Oncbiomune has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, OncBioMune Pharmaceuticals, 2017, MAY 22, 2017, View Source [SID1234522121]).

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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.

On May 18, 2017 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that a series of abstracts highlighting new study results for its in-house discovered lenvatinib mesylate (selective inhibitor of receptor tyrosine kinases (RTKs) with a novel binding mode, product name: Lenvima / Kisplyx, "lenvatinib") and eribulin mesylate (halichondrin class microtubule dynamics inhibitor, product name: Halaven, "eribulin"), as well as H3B-8800, a splicing modulator discovered by Eisai’s U.S. research subsidiary H3 Biomedicine Inc., will be presented during the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), taking place in Chicago, the United States, from June 2 to 6, 2017 (Press release, Eisai, MAY 18, 2017, View Source [SID1234519265]).

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Detailed data regarding the results of a Phase III clinical trial (Study 304) of lenvatinib compared with sorafenib as a first-line treatment for patients with unresectable hepatocellular carcinoma, which has already achieved its primary endpoint, will be presented orally at the ASCO (Free ASCO Whitepaper) Annual Meeting. This presentation is scheduled to take place on Sunday, June 4, 8:12 AM local time, in Hall D2.

Major poster presentations will include a highlight of the results of a Phase Ib/II clinical trial (Study 111) of lenvatinib in combination with the anti-PD-1 antibody pembrolizumab for the treatment of patients with endometrial carcinoma, and the results of a Phase I clinical trial of H3B-8800 in patients with advanced myeloid malignancies.

Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. The company will continue to create innovation in the development of new drugs based on cutting-edge cancer research, as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

Oral Presentations:
Product Abstract title and scheduled presentation date and time (local time)
Lenvatinib

Abstract No: 4001 Phase 3 trial of lenvatinib (LEN) vs sorafenib (SOR) in first-line treatment of patients (pts) with unresectable hepatocellular carcinoma (uHCC)
Oral Presentation | June 4 (Sun), 8:12-8:24 AM
Major Poster Presentations:
Product Abstract title and scheduled presentation date and time (local time)
Lenvatinib

Abstract No: 5598 A Phase Ib/II Trial of Lenvatinib (LEN) Plus Pembrolizumab (Pembro) in Patients (Pts) With Endometrial Carcinoma
Poster Presentation | June 3 (Sat), 1:15-4:45 PM
Lenvatinib

Abstract No: TPS4595 A Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination with Everolimus or Pembrolizumab vs Sunitinib Alone in First-Line Treatment of Patients with Advanced Renal Cell Carcinoma
Poster Presentation | June 4 (Sun), 8:00-11:30 AM
Lenvatinib

Abstract No: 10544 Single-agent Dose-finding Cohort of a Phase 1/2 Study of Lenvatinib (LEN) in Children and Adolescents with Refractory or Relapsed Solid Tumors
Poster Presentation | June 4 (Sun), 8:00-11:30 AM
Eribulin

Abstract No: 6603 Validity and Reliability of Four Value Frameworks for Cancer Drugs

Poster Presentation | June 5 (Mon), 1:15-4:45 PM
H3B-8800

Abstract No: TPS7075 H3B-8800-G0001-101: A first in human phase I study of a splicing modulator in patients with advanced myeloid malignancies
Poster Presentation | June 5 (Mon), 8:00-11:30 AM

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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