On October 3, 2019 Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, is reported that it has received a response on its Investigational New Drug (IND) application that the study may proceed from the U.S. Food and Drug Administration (FDA) for a Phase 1-2a theranostic (i.e. diagnostic and therapy) trial with 64Cu-SARTATE and 67Cu-SARTATE in paediatric patients (Press release, Clarity Pharmaceuticals, OCT 3, 2019, View Source [SID1234540032]).

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This trial will be using Clarity’s lead product, SARTATE, administered to paediatric patients with somatostatin receptor-2 positive, relapsed or refractory, high-risk neuroblastomas. It is a multi-centre, dose escalation, open-label, non-randomised, Phase 1-2a theranostic clinical trial planned for up to 34 patients using 64Cu-SARTATE for PET imaging and 67Cu-SARTATE for therapy.

The FDA response suggests not only the importance of the study in the treatment of neuroblastoma, but also validates the manufacturing of 64Cu-SARTATE and 67Cu-SARTATE to levels suitable for diagnostic and therapeutic use, as well as the suitability of the centralised manufacturing concept of this theranostic pairing.

Neuroblastoma is a disease that occurs most often in infants and young children, usually in children younger than 5 years old. It is the most common type of cancer to be diagnosed in the first year of life and accounts for around 13% of paediatric cancer mortality. High-risk neuroblastoma accounts for approximately 45% of all neuroblastoma cases. Patients with high-risk neuroblastoma have the lowest 5-year survival rates at 40%-50%.

This study is supported by a human imaging study in 10 adults with neuroendocrine tumours and preliminary results of a first-in-human study of adult patients with meningioma, who were administered a diagnostic dose of 64Cu-SARTATE followed by up to four doses of the therapeutic product,67Cu-SARTATE.

Dr Alan Taylor, Clarity’s Executive Chairman, commented on the IND approval "The acceptance of Clarity’s first IND application in a relatively short time indicates the quality and importance of work conducted by our preclinical, clinical and manufacturing teams in the field of theranostics and reflects the support for the development of novel treatments for children with cancer. We are very pleased to have achieved this significant milestone. Our Team is looking forward to progressing this trial at some of the leading cancer centres in the U.S. and we are hoping to commence recruitment shortly which will get us one step closer to our goal of better treating children and adults with cancer."

Media Contact
Dr Alan Taylor

Executive Chairman

Ph: +61 (0)413 871 165

E: [email protected]

On October 2, 2019 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, is reported it has been accepted for an oral presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 34th Annual Meeting, which is being held from 6-10 November 2019 in Maryland (Press release, BerGenBio, OCT 2, 2019, View Source [SID1234540031]).

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The presentation will provide updates on its phase II study of bemcentinib (BGB324) in combination with pembrolizumab in patients with advanced NSCLC.

Abstract titles have been announced online at View Source (abstracts # O26). Details of the presentation are below.

Title: A phase II study of bemcentinib (BGB324), a first-in-class selective AXL inhibitor, in combination with pembrolizumab in patients with advanced NSCLC: Updated analysis.

Date: Friday 8th November 2019

Time: 5:10 pm – 5:25 pm (during High Impact Clinical Trials session)

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body’s immune response to tumours and drives cancer treatment failure across many indications. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases.

About bemcentinib

Bemcentinib (formerly known as BGB324), is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme. Ongoing clinical trials are investigating bemcentinib in multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent. Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity. Increase in AXL function has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers.

On October 2, 2019 Trovagene, Inc. (Nasdaq: TROV), a clinical-stage, Precision Cancer Medicine oncology therapeutics company developing drugs that target cell division (mitosis) for the treatment of various cancers including breast, prostate, colorectal and leukemia, reported the presentation of preclinical data demonstrating significant tumor regression with the combination of onvansertib and paclitaxel, versus either agent alone, in models of triple-negative breast cancer (TNBC) (Press release, Trovagene, OCT 2, 2019, View Source [SID1234540030]).

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The data was featured in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress on Sunday, September 29th, 2019.

"The development of new options to treat TNBC that is resistant to standard-of-care chemotherapy can address a critical unmet clinical need," said Antonio Giordano, MD, PhD, medical oncologist at Medical University of South Carolina (MUSC). "We value our collaboration with Trovagene, and we believe that our preclinical data confirms the potential therapeutic benefit of onvansertib and warrants further evaluation. Planning for the initiation of a clinical trial targeting TNBC patients with the highly-aggressive p53 mutation is currently underway at MUSC."

TNBC is an aggressive form of the disease accounting for 12 to 18% of breast cancers. Although chemotherapy can be effective as standard-of-care, many patients become resistant to treatment. The TP53 gene is mutated in approximately 80% of TNBC and the mutation is considered a target marker. TNBC is defined by the absence of estrogen and progesterone receptors and the absence of HER2 overexpression. These cancers represent a heterogeneous breast cancer subtype with a poor prognosis. Few systemic treatment options exist besides the use of chemotherapy. Currently, there are no approved targeted therapies to treat TNBC.

Presentation Highlights

Background:

Somatic mutation in TP53 gene (mutp53) is a strong prognostic marker in breast cancer
Triple negative breast cancer (TNBC) is characterized by up to 80% mutp53 and the greatest overall genomic instability among subtypes
Polo-like kinase 1 (PLK1) regulates progression of cells through the G2 phase of the cell cycle
Hypothesis that mutp53 in the context of breast cancer can predict synergy to paclitaxel plus onvansertib, an orally available highly selective PLK1 inhibitor
Significant Clinical Need for New Targeted Treatment Option (Onvansertib + Paclitaxel):

Cell lines undergo G2/M cell-cycle arrest following PLK1 (onvansertib) inhibition
Paclitaxel synergizes with onvansertib (the activity of the two drugs together is greater than that of each drug alone) and induces apoptosis (death) of cancer cells
Currently, treatment options are limited to chemotherapy and there is a significant medical need to develop a targeted therapeutic option for the treatment of breast cancer patients with TP53 mutation
A clinical study to assess the safety and preliminary efficacy of the combination of onvansertib and paclitaxel as a potential new targeted treatment option in TNBC is warranted
About Onvansertib

Onvansertib is a first-in-class, third-generation, oral and highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK1) enzyme, which is over-expressed in multiple cancers including leukemias, lymphomas and solid tumors. Onvansertib targets the PLK1 isoform only (not PLK2 or PLK3), is orally administered and has a 24-hour half-life with only mild-to-moderate side effects reported. Trovagene believes that targeting only PLK1 and having a favorable safety and tolerability profile, along with an improved dose/scheduling regimen will significantly improve on the outcome observed in previous studies with a former panPLK inhibitor in AML.

Onvansertib has demonstrated synergy in preclinical studies with numerous chemotherapies and targeted therapeutics used to treat leukemias, lymphomas and solid tumor cancers, including irinotecan, FLT3 and HDAC inhibitors, taxanes and cytotoxins. Trovagene believes the combination of onvansertib with other compounds has the potential to improve clinical efficacy in acute myeloid leukemia (AML), metastatic castration-resistant prostate cancer (mCRPC), non-Hodgkin lymphoma (NHL), colorectal cancer and triple-negative breast cancer (TNBC), as well as other types of cancer.

Trovagene has three ongoing clinical trials of onvansertib: A Phase 2 trial of onvansertib in combination with Zytiga (abiraterone acetate)/prednisone in patients with mCRPC who are showing signs of early progressive disease (rise in PSA but minimally symptomatic or asymptomatic) while currently receiving Zytiga (NCT03414034); a Phase 1b/2 Study of onvansertib in combination with FOLFIRI and Avastin for second-line treatment in patients with mCRC with a KRAS mutation (NCT03829410); and a Phase 1b/2 clinical trial of onvansertib in combination with low-dose cytarabine or decitabine in patients with relapsed or refractory AML (NCT03303339). Onvansertib has been granted orphan drug designation by the FDA in the U.S. and by the EC in the European Union for the treatment of patients with AML.

Trovagene licensed onvansertib (also known as NMS-1286937 and PCM-075) from Nerviano Medical Sciences (NMS), the largest oncology-focused research and development company in Italy, and a leader in protein kinase drug development. NMS has an excellent track record of licensing innovative drugs to pharma/biotech companies, including Array (recently acquired by Pfizer), Ignyta (acquired by Roche) and Genentech.

On October 2, 2019 Q BioMed Inc. (OTCQB: QBIO), reported that it has entered into a settlement agreement with BioNucleonics Inc. to complete the outright acquisition of the non-opioid cancer bone pain drug Strontium-89 Chloride USP (Press release, Q BioMed, OCT 2, 2019, View Source [SID1234540029]). Q BioMed will assume immediate ownership of the drug, including the aNDA (abbreviated new drug application), under a mutually favorable global royalty agreement.

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Strontium-89 is an important therapeutic option for the treatment of metastatic bone cancer pain. The drug has a long history of providing well-documented pain relief for patients suffering from the excruciating pain associated with primary cancers that have spread to the bone, including breast, prostate, lung and others. The drug is administered by a single injection and has been shown to reduce or even eliminate the need for opioid therapies. It is effective in reducing pain in the majority of patients and lasts 3 or more months with one dose.

Q BioMed has been gearing up its commercial efforts in anticipation of the successful outcome of this action as well as the pending FDA approval of the contract facility that will manufacture the drug in the US.

The Company believes that this is the ideal time to be launching the product given the current climate surrounding the over-use of opioid drugs. In addition, as more therapies come to market for the treatment of primary cancers, more people are living longer with metastatic disease. It is estimated that approximately two million patients experience debilitating bone pain from metastatic disease. The opportunity to provide improved quality of life to this group is substantial.

QBioMed CEO Denis Corin said, "We have never been more confident in the merits of this program. It has taken longer than anticipated to get here, but we are soon going to be able to serve the needs of patients suffering from metastatic bone pain and provide them the chance to minimize their pain and improve their quality of life during a meaningful moment in their lives. With millions of potential patients, this is a major market opportunity for us and our shareholders. In addition, we are investigating and planning expansion trials to provide additional indications for the drug and entry into an even larger therapeutic market."

While we cannot comment on the FDA review of our contract facility, we are proactively preparing for launch late this year. We have on-boarded our commercial team and will make further announcements regarding national and international distribution in the very near future. In addition, our commercial infrastructure is prepared, including pharmacovigilance, medical information, government contracting and marketing.

We look forward to updating our shareholders and those awaiting drug availability in the very near term.

On October 2, 2019 Nektar Therapeutics (Nasdaq: NKTR) reported the acceptance of five clinical and preclinical data abstracts for its immuno-oncology portfolio at the 2019 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (Press release, Nektar Therapeutics, OCT 2, 2019, View Source [SID1234540028]). The presentations include an oral session with a presentation of updated data from the PIVOT-02 study of bempegaldesleukin (NKTR-214, bempeg) with nivolumab in patients with first-line metastatic melanoma. The 2019 SITC (Free SITC Whitepaper) Annual Meeting is being held from November 6 to November 10, 2019, at the Gaylord National Hotel & Convention Center in National Harbor, Maryland.

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Details of the oral presentation are as follows:

Abstract Title: "Clinical activity, including deepening of response, of BEMPEG plus NIVO in previously untreated patients with metastatic 1L Melanoma: results from the Phase 1/2 PIVOT-02 Study"
Abstract: O35
Presenter: Dr. Adi Diab, MD Anderson Cancer Center
Session Title: Concurrent Session 310: Combination Phase 1-2 Clinical Trials
Date: Saturday, November 9, 2019, 5:15 p.m. – 5:30 p.m. Eastern Standard Time

Details of the poster presentations are as follows:

Abstract P619: "NKTR-255, a polymer-conjugated IL-15 receptor agonist, enhances efficacy of therapeutic monoclonal antibodies with ADCC activity in solid tumor models", Kivimäe, S., et al.
Session Date and Time: Friday, November 8th from 7:00 a.m. – 8:00 p.m. Eastern Standard Time

Abstract P623: "Bempegaldesleukin in combination with local radiation and systemic checkpoint blockade induces a robust systemic anti-tumor immunity", Pieper, A., et al.
Session Date and Time: Friday, November 8th from 7:00 a.m. – 8:00 p.m. Eastern Standard Time

Abstract P622: "Characterization and comparison of NKTR-255, a polymer-conjugated IL-15 versus IL-15 superagonist", Miyazaki, T., et al.
Session Date and Time: Saturday, November 9th from 7:00 a.m. – 8:00 p.m. Eastern Standard Time

Details of the Trials in Progress poster presentation are as follows:

Abstract P387: "A Multicenter, Open-Label, Exploratory Platform Study to Evaluate Biomarkers and Immunotherapy Combinations for the Treatment of Patients with Metastatic Castration-resistant Prostate Cancer (PORTER)", Nissola, L., et al.
Session Date and Time: Friday, November 8th from 7:00 a.m. – 8:00 p.m. Eastern Standard Time

About Bempegaldesleukin (NKTR-214)
Bempegaldesleukin is designed to stimulate cancer-killing immune cells in the body by targeting CD122 receptors found on the surface of these immune cells. CD122, which is also known as the Interleukin-2 receptor beta subunit, is a key signaling receptor that is known to increase proliferation of these effector T cells.1 In clinical and preclinical studies, treatment with bempegaldesleukin resulted in expansion of these cells and mobilization into the tumor micro-environment.2,3

About NKTR-255
NKTR-255 is an IL-15 receptor agonist designed to engage the IL-15 pathway to stimulate and expand natural killer (NK) cells and promote the survival and expansion of central memory CD8+ T cells without inducing suppressive regulatory T cells. Through optimal engagement of the IL-15Rα/IL-2Rγ receptor complex, NKTR-255 enhances formation of long-term immunological memory which may lead to sustained anti-tumor immune response. Native rhIL-15 is rapidly cleared from the body and must be administered frequently and in high doses limiting its utility due to toxicity. NKTR-255 is designed with IL-15 receptor alpha specificity to optimize biological activity and is uniquely engineered to provide optimal exposure and an improved safety profile.