Morphotek Announces Agreement to License its Proprietary Eribulin-Linker Payload to Bliss Biopharmaceutical Co., Ltd. for Development of a Therapeutic Antibody-Drug Conjugate (ADC)

On April 9, 2018 Morphotek, Inc., a subsidiary of Eisai Inc., reported that it licensed its eribulin-linker payload to Bliss Biopharmaceutical Co., Ltd. (BlissBio) of China (Press release, Morphotek, APR 9, 2018, View Source [SID1234527215]). The licensing agreement grants BlissBio the exclusive right to use the eribulin-linker payload to develop a therapeutic ADC against an undisclosed oncology target for the China market. The licensing agreement includes an upfront payment, milestones and sales royalty payments, which are undisclosed. BlissBio has an exclusivity option to expand the territory beyond China to the global market and to develop therapeutic ADCs to two additional undisclosed oncology targets.

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Morphotek’s ADC Services offer third parties the opportunity to license the proprietary eribulin-linker payload to develop investigational ADCs using either Morphotek’s REsidue-SPEcific Conjugation Technology (RESPECT) or an alternative approach to conjugation. The eribulin-linker payload consists of a cytotoxic agent, eribulin, modified by a chemical linker to facilitate optimal conjugation. Eribulin’s anti-tumor activity is mediated by the inhibition of microtubule elongation and mitotic spindle formation, resulting in apoptosis. Eribulin mesylate, marketed as Halaven, is approved in the U.S. for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for metastatic disease, including an anthracycline and a taxane in either the adjuvant or metastatic setting.

Our end-to-end ADC Services provide multiple entry points for clients, starting from development of an antigen site-specific bioconjugate-ready monoclonal antibody and ADC through in vivo safety and efficacy validation. Additional options include manufacture of GMP clinical trial material, GLP toxicology studies and development of immunohistochemistry (IHC) companion diagnostics for patient screening. For more information on Morphotek’s ADC Services business and RESPECT platform, please contact [email protected].

*The ADCs described herein are investigational, as efficacy and safety have not been established. There is no guarantee that the ADCs will be available commercially.

TARIS® Announces Late-Breaking Poster Presentation at American Association of Cancer Research Annual Meeting

On April 9, 2018 -TARIS reported that it will present a late-breaking poster related to TAR-200 (GemRIS), the company’s lead clinical program in bladder cancer, at the upcoming American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 14-18, 2018 in Chicago (Press release, TARIS Biomedical, APR 9, 2018, View Source [SID1234525235]).

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Poster presentation details are as follows:

Poster Title: Significant cytotoxic and immumomodulatory effects of continuous low dose intravesical gemcitabine in rodent bladder tumor models
Poster Number:

LB-122
Session Title:

LBPO.IM01 – Late-Breaking Research: Immunology 1
Session Date:

April 16, 2018, 8:00 AM – 12:00 PM, Poster Section 45, Board #19

About Muscle Invasive Bladder Cancer

Bladder cancer is the fifth most common neoplasm in industrialized countries, affecting roughly 2.7 million people worldwide. In the United States, there were an estimated 79,000 new cases and nearly 17,000 deaths in 2017; Muscle Invasive Bladder Cancer (MIBC) accounts for 20-25% of the newly diagnosed cases and the majority of disease-related mortality.

While some potentially curative treatments, including surgical organ removal and chemoradiation, are available, 40% or more of patients with MIBC are unfit to undergo these morbid procedures, or opt to not receive them.i Available treatment options for these patients are limited to palliative care.

About TAR-200 (GemRIS)

TAR-200 is TARIS’s lead investigational program in bladder cancer, and is designed to release the chemotherapeutic agent gemcitabine continuously in the bladder for multiple weeks.

CEL-SCI Corporation to Present at The MicroCap Conference

On April 9, 2018 CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy biopharmaceutical company, reported that Geert Kersten, Chief Executive Officer, will present a corporate overview at The MicroCap Conference on Tuesday, April 10th at 10 a.m. Eastern time (Press release, Cel-Sci, APR 9, 2018, View Source [SID1234525236]). The conference will be held April 9-10, 2018 at the Essex House in New York City.

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CEL-SCI Corporation to present at The MicroCap Conference

About The MicroCap Conference

The MicroCap Conference is an exclusive event dedicated to connecting high-performing small and microcap companies with committed investors. It is an opportunity to be introduced to and speak with management at some of the most attractive companies, learn from various expert panels, and network with other small and microcap investors.

MorphoSys Announces Launch of American Depositary Shares (ADS) Offering in the United States

On April 9, 2018 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported that it has commenced an initial public offering in the United States of up to 8,300,000 American Depositary Shares ("ADSs") pursuant to a Registration Statement on Form F-1, as amended, filed with the U.S. Securities and Exchange Commission (Press release, MorphoSys, APR 9, 2018, View Source [SID1234556337]). Furthermore, MorphoSys expects to grant the underwriters a 30-day option to purchase additional ADSs of up to 15% of the total number of ADSs placed in the offering (i.e. up to 1,245,000 additional ADSs). Each ADS will represent 1/4 of a MorphoSys ordinary share. The new ordinary shares underlying the ADSs will be issued from MorphoSys’s authorized capital 2017-II, excluding pre-emptive rights of existing shareholders and representing up to 8.1% (including the underwriters’ option to purchase additional ADSs) of the registered share capital of MorphoSys prior to the consummation of the offering.

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The final price of the offered ADSs will be determined largely on the basis of the XETRA closing price of MorphoSys’s shares on the Frankfurt Stock Exchange on the pricing date (expected for the week of April 16, 2018) translated into U.S. dollars at the then prevailing exchange rate and using an ADS to share ratio of four to one. Application has been made to list the ADSs on the Nasdaq Global Market in the United States under the ticker symbol "MOR".

Within the United States of America, the securities referred to in this release are to be offered only by means of a prospectus. A copy of the preliminary prospectus can be obtained from Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 1-212-902-9316 or by e-mailing [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 1-866-803-9204; Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6132, or by e-mailing [email protected].

A Registration Statement relating to these securities has been filed with the U.S. Securities and Exchange Commission but has not yet become effective. The securities may not be sold, nor may offers to buy be accepted, prior to the time the Registration Statement becomes effective.

Sanofi presents new data at AACR 2018 highlighting advances in early-stage oncology portfolio

On April 6, 2018 Sanofi reported it will present nine abstracts at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago from April 14-18 (Press release, Sanofi Genzyme, APR 6, 2018, View Source [SID1234525209]). Building on its strong heritage in oncology, the company will share new, early-stage studies highlighting an emerging and dynamic portfolio that encompasses diverse strategies, including immuno-oncology (I-O).

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Sanofi’s abstracts at AACR (Free AACR Whitepaper) will include a late-breaking pre-clinical presentation in partnership with BioNTech highlighting the potential impact of combination treatment with intratumoral cytokine mRNAs, an emerging class of immunotherapy medication. Additionally, results on overcoming resistance to an already-established type of immunotherapy, PD-1 (programmed cell death protein 1) inhibitors, will be presented. Notably, these data will feature Sanofi’s TGF-beta candidate, SAR439459, along with a joint presentation with Evotec on the investigational candidate EVT801, a small molecule inhibitor of VEGFR3 to target myeloid derived suppressor cells (MDSCs) in the tumor microenvironment.

Sanofi is also advancing SAR439859, a SERD (selective estrogen receptor degrader) in estrogen-receptor-positive breast cancer, and will have a number of presentations on this candidate.

"Sanofi is excited to share a broad range of promising early-stage science in oncology at AACR (Free AACR Whitepaper) 2018," said Yong-Jun Liu, M.D., Ph.D., Head of Research, Global R&D at Sanofi. "By strengthening our internal research capabilities, and by collaborating with the key therapeutic leaders in this field, we are now able to demonstrate the emerging strength and depth of our oncology pipeline at Sanofi."

The company is pursuing a breadth of approaches and new technologies to shape its early-stage oncology pipeline, including small molecule therapeutics, next-generation biologics such as antibody drug conjugates, and multi-targeting therapies.

AACR 2018 Data Presentations

Sanofi’s presentations at AACR (Free AACR Whitepaper) 2018 can be accessed via the AACR (Free AACR Whitepaper) website, and are summarized below.

Late breaking presentation

Combinatorial treatment with intratumoral cytokine mRNAs results in high frequency of tumor rejection and development of anti-tumor immunity across a range of preclinical cancer models (Session LBPO.IM01 – Late-Breaking Research: Immunology 1, Section 45, April 16, 2018, 8:00 AM – 12:00 PM)

Oral presentation

SAR439859, an orally bioavailable selective estrogen receptor degrader (SERD) that demonstrates robust antitumor efficacy and limited cross-resistance in ER+ breast cancer (Session MS.EN01.01 – Novel Roles of Steroid Hormone Receptors, Room S504 – McCormick Place South (Level 5), April 15, 2018, 3:05 PM – 3:20 PM)

Sanofi presentation with Evotec

Translation to the clinic of EVT801: A novel immune-oncology agent for addressing innate-driven immunosuppression into the tumor microenvironment and expanding patient population responding to immune checkpoint therapies (PO.IM02.03 – Immune Mechanisms Invoked by Therapies 1, Section 33, April 16, 2018, 1:00 PM – 5:00 PM)

Poster presentations

Pre-clinical development of a novel CD3-CD123 bispecific T-cell engager using Cross-Over-Dual-Variable-Domain (CODV) format for the treatment of acute myeloid leukemia (AML) (Session PO.IM02.10 – Therapeutic Antibodies, Including Engineered Antibodies 1, Section 34, April 16, 2018, 8:00 AM – 12:00 PM)

Sensitivity of liver cancer cell lines to B-catenin knock-down correlates with pathway activation (Session PO.MCB03.03 – Nuclear Oncoproteins and Tumor Suppressor Genes, Section 21, April 16, 2018, 1:00 PM – 5:00 PM)

The anti-TGFβ neutralizing antibody, SAR439459, blocks the immunosuppressive effects of TGFβ and inhibits the growth of syngeneic tumors in combination with anti-PD1 (Session PO.IM02.11 – Therapeutic Antibodies, Including Engineered Antibodies 2, Section 34, April 16, 2018, 1:00 PM – 5:00 PM)

Identification of SAR439859, an orally bioavailable selective estrogen receptor degrader (SERD) that has strong anti-tumor activity in wild-type and mutant ER+ breast cancer models. (Session PO.ET06.10 – Canonical Targets 2, Section 36, April 18, 2018 8:00 AM – 12:00 PM)

Basal-like breast cancer subtype is characterized by deregulated glutamine metabolism and is sensitive to GLS inhibition (Session PO.MCB08.03 – Targets Affecting Metabolism Section 21, April 18, 2018, 8:00 AM – 12:00 PM)

Translational biomarkers for SAR439459, an anti-TGFβ antibody for cancer immunotherapy (PO.CL06.08 – Immunomodulatory Agents and Interventions 3, Section 25, April 18, 2018, 8:00 AM – 12:00 PM)

The agents identified above are under investigation only; their safety and efficacy have not been evaluated by any regulatory authority.