverse set of antigens. A growing set of clinical and preclinical data have demonstrated the ability of G100 to activate tumor-infiltrating lymphocytes, macrophages and dendritic cells, and promote antigen-presentation and the recruitment of T cells to the tumor. The ensuing induction of local and systemic immune responses has been shown to result in local and abscopal (shrinking of tumors outside the scope of the localized treatment) tumor control in preclinical studies. G100 was evaluated in a Phase 1 study in Merkel cell carcinoma patients and produced a 50% overall response rate per protocol and a favorable safety profile. Currently, G100 is being evaluated as both a monotherapy with local radiation and in combination with Merck’s anti-PD-1 agent, pembrolizumab, pursuant to a clinical collaboration with Merck, in a randomized Phase 1/2 trial in patients with follicular non-Hodgkin lymphoma.