On May 7, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that its board of directors approved the separation of Organon & Co. (Organon), and declared a special dividend distribution of one-tenth of a share of Organon common stock for every Merck common share outstanding as of the close of business on May 17, 2021, the record date for the distribution (Press release, Merck & Co, MAY 7, 2021, View Source [SID1234579461]). The Company also announced that the U.S. Securities and Exchange Commission (SEC) has declared effective the Registration Statement on Form 10 filed by Organon. The Form 10 includes information regarding Organon’s business and strategy as well as details on the spinoff, which is expected to be completed on June 2, 2021.

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"We are pleased to announce the full details of Organon’s spinoff from Merck, commencing later this month. This spinoff will position Organon as a successful, independent, publicly traded company with a compelling portfolio of important medicines, particularly in women’s health," said Rob Davis, president, Merck. "Organon will have a significant impact on women’s health around the world, providing benefits to patients and shareholders alike."

Organon will not issue fractional shares of its common stock in the distribution. Instead, holders of Merck common shares will receive cash in lieu of any fractional shares of Organon common stock that they would otherwise be entitled to. Merck expects the special dividend of Organon stock will be distributed on June 2, 2021.

There is no current market for Organon common stock. The New York Stock Exchange (NYSE) has authorized the listing of Organon common stock under the symbol "OGN". Organon has been advised that trading in its common stock is expected to begin on a "when issued" basis on May 14, 2021, under the symbol "OGN.WI." "When issued" trading of Organon common stock will continue until Merck pays the special dividend distribution of Organon common stock on June 2, 2021. Organon "when issued" trades are expected to settle after June 2, 2021, with shares of Organon as a standalone company.

Beginning on May 14, 2021, and continuing through June 2, 2021, Merck expects that common shares of Merck will trade in two markets on the NYSE: "regular-way" under the symbol "MRK" and in the "ex-distribution" market under the symbol "MRK.WI." Merck shares trading under "MRK" will carry the right to receive shares of Organon through the special dividend distribution. Merck shares trading under "MRK.WI" will not carry the right to receive shares of Organon through the special dividend distribution.

Merck shareholders who sell their shares in the "regular-way" market on or before June 2, 2021, will also be selling their entitlement to receive the Organon special dividend distribution of Organon common stock. Merck shareholders are encouraged to consult with their financial advisors regarding the specific consequences of selling Merck common shares on or before June 2, 2021.

On June 3, 2021, regular-way trading will commence on the NYSE for Organon under the symbol "OGN" and will continue for Merck under the symbol "MRK."

On May 7, 2021 Celsion Corporation (NASDAQ: CLSN), a clinical-stage development company focused on DNA-based immunotherapy and next-generation vaccines, reported that the Company will host a conference call at 10:00 a.m. EDT on Friday, May 14, 2021 to discuss financial results for the first quarter ended March 31, 2021 and provide an update on product development programs with GEN-1, a DNA-based immunotherapy, currently in Phase II development for the localized treatment of advanced ovarian cancer and PLACCINE, a proprietary synthetic, non-viral vaccine delivery technology currently in preclinical studies (Press release, Celsion, MAY 7, 2021, View Source [SID1234579482]). Celsion has two platform technologies for the development of novel nucleic acid-based immunotherapies and next generation infectious vaccines.

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To participate in the call, interested parties may dial 1-800-353-6461 (Toll-Free/North America) or 1-334-323-0501 (International/Toll) and ask for the Celsion Corporation First Quarter 2021 Earnings Call (Conference Code: 8053366) to register ten minutes before the call is scheduled to begin. The call will also be broadcast live on the internet at www.celsion.com. The call will be archived for replay on Friday, May 14, 2021 and will remain available until May 28, 2021. The replay can be accessed at 1-719-457-0820 or 1-888-203-1112 using Conference ID: 8053366. An audio replay of the call will also be available on the Company’s website, www.celsion.com, for 90 days after 2:00 p.m. EDT Friday, May 14, 2021.

On May 7, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, reported an update on its clinical and preclinical programs (Press release, Immutep, MAY 7, 2021, View Source [SID1234579569]).

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Eftilagimod alpha ("efti") Update

AIPAC – Phase IIb clinical trial

The Company is on track to report final overall survival (OS) data from this metastatic breast cancer trial in H2 of calendar year 2021. Currently the trial has reached approximately 72% of events, indicating 72% of total patients with this late-stage cancer had been followed through until death. Immutep previously reported an improving OS trend from initial data from approximately 60% of events at the San Antonio Breast Cancer Conference in December 2020.

TACTI-002 (also designated KEYNOTE-798) – Phase II clinical trial

The study is continuing to enroll 1st line non-small cell lung cancer (NSCLC) patients (Part A), with 54 patients out of up to 110 patients now enrolled and having received at least the first treatment. Immutep and its collaboration partner, Merck & Co. Inc, Kenilworth, NJ, USA ("MSD") expanded Part A of the TACTI-002 study to up to 110 patients following the encouraging results presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) Congress in November 2020.

Recruitment is also ongoing for patients with 2nd line NSCLC (Part B) which was expanded under the study’s Simon’s two-stage clinical trial design. Currently, 27 patients of a total of 36 patients have received the first treatment. In 2nd line head and neck squamous cell carcinoma (HNSCC, Part C) the recruitment of patients is complete.

Currently the recruitment of TACTI-002 is tracking well and new clinical data from TACTI-002 is planned to be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper) 2021 (4-8 June).

TACTI-003 – a Phase IIb Clinical Trial in 1st line Head and Neck Cancer

Subject to approval by relevant competent authorities, ethics committees and institutional review boards (IRBs), TACTI-003 will evaluate efti in combination with MSD’s KEYTRUDA (pembrolizumab) as a first line

therapy in unresectable recurrent or metastatic HNSCC patients with PD-L1 negative and PD-L1 positive (CPS ³1) tumors. It will be a randomized, controlled clinical study in approximately 154 first line HNSCC patients and will take place across Australia, Europe and the United States of America in up to 35 clinical sites.

The study will evaluate the safety and efficacy of efti in combination with pembrolizumab, compared to pembrolizumab alone in 1st line metastatic or recurrent HNSCC patients with PD-L1 positive (CPS ³1) tumors (cohort A), and determine the efficacy and safety of efti plus pembrolizumab in patients with PD-L1 negative tumors (CPS <1) (cohort B). According to the current plans about 130 patients in cohort A will be randomized 1:1 to receive either efti plus pembrolizumab or pembrolizumab alone. Subjects in cohort B (up to 24 patients) will receive a combination of efti and pembrolizumab.

The primary endpoint of the study is the Overall Response Rate (ORR) according to RECIST 1.1. and iRECIST will be used for treatment decisions. Secondary endpoints include OS and Progression Free Survival (PFS). Following the grant of Fast Track designation for efti to treat 1st line HNSCC patients by the US FDA in early April 2021 and the appointment of a Contract Research Organisation (CRO), Immutep is on track to start the study in mid-2021.

INSIGHT-004 – Phase I clinical trial

The INSIGHT-004 study is expected to deliver final data at ASCO (Free ASCO Whitepaper) 2021 in a poster discussion. INSIGHT-004 is the fourth arm of the INSIGHT trial (INSIGHT-004 is also known as Stratum D of INSIGHT) which is being conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc.

IMP761 Update

The Company has completed the selection of a high-producing CHO cell line for its IMP761 IgG4 mAb and is in the process of selecting a contract manufacturing organization (CMO) for GMP manufacturing of its preclinical candidate IMP761.

Financial Update

Immutep continues to be in a robust financial position with a cash runway into calendar year 2023, beyond the expected timing for several significant data read-outs from its trials.

On May 7, 2021 Luye Pharma Group announced that its biopharmaceutical drug 博优诺 (Bevacizumab Injection), developed by the Group’s holding subsidiary Boan Biotech, has received marketing authorization from China’s National Medical Products Administration (NMPA), for the treatment of advanced, metastatic or recurrent non-small-cell lung cancer (NSCLC), and metastatic colorectal cancer (Press release, Luye Pharma, MAY 7, 2021, View Source [SID1234597708]). 博优诺 is the third biosimilar of Avastin to enter the market in China, as well as the first product from Boan Biotech’s pipeline to receive marketing authorization.

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博优诺 and Avastin are Equivalent in Efficacy – Bevacizumab is a Standard Therapy for the Treatment of Multiple Cancers

The marketing approval for 博优诺 is based on the Guidelines on Similarity Evaluation and Indication Extrapolation of Biosimilars issued by the NMPA’s China Center for Drug Evaluation in February 2021. 博优诺 and Avastin were compared head-to-head in two pivotal clinical studies – the first was a pharmacokinetic(PK) study among healthy subjects, and the second was a comparative study of efficacy and safety in metastatic or recurrent non-squamous NSCLC patients. Both studies met primary endpoints, demonstrating that 博优诺 and Avastin are equivalent in efficacy and highly similar in terms of PK characteristics, safety, and immunogenicity.

As a classic anti-angiogenic oncology drug, Bevacizumab is considered standard therapy and is recommended by a number of guidelines worldwide for treating multiple malignant tumors. The drug is indicated for the treatment of NSCLC, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, ovarian cancer, and other solid tumors worldwide, with its efficacy and safety widely recognized by physicians and patients through its long-term clinical use. According to the Guidelines on Similarity Evaluation and Indication Extrapolation of Biosimilars, all indications for Avastin approved in China can also be gradually applied to 博优诺.

In addition, the combination of Bevacizumab and paclitaxel provides unique advantages in treatment. 博优诺 can be used with Luye Pharma’s core product paclitaxel liposome injection (Lipusu) to achieve a good synergy effect.

Preparing to Market 博优诺 – Meeting Patient Needs

According to data from the World Health Organization’s International Agency for Research on Cancer, the number of new cancer cases reported in 2020 in China was 4.57 million, the highest in the year and accounting for 23.7% of the total in the world. Lung cancer and colorectal cancer are the two cancers with the highest incidence rate in China, with 820 thousand and 560 thousand new cases each, respectively. Based on the high and ever-increasing number of patients in these two disease areas, the approval of 博优诺 is expected to help patients gain access to high-quality medication and address unmet needs.

Meanwhile, Bevacizumab Injection has been included in China’s National Reimbursement Drug List, further increasing accessibility. As the third biosimilar of Avastin to enter Chinese market, 博优诺 is expected to have optimistic prospects. According to the data from IQVIA, global sales of Bevacizumab Injection totaled USD 6.09 billion, with sales in China accounting for RMB 3.63 billion in 2020.

Through comprehensive leverage of its expertise along the whole industry value chain, Boan Biotech has been active in the preparation for 博优诺 entering the market, in manufacturing, sales team building, market access channels, and other areas. In addition, Luye Pharma Group’s long-term accumulated resources and expansive networks in the field of oncology are also expected to bring synergetic effects to enable the success of 博优诺.

Boan Biotech’s Rapid R&D Pipeline Development – Efficiency in Innovation

Boan Biotech’s antibody discovery research is based on three technology platforms: Human Antibody Transgenic Mouse and Phage Display Technology, Bispecific T-cell Engager Technology, and ADC Technology. By leveraging its efficient and innovative capabilities, the company has developed more than 10 innovative antibody product candidates with international intellectual property protection, and 8 biosimilar products including 博优诺 .

"We are delighted to see 博优诺 become the first product from Boan Biotech’s pipeline approved for marketing, and hope it will bring benefit to patients in need of high-quality and affordable anti-angiogenic treatment." said Jiang Hua, Chief Executive Officer of Boan Biotech, "The approval of 博优诺 is an important milestone for us and validates our efforts in the field with a tangible and substantial payoff. Focusing on the development of biopharmaceuticals, we hope to further accelerate R&D progress with more innovative products, serving more patients in China and around the globe."

In addition to 博优诺, Boan Biotech has a series of biopharmaceutical products in various stages of clinical development, including LY-CovMab, an innovative antibody for the treatment of COVID-19, which has completed phase I clinical trial in China and is soon to start the phase II clinical trials in China, the U.S. and Europe. Other Boan Biotech biosimilar products are expected to bear fruit in the near future. Phase III clinical trials in China for LY06006 (a biosimilar of Prolia) are nearing completion, with final administration of the drug completed for all the subjects, and the drug already receiving approval for clinical trials in Europe and the U.S. LY01011 (A biosimilar of Xgeva) is undergoing phase III clinical trials in China and phase I clinical trials in Europe and the U.S., and LY09004, a biosimilar of Eylea is also undergoing phase III clinical trials in China.

On May 7, 2021 OPKO Health, Inc. (NASDAQ: OPK) reported that has entered into exchange agreements with certain noteholders of the Company’s 4.50% Convertible Senior Notes due 2025 ("Notes") (Press release, Opko Health, MAY 7, 2021, View Source [SID1234579462]). The noteholders have agreed to exchange $55.42 million of the Company’s outstanding 2025 Notes for shares of the Company’s common stock.

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The number of shares of common stock to be issued by the Company to the Noteholders will be determined based upon a volume-weighted-average-price per share of common stock, subject to a floor price of $3.50 per share, during a four-trading-day averaging period, commencing today. The Company has agreed to pay the Noteholders accrued and unpaid interest on the exchanged notes in cash.

As announced in February 2019, in connection with the Company’s original issuance of its $200.0 million of Notes, the Company entered into a share lending agreement with Jefferies Capital Services, LLC under which it issued 29.25 million shares of common stock to lend. The Company currently expects that, upon consummation of the exchange of the Notes with its noteholders, there will be a pro rata reduction in the outstanding borrowed shares of its common stock.