On July 9, 2020 OncoDNA SA and IntegraGen SA (Paris: ALINT) reported the signature on July 8th 2020 of an agreement under which the Belgian company OncoDNA will file today a friendly cash tender offer to purchase the shares of the French company IntegraGen, whose securities are admitted to trading on the Euronext Growth market of Euronext Paris, at a price per share of €2.20, valuing IntegraGen share capital at €14.5m1 for 100% (Press release, OncoDNA, JUL 9, 2020, View Source [SID1234561777]). This transaction represents a premium of +36.2% compared to the last closing price of IntegraGen shares and +23.2% compared to the volume-weighted average price over the previous six months. The offer was approved on a unanimous basis by all members of the Board of both companies.

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According to articles 261-1 I 2° et 4° of the general regulations of the AMF, the Board of IntegraGen has mandated on April 26 2020 as independent appraiser the consulting firm Crowe HAF, represented by Mister Olivier Grivillers, in order to prepare a fairness opinion on the financial terms of the offer. His report will be reproduced in extensor in the draft offer document of IntegraGen.

Subject to the approval of the Autorité des Marchés Financiers (AMF) and pursuant to applicable regulations to foreign investment control in France, the public offer shall be opened at the end of the third quarter of 2020. OncoDNA currently owns no share of IntegraGen.

For the last seven years, OncoDNA, a leading international player in oncology precision medicine, has been developing a comprehensive offer for clinicians that provides innovative molecular tests to guide their clinical decision process for the treatment of patients with advanced cancer. OncoDNA also offers liquid biopsy follow-up solutions to better monitor disease progression. OncoDNA’s strength is its proprietary database that enables remote clinical interpretation via a SaaS model for molecular analyses performed by laboratories around the world. Thanks to its network, OncoDNA has established collaborations within the pharmaceutical industry to assist with clinical trials which focus on new oncology treatments.

Backed by a highly competent and qualified team, IntegraGen is a leading player in DNA sequencing services with specialized expertise in exome and complete genome analyses. The company operates sequencing platforms for major players of the genomic sector and has developed a portfolio of software for genomic data interpretation that are distributed on a SaaS model and already commercialized in Europe and the USA. IntegraGen’s activities are particularly complementary to OncoDNA’s offer.

Comprehensive genomic analysis of cancer cells has become increasingly relevant as a part of the cancer treatment decision making process, especially with the surge in targeted therapies and immunotherapies. The ability to detect and determine genomic differences between tumor and normal cells is critical to providing patients the most appropriate treatment options and to ensure a proper follow-up. Similarly, genomic analysis is a key element for diagnostic and research in the fields of rare diseases and microbiology.

In the context of this transaction, the companies, which are already engaged in commercial agreements, plan to integrate their respective service offers by combining DNA sequencing services and the bioinformatics tools developed by IntegraGen with the innovative portfolio of tests OncoDNA offers to oncologists. This joint offer would enable to provide a unique range of services and software solutions to clinicians, oncologists, researchers and biologists worldwide while also leveraging a proprietary database that includes patient follow-up capabilities and artificial intelligence technology.

"We are very happy to announce this friendly takeover bid that will bring together IntegraGen’s know-how in sequencing services and bioinformatics analyses with our expertise in oncology clinical interpretation, making us a major European player in the emerging field of oncology precision medicine", said Jean-Pol Detiffe, OncoDNA founder and CEO. "By uniting our skills, we will integrate the entire chain of genomic operations and benefit from having a large-scale production capacity ready for tomorrow’s analyses, namely the complete sequencing of the tumor. Giving new hope and provide treatment options to patients on a worldwide basis has always been OncoDNA’s motive since day one."

Bernard Courtieu, CEO of IntegraGen, added "We are pleased to create this close working relationship with OncoDNA, a company recognized for its experience and technical skills. We share a common ambition to provide researchers and clinicians’ communities with the best analysis and genomic interpretation tools. OncoDNA’s international presence will enable IntegraGen to fully exploit its sequencing capacities and the integration of both company’s teams, especially our information technology and bioinformatics expertise, will enhance OncoDNA’s global offer."

OncoDNA is advised by ODDO BHF, White & Case and Osborne Clarke. IntegraGen is advised by Portzamparc and Jones Days.

On July 9, 2020 IntegraGen (FR0010908723 – ALINT – Eligible PEA PME) (Paris:ALINT), a company specializing in the decryption of the human genome which performs interpretable genomic analyzes for academic and private laboratories and develops diagnostic tools for oncology, reported its unaudited sales for the first half of 2020 (Press release, Integragen, JUL 9, 2020, View Source [SID1234561776]).

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Unaudited sales during the first half of 2020 were 4,706 k€, an increase of 13% compared to the first half of 2019 and 15% on a like-for-like basis taking into account the sale of the company’s diagnostic business at the start of 2020. The growth in sales was a result of an increase in all sequencing activities, in particular the SeqOIA platform (+33%), activities related to outsourced platforms (+18%), and sequencing services for research and clinical research (+9%).

Software and genomic consulting (GeCo) activities were limited due to the pandemic, which notably resulted in the delay of projects.

The company’s cash position at the end of June 2020 was 5.8 m€, representing an improvement of almost 3.0 m€ compared to the cash position as of December 31, 2019. This difference is mainly due to the receipt of a State Guaranteed Loan (PGE) totaling 1.8 m€, to the implementation of several safeguarding actions during the confinement period linked to the COVID-19 pandemic, and to an equilibrium between the consumption of cash for current operations and business revenue.

Bernard Courtieu, Chairman and Chief Executive Officer of IntegraGen stated, "our sales revenue during the first half of 2020 builds on the previously reported profitable growth trajectory which we experienced during the second half of 2019. These results reinforce our current strategy of focusing on our genomic services business with an emphasis on sequencing and data interpretation. Despite the difficulties linked to the pandemic, sales of our software tools to assist with genomic data interpretation remain a major strategic focus, as evidenced by the announcement in April of an agreement with a major cancer center in the United States. The sustained growth and healthy cash position we have achieved despite the current crisis will enable us to pursue a positive and ambitious trajectory. Lastly, I would like to thank the employees of IntegraGen who have demonstrated exemplary solidarity and dedication to ensuring continuity of operations during containment linked to the pandemic."

The financial results for the first half of 2020 will be published on September 17, 2020.

On July 8, 2020 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, reported the peer-reviewed publication of data focused on generation and evaluation of libraries of checkpoint molecules with directed mutations providing novel biological properties in a paper titled "Mechanistic dissection of the PD-L1:B7-1 co-inhibitory immune complex (Press release, Cue Biopharma, JUL 8, 2020, View Source [SID1234608301])."

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In this work, researchers focused primarily on the recently described interaction between B7-1 and PD-L1, two molecules within the B7 superfamily, which are of critical importance for controlling anti-tumor immunity, autoimmunity and infectious diseases. By combining cell microarray and high-throughput FACS methods to screen binding events and map binding interfaces, selective mPD-L1 and mB7-1 mutants with distinct biochemical and functional properties were generated that altered the binding interactions between PD-1 and PD-L1, and CTLA-4 and B7-1 as well as the recently described PD-L1 and B7-1 binding interaction.

"Our efforts expand upon the fundamental understanding of critical binding interactions and related downstream signaling cascades by more completely defining the molecular interactions between these key cell surface molecules," said Steven C. Almo, Ph.D., professor and chair of biochemistry, professor of physiology & biophysics and the Wollowick Family Foundation chair in multiple sclerosis and immunology at Albert Einstein College of Medicine, and co-founder of Cue Biopharma. "Through these studies we are able to decipher specific molecular and atomic insights to engineer and generate molecules with unique biochemical and functional properties with the aim of developing more efficacious treatments with fewer unwanted side effects."

This approach augments and supplements Cue Biopharma’s Immuno-STAT and Neo-STAT platforms, leveraging rational protein engineering to generate therapeutic frameworks possessing desirable drug properties while attenuating and/or abrogating unwanted, deleterious effects. CUE-101, Cue Biopharma’s lead asset from the IL-2 based CUE-100 Series, was rationally engineered to enhance the selective activation of the beneficial CD8+ anti-tumor T cells, while abrogating the effects on other immune cell populations that are deleterious to cancer therapy, such as regulatory T cells. A CUE-101 Phase 1 monotherapy trial is ongoing, with enrollment of patients in dose escalation at 13 leading centers in the United States for the treatment of post first-line metastatic and recurrent HPV+ advanced head and neck cancer. Early data metrics from this trial are encouraging with demonstration of safety and tolerability, dose proportional exposure pharmacokinetics (PK) and early, albeit anecdotal, evidence of biologic activity through pharmacodynamics (PD) biomarkers and clinical benefit.

"We are highly encouraged by these findings and further research being conducted in Dr. Almo’s laboratory, which provides us with additional, novel insights into immune receptors," said Anish Suri, Ph.D., president and chief scientific officer of Cue Biopharma. "Learnings from this important work will augment and further advance our internal efforts to build out the Immuno-STAT and Neo-STAT platforms and enhance our ability to dial-in/dial-out specific molecular interactions for the therapeutic modulation of the immune system in cancer, autoimmune diseases and chronic infectious diseases."

Albert Einstein College of Medicine and its faculty members acknowledge the following relationships with Cue Biopharma, Inc.: Dr. Almo holds equity in Cue Biopharma, Inc., receives royalties from existing license agreements between Einstein and Cue, and is a member of its Science Advisory Board; Dr. Garrett-Thomson receives royalties; and Albert Einstein College of Medicine holds equity in Cue and receives royalties.

On July 8, 2020, FibroGen China Anemia Holdings, Ltd., FibroGen (China) Medical Technology Development Co., Ltd. ("FibroGen Beijing"), and FibroGen International (Hong Kong) Limited (collectively, "FibroGen China") and AstraZeneca AB ("AstraZeneca", and together with FibroGen China, the "Parties") reported that entered into an amendment, effective July 1, 2020, to the Amended and Restated License, Development and Commercialization Agreement effective as of July 30, 2013 (the "China Agreement"), relating to the development and commercialization of roxadustat in China (the "Amendment") (Filing, 8-K, FibroGen, JUL 8, 2020, View Source [SID1234561813]).

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The Amendment provides for the establishment of a jointly owned entity (the "Distribution Entity") that will perform roxadustat distribution, as well as conduct sales and marketing through AstraZeneca. FibroGen Beijing will continue to hold all of the regulatory licenses issued by China regulatory authorities and will continue to be primarily responsible for regulatory, clinical, manufacturing, medical affairs and pharmacovigilance.

While the responsibilities of the Parties under the China Agreement remain largely the same, and the Parties will continue to share equally in the economics resulting from roxadustat operations in China, certain changes are being made. With effect from April 1, 2020, the Parties have changed the method under which commercial expenses are billed, and the collaboration has been adjusted to more fully account for the cost of manufacturing. AstraZeneca’s sales and marketing costs billed to the joint venture are now subject to an annual cap at a percentage of net sales, until they have been fully reimbursed for their costs, at which point AstraZeneca will invoice based on actual costs. FibroGen Beijing will now manufacture and supply commercial product to the joint venture, at a percentage of net sales and such percentage will be subject to a cap.

Once the Distribution Entity is fully operational, FibroGen will recognize revenue based on its sales to the Distribution Entity. AstraZeneca is expected to consolidate the Distribution Entity, and recognize revenue based on sales to customers. The Amendment better aligns the Parties’ interests and is expected to enable profitability for roxadustat commercialization in China at an earlier point in time.

In addition, AstraZeneca’s right to share in the economic benefits of the collaboration will largely continue to be deferred until certain measures of profitability have been met, but will no longer be subject to a minimum cash level at FibroGen Beijing.

Development costs will continue to be shared 50/50 between the Parties.

The Parties are concurrently amending the Amended and Restated License, Development and Commercialization Agreement for roxadustat for the U.S. and all other countries not previously licensed to Astellas Pharma, effective as of July 13, 2013 (such amendment, together with the Amendment, the "Amendments") to reflect minor changes in the governance structure under the China Agreement.

The foregoing description of the Amendments is not a complete description thereof, and is qualified in its entirety by reference to the full text of the Amendments, which will be filed with the Securities and Exchange Commission as exhibits to FibroGen, Inc.’s Quarterly Report on Form 10-Q for the quarter ending June 30, 2020.

On July 8, 2020 APEIRON Biologics AG ("APEIRON"), a private biotechnology company specializing in the discovery, development and commercialization of novel immunotherapies for cancer and respiratory diseases, and MaxCyte, Inc., a global cell-based therapies and life sciences company, reported the signing of a clinical and commercial licensing agreement (Press release, Apeiron Biologics, JUL 8, 2020, View Source [SID1234561774]).

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APEIRON Biologics will obtain non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation technology and ExPERT platform for the advancement of APN401, a siRNA-based cell therapy currently in clinical development for various solid tumors. In return, MaxCyte will receive undisclosed development and approval milestones and sales-based payments in addition to other licensing fees.

"Securing access to MaxCyte’s ExPERT platform and unique electroporation technology is a crucial next step in the clinical advancement of our lead checkpoint inhibition Cbl-b candidate APN401," said Peter Llewellyn-Davies, CEO of APEIRON Biologics.

Doug Doerfler, President & CEO of MaxCyte, said: "We are proud to support APEIRON in the development of a siRNA-based treatment that could help patients facing cancers with various forms of tumors. This agreement represents an important achievement for MaxCyte, and highlights the value of our next-generation technology platform to companies across the globe seeking to unlock the potential of their engineered cell therapy programs."

MaxCyte’s ExPERT instrument portfolio represents the next generation of leading, clinically validated, electroporation technology for complex and scalable cell engineering. By delivering high transfection efficiency, seamless scalability and enhanced functionality, the ExPERT platform delivers the high-end performance essential to enable the next wave of biological and cellular therapeutics.