(Filing, Annual, Celyad, 2017, APR 6, 2018, View Source [SID1234525205])

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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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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.

On April 6, 2018 Celltrion reported that it has received a Complete Response Letters (CRLs) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for CT-P10 (rituximab), a proposed biosimilar to Rituxan and CT-P6 (trastuzumab), a proposed biosimilar to Herceptin (Press release, Celltrion, APR 6, 2018, View Source [SID1234525568]).

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The FDA Warning Letter issued to Celltrion in January 2018 was directly related to the receipt of the CRL.

Celltrion is making progress addressing the concerns raised by the FDA in a Warning Letter issued in January and is committed to working with the agency to fully resolve all outstanding issues with the highest priority and urgency.

Celltrion is confident that the issues raised by the FDA will be resolved in a timely manner.

We can confirm that the resubmission will be in-place relatively soon. Then, we are expecting approvals in 6 months after resubmission according to regulatory timeline.

On April 6, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) reported a review of its clinical programs (Press release, NewLink Genetics, APR 6, 2018, View Source [SID1234525805]).

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This morning’s announcement by Incyte and Merck on the ECHO-301 trial for patients with advanced melanoma is a disappointing result for the IDO field. Indoximod, NewLink Genetics’ IDO pathway inhibitor, has a differentiated mechanism of action (MOA) which may demonstrate clinical benefit for patients where direct enzymatic inhibitors have not. In light of Incyte’s announcement, however, NewLink is undertaking a review of its clinical programs and will provide an update when it is completed.

NewLink Genetics has generated data for indoximod across several indications, and in combination with different modalities, suggesting the potential for indoximod to improve the outcomes for patients with cancer. The Company will present additional data at AACR (Free AACR Whitepaper) next week, including a poster presentation further supporting indoximod’s differentiated MOA and a plenary session presenting encouraging early clinical data of indoximod plus radiation for pediatric patients with diffuse intrinsic pontine glioma (DIPG), a rare and lethal form of brain cancer.

About Indoximod

Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target involved in regulating the tumor microenvironment and immune escape. Indoximod is being evaluated in combination with treatment regimens including anti-PD-1/PD-L1 agents, cancer vaccines, radiation, and chemotherapy across multiple indications such as melanoma, pancreatic cancer and other malignancies.

On April 4, 2018 Genoscience Pharma, a clinical-stage biotechnology company dedicated to discovering and developing anticancer drugs, reported the first administration of GNS561 in a Phase 1/2a clinical study in advanced hepatocellular carcinoma (Press release, GenoScience, APR 5, 2018, View Source [SID1234525197]). This is the first clinical trial investigating this drug candidate, stemming from Genoscience Pharma’s research.

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This clinical research in liver cancer is led by Professor Ahmad Awada, head of medical oncology and principal investigator at the Jules Bordet Cancer Institute in Brussels, Belgium.

This international phase 1/2a study performed in Europe and the USA will evaluate safety, activity and the pharmacokinetics and pharmacodynamics of escalating doses of GNS561.

Up to 36 patients will be enrolled in six cohorts during the dose escalation phase. Additional patients will be enrolled in the continuation phase to obtain a total of 20 evaluable subjects at the recommended dose.

"This clinical program represents a paradigm shift for our company; it will provide a wealth of valuable additional knowledge and data to drive our platform of metal transporter modulators towards various clinical applications for cancer therapy," said Professor Philippe Halfon, president and CEO of Genoscience Pharma.

"Since being granted a rapid approval from regulatory authorities and institutional review boards, we have initiated the first-in-class GNS561 studies. The enrollment and treatment of the first patient represents a major milestone for Genoscience Pharma," said Professor Eric Raymond, chief medical officer.

"We are excited to be enrolling our first patient with GNS561. We are hopeful that this novel anticancer drug will prove to be a significant and effective weapon against liver cancer," said Pr. Ahmad Awada, principal investigator.
The study is run as an international clinical trial conducted in Europe and the USA. Professor Ghassan Abou Alfa at Memorial Sloan Kettering in New York is co-principal investigator.
His work focuses on preclinical and early-stage testing to optimize the development of stem cell-targeted cancer drugs.

About liver cancer
With more than 780,000 new cases diagnosed each year, liver cancer is the fifth most common cancer worldwide. It is the second leading cause of cancer-related deaths globally, accounting for approximately 746,000 deaths annually. The majority of liver cancers are detected at the advanced stage. New treatment options are urgently needed for these patients. HCC is the most common form of liver cancer, accounting for 90 percent of the worldwide total.

About GNS561
GNS561 is a novel Solute Carrier Transporter (SLCT) inhibitor demonstrating potent antitumor activity against a range of human cancer cell lines, including HCC. It also shows activity in cell lines resistant to current standard-of-care treatment options for HCC. GNS561 is an orally bioavailable compound initially being developed for the treatment of primary liver cancer, including advanced HCC. It is also being investigated preclinically in other solid tumors.