On November 8, 2016 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, reported that three of the Company’s abstracts have been chosen for poster presentations at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held December 3-6, 2016 in San Diego, California (Press release, Affimed, NOV 8, 2016, View Source [SID1234516419]).

Poster Information

AFM13 Is the Most Advanced Bispecific NK-Cell Engaging Antibody in Clinical Development Substantially Enhancing NK-Cell Effector Function and Proliferation (Abstract #1764)
Session: 622. Lymphoma Biology – Non-Genetic Studies: Poster I
Date: Saturday, December 3, 2016: 5:30-7:30 p.m. (PT)
Location: Hall GH (San Diego Convention Center)

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Functional Defects of T Cells of NHL Patients after Different Chemotherapy Regimens Activated By CD19/CD3 Tetravalent Bispecific TandAb AFM11 (Abstract #4130)
Session: 622. Lymphoma Biology – Non-Genetic Studies: Poster III
Date: Monday, December 5, 2016: 6:00-8:00 p.m. Pacific Time
Location: Hall GH (San Diego Convention Center)

Trispecific Antibodies for Selective CD16A-Directed NK-Cell Engagement in Multiple Myeloma (Abstract #4513)
Session: 653. Myeloma: Therapy, excluding Transplantation: Poster III
Date: Monday, December 5, 2016: 6:00-8:00 p.m. Pacific Time
Location: Hall GH (San Diego Convention Center)

About AFM13
AFM13 is a bispecific NK-cell TandAb simultaneously targeting CD16A on NK-cells and CD30 on tumor cells. AFM13 is designed to treat CD30-positive malignancies including Hodgkin lymphoma (HL) and T-cell lymphoma (TCL) and is currently in Phase 2 studies in HL patients. Based on its appropriate safety profile, AFM13 is being developed both as monotherapy and in combination with other therapeutics such as our collaboration partner Merck’s checkpoint inhibitor KEYTRUDA.

About AFM11
AFM11 is a bispecific T-cell TandAb simultaneously targeting CD3 on T-cells and CD19 on tumor cells. AFM11 is specifically designed to treat B-cell malignancies including non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL), in which CD19 is expressed at abnormally high levels. AFM11 is currently in Phase 1 clinical development for NHL and ALL.

About NK- and T-Cell TandAbs and Trispecific Antibodies
TandAbs and Trispecific Abs are immune cell-engaging antibodies with a tetravalent architecture characterized by four binding domains. Affimed develops products from three proprietary platforms:
Bispecific TandAbs engaging NK-cells (via CD16A)
Bispecific TandAbs engaging T-cells (via CD3)
Trispecific Abs engaging either NK- or T-cells
Affimed develops TandAbs and Trispecific Abs to substantially increase the efficacy, specificity and/or extend the therapeutic window of current therapeutics. Binding to targets on both the immune and the tumor cell, they redirect immune cells and establish a bridge between either NK-cells or T-cells and cancer cells, triggering a signal cascade that leads to the destruction of cancer cells. In clinical studies, our TandAb products have already demonstrated promising signs of therapeutic activity in patients.

On November 8, 2016 FibroGen, Inc. (NASDAQ:FGEN), a research-based biopharmaceutical company, reported financial results for the quarter ended September 30, 2016 and provided an update on the company’s recent developments (Press release, FibroGen, NOV 8, 2016, View Source;p=RssLanding&cat=news&id=2220698 [SID1234516521]).

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"The completion of enrollment in our Phase 3 roxadustat studies in China is a significant milestone for FibroGen and our first-in-class small molecule treatment for anemia. We are gratified to be able to advance this promising new therapeutic for patients with chronic kidney disease," said Thomas B. Neff, FibroGen’s Chief Executive Officer. "In collaboration with our world-class partners, AstraZeneca and Astellas, we have substantially expanded the reach of our global development programs, while efficiently managing use of our resources."

Recent Developments

Roxadustat (FG-4592)

Anemia in Chronic Kidney Disease (CKD):

Completed enrollment of Phase 3 clinical development program in China for treatment of anemia in dialysis and non-dialysis chronic kidney disease patients
Initiating new drug application process in China in 2016, and expect to announce topline Phase 3 data in early 2017
In August, the independent data safety monitoring board reviewing the China Phase 3 data recommended that these studies continue without modification to current protocols
In October, the independent data safety monitoring board reviewing Phase 3 studies to support U.S. and European regulatory submissions recommended these studies continue without modification to current protocols
Achieved initial target enrollment objectives for all three FibroGen-sponsored Phase 3 clinical trials supporting U.S. and European approval, and are continuing to enroll Global Phase 3 program focused on U.S. incident dialysis and non-dialysis patients
Results from the Japan Phase 2 study in CKD non-dialysis-dependent patients will be presented at the American Society of Nephrology’s Kidney Week in November 2016
Remain on track for an NDA submission for roxadustat in the United States in 2018
Other Anemia Program Highlights

The U.S. FDA accepted the company’s investigational new drug application for a Phase 3 trial evaluating roxadustat for the treatment of anemia in myelodysplastic syndrome (MDS) patients
Pamrevlumab (FG-3019)

Fibrosis and Other Fibroproliferative Diseases

Data presented from the open-label extension of the 049 study in idiopathic pulmonary fibrosis (IPF) at the 19th International Colloquium on Lung and Airway Fibrosis in September showed no safety issues during prolonged treatment with pamrevlumab
Trends toward improved or stable pulmonary function and stable fibrosis observed in the initial one-year study (049) have continued among patients participating in the extension study
Anticipate topline results for 067 IPF placebo-controlled study and combination therapy sub-study in summer 2017
Continue to enroll locally advanced pancreatic cancer patients in open-label, randomized Phase 2 trial
Expect to present updated, interim results from open-label, randomized Phase 2 pancreatic cancer study in January 2017
Continue to enroll in the company’s open-label study of pamrevlumab in non-ambulatory Duchenne muscular dystrophy patients
Financial Highlights

Net loss per basic and diluted share for the quarter ended September 30, 2016, was $0.38, as compared to $0.74 a year ago.
At September 30, 2016, FibroGen had $356.8 million of cash, cash equivalents, investments, receivables, and restricted cash.

On November 8 Lion Biotechnologies, Inc. (NASDAQ: LBIO), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte technology (TIL), reported encouraging data in four poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 31st Annual Meeting & Associated Programs in National Harbor, Maryland taking place November 9-13, 2016.

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"The data to be presented at SITC (Free SITC Whitepaper) is reflective of our progress in two main directions at Lion; process optimization and expansion of utilization of the TIL technology in new indications. In one abstract, data is provided demonstrating successful culturing of TIL cells from non-melanoma solid tumors, potentially expanding application of the Lion TIL technology in new indications. Additionally, we show progress in process optimization including development of cryopreservation methodology and a more efficient assay to assess potency of TIL cells," said Maria Fardis, PhD, MBA, Lion Biotechnologies President and Chief Executive Officer.

Poster Presentation: "Successful Expansion and Characterization of Tumor Infiltrating Lymphocytes (TILs) from Non-melanoma Tumors"

This study demonstrated the feasibility of culturing and expanding TILs isolated from non-melanoma tumors including bladder, cervical, head and neck, lung and triple negative breast cancer (TNBC).
TILs were harvested to assess cell count and viability, followed by immunophenotyping and cryopreservation for future studies.
Phenotypic characterization of TIL from bladder, cervical and lung cancer were > 60-70% CD8+ T cells whereas TILs from head and neck demonstrated variable distribution of CD8+ and CD4+ T cells. TIL propagated from TNBC were > 80% CD4+ T cells. Regardless of the tumors, most cultures had < 20% CD56+ NK cells.
Based on the successful culturing of TILs, clinical feasibility of adoptive cellular therapy for patients with non-melanoma solid tumors will be investigated.
Poster Presentation: "Artificial Antigen Presenting Cells Promote Expansion of Tumor Infiltrating Lymphocytes (TILs)"

The study evaluated artificial antigen presenting cells (aAPC) as a potential substitute for allogeneic peripheral blood mononuclear cells (PBMC) which are currently required for the expansion of TIL. The benefit of using aAPC is to reduce the price of the manufacturing process as well to turn the process into a more reproducible and scalable one.
A novel aAPC was developed from the CD64+ MOLM-14 human leukemia cell line, genetically engineered to express recombinant CD86 (B7-2) and CD137-L (41BBL) (MOLM14-86/137).
The study showed that co-culture of TILs with MOLM-14-86/137 aAPC resulted in expansion, metabolic activity and cytotoxicity that were sufficiently similar to that obtained with PBMC.
TIL differentiation, cellular respiration (OXPHOS) and redirected cytotoxicity were also within the range expected via co-culture with PBMC.
This data suggests that the expansion protocol using the novel MOLM14-86/137 aAPC can be tested in a clinical setting.
Poster Presentation: "Bioluminescent Redirected Lysis Assay (BRLA) as an Efficient Potency Assay to Assess Tumor-Infiltrating Lymphocytes (TILs) for Immunotherapy"

TIL therapy involves culturing and expanding T cells isolated from a patient’s tumor and then reinfusing them into the patient. TIL antitumor activity is commonly measured using tumor cells from the patient’s tumor, when available.
In order to test the potency of TILs, a BRLA assay was developed using an engineered P815 cell line. It requires no radionuclides and is more efficient than traditional cytotoxicity assays.
The assay was shown to measure TIL cytotoxicity in a highly sensitive dose dependent manner.
Poster Presentation: "Stable Tumor-Infiltrating Lymphocytes (TIL) Phenotype Following Cryopreservation"

Cryopreservation is a beneficial process which allows cell products to be shipped in a safe manner with less time constraints. In this study, the data show that cryopreservation did not affect the measured phenotypic characteristics of TIL, enabling Lion to further investigate the possibility of using cryopreserved TIL in a clinical setting.
Clinical studies using cryopreserved TIL have not been conducted so far.
In this study, fresh versus frozen/thawed TIL samples were tested to evaluate the expression of phenotypic markers.
Cryopreservation did not affect the measured phenotypic characteristics of TIL, with the exception of some regulatory molecules. Lion will further investigate the possibility of using cryopreserved TIL in a clinical setting.

On November 8, 2016 XSpray Microparticles AB, a clinical stage product development company that creates improved and generic versions of existing cancer products, reported the successful completion of a new share issue of SEK 41 million (Press release, XSpray, NOV 8, 2016, View Source [SID1234516858]).
"I’m pleased with the strong interest from both existing and more than 70 new investors. The proceeds from this share issue will allow us to continue to progress our lead product candidate, XS-004, further in clinical development with the goal to achieve next relevant clinical milestone during the first half of 2017 as well as expanding our internal product pipeline with new high value product candidates, "says Per Andersson, CEO of XSpray.

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On November 8 2016 BioInvent International (OMXS: BINV) reported that it has received verbal notice from the U.S. Food and Drug Administration (FDA) that a full clinical hold (i.e. no further dosing of patients) has been placed on BioInvent’s current clinical Phase II study with the antibody BI-505 in patients with multiple myeloma (Press release, BioInvent, NOV 8, 2016, View Source [SID1234516421]).

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BioInvent has not yet received written notice of the clinical hold from the FDA, however, based on verbal communications, the FDA informed BioInvent that the clinical hold is due to an adverse cardiopulmonary event in the clinical study.

The clinical study is being conducted by BioInvent in collaboration with investigators at the University of Pennsylvania in the United States and aims to document the ability of BI-505 to deepen therapeutic response and thereby prevent or delay relapse of multiple myeloma in patients undergoing autologous stem cell transplantation (ASCT) with high-dose melphalan.

BioInvent will analyse the possibility to obtain release of the clinical hold and markets will be updated when there is further information to report.