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.

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 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 Glycotope GmbH (Glycotope or the Company), a clinical-stage oncology/immuno-oncology company built on world-leading glycobiology expertise, reported it has enrolled the first patient in an expansion of its ongoing Phase Ib international GATTO study investigating the combination of Glycotope’s anti-TA-MUC1 antibody (Gatipotuzumab) and anti-EGFR antibody (Tomuzotuximab) (Press release, Glycotope, MAR 25, 2019, View Source [SID1234534576]).

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The phase Ib trial expansion will evaluate the feasibility, safety and efficacy of the combination of Gatipotuzumab with either Tomuzotuximab or a marketed anti EGFR antibody in patients with solid tumors such as metastatic colorectal, lung, breast and head and neck cancers with measurable disease after failure of standard treatment options.

GATTO is an international, multicenter phase Ib trial enrolling patients in Germany, Italy and Spain. The combination of Gatipotuzumab with Tomuzotuximab or a marketed anti EGFR antibodies is based on a strong preclinical rationale and preliminary clinical evidence from the first 20 patients enrolled in the study.

"We are pleased to have enrolled the first patient in this innovative and interesting trial expansion which will enable us to build on the preliminary clinical evidence from the first 20 patients enrolled in the study. We are excited to learn more about Gatipotuzumab’s efficacy when combined with anti EGFR antibodies," said Dr. Alfredo Zurlo, MD, external Medical Head of Glycotope GmbH. "The trial aims to confirm in selected cancer patients the preclinical synergy observed in combining anti-EGFR and anti TA-MUC1 targeting."

"The GATTO trial extension further highlights the potential and wide applicability of gatipotuzumab" said Henner Kollenberg, Managing Director of Glycotope GmbH. "We believe the versatility of our technology platform combined with our world-leading glycobiology expertise and clinical experience in oncology and primarily immuno-oncology leaves us well placed to further strengthen our position in the field."

The GATTO study has been registered with the European Medical Agency under the EudraCT number 2017-001609-33

About Gatipotuzumab

Gatipotuzumab (previously known as PankoMab-GEX) is an anti-tumor antibody developed through Glycotope’s proprietary glyco-epitope targeting and glycooptimization technologies. Gatipotuzumab enables tumor-specific binding to a carbohydrate-induced conformational epitope, the TA-MUC1 (tumor-associated MUC1), which is present across a variety of high prevalence carcinomas. It has thus potential in the treatment of several cancer types and as a platform for the development of multiple further oncology and immuno-oncology products including antibody drug conjugates (ADC) and bi-specifics activating the immune system.

About Tomuzotuximab

Tomuzotuximab (previously known as CetuGEX) is an immune-enhanced monoclonal antibody (mAb) against the epidermal growth factor receptor (EGFR) with optimized and fully human glycosylation. Tomuzotuximab works via several anti-tumor mechanisms of action: a strong antibody dependent cellular toxicity (ADCC), proliferation inhibition via receptor blockage and induction of apoptosis. Thanks to the optimization of a series of sugar determinants, in pre-clinical studies Tomuzotuximab has shown to be more active in eliciting anti-tumor ADCC compared to cetuximab. This enhanced potency may increase the number of patients with EGFR expressing tumors who benefit from treatment.

On March 25, 2019 Australian oncology-focused biotech company Kazia Therapeutics Ltd (ASX: KZA,NASDAQ: KZIA) reported that it has been selected to present data from the Phase I study of Cantrixil in ovarian cancer at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2019 Annual Meeting (Press release, Kazia Therapeutics, MAR 25, 2019, View Source [SID1234534572]).

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AACR’s Annual Meeting is one of the top-tier academic conferences worldwide and brings together around 20,000 representatives from academia, industry, government and advocacy organisations from across the globe. The meeting is being held from 29 March to 3 April at the Georgia World Congress Center in Atlanta, Georgia, USA.

Clinical Program Director, Daniel Berg will be presenting on Kazia’s Cantrixil Phase I in ovarian cancer at the event on 1 April 2019. Mr Berg will present data from Part A of the study — the dose escalation component — which completed recruitment in October 2018.

TRX-E-002-1 (Cantrixil), is a third-generation benzopyran molecule with activity against cancer stem cells and is being developed to treat ovarian cancer. It was developed in Australia and initial preclinical studies were conducted at Yale University. Cantrixil was granted orphan designation for ovarian cancer by the US FDA in April 2015.

The abstract presentation is entitled: Phase I Study of Intraperitoneal TRX-E-002-1 in Patients with Persistent or Recurrent Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer: Results of Dose-Escalation Phase.

The abstract has been authored by the trial’s Principal Investigators (PIs) – led by the two primary PIs in Australia and the US: Associate Professor Jermaine Coward at the ICON Cancer Care in Brisbane, Queensland and Dr Don Dizon at the Lifespan Cancer Institute at Rhode Island Hospital. The trial is being conducted across six sites in the US and Australia as follows:

Country

State

Site

Principal Investigator

US

Rhode Island

Lifespan Cancer Institute, Providence

Dr. Don Dizon

US

Oklahoma

Stephenson Cancer Center, Oklahoma City

Assoc. Prof. Kathleen Moore

US

Texas

Mary Crowley Cancer Research Centre, Dallas

Dr. Minal Barve

Australia

Queensland

ICON Cancer Care, Brisbane

Assoc. Prof. Jermaine Coward

Australia

New South Wales

Westmead Hospital, Sydney

Prof. Paul Harnett

Australia

South Australia

Flinders Medical Centre, Adelaide

Dr. Ganessan Kichenadasse

"The key objective with Part A of the Phase I study was to assess the safety of the drug and find the right dose level to take the study to the next stage. We are delighted to be presenting our data at the AACR (Free AACR Whitepaper) meeting and we look forward to discussing our findings with clinicians and potential partners," said Cantrixil Program Director Daniel Berg.

The presentation session details are as follows:

Session Title: Phase I Clinical Trials: Part 3
Date and Time: Monday April 1, 2019 1:00 PM – 5:00 PM
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 16
Poster Board Number: 15
Permanent Abstract Number: CT091

Interested parties are encouraged to attend and can add the session to their itinerary here: View Source!/6812/session/1315

Meanwhile, the link to the abstract is here: View Source!/6812/presentation/9899

The content of the abstract and presentation is embargoed until the start of the conference when it will be available through the above link and on the Kazia website.