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Sutro Biopharma Collaborates with Celgene Corporation to Design and Develop Next-Generation Antibody Drug Conjugates and Bispecific Antibodies

On December 18, 2012 Sutro Biopharma reported a collaboration with Celgene Corporation to design and develop novel antibody drug conjugates (ADCs) and bispecific antibodies for two undisclosed targets and to manufacture a proprietary Celgene antibody (Press release Sutro Biopharma, DEC 18, 2012, View Source [SID:1234500757]). Under the terms of the agreement, Sutro will receive a substantial upfront payment, an equity investment in the company and payments for the completion of research, development and regulatory milestones. If all programs are successful, the deal could be worth over $500 million to Sutro. The company is also eligible to receive royalties on product sales.

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In the collaboration, Sutro will be responsible for product design and production of preclinical materials using the company’s proprietary, cell-free protein synthesis technology. "We are pleased to work with Celgene on multiple programs that utilize a broad spectrum of Sutro’s cell free protein synthesis technology and capabilities," said William Newell, chief executive officer of Sutro Biopharma. "The scope of this partnership showcases our novel, cell-free approach to designing, developing and manufacturing next-generation ADCs and bispecific antibodies."

Thomas Daniel, M.D., Celgene president, global research and early development, added, "We look forward to working with the team at Sutro and to exploring their platform’s potential to accelerate the discovery and development of superior multifunctional biologics."

Four Oaks Partners advised Sutro on the transaction.

Adimab Announces New Antibody Discovery Collaborations with Pfizer and an Unnamed Partner and Achievement of Milestones in Existing Partnerships with Roche and Merck

On December 17, 2012 Adimab reported the initiation of research collaborations with at the time an undisclosed company (later to known as Merrimack Pharmaceuticals) whereby Adimab will use its proprietary discovery platform to identify fully human antibodies against one oncology target selected by the undisclosed company (Press release Adimab, DEC 17, 2012, View Source [SID:1234500583]). The agreement gives the undisclosed company rights to commercialize antibodies generated from the collaboration. Adimab will receive upfront payments, preclinical milestones and licensing fees. In addition, Adimab is eligible to receive clinical development milestones, commercial milestones and royalties on therapeutic and diagnostic product sales.
Adimab used its proprietary yeast-based antibody discovery platform to discover fully human antibodies against human EGFR that were also cross-reactive with the murine and rhesus forms of the antigen. Adimab delivered the first panel of leads within twelve weeks of project initiation and several leads and backups were further optimized.

4SC Discovery and BioNTech announce exclusive research and license agreement for 4SC’s TLR agonists for cancer immunotherapy

On December 17, 2012 4SC AG (Frankfurt, Prime Standard: VSC), a discovery and development company of targeted small molecule drugs for autoimmune diseases and cancer, reported that its fully-owned research subsidiary 4SC Discovery GmbH has entered into an exclusive worldwide research and license agreement with biopharmaceutical company BioNTech AG, Mainz, Germany (Press release, 4SC, DEC 17, 2012, View Source [SID1234523086]). The goal of the agreement is the development and commercialisation of 4SC’s new small molecule toll-like receptor (TLR) agonists as an anti-cancer immunotherapy.

Under the agreement, 4SC Discovery will receive from BioNTech an upfront payment of EUR 2.5 million for its small molecule TLR agonists to be used as an anti-cancer immunotherapy. The programme is currently in early development. BioNTech will receive an exclusive license for worldwide marketing and commercialisation rights of the TLR agonists for use in cancer immunotherapy and in other therapeutic areas. 4SC Discovery is eligible for shares of sublicensing proceeds of BioNTech, payments for specific sales milestones as well as for royalties linked to product net sales.

Dr. Daniel Vitt, Managing Director of 4SC Discovery GmbH and Chief Scientific Officer at 4SC AG, commented: ‘We are very pleased to have won BioNTech – a pioneer in the field of cancer immunotherapies – as an ideal license partner for our TLR agonists. Our goal is now to speed-up and jointly develop a novel breakthrough therapy toward the market addressing the high medical need in the exciting field of cancer immunotherapy.’

Dr. Ulrich Dauer, Chief Executive Officer of 4SC AG, added: ‘We are proud that, only a year after launching its operations, our research subsidiary 4SC Discovery has entered into its first early-stage partnering deal with one of the programmes from our research engine and with such a highly innovative partner as BioNTech. After having already secured a number of research service collaborations with biotech and pharma companies this year, this first licensing partnership of 4SC Discovery is another strong signal for the value generation potential of 4SC’s research. It is also a clear fulfilment of the promise we made to the capital markets at the beginning of the year when we started 4SC Discovery with the strong intention to focus on the commercialisation of our early-stage research activities.’

Prof. Dr. Ugur Sahin, Chief Executive Officer of BioNTech AG, noted: ‘We are delighted to enter this partnership with 4SC Discovery – a company with a great track record and vast expertise in small molecule drug discovery in oncology. With 4SC’s TLR agonists, we expect to create additional value to our own proprietary cancer immunotherapy platform. We see a particular opportunity since TLR agonists, given as a supplementary therapy, are expected to increase the efficacy of our cancer immunotherapy programmes.’

Ends

About 4SC’s TLR research programme for cancer immunotherapy

4SC Discovery GmbH has a strong research focus on cancer immunotherapy, besides epigenetics and cancer stem cells. The aim of cancer immunotherapy is to develop substances that can influence the immune system of cancer patients in such a way that the patient’s immune system recognises and destroys the primary cancer cells and tumour metastases.

Toll-like receptors represent a promising target class for cancer immunotherapy. They represent a kind of alarm system in the human body. The activation of this alarm system, for instance by 4SC’s small molecule substances (TLR agonists), results in the stimulation of the immune system and a release of messenger and signaling molecules in the body, including interferons as well as other cytokines and chemokines. Applying a TLR agonist in combination with a chemotherapeutic drug, results in the destruction of the primary tumour bulk by the chemotherapeutic agent, while the activated immune system can achieve a final ‘clean up’ of undetectable tumour remainders which are otherwise often the cause for a later relapse of the disease. A further advantage of TLR agonists lies in the combination with various forms of vaccines. Thus TLR agonists have the potential to increase the efficacy of these cancer vaccines.

About BioNTech AG

BioNTech AG (Biopharmaceutical New Technologies) is a spin-off of Johannes Gutenberg-Universität Mainz. As a holding company with six subsidiaries, BioNTech researches and develops novel immune-based technologies to boost the body’s immune system for the targeted treatment of numerous cancers. The company owns a number of cancer-specific target structures and uses proprietary technology platforms to develop medicines that are specifically directed against these target structures. BioNTech also researches, develops and manufactures diagnostics for the detection of cancer, based upon identification of selectively expressed biomarkers.

Proposed Merger of Equals between Vivalis and Intercell

On December 16th, 2012 Vivalis and Intercell reported that they have agreed the terms of a
merger to create the newly-named Valneva, a leading European biotechnology company in
vaccines and antibodies (Press release Valneva, DEC 16, 2012, View Source;file=2012_12_16_PR_Intercell_and_Vivalis_ENG_final.pdf [SID:1234500598]).
The merger will create an integrated company with greater scale and diversification,
strengthened financial profile and complementary talent and capabilities:
* Complementary business models operating across the value chain with innovative
technology platforms, discovery and development capabilities, state-of-the-art
manufacturing and commercialization expertise
* Diversified revenue streams from a marketed vaccine against Japanese Encephalitis Virus
and income from multiple commercial technology licenses
* A broad portfolio of promising partnered product candidates including a pandemic Influenza
vaccine in Phase III, a Pseudomonas vaccine in Phase II/III and a Tuberculosis vaccine in
Phase II
* A portfolio of validated and commercialized technology platforms including the EB66 cell
line for human and veterinary product development which is becoming the industry
standard, the VIVA|ScreenTM antibody discovery platform and the IC31 novel adjuvant
* EUR 5-6 million of expected cost synergies, on an annual run-rate basis, achieved within
two years following completion of the merger
* Substantially improved financial profile with a combined cash balance of EUR 94 million as
at 30 September 2012 (adjusted for the planned EUR 40 million rights issue and the
repayment of Intercell’s outstanding convertible bond). This improved financial position will
enhance the development of Valneva’s vaccine and antibody portfolio and will de-risk the
path to profitability
* A complementary and experienced management team led by Thomas Lingelbach as
President and Chief Executive Officer, Franck Grimaud as President and Chief Business
Officer, Majid Mehtali as Chief Scientific Officer and Reinhard Kandera as Chief Financial
Officer
Franck Grimaud, CEO and Majid Mehtali, CSO, co-managers of Vivalis, commented: "The
merger with Intercell is an important step towards Vivalis’ strategic goal of building a profitable,
product-based biopharmaceutical company and laying the foundations for rapid revenue and
profit growth going forward. The merger will significantly complement our core capabilities, in
particular towards product development, while also adding strength and breadth to our R&D
portfolio. As a result of multiple revenue streams, Valneva will also enjoy enhanced financial
strength to fund its future growth."
Thomas Lingelbach, CEO of Intercell, commented: "Our strategy is to build a sustainable
biotech company with a well-balanced and diversified value proposition enabling us to develop
innovative products with a strong focus on preventing and treating infectious diseases. The
merger will help achieve this goal by combining Vivalis’ discovery and technology capabilities
with Intercell’s development, manufacturing and commercialization expertise. The increased
financial strength will provide us greater capabilities to progress our pipeline. We expect both
sets of shareholders will substantially benefit from the strengthened capabilities of the combined
company."

Kyowa Hakko Kirin Initiates Pivotal Phase 3 Trial of Mogamulizumab (KW-0761) in Patients with Cutaneous T-Cell Lymphoma in the United States

On December 13, 2012 Kyowa Hakko Kirin reported the initiation of a Phase 3 clinical trial (NCT01728805) in the United States to evaluate the efficacy and safety of mogamulizumab (generic name / code name: KW-0761) in patients with relapsed/refractory Cutaneous T-Cell Lymphoma (CTCL) (Press release Kyowa Hakko Kirin, DEC 13, 2012, View Source [SID:1234500289]). Mogamulizumab has been granted orphan-drug designation for the treatment of CTCL by the U.S. Food and Drug Administration and the European Commission.
Mogamulizumab is a novel, humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4), which is over-expressed on various malignant T cells, including CTCL cells. Engineered by Kyowa Hakko Kirin’s unique POTELLIGENT Technology, the antibody is designed to kill its target cells through potent antibody-dependent cellular cytotoxicity (ADCC).
Mogamulizumab was approved in Japan in March 2012 for the treatment of patients with relapsed or refractory CCR4-positive Adult T-Cell Leukemia-Lymphoma (ATL), and is being investigated world-wide in a number of clinical studies for other potential indications.