2016 – Page 793 – 1stOncology™: Cancer Intelligence Service

20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

(Filing, Annual, Adaptimmune, 2015, MAR 17, 2016, View Source [SID:1234509607])

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Affimed to Present Data on NK- and T-Cell Engagers at the AACR Annual Meeting 2016

On March 17, 2016 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, reported that preclinical data from a combination study of Affimed’s lead candidate AFM13 and checkpoint modulators, including checkpoint inhibitor PD-1, as well as data on Affimed’s preclinical programs AFM21/22 and AFM24 will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2016 Annual Meeting being held April 16 – 20, 2016 in New Orleans, LA (Press release, Affimed Therapeutics, MAR 17, 2016, View Source [SID:1234512470]).

AFM13

On Monday, April 18, "Immune checkpoint inhibition by anti-PD-1 or CD137 co-stimulation enhances cytotoxicity towards CD30+ tumors mediated by the bispecific tetravalent CD30/CD16A TandAb AFM13" (Abstract #2323) will be available in a poster session. The results of this preclinical study, conducted in collaboration with Stanford University, confirm earlier evidence of the synergy of our lead candidate, the CD30/CD16A-specific NK-cell engager AFM13, in combination with PD-1 inhibitors in in vivo PDX models with human CD30+ Hodgkin lymphoma (HL) tumors. Our data demonstrate that this synergy is mediated by tumor-infiltrating lymphocytes, macrophages and dendritic cells, and provide strong evidence for cross-talk between innate and adaptive immunity induced by AFM13-recruited human NK-cells. Together with AFM13’s adequate safety profile in patients, these results further justify the Phase 1b combination study investigating AFM13 in combination with pembrolizumab in relapsed/refractory HL patients which we expect to be initiated in the first half of this year.

AFM21/22

On Sunday, April 17, "Anti-EGFRvIII TandAbs recruiting either T or NK cells are highly specific and potent therapeutic antibody candidates for the treatment of EGFRvIII+ tumors" (Abstract #580) will be available in a poster session. In this preclinical study we report development of tetravalent, bi-specific TandAbs (tandem antibodies) that recognize EGFRvIII, the most prevalent tumor-specific variant of the epidermal growth factor receptor, EGFR. Our TandAbs recruit either T-cells or NK-cells, both of which are highly potent and efficacious immune effector cells, by binding to their activating receptors CD3 (AFM21) and CD16A (AFM22), respectively. This allows for the selective destruction of EGFRvIII-positive tumor cells, while sparing healthy, EGFRvIII-negative cells. The AFM21/22 program further validates the robustness of our proprietary TandAb technology platform, allowing for rapid identification of candidate molecules which are stable, highly expressed, and display significant in vitro and in vivo cytotoxicity to cancer cells.

AFM24

On Sunday, April 17, "Highly cytotoxic EGFR/CD16A TandAbs specifically recruit NK cells to potently kill various types of solid tumors" (Abstract #593) will be available in a poster session. In this preclinical study we describe the development of our novel bispecific, tetravalent EGFR/CD16A-specific NK-cell TandAbs and provide evidence for their therapeutic potential. When constitutively activated through amplification or dysregulation, the EGFR wild type (EGFRwt) plays an important role in the pathophysiology of numerous solid cancers. Specifically utilizing the cytotoxic potential of NK-cells for the elimination of EGFR-overexpressing cancer cells, we engineered a set of EGFR/CD16A TandAbs and selected ideal candidates based on their binding, thermostability and cytotoxic properties. Our data suggest that EGFR/CD16A TandAbs are novel, highly potent drug candidates suitable for the treatment of EGFR-overexpressing malignancies and suited to overcome the intrinsic or acquired resistance to other EGFR-targeting treatments such as tyrosine kinase inhibitors or monoclonal antibodies, which has been observed in a large number of patients.

Full abstracts of the presentations can be accessed on the AACR (Free AACR Whitepaper) website at www.aacr.org.

Clinical data of Medigene’s dendritic cell (DC) vaccines in prostate cancer to be presented at AACR conference

On March 17, 2016 Medigene AG (MDG1, Frankfurt, Prime Standard), a clinical stage immune-oncology company focusing on the development of T cell immuno-therapies for the treatment of cancer, reported that the academic group of Prof. Gunnar Kvalheim at the Department of Cellular Therapy at the Oslo University Hospital, Norway, will present preliminary clinical phase I/II data on dendritic cell (DC) vaccines for the treatment of prostate cancer utilising Medigene’s DC vaccine technology at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in New Orleans, LA, USA from 16 – 20 April 2016 (Press release, MediGene, MAR 17, 2016, View Source [SID:1234509841]).

The poster entitled "Clinical results of a Phase I/II trial of adjuvant therapeutic vaccination in high risk resected prostate cancer patients using autologous dendritic cells loaded with mRNA from primary prostate cancer tissue, hTERT and survivin" will be presented during the poster session on Adoptive Cell Therapy, Immune Checkpoints, and Vaccines on Monday, 18 April, providing data from an ongoing investigator-initiated trial (IIT) conducted at the Oslo University Hospital.

More detailed information can be found in the abstract under the following link: View Source;sKey=ac456e79-efd5-416e-a7de-67382c67723a&cKey=2ab5cd11-b3d8-40a8-8087-b0c57f2e8034&mKey=1d10d749-4b6a-4ab3-bcd4-f80fb1922267

Presentation Time: Monday, April 18, 2016, 1:00 PM – 5:00 PM
Location: Section 21
Poster Board Number: 27

The Oslo University Hospital has an agreement with Medigene for use of Medigene`s new generation DC vaccines for their ongoing academic clinical studies.

About Medigene’s DC vaccines: The platform for the development of antigen-tailored DC vaccines is the most advanced platform of the highly innovative and complementary immunotherapy platforms of Medigene Immunotherapies. Currently, Medigene evaluates its DC vaccines in a company-sponsored phase I/II clinical trial in acute myeloid leukaemia (AML). Further studies utilising Medigene’s DC vaccine technology include two ongoing clinical investigator-initiated trials (IITs): a clinical phase I/II trial for treating acute myeloid leukaemia (AML) at Ludwig Maximilians University Hospital Grosshadern, Munich, and a clinical phase II trial of a treatment for prostate cancer at Oslo University Hospital. Moreover, compassionate use patients are treated with DC vaccines at the Department of Cellular Therapy at Oslo University Hospital.

Dendritic cells (DCs) are the most potent antigen presenting cells of our immune system. Their task is to take up, process and present antigens on their cell surface, which enables them to activate antigen-specific T cells for maturation and proliferation. This way T cells can recognise and eliminate antigen-bearing tumour cells. Dendritic cells can also induce natural killer cells (NK cells) to attack tumour cells. The team of Medigene Immunotherapies GmbH’s scientists has developed new, fast and efficient methods for generating dendritic cells ex-vivo, which have relevant characteristics to activate both T cells and NK cells. The DC vaccines are developed from autologous (patient-derived) precursor cells, isolated from the patient’s blood, and can be loaded with tumour-specific antigens to treat different types of cancer. Medigene’s DC vaccines are in development for the treatment of minimal residual disease or use in combination therapies.

Further audio-visual education about Medigene’s DC-Vaccines at:
View Source

Allergan Confirms Generic Abraxane® Patent Challenge

On March 17, 2016 Allergan plc (NYSE: AGN), a leading global pharmaceutical company, reported that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Paclitaxel Protein-Bound Particles for Injectable Suspension, 100 mg/vial (Press release, Allergan, MAR 17, 2016, View Source;p=irol-newsArticle&ID=2149174 [SID:1234509619]).

Logo – View Source

Allergan’s ANDA product is a generic version of Celgene’s Abraxane, which is indicated for the treatment of metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy; locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy; and metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.

Based on available information, Allergan believes it is a "first applicant" to file an ANDA for the generic version of Abraxane and, should it’s ANDA be approved, may be entitled to 180 days of generic market exclusivity.

For the 12 months ending January 31, 2016, Abraxane had total U.S. sales of approximately $683 million, according to IMS Health data.

Abraxane is a registered trademark of Abraxis BioScience, LLC.

Celldex Therapeutics to Present New Clinical and Preclinical Data at the AACR Annual Meeting 2016

On March 17, 2016 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported that the Company and its collaborating investigators will present seven posters with new clinical and preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2016 in New Orleans (Press release, Celldex Therapeutics, MAR 17, 2016, View Source [SID:1234509616]).

Highlights include immune response data from the ongoing Phase 1/2 study of varlilumab and nivolumab in multiple solid tumors, the role of gpNMB as a relevant therapeutic target across multiple cancers and a late-breaking poster from the Phase 1 investigator-sponsored study of CDX-301 (Flt3L) in B-cell lymphomas.

The following Celldex-sponsored abstracts have been selected for poster presentations at AACR (Free AACR Whitepaper):

Title: Phase 1 results from the combination of an immune-activating anti-CD27 antibody (varlilumab) in combination with PD-1 blockade (nivolumab): activation across multiple immune pathways without untoward immune-related adverse events

Date/Time: Monday, April 18, 8:00 a.m. – 12:00 p.m. CDT
Location: Section 13
Abstract: CT023

Title: Glycoprotein NMB (gpNMB) overexpression is prevalent in human cancers: pancreatic cancer, non-small cell lung cancer, head and neck cancer, and osteosarcoma

Date/Time: Wednesday, April 20, 8:00 a.m. – 12:00 p.m. CDT
Location: Section 27
Abstract: 5032

Title: IHC and RT-PCR assays for detection of cancer antigen NY-ESO-1 in human tissues

Date/Time: Monday, April 18, 8:00 a.m. – 12:00 p.m. CDT
Location: Section 21
Abstract: 1373

Title: Development and characterization of novel CD40 antibody agonists for cancer immunotherapy

Date/Time: Wednesday, April 20, 8:00 a.m. – 12:00 p.m. CDT
Location: Section 22
Abstract: 4866

The following investigator-sponsored abstracts have been selected for poster presentations at AACR (Free AACR Whitepaper):

Title: In situ vaccination of low-grade lymphoma with intratumoral Flt3L and poly-ICLC with low-dose radiotherapy

Date/Time: Monday, April 18, 8:00 a.m. – 12:00 p.m. CDT
Location: Section 10
Abstract: LB-081

Title: Targeting GPNMB with 89Zr-CR011 for PET imaging of triple negative breast cancer

Date/Time: Tuesday, April 19, 1:00 p.m. – 5:00 p.m. CDT
Location: Section 33
Abstract: 4209

Title: Targeting the melanosome: overcoming MAPK-inhibitor resistance in melanoma

Date/Time: Sunday, April 17, 1:00 p.m. – 5:00 p.m. CDT
Location: Section 16
Abstract: 296

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Year: 2016

20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

Affimed to Present Data on NK- and T-Cell Engagers at the AACR Annual Meeting 2016

Clinical data of Medigene’s dendritic cell (DC) vaccines in prostate cancer to be presented at AACR conference

Allergan Confirms Generic Abraxane® Patent Challenge

Celldex Therapeutics to Present New Clinical and Preclinical Data at the AACR Annual Meeting 2016