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MOMA Therapeutics Appoints Asit Parikh, M.D., Ph.D. as President and Chief Executive Officer

On February 1, 2021 MOMA Therapeutics, a biopharmaceutical company discovering the next generation of precision medicines by targeting molecular machines that underlie human disease, reported that Asit Parikh, M.D., Ph.D., has been appointed as the company’s president and chief executive officer, effective April 5, 2021 (Press release, MOMA Therapeutics, FEB 1, 2021, View Source [SID1234574469]). Dr. Parikh brings more than 20 years of academic and industry experience to MOMA. He will succeed interim founding CEO, Reid Huber, Ph.D., a partner at Third Rock Ventures, who will remain on MOMA’s Board of Directors.

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"Asit shares MOMA’s singular focus on patients and brings to our team a deep and diverse R&D, strategy and business background. His experience leading successful interdisciplinary teams and building innovation-rich product portfolios will be highly synergistic with MOMA’s team of passionate drug hunters," said Dr. Huber. "Asit’s appointment as MOMA’s CEO marks an important milestone toward our goal of transforming the lives of patients. We are thrilled to welcome him to our team."

Prior to MOMA, Dr. Parikh served as senior vice president and head of Takeda’s gastroenterology unit since 2012. Under his leadership, Takeda has achieved global approvals for Entyvio for ulcerative colitis and Crohn’s disease, European adult and U.S. pediatric approvals for Gattex/Revestive for short bowel syndrome, Japan and China approvals for Takecab/Vocinti for acid related disorders, a European approval for Alofisel for perianal fistulizing Crohn’s disease, and a U.S. approval for Motegrity for chronic constipation. Prior to Takeda, he worked in the clinical research division at Millennium Pharmaceuticals, where he held leadership roles in inflammation and oncology drug development. Dr. Parikh remains actively engaged in the practice of medicine as a consulting gastroenterologist at Newton-Wellesley Hospital in Newton, Mass., and serves as a board member of Ambys Medicines, Phathom Pharmaceuticals and Vanderbilt University School of Medicine, Basic Sciences. Dr. Parikh earned his Ph.D. in biochemistry and M.D. from Vanderbilt University, completed his internal medicine residency at the University of Pennsylvania and subspecialty training in gastroenterology at Massachusetts General Hospital. He performed postdoctoral research in cancer biology at the Massachusetts Institute of Technology.

"I joined MOMA in large part because of its unique and compelling vision – the possibility that systematically drugging molecular machines can deliver an entirely new class of medicines to patients who need them," said Dr. Parikh. "MOMA’s approach, coupled with its world-class team and scientific founders, represented an unprecedented opportunity to join a disruptive young biotech poised to make a true difference in medicine."

Legend Biotech Announces BCMA CAR-T Therapy Cilta-cel Accepted for Accelerated Assessment in Europe for the Treatment of Relapsed and/or Refractory Multiple Myeloma

On February 1, 2021 Legend Biotech Corporation (NASDAQ: LEGN) ("Legend Biotech"), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has accepted a request for an accelerated assessment of the Marketing Authorisation Application (MAA) for the investigational B-cell maturation antigen (BCMA) targeted chimeric antigen receptor T-cell (CAR-T) therapy ciltacabtagene autoleucel (cilta-cel) (Press release, Legend Biotech, FEB 1, 2021, View Source [SID1234574468]).

The request was made by Legend’s collaborator, Janssen Biotech, Inc. (Janssen). An accelerated assessment of the MAA is granted by the CHMP when a medicinal product is expected to be of major public health interest and therapeutic innovation.1

The MAA, which is targeted for submission in the first half of 2021, is based on results from the pivotal Phase 1b/2 CARTITUDE-1 study which evaluated the efficacy and safety of cilta-cel in the treatment of patients with relapsed and/or refractory multiple myeloma. Results from the study were presented (Abstract #177) at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting last month.2

"The acceptance of the request for an accelerated assessment is an important testament for the potential use of cilta-cel in treating patients with multiple myeloma," said Ying Huang, PhD, CEO and CFO of Legend Biotech. "Together with our collaborator Janssen, we look forward to working with the EMA as we advance this treatment option toward market and provide new hope for patients."

The accelerated assessment milestone in Europe follows the December 2020 announcement of initiation of a rolling submission of the Biologics License Application for cilta-cel to the U.S. Food and Drug Administration (FDA). Cilta-cel previously received a PRIority MEdicines (PRiME) designation from the European Commission in April 2019.

About CARTITUDE-1

CARTITUDE-1 (NCT03548207) is an ongoing Phase 1b/2, open-label, multicenter study evaluating the safety and efficacy of cilta-cel in adults with relapsed and/or refractory multiple myeloma, 99 percent of whom were refractory to the last line of treatment; 88 percent of whom were triple-class refractory (to at least 1 immunomodulatory drug [IMiD], 1 proteasome inhibitor [PI] and 1 anti-CD38 antibody).3

The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the dose of cilta-cel, informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2). The Phase 2 portion further evaluated the efficacy of cilta-cel with overall response rate as the primary endpoint. 3

About Ciltacabtagene autoleucel (cilta-cel)

Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 outside of China and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed and/or refractory multiple myeloma and in earlier lines of treatment. The design consists of a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies. In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel.

In addition to a Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, cilta-cel received a BTD in China in August 2020. In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. FDA in February 2019, and by the European Commission in February 2020.

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.4 Although treatment may result in remission, unfortunately, patients will most likely relapse. 5 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory.6 Refractory multiple myeloma is when a patient’s disease is non-responsive or progresses within 60 days of their last therapy.7,8 While some patients with multiple myeloma have no symptoms until later stages of the disease, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.9 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options.10

Sensei Biotherapeutics Announces Launch of Initial Public Offering

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."

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.

SQZ Biotechnologies Announces FDA Clearance of IND Application to Allow for Clinical Trial with SQZ Activating Antigen Carriers (SQZ AACs) in Patients with HPV+ Tumors

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.

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.

Kadmon Announces Publication of Preclinical Data Demonstrating Anti-PD-L1/IL-15 Fusion Protein KD033 Achieves Robust Anti-Tumor Response

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.

"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.