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.

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 Kadmon Holdings, Inc. (NASDAQ:KDMN) reported the publication of preclinical data demonstrating that KD033, the Company’s anti-PD-L1/IL-15 fusion protein, achieved robust anti-tumor responses in multiple syngeneic tumor models (Press release, Kadmon, FEB 1, 2021, View Source [SID1234574464]). The data were published in Molecular Cancer Therapeutics, an American Association for Cancer Research (AACR) (Free AACR Whitepaper) journal. KD033 is currently being evaluated in a Phase 1 study in patients with metastatic or locally advanced solid tumors.

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"These preclinical data demonstrate the ability of KD033 to produce meaningful efficacy and generate a memory response in a variety of tumors after a single dose," said Harlan W. Waksal, M.D., President and CEO of Kadmon. "The biological activity and safety shown to date further reinforce the potential of KD033 to stimulate innate and adaptive immune responses in patients with metastatic or locally advanced solid tumors."

KD033 is an antibody-cytokine fusion protein harnessing the immunostimulatory activity of IL-15. The IL-15 cytokine expands key tumor-fighting immune cells, including natural killer (NK), NKT and memory CD8 cells, to induce long-lasting responses. Importantly, IL-15 does not expand immunosuppressive Treg CD4 cells, allowing for a robust and durable anti-tumor response. With KD033, Kadmon has fused IL-15 to a PD-L1 antibody to direct IL-15 activity to the tumor microenvironment, promoting efficacy and inducing durable responses while potentially increasing tolerability.

Preclinical data published in MCT demonstrated that a single dose of KD033 inhibited tumor growth across multiple in vivo syngeneic tumor models and achieved dose-dependent efficacy in a resistant melanoma syngeneic mouse model. KD033 induced a strong immune memory response with a single treatment, resulting in mice that remained tumor-free following several tumor re-challenges. Furthermore, KD033 in combination with anti-PD1 therapy demonstrated synergistic activity, providing rationale for administering KD033 in combination with other immune checkpoint inhibitors.

The manuscript, titled "Single-dose anti-PD-L1/IL-15 fusion protein KD033 generates synergistic anti-tumor immunity with robust tumor-immune gene signatures and memory responses," is now available online preprint at View Source and will be published in the journal’s February 2021 issue.

About the KD033-101 Clinical Trial

KD033-101 is a Phase 1, open-label, dose-escalation and dose-expansion study investigating the safety and efficacy of KD033 in patients with metastatic or locally advanced solid tumors. The dose-escalation phase of the study will evaluate the pharmacokinetics and pharmacodynamics and identify the maximum tolerated dose (MTD) of KD033. The dose-expansion phase of the study will enroll approximately 15 patients who have progressed or are refractory to programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor therapy to assess safety, efficacy and determine the recommended Phase 2 dose (RP2D) of KD033.

About KD033

KD033 is a novel immunotherapy developed in-house and is fully owned by Kadmon. KD033 combines an anti-PD-L1 antibody with IL-15, a cytokine that expands key tumor-fighting cell types, including natural killer (NK), natural killer T (NKT) and memory T cells, to potentially induce durable responses and inhibit tumor growth. The anti-PD-L1 antibody directs IL-15 activity to the tumor microenvironment, limiting systemic exposure of IL-15 to potentially increase safety and tolerability. KD033 was well tolerated in GLP toxicology studies at clinically relevant doses. KD033 process development and manufacturing was completed through a successful collaboration with Wuxi Biologics and exhibited desired manufacturability and stability criteria.

KD033 is the most advanced candidate from Kadmon’s IL-15 fusion protein platform. The Company is developing a portfolio of therapies combining IL-15 with select antibodies for the treatment of cancer.

On February 1, 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 January 29, 2021 the Company participated in a productive Application Orientation Meeting with the FDA regarding its Biologic License Application (BLA) for Vicineum, for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) (Press release, Sesen Bio, FEB 1, 2021, View Source [SID1234574463]).

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After the Company submitted its BLA to the FDA in December 2020, Sesen Bio was invited to participate in an Application Orientation Meeting, which is available in certain Center for Drug Evaluation and Research (CDER) review divisions, at the review team’s discretion, for priority applications where early action is expected and/or desired. The objectives of an Application Orientation Meeting include familiarizing the FDA with application datasets, discussing scientific aspects including clinical risk-benefit, and establishing early communication between applicants and the FDA.

"We are very pleased with the outcome of Friday’s 90-minute meeting with the FDA," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "We continue to believe Vicineum has a favorable risk-benefit profile which positions it to be best-in-class, and we are encouraged by the high level of time and engagement the FDA has demonstrated toward our review. We look forward to continuing to work with the FDA to expeditiously bring Vicineum to the market."

The Company expects to learn if the BLA is accepted for filing by the FDA on February 16, 2021. If the file is accepted, in the following two to four weeks, the Company expects to receive a decision on the following three items:

Priority vs. Standard review
Target PDUFA date for approval
Necessity of an FDA Advisory Committee meeting
About Vicineum

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk 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 high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. In December 2020, Sesen Bio completed the BLA submission for Vicineum to the FDA. 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. 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 February 1, 2021 Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported that Bill Lundberg, M.D., Chief Executive Officer, will participate in the following investor conferences (Press release, Merus, FEB 1, 2021, View Source [SID1234574462]):

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Guggenheim Healthcare Talks 2021 Oncology Days (Fireside chat): Friday, Feb. 12 at 10:30-10:55 a.m. ET

LifeSci Partners Precision Oncology Day (Presentation): Wednesday, Feb. 17 at 10:30-10:55 a.m. ET

2021 SVB Leerink Global Healthcare Conference (Presentation): Friday, Feb. 26 at 8:40-9:10 a.m. ET

The live webcasts of the presentations will be available on the Investors page of the Company’s website, View Source An archived presentation will be available on the Merus website for a limited time.