On March 4, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported through a subsidiary, a cash tender offer to purchase all outstanding shares of common stock of Pandion Therapeutics, Inc. (Nasdaq: PAND) (Press release, Merck & Co, MAR 4, 2021, View Source [SID1234576054]). On Feb. 25, 2021, Merck announced its intent to acquire Pandion.

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Upon the successful closing of the tender offer, stockholders of Pandion will receive $60 in cash for each share of Pandion common stock validly tendered and not validly withdrawn in the offer, without interest and less any required withholding taxes. Following the purchase of shares in the tender offer, Pandion will become a subsidiary of Merck.

Merck will file today with the U.S. Securities and Exchange Commission (the "SEC") a tender offer statement on Schedule TO, which provides the terms of the tender offer. Additionally, Pandion will file with the SEC a solicitation/recommendation statement on Schedule 14D-9 that includes the recommendation of the Pandion board of directors that their stockholders accept the tender offer and tender their shares.

The tender offer will expire at one minute past 11:59 pm Eastern Time on March 31, 2021, unless extended in accordance with the merger agreement and the applicable rules and regulations of the SEC. The closing of the tender offer is subject to certain conditions, including the tender of shares representing at least a majority of the total number of Pandion’s shares of fully-diluted common stock, the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to close in the first half of 2021.

Additional Information About the Tender Offer

This press release is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell any shares of the common stock of Pandion Therapeutics, Inc. ("Pandion") or any other securities. A tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, will be filed today by Merck Sharp & Dohme Corp. and Panama Merger Sub, Inc., a wholly-owned subsidiary of Merck, with the SEC, and a solicitation/recommendation statement on Schedule 14D-9 will be filed today by Pandion with the SEC. The offer to purchase shares of Pandion common stock will only be made pursuant to the offer to purchase, the letter of transmittal and related documents filed as a part of the Schedule TO.

INVESTORS AND SECURITY HOLDERS ARE URGED TO READ BOTH THE TENDER OFFER STATEMENT AND THE SOLICITATION/RECOMMENDATION STATEMENT REGARDING THE OFFER, AS THEY MAY BE AMENDED FROM TIME TO TIME, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION.

Investors and security holders may obtain a free copy of these statements and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov or by directing such requests to the Information Agent for the offer, which will be named in the tender offer statement. Additional copies of the tender offer materials may be obtained at no charge by contacting Merck at 2000 Galloping Hill Road, Kenilworth, N.J., 07033 or by phoning (908) 423-1000. In addition, Merck and Pandion file annual, quarterly and current reports and other information with the SEC. Merck’s and Pandion’s filings with the SEC are also available to the public from commercial document-retrieval services and at the SEC’s website at www.sec.gov.

On March 4, 2021 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported the publication of pre-clinical data highlighting the potential of its alternating 2-vector, intravenously administered cancer therapeutics in the peer-reviewed journal, Cell Reports Medicine (Press release, Hookipa Pharma, MAR 4, 2021, View Source [SID1234576053]). The publication, which is available online now, will appear in the 16 March print issue.

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"The pre-clinical data published in Cell Reports Medicine underscore the potential of our engineered arenavirus platform to redefine success in cancer immunotherapy. Specifically, our alternating 2-vector approach delivered a substantial tumor-specific response, resulting in tumor cures and long-term anti-tumor immunity in a pre-clinical setting," said Joern Aldag, Chief Executive Officer at HOOKIPA. "The data in this peer-reviewed publication provide the scientific substantiation for the ongoing clinical trial of the alternating 2-vector therapy for Human Papillomavirus 16-positive (HPV16+) cancers as well as for advancing to prostate cancer."

Pre-clinical data featured in the article showed that intravenous, alternating administration of two different replicating arenaviral vectors that express the same antigen induces potent T cell response, exceeding 50% of the circulating T cell pool, and robust anti-tumor activity. The anti-tumor activity and very high T cell generation were demonstrated both with onco-viral antigens and also with a cancer self-antigen, illustrating the ability of the arenaviral platform to break tolerance.

Other key highlights from the paper include:

Single-vector and alternating 2-vector therapy did not induce vector-neutralizing antibodies, supporting repeated intravenous administration
Mice that cleared tumors after therapy were protected from tumor re-challenge
Expanding on the data observed with single-vector therapy, alternating 2-vector therapy induced an even higher T cell response and more efficient tumor control
The study on which this publication is based, was conducted and led by an international group of researchers at the University of Basel.

HOOKIPA is evaluating its single-vector and alternating 2-vector technologies in the ongoing Phase 1/2 clinical trial of its lead oncology candidates, HB-201 and HB-202. HB-201 and HB-202 use the LCMV and PICV arenaviral backbones, respectively, while expressing the same antigen, an E7/E6 fusion protein derived from HPV16. Interim Phase 1 monotherapy data on HB-201 for the treatment of advanced HPV16+ cancers showed promising anti-tumor activity and favorable tolerability. Data demonstrated responses and stable disease in head and neck cancer patients who failed prior standard of care therapy, platinum therapy, PD(L)1 inhibitor, or both. Initial data on HB-201 and HB-202 as a replicating 2-vector therapy are anticipated by mid-2021. HOOKIPA’s HB-300 program for prostate cancer also uses the LCMV and PICV arenaviral backbones directed against three validated antigens for prostate cancer: PAP, PSA, and PSMA.

On March 4, 2021 Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare and orphan diseases, reported that Michael F. Cola, President and Chief Executive Officer, will present at two upcoming virtual conferences (Press release, Cerecor, MAR 4, 2021, View Source [SID1234576051]).

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H.C. Wainwright Global Life Sciences Conference
Date: March 9-10, 2021
Pre-Recorded Formal Presentation will be made available on Tuesday, March 9, 2021 at 7:00 AM ET

Oppenheimer’s 31st Annual Healthcare Conference
Date: Wednesday, March 17, 2021
Time: 8:00 AM ET

A live webcast of the presentations can be accessed under "News/Events" page in the Investors section of the Company’s website at www.cerecor.com.

On March 4, 2021 Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, reported that the first patient has been successfully enrolled into a Phase 1 clinical trial of APL-106 (uproleselan injection) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) in China (Press release, Apollomics, MAR 4, 2021, View Source [SID1234576050]). In February of this year, the two Phase 1 study sites were initiated.

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The Phase 1 clinical trial is a part of the Phase 1 and Phase 3 bridging clinical study of APL-106 in combination with chemotherapy in adults with relapsed or refractory AML. Its principal investigator is Professor Jianxiang Wang of the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College. The primary objective of the Phase 1 is to study the pharmacokinetic (PK) characteristics of APL-106 in Chinese subjects with relapsed or refractory AML and to evaluate the safety and tolerability of APL-106 in combination with chemotherapy.

About APL-106 (uproleselan injection)

APL-106 (uproleselan injection) is an innovative drug discovered and developed by GlycoMimetics. Uproleselan (yoo’ pro le’ sel an) is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells, thereby disrupting the mechanism of leukemic cell resistance within the bone marrow microenvironment. In 2017, the U.S. FDA granted Breakthrough Therapy Designation to uproleselan for the treatment of adults with relapsed or refractory acute myeloid leukemia. Apollomics licensed uproleselan from GlycoMimetics in January 2020. Apollomics has the rights to clinical development, production and commercial sales in the Chinese market (Mainland China, Hong Kong, Macau and Taiwan).

In September 2020, APL-106 received the approval of the National Medical Products Administration (NMPA) through the issuance of the "Clinical Trial Drug Approval Notification". This approval enables the conduct of Phase I and Phase III bridging clinical study of APL-106 in combination with chemotherapy in adults with relapsed or refractory acute myeloid leukemia. In January 2021, APL-106 was also granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the NMPA.

About Acute Myeloid Leukemia (AML)

Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow. It is an aggressive disease that causes the bone marrow to produce immature cells that are unable to carry out their normal function and develop into leukemia cells. In the U.S., there are approximately 20,000 new cases of AML each year, and the 5-year survival rate is 28.7%1. The annual incidence of AML in China in 2019 is approximately 26,9002, and relapsed/refractory AML has an extremely poor prognosis.

On March 4, 2021 Aileron Therapeutics (NASDAQ:ALRN) reported that Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer, will give a corporate presentation at the 2021 H.C. Wainwright Global Life Sciences Conference, which is taking place March 9 – 10, 2021 (Press release, Aileron Therapeutics, MAR 4, 2021, View Source [SID1234576049]). Dr. Aivado’s presentation will include an overview of Aileron’s upcoming Phase 1b placebo-controlled trial of ALRN-6924 in patients with advanced p53-mutated non-small cell lung cancer, anticipated to begin in the second quarter of 2021, including the company’s target enrollment expansion announced earlier this week.

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A webcast of the presentation will be available on demand under the Investors and Media section of Aileron’s website at View Source beginning March 9, 2021 at 7:00 a.m. EST. A replay of the webcast will be archived on Aileron’s website for 90 days following the event.