On October 23, 2018 Ophthotech Corporation (Nasdaq:OPHT) reported that it will report its third quarter 2018 financial and operating results on Wednesday, October 31, 2018 (Press release, Ophthotech, OCT 23, 2018, View Source [SID1234530059]). Following the announcement, Ophthotech’s management team will host a live conference call and webcast at 8:00 a.m. Eastern Time to discuss the Company’s financial results and provide a general business update.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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To participate in this conference call, dial 888-204-4368 (USA) or 323-994-2082 (International), passcode 3714524. A live, listen-only audio webcast of the conference call can be accessed on the Investor Relations section of the Ophthotech website at: www.ophthotech.com. A replay will be available approximately two hours following the live call for two weeks. The replay number is 888-203-1112 (USA Toll Free), passcode 3714524.

On October 23, 2018 Pain Therapeutics, Inc. (Nasdaq:PTIE), a biopharmaceutical company, reported it will release third quarter 2018 financial results, and hold a conference call with a Q&A session, on Monday, October 29, 2018 at 4:30 p.m. Eastern Time (Press release, Pain Therapeutics, OCT 23, 2018, View Source [SID1234530058]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The Company’s conference call can be accessed by dialing toll-free (877) 407-4018 (or 201 689-8471 for international callers). A replay will be available toll-free at (844) 512-2921, (or 412 317-6671 for international callers), using the conference ID code 13684539.

To listen to the Company’s webcast, please go to View Source and click on "News", then "Event & Presentations" to register. You may access View Source at any time through Monday, November 5th, 2018, for a replay of the webcast for this conference call.

About the Company’s Neuroprotection Program
Our lead drug candidate, PTI-125, is a small molecule with a unique mechanism of action for treating Alzheimer’s disease ("AD"). We expect to initiate a Phase IIa study with PTI-125 in AD in Q4 2018.

The underlying science for PTI-125 is published in prestigious peer-reviewed journals, including Journal of Neuroscience, Neurobiology of Aging, and Neuroimmunology and Neuroinflammation, and benefits from several peer-reviewed research grant awards from the NIH.

We are also developing a blood-based test, called PTI-125Dx, to detect whether a person has Alzheimer’s disease, possibly years before any symptoms appear. An early diagnosis of AD could optimize treatment options and empower physicians and patients to slow or halt the disease.

About Alzheimer’s Disease
Alzheimer’s Disease (AD) is a progressive brain disorder that destroys memory and thinking skills. Eventually, a person with AD may be unable to carry out even the simplest tasks. There is a profound and timely need to develop new drugs for Alzheimer’s. Currently, there are no drug therapies to halt Alzheimer’s, much less reverse its course.

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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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