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Chi-Med Initiates a Phase I Trial of HMPL-523 in Combination with Azacitidine in Elderly Patients with Acute Myeloid Leukemia in China

On October 18, 2018 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that it has initiated a Phase I study of HMPL-523, its novel spleen tyrosine kinase ("Syk") inhibitor, in combination with azacitidine, an approved nucleoside metabolic inhibitor, in elderly patients with acute myeloid leukemia ("AML") in China (Press release, Hutchison China MediTech, OCT 18, 2018, https://www.chi-med.com/phasei-hmpl523-azacitidine-aml-china/ [SID1234529956]).

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This is a Phase I, open-label, non-randomized, multicenter study to evaluate the safety, pharmacokinetics and preliminary efficacy of the combination in previously untreated elderly patients with AML who are not eligible for standard induction therapy. The primary outcome measures are overall response rate (ORR) and adverse events (AE). The two-stage study will have a dose escalation and dose expansion stage. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT03483948.

This study complements the ongoing Phase Ib dose expansion program of HMPL-523 in a broad range of hematological cancers in Australia (clinicaltrials.gov identifier: NCT02503033) and China (clinicaltrials.gov identifier: NCT02857998). These include chronic lymphocytic leukemia, small lymphocytic lymphoma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, diffuse large B-cell lymphoma and Waldenstrom’s macroglobulinemia. Chi-Med targets to present dose escalation results at a major scientific conference later in 2018 or in 2019. Chi-Med’s U.S. Investigational New Drug (IND) application for HMPL-523 in hematological cancers was cleared by the Food and Drug Administration (FDA) at the end of June 2018 and hence Chi-Med is now planning for proof-of-concept development in the U.S.

About Syk
Syk is a non-receptor cytoplasmic tyrosine kinase primarily expressed in cells of hematopoietic lineage. Constitutive activation of Syk in AML has been reported and targeted inhibition of Syk demonstrated anti-leukemia activity in AML mouse models. Syk has also been shown to directly phosphorylate the FLT3 receptor, modulating its activation and possibly promoting its role in leukemogenesis.

About AML
AML, a cancer of blood and bone marrow characterized by rapid disease progression, is the most common acute leukemia. Undifferentiated blast cells proliferate in the bone marrow rather than mature into normal blood cells. AML occurs in children and adults of all ages, but is primarily a disease of older adults, with a median age at diagnosis of 67 years. AML is universally fatal without treatment, with a median survival of approximately two months.[i] The vast majority of patients do not respond to chemotherapy and progress to relapsed/refractory AML. The five-year survival rate for AML is approximately 27%.[ii]

Combination chemotherapy regimens with or without hematopoietic stem cell transplantation (HSCT) are a mainstay of therapy for patients with newly diagnosed AML. Older patients with newly diagnosed AML who are ineligible for intensive chemotherapy typically have poor outcomes and few available treatment options. There is a clear need for new treatments for AML.

Invenra Secures $7M in Series B Growth Round to Accelerate Bispecific Antibody Development

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.

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."

Nordic Nanovector ASA: Change of Date for Q3 2018 Results Presentation and Webcast

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]).

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

Spherix Provides Video Demonstration of CBM Drug Reversing Paralysis in Preclinical Study

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.

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."

Anixa Biosciences Releases Data Presented at AACR Artificial Intelligence Conference

On October 17, 2018 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, presented the results from its ongoing study utilizing Cchek, its artificial intelligence (AI) driven early cancer detection technology, at the 30th Anniversary AACR (Free AACR Whitepaper) Special Conference – Convergence: Artificial Intelligence, Big Data and Prediction in Cancer (Press release, Anixa Biosciences, OCT 17, 2018, View Source [SID1234530497]). This AACR (Free AACR Whitepaper) special conference covered the state of research in understanding cancer from incident to early diagnosis, prevention, and treatment using big data and machine learning. The meeting was held October 14–17, 2018 in Newport, Rhode Island and was attended by global leaders in the intersection of cancer research and artificial intelligence.

Anixa, for the first time, presented data demonstrating the ability of Cchek to distinguish, among patients scheduled for biopsy, those who have high risk prostate cancer and those who have benign conditions or low grade cancer, for whom surgery is not required and a biopsy is unnecessary. In addition, Anixa’s Cchek data showed the ability to distinguish healthy males from high risk prostate cancer patients with a sensitivity of 89% and a specificity of 100%. This study further demonstrated the potential for Cchek to reduce the number of unnecessary prostate biopsies by up to 56%, while still retaining 89% sensitivity for detecting prostate cancers.

Dr. Amit Kumar, Anixa President and CEO stated, "We are pleased with the results of our ongoing study presented at the AACR (Free AACR Whitepaper) AI conference, and we are excited about the potential for us to dramatically reduce the number of unnecessary prostate biopsies. The ability to distinguish between high risk prostate cancer patients and those with a benign condition or low grade, non-surgically treated cancer is significant, and is a distinct differentiator between Cchek and many other liquid biopsy tests being developed today."