On June 18, 2019 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that it intends to offer and sell, subject to market conditions, shares of its common stock and warrants to purchase shares of its common stock in an underwritten public offering (Press release, Eleven Biotherapeutics, JUN 18, 2019, View Source [SID1234537135]). All of the shares of common stock and warrants to purchase shares of common stock to be sold in the offering will be offered by Sesen Bio. 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.

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Sesen Bio intends to use the net proceeds from this offering for the clinical development and FDA regulatory submission of Vicinium for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC), the continued development of commercial-scale manufacturing capabilities for Vicinium for the treatment of high-risk NMIBC by our third-party contract manufacturers (including the manufacturing process and technology transfer of Vicinium production to Fujifilm to support such efforts), the development of commercial capabilities for a potential launch of Vicinium, if approved, for the treatment of high-risk NMIBC, including investment to establish and continue to build our commercial infrastructure and supply chain, and general corporate purposes, which may include capital expenditures and other operating expenses.

Canaccord Genuity is acting as the sole book-running manager for the proposed offering.

A shelf registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on June 8, 2018. The offering is being made only by means of a written prospectus and a preliminary prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement, which will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, by contacting Canaccord Genuity LLC, Attention: Syndicate Department, 99 High Street, Suite 1200, Boston, MA 02110, by telephone at (617) 371-3900 or by email at [email protected].

This press release shall not constitute an offer to sell or a 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 June 18, 2019 Torque, a clinical-stage immuno-oncology company developing Deep-Primed T Cell Therapeutics to direct immune power deep within the tumor microenvironment, reported that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Torque’s first Deep-Primed T cell immunotherapy program, TRQ-1501 (Deep IL-15 Primed T cells) (Press release, Torque Therapeutics, JUN 18, 2019, View Source [SID1234537152]). The Fast Track designation is for the treatment of relapsed or refractory solid tumors and lymphomas that express any of five tumor-associated antigens (PRAME, WT-1, SSX2, Survivin, and NY-ESO-1). Torque is currently conducting a Phase 1/2 clinical trial of TRQ-1501 for this indication.

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"Patients with relapsed or refractory solid tumors and lymphomas have a poor prognosis and limited treatment options. We are delighted to receive this Fast Track designation of TRQ-1501 for a broad, tumor-agnostic indication, which provides significant flexibility for our clinical trial program," said Becker Hewes, MD, Chief Medical Officer of Torque. "Working in close collaboration with the FDA supports our goal of improving patient outcomes in multiple difficult-to-treat solid and hematologic cancers."

The FDA’s Fast Track designation is designed to facilitate the development and expedite the regulatory review of drugs and biologics that have shown the potential to address an unmet medical need associated with a serious or life-threatening disease. Fast Track status provides for more frequent interactions with the FDA during drug development and the possibility of Priority Review of New Drug or Biologic Licensing Applications.

About TRQ-1501
TRQ-1501 is an investigational immune cell therapy produced from a patient’s own T cells, which are primed to target multiple tumor-associated antigens (PRAME, WT-1, SSX2, Survivin, NY-ESO-1) and loaded with Deep IL-15 (a multimer of IL-15 cytokine) anchored to the T cells’ surface. A Phase 1/2 clinical trial of TRQ-1501 in solid cancers and lymphoma is currently enrolling (NCT03815682) and will evaluate TRQ-1501 both as a single agent and in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy.

About Torque’s Deep-Primed Immune Cell Therapy Platform
Torque is developing a new class of Deep-Primed cellular immunotherapy designed to overcome the key challenges limiting broad use of cellular therapy in oncology, including the capability to target tumors that express multiple heterogeneous antigens, the ability to overcome the immunosuppressive microenvironment that shuts down T cell function, and the need for outpatient treatment with a high margin of safety. Torque uses its Deep-Priming technology to develop multi-targeted, antigen-primed T cells that carry surface-anchored immune-stimulatory drugs to drive a full immune response within the tumor microenvironment against tumors with heterogenous antigens.

Torque’s Deep-Priming platform uses advanced cell process engineering to:

prime and activate T cells to target multiple tumor antigens and
tether immune-stimulatory drugs to the surface of these multi-target T cells to direct immune activation in the tumor microenvironment
using a proprietary technology platform, without genetic engineering, for a high margin of safety.
Deep-Primed T cells both target multiple tumor antigens and pharmacologically activate an immune response with anchored cytokines. This process does not require genetic engineering of the T cells and so preserves the natural T cell receptor for delivering a regulated immune response, with the potential for a high margin of safety. In addition to antigen priming, immunomodulators are tethered to the surface of Deep-Primed T cells—initially IL-15 and IL-12 cytokines, and TLR agonists—that activate both innate and adaptive immunity. Administering these immunomodulators systemically to a patient can cause lethal toxicity by activating immune cells throughout the body. By loading precise doses of cytokines onto the surface of T cells, Deep Priming focuses the immune response to target the tumor, without systemic exposure.

In hematologic cancers, this new class of immune cell therapeutics has the potential to improve on the initial success of single-target CAR T therapeutics with expanded efficacy and also move cell therapy treatment out of the hospital with a high margin of safety. For solid tumors, Deep-Primed T cells have the potential to enable efficacy against tumors with heterogeneous antigens protected by hostile microenvironments, which are not readily addressable with the first generation of immune cell therapies.

On June 18, 2019 RAPT Therapeutics, Inc., a clinical-stage immunology-based biopharmaceutical company developing oral small molecules for oncology and inflammatory diseases, reported that it secured an additional $37 million in an extension of its Series C financing (Press release, RAPT Therapeutics, JUN 18, 2019, https://www.rapt.com/rapt-therapeutics-completes-37-million-series-c-extension/ [SID1234537136]). The extension of the financing round included funds and accounts advised by T. Rowe Price Associates, Inc. as well as existing investors The Column Group (through its affiliated Ponoi Capital funds), GV (formerly Google Ventures), Kleiner Perkins, Topspin Partners, and Celgene Corporation.

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"We continue to advance our pipeline of oral small molecule therapeutics, with proof-of-concept results expected in the first half of 2020 from our FLX475 program targeting multiple cancers and in mid-2020 from our RPT193 program in atopic dermatitis," said Brian Wong, M.D., Ph.D., president and CEO of RAPT Therapeutics. "We appreciate the belief in our vision to use our immunology-based drug discovery and development engine to bring new therapeutics to patients in need of safe and effective treatment options, both in cancer and in inflammatory disease."

On June 18, 2019 Kleo Pharmaceuticals, Inc. (Kleo), an immuno-oncology company developing next-generation synthetic bispecific compounds designed to emulate or enhance the activity of biologics, reported that CD38-ARM, a CD38 targeting antibody recruiting molecule (ARM) to treat multiple myeloma, will be its first product candidate to move into the clinic with anticipated human studies to commence in 2020 (Press release, Kleo Pharmaceuticals, JUN 18, 2019, View Source [SID1234537153]).

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CD38-ARM is designed to recruit endogenous antibodies to multiple myeloma cancer cells, targeting them for destruction by natural killer (NK) cells and macrophages. CD38 is a validated multiple myeloma target, which is also overexpressed in chronic lymphocytic leukemia and other cancers. The molecule was chosen after showing positive signals towards safety and efficacy in preclinical models. This is the first candidate to emerge from Kleo’s strategic alliance with PeptiDream Inc., (Tokyo:4587).

"We’re excited to announce CD38-ARM as the first clinical candidate for Kleo, which is also the first clinical candidate resulting from our collaboration agreement with PeptiDream," said Douglas Manion, MD, CEO of Kleo. "PeptiDream’s PDPS technology and Kleo’s ARM platform together have created a product candidate we intend to advance into the clinic next year. CD38-ARM is being developed to enhance, complement or replace currently marketed anti-CD38 multiple myeloma drugs through better safety and efficacy. We are hopeful CD38-ARM will be the first of a series of novel clinical candidates to emerge from our innovative development platforms."

"PeptiDream takes great pride in being a strong leader in transforming peptides into new effective treatment options using our Peptide Discovery Platform System (PDPS)," stated Patrick Reid, PhD, CEO of PeptiDream. "We are pleased to partner with Kleo in CD38-ARM’s advancement into the clinic recognizing its potential in becoming the next generation of first-in-class and best-in-class immunotherapies."

On June 18, 2019 G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, reported preliminary overall survival (OS) results from a randomized Phase 2 trial which demonstrated that women with metastatic triple-negative breast cancer (mTNBC) lived significantly longer when receiving trilaciclib and chemotherapy compared with women receiving chemotherapy alone (Press release, G1 Therapeutics, JUN 18, 2019, View Source [SID1234537137]). Detailed data from this trial will be presented at a medical meeting later this year.

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Myelopreservation results, objective response rate (ORR), progression-free survival (PFS) and safety data from this trial were presented at the 2018 San Antonio Breast Cancer Symposium (SABCS). Updated anti-tumor efficacy results demonstrated that women receiving trilaciclib and a chemotherapy regimen of gemcitabine/carboplatin had a statistically significant improvement in OS compared with those receiving gemcitabine/carboplatin alone.

"Triple-negative breast cancer is the most aggressive type of breast cancer, and women diagnosed with metastatic TNBC need new treatment options. We look forward to sharing these data with regulators, as well as presenting findings from this trial at a medical meeting later this year," said Mark Velleca, M.D., Ph.D., Chief Executive Officer. "As a company committed to improving the lives, treatment options and outcomes of those living with cancer, we’re proud to have a pipeline that now includes three investigational therapies with the potential to become new standards of care for those with breast cancer and benefit women at the earliest stages of their disease."

About the Study

This randomized, open-label Phase 2 clinical trial (NCT02978716) enrolled 102 patients with mTNBC who had received 0-2 prior lines of therapy in the recurrent/metastatic setting. In this three-arm trial, all patients received a chemotherapy regimen of gemcitabine/carboplatin (GC). Patients were randomized to receive GC only or GC plus one of two dosing schedules of trilaciclib: trilaciclib administered on the day of chemotherapy or trilaciclib administered the day prior to and the day of chemotherapy. Primary endpoints for the trial included myelopreservation measures; secondary endpoints included additional myelopreservation measures and anti-tumor efficacy measures of ORR, PFS and OS.

Topline OS improvements were statistically significant in both trilaciclib arms compared with the control arm. ORR and PFS data were consistent with results presented at SABCS 2018. The safety and tolerability of trilaciclib were consistent with previously reported data and there have been no serious adverse events attributed to treatment with trilaciclib in this trial.

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About Trilaciclib

Trilaciclib is a first-in-class myelopreservation agent designed to protect the bone marrow from damage by chemotherapy and improve patient outcomes. G1 expects to submit marketing applications in the U.S. and Europe for myelopreservation in small cell lung cancer in 2020. In a randomized trial of women with metastatic triple-negative breast cancer, trilaciclib improved overall survival when administered in combination with chemotherapy compared with chemotherapy alone. The company plans to initiate additional randomized trials to evaluate the myelopreservation and survival benefits of trilaciclib in other tumor types and chemotherapy regimens.