Affimed Announces First Patient Successfully Dosed in First-in-Human Phase 1/2A Study of AFM24 for the Treatment of Advanced EGFR-Expressing Solid Tumors Including Colon, Lung and Other Cancers

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.

Autolus Therapeutics Announces FDA Acceptance of IND Application for AUTO1 for Adult Acute Lymphoblastic Leukemia

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."

4SC AG: Conference call to be hosted on 21 April 2020 to present the Q1 report 2020

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.

Mallinckrodt to Report Earnings Results for First Quarter 2020

On April 16, 2020 Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, reported that it will report first quarter 2020 earnings results for the period ended March 27, 2020 on Tuesday, May 5, 2020 (Press release, Mallinckrodt, APR 16, 2020, View Source [SID1234556397]).

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A conference call for investors will begin at 8:30 a.m. Eastern Time. The call can be accessed in three ways:

At the Mallinckrodt website: http://mallinckrodt.com/investors/events-calendar/.
By telephone: For both listen-only participants and those who wish to take part in the question-and-answer portion of the call, the telephone dial-in number in the U.S. is (877) 359-9508. For participants outside the U.S., the dial-in number is (224) 357-2393. Callers will need to provide the Conference ID of 1572379.
Through an audio replay: A replay of the call will be available beginning at 11:30 a.m. Eastern Time on Tuesday, May 5, 2020, and ending at 11:59 p.m. Eastern Time on Tuesday, May 19, 2020. Dial-in numbers for U.S.-based participants are (855) 859-2056 or (800) 585-8367. Participants outside the U.S. should use the replay dial-in number of (404) 537-3406. All callers will be required to provide the Conference ID of 1572379.

Zimmer Biomet Announces Audio Webcast and Conference Call of First Quarter 2020 Results

On April 16, 2020 Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) reported its first quarter sales and earnings conference call will be broadcast over the Internet on Monday, May 11, 2020, at 8:30 a.m. Eastern Time (Press release, Zimmer Holdings, APR 16, 2020, View Source [SID1234556396]). A news release detailing the quarterly results will be made available at 6 a.m. Eastern Time the morning of the conference call.

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The live audio webcast can be accessed via Zimmer Biomet’s Investor Relations website at https://investor.zimmerbiomet.com. It will be archived for replay following the conference call.

Individuals in the U.S. and Canada who wish to dial into the conference call may do so by dialing (888) 312-9837 and entering conference ID 7278985. For a complete listing of international toll-free and local numbers, please visit https://investor.zimmerbiomet.com. A digital recording will be available after the completion of the conference call, from May 11, 2020 to June 10, 2020. To access the recording, U.S. callers should dial (888) 203-1112 and international callers should dial +1 (719) 457-0820, and enter the Access Code ID 7278985.