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]).

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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.

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.

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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.

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.

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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.

On January 19, 2021 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a clinical-stage, oncology-focused biopharmaceutical company with a vision of transforming lives with safer, more effective therapies, reported that it has commenced an underwritten public offering of $75.0 million of its common stock (Press release, CytomX Therapeutics, JAN 19, 2021, View Source [SID1234574103]). In addition, CytomX expects to grant the underwriters a 30-day option to purchase up to an additional $11.25 million of its common stock at the public offering price, less underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares are to be offered by CytomX.

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CytomX expects to use the net proceeds from this offering to further develop its proprietary Probody therapeutics pipeline and research. In particular, CytomX expects to use the net proceeds, together with existing cash resources, to fund: (i) the advancement and expansion of the clinical development program for CX-2009, including the ongoing Phase 2 study of CX-2009 as monotherapy and in combination with CX-072 in breast cancer; (ii) the advancement and expansion of the clinical development program for CX-2029, including the ongoing Phase 2 study of CX-2029 in four types of cancer; (iii) IND enabling studies for CX-2043 and CX-904, their IND submissions and Phase 1 clinical development; and (iv) further research and development activities related to our Probody platform, the tumor microenvironment, new drug candidates and translational sciences. CytomX expects to use any remaining net proceeds from this offering for capital expenditures, working capital and other general corporate purposes.

J.P. Morgan Securities LLC, Cowen & Company, LLC and Piper Sandler & Co. are acting as joint bookrunning managers for the offering.

The securities are being offered pursuant to a registration statement that was filed with the Securities and Exchange Commission ("SEC") on November 6, 2018, amended on February 6, 2019, and was declared effective on February 11, 2019. A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC on January 19, 2021 and is available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may also be obtained for free from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 1-866-803-9204, or by emailing at [email protected]; Cowen & Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, via telephone: +1 (833) 297-2926, or via email: [email protected]; and Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification of these securities under the securities laws of any such state or jurisdiction.

On January 19, 2021 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that it is offering to sell shares of its common stock in an underwritten public offering (Press release, Syros Pharmaceuticals, JAN 19, 2021, View Source [SID1234574102]). The proceeds of the offering are expected to be used to fund the development of Syros’ ongoing clinical and preclinical programs, and for working capital and other general corporate purposes. All of the shares in the offering are to be sold by Syros. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering. Syros also intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock sold in the offering on the same terms and conditions.

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Cowen and Piper Sandler & Co. are acting as joint book-running managers for the offering.

The proposed offering is being made pursuant to a shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on June 12, 2020 and declared effective by the SEC on June 22, 2020. The offering will be made only by means of the prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to, and describing the terms of, the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov.

Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering can be obtained from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or by telephone at 833-297-2926; or from Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.