invoX Pharma Commences Tender Offer for F-star Therapeutics, Inc.

On July 8, 2022 InvoX Pharma Limited ("invoX"), a wholly owned subsidiary of Sino Biopharmaceutical Limited ("Sino Biopharm") (HKEX 1177 HK) reported a cash tender offer for all of the issued and outstanding shares of common stock of F-star Therapeutics, Inc. ("F-star") (NASDAQ:FSTX) for a price of $7.12 per share (Press release, InvoX Pharma, JUL 8, 2022, View Source [SID1234616567]). The tender offer is being made pursuant to an Offer to Purchase, dated July 7, 2022 (the "Offer to Purchase"), and in connection with the previously announced Agreement and Plan of Merger, dated June 22, 2022, among invoX, Sino Biopharm, Fennec Acquisition Incorporated ("Purchaser"), an indirect wholly owned subsidiary of Sino Biopharm, and F-star (the "Merger Agreement").

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The tender offer commenced on July 7, 2022 and will expire at one minute past 11:59 p.m., Eastern Time, on August 3, 2022 (the "Expiration Date"), unless otherwise extended or terminated. Any extensions of the tender offer will be followed as promptly as practicable by public announcement thereof, and such announcement will be made no later than 9:00 a.m., Eastern Time, on the next business day after the previously scheduled Expiration Date.

invoX, Sino Biopharm and Purchaser have filed a tender offer statement on Schedule TO with the United States Securities and Exchange Commission (the "SEC"). The Offer to Purchase contained within the Schedule TO sets out the terms and conditions of the tender offer.

F-star has filed a Solicitation/Recommendation Statement on Schedule 14D-9 (the "Schedule 14D-9") with the SEC, which includes, among other things, the recommendation of F-star’s board of directors that F-star stockholders tender all of their shares in the tender offer.

As soon as practicable following the completion of the tender offer, Purchaser will acquire all remaining F-star shares through a merger at the tender offer price.

The tender offer and the merger are subject to customary closing conditions, including (i) the tender by F-star stockholders of at least one more share than 50% of the total number of F-star shares outstanding at the time of the expiration of the tender offer and (ii) required regulatory approvals, including the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, having expired or been terminated. The tender offer is subject to other important conditions set forth in the Offer to Purchase.

Concurrently with entering into the Merger Agreement, invoX and Purchaser entered into Tender and Support Agreements with each of Eliot Forster, Ph.D., Darlene Deptula-Hicks, Louis Kayitalire, M.D., Neil Brewis, PhD., Nessan Bermingham, Ph.D., Edward Benz Jr., M.D., Geoffrey Race, David Arkowitz, Pamela Klein, M.D., and Todd Brady, M.D., Ph.D. (collectively, the "Supporting Stockholders"), pursuant to which such Supporting Stockholders agreed to tender their shares into the tender offer. As of July 5, 2022, the Supporting Stockholders collectively, directly and indirectly own approximately 1.02% of all issued and outstanding shares of F-star.

The Information Agent for the tender offer is Innisfree M&A Incorporated. The Depositary and Paying Agent for the tender offer is Computershare Trust Company, N.A. For all questions relating to the tender offer, please call the Information Agent, Innisfree M&A Incorporated toll-free at (888) 750-5830; banks and brokers may call collect at (212) 750-5833.

Important Notices

This communication is for informational purposes only and is neither a recommendation, an offer to purchase nor a solicitation of an offer to sell securities. On July 7, 2022, invoX, Sino Biopharm and Purchaser filed with the SEC a tender offer statement on Schedule TO regarding the tender offer described in this communication. Holders of shares of common stock of F-star are urged to read the tender offer statement (as it may be updated and amended from time to time) and the Schedule 14D-9 filed by F-star as they contain important information that holders of shares of common stock of F-star should consider before making any decision regarding tendering their shares. These materials will be made available to F-star’s stockholders at no expense to them by Innisfree M&A Incorporated, the Information Agent, for the tender offer. In addition, the tender offer statement and other documents filed by invoX, Sino Biopharm and Purchaser, and F-star with the SEC are available for free at the SEC’s website at www.sec.gov.

This release is not intended for distribution to, or use by, any person or entity in any jurisdiction or country where such distribution or use would be contrary to local law or regulation. This release has been prepared by invoX and Sino Biopharm. No representation or warranty (express or implied) of any nature is given, nor is any responsibility or liability of any kind accepted, with respect to the truthfulness, completeness or accuracy of any information, projection, statement or omission in this release. This release does not constitute, nor does it form part of, any offer or invitation to buy, sell, exchange or otherwise dispose of, or any issuance, or any solicitation of any offer to sell or issue, exchange or otherwise dispose of any securities. This release does not constitute investment, legal, tax, accountancy or other advice or a recommendation with respect to such securities, nor does it constitute the solicitation of any vote or approval in any jurisdiction. There shall not be any offer or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the applicable securities laws of any such jurisdiction (or under exemption from such requirements).

Emergent BioSolutions and Ridgeback Biotherapeutics Enter Into Agreement for Ebanga™ Treatment for Ebola

On July 7, 2022 Emergent BioSolutions Inc. (NYSE: EBS) reported that it has entered into an agreement with Ridgeback Biotherapeutics ("Ridgeback Bio"), a biotechnology company focused on emerging infectious diseases, intended to create a collaboration to expand the availability of Ebanga (Ansuvimab-zykl) (Press release, Emergent BioSolutions, JUL 7, 2022, View Source [SID1234616551]). Under the terms of the contemplated collaboration, Emergent will be responsible for the manufacturing, sale, and distribution of Ebanga in the United States and Canada, and Ridgeback Bio will serve as the global access partner for Ebanga, ensuring it remains available to patients in endemic countries free of charge through Ridgeback Bio’s compassionate use program. Ebanga was approved by the U.S. Food and Drug Administration (FDA) in December 2020 for the treatment of Ebola.

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Ebanga is a monoclonal antibody with antiviral activity provided through a single injection and was developed for the treatment of Ebola by Ridgeback Bio under license from the National Institute of Allergy and Infectious Diseases. Ridgeback Bio provided funding and operational support for clinical testing, with additional funding received under contracts with the Biomedical Advanced Research and Development Authority for late-stage manufacturing and regulatory activities and ensured that the work necessary for FDA approval of Ebanga was completed.

"This relationship with Ridgeback Bio builds on our strategic focus and deep expertise in developing and supplying medical countermeasures against serious health threats," said Robert G. Kramer, CEO of Emergent. "Ebanga is crucial in the ongoing fight to contain Ebola and we are excited about the future of this collaboration to create a healthier, more secure world."

"We’re thrilled to collaborate with Emergent BioSolutions in making sure that the United States and Canada receive the supply they need of Ebanga, while also continuing our ongoing local support for the prompt treatment of outbreaks that includes free patient access and funding on-the-ground support through our Rapid Response Program," said Wendy Holman, CEO of Ridgeback Bio.

About Ebanga
Ebanga (ansuvimab-zykl, formerly referred to as mAb114) is a monoclonal antibody with antiviral activity provided through a single injection. Ebanga development has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract Numbers 75A50119C00059 and 75A50120C00009.

Kernal Biologics Announces $25M Series A Financing to Advance its mRNA 2.0 Technology for Oncology

On July 7, 2022 Kernal Biologics, Inc. (Kernal Bio) — a development-stage mRNA-technology company developing cancer therapeutics designed to improve patients’ survival rate and quality of life — reported the completion of a $25 million Series A financing led by Hummingbird Ventures. Amgen Ventures, HBM Genomics and Civilization Ventures along with other VCs, family offices and high net worth individuals also participated in the round (Press release, Kernal Biologics, JUL 7, 2022, View Source [SID1234616552]).

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The new capital will extend Kernal’s mRNA 2.0 platform and support the filing of an IND for Kernal’s immuno-oncology candidate KR-335. In connection with the financing, Firat Ileri, Managing Partner of Hummingbird Ventures joins the board.

"We have closely followed the work of the Kernal Bio team over the past few years and we are excited to see them bring their mRNA technology to fruition in an area of medicine with high unmet medical need," said Firat Ileri, Managing Partner of Hummingbird Ventures. "Kernal Bio is building on the success stories of Moderna and Pfizer/BioNTech with legacy mRNA technologies. We are delighted to partner with them to bring this innovative approach to cancer patients."

"There’s a major unmet need to improve outcomes for cancer patients and Kernal Bio has built a strong rational for the use of its novel mRNA technology in cancer therapeutics," said Kernal Bio Co-founder and Chief Executive Officer Yusuf Erkul, M.D. "This financing further validates that rational. Our breakthrough onco-selective mRNA approach can enable specific protein expression in malignant cells, widening the therapeutic window of mRNAs in oncology."

Additionally, Manfred Kraus Ph.D., who was previously the Scientific Senior Director at the Tumor Microenvironment Thematic Research Center at Bristol-Myers Squibb (BMS), joins the company as Vice President of Research and Development. Before BMS, Dr. Kraus was a Director at Pfizer’s Oncology Research Unit where he led the in vivo pharmacology teams supporting the oncology portfolio from new target identification to clinical proof of concept. Previously, he worked in the oncology departments at Astra-Zeneca, Merck & Co., and Serono.

Dr. Kraus earned his Ph.D. in immunology with Dr. Klaus Rajewsky at the University of Cologne in Germany, followed by post-doctoral training at Harvard Medical School investigating the role of B cell receptor signaling in mature B lymphocytes. His scientific accomplishments include the discovery of the tonic BCR-mediated survival signal in mature B cells. Dr. Kraus pushed our understanding of the role of ITAM and non-ITAM phosphorylation in the CD79a/b signaling subunit of the B cell receptor plus advanced and mentored technical innovation such as conditional gene-targeting, reversible RNAi in mice and multi-parametric flow cytometry. He is an author on 27 peer-reviewed articles and an inventor on four patents.

"We are thrilled to have Dr. Kraus join Kernal as he brings extensive drug development experience in oncology which will help us to expand our mRNA 2.0 platform and advance our lead program. Dr. Kraus will oversee the expansion of our R&D team as well as the advancement of our therapeutic programs into the clinic," said Burak Yilmaz, M.S., Co-founder and President of Kernal Bio.

Kiromic BioPharma Achieves Milestone with Timely Completion of Expanded cGMP Manufacturing Facility to Support Cell Therapy Oncology Pipeline

On July 7, 2022 Kiromic BioPharma, Inc. (NASDAQ: KRBP) ("Kiromic" or the "Company"), a clinical-stage fully integrated biotherapeutics company using its proprietary DIAMOND artificial intelligence and data mining platform to develop cell and gene therapies with a focus on immuno-oncology, reported the timely completion of construction on its expanded current good manufacturing practice (cGMP) manufacturing facility in Houston (Press release, Kiromic, JUL 7, 2022, View Source [SID1234616535]). This significant milestone was accomplished within the timeline established by the Company, specifically June 30, 2022.

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The expanded facility located at Kiromic’s headquarters is one of the conditions required for the Company to begin the activation of its cell therapy clinical trial for the Deltacel product candidate by the end of this year. The completion also addresses a key component in the clinical hold communication the Company received from the U.S. Food and Drug Administration (FDA) in June 2021.

"The on-time completion of our cGMP manufacturing facility is one of the conditions necessary to begin the activation of the Deltacel clinical trial by the end of this year," stated Pietro Bersani, Kiromic BioPharma’s Chief Executive Officer. "The facility supports an expanding product pipeline of cell therapies designed to target solid tumors, furthering our commitment to delivering lifesaving treatments to patients with cancer who have limited therapeutic options. We believe our allogeneic, off-the-shelf manufacturing process will result in shorter lead times and lower costs, thereby increasing the availability of these promising cellular therapies for oncology patients."

The expanded 34,000-square-foot facility includes flexible cellular therapy and viral vector suites, a dedicated cGMP microbiology lab, a dedicated cGMP quality control (QC) lab, a research and development laboratory, and an FDA Code of Federal Regulations (CFR-9) compliant vivarium.

InnoCare Announces Approval of Clinical Trial of Novel Targeted Protein Degrader ICP-490 in China

On July 7, 2022 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the company has received Investigational New Drug (IND) approval of clinical trial from the NMPA (National Medical Products Administration) for its novel targeted protein degrader ICP-490 for the treatment of multiple myeloma (MM) and non-Hodgkin’s lymphoma (NHL) (Press release, InnoCare Pharma, JUL 7, 2022, View Source [SID1234616517]).

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ICP-490 is developed from InnoCare’s molecular glue platform. By specifically binding to CRL4-CRBN-E3 ligase complex, ICP-490 induces ubiquitination and degradation of transcription factors including Ikaros and Aiolos, thereby downregulating the expression of IRF4, an oncogenic transcription factor that drives multiple myeloma to exert direct anti-myeloma effects. It also has immunomodulatory effects by enhancing the function of effector T cells, resulting from Ikaros and Aiolos degradation and the degradation-mediated releasing of interleukin IL-2.

Multiple myeloma (MM) is a malignant tumor with clonal abnormal proliferation of plasma cells, which is characterized by abnormal proliferation of bone marrow plasma cells and most of them with overproduction of monoclonal immunoglobulin (M protein). MM is often accompanied by multiple osteolytic lesions, hypercalcemia, anemia, kidney injury, etc. MM accounts for about one percent of tumor diseases and 10 percent of blood tumors1.

Non-Hodgkin’s lymphoma (NHL) is the most common hematological malignancy in the world, accounting for nearly three percent of cancer diagnosis and death2. NHL ranks among the top 10 common malignant tumors in China. Its common types include diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL).

Dr. Jasmine Cui, the co-founder, Chairwoman and CEO of InnoCare said, "InnoCare has built a strong pipeline in the field of blood tumor. With the approval of ICP-490 for clinical trials, InnoCare will further strengthen its blood tumor pipeline and aim to provide better treatment options for those patients in China and around the world."