On March 25, 2019 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, reported that the U.S. Food and Drug Administration (FDA) completed their review of the Company’s Investigational New Drug (IND) submission for CG-806 (Press release, Aptose Biosciences, MAR 25, 2019, View Source [SID1234534580]). Aptose has been granted IND allowance to initiate its Phase 1 clinical trial, which is a Phase 1, multicenter, open label, dose-escalation study with expansions to assess the safety, tolerability, PK, and preliminary efficacy of CG-806 in patients with chronic lymphocytic leukemia (CLL/SLL) or non-Hodgkin lymphomas (NHL).

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Aptose will conduct a Phase 1 trial with orally administered CG-806 in patients with relapsed or refractory B cell malignancies, including CLL/SLL and NHL who have failed or are intolerant to standard therapies. The Phase 1 trial is expected to initiate in the 2nd quarter of 2019. Pending collection and careful review of the initial safety data and predictive pharmacokinetic data in humans from this trial, Aptose plans to seek allowance from the FDA to move into patient populations that include relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) in a separate Phase 1 trial.

"We are pleased that the FDA has allowed Aptose to perform clinical trials with CG-806, our first-in-class pan-FLT3/pan-BTK inhibitor," said William Rice, Ph.D., Chairman, President & CEO. "CG-806 has demonstrated a favorable safety profile and compelling durable tumor elimination in animal models of cancer, and we look forward to advancing it into human clinical testing."

About CG-806

CG-806 is an oral, first-in-class pan-FLT3/pan-BTK multi-cluster kinase inhibitor and is in a Phase 1 clinical trial for hematologic malignancies. This small molecule, in-licensed from CrystalGenomics Inc. in Seoul, South Korea, demonstrates potent inhibition of wild type and all mutant forms of FLT3 (including internal tandem duplication, or ITD, and mutations of the receptor tyrosine kinase domain and gatekeeper region), cures animals of acute myeloid leukemia (AML) tumors in the absence of toxicity in murine xenograft models, and represents a potential best-in-class therapeutic for patients with AML. Likewise, CG-806 demonstrates potent, non-covalent inhibition of the wild type and Cys481Ser (C481S) mutant forms of the BTK enzyme, as well as other oncogenic kinase pathways operative in B cell malignancies, suggesting CG-806 may be developed for various B cell malignancy patients (including CLL/SLL, FL, MCL, DLBCL and others) that are resistant/refractory/intolerant to covalent BTK inhibitors. Because CG-806 targets key kinases/pathways operative in malignancies derived from the bone marrow, it is in development for B-cell cancers and AML.

On March 25, 2019 NantKwest (Nasdaq:NK), a leading clinical-stage, natural killer cell based therapeutics company, reported that Patrick Soon-Shiong, MD, the company’s Chairman & CEO, on March 21, 2019, exercised 17,589,250 warrants with an exercise price of $1.9984 and 1,851,000 options with an exercise price of $2.1983, representing an aggregate cash exercise price of $39.2 million (Press release, NantKwest, MAR 25, 2019, https://ir.nantkwest.com/news-releases/news-release-details/nantkwest-chairman-ceo-dr-patrick-soon-shiong-exercises-39?field_nir_news_date_value[min]=2019 [SID1234534603]).

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In commenting on the exercise of the warrants and options, Dr. Soon-Shiong said the following: "Since the launch of NantKwest in 2015, the company has made remarkable progress in the development of a true, ‘off-the-shelf’ and ‘ready-to-use’ Natural Killer (NK) cell therapy that could be shipped on an ‘as needed basis,’ just about anywhere in the world. We have successfully established a truly off-the-shelf, cryopreserved product and are now ready to embark on pivotal trials. This advanced manufacturing capability combined with our ability to develop NK cells with high killing activity provides us with a distinct advantage as the leading company developing an immediately available NK cell therapy for patients with cancer."

Dr. Soon-Shiong continued, "My commitment and confidence in the future success of NantKwest has never been stronger. I firmly believe that the natural killer cell represents the missing link in our war against cancer. I believe that only by orchestrating the activity of the natural killer cell, the innate immune system, as well as the killer T cell, the adaptive immune system, could we achieve long lasting responses to immunotherapy. NantKwest represents this next generation of cell therapy with the potential to achieve activation of the memory T and NK cell, the holy grail of immunotherapy. Contributing an additional $39.2 million to the financial resources of NantKwest will enable the rapid opening of multiple clinical trial sites for the Phase 2 trial of off-the-shelf activated natural killer cells (haNK cells), combined with an IL-15 cytokine (N-803) which may proliferate NK and T cells, to treat refractory patients suffering from a deadly disease, Merkel Cell Carcinoma. In addition, preclinical data of the world’s first targeted off-the-shelf haNK cells (t-haNK) are highly encouraging and we are planning the first in human trials of both PD-L1 t-haNK and CD-19 t-haNK (targeted-haNKs) this year."

Dr. Soon-Shiong provided an update on the haNK and t-haNK programs at his keynote address to the scientific community at "The Innate Killer Summit" in San Diego on March 20, 2019.

On March 25, 2019 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc"), a biopharmaceutical company developing new cancer treatments for patients suffering from recurring and metastatic cancer, reported that it has initiated development of a bio-analytical assay intended to quantify the active ingredients of the company’s lead product candidate, PRP, in preparation for human trials, planned for later this year (Press release, Propanc, MAR 25, 2019, View Source [SID1234534581]). The work will be conducted by a specialist Contract Research Organization with extensive knowledge in the development of functional assays for different bio-therapeutics. PRP is a solution of two proenzymes, trypsinogen and chymotrypsinogen, administered by I.V. injection.

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"We are keen to undertake this important work, as the quantification of PRP in human serum will provide invaluable information that links the biodistribution of the two proenzymes, as it exerts its potent anti-cancer and anti-tumor effects, to the efficacy and safety of our therapy on patients at different dosing levels," said Dr. Julian Kenyon, Propanc’s Chief Scientific Officer. "Initially we will carry out a feasibility study to quantify the two proenzymes trypsinogen and chymotrypsinogen, but in addition, the enzymes which become activated at the tumor site, trypsin and chymotrypsin. It is the activated enzymes which exert their effects on the cancer cells, by turning off important protein markers responsible for tumorigenicity and malignancy, so that the cancer cells die naturally. Measuring all four analytes will provide an important link to the action of PRP and its effects on cancer patients."

Development of the bio-analytical assay will be an important step towards the clinical development of PRP, as Propanc considers the possible sites to conduct a First-In-Human study in advanced cancer patients, possibly in Europe, specifically the UK, or at a prominent cancer hospital in Australia, with significant experience in early stage clinical development. Attractive R&D tax incentive benefits could be gained by undertaking the trial in Australia, as well as utilizing world-class facilities dedicated to treating and caring for people with cancer. Propanc will investigate selected clinical trial sites more thoroughly as it commences preparation of a clinical trial application for PRP.

On March 25, 2019 VBL Therapeutics (Nasdaq: VBLT), reported that the Company will present data on its Phase 3 drug candidate VB-111, at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, to be held March 29 – April 3, 2019 at Georgia World Congress Center in Atlanta, Georgia (Press release, VBL Therapeutics, MAR 25, 2019, View Source [SID1234534604]). VB-111 is a first-in-class, targeted anti-cancer gene-therapy biologic with broad potential to treat a wide range of solid tumors. In addition, the company will provide a corporate overview at the H.C. Wainwright Global Life Sciences Conference to be held April 7 – 9, 2019 at the Grosvenor House, a JW Marriott Hotel in London, UK.

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The AACR (Free AACR Whitepaper) Annual Meeting – Presentation Details:
Title: Ofranergene Obadenovec (VB-111), an anti-cancer gene therapy, induces immunologic responses in solid tumors transforming ‘cold’ tumors to ‘hot’ tumors
Session Category: Immunology
Session Title: Immunomodulators and Response to Therapy
Date: Wednesday Apr 3, 2019
Time: 8:00 AM – 12:00 PM Eastern Time
Session Location: Exhibit Hall B, Poster Section 24
Poster Board Number: 2
Abstract Number: 4979

HCW Global Life Sciences Conference – Presentation Details:

Date:Monday, April 8
Time: 15:40 – 16:00 BST

On March 25, 2019 Race Oncology reported that it has announced the US Food and Drug Administration has received its Investigational New Drug (IND) application for the company’s cancer drug Bisantrene (Press release, Race Oncology, MAR 25, 2019, View Source [SID1234534583]).

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The IND application is a major milestone in the approval process for the company’s Acute Myeloid Leukaemia (AML) drug in the United States. The application is a precursor to Race Oncology’s intended 250-patient clinical trial of Bisantrene for the treatment of adult AML.

"The filing of the IND definitely brands Bisantrene as a Phase III asset," said Race Oncology CEO Peter Molloy.

Because Bisantrene is entering the clinical and regulatory process at Phase III, the IND comprises the entire history of Bisantrene’s preclinical and clinical development, along with Phase III quality manufacturing and other data.

"Race Oncology is well advanced in our push to get FDA approval of Bisantrene in the United States. Our team has been focused on this milestone for the past six months," said Race Oncology CEO Peter Molloy.

The FDA will now take 30 days to review the application, which consists of new chemistry and manufacturing data developed by Race Oncology, as well as the entire history of the pre-clinical and clinical development of Bisantrene over three decades.

Bisantrene is a chemotherapy drug that was the subject of more than forty phase two clinical studies during the 1980s and 1990s. Race has rescued the drug after it was lost in a series of big pharma mergers.

In addition to underpinning the adult AML approval of Bisantrene, the IND will be the core regulatory document and springboard for Race’s planned trial in paediatric AML.

Race has received a Rare Paediatric Disease designation for Bisantrene from the FDA, and upon a successful paediatric trial, could receive a valuable and saleable ‘Priority Review Voucher’ (PRV).

The Company is now in advanced discussions around the funding and conduct of the paediatric trial.

"The IND is the culmination of nearly three years of manufacturing and development work at Race Oncology, and it now provides the launch pad for a number of value creating programs," said Mr Molloy.

"I regard this IND as our most important achievement to date," added Mr Molloy.