On April 16, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that it has entered a new worldwide collaboration with Bristol-Myers Squibb Company on a program to develop and commercialize Factor XIa (FXIa) inhibitors, including BMS-986177, for the prevention and treatment of major thrombotic conditions (Press release, Johnson & Johnson, APR 16, 2018, View Source [SID1234525347]). Under the agreement, Janssen Pharmaceuticals, Inc. and Bristol-Myers Squibb Company will advance BMS-986177 into Phase 2 clinical trials and establish a broad development program across multiple therapeutic indications.

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The development of novel oral anticoagulants has been a major step forward in the prevention and treatment of thrombosis. The goal for next-generation anticoagulants is to achieve the same efficacy as the current standard of care while substantially lowering the risk of bleeding. Early clinical research has shown that

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FXIa inhibition has the potential to reduce the risk of thrombotic events with a significantly lower risk of bleeding compared to currently available therapies.

"Janssen has built deep knowledge in the anticoagulation space through our extensive experience researching and developing innovative cardiovascular therapies," said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular and Metabolism, Janssen Research & Development, LLC. "We look forward to applying our expertise to this collaboration with Bristol-Myers Squibb to explore the full potential of BMS-986177 through Factor XIa inhibition to provide a wider safety window for anticoagulation than current therapies."

"With the addition of a Factor XIa inhibitor program to our pipeline, Janssen continues to live up to our long-standing commitment of working tirelessly to bring truly transformational therapies to patients worldwide," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. "With this new collaboration we have the potential to improve the standard of care for patients with cardiovascular conditions characterized by pathologic thrombosis."

The companies will share development costs and commercial profits and losses. Additional terms of the agreement were not disclosed

On April 16, 2018 VBL Therapeutics (NASDAQ:VBLT) reported that its presented a late-breaking study demonstrating a novel bi-specific antibody that induces immune-cell mediated killing of cancer cells through binding to a tumor membrane receptor, MOSPD2 (Press release, VBL Therapeutics, APR 16, 2018, View Source [SID1234525364]). Data are presented today at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting in Chicago, Illinois

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.
"Selective targeting of tumor cells is challenging, as it requires a tumor-specific receptor, or process, that can be attacked without compromising safety. Our new data demonstrate that different solid tumors show high expression of MOSPD2 as it likely supports their ability to invade and metastasize. Our bi-specific antibody is taking advantage of this tumor-specificity to induce killing of tumor cells. We continue to advance our exciting VB-600 series of antibodies as drug candidates for oncology and inflammatory indications," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics.

VBL research has identified MOSPD2 (Motile Sperm Domain-containing Protein 2) as a protein involved in cell motility. Previously, the Company published data on the involvement of MOSPD2 in immune cell migration, and new data presented today at AACR (Free AACR Whitepaper) show high and selective MOSPD2 expression by multiple tumor types along with involvement of MOSPD2 in tumor cell invasiveness. In addition, a novel bi-specific antibody that was engineered to bridge interaction of T-cells with tumor cells, via binding to the T-cell protein CD3 and the tumor receptor MOSPD2, induced T-cell activation and resulted in the killing of cancer cells in a pre-clinical setting.
These data provide proof-of-concept for the use of antibody-mediated killing of MOSPD2-expressing cancer cells, with potential applicability to solid tumors and myeloid malignancies. VBL is developing its VB-600 series of antibodies targeting MOSPD2 for oncology and inflammatory applications.
For VBL’s poster presentation at AACR (Free AACR Whitepaper) kindly see the following link.

On April 16, 2018 Nordic Nanovector ASA (OSE: NANO) reported that a poster reporting the anti-tumour effect of Humalutin (177Lu-conjugated humanized anti-CD37 antibody, 177Lu-NNV003) in preclinical models of non-Hodgkin’s lymphoma (NHL) was presented yesterday at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018 in Chicago, USA (Press release, Nordic Nanovector, APR 16, 2018, View Source [SID1234553507]). The company previously announced the publication of the poster abstract (abstract 848) on 15 March 2018.

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The poster was entitled "In vitro and in vivo evaluation of the beta-emitting lutetium-177 labeled anti-CD37 antibody radionuclide conjugate 177Lu-NNV003 in DLBCL, CLL and MCL models," and showed that:

In tumour cell lines:

• The unlabelled anti-CD37 antibody (NNV003) kills tumour cells mainly through an immunological process called antibody dependent cellular cytotoxicity

• Humalutin (177Lu-NNV003) was found to inhibit tumour cell growth.

In preclinical lymphoma models:

• Humalutin has shown significant tumour uptake and demonstrated an anti-tumour effect in all three NHL models (mantle cell lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukaemia).

On April 16, 2018 Only a couple weeks after Takeda Pharmaceuticals reported it was interested in buying Shire, Shire sells its oncology business to France’s Servier for $2.4 billion (Press release, BioSpace, APR 16, 2018, View Source [SID1234525333]).

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It’s possible the sale will make Shire less desirable for Takeda, since Shire’s oncology business was part of the rationale for buying the company. It’s also possible it will make it more desirable by dropping the price slightly. Reuters notes, "The [Servier} deal suggests there is value locked up within Shire’s portfolio—despite a dismal share price performance in the past two years—as its management braces for a possible $50-billion bid battle with Japan’s biggest drugmaker."

Shire has suggested the proceeds from the sale may be returned to shareholders via a buyback. It also indicated that further sales of non-strategic assets were a possibility.
Shire is making it clear that is began looking to sell its oncology business in December and began the sale process in January. In other words, they want it understood that they didn’t quickly sell off the cancer unit to fend off an unwanted Takeda acquisition.

Under UK acquisition laws, Takeda has until April 25 to announce an official bid. The market value of Shire is about $47 billion. Reuters writes, "Buying Shire would be transformational for Takeda but would be a huge financial stretch, since the company is worth around $10 billion more than the Japanese group. Shire also had debt of around $19 billion as of the end of 2017."

Shire’s oncology business includes products such as Oncaspar (pegaspargase), part of a multi-agent treatment for acute lymphoblastic leukemia (ALL) and ex-U.S. rights to Onivyde (irinotecan pegylated liposomal formulation), part of a multi-agent treatment for metastatic pancreatic cancer after gemcitabine-based therapy, and Calaspargase Pegol (Cal-PEG), which is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of ALL and early stage immuno-oncology pipeline collaborations.

"This transaction is a key milestone for Shire, demonstrating the clear value embedded in our portfolio," said Flemming Ornskov, Shire’s chief executive officer, in a statement. "While the Oncology business has delivered high growth and profitability, we have concluded that it is not core to Shire’s longer-term strategy. We will continue to evaluate our portfolio for opportunities to unlock further value and sharpen our focus on rare disease leadership with selective disposals of non-strategic assets."
Last year the Oncology business created revenues of $262 million.

If Takeda does make an official bid for Shire, this sale might make it slightly more affordable. Last year Takeda acquired Ariad Pharmaceuticals for $4.7 billion. "Shire’s decision to buy back shares may also indicate a positive view of the bid, since increasing shareholder returns would make it easier to get approval for a deal, Kazuyoshi Saito, a senior analyst for Iwai Cosmo Securities Co." told Bloomberg in a phone interview. "I have an impression that Takeda and Shire are heading in the same direction," Saito said.

Meanwhile, buying Shire’s oncology business bolster’s Servier’s presence in oncology. Olivier Laureau, Servier Group President, said in a statement, "The acquisition of Shire’s oncology franchise enables Servier to meet its strategic ambitions to become a global key player in oncology. As an essential step in the evolution of the Group, this acquisition allows us to establish a direct commercial presence in the United States, the world’s leading pharmaceuticals market, and to strengthen our portfolio of marketed products in the territories where Servier is already present. Our goal is to bring these treatments to greater numbers of cancer patients around the world. We thoroughly look forward to welcoming Shire’s oncology teams who will join Servier after the closing."

On April 16, 2018 Humanigen, Inc. (OTCQB: HGEN), a biopharmaceutical company pursuing cutting-edge science to develop its proprietary monoclonal antibodies for immunotherapy and oncology treatments, reported it has signed an agreement with The University of Texas MD Anderson Cancer Center to begin investigator-led research on lenzilumab and its potential to support chimeric antigen receptor T cell (CAR-T) therapy (Press release, Humanigen, APR 16, 2018, View Source [SID1234525348]). Lenzilumab is a first-in-class Humaneered recombinant monoclonal antibody that targets and is an antagonist of soluble granulocyte-macrophage colony-stimulating factor (GM-CSF).

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Preclinical work assessing lenzilumab’s action on one of the mechanisms in the inflammatory cascade induced by CAR-T will proceed in parallel with a planned study that could potentially qualify as a registration study, testing lenzilumab as a potential prophylaxis for neurotoxicity induced by CAR-T therapy. Neutralization of circulating GM-CSF has the potential to blunt or prevent an inflammatory cascade that can result in serious and life-threatening CAR-T-induced side effects – neurotoxicity and Cytokine Release Syndrome.

"With this agreement, we are excited that the team at MD Anderson Cancer Center is beginning to investigate lenzilumab’s potential to make groundbreaking CAR-T therapy safer, better and more routine," said Cameron Durrant, M.D., chairman and chief executive officer of Humanigen. "CAR-T science has moved quickly in the past few years with the two currently marketed CAR-T therapies having been approved based on single Phase 1/2 studies. We look forward to adding to the burgeoning, cutting-edge science studying lenzilumab as a potential critical CAR-T support therapy."

The preclinical study will measure the ability of lenzilumab to block patient CD19-CAR-T cells-treatment-derived GM-CSF induction of human leukocyte antigen-DR (HLA-DR) expression on CD14+ monocytes. It will assess the inhibitory effect of lenzilumab on GM-CSF-induced HLA-DR expression on CD14+ cells, plus other phenotypic and functional monocyte assays.

About Lenzilumab

Lenzilumab is a first-in-class, novel Humaneered recombinant monoclonal antibody designed to target and neutralize circulating granulocyte-macrophage colony-stimulating factor (GM-CSF), the myeloid inflammation factor involved in the recruitment of myeloid cells to a tumor and a central actor in leukocyte differentiation, autoimmunity and inflammation. There is also extensive evidence linking GM-CSF expression to serious and potentially life-threatening side effects in chimeric antigen receptor T-cell (CAR-T) therapy, such as neurotoxicity and Cytokine Release Syndrome (CRS). Humanigen is working with leading CAR-T experts to develop lenzilumab as a potential prophylactic treatment to minimize neurotoxicity associated with CAR-T cancer therapy. In addition, lenzilumab is currently being evaluated as a potential treatment for rare leukemias in a phase 1 trial (NCT02546284) in patients with chronic myelomonocytic leukemia (CMML) with additional potential in juvenile myelomonocytic leukemia (JMML), a rare pediatric cancer. In previous clinical trials, lenzilumab has shown to be safe and well-tolerated in more than 100 patients, including those with rheumatoid arthritis, asthma and healthy volunteers. It is a potent inhibitor of GM-CSF in vivo.