On January 29, 2018 TrakCel, the software developer for cell and gene therapy supply chain tracking and orchestration systems, and WindMIL Therapeutics, a clinical stage oncology cell therapy company leveraging a proprietary platform to develop a novel class of cell therapies called MILs (Marrow Infiltrating Lymphocytes), reported they have partnered to build a custom-configured cellular supply chain tracking and orchestration platform to support clinical development of proprietary autologous cell therapies by WindMIL (Press release, TrakCel, JAN 29, 2018, View Source [SID1234553992]).

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The supply chain platform will be used to manage WindMIL’s entire supply chain as WindMIL expands its program of cell therapy clinical trials later this year. This expansion of clinical trials follows WindMIL’s completion of a $32.5 million Series B fundraising in June 2018. WindMIL’s unique expertise in bone marrow immunology includes the only replicable and scalable process to create a cell therapy product from bone marrow-derived T cells, which are naturally tumor specific and of a memory phenotype.

The TrakCel platform will be live in over 100 sites globally by Q1 2019. This will enable WindMIL to leverage clinical site familiarity with the platform, while ensuring connectivity across all organizations and professionals involved. The system will harmonize with all partner internal systems, including those of clinical sites, couriers, CROs and CMOs. This will support an efficient and well controlled supply chain that makes the precision of collection, transportation and manufacturing visible to all involved. It also will encompass a specifically designed
interface for physicians and medical teams.

"We are excited to soon treat more patients with MILs through this expansion of our clinical trial program. MILs harness the power of the body’s own immune system, specifically cells residing in the bone marrow. We are the only company focused on manufacturing and developing this natural source of tumor-targeting, central-memory T cells," said Brian Halak, President and CEO, WindMIL
Therapeutics. "However, developing novel cellular therapies is also about logistics. It is important for us to ensure the supply chain works for each of the individuals involved in the patient’s care and for the oncology patients themselves. We wanted to appoint a company that we saw as a partner, capable of delivering a supply chain solution that is essential for clinical success. TrakCel had the expertise and experience to achieve this."

"The entire cell therapy sector now realizes the importance of managing and tracking the supply chain from an early stage. As a result, TrakCel is now working with a range of companies at the initiation of the clinical stage as well as at the late stage of clinical development," said Ravi Nalliah, CEO of TrakCel. "The opportunity cost of the resources used for managing supply chains is even more important for companies at the earlier clinical stage. This means it is essential for TrakCel to continue to develop our cell therapy supply chain solutions as the cell therapy market continues to evolve."

On January 29, 2018 Lee’s Pharm and Sorrento Therapeutics reported that the Chinese authorities have approved China Oncology Focus Limited (COF, an affiliate of Lee’s Pharmaceutical Holdings Limited, Hong Kong Stock Symbol: 0950.HK) to proceed with the clinical trials for ZKAB001, an anti-PD-L1 monoclonal antibody exclusively licensed to COF for Greater China territories, by Sorrento Therapeutics (Press release, Sorrento Therapeutics, JAN 29, 2018, View Source [SID1234532254]).

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The investigation sites will be:

Beijing Cancer Hospital
The Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Wuhan Union Hospital
Shanghai Sixth People’s Hospital
The trials will be anticipated to use a 3+3 design with 5mg/kg, 10mg/kg and 15mg/kg dosing regimens. Once the Maximum Tolerated Dose (MTD) has been established, additional patients are expected to be recruited in an expanded Phase 1 protocol. Clinical data from these studies could be available by the end of the year 2019, and positive results could lead to conditional approval of the antibody prior to a confirmatory Phase 3 study.

"We are proud to announce the acceptance of the IND for our anti-PD-L1 antibody ZKAB001. It’s further evidence for COF continued commitment to addressing high unmet oncology needs by bringing new effective immuno-oncology therapies to the Chinese market. Throughout the IND-enabling activities and the extensive IND review process by the Chinese FDA, the COF team has worked closely and efficiently with Sorrento colleagues. In the landscape of anti-PD-L1 therapies in China, we believe our program is part of the first wave of immune checkpoint inhibitors. Encouraged by our impressive preclinical data, we are excited about evaluating our immunotherapy and addressing unmet medical needs of cancer patients in the Greater China region. Based on this highly productive first joint project, we look forward to potentially expanding our partnership with Sorrento," said Dr. Xiaoyi (Benjamin) Li, Chief Executive Officer and Executive Director of COF.

"We believe COF’s progress in the development of cancer therapeutics for the Greater China market utilizing our G-MAB library of fully human antibodies is a testimony of the value of Sorrento’s comprehensive portfolio of immuno-oncology platform technologies and products acquired and developed over the years," stated Dr. Henry Ji, Chairman and CEO. "Although our own internal resources are currently focused on the development of CAR-T platforms and programs, we think we have shown success in collaborations and out-licensing of other therapeutic assets to a number of strategic partners. COF’s success in developing ZKAB001 could lead to milestone and royalty payments to Sorrento."

About ZKAB001 (anti-PD-L1 monoclonal antibody)

ZKAB001 is a fully human anti-PD-L1 monoclonal antibody (mAb), an immune checkpoint inhibitor. The mAb blocks the interaction of PD-L1 protein with its receptor PD-1, then suppressing the inhibition of PD-1/PDL1 signal to T cells and enhancing the killing effect of T cells on tumors. This antibody also kills cancer cells through traditional antibody-dependent cell-mediated cytotoxicity (ADCC) recruiting Natural Killer (NK) cells and other effector cells against the tumor potentially further strengthening the anti-tumor effect of the antibody. It was licensed from Sorrento Therapeutics, Inc. (SRNE) to COF in Q4 2014.

On January 29, 2018 Lee’s Pharm and Sorrento Therapeutics reported that the Chinese authorities have approved China Oncology Focus Limited (COF, an affiliate of Lee’s Pharmaceutical Holdings Limited, Hong Kong Stock Symbol: 0950.HK) to proceed with the clinical trials for ZKAB001, an anti-PD-L1 monoclonal antibody exclusively licensed to COF for Greater China territories, by Sorrento Therapeutics (Press release, Sorrento Therapeutics, JAN 29, 2018, View Source [SID1234532252]).

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The investigation sites will be:

Beijing Cancer Hospital
The Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Wuhan Union Hospital
Shanghai Sixth People’s Hospital
The trials will be anticipated to use a 3+3 design with 5mg/kg, 10mg/kg and 15mg/kg dosing regimens. Once the Maximum Tolerated Dose (MTD) has been established, additional patients are expected to be recruited in an expanded Phase 1 protocol. Clinical data from these studies could be available by the end of the year 2019, and positive results could lead to conditional approval of the antibody prior to a confirmatory Phase 3 study.

"We are proud to announce the acceptance of the IND for our anti-PD-L1 antibody ZKAB001. It’s further evidence for COF continued commitment to addressing high unmet oncology needs by bringing new effective immuno-oncology therapies to the Chinese market. Throughout the IND-enabling activities and the extensive IND review process by the Chinese FDA, the COF team has worked closely and efficiently with Sorrento colleagues. In the landscape of anti-PD-L1 therapies in China, we believe our program is part of the first wave of immune checkpoint inhibitors. Encouraged by our impressive preclinical data, we are excited about evaluating our immunotherapy and addressing unmet medical needs of cancer patients in the Greater China region. Based on this highly productive first joint project, we look forward to potentially expanding our partnership with Sorrento," said Dr. Xiaoyi (Benjamin) Li, Chief Executive Officer and Executive Director of COF.

"We believe COF’s progress in the development of cancer therapeutics for the Greater China market utilizing our G-MAB library of fully human antibodies is a testimony of the value of Sorrento’s comprehensive portfolio of immuno-oncology platform technologies and products acquired and developed over the years," stated Dr. Henry Ji, Chairman and CEO. "Although our own internal resources are currently focused on the development of CAR-T platforms and programs, we think we have shown success in collaborations and out-licensing of other therapeutic assets to a number of strategic partners. COF’s success in developing ZKAB001 could lead to milestone and royalty payments to Sorrento."

About ZKAB001 (anti-PD-L1 monoclonal antibody)

ZKAB001 is a fully human anti-PD-L1 monoclonal antibody (mAb), an immune checkpoint inhibitor. The mAb blocks the interaction of PD-L1 protein with its receptor PD-1, then suppressing the inhibition of PD-1/PDL1 signal to T cells and enhancing the killing effect of T cells on tumors. This antibody also kills cancer cells through traditional antibody-dependent cell-mediated cytotoxicity (ADCC) recruiting Natural Killer (NK) cells and other effector cells against the tumor potentially further strengthening the anti-tumor effect of the antibody. It was licensed from Sorrento Therapeutics, Inc. (SRNE) to COF in Q4 2014.

On January 30, 2018 Varian Medical Systems (NYSE: VAR) reported it has signed an agreement to acquire all the outstanding shares of Sirtex Medical Limited (ASX: SRX) ("Sirtex"), an Australia-based global life sciences company focused on interventional oncology therapies, that is listed on the Australian Securities Exchange, for A$28 per share in cash (Press release, Varian Medical Systems, JAN 29, 2018, View Source [SID1234523895]). On a fully diluted basis, this represents a total equity purchase price for the acquisition of approximately A$1,585M (approximately US$1,283M as of the date of this release). The acquisition has been unanimously approved by the Board of Directors of each company and the Sirtex Board of Directors has agreed to unanimously recommend that Sirtex shareholders approve the transaction, provided that an independent expert, to be retained by Sirtex, considers the transaction to be in the best interests of Sirtex shareholders and in the absence of a superior offer.

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This acquisition of a global leader in radioembolization extends Varian’s leadership in radiation medicine, expands Varian’s addressable market into interventional oncology, and is consistent with Varian’s long-term growth and value creation strategy. Varian expects to leverage its capabilities in treatment planning and delivery, image guidance and processing, oncology practice management software, and radiation safety in combination with Sirtex’s interventional oncology platform to provide customers of both companies with a wider range of cancer care solutions.

"This acquisition is the latest step in Varian’s long-term strategy to become a global leader in multi-disciplinary integrated cancer care solutions," said Dow Wilson, CEO of Varian. "The combination of the two companies will expand the reach of the Sirtex platform by making it more broadly available to the clinical community. Our companies share a common vision of a world without fear of cancer, and we look forward to completing this acquisition and positively impacting more patients’ lives around the world."

Sirtex’s lead product is a targeted internal radiation therapy for certain liver cancers. Approximately 80,000 doses of SIR-Spheres Y-90 resin microspheres have been supplied to treat patients with liver cancer at over 1,090 medical centers in over 40 countries. It has PMA approval from the U.S. Food & Drug Administration (FDA), the European Union (CE Mark) and Australia’s Therapeutic Goods Administration (TGA). Sirtex has manufacturing capabilities in the United States, Singapore and Germany.

Sirtex generated annual revenues of A$234mm in the fiscal year ended June 30, 2017. Sirtex has approximately 300 employees worldwide and maintains sales and distribution operations primarily in the United States, Europe and Asia.

Transaction and Financial details

Varian plans to finance the acquisition using cash on hand as well as proceeds from borrowings. The transaction, which is expected to close in late May 2018, is subject to the approval of the Sirtex shareholders, the Federal Court of Australia and other customary closing conditions, including applicable regulatory approvals. Varian expects this acquisition to be accretive to earnings per share in the first full fiscal year after the closing of the transaction.

J.P. Morgan Securities LLC is acting as financial advisor and Norton Rose Fulbright is acting as legal counsel to Varian.

Webcast

Varian will webcast a conference call to discuss the details of this acquisition. The webcast will start at 9:00am ET on Tuesday, January 30, 2018. The live webcast will be available on the Varian Investor Relations website at www.varian.com/investors.

On January 29, 2018 Sanofi and Ablynx, a biopharmaceutical company engaged in the discovery and development of Nanobodies, reported to have entered into a definitive agreement under which Sanofi will offer to acquire all of the outstanding ordinary shares, including shares represented by American Depositary Shares (ADSs), warrants and convertible bonds of Ablynx at a price per Ablynx share of €45 in cash, which represents an aggregate equity value of approximately €3.9 billion (Press release, Sanofi, JAN 29, 2018, View Source [SID1234523615]). The transaction was unanimously approved by both the Sanofi and Ablynx Boards of Directors.

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Sanofi’s Chief Executive Officer Olivier Brandicourt commented, "With Ablynx, we continue to advance the strategic transformation of our Research and Development, expanding our late-stage pipeline and strengthening our platform for growth in rare blood disorders. This acquisition builds on a successful existing partnership. We are also pleased to reaffirm our commitment to Belgium, where we have invested significantly over the years in our state-of-the-art biologics manufacturing facility in Geel. We intend to maintain and support the Ablynx science center in Ghent."

Ablynx’s Chief Executive Officer Edwin Moses noted, "Since our founding in 2001, our team has been focused on unlocking the power of our Nanobody technology for patients. The results of our work are validated by clinical data. As we look ahead, we believe Sanofi’s global infrastructure, commitment to innovation and commercial capabilities will accelerate our ability to deliver our pipeline. Our Board of Directors feels strongly that this transaction represents compelling value for shareholders and maximizes the potential of our pipeline to the benefit of all stakeholders."

Sustaining Innovation in R&D

The acquisition of Ablynx continues Sanofi’s commitment to breakthrough innovation, focused on technologies addressing multiple disease targets with single multi-specific molecules.

Nanobodies are a novel class of proprietary next generation biologicals. Ablynx is at the leading edge of Nanobody technology supporting a deep pipeline of more than 45 proprietary and partnered candidates for a wide range of therapeutic areas such as hematology, inflammation, immuno-oncology and respiratory diseases. Eight Nanobodies have entered clinical development.

Sanofi is committed to accelerating development and maximizing the commercial potential of Ablynx’s ongoing and emerging programs.

Strengthening Sanofi’s Platform in Rare Blood Disorders

Ablynx’s most-advanced product in development is caplacizumab (anti-vWF Nanobody), a wholly-owned development program for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP). The product is already filed in the European Union and expected to be filed in the U.S. during the first half of this year. Caplacizumab, if approved, would be the first-in-class treatment for this acute, life-threatening disease.

The addition of caplacizumab to Sanofi’s platform strengthens its position in rare blood disorders, complementing the recently announced agreements to acquire Bioverativ and obtain global rights for fitusiran from Alnylam.

Combining Complementary Capabilities to Address
Respiratory Syncytial Virus (RSV) Infections

Ablynx’s ALX-0171, an inhaled anti-RSV Nanobody, currently in Phase 2b, is a potential breakthrough for the symptomatic treatment of RSV infections—for which there is no widely used therapy available—and is very complementary to Sanofi Pasteur RSV associated programs.

Delivering Long-Term Shareholder Value

The addition of Ablynx is anticipated to drive meaningful long-term value for Sanofi’s shareholders by enhancing its pipeline and research capabilities. Including R&D expenses, the acquisition is expected to be neutral to Business EPS[1] in 2018 and 2019.

Transaction Terms

Under the terms of the agreement, Sanofi will launch public offers to acquire all of the outstanding ordinary shares (including shares represented by ADSs), warrants and convertible bonds of Ablynx in cash. Sanofi has complied with the formalities set forth in the Belgian takeover legislation and filed the mandatory documents with the Belgian Financial Services and Markets Authority (FSMA). A notice was published by the FSMA on its website.

The consummation of the public offers is subject to customary conditions, including the tender of securities representing at least 75% of the outstanding shares of Ablynx at the end of the initial acceptance period of the Belgian Tender Offer, and the receipt of required regulatory approvals. The public offers are expected to be launched by the beginning of the second quarter of 2018.

In accordance with the Belgian requirement of certainty of funds, Sanofi has entered into a bank credit facility with BNP Paribas Fortis SA/NV acting as the sole credit facility arranger. Subject to the satisfaction or waiver of customary closing conditions, the transaction is expected to close by the end of the second quarter 2018.

Morgan Stanley and Lazard are acting as financial advisors to Sanofi. J.P. Morgan is acting as financial advisor to Ablynx. Weil, Gotshal & Manges LLP and NautaDutilh are serving as legal counsels to Sanofi. Eubelius CVBA, Goodwin Procter LLP and Linklaters LLP are serving as legal counsels to Ablynx.

Sanofi Conference Call

Sanofi will host a webcast live on Sanofi’s website at 2:30 p.m. CET / 8:30 a.m. EST on Monday, January 29, 2018. The webcast details and full presentation will be made available on Sanofi’s Investor Relations webpage.