On February 1, 2021 Exelixis, Inc. (Nasdaq: EXEL) and Adagene reported a collaboration and license agreement under which Exelixis will utilize Adagene’s SAFEbody technology platform to generate masked versions of monoclonal antibodies from Exelixis’ growing preclinical pipeline for the development of ADCs or other innovative biologics against Exelixis-nominated targets (Press release, Exelixis, FEB 1, 2021, View Source [SID1234574449]). Under the terms of the agreement, Exelixis will make an upfront payment of $11 million to Adagene and will have the ability to nominate two targets during the collaboration term. Adagene will be eligible for development and commercialization milestones, as well as royalties on net sales of products developed around each of these targets.

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"SAFEbody provides a solution to on-target off-tumor toxicity, which is a long-lasting challenge associated with many approved antibody therapeutics," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer, and Chairman of Adagene. "This partnership with Exelixis strengthens our growing roster of collaborations with global biopharmaceutical companies. We are very pleased to collaborate with Exelixis and look forward to the company’s development of ADCs that leverage our SAFEbody technology."

Biologic therapies, including therapeutic antibodies such as ADCs, are designed to bind to their targets with high efficiency. However, while the targets for biologic cancer therapies are expressed at high levels in cancer cells, many are also expressed at lower levels on healthy cells. Binding of these therapies to healthy cells may lead to unwanted safety or tolerability issues. Adagene’s SAFEbody platform is designed to overcome this challenge by incorporating a masking peptide that covers the binding domain of the biologic therapy. Specific conditions within the tumor environment allow the biologic therapy to preferentially bind to its target in tumor cells. This allows for improved tumor-specific targeting of antibodies while minimizing on-target toxicity in healthy tissues. Adagene’s most advanced SAFEbody candidate has been approved to start a clinical trial in Australia and the United States.

"As we expand our pipeline beyond small molecule therapies, we are committed to developing novel biotherapeutics that are optimized for safety and efficacy," said Peter Lamb, Ph.D., Executive Vice President, Scientific Strategy and Chief Scientific Officer of Exelixis. "We believe the SAFEbody platform has the potential to significantly improve the safety profile of ADCs, and we will initially focus on incorporating this innovative technology into novel ADCs that also utilize next-generation linkers and payloads. The combination of these cutting-edge technologies is expected to yield ADC product candidates with differentiated target profiles and/or improved therapeutic indices. We are committed to expanding our development pipeline into additional therapeutic classes even as we drive additional momentum toward broadening the label for cabozantinib into additional cancer indications."

On February 1, 2021 SQZ Biotechnologies (NYSE: SQZ), a cell therapy company developing novel treatments for multiple therapeutic areas, reported that the company’s Investigational New Drug (IND) application for SQZTM Activating Antigen Carriers (SQZ AACs) in HPV+ tumors was cleared by the U.S. Food and Drug Administration (FDA) (Press release, SQZ Biotech, FEB 1, 2021, View Source [SID1234574465]). The clinical trial will investigate SQZ-AAC-HPV, a cell therapy candidate generated from red blood cells (RBCs) engineered with tumor-specific antigen to treat HPV+ tumors. This trial, SQZ-AAC-HPV-101, marks the first clinical program from the company’s wholly-owned SQZ AAC platform.

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SQZ AACs are a novel cellular immunotherapy candidate designed to transport tumor-specific antigen and TLR agonists to the patient’s endogenous, professional, antigen presenting cells in vivo. These antigen presenting cells are capable of potent T cell activation that could potentially drive an anti-tumor effect. In preclinical studies, SQZ AACs in mouse models have demonstrated robust immune responses, CD8 T cell infiltration, and correlated tumor reduction.

"Advancing our SQZ AAC program into the clinic is a significant milestone for our team," said Armon Sharei, PhD, founder and chief executive officer of SQZ Biotechnologies. "This program further illustrates the broad cell engineering capabilities of our core technology and the diversity of our pipeline. SQZ AACs potentially open another dimension of biology where SQZ cell therapy candidates could drive patient impact."

The Phase 1 multi-center trial will enroll multiple cohorts to assess SQZ-AAC-HPV as both monotherapy and in combination with other immunoncology therapies. HLA-A*02+ patients with recurrent, locally advanced or metastatic HPV16+ head & neck, cervical, anal, penile, vulval and vaginal cancers are all eligible for the study.

"We are dedicated to leveraging our unique capabilities and novel cell therapy candidates to try to improve patients’ lives by offering them potential outcomes that they need and deserve. SQZ AACs are our next approach for a potential differentiated cell therapy targeting solid tumors that could represent an exciting evolution in the cancer patient experience," said Oliver Rosen, MD, chief medical officer.

About SQZ-AAC-HPV

SQZ AACs are generated by squeezing red blood cells (RBCs) with an antigen and activating adjuvant. The process is tuned to make the engineered RBCs appear aged. Once administered to patients, SQZ AACs aim to be rapidly taken up by professional antigen presenting cells through a natural process to destroy aged RBCs in the body known as eryptosis. To take advantage of this process, SQZ AACs are designed to act as a "Trojan horse" to deliver significant quantities of antigen and activation factors to the professional, endogenous antigen presenting cells in the lymphoid organs and drive subsequent activation of T cells specific to HPV+-tumors. SQZ-AAC-HPV is the first product candidate from the SQZ AAC platform.

On February 1, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will participate in the following conferences and invited investors to participate by webcast (Press release, Exact Sciences, FEB 1, 2021, View Source [SID1234574482]).

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BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference
Fireside Chat on Thursday, February 18, 2021 at 10:30 a.m. EST
Citi Healthcare Services, Medtech, Tools, & HCIT Virtual Conference
Fireside Chat on Wednesday, February 24, 2021 at 9:50 a.m. EST
SVB Leerink Global Healthcare Virtual Conference
Fireside Chat on Thursday, February 25, 2021 at 1:40 p.m. EST
The webcasts can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

On February 1, 2021 argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, reported that it has commenced a global offering of $750 million (approximately €618 million) of ordinary shares, which may be represented by American Depository Shares ("ADSs") (Press release, argenx, FEB 1, 2021, View Source [SID1234574666]). The global offering will be comprised of an offering of ordinary shares represented by ADSs in the United States and certain other countries outside of the European Economic Area and a simultaneous private placement of ordinary shares in the European Economic Area and the United Kingdom. Each of the ADSs represents the right to receive one ordinary share, nominal value of €0.10 per share. The U.S. offering and the European private placement are expected to close simultaneously.

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In addition, argenx intends to grant the underwriters of the offering a 30-day option to purchase additional ordinary shares (which may be represented by ADSs) in an aggregate amount of up to 15% of the total number of ordinary shares (including represented by ADSs) proposed to be sold in the offering, on the same terms and conditions.

Baillie Gifford Overseas Limited and entities affiliated with it have indicated an interest in purchasing an aggregate of up to $415 million (approximately €342 million) of ordinary shares in this offering at the offering price per share and on the same terms as the other purchasers in this offering. However, because indications of interest are not binding agreements or commitments to purchase, the underwriters could determine to sell more, fewer or no ordinary shares to these potential purchasers, and these potential purchasers could determine to purchase more, fewer or no shares in this offering.

argenx’s ADSs are currently listed on the Nasdaq Global Select Market under the symbol "ARGX." and argenx’s ordinary shares are currently listed on Euronext Brussels under the symbol "ARGX.".

J.P. Morgan, Morgan Stanley, BofA Securities and Cowen are acting as joint bookrunning managers for the offering.

The securities are being offered in the United States pursuant to an automatically effective shelf registration statement that was previously filed with the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement relating to the securities being offered in the United States will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities being offered in the United States may be obtained for free from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; from Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attn: Prospectus Department, by email at [email protected], or by telephone at (866) 718-1649; from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, North Carolina 28255-0001, Attn: Prospectus Department, or by email at [email protected]; or from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected], or by telephone at (833) 297-2926.

A request for the admission to listing and trading of the ordinary shares (including the ordinary shares underlying the ADSs) on the regulated market of Euronext Brussels will be made following pricing of the offering.

This press release is for information purposes only and does not constitute, and should not be construed as, an offer to sell or the solicitation of an offer to buy or subscribe to any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale is not permitted or to any person or entity to whom it is unlawful to make such offer, solicitation or sale. Reference is also made to the restrictions set out in "Important information" below. This press release is not for publication or distribution, directly or indirectly, in or into any state or jurisdiction into which doing so would be unlawful or where a prior registration or approval is required for such purpose.

On February 1, 2021 Sensei Biotherapeutics, Inc., a clinical-stage immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, reported that it has launched an underwritten initial public offering of 5,885,000 shares of its common stock at an anticipated initial public offering price between $16.00 and $18.00 per share pursuant to a registration statement on Form S-1 filed with the U.S. Securities and Exchange Commission (the "SEC") (Press release, Sensei Biotherapeutics, FEB 1, 2021, View Source [SID1234574466]). In addition, Sensei intends to grant the underwriters a 30-day option to purchase up to an additional 882,750 shares of common stock. All of the shares to be sold in the proposed offering will be offered by Sensei. Sensei has applied to list the shares on the Nasdaq Global Market under the symbol "SNSE."

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Citigroup, Piper Sandler and Berenberg are acting as joint book-running managers for the offering. Oppenheimer & Co. is acting as the lead manager for the proposed offering. 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.

The proposed offering of these securities is being made only by means of a prospectus. A copy of the preliminary prospectus may be obtained from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 800-831-9146 or by email at [email protected]; 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]; or Berenberg Capital Markets LLC, Attention: Investment Banking, 1251 Avenue of the Americas, 53rd Floor, New York, NY 10020, or by telephone at 646-949-9000 or by email at [email protected].

Sensei is offering access to roadshow materials to both institutional and retail investors. Interested retail investors can view the management presentation at www.retailroadshow.com/?link=SNSE.

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 under the securities laws of any such state or jurisdiction.