On July 9, 2020 Forbion, a leading European life sciences venture capital firm, reported the first close at
EUR 185 million (USD 208 million) of its new Forbion Growth Opportunities Fund ("Forbion Growth"), focused on investing in late-stage European life sciences companies (Press release, Forbion Capital Partners, JUL 9, 2020, View Source [SID1234561781]).

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Returning investors to the new Forbion fund include Pantheon, KfW Capital and the European Investment Fund (EIF). New investors include Eli Lilly and Company, Horizon Therapeutics plc (Nasdaq: HZNP), Belgian Growth Fund and New Waves Investments.

Forbion Growth will focus on later-stage investments, particularly in European biotech companies developing novel therapies for areas of high medical need. The Fund will target this market segment with three distinct strategies: providing private growth capital for mature clinical development assets, providing pre-IPO funding to companies aiming to pursue a public listing in the near-term and providing capital injections, supporting existing, under-valued public companies. In all cases, Forbion Growth aims to take leading positions with an investment size of up to EUR 30 million per deal.

Forbion’s strong historical performance and market position in the German market have allowed KfW Capital and EIF to commit to Forbion Growth from their respective ERP facilities, thereby mobilizing smart growth capital for the German life sciences sector. Both KfW Capital and EIF have been long-term supporters of the Forbion family of funds.

In executing its strategy, Forbion Growth will work closely with its newly established Advisory Group, consisting of the most successful and entrepreneurial CEOs and advisors in the European BioPharma space. The Fund’s Advisory Group consists of Onno van de Stolpe (CEO Galapagos), Jan van de Winkel (CEO Genmab), Tim van Hauwermeiren (CEO Argenx), Werner Lanthaler (CEO Evotec) and Maarten de Jong (Moelis & Co).

Forbion started the fund-raising process for Forbion Growth in February 2020 and expects to complete the Fund by the end of this year. The goal is to raise EUR 250 million and to build a portfolio of 8-12 investments in the most promising European growth-stage life sciences companies.

Sander Slootweg, Managing Partner and co-founder of Forbion said:
"The market for late-stage, private European life sciences investments is already sizable at
EUR 2 billion per annum and rapidly growing. Despite the de-risked nature of the late-stage clinical assets in these companies, this market segment is still underserved. As a result, many companies and assets stall in late-stage development, due to a lack of specific funding. With our dedicated Growth Fund and specialized team, we are well-positioned to optimally exploit this opportunity and ensure that new, impactful treatments and therapies will make their way to patients and doctors."

With well over EUR 1.25 billion of assets under management, Forbion has been ranked "the #1 most consistently performing VC Manager in Europe" by Preqin’s fund performance database. Forbion’s investment team has built an impressive performance track record with over 66 investments in both the EU and North America over the past 15 years.

Forbion has led the first institutional rounds of several of Europe’s leading biotech companies such as Argenx (ARGX; market cap USD 10 billion), Uniqure (QURE; market cap USD 2 billion) as well as clinical-stage companies such as Promedior (acquired by Roche for up to EUR 1.4 billion), Dezima Pharma (acquired by Amgen for up to EUR 1.55 billion) and Prexton Therapeutics (acquired by Lundbeck for up to EUR 905 million).

Dirk Kersten, General Partner, added:
"We have assembled a world-class team and Advisory Group to manage our new Growth Fund. Wouter Joustra, General Partner, and Anastasia Karpova, Principal, both joined us from Kempen, a leading Life Sciences boutique bank in Europe. In addition, Carlo Incerti, former Chief Medical Officer at Sanofi-Genzyme, and Patrick Vink, former Chief Operating Officer at Cubist Pharmaceuticals, have joined the team as Operating Partners. This very experienced Growth team will work in a fully integrated manner in the broader Forbion organization".

"We will be looking to partner with world-class European companies and entrepreneurs to provide both capital and expertise, building the next generation of successful European Life Sciences companies."

On July 9, 2020 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for FT819, an off-the-shelf allogeneic chimeric antigen receptor (CAR) T-cell therapy targeting CD19+ malignancies (Press release, Fate Therapeutics, JUL 9, 2020, View Source [SID1234561780]). FT819 is the first-ever CAR T-cell therapy derived from a clonal master induced pluripotent stem cell (iPSC) line, and is engineered with several first-of-kind features designed to improve the safety and efficacy of CAR T-cell therapy. The Company plans to initiate clinical investigation of FT819 for the treatment of patients with relapsed / refractory B-cell malignancies, including chronic lymphocytic leukemia (CLL), acute lymphoblastic leukemia (ALL), and non-Hodgkin lymphoma (NHL).

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"The clearance of our IND application for FT819 is a ground-breaking milestone in the field of cell-based cancer immunotherapy. Our unique ability to produce CAR T cells from a clonal master engineered iPSC line creates a pathway for more patients to gain timely access to therapies with curative potential," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "Four years ago, we first set out under our partnership with Memorial Sloan Kettering led by Dr. Michel Sadelain to improve on the revolutionary success of patient-derived CAR T-cell therapy and bring an off-the-shelf paradigm to patients, and we are very excited to advance FT819 into clinical development."

FT819 was designed to specifically address several limitations associated with the current generation of patient- and donor-derived CAR T-cell therapies. Under a collaboration with Memorial Sloan Kettering Cancer Center (MSK) led by Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering, and Head, Gene Expression and Gene Transfer Laboratory at MSK, the Company incorporated several first-of-kind features into FT819 including:

Use of a clonal master iPSC line as the starting cell source, which enables CAR T cells to be mass produced and delivered off-the-shelf for broad patient access;
Incorporation of a novel 1XX CAR signaling domain, which has been shown to extend T-cell effector function without eliciting exhaustion in published work described in the journal Nature Medicine (View Source);
Insertion of the CAR transgene directly into the T-cell receptor alpha constant (TRAC) locus, which has been shown to promote uniform CAR expression and enhanced T-cell potency in published work described in the journal Nature (View Source); and
Complete bi-allelic disruption of T-cell receptor (TCR) expression for the prevention of graft-versus-host disease (GvHD), a potentially life-threatening complication associated with allogeneic T-cell therapy.
The multi-center Phase 1 clinical trial of FT819 is designed to determine the maximum tolerated dose of FT819 and assess its safety and clinical activity in up to 297 adult patients across three types of B-cell malignancies (CLL, ALL, and NHL). Each indication will enroll independently and evaluate three dose-escalating treatment regimens: Regimen A as a single dose of FT819; Regimen B as a single dose of FT819 with IL-2 cytokine support; and Regimen C as three fractionated doses of FT819. For each indication and regimen, dose-expansion cohorts of up to 15 patients may be enrolled to further evaluate the clinical activity of FT819.

At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual 2020 Meeting, the Company presented preclinical data demonstrating FT819 is comprised of CD8αβ T cells with uniform 1XX CAR expression and complete elimination of endogenous TCR expression. Additionally, data from functional assessments showed FT819 has antigen-specific cytolytic activity in vitro against CD19-expressing leukemia and lymphoma cell lines that is comparable to that of healthy donor-derived CAR T cells, and persists and maintains tumor clearance in the bone marrow in an in vivo disseminated xenograft model of lymphoblastic leukemia.

Fate Therapeutics has an exclusive license for all human therapeutic use to U.S. Patent No. 10,370,452 pursuant to its license agreement with MSK1, which patent covers compositions and uses of effector T cells expressing a CAR, where such T cells are derived from a pluripotent stem cell including an iPSC. In addition to the patent rights licensed from MSK, the Company owns an extensive intellectual property portfolio that broadly covers compositions and methods for the genome editing of iPSCs using CRISPR and other nucleases, including the use of CRISPR to insert a CAR in the TRAC locus for endogenous transcriptional control.

1 Fate Therapeutics has licensed intellectual property from MSK on which Dr. Sadelain is an inventor. As a result of the licensing arrangement, MSK has financial interests related to Fate Therapeutics.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 300 issued patents and 150 pending patent applications.

On July 9, 2020 Case Western Reserve University Research reported that it has found that those living with HIV have a higher risk for certain kinds of cancers—such as lung cancer (Press release, Case Western Reserve University, JUL 9, 2020, View Source [SID1234561779]). Now, with a new five-year, $3.7 million grant from the National Cancer Institute (NCI), researchers from Case Western Reserve University hope to find out why.

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Ge Jin, professor at the School of Dental Medicine and co-principal investigator on the research team, called the phenomenon "a mystery."

There are more than an estimated 1.7 million people newly infected with HIV every year, according to the U.S. Department of Health and Human Services. That’s 1.7 million people who are more likely to get cancer—and get it at an earlier age and at a higher frequency—than 1.7 million people who do not have HIV, Jin said.

"We want to look at the molecular events involved in these processes, and find out why," he said. "We need to find a better way to detect cancer in these patients at an earlier stage."

Jin is partnering with co-principal investigator Bingcheng Wang, the John A. and Josephine B. Wootton Endowed Chair of Research and Professor at the School of Medicine, who’s also a researcher at MetroHealth System. They found that the immune cells from HIV patients secrete exosomes—think tiny nanoparticles—and attack lung cells, thus promoting the growth of cancer.

Wang said he believes that grant from NCI will "further investigate this novel mechanism of lung cancer promotion by HIV and develop new therapeutic agents to treat the disease among people living with HIV."

HIV patients with lung cancer have a worse prognosis than those in the general population, multiple studies have shown. Previous research has shown certain remedies can neutralize the effects of the exosomes, also known as vesicles.

However, the causes for increased lung cancer among people living with HIV remain elusive.

The prevailing belief has been that those with HIV have weakened immune systems, but it’s not that simple, Jin said.

"If you’re living with HIV, the virus is arrested­—it’s kept at bay," he said. "That’s why the disease doesn’t manifest itself to become AIDS. It’s why those with HIV can live normal, healthy lives. There’s something else going on at the cellular level."

Jin said the new research will further explore potential causes—and remedies. He called his laboratory at the School of Dental Medicine "a pioneer" in the field of identifying exosomes in the blood of HIV patients promoting the growth of oral cancer cells.

"This is a very exciting project, as our investigation will help understand how lung cancer progresses in people living with HIV, which will potentially assist clinicians to assess risk factors of cancers and better treatment in the population," he said.

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.