On April 20, 2021 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") reported that convertible bonds with a nominal value of EUR 4,357,606.00 have been converted into 3,961,460 new shares (ISIN DE000A3H2184) in the first conversion period of the mandatory convertible bond 2021/2024 (Press release, Epigenomics, APR 20, 2021, https://www.epigenomics.com/%E2%80%8B%E2%80%8B%E2%80%8B%E2%80%8B%E2%80%8B%E2%80%8B%E2%80%8Bepigenomics-ag-announces-conversion-result-of-the-first-conversion-period-of-the-mandatory-convertible-bond-2021-2024/ [SID1234578240]). Accordingly, the number of issued shares increased from 5,891,230 to 9,852,690 no par value registered shares of the Company. The Company’s share capital increases correspondingly by EUR 3,961,460.00 to EUR 9,852,690.00. The outstanding portion of the mandatory convertible bond 2021/2024 therefore has a nominal value of EUR 1,142,394.00.

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The new shares, which carry full dividend rights as of January 1, 2021, were admitted to trading on the stock exchange on April 16, 2021. Delivery of the new shares to the custodian banks will be carried out promptly.

The first conversion period ran from April 1 to 14, 2021. The next opportunity to convert is offered to creditors of the convertible bond from July 1 to 14, 2021.

On April 20, 2021 Tubulis reported the appointment of Günter Fingerle-Rowson, MD, PhD, as Chief Medical Officer to complement the leadership team and to further build the company’s clinical expertise (Press release, Tubulis, APR 20, 2021, View Source [SID1234578239]). Dr. Fingerle-Rowson is an experienced hematologist and medical oncologist who brings to Tubulis more than two decades of academic, biotechnology and pharmaceutical industry experience. Moreover, he has a proven track record of advancing product candidates from early clinical phase through regulatory approval and into clinical practice. In this newly established role, he will use his extensive knowledge in the development of cancer therapeutics to oversee Tubulis’ clinical activities and advance the company’s Antibody Drug Conjugates (ADCs) towards clinical evaluation.

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"Günter is an expert in developing successful clinical oncology programs that resulted in the regulatory approval of several monoclonal antibodies. His wealth of experience and his track record of execution will be a great asset to Tubulis as we transition towards becoming an established clinical-stage drug developer," said Dr. Dominik Schumacher, CEO and co-founder of Tubulis. "In addition, his background in translational research in immuno-oncology will further strengthen our team and our capabilities to rapidly deliver the benefits of our ADC approach to cancer patients."

Dr. Fingerle-Rowson commented: "I am thrilled to join Tubulis to be part of the team that brings ADC technology to a new level. The technological advancements that the company has made in a short period of time and the team’s clear vision to become a leader in the field of ADCs instantly drew my interest. I look forward to help shape the clinical development plan for Tubulis’ exciting technology platform and to bring its first candidate TUB-010 to patients in the near term. Tubulis´ proprietary ADC technology enables us to develop novel ADCs that have a better versability and an improved benefit/risk profile than current ADC options."

Prior to joining Tubulis, Dr. Fingerle-Rowson worked in Global Clinical Development at MorphoSys and F. Hoffmann-La Roche as well as in Medical Affairs at Janssen-Cilag, a J&J company. He has contributed to bring three drugs to patients with malignancies. In his latest role as VP, Global Product Head at MorphoSys, he steered the clinical development as well as the regulatory approval for Tafasitamab (MOR208, Monjuvi). From 2011-2018, he served as Associate Medical Group Director, Global Development Team Leader and Global Clinical Leader at F. Hoffmann-La Roche where he was responsible for the clinical development and regulatory approvals of Obinutuzumab (GA101, Gazyva). Dr. Fingerle-Rowson also worked as Medical Manager at Janssen-Cilag, and as academic physician in internal medicine, hemato-oncology at the University Hospitals in Cologne and Munich where he also led own research in the field of immuno-oncology. Dr. Fingerle-Rowson was a longstanding active member of the German CLL Study Group where he contributed to the approval of Rituximab. He is a board-certified hematologist/medical oncologist and holds an MD in Internal Medicine from Munich University, and a MD-PhD in Molecular Medicine from New York University.

On April 20, 2021 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell transplants for serious medical conditions, reported a worldwide license and development collaboration agreement with Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms (Press release, Lineage Cell Therapeutics, APR 20, 2021, View Source [SID1234578238]). The collaboration will generate a novel product candidate derived from Lineage’s VAC allogeneic cancer immunotherapy platform and targeting a proprietary Tumor Associated Antigen (TAA) construct provided by ITI, for the treatment of glioblastoma multiforme (GBM). Lineage and ITI will collaborate in the manufacturing and clinical development of a novel VAC product candidate. Following the full development and delivery of Current Good Manufacturing Practice (cGMP) VAC product material, ITI will assume full and independent clinical and commercial responsibility and further advancement of the program. Under the terms of the agreement, Lineage will be entitled to upfront payments totaling $2 million anticipated in the first year and up to $67 million in development and commercial milestones across multiple indications and territories. Lineage also will be eligible to receive royalties up to 10% on net sales of future products.

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"The VAC platform provides us with the opportunity to generate a broad pipeline of product candidates, each targeting a different type of cancer," stated Brian Culley, Lineage CEO. "This collaboration represents the first of many partnerships we hope to enter into with our platform and we believe it helps further validate VAC as a promising new therapeutic vaccine platform. Our objective is to leverage our technology to generate additional VAC-derived cell therapies for our pipeline, as well as in collaboration with partners, capitalizing on the strength of Lineage’s recent manufacturing and cell transplant success. These alliances also will diversify our oncology pipeline across more programs, providing new opportunities for success without the financial burden of independent development. We appreciate ITI selecting our antigen delivery platform for this collaboration and look forward to a productive partnership on this new VAC-derived product candidate. We also are eager to collaborate with additional partners on future versions of VAC."

"We’re very pleased to collaborate with Lineage, a well-recognized cell therapy company, to expand our pipeline with the development of a novel product candidate to treat GBM," commented Dr. William Hearl, CEO of ITI. "Over the last several years, ITI has invested significant capital and development resources to identifying multiple novel paths forward in GBM. By teaming up with Lineage, we are hoping to expand our efforts in this difficult to treat indication and look forward to the benefit that the VAC immunotherapy platform can bring to our antigen constructs."

About Glioblastoma multiforme (GBM)

Glioblastoma multiforme (GBM) (also called glioblastoma) is a fast-growing glioma that develops from star-shaped glial cells (astrocytes and oligodendrocytes) that support the health of the nerve cells within the brain. GBM is often referred to as a grade IV astrocytoma. These are the most invasive type of glial tumors, rapidly growing and commonly spreading into nearby brain tissue. GBMs can arise in the brain "de novo" or evolve from lower-grade astrocytomas or oligodendrogliomas. In adults, GBM occurs most often in the cerebral hemispheres, especially in the frontal and temporal lobes of the brain. GBM is a devastating brain cancer that typically results in death in the first 15 months after diagnosis, with only 25% of glioblastoma patients surviving more than one year, and only 5% of patients surviving more than five years.

About VAC2

VAC2 is an allogeneic, or non-patient specific "off-the-shelf," cancer vaccine product candidate designed to stimulate patient immune responses to an antigen commonly expressed in cancerous cells but not in normal adult cells. VAC2, which is produced from a pluripotent cell technology using a directed differentiation method, is comprised of a population of nonproliferating mature dendritic cells. As the most potent type of antigen presenting cell in the body, dendritic cells instruct the body’s immune system to attack and eliminate harmful pathogens and unwanted cells. Because the tumor antigen is loaded exogenously into the dendritic cells prior to administration, VAC2 is a platform technology that can be modified to carry selected antigens, including patient-specific tumor neo-antigens or viral antigens. VAC2 is currently being tested in a Phase 1 study in adult patients with non-small cell lung cancer (NSCLC) in the advanced and adjuvant settings (NCT03371485), conducted by Cancer Research UK.

On April 20, 2021 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous formulation (sold under the tradename DARZALEX FASPRO in the U.S.), as reported by Johnson & Johnson were USD 1,365 million in the first quarter of 2021 (Press release, Genmab, APR 20, 2021, View Source [SID1234578236]). Net trade sales were USD 691 million in the U.S. and USD 674 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX and DARZALEX FASPRO under the exclusive worldwide license to Janssen Biotech, Inc. (Janssen) to develop, manufacture and commercialize daratumumab. As previously announced, Janssen is reducing its royalty payments to Genmab by what it claims to be Genmab’s share of Janssen’s royalty payments to Halozyme, cf. company announcement No. 39 of September 22, 2020.

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About DARZALEX(daratumumab)
DARZALEX (daratumumab) has become a backbone therapy in the treatment of multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy; in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma.

DARZALEX is indicated for the treatment of adult patients in Europe via intravenous infusion or subcutaneous administration: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy2. Daratumumab is the first subcutaneous CD38 antibody approved in Europe for the treatment of multiple myeloma. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S.

In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit www.DARZALEX.com.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with newly diagnosed light-chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide, and dexamethasone. It is also approved in the U.S. for the treatment of adult patients with multiple myeloma: in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for ASCT; in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.3 DARZALEX FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology. .DARZALEX FASPRO is the first subcutaneous CD38 antibody approved in the U.S. for the treatment of multiple myeloma and the first and only approved treatment for patients with AL amyloidosis in the U.S.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,4,5,6,7

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis and T-cell acute lymphocytic leukemia (ALL). Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

On April 20, 2021 Forbion, a leading European life sciences venture capital firm, reported the final close of its Forbion Growth Opportunities Fund I ("Forbion Growth I") at the hard cap amount of EUR 360 million (USD 428 million) (Press release, Forbion Capital Partners, APR 20, 2021, View Source [SID1234578235]). Forbion Growth I is focused on investing in late-stage European life sciences companies.

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Pantheon, Eli Lilly and Company, Horizon Therapeutics plc (Nasdaq: HZNP), the Belgian Growth Fund, New Waves Investments, Wealth Management Partners, KfW Capital and the European Investment Fund (EIF) are part of a strong base of institutional LPs that supported the fund. Forbion Growth I concentrates on later-stage investments, particularly in European biotech companies that develop novel therapies for areas of high medical need.

The Fund targets this market segment using three distinct strategies that provide: private growth capital for clinical stage development assets, cross-over capital to companies aiming to pursue a public listing in the near-term, as well as capital injections that support existing under-valued public companies. In all cases, Forbion Growth I aims to take leading positions with an investment size of up to EUR 35 million per deal.

In executing its strategy, Forbion Growth I is working closely with its Advisory Group, consisting of CEOs from Europe’s leading BioPharma companies, comprising Jan van de Winkel (CEO Genmab), Tim van Hauwermeiren (CEO ArgenX), Werner Lanthaler (CEO Evotec), Onno van de Stolpe (CEO Galapagos), and Maarten de Jong, a leading Life Sciences banker with Moelis & Co.

Forbion Growth I will aim to build a portfolio of 10-12 investments in the most promising European late-stage life sciences companies. Thus far, the Fund has already made three investments: SynOx Therapeutics (Ireland), New Amsterdam Pharma (Netherlands), and Gyroscope Therapeutics (UK).

Sander Slootweg, Managing Partner and co-founder of Forbion said:

"We were very pleased to see Forbion Growth I reach its final close at the hard cap amount, well exceeding our original target size of EUR 250 million. Since launching the fund, it has become even clearer that this European market segment of late-stage life sciences companies with de-risked assets is rapidly maturing, but remains under-served. Forbion Growth I and its specialized team positions us well to enable the most innovative of these companies to bring new, impactful treatments and therapies to market."

Dirk Kersten, General Partner of Forbion Growth I said:

"The successful close of Forbion Growth I allows us to become a preferred partner for the most promising European biotech companies and ambitious management teams, and be an anchor investor in the final private financing round before an M&A or IPO exit. We are looking to expand our current portfolio of three investments with new opportunities that can deliver meaningful benefits to patients whilst providing strong financial returns. To be optimally positioned to execute this strategy, we will be further expanding our team of key investment professionals with new hires expected to join by mid 2021."

With well over EUR 1.8 billion of assets under management, Forbion has been ranked "…#1 most consistently performing VC Manager in Europe.." by Preqin’s fund performance database in 2019. Forbion’s investment team has built an impressive performance track record with over 70 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 15 billion), Replimune (REPL; market cap of USD 1.4 billion) Uniqure (QURE; market cap USD 1.5 billion), and Dyne Therapeutics (DYN; market cap 815 million), 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 KandY Therapeutics (acquired by Bayer for an upfront payment of EUR 378 million and an undisclosed total deal value), and Achilles Therapeutics (ACHL; market cap USD 612 million).