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ARTMS and Isotopia Molecular Imaging Announce Successful Multi-Curie Labeling of PSMA-11 With Cyclotron Produced 68Ga Utilizing the QUANTM Irradiation System™ and Solid Targets

On January 19, 2021 ARTMS Inc. (ARTMS) and Isotopia Molecular Imaging (Isotopia) reported that the successful radiolabeling of Isotopia’s prostate cancer imaging kit product, PSMA-11, with over 2 Ci of cyclotron-produced Gallium-68 (68Ga) using ARTMS’ proprietary Quantum Irradiation System (QIS) solid target system (Press release, ARTMS Products, JAN 19, 2021, View Source [SID1234574108]).

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The specially designed Prostate-Specific Membrane Antigen (PSMA) kit for the preparation of 68Ga-PSMA-11 (a radiopharmaceutical targeting PSMA for the imaging of prostate cancer using Positron Emission Tomography (PET)) was radiolabeled with high activity cyclotron produced 68Ga following irradiation times of less than two hours. The Isotopia kit was radiolabeled with between 500 mCi and just over 2900 mCi of 68Ga following multiple successful 68Ga production runs utilizing the QIS and ARTMS’ high performance 68Zn solid targets. The resultant product demonstrated 6-hour stability and radiochemical purity, which met or exceeded all regulatory standards. Cyclotron produced 68Ga combined with a kit solution will give radiopharmacies near unlimited access to this diagnostic product and a cost effective solution.

"The demand for 68Ga radiolabeled products will soon exceed the supply coming from 68Ge/68Ga generators. ARTMS’ QUANTM Irradiation System (QIS) allows for the high activity and high quality 68Ga production the Molecular Imaging community requires to properly serve their patients. The QIS’ multiple-curie per hour 68Ga production is one of the few true game changers I have seen during my career in Nuclear Medicine. We are very excited to bring on-demand 68Ga doses to clinicians and patients in collaboration with our partners," says Charles S. Conroy, Chief Executive Officer of ARTMS.

"Isotopia is focused on developing diagnostic and therapeutic tools that best serve our patients. We see 68Ga as a better diagnostic tool to pair with Lu177 treatments. Isotopia’s high activity PSMA "kit" is a major step forward in how the global imaging community diagnoses prostate cancer. Multi-dose vial preparation will allow pharmacies to provide unit doses and allow clinicians to image patients with little to no restrictions. In addition, a 5 minute preparation and more than 95% radiochemical purity will enhance efficiency and save the radiopharmacies time and money. We aim to keep introducing to the market kit-based solutions for 50 and 100mCi Generators, cyclotron produced 68Ga, and Lu177 labeling," says Dr. Eli Shalom, CEO of Isotopia Molecular Imaging.

ARTMS recently announced the approval for its cyclotron produced 99mTc product by Health Canada. ARTMS will continue the development of cyclotron-based products including 68Ga with a focus on optimizing production potential and satisfying regulatory requirements for use in radiopharmaceutical kits.

About Prostate Cancer
Prostate cancer is the fourth most common cancer worldwide. In 2018, 1.3 million men were diagnosed with prostate cancer for the first time. Despite advances in treatments, prostate cancer still accounts for a significant number of deaths. In 2018, more than 365,000 men died from the disease. Rates of diagnosis are increasing, and the highest levels of prostate cancer are found in the US, Europe, Australia, and New Zealand.

Iovance Biotherapeutics to Present at Upcoming Healthcare Conferences

On January 19, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that senior leadership plans to present at the following virtual healthcare conferences (Press release, Iovance Biotherapeutics, JAN 19, 2021, View Source [SID1234574107]):

B. Riley Oncology Investor Conference
Date/Time: Wednesday, January 20, 2021 at 1:00 p.m. ET
The live and archived webcast of the presentation will be available in the Investors section of the Iovance website at View Source
Guggenheim Healthcare Talks Oncology Days
Date/Time: Thursday, February 11, at 12:00 p.m. ET
The live and archived webcast of the presentation will be available in the Investors section of the Iovance website at View Source
7th Annual Immuno-Oncology 360° Conference – Event Information
Panel Title: Biotech CEO Leadership on the Business and Science of Cell and Gene Therapy
Date/Time: Tuesday, February 23, at 11:10 a.m. ET

Presentation Title: Tumor Infiltrating Lymphocyte Cell Therapy for Treatment of Solid Tumors
Date/Time: Tuesday, February 23, at 1:45 p.m. ET

EDAP to Participate in B. Riley Securities Virtual Oncology Investor Conference

On January 19, 2021 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in robotic energy based therapies, reported that Marc Oczachowski, President and CEO, will participate in a fireside chat at the B. Riley Securities Virtual Oncology Investor Conference on Wednesday, January 20, at 10:00 a.m. ET (Press release, EDAP TMS, JAN 19, 2021, View Source [SID1234574106]).

An audio webcast of the presentation will be available on replay on the "Events and Presentations" section of the EDAP’s investor website, View Source The replay of the webcast will be available on the Company’s website for 90 days.

Transgene and BioInvent Receive Approval From ANSM to Proceed With Phase I/IIa Trial of Anti-CTLA4-armed Oncolytic Virus BT-001 in Solid Tumors

On January 19, 2021 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported it has received approval from the French National Agency for the Safety of Medicines and Health Products (ANSM) to proceed with a Phase I/IIa study of the novel oncolytic Vaccinia virus BT-001 (Press release, Transgene, JAN 19, 2021, View Source [SID1234574105]). This announcement follows the approval received in December 2020 from the Belgian health authorities. The first patient is expected to be enrolled in this trial in the upcoming weeks.

BT-001 IS AN ONCOLYTIC VIRUS GENERATED WITH TRANSGENE’S INNOVATIVE INVIR.IO PLATFORM

BT-001 is based on the patented Invir.IO oncolytic virus (VVcopTK-RR-), and has been engineered to encode both a Treg-depleting human recombinant anti-CTLA4 antibody generated by BioInvent’s proprietary n-CoDeR/F.I.R.S.T platforms, and the human GM-CSF cytokine. By selectively targeting the tumor microenvironment, BT-001 is expected to elicit a much stronger and more effective antitumoral response and greatly increase the safety and tolerability profile of the anti-CTLA4 antibody. BT-001 is being co-developed through a 50/50 collaboration between Transgene and BioInvent.

IN FRANCE, FOUR CLINICAL CENTERS WILL ENROLL PATIENTS

"The development of BT-001 is progressing well and we are pleased to start this clinical trial in France with patients being enrolled across the country in four reference clinical centers, and in other hospitals in Europe. BT-001 is a highly innovative oncolytic virus, that has been designed to achieve a strong anti-tumor response by combining multiple mechanisms of action. We would like to thank the investigators and the clinical teams for their support and look forward to treating the first patients with this first Invir.IO generated oncolytic virus candidate to enter clinical development" said Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene.

In France, the BT-001 Phase I/IIa trial will be conducted in four clinical centers: the Bergonié Institute (Bordeaux), the Gustave Roussy Institute (Paris area), the Centre Léon Bérard (Lyon) and the Hôpital Saint-Louis (Paris).

This international study will enroll up to 48 patients with metastatic/advanced solid tumors in its Phase I part followed by expansion cohorts in its Phase IIa part. The trial will evaluate the administration of BT-001 as a single agent and in combination with pembrolizumab, an anti-PD1.

About the trial
The trial is a multicenter, open-label, dose-escalation Phase I/IIa trial evaluating BT-001 alone or in combination with pembrolizumab. The trial has been approved in Europe (France and Belgium) and will be next conducted in the USA. The Phase I will be divided into two parts. Part A will enroll up to 36 patients with metastatic/advanced solid tumors, who have already been pretreated, including with immunotherapies. Patients will receive single agent, intra-tumoral administrations of BT-001, in cutaneous or palpable subcutaneous lesions or easily injectable lymph nodes, to select the recommended dose and best regimen. Part B will explore the combination of intra-tumoral injections of BT-001 with pembrolizumab, an anti-PD1 targeting agent in 12 patients. The Phase IIa will evaluate the combination regimen in several patient cohorts with different tumors types. These expansion cohorts will offer the possibility of exploring the activity of this approach to treat other malignancies not traditionally addressed with this type of treatment.

About BT-001
BT-001 is a best-in-class oncolytic virus developed with Transgene’s Invir.IO platform. Invir.IO’s viruses are based on the patented large capacity Vaccinia virus Copenhagen strain genetically modified with the double deletion TK-RR-. This optimization enhances the safety profile of the virus. From this, BT-001 is engineered to encode both a highly differentiated Treg depleting anti-CTLA4 antibody and the human GM-CSF cytokine. The recombinant antibody recognizing human CTLA4 was generated by BioInvent’s proprietary n-CoDeR/F.I.R.S.T platforms. The use of an oncolytic virus to deliver the anti-CTLA4 locally and selectively in the tumor microenvironment allows high intratumoral concentrations of both transgenes eliciting a stronger and more effective antitumor response. By reducing systemic exposure to a very low level, this local therapeutic activity furthermore allows to increase the safety and tolerability profile of the anti-CTLA4 antibody. Preclinical data have shown that BT-001 has potential for broad single agent activity, and that selective tumor-localized delivery of anti-CTLA4 may allow for a better tolerated, sustained and more effective combination therapy with antibodies targeting the PD-1/PDL1 axis.
A multicenter, open-label, dose-escalation Phase I/IIa trial evaluating BT-001 alone or in combination with pembrolizumab has been approved in Europe (France and Belgium) and should be next conducted in the USA.
The scientific and clinical development of the oncolytic virus candidate BT-001 is a 50/50 collaboration between BioInvent and Transgene.

OncoSec Enters into Option Agreement with Sirtex Medical to Co-Promote TAVO™

On January 19, 2021 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec") reported it entered into an agreement with Sirtex Medical, Inc. (Sirtex) granting Sirtex an option to non-exclusively co-promote the Company’s lead product candidate, TAVO (tavokinogene telseplasmid) in anti-PD-1 checkpoint refractory metastatic melanoma in the U.S (Press release, OncoSec Medical, JAN 19, 2021, View Source [SID1234574104]). By entering into this co-promotion, OncoSec intends to capitalize on both the extensive experience Sirtex has in marketing drug/device combination products, as well as their established oncology sales force in the U.S.

Daniel O’Connor, President and Chief Executive Officer of OncoSec, stated, "Sirtex is a strong company with significant experience in the sales and marketing of drug/device combination products to treat cancer. This deal provides OnocSec with the potential to commercialize TAVO with a highly skilled U.S. sales force in this initial indication, while retaining the right to grant others the ability to do so and the flexibility to buy back the rights if warranted."

Under the terms of the agreement, Sirtex will pay OncoSec $5 million for a non-exclusive option to co-promote TAVO in combination with KEYTRUDA in patients with anti-PD-1 checkpoint refractory metastatic melanoma in the U.S. If exercised, this option would require Sirtex to pay an additional $20 million in cash and purchase $5 million in common stock of the Company at a market price. The option must be exercised by Sirtex within 90 days of OncoSec’s filing a Biologics License Application (BLA) with the FDA and carries a co-promote term of eight years. OncoSec reserves the right to grant others co-promotion rights, as well as the right to buy back the co-promotion rights for a certain amount determined by the remaining number of years left in the term, but not to exceed $45 million.

Kevin Smith, Chief Executive Officer of Sirtex, stated, "Sirtex has an established oncology sales force in the U.S. and welcomes the opportunity to leverage our resources to market TAVO in patients with anti-PD-1 checkpoint refractory metastatic melanoma in the U.S. We are very impressed with the progress OncoSec has made to date and believe that TAVO represents a viable opportunity to address this high unmet medical need."

If exercised, the option would require Sirtex to field a sales force to promote TAVO among key target audiences to be agreed upon by OncoSec and Sirtex. To support these efforts, OncoSec will provide materials to help train Sirtex’s team of sales representatives. The companies will share the sales and marketing costs, with OncoSec assuming approximately two thirds of such costs and Sirtex assuming approximately one third. OncoSec will pay Sirtex a high-teens royalty on net sales in the indication in the U.S. The companies will establish a joint committee pertaining to sales and marketing activities to be undertaken, with OncoSec retaining final decision making authority for all matters relating to TAVO, including, but not limited to, pricing, supply terms, manufacturing and clinical trials. Additionally, OncoSec shall invoice and book all sales.

Sirtex is a global healthcare business with offices in the U.S., Australia, Europe and Asia, working to improve outcomes in people with cancer. Sirtex’s current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres Y-90 resin microspheres. More than 100,000 doses have been supplied to treat patients with liver cancer at more than 1,400 medical centers in over 50 countries. For more information, visit www.sirtex.com.

About TAVO

OncoSec’s gene therapy technology combines TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), with an intra-tumoral electroporation gene delivery platform to achieve endogenous IL-12 production in the tumor microenvironment that enables the immune system to target and attack tumors throughout the body. TAVO has demonstrated a local and systemic anti-tumor response in several clinical trials, including the pivotal Phase 2b trial KEYNOTE-695 for metastatic melanoma and the KEYNOTE-890 Phase 2 trial in triple negative breast cancer (TNBC). TAVO has received both Orphan Drug and Fast-Track Designation by the U.S.Food & Drug Administration for the treatment of metastatic melanoma.