On May 19, 2017 Lion Biotechnologies, Inc. (NASDAQ: LBIO), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that the first patient was dosed in the second cohort of its ongoing Phase 2 trial of LN-144 for the treatment of patients with metastatic melanoma (Press release, Lion Biotechnologies, MAY 19, 2017, View Source [SID1234519274]). This cohort utilizes the company’s generation 2 manufacturing process which includes cryopreservation of the outbound products.

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"We are pleased to be able to offer a shorter manufacturing process for TIL to the melanoma patients enrolling in Cohort 2 of LN-144 trial. This process reduces the time from excision to infusion from approximately six weeks to just over three weeks and includes cryopreservation for the outbound product," said Maria Fardis, PhD, MBA, Lion Biotechnologies President and Chief Executive Officer. "Reducing the time from excision to infusion is critical for treatment of advanced melanoma patients. This process provides greater flexibility for physicians and patients in scheduling the time of the infusion due to the cryopreserved nature of the TIL product. Further, the shorter process increases the manufacturing flexibility for Lion leading to lower production costs."

This Phase 2, multicenter, three-cohort study will assess the safety and efficacy of LN-144 for treatment of patients with metastatic melanoma. Cohorts one and two will enroll 20 patients each and cohort three is a re-treatment cohort for a second LN-144 infusion in ten patients. Lion Biotechnologies will be releasing interim data from the first cohort of this study at the upcoming 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 2-6 in Chicago, IL. For additional information on this study please go click on the link below:

View Source;rank=1

On May 19, 2017 AVEO Oncology (NASDAQ:AVEO) reported its European licensee for tivozanib, EUSA Pharma, has completed an oral explanation to the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), as part of the Marketing Authorization Application (MAA) review process for tivozanib as a treatment for patients with first-line renal cell carcinoma (RCC) (Press release, AVEO, MAY 19, 2017, View Source;p=RssLanding&cat=news&id=2274241 [SID1234519231]). It is expected that with the oral explanation complete, the CHMP will proceed to an opinion which they will submit to the European Commission (EC), which has the authority to approve medicines for use in the 28 countries in the European Union. The opinion is expected to be announced at a future CHMP meeting.

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"We are pleased that the file continues to progress through the CHMP review process with EUSA having completed an oral explanation for tivozanib," said Michael Bailey, president and chief executive officer of AVEO. "We believe tivozanib’s unique tolerability profile, together with the longest progression free survival from a Phase 3 first line RCC study, demonstrates its potential to enhance treatment options for RCC patients."

RCC is the most common form of kidney cancer,i which accounts for an estimated 49,000 deaths in Europe each year.ii It is expected to be one of the fastest increasing cancers over the next ten years.iii Tyrosine Kinase Inhibitor (TKI) vascular endothelial growth factor (VEGF) inhibitors are the gold standard treatment for advanced RCC in Europe, however, patients on current treatments can often experience significant side effects.iv,v

About Tivozanib

Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications. Tivozanib has been investigated in several tumors types, including renal cell, colorectal and breast cancers.

Background: FGFR2b-overexpressing gastric cancer is characterized by poor prognosis. FPA144, a humanized monoclonal IgG1 antibody that specifically binds to and blocks FGFR2b, has been engineered for enhanced antibody-dependent cell-mediated cytotoxicity (ADCC). FPA144-001 is a two-part Phase 1 study of FPA144 monotherapy in patients with advanced solid tumors, including gastric and gastroesophageal cancers (GEJ cancers).
Methods: Part 1A was a 3+3 design to assess safety and PK and to establish a recommended dose (RD) of FPA144. Patients with gastric cancer were enrolled in Part 1B to assess PK in gastric cancer. Part 2 includes 4 cohorts of gastric cancer patients with either high, moderate, low or no FGFR2b overexpression based on a centralized immunohistochemistry (IHC) assay. Here, we describe results of gastric cancer patients that highly overexpress FGFR2b (FGFR2b+ High) enrolled in Parts 1 and 2 of the study.
Results: As of October 28, 2016, 18 FGFR2b+ High (IHC 3+ ³10% tumor membrane staining) patients were enrolled in the study. 12 of these patients received the RD of 15 mg/kg every 2 weeks. Enrolled patients received a median of 3 prior treatment regimens. Fatigue (22.2%, none ³ gr 3) and infusion reaction (16.7%, 5.6% gr 3) were the most common treatment-related AEs. Treatment-related SAEs were reported in 2 patients: Grade 2 ulcerative keratitis and Grade 3 infusion reaction. There were 5 PRs, 4 confirmed and 1 unconfirmed. Disease control (PR+SD) was 55.6%, including a confirmed ORR of 22% with median DOR of 15.4 weeks. ctDNA analysis of a responding patient revealed baseline elevated FGFR2 gene copy (165 copies in the blood, mutation allele burden 66%) that decreased after monotherapy (nadir 75 copies, mutation allele burden 38.5%) corresponding with clinical response, serum tumor markers and near complete response on PET imaging.
Conclusions:
The demonstration of activity and an acceptable safety profile supports further development of FPA144 in patients with FGFR2b+ tumors. FGFR2 gene amplification detected in ctDNA may provide a non-invasive diagnostic test for patient selection. Updated data will be presented. NCT02318329.

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t epotinib c-Met kinase inhibitor Non-small cell lung cancer tepotinib c-Met kinase inhibitor Hepatocellular cancer avelumab anti-PD-L1 mAb Merk el cell cancer 1L 1 sprifermin fibroblast growth factor 18 O steoarthritis atacicept anti-Blys /anti-APRIL fusion protein Systemic lupus erythematosus atacicept anti-Blys /anti-APRIL fusion protein IgA nephropathy abituzumab anti-CD 51 mAb Systemic sclerosis with interstitial lung dis. evobrutinib BTK inhibitor R heumatoid arthritis evobrutinib BTK inhibitor Systemic lupus erythematosus evobrutinib BTK inhibitor Multiple sclerosis 1 Merck pipeline M2698 p70S6K & Akt inhibitor Solid tumors M3814 DNA-PK inhibitor Solid tumors M9831 (VX-984) DNA-PK inhibitor Solid tumors M6620 (VX-970) ATR inhibitor Solid tumors M4344 (VX-803) ATR inhibitor Solid tumors M7583 BTK inhibitor Hem atological malignancies avelumab anti-PD-L1 mAb Solid tumors avelumab anti-PD-L1 mAb Hem atological malignancies M9241 (NHS-IL12) 8 Cancer immunotherapy Solid tumors M7824 anti-PD-L1/ TGFbeta trap Solid tumors M1095 (ALX-0761) 10 anti-IL-17 A/F nanobody Psoriasis Registration Phase III Phase II Phase I cladribine 4 tablets lymphocyte targeting agent Relapsing-remitting multiple sclerosis avelumab 6 anti-PD-L1 mAb Merk el cell cancer (EU) avelumab-anti-PD-L1 mAb Non-small cell lung cancer 1L 1 avelumab-anti-PD-L1 mAb Non-small ce ll lung cancer 2L 2 avelumab-anti-PD-L1 mAb Gastric cancer 1L-M 1M avelumab-anti-PD-L1 mAb Gastric cancer 3L 3 avelumab-anti-PD-L1 mAb O varian cancer platinum resistant/refractory avelumab-anti-PD-L1 mAb O varian cancer 1L 1 avelumab-anti-PD-L1 mAb Urothelial cancer 1L-M 1M avelumab-anti-PD-L1 mAb Renal cell cancer 1L 1 avelumab-anti-PD-L1 mAb Locally advanced head and neck cancer MSB 11022 9 proposed biosimilar of adalimumab Chronic plaque psoriasis 1 First Line treatment; 1M First Line maintenance treatment; 2 Second Line treatment; 3 Third Line treatment; 4 As announced on July 18, 2016, the EMA has accepted for review the Marketing Authorization Application (MAA) of Cladribine Ta ble ts for the treatment of relapsing-remitting multiple sclerosis. 5 As announced on March 23, 2017, the US FDA has granted accelerated approved of avelumab for the treatment of adults and pedia tri c patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication was approved under accelerated approval based on tumor response and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Avelumab has not yet been approved for metastatic MCC outside of the US. 6 As announced on October 31, 2016, the EMA has validated for review Merck’s MAA for avelumab, for the proposed indication of m eta static Merkel cell cancer. 7 As announced on May 9, 2017 the US FDA granted accelerated approval of avelumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy therapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication was approved under accelerated approval based on tumor response and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Avelumab has not yet been approved f or metastatic UC outside of the US. 8 Sponsored by the National Cancer Institute (USA). 9 On April 24, 2017 the divestment of Merck’s Biosimilars business to Fresenius was announced. Closing is expected in H2, 2017, s ubject to regulatory approvals and other conditions. 10 As announced on March 30, 2017 in an agreement with Avillion, anti-IL-17 A/F nanobody will be developed by Avillion for plaque psoriasis and commercialized by Merck. May 18, 2017 Recently Registered avelumab 5-anti-PD-L1 mAb Merk el cell cancer (US) avelumab 7-anti-PD-L1 mAb Urothelial cancer (US) Neurology Oncology Immunology Immuno-Oncology B iosimilars P ipeline products are under clinical investigation and have not been proven to be s afe and effective. T here is no guarantee any product will be approved in the s ought-after indication.

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On May 18, 2017 Bellicum Pharmaceuticals, Inc. (Nasdaq:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported that three abstracts have been accepted for presentation at the 22nd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) being held in Madrid, Spain on June 22-25, 2017 (Press release, Bellicum Pharmaceuticals, MAY 18, 2017, View Source;p=RssLanding&cat=news&id=2273891 [SID1234519217]).

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Bellicum’s presentation of the overall cohort of children with malignant and non-malignant diseases treated with BPX-501 was selected as one of the Congress’ five best abstracts, and will be reviewed during the Presidential Symposium.

Additional oral and poster presentations selected include clinical data on BPX-501 for the treatment of pediatric leukemias, hemoglobinopathies and erythroid disorders. The abstracts are now available online at the EHA (Free EHA Whitepaper) conference website.

EHA Presentation Details

Oral Presentation – Presidential Symposium
Title: BPX-501 Donor T-Cell Infusion (with Inducible Caspase 9 Suicide Gene) Facilitates HLA Haploidentical Stem Cell Transplant in Children with Both Hematological Malignancies and Non-Malignant Conditions
Session Title: Presidential Symposium
Date: Friday, June 23
Time: 3:45 – 4:00 PM CEST
Location: Hall A
Abstract Code: S146

Oral Presentation
Title: Impact of Post-Transplant Infusion of Donor T-Cells Genetically Modified with Inducible Caspase 9 Suicide Gene (BPX-501 Cells) on Children with Leukemia Given Alpha-Beta T-Cell Depleted Haplo-HSCT
Session Title: Stem cell transplantation – Clinical 1
Date: Saturday, June 24
Time: 5:00 – 5:15 PM CEST
Location: Room N103
Abstract Code: S495

Poster Presentation
Title: The Use of BPX-501 Donor T-Cell Infusion (with Inducible Caspase 9 Suicide Gene) Together with HLA-Haploidentical Stem Cell Transplant to Treat Children with Hemoglobinopathies and Erythroid Disorders
Session Title: Stem cell transplantation – Clinical 1
Date: Friday, June 23
Time: 5:15 – 6:45 PM CEST
Location: Poster Area (Hall 7)
Abstract Code: P381