On June 08, 2016 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported updated results from clinical trials of three immuno-oncology product candidates demonstrating promising and potentially clinically meaningful anti-tumor immune responses for Immune Design’s lead products (Press release, Immune Design, JUN 8, 2016, View Source [SID:1234513139]). This includes data presented at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting and involves Immune Design’s two distinct immunotherapy applications — the ‘Specific Antigen’ and ‘Endogenous Antigen’ Approaches.

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"The data reflect single agent Phase 1 studies and provide strong rationale for continued development, including our ongoing randomized Phase 2 studies," said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer. "We believe both of our approaches are disruptive and have the potential to impact the immunotherapy treatment landscape."

LV305 & CMB305: Specific Antigen Approach Targeting NY-ESO-1 Positive Tumors — Emerging Profile of Prolonged Survival Benefit

LV305 Phase 1 single agent trial completed in 24 patients with advanced or metastatic sarcoma cancers expressing NY-ESO-1 (ASCO abstract #3093)
Median overall survival (OS) has not been reached. One-year survival is 81%.
Median progression free survival (PFS) is 4.6 months.
14 patients (58%) had clinical benefit: One patient (4%) had a late-onset partial response and 13 patients (54%) had stable disease.
7/11 patients with pretreatment progressive disease (PD) had SD or PR following LV305.
Safety profile is very favorable, with only Grade 1/2 adverse effects (AEs).
CMB305 Phase 1 single agent trial ongoing in patients with NY-ESO-1 positive soft tissue sarcomas (preliminary analysis of first 14 patients)
Median OS has not been reached. 93% (13/14 patients) survival to date.
Median PFS is 5.5 months.
Best response to date is stable disease (10/14, 71%)
Safety profile is very favorable, with only Grade 1/2 AE
G100: Intratumoral Immune Activation Approach: Transforming "cold" tumors to "hot" tumors

G100 single agent and in combination with radiation in patients with Merkel cell carcinoma (ASCO Abstract #3021)
In final results from 10 patients, G100 produced a 50% overall response rate (ORR) per protocol, including a pathologic complete response (CR) following single agent G100 alone.
Four patients remain relapse-free in long-term follow up (range 13+ to 27.5+ months).
Analysis of the tumor microenvironment (TME) in G100-treated patients demonstrates the transformation of a "cold" to a "hot" tumor: increase of innate immune molecules that favor immune cell chemotaxis; increased NK cells and M1 macrophage markers; and dendritic cell antigen presentation. In addition, trafficking of CD4 and CD8 T cells from the stroma into the tumor bed was observed.
These changes in the TME were most prominent in the G100 responding patients.
No treatment-related AEs where observed; all AEs were grade 1/2.

On June 8, 2016 Kite Pharma, Inc. (Nasdaq:KITE) ("Kite"), a clinical-stage biopharmaceutical company focused on developing engineered autologous T-cell therapy (eACT) products for the treatment of cancer, reported three oral presentations relating to its clinical programs will be delivered at the upcoming 2016 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress in Copenhagen, Denmark, June 9-12, 2016 (Press release, Kite Pharma, JUN 8, 2016, View Source [SID:1234513140]).

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"We are excited to showcase the progress we have made with personalized T-cell immuno-oncology for people with refractory lymphoma and to share our understanding of the outcomes for this patient population who have limited or no treatment options," said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer of Kite. "These data are important to advance our novel breakthrough personalized treatments and ultimately address critical unmet medical needs."

Updated data from Phase 1 of Kite’s ZUMA-1 study of KTE-C19 in patients with chemorefractory non-Hodgkin lymphoma (NHL) will be presented in an oral presentation. An additional oral presentation will feature data from the SCHOLAR-1 study, the first and largest meta-analysis of outcomes in patients with chemorefractory diffuse large B-cell lymphoma (DLBCL), an aggressive and common form of NHL that is difficult to treat. Patients with chemorefractory DLBCL have not responded to prior treatment with chemotherapy or have relapsed within a year after autologous stem cell transplantation.

Data from a Phase 1-2a study evaluating anti-CD19 CAR T-cell therapy after low-dose chemotherapy in people with advanced lymphoma will also be highlighted in an oral presentation. This study is being conducted as part of a Cooperative Research and Development Agreement (CRADA) between Kite and the National Cancer Institute (NCI).

Kite also recently announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) has granted access to its newly established Priority Medicines (PRIME) regulatory initiative for KTE-C19 in the treatment of patients with refractory DLBCL. PRIME provides early and enhanced regulatory support to optimize regulatory applications and speed up the review of medicines that address a high unmet need. KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a chimeric antigen receptor (CAR) designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias.

Oral presentations at the 2016 EHA (Free EHA Whitepaper) Annual Congress:

Results from SCHOLAR-1: Outcomes in patients with refractory aggressive diffuse large B-cell lymphoma (DLBCL)

Date: Saturday, June 11, 2016, 5:00 – 5:15 PM CEST
Location: Hall A1
Abstract Number: S481
Presenter: Christian Gisselbrecht, M.D., The Lymphoma Academic Research Organisation (LYSARC), Pierre-Bénite, France

Updated results from ZUMA-1: A phase 1-2 multicenter study evaluating the safety and efficacy of KTE-C19 (anti-CD19 CAR T cells) in refractory aggressive B-cell Non-Hodgkin Lymphoma (NHL)

Date: Sunday, June 12, 2016, 8:45 – 9:00 AM CEST
Location: Hall A1
Abstract Number: S791
Presenter: Tanya Siddiqi, M.D., City of Hope National Medical Center, Duarte, CA

Low-dose chemotherapy followed by anti-CD19 chimeric antigen receptor (CAR) T cells induces remissions in patients with advanced lymphoma

Date: Sunday, June 12, 2016, 9:00 – 9:15 AM CEST
Location: Hall A1
Abstract Number: S792
Presenter: Stephanie L. Goff, M.D., Surgery Branch, Center for Cancer Research, The National Cancer Institute, Bethesda, MD

About Kite’s ZUMA Clinical Programs for KTE-C19

KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a CAR that is designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias. Kite is currently enrolling four pivotal studies (also known as ZUMA studies) for KTE-C19 in patients with various B-cell malignancies.

Study Phase Indication Status
ZUMA-1
NCT02348216 Phase 2 Pivotal
(N=112) Chemorefractory DLBCL, PMBCL, TFL Phase 2 enrolling
ZUMA-2
NCT02601313 Phase 2 Pivotal
(N=70) Relapsed/refractory MCL Phase 2 enrolling
ZUMA-3
NCT02614066 Phase 1/2 Pivotal
(N=75) Relapsed/refractory Adult ALL Phase 1/2 enrolling
ZUMA-4
NCT02625480 Phase 1/2 Pivotal
(N=75) Relapsed/refractory Pediatric ALL Phase 1/2 enrolling

DLBCL = diffuse large B-cell lymphoma
PMBCL = primary mediastinal B-cell lymphoma
TFL = transformed follicular lymphoma
MCL = mantle cell lymphoma
ALL = acute lymphoblastic leukemia

On June 8, 2016 AstraZeneca reported it has entered into a commercialisation agreement with Aspen Global Incorporated (AGI), part of the Aspen Group, for rights to its global anaesthetics portfolio outside the US (Press release, AstraZeneca, JUN 8, 2016, View Source [SID:1234513247]). The agreement covers seven established medicines – Diprivan (general anaesthesia), EMLA (topical anaesthetic) and five local anaesthetics (Xylocaine/Xylocard/Xyloproct, Marcaine, Naropin, Carbocaine and Citanest).

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Under the terms of the agreement, AGI will acquire the commercialisation rights, outside the US, to AstraZeneca’s portfolio of anaesthetic medicines for an upfront consideration of $520 million. Additionally, AGI will pay AstraZeneca up to $250 million in a Product Sales-related payment, as well as double-digit percentage trademark royalties on Product Sales. AstraZeneca will manufacture and supply the products on a cost plus basis to AGI for an initial period of 10 years. Upon completion, Aspen will assume responsibility for all activities relating to the sale of the portfolio in all relevant markets.

Pascal Soriot, Chief Executive Officer, AstraZeneca, said: "AstraZeneca has a rich heritage in anaesthetic medicines and this agreement will extend the reach of our established portfolio to a greater number of patients through AGI’s extensive commercial network. This agreement supports our strategic focus on the new medicines in three main therapy areas."

Stephen Saad, Group Chief Executive, Aspen, said: "This is a strategically-important investment for AGI and it is pleasing to have a company such as AstraZeneca recognise Aspen’s commercial competencies. This transaction is an excellent opportunity to build on the quality brands commercialised through AGI, working alongside an acknowledged pioneer and leader in the field of anaesthetics."

AstraZeneca’s portfolio of anaesthetics is available in over a hundred countries worldwide, including key markets such as China, Japan, Australia and Brazil. The portfolio continues to generate stable revenue, with global Product Sales in 2015 of $592 million. The US rights to the products were divested to Abraxis, now part of Fresenius Kabi, in 2006.

Financial considerations

The transaction is subject to customary closing conditions and is anticipated to complete in the third quarter of 2016. AstraZeneca will retain a significant ongoing interest in the anaesthetics portfolio through ongoing milestone and royalty payments and the manufacture and supply of the products to Aspen. The upfront and milestone payments, as well as royalty receipts, which are open-ended, will therefore be reported as Externalisation Revenue in the Company’s financial statements. The agreement will not impact the Company’s financial guidance for 2016.

On June 8, 2016 Cantargia AB reported that its patent application for IL1RAP as target molecule for antibody-based therapies and diagnostics of solid tumours has been approved by the Japan Patent Office (JPO) (Press release, Cantargia, JUN 8, 2016, View Source [SID:1234513154]).

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The patent approval (patent no. 5940093) refers to the company’s method of using IL1RAP as target molecule for treatment of the vast majority of solid tumours. The approved patent includes those diseases which Cantargia has chosen to focus its initial development activities on, i.e. lung cancer and pancreatic cancer, as well as other major diseases such as breast cancer, colorectal cancer and prostate cancer. The patent’s validity extends to 2032. The patent also provides protection for several different antibody-drug conjugates targeted to IL1RAP and for associated diagnostic methods.

"The approval of the patent is of great strategic significance for Cantargia and the future commercialisation of our CAN04 product candidate", CEO Göran Forsberg says. "Having received approval in Japan, we now have protection for treatment of solid tumours in both Europe and Japan, which are two of the largest pharmaceutical markets".

On June 7, 2016 Blue Earth Diagnostics Ltd., a molecular imaging diagnostics company, and Siemens’ PETNET Solutions, Inc., a wholly-owned subsidiary of Siemens Medical Solutions USA, Inc., reported the commercial availability of Axumin (fluciclovine F 18) injection in the United States (Press release, Blue Earth Diagnostics, JUN 7, 2016, View Source [SID:1234513123]). Axumin is a novel molecular imaging agent indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men who have elevated blood levels of prostate specific antigen (PSA) following prior treatment. Axumin was approved by the U.S. Food and Drug Administration (FDA) on May 27, 2016, and is the first FDA-approved F-18 PET imaging agent indicated for use in patients with suspected recurrent prostate cancer.

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"Blue Earth Diagnostics is extremely pleased to be working with Siemens’ PETNET Solutions, the leading supplier of PET radiopharmaceuticals in the United States; we both share a passion for PET molecular imaging, and for providing imaging tools to improve patient management."
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Axumin will be commercially available this month through Blue Earth Diagnostics’ manufacturer and exclusive distributor in the United States, Siemens’ PETNET Solutions. Initial commercial production of Axumin will be underway at certain Siemens’ PETNET Solutions radiopharmacies, with increasingly broader availability planned in the coming months.

"We are tremendously pleased with FDA’s recent approval of Axumin for suspected biochemically recurrent prostate cancer, and hope that this will make a real difference to patients and their physicians," said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics Ltd. "Blue Earth Diagnostics is extremely pleased to be working with Siemens’ PETNET Solutions, the leading supplier of PET radiopharmaceuticals in the United States; we both share a passion for PET molecular imaging, and for providing imaging tools to improve patient management."

"This is a significant milestone for the PET industry, as this is the first proprietary F-18 labeled agent for an oncology indication approved by the FDA. And, being F-18 labeled enables efficient distribution and wide patient access," said Barry Scott, head of Siemens’ PETNET Solutions. "Through our broad network of radiopharmacies we are able to increase access to PET tracers, like Axumin, helping healthcare providers to address society’s most challenging diseases. We are proud to work with Blue Earth Diagnostics as the U.S. commercial supplier making Axumin available to imaging centers and their patients."

Blue Earth Diagnostics and Siemens’ PETNET Solutions welcome visitors to the upcoming SNMMI meeting to visit their exhibit booths. Blue Earth Diagnostics is at Booth 337; Siemens’ PETNET Solutions is at Booth 431.

About AxuminTM (fluciclovine F 18)

Axumin (fluciclovine F 18) injection is a novel product indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men. Recurrence of prostate cancer is suspected by an increase in prostate specific antigen (PSA) levels following initial therapy. PET imaging with Axumin may identify the location and extent of such recurrence. Axumin was developed to enable visualization of the increased amino acid transport that occurs in many cancers, including prostate cancer. It consists of a synthetic amino acid that is preferentially taken up by prostate cancer cells compared with surrounding normal tissues, and is labeled with the radioisotope F18 for PET imaging. Axumin was approved by the U.S. Food and Drug Administration on May 27, 2016 following Priority Review, and is the first product commercialized by Blue Earth Diagnostics, which licensed the product from GE Healthcare. The molecule is being investigated by Blue Earth Diagnostics for other potential cancer indications, such as glioma.

Indication and Important Safety Information About Axumin

INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full Axumin prescribing information is available at www.axumin.com.

About Prostate Cancer/Recurrent Prostate Cancer

Prostate cancer is the second leading cause of cancer death in men. While most primary prostate cancer can be successfully treated, the disease recurs in up to one-third of patients. In some patients recurrent disease is detectable only by a rise in prostate specific antigen (PSA) levels, yet the location of the recurrence cannot consistently be located by conventional imaging, severely limiting treatment guidance for these patients.