On December 19, 2022, F-star Therapeutics, Inc., a Delaware corporation (the "Company"), invoX Pharma Limited, a private limited company organized under the laws of England and Wales ("Parent") and Fennec Acquisition Incorporated, a Delaware corporation and a wholly owned subsidiary of Parent ("Purchaser" and together with the Company and Parent, the "Parties"), entered into Amendment No. 2 ("Amendment No. 2") to the Agreement and Plan of Merger, dated as of June 22, 2022, by and among the Parties and Sino Biopharmaceutical Limited, a company organized under the laws of the Cayman Islands, as "Guarantor" (the "Merger Agreement") (Filing, 8-K, F-star, DEC 19, 2022, View Source [SID1234625400]). Capitalized terms used herein without definition shall have the same meanings as assigned to them in the Merger Agreement or Amendment No. 2, as the case may be.

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Amendment No. 2 extends the End Date of the Merger Agreement from December 19, 2022 at 5:00 p.m., Eastern Time, to December 30, 2022 at one (1) minute past 11:59 p.m., Eastern Time. The parties are in discussions with the Committee on Foreign Investment in the United States (CFIUS) regarding the Transactions and have extended the End Date to provide for additional time to satisfy the Foreign Investment Condition with respect to CFIUS.

CFIUS has identified national security risks arising from the Transactions and is continuing to consider whether mitigation measures could adequately resolve the identified risks. On December 15, 2022, CFIUS advised the parties that it is availing itself of another 45-day investigation period, and that its investigation will be completed by no later than January 30, 2022, unless extended further.

Previously, the regulatory body in the United Kingdom, where the Company is based, cleared the voluntary notice filing regarding the Transactions under UK’s foreign investment regulations.

As previously described, the Merger Agreement may be terminated by either party, subject to certain exceptions, if any of the Offer conditions, are not satisfied or waived, to the extent waiveable, by Purchaser on or before the End Date.

Other than as expressly modified pursuant to Amendment No. 2, the Merger Agreement, which was previously filed as Exhibit 2.1 to the Current Report on Form 8-K filed with the Securities and Exchange Commission by the Company on June 23, 2022, remains in full force and effect as originally executed on June 22, 2022, as amended. The foregoing description of Amendment No. 2 does not purport to be complete and is subject to, and qualified in its entirety by, the full text of Amendment No. 2 attached hereto as Exhibit 2.1 to this Current Report on Form 8-K, which is incorporated herein by reference.

On December 19, 2022 EORTC and ALLIANCE reported that the target accrual in A031102/EORTC1407 TIGER study has been reached (Press release, EORTC, DEC 19, 2022, View Source [SID1234625398]).

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A031102/EORTC 1407 (TIGER) is an international phase III trial that seeks to establish the standard of care for second-line (also called initial salvage) chemotherapy in patients with advanced germ cell tumors (GCT). TIGER compares initial salvage conventional-dose chemotherapy (CDCT) with the TIP regimen vs. high-dose chemotherapy and autologous stem cell transplant (HDCT/ASCT) with the TI-CE regimen with a primary endpoint of overall survival. The completion of patient recruitment is a major milestone for this groundbreaking trial.

EORTC would like to thank the collaborating groups who have supported this trial, including our funding partner @MOVEMBER. Without them, this trial would not have been possible in Europe.

"The TIGER trial is significant because collaboration between the Alliance/NCI and EORTC demonstrates that it is possible to conduct investigator-initiated randomized clinical trials in rare malignancies through the cooperative group mechanism in the absence of pharmaceutical company support. To our knowledge, TIGER is the first transatlantic cooperative group-led randomized trial conducted in GCT. This landmark study was open at 63 enters within 13 countries across 3 continents (North America, Europe, and Australia/New Zealand), and has helped pave the way for additional CTEP/NCI-led trials in other rare malignancies via collaboration with EORTC or other international partners."

On December 19, 2022 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported that the U.S. Food and Drug Administration ("FDA") has approved an additional indication for PEMFEXY (pemetrexed injection) in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer ("NSCLC") with no EGFR or ALK genomic tumor aberrations (Press release, Eagle Pharmaceuticals, DEC 19, 2022, View Source [SID1234625397]). Eagle’s approved PEMFEXY (pemetrexed injection) is a ready-to-dilute ("RTD") novel liquid intravenous formulation developed to eliminate the reconstitution step of the Listed Drug ("LD"), ALIMTA.

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"With this fifth indication, PEMFEXY is now approved for all of the same indications as ALIMTA, and we believe it allows for key advantages such as eliminating the need for reconstitution. Since its initial launch in February 2022, PEMFEXY has been an important addition to Eagle’s hospital and acute care product portfolio, and we are pleased to bring this treatment option to patients undergoing chemotherapy. At the same time, we also believe that Eagle is well positioned to capture the commercial opportunity that PEMFEXY represents," stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

Effective October 1, 2022, the Company amended its agreement to reduce future royalties related to PEMFEXY profits from 25% to a range of 0% to 12.5% based on aggregate profits achieved in exchange for a one-time payment of $15 million.

In February 2020, Eagle received approval from the FDA of its New Drug Application for PEMFEXY, following the settlement agreement of patent litigation with Eli Lilly and Company (NYSE: LLY) in December 2019. The agreement provided for a release of all claims by the parties and allowed for an initial entry of PEMFEXY into the market (equivalent to approximately a three-week supply of current ALIMTA utilization) on February 1, 2022, and a subsequent uncapped entry on April 1, 2022.

On December 19, 2022 Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, and the Menarini Group ("Menarini"), a privately-held, leading international pharmaceutical company, reported a clinical trial collaboration and supply agreement (Press release, Carrick Therapeutics, DEC 19, 2022, https://www.carricktherapeutics.com/carrick-therapeutics-menarini-group-announce-clinical-trial-collaboration-evaluate-samuraciclib-elacestrant-combination/ [SID1234625396]).

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This agreement covers the execution of a Phase 2 clinical trial to evaluate the novel combination of Carrick’s samuraciclib (CT7001), an oral and first-in-class inhibitor of CDK7, and Menarini‘s oral selective estrogen receptor degrader (SERD), elacestrant, in patients with CDK4/6i resistant HR+, HER2- metastatic breast cancer. Menarini and Carrick will jointly sponsor the clinical trial.

"We are excited to initiate this collaboration with Menarini to explore the potential of samuraciclib in combination with elacestrant for the treatment of advanced breast cancer," said Tim Pearson, Chief Executive Officer of Carrick Therapeutics. "Our pre-clinical work and prior clinical studies have validated the biology for SERD combinations with CDK7, pointing to potential synergies when combining samuraciclib with Menarini’s oral SERD, elacestrant. This collaboration represents a shared commitment to maximizing the potential of novel combination therapies to improve outcomes for people living with breast cancer."

"This new clinical collaboration with Carrick Therapeutics is yet another step we are making to develop elacestrant in an extensive way to address unmet needs of patients resistant to CDK4/6 therapies in HR+, HER2- metastatic breast cancer," said Elcin Barker Ergun, Chief Executive Officer of Menarini. "Menarini will continue to pursue research collaborations that have the potential to improve patients’ lives in breast cancer."

Carrick anticipates initiating the Phase 2 clinical trial in 2023. This new study will expand Carrick’s portfolio of ongoing clinical trials with samuraciclib. The company presented encouraging results from a clinical study combining samuraciclib with fulvestrant at the 2021 San Antonio Breast Cancer Symposium.

On December 19, 2022 Cardinal Health (NYSE: CAH) and its board of directors reported that Aaron Alt will become the company’s new chief financial officer (CFO) (Press release, Cardinal Health, DEC 19, 2022, View Source [SID1234625395]). Alt will succeed interim CFO, Trish English and will report to CEO, Jason Hollar, as a member of the company’s Executive Committee effective Feb. 10.

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In his capacity as CFO, Alt will lead financial activities across the enterprise, including Financial Strategy, Capital Deployment, Treasury, Tax, Investor Relations, Accounting, and Reporting. Additionally, he will lead the Corporate Development team.

"We’re pleased to welcome Aaron as the new CFO of Cardinal Health," said Jason Hollar, CEO of Cardinal Health. "He’s an exceptional talent with a breadth of experience across complex organizations that will position him well for this critical companywide role. I’d also like to thank Trish for her contributions as interim CFO and her commitment to help with this transition."

Alt most recently served as EVP and CFO for Sysco Corporation, the leading global foodservice distribution company. In this role, he drove significant improvements to the balance sheet and underlying profitability of Sysco.

Prior to Sysco, Alt was SVP and CFO for Sally Beauty Holdings, an international specialty retailer and wholesale distributor of professional beauty supplies. He has also held senior executive roles in Finance, Operations and Grocery Transformation at Target Corporation. Prior to joining Target, he held senior-level Finance and Operations positions with Sara Lee Corporation.

Aaron holds an M.B.A. from the J.L. Kellogg School of Management at Northwestern University, a J.D. from Harvard Law School and a B.A. in History and Political Science from Northwestern University.