On January 25, 2021 Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) reported that the Company will report its financial results for the fourth quarter and full year ended December 31, 2020 before the US financial markets open on February 4, 2021 (Press release, Alexion, JAN 25, 2021, View Source [SID1234574259]).

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Given the recently announced agreement to be acquired by AstraZeneca, Alexion will not be hosting a conference call. Earnings materials will be made available publicly on the Investor Relations page of our website at View Source Questions may be directed to the Investor Relations team via e-mail at [email protected] or the contact information below.

AstraZeneca and Alexion Combination

On December 12, 2020, AstraZeneca and Alexion announced that the companies entered into a definitive agreement for AstraZeneca to acquire Alexion, in which Alexion shareholders will receive $60 in cash and 2.1243 AstraZeneca American Depositary Shares (ADSs) for each Alexion share. Based on AstraZeneca’s reference average ADR price of $54.14 at the time of the announcement, this implied total consideration to Alexion shareholders of $39 billion or $175 per share. The acquisition has the potential to advance the shared science-led mission of both companies to leverage complementary approaches to developing life-changing medicines. The proposed combination will broaden Alexion’s footprint, enabling the company to help more patients, pursue innovative science in new areas and expand its therapies in additional geographies. In addition, the transaction delivers significant value for Alexion’s shareholders, who will have an important stake in the combined company’s future results. Subject to receipt of regulatory clearances and the approval by AstraZeneca and Alexion shareholders, the companies expect the acquisition to close in the third quarter of 2021.

Additional Information and Where to Find It

In connection with the proposed transaction, AstraZeneca PLC ("AstraZeneca") intends to file with the SEC a registration statement on Form F-4 that will include a proxy statement of Alexion and that also constitutes a prospectus of AstraZeneca. Each of Alexion and AstraZeneca may also file other relevant documents with the U.S. Securities and Exchange Commission ("SEC") regarding the proposed transaction. This document is not a substitute for the proxy statement/prospectus or registration statement or any other document that Alexion or AstraZeneca may file with the SEC. The definitive proxy statement/prospectus (if and when available) will be mailed to stockholders of Alexion. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT, PROXY STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able to obtain free copies of the registration statement and proxy statement/prospectus (if and when available) and other documents containing important information about Alexion, AstraZeneca and the proposed transaction, once such documents are filed with the SEC through the website maintained by the SEC at View Source Copies of the documents filed with the SEC by Alexion will be available free of charge on Alexion’s website at View Source or by contacting Alexion’s Investor Relations Department by email at [email protected]. Copies of the documents filed with the SEC by AstraZeneca will be available free of charge on AstraZeneca’s website at View Source or by contacting AstraZeneca’s Investor Relations department by email at [email protected].

Participants in the Solicitation

Alexion, AstraZeneca, their respective directors and certain of their executive officers and other employees may be deemed to be participants in the solicitation of proxies from Alexion’s stockholders in connection with the proposed transaction. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of Alexion stockholders in connection with the proposed mergers, including a description of their direct or indirect interests, by security holdings or otherwise, will be set forth in the proxy statement/prospectus when it is filed with the SEC. Information about Alexion’s directors and executive officers is available in Alexion’s proxy statement for its 2020 annual meeting of stockholders, which was filed with the SEC on March 26, 2020, Alexion’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019, which was filed with the SEC on February 4, 2020, and other documents subsequently filed by Alexion with the SEC. Information about AstraZeneca’s directors and executive officers is available in AstraZeneca’s Form 20-F filed with the SEC on March 3, 2020, and other documents subsequently filed by AstraZeneca with the SEC.

No Offer or Solicitation

This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended.

On January 25, 2021 MorphoSys (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) and I-Mab (NASDAQ: IMAB) reported that the first patient has been dosed in a phase 1 dose escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of MOR210/ TJ210 monotherapy in patients with relapsed or refractory advanced solid tumors in the United States (Press release, MorphoSys, JAN 25, 2021, View Source [SID1234574257]).

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MOR210/TJ210 is a monoclonal antibody developed by MorphoSys that is directed against complement factor C5a receptor 1 (C5aR1). Produced in the tumoral microenvironment, its ligand C5a acts as a chemoattractant to recruit tumor-promoting cells such as myeloid-derived suppressor cells, M2 macrophages and neutrophils. MOR210/TJ210 is designed to induce anti-tumor properties by blocking the activation and migration of C5aR1-expressing myeloid cells.

Preclinical studies have shown that targeting the C5aR-C5a axis exerts anti-tumor activity with immune checkpoint inhibitors. Furthermore, in vitro activity was observed for blocking the C5a/C5aR pathway also at very high C5a concentrations leading to a long duration of action. MOR210/TJ210 demonstrated a good safety profile with no observed adverse effects up to the highest dose tested in non-clinical safety studies.

The phase 1 clinical trial is an open-label dose escalation study with multiple doses in multiple centers in the U.S. to evaluate the safety, tolerability, and PK/PD of MOR210/TJ210 in subjects with advanced solid tumors. The development program will evolve into further clinical combination studies of MOR210/TJ210 with checkpoint inhibitors.

"We are encouraged by the data observed in the preclinical studies and believe that TJ210/MOR210 with its unique properties has great potential to target difficult-to-treat cancers," said Dr. Joan Shen, CEO of I-Mab. "The data generated from this study will provide valuable information about TJ210/MOR210’s safety and tolerability profile and its potential benefits in patients with advanced cancers."

"We look forward to progressing with MOR210/TJ210 into clinical studies together with I-Mab to investigate its potential as a novel therapeutic option for patients with advanced solid tumors," said Dr. Malte Peters, Chief Research & Development Officer of MorphoSys.

MorphoSys will receive a $1.5 million payment from I-Mab for achieving this milestone under the license agreement between the two companies. MorphoSys and I-Mab entered into an exclusive strategic collaboration and licensing agreement to develop and commercialize MOR210/TJ210 in November 2018. Under the terms of agreement, I-Mab receives exclusive rights to develop and commercialize MOR210/TJ210 in Greater China and South Korea, while MorphoSys retains rights in other parts of the world. With support from MorphoSys, I-Mab will also fund and conduct all global development activities of MOR210/TJ210, including clinical trials in China and the U.S., towards clinical proof-of-concept (PoC) in oncology.

About MOR210/TJ210
MOR210/TJ210 is a novel human antibody directed against C5aR1 derived from MorphoSys’s HuCAL Platinum(R) technology. C5aR1, the receptor of the complement factor C5a, is investigated as a potential new drug target in the field of immuno-oncology and autoimmune diseases. Tumors have been shown to produce high amounts of C5a, which, by recruiting and activating myeloid-derived suppressor cells (MDSCs), M2 macrophages and neutrophils, is assumed to contribute to an immune-suppressive pro-tumorigenic microenvironment. MOR210/TJ210 is intended to block the interaction between C5a and its receptor, thereby potentially neutralizing the immune suppressive function of C5a and enabling immune cells to attack the tumor.

HuCAL Platinum(R) is a registered trademark of MorphoSys AG.

On January 25, 2021 Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, reported that U.S. Food and Drug Administration (FDA) has granted toripalimab Fast Track designation for the first-line treatment of mucosal melanoma (Press release, Shanghai Junshi Bioscience, JAN 25, 2021, View Source [SID1234574255]). Meanwhile, the FDA has also approved the Investigational New Drug (IND) application for a global Phase III trial of Toripalimab in combination with Axitinib versus Pembrolizumab for the first-line treatment of patients with advanced mucosal melanoma (Combination Clinical Trial).

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About Toripalimab
Toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing in China. More than thirty company-sponsored clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. On December 17, 2018, Toripalimab obtained a conditional approval from the National Medical Products Administration (the "NMPA") for the second-line treatment of unresectable or metastatic melanoma. Toripalimab was included in the 2019 and 2020 Guidelines of Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of Melanoma. Two supplemental New Drug Applications (NDAs) of Toripalimab for the third-line treatment of recurrent/metastatic nasopharyngeal carcinoma and the second-line treatment of metastatic urothelial carcinoma were accepted by the NMPA in April and May 2020, respectively. Both supplemental NDAs received priority review designations from the NMPA in July 2020. In addition, Toripalimab for the treatment of recurrent/metastatic nasopharyngeal carcinoma was granted the Breakthrough Therapy Designation (BTD) by the FDA in September 2020. In December 2020, Toripalimab was included in the updated National Reimbursement Drug List (NRDL) (2020 Edition).

About Combination Clinical Trial
The Combination Clinical Trial is an international, multi-center, randomized Phase III study designed to evaluate the efficacy and safety of Toripalimab in combination with Axitinib versus Pembrolizumab as a first-line treatment in patients with unresectable, locally advanced or metastatic mucosal melanoma. The trial intends to enroll 220 patients who will be randomized at 1:1 ratio into two study arms. The primary endpoint of the Combination Clinical Trial is progression-free survival (PFS). The secondary endpoints include objective response rate (ORR), duration of response (DOR), overall survival (OS), and safety.

Mucosal melanoma is a subtype of melanoma with mucosal origin. Compared with cutaneous melanoma, mucosal melanoma is less responsive to traditional chemotherapy and immunotherapy, and thus remains an unmet medical need. Toripalimab and Axitinib combination was the world’s first clinical application of PD-1 checkpoint blockade with a VEGFR inhibitor for the treatment of mucosal melanoma in a Phase Ib study (NCT03086174). The results of the study were published in the Journal of Clinical Oncology in August 2019. The study showed that the combination of Toripalimab with Axitinib in the first-line setting achieved an ORR of 48.3% and a disease control rate (DCR) of 86.2% for advanced mucosal melanoma with a manageable safety profile. The median progression-free survival (mPFS) was 7.5 months. In March 2020, Toripalimab in combination with Axitinib for the treatment of mucosal melanoma was granted the Orphan-Drug Designation (ODD) by the FDA.

About Fast Track Designation (FTD)
The FTD aims to facilitate the development and accelerate the review process of treatments for serious or life-threatening diseases or conditions that remain unmet clinical needs. The FTD is designed to make important new drugs accessible to patients faster. According to FDA regulations, drugs that receive FTDs will be granted an accelerated review process through various forms, including but not limited to (1) more frequent interactions and meetings with the FDA to discuss drug development and clinical trial design; (2) eligibility for priority review and accelerated approval after meeting relevant criteria; (3) rolling review, which means instead of waiting until all sections of the NDA are completed, a company can submit completed sections of its biologic license application (BLA) or new drug application (NDA) for review on a rolling basis.

The FTD will significantly accelerate the research, development, and marketing of Toripalimab in the United States. This marks another important milestone, after Toripalimab was granted the ODD and the BTD by the FDA.

On January 25, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL) a clinical stage biotechnology company dedicated to improving life with its wholly proprietary ARCUS genome editing platform, reported it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent application covering PBCAR19B, a next-generation, stealth cell, CD19 product candidate for patients with relapsed/refractory (R/R) Non-Hodgkin Lymphoma (NHL) (Press release, Precision Biosciences, JAN 25, 2021, View Source [SID1234574253]).

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The allowed composition claims of U.S. Patent Application No. 16/908,030 encompass genetically-modified human T cells comprising the Company’s PBCAR19B construct, which is inserted within the T cell receptor alpha constant (TRAC) locus. Once issued, patents arising from this patent family will have standard expiration dates in April 2040.

"This patent, when issued, will cover important design elements of our PBCAR19B stealth cell candidate, which is engineered to knock down expression of beta-2 microglobulin to reduce killing of CAR T cells by cytotoxic T cells, and to reduce CAR T cell rejection by natural killer cells," said Derek Jantz, Ph.D., Chief Scientific Officer and Co-Founder of Precision BioSciences. "Additionally, PBCAR19B CAR T cells are generated using a single gene editing step by inserting one cassette, encoding all the necessary elements, into the TRAC locus. Not only will this patent strengthen our intellectual property portfolio, it will further distinguish our ARCUS-based allogeneic CAR T development approach."

About PBCAR19B

PBCAR19B is a next-generation, stealth cell candidate for patients with CD19-positive malignancies such as relapsed/refractory Non-Hodgkin Lymphoma. PBCAR19B is designed to improve the persistence of allogeneic CAR T cells following infusion by reducing rejection by T cells and natural killer (NK) cells. In addition to the CAR gene, the stealth vector includes a short hairpin RNA (shRNA) that suppresses expression of beta-2 microglobulin (B2M), a component of Class 1 major histocompatibility complex (MHC) molecules found on the cell surface. Reducing or knocking down Class 1 MHC expression on allogeneic CAR T cells has been shown to reduce CAR T cell killing by cytotoxic T cells. The stealth vector also carries an HLA-E gene intended to reduce rejection of CAR T cells by NK cells that can be stimulated as a result of reduced MHC molecule expression on the cell surface. The U.S. Food and Drug Administration has accepted the Investigational New Drug application for PBCAR19B, and the Phase 1 clinical study is expected to begin by mid-2021.

On January 25, 2021 Exelixis, Inc. (NASDAQ: EXEL) reported that initiation of the first-in-human phase 1 trial evaluating the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of XL102 alone or in combination with other anti-cancer agents in patients with inoperable locally advanced or metastatic solid tumors (Press release, Exelixis, JAN 25, 2021, View Source [SID1234574252]). XL102 is a potent, selective and orally bioavailable inhibitor of cyclin-dependent kinase 7 (CDK7), an important regulator of the cell cycle that has been implicated in cancer.

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"The initiation of our first-in-human phase 1 trial of XL102 is an important step in our commitment to developing novel medicines that can help patients with cancer," said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. "The potential of this novel CDK7 inhibitor has been shown in preclinical studies demonstrating anti-proliferative activity and an ability to induce cell death in multiple cancer cell lines. We are excited to begin this trial and look forward to the possibility of helping more patients with advanced or metastatic solid tumors."

The XL102-101 trial is a phase 1, open-label dose-escalation and cohort-expansion study evaluating the safety, tolerability, pharmacokinetics, anti-tumor activity and effect on biomarkers of XL102 administered orally alone and in multiple combination regimens in up to 298 patients with advanced solid tumors. The study will include patients with advanced solid tumors for whom either life-prolonging therapies do not exist or available therapies are intolerable or no longer effective. It will begin with a dose-escalation stage to determine the maximum tolerated dose or recommended dose of XL102 as a single agent and in combination therapy. In the subsequent cohort-expansion stage, XL102 will be evaluated in patients with certain types of ovarian, breast and prostate cancers. The goal of the cohort-expansion stage is to evaluate the anti-tumor activity of XL102, as assessed per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as well as its safety, tolerability and pharmacokinetic profile.

About XL102

XL102 is a potent, selective and orally bioavailable covalent inhibitor of CDK7, which is an important regulator of the cellular transcriptional and cell cycle machinery. CDK7 helps regulate cell cycle progression, with overexpression observed in multiple cancers, such as breast and gastric. In preclinical studies, XL102 revealed potent anti-proliferative activity, induced cell death in a large panel of cancer cell lines and caused tumor growth inhibition and regression in xenograft models, demonstrating its potential as a targeted antitumor agent.

XL102 (previously known as AUR102) was in-licensed by Exelixis from Aurigene in 2020. Exelixis has assumed responsibility for the future clinical development, commercialization and global manufacturing of XL102.