On June 2, 2021 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported that presentations at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held in a virtual format from June 4 to 8, 2021 (Press release, Blue Earth Diagnostics, JUN 2, 2021, View Source [SID1234583374]). The two abstracts outlined the launch of studies investigating the use of Axumin (fluciclovine F 18, also known as FACBC) PET in the management of oligometastatic, recurrent prostate cancer, and its role, as assessed by the impact on radiographic progression-free survival, in guiding radiotherapy planning for patients with recurrent disease. Details of the presentations to be given by Blue Earth Diagnostics’ collaborators are listed below.

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NOTE: Axumin (fluciclovine F 18) injection is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. Axumin is a registered trademark of Blue Earth Diagnostics, Ltd., or its related companies. All other marks are the property of their respective owners.

Highlighted Axumin (Fluciclovine F 18) Scientific Presentations

All ASCO (Free ASCO Whitepaper) presentations are available beginning Friday, June 4, 2021, at 9:00 a.m. ET.

Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Subtrack: Prostate Cancer – Local-Regional Disease

Title: The fluciclovine (FACBC) PET/CT site-directed therapy of oligometastatic prostate cancer (Flu-BLAST-PC) trial

Author(s): Risa Liang Wong, Sarah K Holt, Jing Zeng, Laura Graham, Rachel Kang, Nathan Conrad, Andrea Toulouse, Zoya Bauer, Michael Lai, Todd Yezefski, Jonathan L. Wright, Emily Steinberger Weg, Andrew Caleb Hsieh, Heather H. Cheng, Jean H Lee, Delphine L. Chen, Daniel W. Lin, Evan Y. Yu

Session: Poster session

Abstract: TPS5099

Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Subtrack: Prostate Cancer – Local-Regional Disease

Title: Phase III study of local or systemic therapy INtensification DIrected by PET in prostate

CAncer patients with post-prostaTEctomy biochemical recurrence (INDICATE): ECOGACRIN EA8191

Author(s): Neha Vapiwala, Yu-Hui Chen, Steve Y. Cho, Fenghai Duan, Christos Kyriakopoulos, Daniel H. Shevrin, Rana R. McKay, Bridget F. Koontz, Evan Y. Yu, Volkan Beylergil, David A. Mankoff, Jonathan McConathy, Glenn Liu, Terence Z. Wong, Michael Anthony Carducci

Session: Poster session

Abstract: TPS5098

Blue Earth Diagnostics invites participants at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting to attend the above presentations and to learn more about the Company at www.blueearthdiagnostics.com. For full session details and scientific presentation listings, please see the ASCO (Free ASCO Whitepaper) online program here.

U.S. INDICATION AND IMPORTANT SAFETY INFORMATION ABOUT AXUMIN
INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full U.S. Axumin prescribing information is available at:

View Source
About Axumin (fluciclovine F 18)

Axumin (fluciclovine F 18) injection is a novel product indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men. Recurrence of prostate cancer is suspected by an increase in prostate specific antigen (PSA) levels following prior treatment. PET imaging with Axumin may identify the location and extent of such recurrence. Axumin was developed to enable visualization of the increased amino acid transport that occurs in many cancers, including prostate cancer. It consists of a synthetic amino acid that is preferentially taken up by prostate cancer cells compared with surrounding normal tissues and is labeled with the radioisotope F 18 for PET imaging. Fluciclovine F 18 was invented at Emory University in Atlanta, Ga., with much of the fundamental clinical development work carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences. Axumin was approved by the U.S. Food and Drug Administration in May 2016, following Priority Review, and is the first product commercialized by Blue Earth Diagnostics, which licensed the product from GE Healthcare. The molecule is being investigated by Blue Earth Diagnostics for other potential cancer indications including in neuro-oncology.

On June 2, 2021 Race Oncology Limited ("Race") reported it has appointed the Contract Research Organisation (CRO), Parexel International, to support an open label Phase 1/2 clinical trial in patients with relapsed or refractory (r/r) extramedullary Acute Myeloid Leukemia (AML) (Press release, Race Oncology, JUN 2, 2021, View Source [SID1234583390]).

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The trial will be led by Principal Investigator Associate Professor Anoop Enjeti, Director of Haematology at the Calvary Mater Newcastle and John Hunter Hospitals.

Dr Enjeti is a highly experienced clinical haematologist having designed and led more than 25 clinical trials. Dr Enjeti is the co-chair of the MDS/AML working party for the Australasian Lymphoma and Leukemia Group (ALLG) for Cooperative Clinical Trials.

Extramedullary AML
Extramedullary AML occurs when leukaemia spreads from the bone marrow and forms solid tumours in tissues such as the skin, breast, kidney, brain, or other organs. A 2020 prospective positron imaging trial identified that up to 22% of AML patients have the extramedullary form1. Extramedullary AML patients have no clinically approved treatments and limited experimental treatment options, with many clinical trials explicitly excluding this difficult to treat form of AML.

A recent Phase 2 clinical trial in r/r AML patients treated with Bisantrene by a team led by Prof Arnon Nagler of the Chiam Sheba Medical Center, Israel reported a 100% clinical response rate (4/4 patients) in those patients with the extramedullary form of this deadly cancer (ASX announcement: 16 June 2020).

Clinical Trial Design
This open label Phase 1/2 trial will recruit approximately 60 patients with 18F-FDG PET/CT imaging-identified extramedullary AML at 10 clinical sites across Australia using a two-stratum (arm) design. The first stratum will utilise Bisantrene as a high dose, single agent, treatment over 7 days in patients with extramedullary AML who are able to tolerate high intensity chemotherapy, followed by one or more cycles of consolidation treatment of Bisantrene in combination with azacitidine, a standard of care drug.

The second stratum will use Bisantrene as a low dose FTO-targeted agent in combination with the oral hypomethylating agent, Inqovi (decitabine and cedazuridine) for patients unable to tolerate high intensity chemotherapy. Published preclinical data from the City of Hope Hospital by Prof Chen’s team identified that Bisantrene is able to synergize with decitabine2. In mouse models of AML the combination provided improved therapeutic efficacy with, lower toxicity compared to when either drug was used alone3.

The primary endpoint for both strata will be complete response (CR) and complete response with incomplete haematological recovery (CRi) with an aim of bridging to an allogeneic hematopoietic stem cell transplant. Key secondary endpoints include safety and tolerability of Bisantrene, overall and event-free survival, and the level of FTO expression with response to treatment.

Indicative Costs and Timelines
The trial is expected to take 36 to 40 months to complete with full patient recruitment over approximately 18 months. Treatment of the first patient is targeted for Q4 CY 2021, subject to human ethics approval of the study and patient recruitment.

Race will pay Parexel an initial fee of $1.11 million under the Start Up Agreement (SUA). Additional payments will be made to Parexel under the Master Service Agreement (MSA) throughout the study upon reaching key milestones and will depend on the number of patients recruited and other operational variables.

Due to the adaptive nature of this study, the total study costs cannot be determined at this stage.

Race CSO Daniel Tillett said: "We are excited to begin this study with the twin aims of exploring the use of Bisantrene to treat FTO overexpressing cancers and bring it to market as a heart safer orphan drug treatment for AML. This trial will be transformational for Race and our shareholders."

Race CEO & MD Phillip Lynch said: "This study supports our Pillar 3 registration ambition to see Bisantrene’s historical safety and efficacy in AML demonstrated with superior drug combinations that may benefit patients who remain challenged by initial treatment failures."

Clinical Trial Summary
Study Title An open label Phase 1/2 study of high dose Bisantrene with cytarabine arabinoside (Ara-C) or low dose Bisantrene with oral decitabine for treatment of relapsed or refractory Acute Myeloid Leukemia (r/r AML) patients with extramedullary disease (BISECT)
Phase of Development Phase 1/2
Active Ingredient Bisantrene dihydrochloride
Study Description A two stratum trial of Bisantrene in patients with extramedullary AML diagnosed by 18F-FDG PET/CT imaging.
Principal Investigator A/Prof Anoop Enjeti
Sponsor Race Oncology
Indication/population Adult men and women ≥18 years of age with relapsed and/ or refractory Acute Myeloid Leukemia (R/R AML) presenting with non-CNS extramedullary disease.
Number of Subjects Stratum 1: up to 30 patients Stratum 2: 4 -10 patients (dose escalation); up to 30 patients in the expansion phase
Study Period 36 – 40 months
Study Design This is a two strata Phase 2, open-label study of high dose Bisantrene treatment given as a monotherapy induction and in combination with Ara-C as consolidation (Stratum 1) and lower dose Bisantrene in combination with decitabine (Inqovi) (Stratum 2) in patients with extramedullary r/r AML. As the patient population is considered relapsed and/or refractory to existing treatments, a comparator arm will not be used.
Statistical methods Bayesian Optimal Interval (BOIN) model-based design based on observed response rate of 30% for RR AML where the true response rate is expected to be <20% applying a 90% power.
End Points Primary: Achievement of a morphological overall response, i.e. complete response (CR) or complete response with incomplete count recovery (CRi), after commencing cycle 1 and before commencement of cycle 2. Key Secondary: Achievement of a PET/radiologic overall response, i.e. complete or partial metabolic response, after cycles 1, 2 and 4. Other Secondary: FTO status, event free survival, overall survival
Participating Centres 10 ALLG participating sites across Australia
Start Date First patient In: Q4 CY2021
End Date Last Patient In (anticipated): Q2 CY2023
End Date Last Patient In (anticipated): Q2 CY2023

On June 2, 2021 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that on Tuesday, June 1, 2021 the Company entered into a global supply agreement for Vicineum drug substance and drug product with the Company’s partner in China, Qilu Pharmaceutical (Press release, Sesen Bio, JUN 2, 2021, View Source [SID1234583406]).

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Under the terms of the global supply agreement, Qilu Pharmaceutical will be part of the manufacturing network for global commercial supply of Vicineum drug substance and drug product. In February 2021, the U.S. Food and Drug Administration (FDA) accepted for filing the Company’s Biologics License Application (BLA) for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) and granted the application Priority Review, with a target Prescription Drug User Fee Act (PDUFA) date of August 18, 2021. The Company anticipates initiating promotion to physicians and patients in the US upon approval, with commercial product supply broadly available to urology clinics by the fourth quarter of 2021.

In December 2020, Sesen Bio entered into a commercial manufacturing and supply framework agreement with Qilu Pharmaceutical in which both parties aligned on key components of the structure of a global supply partnership. The new global supply agreement with Qilu Pharmaceutical builds on the Company’s existing partnership by setting specific terms such as capacity, forecasts, pricing and product delivery. The completion of the global supply agreement expands the Company’s network of world-class partners committed to providing reliable supply of Vicineum worldwide. Sesen Bio is entitled to a $2 million milestone payment upon completion of technology transfer to Qilu Pharmaceutical, which the Company believes is on track for completion in 2021.

"Given the chronic product shortage issues that exist for patients with NMIBC, we have thoughtfully developed what we believe to be a very reliable and robust supply chain with world-class manufacturing partners," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Qilu Pharmaceutical has extensive biomanufacturing expertise and experience supplying products for commercial sale around the world, which positions them well to support the anticipated significant global demand for Vicineum."

Sesen Bio also continues to support Qilu Pharmaceutical in the development and commercialization of Vicineum in China. In March 2021, the Investigational New Drug (IND) application for Vicineum was approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) thereby triggering a $3 million milestone payment to Sesen Bio, which the Company received, net of taxes, on May 24, 2021. The approval of the IND enables Qilu Pharmaceutical to conduct the proposed clinical trial to assess the efficacy and safety of Vicineum for patients in China. It is anticipated that the first patient will be dosed in the trial within the next month. Assuming a successful trial, Qilu Pharmaceutical anticipates submission of the product market application for Vicineum in 2022 with potential approval in China expected in 2023.

About Vicineum

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted for filing the Company’s BLA for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of August 18, 2021. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. For this reason, the activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On June 2, 2021 QBiotics Group Limited (QBiotics), a life sciences company developing novel small molecule anticancer and wound healing pharmaceuticals, reported that it has dosed the first patient in the Phase Ib/IIa clinical trial of the company’s lead oncology molecule, tigilanol tiglate in combination with MSD’s immune checkpoint inhibitor KEYTRUDA (pembrolizumab) for patients with unresectable melanoma, the deadliest form of skin cancer (Press release, QBiotics, JUN 2, 2021, View Source;msd-clinical-trial-collaboration-for-unresectable-melanoma-301304596.html [SID1234583423]).

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The QB46C-H06 multi-centre, open label study will enrol approximately 22 patients with Stage IIIB to IV M1c-melanoma across a number of Australian sites over 24 months. The study will test up to three intratumoural doses of tigilanol tiglate at three escalating dose levels, administered 3 weeks apart in combination with intravenous pembrolizumab administered every 3 weeks for up to 24 months. The study will evaluate the safety, optimal dose and tumour response of the tigilanol tiglate and pembrolizumab combination in patients with late-stage unresectable melanoma, who have been previously exposed to immune checkpoint inhibitors.

Dr Victoria Gordon, Managing Director and CEO of QBiotics, said "We are very pleased to be collaborating with MSD in the fight against melanoma, a deadly form of skin cancer prevalent worldwide, but especially so here in Australia.

Dr Gordon continued "Patients with unresectable melanoma who have received prior checkpoint inhibitors currently have limited effective treatment options. We hope to see that when combined, tigilanol tiglate and KEYTRUDA may produce additive anti-tumour immune responses, improving outcomes for patients."

Over the last decade, the global cases of melanoma have increased by nearly 50 percent, with more than 320,000 people diagnosed annually. This translates to approximately 60,000 melanoma-related deaths per year[1]. Australia has the highest melanoma rates in the world, with one person diagnosed every 30 minutes, and an estimated 1,300 deaths each year.[2]

Tigilanol tiglate is a plant-derived small molecule, administered by injection directly into a solid tumour. Injected tumours are rapidly destroyed by tumour cell necrosis, vascular disruption, and immune-mediated mechanisms.[3] Pembrolizumab is a systemic immune checkpoint inhibitor, which reactivates the immune system by blocking the activity of PD-1, an immune checkpoint protein that prevents T cells from recognising and killing cancer cells.[4]

"The commencement of this trial with our first patient dosed is a significant milestone for QBiotics and is underpinned by positive outcomes from our Phase I QBC46-H01 Phase I study using tigilanol tiglate as a monotherapy in 22 patients with a broad range of refractory solid tumours. In this Phase I study a single injection of tigilanol tiglate showed an injected tumour response rate of 60% (CR of 20%, PR of 28%, SD of 12%).[5] Non-injected (abscopal) responses in distal tumours were observed in two patients with melanoma[6]," said Dr Gordon.

ABOUT TRIAL NCT04834973

A Phase Ib/IIa, multicentre, open label, dose-escalation study to evaluate the safety, tolerability, and preliminary effectiveness of intratumoural tigilanol tiglate in combination with intravenous pembrolizumab in adult patients with unresectable, Stage IIIB to IV M1c melanoma.

The primary objectives are 1. To determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) level of a single intratumoural injection of tigilanol tiglate administered in combination with intravenous pembrolizumab (200 mg), and 2. To assess the safety and tolerability of i) A single injection of tigilanol tiglate at escalating dose levels (dose-escalation) administered in combination with pembrolizumab; and ii) Repeat injections of tigilanol tiglate (maximum of 3) administered in combination with pembrolizumab. Secondary objectives include tumour responses according to RECIST 1.1 criteria, including loco-regional control of injected tumour(s) and non-injected tumour(s), and survival in patients. For more information, visit View Source

On June 1, 2021 Amgen (NASDAQ: AMGN) reported that it will host a webcast call for the investment community in conjunction with the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting at 4:00 p.m. ET on Friday, June 4, 2021 (Press release, Amgen, JUN 1, 2021, View Source [SID1234583310]). David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team, will discuss clinical data being presented on the Company’s recently FDA-approved KRASG12C inhibitor LUMAKRAS (sotorasib), anti-FGFR2b antibody bemarituzumab and delta-like ligand 3-targeting half-life extended bispecific T-cell engager (BiTE) tarlatamab.

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Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.