On October 17, 2018 Intensity Therapeutics, Inc., a clinical-stage biotechnology company developing proprietary immune cell-activating cancer treatments, reported that preliminary data from a Phase 1/2 clinical study of INT230-6 will be presented in poster sessions at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, which is being held October 19-23 in Munich, Germany, and the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting, which is being held November 7-11 in Washington, DC (Press release, Intensity Therapeutics, OCT 17, 2018, View Source [SID1234530320]).
Details of the posters are below.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

ESMO 2018 Congress

Title: Phase 1/2 trial evaluation of intratumoral INT230-6 for the treatment of solid tumors

Abstract Number: 4458

Presentation Number: 1160P

Session: Poster Display Session – Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)

Date/Time: October 20, 2018, 12:30 p.m. CEST

Location: Hall A3; Poster Area Networking Hub, ICM München

Presenter: Anthony El-Khoueiry, MD (University of Southern California, USA)

For more information about the ESMO (Free ESMO Whitepaper) 2018 Congress, please visit View Source

SITC Annual Meeting

Title: Phase 1/2 evaluation of intratumoral INT230-6 for the treatment of solid tumors

Poster Number: P622

Poster Hall Hours: November 9, 8 a.m.-8 p.m.; November 10, 8 a.m.-8:30 p.m. EST

Poster Presentation Hours: November 10, 12:20-1:50 p.m. and 7-8:30 p.m. EST

Poster Hall Location: Hall E; Walter E. Washington Convention Center

Presenter: Anthony Olszanski, MD, RPh (Fox Chase Cancer Center)

For more information about the SITC (Free SITC Whitepaper) Annual Meeting, please visit View Source

About INT230-6

INT230-6, Intensity’s lead product candidate designed for direct intratumoral injection, is comprised of two proven, potent anti-cancer agents and a penetration enhancer molecule that helps disperse the drugs throughout tumors and diffuse into cancer cells. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor kill and recruitment of dendritic cells to the tumor micro-environment that induced anti-cancer T-cell activation. Treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responder animals with long-term, durable protection from multiple re-inoculations of the initial cancer and resistance to other cancers. In mouse models, INT230-6 has shown strong synergy with checkpoint blockage, including anti-PD-1 and anti-CTLA4 antibodies. INT230-6 was discovered from Intensity’s DfuseRxSM platform.

About the Phase 1/2 Clinical Study

INT230-6 is being evaluated in a Phase 1/2 clinical study in patients with different types of advanced solid tumor malignancies. The study’s primary objective is to assess the safety and tolerability of multiple intratumoral doses of INT230-6. Secondary assessments are the measurement of injected and bystander tumor responses, and determination of the systemic pharmacokinetic profile of multiple doses of INT230-6’s drug substances after single and then multiple intratumoral injections. Exploratory analysis will characterize patient outcome, as well as evaluate various tumor and anti-tumor immune response biomarkers that may correlate with response. The study includes several adaptive components that will allow for adjustments in patient groups, dosing schedule and dose volumes administered. Data will be used to assess the progression free and overall survival in patients receiving INT230-6. For more information, please visit www.clinicaltrials.gov (NCT03058289).

On October 17, 2018 Nordic Nanovector ASA (OSE: NANO) reported it will present its results for the third quarter 2018 on Tuesday, 6 November 2018 (previously scheduled for Tuesday, 21 November), and will host a results presentation and webcast on the same day (details will be announced nearer the time) (Press release, Nordic Nanovector, OCT 17, 2018, View Source [SID1234553492]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

During this presentation, the Company will present updated clinical results from the LYMRIT 37-01 trial with Betalutin in relapsed/refractory indolent non-Hodgkin’s lymphoma patients. These results will be published on 1 November in an abstract* that will be presented in a poster at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (1-4 December 2018).

As a consequence of the change in date of the third quarter 2018 results presentation, the Company will enter its two-week ‘quiet period’ starting on the 23 October 2018.

In addition, the Company has decided it will not continue hosting separate presentations of the results in Norwegian.

*ASH abstract

Title: LYMRIT 37-01: A phase I/II study of 177Lu-lilotomab satetraxetan (Betalutin) antibody-radionuclide-conjugate (ARC) for the treatment of relapsed non-Hodgkin’s lymphoma (NHL) – Analysis with 6-month follow-up

Authors: A. Kolstad, et al.

The abstract will be published on 1 November 2018 at 09:00am Eastern time at View Source

On October 17, 2018 Spherix Incorporated (Nasdaq: SPEX) today provided shareholders with a video demonstration on its website of the potential effectiveness of CBM BioPharma, Inc.’s ("CBM) innovative drug platform (Press release, Spherix, OCT 17, 2018, View Source [SID1234538989]). As previously disclosed on October 11, 2018, Spherix entered into a merger agreement with CBM, a privately held innovative pharmaceutical company focused on the development of drugs in the multibillion-dollar oncology therapeutics market . The notable video, which was recorded at Wake Forest University, visually demonstrates the potential effectiveness of one of CBM’s primary drug candidates known as KPC34. Researchers at Wake Forest have been testing whether KPC34 can be used on mouse subjects to treat Acute Lymphoblastic Leukemia (ALL) that has spread to the nervous system. Once recurrent ALL spreads to the nervous system, patients often experience paralysis.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

In the video, a mouse which suffers from hind leg paralysis as a result of recurrent late staged ALL is shown to improve dramatically from the paralysis within forty-eight hours of being treated with KPC34. Within just twenty-four hours of the first injection of KPC34, the mouse could walk. Forty-eight hours later a second injection was administered and the mouse was able to move about without challenges.

Anthony Hayes, CEO of Spherix, stated, "This remarkable video demonstrates the tremendous potential for this drug to treat ALL. The video was part of a written submission on KPC34 to PLOS OneTM a peer reviewed medical journal. We are collecting additional information to continually provide our shareholders with updates to help better educate them on these compounds and the biotechnology space generally. We anticipate further updates in the future."

On October 17, 2018 Invenra, an antibody drug discovery and development company with novel multispecific platforms and product candidates, reported the close of a $7M Series B financing round (Press release, Invenra, OCT 17, 2018, View Source [SID1234570587]). The financing will be used to expand the company to meet growing demand for partnerships using its’ B-Body multispecific technology as well as continuing development of its internal pipeline.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Venture Investors led the round with participation from existing investors including Series A leader Wisconsin Investment Partners. The State of Wisconsin Investment Board (SWIB) also joined as a new investor. Additionally, Paul Weiss, Managing Director at Venture Investors, will join Invenra’s Board of Directors.

"Invenra’s discovery and development platform for bispecific antibodies has the potential to make meaningful contributions to the advancement of immuno-oncology", said Paul Weiss. "We already knew the capability of the team from our experience in backing Roland Green and members of the Board at NimbleGen Systems. We look forward to the opportunity to work together again on the important mission of Invenra."

Roland Green, CEO of Invenra, says "Invenra is excited to have Venture Investors and SWIB as part of our team. We look forward to working with Paul on our board as we develop our pipeline and partnerships. The additional funding will allow us to further leverage the B-Body platform for the high-throughput assessment of multispecific antibodies. This throughput and performance unlocks new and important therapeutic targets and mechanisms of action that were previously impractical through traditional methods. This funding along with milestones from partnerships will allow us to advance the preclinical development of our lead product candidates, namely our Biparatopic OX40 Agonist B-Body program and our tumor-specific Treg depleter SNIPER program."

On October 17, 2018 Foundation Medicine, Inc. reported a strategic collaboration with Novartis allowing the development of companion diagnostic (CDx) tests for the Novartis portfolio of targeted oncology and immuno-oncology therapeutics (Press release, Foundation Medicine, OCT 17, 2018, View Source [SID1234529950]). The collaboration structure allows for multiple therapy programs and includes development, regulatory support and commercialization of CDx tests for inclusion on FoundationOne CDx. FoundationOne CDx is Foundation Medicine’s FDA-approved comprehensive genomic profiling (CGP) assay for all solid tumors that incorporates multiple companion diagnostics.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

"It is imperative that we collaborate with all of the key stakeholders in oncology to accelerate patient access to personalized medicine," said Melanie Nallicheri, chief business officer and head of biopharma at Foundation Medicine. "Novartis shares this mission and we look forward to working with them to develop companion diagnostics across multiple therapies. This collaboration reaffirms our commitment to expedite biomarker-driven development and ultimately bring more personalized treatment options to patients."

The agreement also allows for global expansion in ex-US markets including Japan, where in partnership with Chugai, Foundation Medicine has submitted FoundationOne CDx for regulatory approval from the Ministry of Health, Labour and Welfare (MHLW). If approved in Japan, FoundationOne CDx would enable access to MHLW-approved targeted therapies and immunotherapies, as well as clinical trials, for patients with cancer in Japan.