On April 16, 2020 F-star Therapeutics Ltd., a clinical-stage biopharmaceutical company focused on transforming the lives of patients with cancer through the development of innovative tetravalent bispecific antibodies (mAb2), reported the publication in Clinical Cancer Research of preclinical data highlighting the potential novel mechanism of action of its wholly-owned lead clinical asset FS118, a LAG-3/PD-L1-targeting tetravalent bispecific antibody (Press release, F-star, APR 16, 2020, View Source;1 [SID1234556384]).

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FS118 is currently in a Phase 1 study in patients with late-stage solid tumors who have relapsed following prior successful PD-(L)1 therapy.

Despite advances with therapies targeting the highly immuno-suppressive molecules PD-1 (programmed cell death protein 1) or its ligand, PD-L1, many cancer patients are refractory to, or relapse following treatment. Relapse is associated with upregulation of other checkpoint inhibitor receptors such as LAG-3 (Lymphocyte Activation Gene 3). FS118 was selected for development based on its ability to overcome immunosuppression mediated by both LAG-3 and PD-L1 in cancer patients.

The in vitro and in vivo studies reported in Clinical Cancer Research demonstrated that FS118 simultaneously bound LAG-3 and PD-L1 with high affinity. FS118 showed a greater enhancement in T cell activity, and reversal of LAG-3 and PD-L1 immunosuppression, than the combination of the single component parts of the bispecific antibody. The authors concluded that targeting both LAG-3 and PD-L1 in a single tetravalent bispecific antibody can work synergistically to overcome inhibition of T cell activation.

In tumor mouse models, a bispecific antibody targeting LAG-3/PD-L1 significantly suppressed tumor growth. The anti-tumor immune response was greater than using PD-L1 or LAG-3 antibody monotherapy and was also more effective than a combination of those monotherapies. These data demonstrated that a LAG-3/PD-L1 targeting tetravalent bispecific antibody can provide dual blockade of LAG-3 and PD-L1 in vivo and can enhance the anti-tumor immune response.

The authors concluded that the study demonstrated a benefit from FS118, not observed with the combination of single PD-L1 and LAG-3 monoclonal antibodies, to drive a potent anti-tumor response, supporting the further development of FS118 for the treatment of patients with cancer.

Neil Brewis, Chief Scientific Officer of F-star, said: "These data are the foundation for our confidence in FS118 and its potential to overcome cancer immune resistance. Currently only the minority of patients realize durable benefit from immunotherapy, so there remains a huge need to develop more effective options. At F-star we are developing antibodies with an innovative tetravalent bispecific format and the potential to elicit better biological responses compared to traditional antibodies or combinations. We believe FS118, with its novel approach to overcoming resistance to PD-(L)1 blockade will be an important part of the exciting next wave of checkpoint therapies. We look forward to providing additional data from our ongoing Phase I study to validate our approach later this year."

A link to the full study, entitled "FS118, a bispecific antibody targeting LAG-3 and PD-L1 utilises a novel mechanism to enhance T cell activation resulting in potent anti-tumor activity" can be found here.

About FS118

Currently in a Phase 1 study at four clinical sites in the United States, FS118 is a potentially first-in-class medicine for the treatment of resistant and refractory cancer. This tetravalent, bispecific antibody is developed to overcome tumor evasion mechanisms promoted by two highly immuno-suppressive molecules: LAG-3 (Lymphocyte-Activation Gene 3) and PD-L1 (Programmed Death-Ligand 1). By simultaneously blocking both inhibitory pathways, FS118 has preclinically demonstrated a potent anti-tumor growth activity as well as a highly differentiated mechanism of action when compared to checkpoint monotherapies alone or in combinations. In April 2018, a Phase 1 clinical study started in patients who have relapsed following a prior PD-(L)1-containing therapy. Information about the trial is available on clinicaltrials.gov NCT03440437. FS118 is manufactured at 2000L scale using standard mAb manufacturing processes.

On April 16, 2020 RefleXion Medical, a therapeutic oncology company pioneering the use of biology-guided radiotherapy (BgRT) for all stages of cancer, reported the close of a $100 million equity financing led by Public Sector Pension Investment Board (PSP Investments), one of Canada’s largest pension investment managers that focuses on long-term investments with partners demonstrating strong value orientation strategies (Press release, RefleXion Medical, APR 16, 2020, View Source [SID1234556383]).

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"RefleXion’s bold vision for the future of cancer care stands to completely reshape how physicians think about treating patients with stage 4 cancer," said Loïc Julé, managing director, Global Investment Partnerships Portfolio, PSP Investments."This is exactly the mindset of companies we strive to build long-term relationships with. We are thrilled to support RefleXion during this next phase of their growth as they ramp up market and clinical adoption of this groundbreaking technology."

RefleXion’s existing investors, TPG’s The Rise Fund, KCK Group, Sofinnova Partners, Venrock, T. Rowe Price, and global pharmaceutical leaders, Pfizer Ventures and Johnson & Johnson Innovation, JJDC Inc., all participated in the round. BofA Securities and Morgan Stanley & Co., LLC acted as placement agents for the company.

"This new influx of capital continues our momentum initiated first by FDA clearance of the RefleXion X1 platform last month, then quickly followed by the close of our first system order at one of the world’s leading cancer centers," said Todd Powell, president and CEO of RefleXion. "The support of this top-tier investment syndicate enables us to further scale operations around commercializing the X1 platform.

"Moreover, these funds allow us to validate the practical implications of using BgRT on a daily basis as we transform radiotherapy from early-stage cancer treatment to an option for patients with all stages of cancer," continued Powell.

The RefleXion X1 machine with BgRT is designed to overcome the technical limitations that currently restrict radiotherapy to one or two tumors. When available, RefleXion will scale BgRT to treat all visible tumors, even those that move rapidly due to bodily functions such as breathing or digestion, in the same treatment session.

RefleXion recently announced FDA clearance for stereotactic body radiotherapy (SBRT), stereotactic radiosurgery (SRS) and intensity modulated radiotherapy (IMRT), and its first clinical and commercial client.

On April 16, 2020 LegoChem Biosciences, Inc. ("LCB") (KOSDAQ:141080), based in Daejeon, South Korea, reported that it has entered a research collaboration and license agreement with Iksuda Therapeutics ("Iksuda") for the development of antibody-drug conjugates in oncology (Press release, LegoChem Biosciences, APR 16, 2020, View Source [SID1234556382]).

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Iksuda gains certain rights to LCB’s antibody-drug conjugate (ADC) technology, ConjuALL, including LCB’s cancer-selectively activated payloads as well as its proprietary linker and conjugation platform, to research, develop and commercialize targeted anti-cancer therapeutics. Under the terms of the agreement, Iksuda has the rights to use the LCB technology to develop therapeutics directed to up to three undisclosed targets.

LCB will receive development, regulatory and commercial milestone payments of up to $407.25 million as well as royalties on the sales of any resulting ADC products. In addition, LCB is eligible to receive a prearranged percentage of sublicense revenue if Iksuda enters into a license agreement with third party companies.

Iksuda, a UK-based biotech company established in 2012, is focusing on the development of novel ADC therapeutics. Iksuda has built up a world-class R&D team including Dr. Robert Lutz, CSO of Iksuda, who is a global ADC expert and has significantly contributed to the successful development and commercialization of a blockbuster drug, Kadcyla as well as several other ADC therapeutics when he was at Immunogen.

"We plan to advance ADC products from this partnership to clinical stage as quickly as possible," said Dr. David Simpson, the CEO of Iksuda. "This collaboration will allow us to leverage LCB’s next-generation linker and payload platform and combining it with our expertise and capabilities in ADC development will enable success."

"We are pleased to collaborate with Iksuda given its experience and expertise in ADC research and development. This agreement highlights that not only is LCB delivering unique, differentiated linker technology, but great potential and wide applicability of our proprietary payload, is also now endorsed by global experts from Iksuda," said Dr. Yong-Zu Kim, the CEO & President of LCB. "Our goal is to demonstrate the competitiveness of LegoChem Bio in human trials in a most efficient way by applying our ADC platform to Iksuda’s pipelines."

On April 16, 2020, Aeglea BioTherapeutics, Inc. (the "Company") reported that entered into a Capital on DemandTM Sales Agreement (the "Offering Agreement") with JonesTrading Institutional Services LLC, as agent ("JonesTrading"), pursuant to which the Company may offer and sell, from time to time through JonesTrading shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), having an aggregate offering price of up to $60.0 million (the "Shares") (Filing, 8-K, Aeglea BioTherapeutics, APR 16, 2020, View Source [SID1234556381]).

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The offer and sale of the Shares will be made pursuant to a shelf registration statement on Form S-3 (File No. 333-228967) and the related base prospectus filed by the Company with the Securities and Exchange Commission (the "SEC") on December 21, 2018 as subsequently amended, and declared effective by the SEC on February 13, 2019, as supplemented by a prospectus supplement (the "Prospectus Supplement") dated April 16, 2020 and filed with the SEC pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the "Securities Act").

Pursuant to the Offering Agreement, JonesTrading may sell the Shares by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415 of the Securities Act (the "Offering"). JonesTrading will use commercially reasonable efforts consistent with its normal trading and sales practices to sell the Shares from time to time, based upon instructions from the Company, including any price or size limits or other customary parameters or conditions the Company may impose.

The Company is not obligated to make any sales of the Shares under the Offering Agreement. The offering of Shares pursuant to the Offering Agreement will terminate upon the earliest of (a) the sale of all the Shares subject to the Offering Agreement or (b) the termination of the Offering Agreement by JonesTrading or the Company, as permitted therein.

The Company will pay JonesTrading a commission rate up to 3.0% of the aggregate gross proceeds from each sale of Shares and have agreed to provide JonesTrading with customary indemnification and contribution rights. The Company will also reimburse JonesTrading for certain specified expenses in connection with entering into the Offering Agreement. The Offering Agreement contains customary representations and warranties and conditions to the placements of the Shares pursuant thereto.

The foregoing description of the Offering Agreement is not complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference. The opinion of the Company’s counsel regarding the validity of the Shares that will be issued pursuant to the Offering Agreement is also filed herewith as Exhibit 5.1.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Common Stock discussed herein, nor shall there be any offer, solicitation, or sale of common stock in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On April 16, 2020 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported the formation of the Steering Committee for its Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in patients with acute myeloid leukemia (AML) who have achieved complete remission after second-line anti-leukemic therapy (CR2) (Press release, Sellas Life Sciences, APR 16, 2020, View Source [SID1234556380]).

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"We continue to make important progress toward ensuring that our Phase 3 AML trial is a well-executed pivotal study and are working diligently toward its timely execution despite the COVID-19 pandemic," said Dr. Angelos Stergiou, MD, ScD h.c., SELLAS’ President & Chief Executive Officer. "We are pleased that our internal clinical leadership team, which includes individuals with extensive late-stage hematology-oncology development experience, is now supplemented by a Steering Committee with deep and extraordinary international hematology experience."

The Steering Committee will provide scientific oversight and guidance of the practical aspects of the ongoing REGAL study. The Steering Committee will also review the results of the trial as they become available, analyze current clinical practices to identify AML patients most likely to benefit from entry to the study, design and implement the most efficient continued approaches to conducting the study and make recommendations regarding the monitoring of the clinical study in consultation with the independent data monitoring committee.

Dr. M. Yair Levy, MD, Director of Hematologic Malignancies at the Baylor University Medical Center commented, "Over the past several years, new treatment modalities have improved response rates in AML in the second line (salvage) setting, resulting in an increasing number of patients achieving complete remission (CR2). However, patients who successfully enter CR2 represent a clinical population for which there is an enduring unmet medical need, with a median overall survival of around five months. Currently, REGAL is the only Phase 3 study aiming at remission prolongation through maintenance post-CR2 therapy – other than allogeneic stem cell transplantation – that is actively enrolling patients in this setting."

"The REGAL trial is a rigorously designed study which will provide pivotal data assessing the potential contribution of maintenance therapy with galinpepimut-S, an innovatively engineered and promising WT1-targeting immunotherapeutic, in candidate AML patients in CR2. I look forward to reviewing the clinical and safety data as they become available and to serving as a member of its Steering Committee," concluded Dr. Levy.

The Steering Committee currently consists of three members:

Dr. Hagop Kantarjian, MD, Professor and Chair of the Department of Leukemia at The University of Texas MD Anderson Cancer Center, and Principal Investigator at MD Anderson for the multi-center Phase 3 REGAL study and Chair of the REGAL Steering Committee*

Dr. Javier Pinilla-Ibarz, MD, PhD, Director of Immunotherapy for Malignant Hematology at the H. Lee Moffitt Cancer Center and member of the SELLAS Scientific Advisory Board

Dr. Moshe Yair Levy, MD, Director of Hematologic Malignancies at the Texas Oncology – Baylor Charles A. Sammons Cancer Center
The Company previously reported initial data from the Phase 2a study of galinpepimut-S in AML patients in CR2 at a median follow-up of 19.3 months, showing median overall survival (OS) in vaccine-treated patients of 16.3 months vs. 5.4 months in a patient cohort contemporaneously treated with best standard therapy (p = 0.0175). The final analysis, at a median follow-up of 30.8 months, showed a median OS of 21 months in the GPS-treated patient cohort. A second previous Phase 2 study of galinpepimut-S in AML patients who achieved first complete remission (CR1) also met its primary endpoint with an OS rate at 3 years from first vaccination of 47%.

The REGAL study is an ongoing 1:1 randomized, open-label study comparing GPS monotherapy in the maintenance setting to investigators’ choice best available treatment in AML patients who have achieved hematologic complete remission, with or without thrombocytopenia (CR2/CR2p), after second-line antileukemic therapy and who are deemed ineligible for or unable to undergo allogeneic stem-cell transplantation. The primary endpoint is OS from the time of study entry. Secondary endpoints include leukemia-free survival, antigen-specific T-cell immune response dynamics, measurable residual disease by multigene array, and assessments of AML clonal evolution and inflammasome molecular signatures in the tumor microenvironment in bone marrow biopsy samples. The Company anticipates interim analysis for safety and futility in the fourth quarter of 2021.

For further information on enrolling in the REGAL study, please visit: View Source

*Dr. Kantarjian’s role on the steering committee is under review by MD Anderson’s Conflict of Interest Committee to ensure compliance with institutional policy.