On April 16, 2020 4SC AG (4SC, FSE Prime Standard: VSC) reported that it will publish its Q1 report 2020 on 21 April 2020 (Press release, 4SC, APR 16, 2020, View Source [SID1234556398]). On this day, the Management of 4SC AG will host a conference call at 3 pm CEDT (9 am EDT) to inform about important developments in the reporting period and beyond.

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Investors, financial analysts, and journalists interested in participating in the conference call can access via the telephone numbers stated below. Please join the event conference 5-10 minutes prior to the start time. You will be asked to provide the confirmation code.

Date: 21 April 2020
Time: 3 pm CEDT (9 am EDT)
Phone Numbers: +49 (0)32 22109 8334 (Germany)
+44 (0)20 3936 2999 (United Kingdom)
+1 646 664 1960 (USA)
Confirmation Code: 754006
A presentation document supporting the conference call will be available on 21 April 2020, at 4SC’s website. After the event, a replay can be accessed from there as well.

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 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for AUTO1, its lead CAR T product candidate for the treatment of adults with acute lymphoblastic leukemia (ALL) (Press release, Autolus, APR 16, 2020, View Source [SID1234556399]). The active IND allows initiation of the US sites in the company’s first pivotal study, AUTO1-AL1. The AUTO1-AL1 study clinical trial application was approved by the MHRA in January 2020 and the first site opened in the UK in March of this year.

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The COVID-19 situation has had varying degrees of impact on the ability of clinical sites to operate normally; however, based on current expectations, the company anticipates that the impact on the AUTO1-AL1 clinical study will be minimal. The AUTO1-AL1 study has a run in phase, with a small number of patients scheduled to be enrolled into the study in Q2, limiting the impact from the COVID-19 situation at this stage. The company has continued to manufacture, without interruption, from its operations at the Cell and Gene Therapy Catapult located in Stevenage, UK, including supply to the US of clinical products for the treatment of DLBCL patients in its AUTO3-ALEXANDER study.

"We are looking forward to starting the treatment of patients at US clinical study sites in an indication where currently no CAR T therapy is approved," said Dr. Christian Itin, chairman and chief executive officer of Autolus. "Our AL1 clinical trial is already open in the UK and this milestone enables us to build on the encouraging data published to date, which suggests AUTO1 has a high level of clinical activity combined with a manageable safety profile."

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 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that the first patient was successfully dosed in a Phase 1/2a clinical trial of AFM24, a first in human study evaluating AFM24 as monotherapy in patients with advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies (Press release, Affimed, APR 16, 2020, View Source [SID1234556400]). AFM24, a tetravalent, bispecific epidermal growth factor receptor (EGFR)- and CD16A-binding innate cell engager, is novel due to its activation of innate immunity to kill solid tumors, inducing both antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as compared to other therapies that rely heavily on signal or checkpoint inhibition.

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"Today is a landmark day for Affimed and, more importantly, for patients whose solid tumors continue to progress," said Dr. Adi Hoess, Chief Executive Officer of Affimed. "This major milestone marks the first time a patient with solid tumors has been dosed with an innate cell engager. AFM24 has demonstrated preclinically the ability to bridge NK cells and macrophages to EGFR-expressing tumor cell lines, and to induce lysis through ADCC and ADCP, respectively, independent of RAS mutational status. We look forward to the continued study of this novel agent and further validating its safety and efficacy through this human clinical trial."

"Initiation of dosing in the first in human clinical trial of AFM24 is exciting news for the broad set of patients with hard to treat EGFR-expressing cancers," said Dr. Anthony El-Khoueiry, Phase I program director at the USC Norris Comprehensive Cancer Center and Keck School of Medicine, and principal investigator for the study. "While available EGFR therapies have improved the lives of patients, new therapeutic options are needed that are broadly efficacious, easier for patients to tolerate and can also address the issue of resistance associated with currently available treatments."

The study is an open-label, non-randomized, multi-center, multiple ascending dose escalation/expansion study to evaluate AFM24 as monotherapy in adult patients with advanced solid malignancies known to be EGFR-positive. The aim of the dose escalation phase is the determination of the maximum tolerated dose and the establishment of a recommended Phase 2a dose. The dose expansion phase is intended to collect preliminary evidence of efficacy and to further confirm the safety of AFM24. For more information including eligibility criteria, visit www.clinicaltrials.gov, using Identifier NCT04259450.

About AFM24
AFM24 is a tetravalent, bispecific EGFR- and CD16A-binding innate cell engager generated from Affimed’s fit-for-purpose ROCK platform. AFM24 uses the cytotoxic potential of the innate immune system by redirecting and activating NK cells and macrophages to kill EGFR-positive cancer cells through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), respectively. Due to its unique mechanism of action, AFM24 is potentially not limited to patient subtypes based on mutational status. Treatment of cynomolgus monkeys with AFM24 showed a favorable safety profile, even when the animals were treated at high dose levels, demonstrating AFM24’s potential to have lower toxicities in humans compared to other EGFR-targeted therapies.