On October 23, 2018 VBL Therapeutics (NASDAQ:VBLT), reported the issuance by the European Patent Office (EPO) of Patent No. 2908865, a composition of matter patent which covers VB-111, VBL’s lead drug candidate (Press release, VBL Therapeutics, OCT 23, 2018, View Source [SID1234530057]). The patent provides intellectual property protection for VB-111 in Europe until October 2033, before any potential extension. The patent further strengthens the VB-111 intellectual property portfolio, which comprises multiple granted patents including composition of matter patents in the US, Japan, China and additional countries.

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"VBL is focused on continually innovating and advancing cancer treatments," said Dror Harats, M.D., CEO of VBL Therapeutics. "This latest patent grant by the EPO further reinforces our commitment to excellent research and innovation as well as to protecting our lead candidate, VB-111, which is currently being investigated in our OVAL Phase 3 trial in platinum-resistant ovarian cancer."

About Ofranergene Obadenovec (VB-111)
VB-111, a potential first-in-class anticancer therapeutic candidate, is the Company’s lead oncology product currently being studied in a Phase 3 trial for ovarian cancer. VB-111 has received orphan drug designation in both the US and Europe, and fast track designation in the US for prolongation of survival in patients with rGBM. In addition, VB-111 successfully demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer and recurrent platinum-resistant ovarian cancer. VB-111 has received an Orphan Designation for the treatment of ovarian cancer by the European Medicines Agency (EMA).

On October 23, 2018 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq:YMAB) reported that the Committee for Orphan Medicinal Products ("COMP") of the European Medicines Agency ("EMA") has recommended the granting of orphan medicinal product designation ("OMPD") in the European Union ("EU") for naxitamab, one of the Company’s lead product candidates, for the treatment of relapsed or refractory high-risk neuroblastoma (Press release, Y-mAbs Therapeutics, OCT 23, 2018, View Source [SID1234530055]). The positive opinion from the EMA’s COMP has been sent to the European Commission ("EC"), which is expected to grant the orphan drug designation within 30 days.

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Obtaining OMPD for naxitamab is part of an overall plan to expand the Company’s European development program and ultimately obtain orphan drug exclusivity to protect naxitamab in the EU for the treatment of relapsed or refractory high-risk neuroblastoma.

Under the EMA’s Regulation (EC) No. 141/2000 an orphan medicinal product designation gives companies access to protocol assistance and guidance on preparing a dossier that will meet European regulatory requirements and thereby maximize the chance of success at the time of marketing authorization. Once approved, an orphan drug is also granted 10 years of market exclusivity during which directly competitive similar products cannot normally be placed on the market.

The EMA grants orphan medicinal product designation based upon several criteria: the life threatening and debilitating nature of the condition; the medical plausibility of the proposed orphan indication; a prevalence in Europe of less than 5 cases for each 10,000 of population; no satisfactory method of diagnosis, prevention or treatment exists or if such method exists the medicinal product will be of significant benefit to those affected by that condition.

Y-mAbs Founder, President and Head of Business Development and Strategy, Thomas Gad said, "We are very pleased that the COMP has issued a positive opinion for orphan drug designation to naxitamab which will give us a string of development incentives."

Dr. Claus Møller, Chief Executive Officer, further notes, "The orphan designation strengthens our opportunity to bring naxitamab to patients who desperately need alternative methods of treatment. Further, the designation marks a substantial milestone in Y-mAbs’ expansion into European development."

More than 60 Late Breaking Abstracts (LBA’s) were published at this year’s European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (E.S.M.O 2018). Below you will find the 16 published at the sessions on Monday 22nd October, the fourth and final day of the conference.

For full analysis identifying new technologies, drugs, targets, start-ups etc. we recommend Commercial Interest at E.S.M.O Annual Meeting 2018: Analytical Tool.

• LBA8_PR – KEYNOTE-048: Phase 3 study of first-line pembrolizumab (P) for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC)
• LBA9_PR – Cetuximab versus cisplatin in patients with HPV-positive, low risk oropharyngeal cancer, receiving radical radiotherapy
• LBA10 – Primary results of ALESIA: A randomised, phase III, open-label study of alectinib vs crizotinib in Asian patients with treatment-naïve ALK+ advanced NSCLC
• LBA18_PR – Durable Clinical Benefit With Nivolumab (NIVO) Plus Low-Dose Ipilimumab (IPI) as First-Line Therapy in Microsatellite Instability-High/Mismatch Repair Deficient (MSI-H/dMMR) Metastatic Colorectal Cancer (mCRC)
• LBA19 – Fluoropyrimidine (FP) + bevacizumab (BEV) + atezolizumab vs FP/BEV in BRAFwt metastatic colorectal cancer (mCRC): Findings from Cohort 2 of MODUL – a multicentre, randomized trial of biomarker-driven maintenance treatment following first-line induction therapy
• LBA20 – TRIBE2: a phase III, randomized strategy study by GONO in the 1st- and 2nd-line treatment of unresectable metastatic colorectal cancer (mCRC) patients (pts).
• LBA21 – InterAACT: A multicentre open label randomised phase II advanced anal cancer trial of cisplatin (CDDP) plus 5-fluorouracil (5-FU) vs carboplatin (C) plus weekly paclitaxel (P) in patients (pts) with inoperable locally recurrent (ILR) or metastatic treatment naïve disease – An International Rare Cancers Initiative (IRCI) trial.
• LBA37_PR – Neoadjuvant ipilimumab plus nivolumab in early stage colon cancer
• LBA42 – OpACIN-neo – A Multicenter Phase 2 Study to identify the Optimal neo-Adjuvant Combination scheme of Ipilimumab (IPI) and Nivolumab (NIVO).
• LBA43 – Updated relapse-free survival (RFS) and biomarker analysis in the COMBI-AD trial of adjuvant dabrafenib + trametinib (D + T) in patients (pts) with resected BRAF V600–mutant stage III melanoma
• LBA44 – Overall survival at 4 years of follow-up in a phase 3 trial of nivolumab plus ipilimumab combination therapy in advanced melanoma (CheckMate 067)
• LBA52 – Results of the GEOMETRY mono-1 phase II study for evaluation of the MET inhibitor capmatinib (INC280) in patients (pts) with METΔex14 mutated advanced non-small cell lung cancer (NSCLC)
• LBA53 – IMpower130: Progression-free survival (PFS) and safety analysis from a randomised phase 3 study of carboplatin + nab-paclitaxel (CnP) with or without atezolizumab (atezo) as first-line (1L) therapy in advanced non-squamous NSCLC
• LBA54 – IMpower132: efficacy of atezolizumab (atezo) + carboplatin (carbo)/cisplatin (cis) + pemetrexed (pem) as 1L treatment in key subgroups with stage IV non-squamous non-small cell lung cancer (NSCLC)
• LBA55 – Primary efficacy results from B-F1RST, a prospective Phase II trial evaluating blood-based tumour mutational burden (bTMB) as a predictive biomarker for atezolizumab (atezo) in 1L non-small cell lung cancer (NSCLC)
• LBA56 – Maintenance chemotherapy versus follow-up after carboplatin and weekly paclitaxel doublet chemotherapy in elderly patients with advanced non-small cell lung cancer (NSCLC): IFCT-1201 MODEL randomised phase 3 trial

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On October 22, 2018 Coherus BioSciences, Inc. (Nasdaq: CHRS) reported that its third quarter 2018 financial results will be released after market close on Thursday, November 8, 2018 (Press release, Coherus Biosciences, OCT 22, 2018, View Source/news-releases/news-release-details/coherus-biosciences-report-third-quarter-2018-financial-results" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-report-third-quarter-2018-financial-results" rel="nofollow">View Source [SID1234531696]). Starting at 4:30 p.m. ET, Coherus’ management will host a conference call to discuss the financial results and provide a general business update.

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After releasing third quarter 2018 financial results, we will post them on the Coherus website at View Source." target="_blank" title="View Source." rel="nofollow">View Source

Conference Call Information
When: Thursday, November 8, 2018 at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 7181479
Webcast: View Source
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

On October 22, 2018 Forbius, a clinical stage company developing biotherapeutics targeting EGFR and TGF-β pathways, reported that the first patient has been dosed in a Phase 2a trial evaluating the efficacy and safety of AVID100 in patients with squamous non-small cell lung cancer (sqNSCLC) whose tumors over express epidermal growth factor receptor (EGFR) (Press release, Forbius, OCT 22, 2018, View Source [SID1234531670]).

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Approximately 25% of patients with sqNSCLC have tumors that highly overexpress EGFR. Currently, no therapy is approved for the treatment of EGFR-overexpressing sqNSCLC.

An initial safety Phase 1 study for AVID100 was completed mid 2018, having enrolled 24 patients, and established a recommended Phase 2 dose (RP2D) of AVID100 of 240 mg/m2 (~6 mg/kg). This is one of the highest RP2Ds reported for maytansinoid payload ADCs (Deslandes, MAbs. 2014 Jul 1; 6(4):859–870) and is expected to be in the therapeutically active range based on preclinical efficacy studies. The majority of treatment related adverse events at RP2D were well-tolerated and grade 1 and 2 in severity. Of note, skin-related side-effects, that have been observed previously for therapeutic anti-EGFR antibodies, remained low grade and well tolerated.

"The sqNSCLC trial, along with additional soon-to-be launched Phase 2a trials, will provide us with important information about the efficacy of AVID100 in patients with confirmed EGFR overexpression. No therapy is approved for the treatment of EGFR-overexpressing malignancies, and AVID100 could be the first agent to address this significant unmet medical need," commented Paul Nadler, M.D., Chief Medical Officer of Forbius.

The primary goal of the Phase 2a trial is to evaluate efficacy, safety, and tolerability of AVID100 when administered to sqNSCLC patients with confirmed EGFR-overexpression. The study is being conducted at multiple sites across North America and will initially enroll approximately 15 sqNSCLC patients who failed all prior lines of treatment. The number of patients will be increased pending preliminary signs of AVID100 efficacy. This Phase 2a study is being supported by the previously announced $18.8M peer-reviewed grant from the Cancer Prevention Institute of Texas(CPRIT).

About AVID100
AVID100 is a highly potent EGFR-targeting antibody-drug conjugate (ADC) that was engineered to achieve enhanced anti-tumor efficacy without a corresponding increase in toxicity against skin and other EGFR-expressing normal tissues. In preclinical studies, AVID100 demonstrated significant anti-cancer activity, including in EGFR overexpressing tumor models that are resistant to marketed EGFR inhibitors. AVID100 is the only broadly active anti-EGFR ADC in clinical development