On June 19, 2018 Targovax ASA ("Targovax" or "the Company"; OSE: TRVX), is a clinical stage company focused on developing and commercializing immune activators to target hard to treat solid tumors, reported that the European Patent Office has granted European Patent no 3079715, A Peptide mixture (Press release, Targovax, JUN 19, 2018, View Source [SID1234527398]). The patent protects the composition of Targovax’s mutant-RAS specific neoantigen vaccine TG02, for stimulating the immune system of cancer patients with RAS mutated tumors.

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Targovax’s proprietary mutant-RAS neoantigen vaccine platform is designed to treat patients with tumors harboring RAS mutations. Mutations in the RAS genes are a driving cause of cancer development and progression, and is linked to poor prognosis. By inducing an anti-mutant-RAS specific immune response, the TG products have the potential to delay disease progression and increase survival, with a favorable safety profile compared to chemotherapy and many other treatment options.

TG02 expands the coverage of RAS mutations beyond TG01, and is targeting all relevant RAS exon 2 oncogenic point mutations which are found in the vast majority of all RAS mutated cancers. Currently, TG02 is being tested in an exploratory Phase Ib clinical trial in patients with locally recurrent RAS-mutated colorectal cancer in combination with the checkpoint inhibitor KEYTRUDA (clinical study CT TG02-01). This study will provide important clinical data on the safety, immune activation and mechanism of action of TG02.

Jon Amund Eriksen, inventor of the TG technology and Co-founder of Targovax, said: "We are glad to see the European patent for TG02 being granted, further strengthening Targovax’s intellectual property portfolio covering the very important mutant-RAS trunk neoantigens. RAS is mutated in 20-30% of all cancers, and this 2nd generation product from the TG platform puts Targovax in a position to address an important unmet medical need, which could eventually benefit all RAS mutated cancer patients."

1stOncology’s ‘Commercial Interests at EHA (Free EHA Whitepaper) 2018‘ report highlights the landscape of commercial oncology drug development presenting abstracts at the 2018 European Hematology Association meeting. Below is some interesting headline points our analyst team picked from EHA (Free EHA Whitepaper) 2018, but if you would like to get the full picture, we invite you to 48 hours of free access to our European Hematology Association (EHA) (Free EHA Whitepaper) 2018 whitepaper report. Sign up here for your free access.

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Two out of Five Drugs at EHA (Free EHA Whitepaper) 2018 are in Immuno-Oncology:

Here are Two Interesting Young Cancer Companies Presenting Abstracts at EHA (Free EHA Whitepaper) 2018:

The 5 Most Reported-On Drug Targets from More than 100 at EHA (Free EHA Whitepaper) 2018:

Here are 5 First-in-Class Cancer Drug Targets at EHA (Free EHA Whitepaper) 2018:

Bispecific Cancer Antibodies at EHA (Free EHA Whitepaper) 2018 are Dominated by CD3 Targeting:

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On June 18, 2018 Crinetics Pharmaceuticals, Inc., a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported the appointment of Alan S. Krasner, M.D. as Chief Medical Officer (Press release, Crinetics Pharmaceuticals, JUN 18, 2018, View Source [SID1234527377]).

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"We are delighted to welcome Alan to the Crinetics management team," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "Alan has extensive experience in clinical development of endocrine drugs at both big pharma and smaller biotech companies. We are fortunate to have his leadership to oversee our development programs as we advance our product candidates into and through the clinic."

Dr. Krasner joins Crinetics from Shire Pharmaceuticals where he was a Senior Medical Director and served as Global Development Lead for Natpara, the first recombinant human intact parathyroid hormone treatment for hypoparathyroidism. Prior to Shire, he worked at Biodel and Pfizer conducting clinical research at various stages of development in diabetes and obesity. He obtained his undergraduate and M.D. degrees from Northwestern University and received his clinical training in Internal Medicine and Endocrinology at Johns Hopkins University.

On June 18, 2018 TG Therapeutics, Inc. (NASDAQ: TGTX), reported an oral presentation of clinical data from its ongoing Phase 2 study evaluating umbralisib (TGR-1202), the Company’s PI3K delta inhibitor, in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) who are intolerant to prior BTK or PI3K delta inhibitor therapy (Press release, TG Therapeutics, JUN 18, 2018, View Source [SID1234527378]). Data from this trial were presented over the weekend during an oral session at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper).

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "We are pleased to present data evaluating umbralisib in patients intolerant to currently approved BTK or PI3K therapies during the EHA (Free EHA Whitepaper) annual congress. While there have been great advancements in recent years in the treatment of CLL, this study confirms that there are many patients still in need of an alternative treatment option and that umbralisib can be used safely and effectively in those patients who were not able to tolerate a prior BTK or PI3K therapy. The rate of patients withdrawing from kinase treatment for CLL in real world settings has been estimated to reach upwards of 40%, representing a significant unmet medical need." Mr. Weiss continued, "We are extremely pleased with the data presented at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) this month and we look forward to presenting the topline response rate data from the UNITY- CLL Phase 3 trial by the end of summer 2018."

Highlights from the oral presentation include the following:

Oral Presentation: A Phase 2 Study to Assess the Safety and Efficacy of Umbralisib (TGR-1202) In Patients with Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or PI3K-delta Inhibitor Therapy (Abstract Number S808)

This presentation includes data from patients with CLL who are intolerant to prior BTK or PI3K delta inhibitor therapy who were then treated with single agent umbralisib (TGR-1202). To be eligible for the study patients had to have received prior treatment with a BTK inhibitor (ibrutinib, acalabrutinib) or a PI3K delta inhibitor (idelalisib, duvelisib) and discontinued therapy due to intolerance within 12 months of starting treatment on this study. Forty-seven patients were evaluable for safety of which 46 were evaluable for Progression Free Survival (PFS), (1 patient had a confirmed Richter’s Transformation (RT) at enrollment which did not meet eligibility criteria).

Highlights from this presentation include:

●Umbralisib demonstrated a favorable safety profile in patients intolerant to prior BTK or PI3K therapy

●Only 13% discontinued due to an adverse event, of which only one patient discontinued due to a recurrent adverse event (AE) also experienced with prior kinase inhibitor therapy

●Median progression free survival (PFS) and overall survival has not been reached with a median follow-up of 9.5 months

●In this relapsed/refractory CLL population, of which 77% required treatment within 6 months of prior KI discontinuation, 64% had a high-risk molecular / genetic marker and 6% had an ibrutinib resistance mutation, significant clinical activity has been observed

PRESENTATION DETAILS
The above referenced presentation is now available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.

On June 18, 2018 Gamida Cell, a leading cellular and immune therapeutics company, reported that preliminary data from an ongoing phase I study from the nicotinamide-based natural killer cell expansion, or NAM-NK, program will be presented during the Inaugural AACR (Free AACR Whitepaper) International Meeting on Advances in Malignant Lymphoma, held June 22 – 26 in Boston, Massachusetts (Press release, Gamida Cell, 18 18, 2018, View Source [SID1234527379]).

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Veronika Bachanova, M.D., Ph.D., hematologist/oncologist at the Blood and Marrow Transplantation and Cellular Therapy Program of the University of Minnesota, and lead investigator of the investigator-sponsored phase I NAM-NK clinical study at the Masonic Cancer Center, will present a poster of early patient outcomes from the study in patients with refractory non-Hodgkin lymphoma and multiple myeloma.

Title: Phase I study of nicotinamide-expanded related donor Natural Killer (NK) cells for the treatment of relapsed/refractory CD20+ non-Hodgkin lymphoma (Abstract: B05)
Session: Poster Session B: Therapeutics and Clinical Trials in Lymphoma 2
Location: Salon F, Boston Marriott Copley Place
Date: Sunday June 24, 2018 11:45 AM – 1:45 PM

About NAM-NK
Gamida Cell applied the capabilities of its NAM-based cell expansion technology to highly functional NK cells to develop NAM-NK, an innate immunotherapy for the treatment of hematologic and solid tumors in combination with SoC antibody therapies. NAM-NK addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded in culture. NAM-NK is in phase I development (NCT03019666) through an investigator-sponsored trial in patients with refractory non-Hodgkin lymphoma and multiple myeloma.