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 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 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.

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.

On April 16, 2020 Alphamab Oncology (stock code: 9966 HK) reported that Jiangsu Alphamab Biopharmaceuticals Co., Ltd. ("Jiangsu Alphamab"), a wholly-owned subsidiary of the Company, received Safe to Proceed Letter from the US Food & Drug Administration ("FDA") for its recombinant humanized PD-L1/CTLA-4 bispecific antibody KN046, to initiate Phase II clinical trial in anti-PD-(L)1 refractory or relapsed Non-Small-Cell Lung Cancer ("NSCLC") (Press release, Alphamab, APR 16, 2020, View Source [SID1234556395]). KN046’s Phase I clinical trials in Australia and China, along with multiple Phase II trials in China have shown a good safety profile and promising efficacy.

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KN046 is a global first-in-class programmed death ligand 1 ("PD-L1")/ cytotoxic T-lymphocyte-associated protein 4 ("CTLA-4") bispecific antibody developed by the Jiangsu Alphamab. PD-(L)1 and CTLA-4 are the only two clinically validated immune checkpoints, and their combo therapy has been approved for the treatment of melanoma, colorectal cancer and kidney cancer, but application of the combo therapy has limited application due to its toxicity. Through innovative drug design, Jiangsu Alphamab has fused a novel CTLA-4 single-domain antibody with PD-L1 antibody to form KN046, a bispecific antibody with acceptable safety. KN046 has the capacity to block both PD-(L)1 and CTLA-4, effectively activate T-cells and strengthen anti-tumor immune activity.

KN046 is the only anti-PD-L1/CTLA-4 bispecific antibody drug in clinical development phase globally, and also Jiangsu Alphamab’s third drug candidates which have been approved to enter clinical trial in the United Sates. KN046 is currently undergoing multiple Phase II clinical trials for NSCLC, triple-negative breast cancer ("TNBC"), esophageal squamous cell carcinoma ("ESCC") and pancreatic cancer. The result from these clinical trials is scheduled to be released in various occasions including international medical conferences. This Phase II clinical trial in the United States aims to evaluate the safety, tolerability and efficacy of KN046 monotherapy or in combination with chemotherapy in locally advanced unresectable or metastatic NSCLC.

Dr. Ting XU, Founder, Chairman and CEO of Alphamab Oncology commented, "We are unwaveringly committed to providing world class therapeutic biologics to global patients. Represented by KN046, our innovative bispecific antibodies pipeline has given us a head start to fulfill this mission. The IND approval from FDA is an important milestone for KN046’s the global development. We will accelerate clinical development on multiple oncology indications, and work hard towards an earlier market launch and provide cancer patients with a safe and more effective treatment option."

About KN046

KN046 is the world’s first recombinant humanized PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab. Its innovative designs include: a proprietary CTLA-4 domain antibody with a significantly improved safety profile; a bispecific antibody fused with PD-L1 antibody; engineered to target the tumor microenvironment with high PD-L1 expression, and Treg clearing function. The preclinical and clinical study results of KN046 have shown promising efficacy and significantly reduced toxicity to human peripheral system, with the potential to become the backbone of next generation immuno-oncology therapy in the future.

Previously, KN046’s phase I clinical trials in Australia and China have shown a preliminary profile of good safety and promising efficacy, and several phase II clinical trials are ongoing in China for NSCLC, TNBC, ESCC and pancreatic cancer.