On June 23, 2022 invoX Pharma ("invoX"), a wholly owned subsidiary of Sino Biopharmaceutical Limited ("Sino Biopharm") (HKEX 1177 HK), focused on research and development (R&D) and business development activities outside of China, and F-star Therapeutics, Inc. ("F-star") (NASDAQ:FSTX), a clinical-stage biopharmaceutical company pioneering bispecifics in immunotherapy so more people with cancer can live longer and improved lives, reported that the companies have entered into a definitive agreement whereby invoX will acquire all of the issued and outstanding shares of F-star common stock for $7.12 per share (Press release, F-star, JUN 23, 2022, View Source [SID1234616209]). The proposed acquisition values F-star at approximately $161 million. The transaction has been unanimously approved by the invoX and F-star Boards of Directors and is expected to close in the second half of 2022.

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F-star’s proprietary platform technology pioneers the use of tetravalent (2+2) bispecific antibodies that enable the simultaneous targeting of two different antigens and a unique set of pharmacology to deliver focused, potent and safe immune activation in the tumor microenvironment. Four programs are progressing in clinic, three based on F-star’s tetravalent platform and one next generation STING agonist, with multiple further undisclosed programs in development. These programs represent potentially first- and best-in-class drug candidates for many areas of unmet medical need, including patients with cancer and other serious diseases who have few other options available. Leveraging its modular antibody technology, F-star has forged collaborations with major international biopharma companies across a wide range of therapeutic areas including oncology, immunology and neurology.

invoX, established in 2021 in the United Kingdom, is Sino Biopharm’s international expansion platform, focusing on R&D and business development activities outside of China, with a core focus on oncology and respiratory therapeutics. F-star will form a key element of invoX’s strategy to accelerate Sino Biopharm’s development of innovative medicines to transform the lives of patients worldwide, complementing its existing R&D platforms and pipeline.

Ben Toogood, Chief Executive Officer of invoX commented: "Today’s proposed acquisition is aligned with invoX’s strategy to become a fully integrated biopharmaceutical company with an advancing pipeline of innovative products addressing unmet healthcare needs, worldwide. We are excited to welcome F-star employees and look forward to working with them as we invest in the company to progress and grow its clinical pipeline to realize the full potential of the platform."

Eliot Forster, Chief Executive Officer of F-star said: "We believe our tetravalent bispecifics offer the best approach to tackle hard-to-treat cancers and other serious diseases, with the ambition to deliver longer and improved lives for patients. Today’s announcement is good news for F-star, for our shareholders and, of course, for patients. This transaction enables greater and longer-term opportunities to develop the F-star platform and accelerate delivery of our novel medicines as we work together towards a future free from cancer and other serious diseases. I’d like to thank the fantastic team at F-star as well as our partners for all their hard work, support and dedication and I’m delighted to share this exciting development."

Transaction Terms

Under the terms of the merger agreement, invoX, a wholly owned subsidiary of Sino Biopharm, will commence a tender offer within the next 10 business days to acquire all of the issued and outstanding shares of F-star common stock for a price of US$7.12 per share in cash upon the completion of the offer. The transaction is expected to complete in the second half of 2022, subject to certain customary closing conditions, including the tender by F-star stockholders of greater than 50 percent of the issued and outstanding shares of F-star common stock and required regulatory approvals, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary closing conditions. Following the closing of the tender offer, invoX will acquire any shares of F-star that are not tendered in the tender through a second-step merger under Delaware law at the tender offer price.

Advisors

PJT Partners is acting as financial advisor to invoX, and Morgan Stanley & Co. LLC is acting as financial advisor to F-star. Shearman & Sterling LLP is serving as legal counsel to invoX and Sino Biopharm and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is serving as legal counsel to F-star.

On June 23, 2022 EXACT Therapeutics AS ("EXACT-Tx" or "the Company", Euronext Growth: EXTX), a clinical-stage precision health company developing the Acoustic Cluster Therapy (ACT), a proprietary ultrasound-mediated drug delivery platform to enhance the efficacy of therapies across multiple diseases, reported that its collaboration partner GE Healthcare has been awarded with an innovation grant from the Norwegian Research Council (NRC) of NOK 16M to support the development of a ready-to-use formulation of Sonazoid for ultrasound imaging and therapy (Press release, Exact Therapeutics, JUN 23, 2022, View Source [SID1234616208]).

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The funding will support the development, the documentation and the regulatory approval of a non-lyophilised and ready-to-use liquid formulation of Sonazoid for ultrasound imaging, and regulatory approval for its use in ACT clinical trials. Academic groups Prof. Catharina de Lange Davies from the Norwegian University of Science and Technology (NTNU, long term collaborator of EXACT-Tx) and the French National Institute for Health and Medical Research (Lyon), are also involved in the collaboration.

Dr Sigrid Fossheim, Global Product Leader Ultrasound, GE Healthcare AS commented: "Removing the lyophilisation – or freeze drying – process aims to help increase manufacturing capacity for Sonazoid, and this innovation grant is a significant milestone in our ambition to grow utilization of the product."

Dr Per Walday, Chief Executive Officer, EXACT-Tx, commented: "We are very pleased with the award of this NRC grant, which brings a range of improvements and strengthens our partnership with GE Healthcare and supports an important part of the path to successful commercialisation of our PS101 product."

On June 20, 2022, Celldex Therapeutics Inc. (the "Company") reported that entered into a binding settlement term sheet (the "Term Sheet") with Shareholder Representatives Services LLC ("SRS"), relating to the previously disclosed litigation brought by the Company (the "Litigation") arising under the Agreement and Plan of Merger, dated November 1, 2016 (the "Merger Agreement"), by and among Kolltan Pharmaceuticals, Inc., the Company, Connemara Merger Sub 1 Inc., Connemara Merger Sub 2 LLC and SRS, solely in its capacity as the Stockholders Representative, which, upon execution of a definitive settlement agreement and the payment of the Initial Payment (as defined below), will result in the joint dismissal, with prejudice, of all claims and counterclaims in the Litigation (Filing, 8-K, Celldex Therapeutics, JUN 20, 2022, View Source [SID1234616207]).

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Pursuant to the terms of the Term Sheet, all milestone payments provided for by the Merger Agreement are replaced in their entirety with the following payments, each of which is payable only once:

(i)The Company shall pay $15,000,000 upon execution of the Settlement Agreement (the "Initial Payment").
(ii)The Company shall pay $15,000,000 upon the Successful Completion (as defined in the Term Sheet) of a Phase 2 Clinical Trial (as defined in the Merger Agreement) of CDX-0159, subject to the $2,500,000 contractual credit as set forth in the Merger Agreement.
(iii)The Company shall pay $52,500,000 upon the first United States Food and Drug Administration or European Medicines Agency, or, in each case, any successor organization, regulatory approval of a Surviving Company Product (as defined the Term Sheet).

The above payment obligations replace, in their entirety, the contingent consideration in the form of development, regulatory approval and sales-based milestones of up to $172.5 million contained in the Merger Agreement.

Each of the Company and SRS will provide broad mutual releases of all claims relating to or arising out of the Merger Agreement, including without limitation, all claims brought in the Litigation or that could have been brought in the Litigation. The Term Sheet is binding pending the execution of a formal settlement agreement on or before July 15, 2022.

The Company has elected to pay the Initial Payment in cash. When and if any of the remaining payments described above become due, they shall be payable, at the Company’s sole election, in either cash or stock (as set forth in the Merger Agreement) or a combination thereof.

On June 23, 2022 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision-oncology biopharmaceutical company, reported that the first patient has been enrolled in a multicenter phase 2 clinical trial evaluating its spleen tyrosine kinase (SYK) inhibitor mivavotinib (CB-659) in patients with relapsed/refractory non-germinal center B-cell like (non-GCB) diffuse large B-cell lymphoma (DLBCL), a DLBCL subpopulation that primarily comprises patients with activated B-cell like disease (ABC) (Press release, Calithera Biosciences, JUN 23, 2022, View Source [SID1234616206]).

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In a retrospective analysis of prior phase 1/2 studies in patients with DLBCL, patients with non-GCB DLBCL who received mivavotinib had a response rate of 53%, as compared to a response rate of 22% in patients with GCB DLBCL. Additionally, recent preclinical studies have shown enhanced SYK activity, and greater sensitivity to SYK inhibition, in DLBCL tumor-cell lines with mutations in MYD88 and CD79b genes. A significant fraction of patients with non-GCB DLBCL have tumors that harbor these mutations, and this subset of patients is known to have poorer outcomes with standard-of-care therapies.

"Mivavotinib has demonstrated potential to be a first-to-market approach for non-GCB DLBCL, including the genetic subset of patients harboring MYD88 and/or CD79 mutations," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "This study will advance understanding of how our novel biomarker-driven approach could help address this high unmet therapeutic need, and we look forward to sharing data by the first quarter of 2023."

The phase 2 clinical trial (NCT05319028) is an open-label study of mivavotinib monotherapy in patients with relapsed/refractory non-GCB DLBCL. The main study objectives are to confirm previously seen single-agent activity in non-GCB DLBCL patients, evaluate activity according to MYD88/CD79b mutational status, and refine dose/schedule in this patient population. Approximately 50 non-GCB DLBCL patients, with or without MYD88/CD79b mutations, will be randomized 1:1 to one of two oral dose/schedule cohorts: a continuous dosing schedule (100 mg QD) or an induction dosing schedule (120 mg QD x 14 days, then 80 mg QD starting Day 15).

Centrally assessed ctDNA-based liquid next-generation sequencing (NGS) will be performed after randomization to ascertain MyD88/CD79b mutation status. The primary endpoints of the study are overall response rate as assessed by an independent radiology review committee and safety. Key secondary endpoints include duration of response, progression-free survival, and complete response.

Data from the trial could position Calithera to initiate a study with registrational intent in biomarker-specific DLBCL populations.

On June 23, 2022 DEM BioPharma, Inc. (DEM Bio), an immuno-oncology company developing therapies that target novel innate immune system checkpoints to eliminate cancer, reported its initial $70 million financing led by founding investor Longwood Fund and Alta Partners, with additional participation from Insight Partners, Pfizer Ventures, Astellas Venture Management, Emerson Collective, UTokyo Innovation Platform and Alexandria Venture Investments (Press release, DEM BioPharma, JUN 23, 2022, View Source [SID1234616205]).

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DEM Bio is pioneering the next generation of immunotherapeutics designed to unleash macrophages and other myeloid effector cells to eliminate tumors by targeting novel ‘don’t eat me’ (DEM) and ‘eat me’ (EM) signals on cancer cells and macrophages. The company’s approach builds on the groundbreaking research from its scientific co-founders:

Jonathan Weissman, Ph.D. – Whitehead Institute, National Academy of Sciences member, HHMI, world leader in genome-wide CRISPR screens;
Michael Bassik, Ph.D. – Stanford University, a distinguished biologist in cancer, phagocytes, and CRISPR screening; and
Kipp Weiskopf, M.D., Ph.D. – Whitehead Fellow and physician at Dana-Farber Cancer Institute, one of the world’s leaders in macrophage and cancer biology.
DEM Bio is focused on accessing the largely untapped opportunity around macrophage biology and innate immune system pathways to discover potent DEM and EM signals on cancers and expand the therapeutic potential of the field beyond the relatively small number of signals targeted by current investigational therapies. The company’s proprietary CHoMP platform (Co-culture with Human Myeloid Phagocytes) will be used to identify unexplored DEM and EM signals in a systematic and unbiased manner via inter-cellular CRISPR screening using tumor cells, primary macrophages, and other innate immune effector cells.

DEM Bio also announced the appointment of Jan Skvarka, former CEO of Trillium Therapeutics (acquired by Pfizer for $2.22 billion in November 2021), as Executive Chairman. As part of the financing, Christoph Westphal, M.D., Ph.D., Founding CEO, DEM Bio, and Founding Partner Longwood Fund; Dan Janney, Managing Partner, Alta Partners; Dylan Morris, Managing Director, Insight Partners; Marie-Claire Peakman, Ph.D., Principal, Pfizer Ventures; and Hiro Kimura, Ph.D., Investment Director, Astellas Venture Management have joined DEM Bio’s Board of Directors.

"Currently known DEM signals have been described in an ad hoc manner. DEM Bio’s founders discovered a scalable approach to systematically unlock the potential of innate immune system checkpoints," noted Dr. Westphal.

"This financing from an exceptional group of investors positions us to execute on our ambitious plans to develop the next generation of macrophage checkpoint inhibitors that may revolutionize how we treat cancer," said Mr. Skvarka.

DEM Bio has assembled a world-class Scientific Advisory Board consisting of leaders in the field of CRISPR high-throughput screening, immune phagocytes, cancer biology, and therapeutic development, including co-founders Drs. Weissman, Bassik and Weiskopf, Roarke Kamber, Ph.D., Postdoctoral fellow, Genetics, Stanford School of Medicine, Dian Yang, Ph.D., Postdoctoral fellow, Whitehead Institute for Biomedical Research, as well as Kai Wucherpfennig, M.D., Ph.D., Professor and Chair, Dana-Farber Cancer Institute; Dane Wittrup, Ph.D., Professor of Chemical Engineering & Bioengineering, MIT; and Bob Uger, Ph.D., former CSO, Trillium Therapeutics.

"The currently known DEM and EM pathways were discovered serendipitously," said Dr. Bassik. "Similar to other areas of immunotherapy, there are likely other signals that are more potent and offer better therapeutic targets, but no one has yet taken a systematic approach to identifying those pathways."

"By leveraging cutting-edge functional genomics and macrophage biology, we created the CHoMP platform to discover new DEM/EM signals in a fully unbiased and systematic way," said Dr. Weiskopf.

"CHoMP is a highly differentiated platform built on unique, proprietary CRISPR screening capabilities in primary human cells, enabling DEM Bio to methodically evaluate unexplored DEM/EM signals," said Dr. Weissman.

The CHoMP platform has identified a number of promising new DEM/EM signals, including the novel DEM pathway APMAP. In preclinical work, targeting APMAP enhanced tumor cell phagocytosis in multiple cancer cell types and animal cancer models, and demonstrated synergistic effects with a broad range of tumor-binding antibodies.

David Donabedian, Co-founder and start-up CEO of DEM Bio, and Operating Partner, Longwood Fund added, "APMAP is just one of the promising programs identified using the CHoMP platform, and the encouraging initial data on this pathway has helped validate our differentiated approach to identifying novel, potent DEM/EM signals. The company plans to use proceeds from this financing to further develop our platform and to advance our portfolio of novel targets towards therapeutic development in oncology."