Merck to Present at the Goldman Sachs Healthcare CEOs Unscripted Conference

On December 22, 2022 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that Robert M. Davis, chairman and chief executive officer, is scheduled to participate in a fireside chat at the Goldman Sachs Healthcare CEOs Unscripted Conference on Thursday, Jan. 5, 2023, at 8:55 a.m. ET (Press release, Merck & Co, DEC 22, 2022, View Source [SID1234625546]).

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Investors, analysts, members of the media and the general public are invited to watch a live video webcast of the presentation at this weblink.

Merck and Kelun-Biotech Announce Exclusive License and Collaboration Agreement for Seven Investigational Antibody-drug Conjugate Candidates for the Treatment of Cancer

On December 22, 2022 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Kelun-Biotech (a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd), a clinical-stage biotech company focused on biologic and small molecule discovery and development, reported that the companies have entered into an exclusive license and collaboration agreement to develop seven investigational preclinical antibody-drug conjugates (ADC) for the treatment of cancer (Press release, Merck & Co, DEC 22, 2022, View Source [SID1234625543]).

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"Advances in ADC technologies are yielding a new generation of candidates designed to more precisely target and deliver potent anticancer agents to the tumor site," said Dr. Dean Y. Li, president, Merck Research Laboratories. "We continue to augment our oncology pipeline and look forward to working with the Kelun-Biotech team to advance these candidates to the patients that need them."

Under the agreement, Kelun-Biotech has granted Merck exclusive global licenses to research, develop, manufacture and commercialize multiple investigational preclinical ADC therapies and exclusive options to obtain additional licenses to ADC candidates. Kelun-Biotech retains the right to research, develop, manufacture and commercialize certain licensed and option ADCs for mainland China, Hong Kong and Macau.

"The further expansion of our collaboration with Merck provides a strong endorsement for our technology from a leader in the development of cancer treatments," said Dr. Junyou Ge, chief executive officer of Kelun-Biotech. "We are grateful for our partnership with the Merck scientists."

Kelun-Biotech will receive an upfront payment of $175 million from Merck. Kelun-Biotech is also eligible to receive future development, regulatory and sales milestone payments totaling up to $9.3 billion, if Kelun-Biotech does not retain mainland China, Hong Kong and Macau rights for the option ADCs and all candidates achieve regulatory approval, plus tiered royalties on net sales for any commercialized ADC product. Merck also intends to make an equity investment in Kelun-Biotech. The transaction is subject to customary closing conditions including regulatory approval under the Hart-Scott Rodino (HSR) Act and approvals by the shareholders of Kelun-Biotech and Sichuan Kelun Pharmaceutical Co., Ltd.

This announcement follows previously disclosed research collaboration and licensing agreements for two ADC candidates including MK-2870 (also known as SKB-264), an investigational TROP2 targeting ADC currently being evaluated in late-stage clinical trials.

Johnson & Johnson Completes Acquisition of Abiomed

On December 22, 2022 Johnson & Johnson (NYSE: JNJ), the world’s largest, most diversified healthcare products company, reported that it has completed its acquisition of Abiomed, Inc. Abiomed is now part of Johnson & Johnson and will operate as a standalone business within Johnson & Johnson’s MedTech segment (Press release, Johnson & Johnson, DEC 22, 2022, View Source [SID1234625542]).

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"We are excited to officially welcome the talented Abiomed team to Johnson & Johnson. Their patient-first philosophy aligns with Our Credo and Our Purpose to change the future of health for humanity," said Joaquin Duato, Chief Executive Officer of Johnson & Johnson. "This acquisition marks another important step on Johnson & Johnson’s path to accelerating growth in our MedTech business and delivering innovative medical technologies to more people around the world."

Ashley McEvoy, Executive Vice President and Worldwide Chairman of MedTech at Johnson & Johnson, added, "The completion of this acquisition allows Johnson & Johnson MedTech to expand our portfolio in the high growth cardiovascular markets, adding solutions for heart recovery to our global market leading Biosense Webster electrophysiology business. Fueled by Johnson & Johnson’s global scale and commercial and clinical strength, we are excited to explore the opportunities and possibilities ahead to reach even more patients with critical unmet need."

Johnson & Johnson’s tender offer for all outstanding shares of Abiomed for an upfront payment of $380.00 per share in cash, corresponding to an enterprise value of approximately $16.6 billion, which includes cash acquired, expired at 11:59 p.m., New York City time, on December 21, 2022. Abiomed shareholders will also receive a non-tradeable contingent value right ("CVR") entitling the holder to receive up to $35.00 per share in cash if certain commercial and clinical milestones are achieved. American Stock Transfer & Trust Company, LLC, the depositary for the tender offer, has advised Johnson & Johnson that approximately 25,759,195 shares of Abiomed common stock were validly tendered and not properly withdrawn in the tender offer, representing approximately 57.1% of the then-outstanding shares of Abiomed’s common stock. All of the conditions to the tender offer have been satisfied, and on December 22, 2022, Athos Merger Sub, Inc. ("Purchaser"), a wholly-owned subsidiary of Johnson & Johnson, accepted for payment, and will as promptly as practicable pay for, all shares validly tendered and not properly withdrawn in the tender offer.

The acquisition was completed on December 22, 2022 through a merger of Purchaser with and into Abiomed in accordance with Section 251(h) of the General Corporation Law of the State of Delaware without a vote of Abiomed stockholders. In connection with the merger, shares of Abiomed that were not tendered in the tender offer were acquired by Johnson & Johnson and converted into the right to receive $380.00 per share in cash plus a CVR.

The transaction will not have a material impact on financial results for 2022. As previously announced, the transaction will accelerate pro forma MedTech and Johnson & Johnson enterprise revenue growth. It is also expected to be slightly dilutive to neutral to adjusted earnings per share in the first year, considering the impact of financing, and then accretive by approximately $0.05 in 2024, and increasingly accretive thereafter.

In connection with the completion of the transaction, Abiomed’s common stock ceased trading on NASDAQ.

INmune Bio, Inc., Virginia Commonwealth University, and Barrow Neurological Institute Receive Department of Defense Funding to Study the Role of Traumatic Brain Injury in the Development of Alzheimer’s Disease

On December 22, 2022 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease in concert with Virgina Commonwealth University (VCU) and Barrow Neurological Institute have received a grant from the Department of Defense (DoD) (Press release, INmune Bio, DEC 22, 2022, View Source [SID1234625540]). The grant is titled: Novel solTNF inhibitor improves outcomes in a mouse model of TBI-induced AD. The funding covers a collaboration that studies the impact of traumatic brain injury (TBI) in the development of Alzheimer’s disease (AD) related pathology. These DoD funded studies are a collaboration between Dr. Kirsty Dixon, Associate Professor of Surgery and director of Surgery’s Neurotrauma Repair Laboratory at Virginia Commonwealth University, and Dr. Elliott Mufson, Professor of Neurobiology and the director of the Alzheimer’s disease research laboratory at Barrow Neurological Institute and INmune Bio.

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"This is a great example of collaboration for innovation," said RJ Tesi MD, CEO of INmune. "Two stellar academic institutions combine with industry (INMB) and government (DoD) to answer an important medical question."

TBI is a risk factor for developing AD, although reasons for this remains largely unknown. The ApoE4 allele is the strongest known risk factor for late onset AD, and the presence of human ApoE4 following TBI results in accumulation of AD pathology (soluble Aβ and tau/p-tau levels). Evidence suggests a role for soluble tumor necrosis factor (sTNF) and its receptor TNFR1 in the development of AD in patients with previous TBI, especially in individuals carrying the APOE4 allele. These studies will use XPro1595 to determine the contribution of ApoE4 and TBI on sTNF/TNFR1-induced hippocampal inflammation, AD pathology and dendritic spine plasticity, that collectively promote cognitive impairment.

"Much of the neurologic damage after TBI is driven by neuroinflammation," said Kirsty Dixon, PhD, associate professor in the Department of Surgery at the VCU School of Medicine. "This study aims to confirm that neuroinflammation caused by an acute neurologic injury has long-term consequences that contribute to dementia and that early intervention can prevent disability later in life."

"We know that traumatic brain injury can accelerate the onset of Alzheimer’s disease, however little is known about the association between the two diseases," says Elliott Mufson, PhD, researcher at Barrow Neurological Institute. "This study is an important step toward helping us better understand the relationship between these disorders and to develop effective therapies."

Geron Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On December 22, 2022 Geron Corporation (Nasdaq: GERN) reported that it has granted non-statutory stock options to purchase an aggregate of 867,130 shares of Geron common stock as inducements to newly hired employees in connection with commencement of employment with the Company (Press release, Geron, DEC 22, 2022, View Source [SID1234625538]).

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The stock options were granted on December 21, 2022 at an exercise price of $2.08 per share, which is equal to the closing price of Geron common stock on the date of grant. Stock options representing an aggregate of 750,000 shares have a 10-year term and vest over four years, with 12.5% of the shares underlying the options vesting on the six-month anniversary of commencement of employment for the respective employees and the remaining shares vesting over the following 42 months in equal installments of whole shares, subject to continued employment with Geron through the applicable vesting dates. Stock options representing an aggregate of 117,130 shares have a 10-year term and vest in full upon achievement of certain regulatory milestones, subject to continued employment with Geron through the applicable vesting dates. All of the stock options were granted as material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and are subject to the terms and conditions of the stock option agreements covering the grants and Geron’s 2018 Inducement Award Plan, which was adopted December 14, 2018 and provides for the granting of stock options to new employees.