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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.

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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.

Phase III APHINITY study shows Roche’s Perjeta® regimen helped people with an aggressive type of early breast cancer live longer without their disease returning compared to Herceptin® and chemotherapy

On March 1, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY), the Breast International Group (BIG), Breast European Adjuvant Study Team (BrEAST) and Frontier Science Foundation (FS) reported positive results from the phase III APHINITY study (Press release, Hoffmann-La Roche, MAR 1, 2017, View Source [SID1234517924]). The study met its primary endpoint and showed that adjuvant (after surgery) treatment with the combination of Perjeta (pertuzumab), Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen) achieved a statistically significant reduction in the risk of recurrence of invasive disease or death (invasive disease-free survival; iDFS) in people with HER2-positive early breast cancer (eBC) compared to Herceptin and chemotherapy alone. The safety profile of the Perjeta-based regimen was consistent with that seen in previous studies1, and no new safety signals were identified. Full results from the APHINITY trial will be presented at an upcoming medical meeting in 2017.

"These results from the positive APHINITY study represent an important addition to the body of data for Perjeta in the treatment of people with HER2-positive early breast cancer," said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development at Roche. "We look forward to discussing these adjuvant results with global regulatory authorities."

Gunter von Minckwitz, MD, study coordinator from the Breast International Group and academic study partners, added, "APHINITY provides yet another example of the importance of industry-academic collaborations and their value in advancing cancer care for people affected by this challenging disease."

HER2-positive breast cancer is an aggressive form of the disease, which affects approximately one in five people with breast cancer2 and is associated with a poor prognosis if left untreated.3 Despite advancements in the treatment of HER2-positive eBC, up to one in three people treated with Herceptin and chemotherapy may eventually see their cancer return.4,5 Treatment options are needed to improve the outcomes of people with this aggressive disease. Treating breast cancer early, before it has spread, may improve the chance of preventing the disease from returning and potentially reaching an incurable stage.6 Adjuvant therapy is given after surgery and is aimed at killing any remaining cancer cells to reduce the risk of the cancer returning.6

The combination of Perjeta, Herceptin and chemotherapy is licenced as a neoadjuvant (before surgery) treatment for people with HER2-positive eBC in more than 75 countries worldwide following approvals by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).1,7 In the US, the regimen is currently available under the FDA accelerated approval programme. The APHINITY trial reflects the commitment to evaluate the Perjeta-based regimen as part of a complete treatment approach for eBC. These data will be discussed with health authorities across the world, including the US FDA with the hope to convert the current US accelerated approval to a full approval.

About APHINITY8
APHINITY (Adjuvant Pertuzumab and Herceptin IN Initial TherapY in Breast Cancer, NCT01358877/ BO25126/ BIG 4-11) is an international, phase III, randomised, double-blind, placebo-controlled, two-arm study evaluating the efficacy and safety of Perjeta plus Herceptin and chemotherapy compared to Herceptin and chemotherapy as an adjuvant therapy in 4,805 people with operable HER2-positive eBC.

People enrolled in the study underwent surgery and were randomised to one of two arms (1:1) to receive either:
Six to eight cycles of chemotherapy (anthracycline or non-anthracycline-containing regimen) with Perjeta and Herceptin, followed by Perjeta and Herceptin every three weeks for a total of one year (52 weeks) of treatment.
Six to eight cycles of chemotherapy (anthracycline or non-anthracycline-containing regimen) with placebo and Herceptin, followed by placebo and Herceptin every three weeks for a total of one year (52 weeks) of treatment.
Radiotherapy and/or endocrine therapy could be initiated at the end of adjuvant chemotherapy. The APHINITY study allowed for a range of standard chemotherapy regimens to be used and both lymph node-positive and lymph node-negative participants were eligible for enrolment. The primary efficacy endpoint of the APHINITY study is iDFS, which is the time a patient lives without return of invasive breast cancer at any site or death from any cause after adjuvant treatment. Secondary endpoints include cardiac and overall safety, overall survival, disease-free survival and health-related quality of life.

About Perjeta
Perjeta is a medicine that targets the HER2 receptor, a protein found on the outside of many normal cells and in high quantities on the outside of cancer cells in HER2-positive cancers.9,10 Perjeta is designed specifically to prevent the HER2 receptor from pairing (or ‘dimerising’) with other HER receptors (EGFR/HER1, HER3 and HER4) on the surface of cells, a process that is believed to play a role in tumour growth and survival. Binding of Perjeta to HER2 may also signal the body’s immune system to destroy the cancer cells. The mechanisms of action of Perjeta and Herceptin are believed to complement each other, as both bind to the HER2 receptor, but to different places. The combination of Perjeta and Herceptin is thought to provide a more comprehensive, dual blockade of HER signalling pathways, thus preventing tumour cell growth and survival.11,12