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.

Celltrion’s Statement on CRLs from the U.S. FDA for rituximab and trastuzumab biosimilar

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.

FORMA Therapeutics Achieves Key Objective in Collaboration with Celgene Corporation to Advance a Novel Protein Homeostasis Oncology/Immuno-Oncology Program

On April 5, 2018 FORMA Therapeutics reported that it has successfully completed a critical objective under its strategic collaboration agreement with Celgene Corporation, triggering an undisclosed payment from Celgene (Press release, Forma Therapeutics, APR 5, 2018, View Source [SID1234525190]). Previously, FORMA and Celgene entered into a collaboration in the promising area of protein homeostasis to discover, develop and commercialize innovative drug candidates. This collaboration enables Celgene to evaluate select therapeutic candidates and programs in protein homeostasis during preclinical development.

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Jim Winkler, Ph.D., Vice President, Biology at FORMA Therapeutics said, "We are pleased with Celgene’s continued confidence in FORMA’s discovery research. This program represents a potential first-in-class therapeutic mechanism, by conferring both anti-tumor and immune-modulatory effects. We believe the field of protein homeostasis will deliver a promising pipeline of drugs, moving beyond cancer into immuno-oncology, inflammation and neurodegeneration."

About Protein Homeostasis

Protein homeostasis, which is important in oncology, neurodegenerative and other disorders, involves a tightly regulated network of pathways controlling the biogenesis, folding, transport and degradation of proteins. Exploring the maintenance and regulation of such competing, yet integrated, biological pathways using a chemical biology approach, should directly contribute to the understanding of diseases associated with excessive protein misfolding, aggregation and degradation

Seattle Genetics to Host Conference Call and Webcast Discussion of First Quarter Financial Results on April 26, 2018

On April 5, 2018 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that it will report its first quarter financial results on Thursday, April 26, 2018 after the close of financial markets (Press release, Seattle Genetics, APR 5, 2018, View Source;p=RssLanding&cat=news&id=2341209 [SID1234525192]). Following the results announcement, company management will host a conference call and webcast discussion of the results and provide a general corporate update. Access to the event can be obtained as follows:

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LIVE access on Thursday, April 26, 2018

1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time

Telephone 800-263-0877 (domestic) or +1 646-828-8143 (international); conference ID 9171561
Webcast available at www.seattlegenetics.com in the Investors section
REPLAY access

Telephone replay will be available beginning at approximately 4:30 p.m. PT on Thursday, April 26, 2018 through 5:00 p.m. PT on Monday, April 30, 2018 by calling 888-203-1112 (domestic) or +1 719-457-0820 (international); conference ID 9171561
Webcast replay will be available on the Seattle Genetics website at www.seattlegenetics.com in the Investors section

SORRENTO AND CELULARITY TO START ANTI-CD38 CAR-T PHASE 1 CLINICAL TRIAL
IN PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA (NCT03464916)

On April 5, 2018 Sorrento Therapeutics, Inc. (NASDAQ: SRNE) and Celularity Inc. reported that the companies have started screening patients for its leading CD38 chimeric antigen receptor (CAR) T cell therapy drug development program, following FDA review allowing clinical trial initiation (Press release, Sorrento Therapeutics, APR 5, 2018, View Source [SID1234525804]).

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Phase 1, Open-Label, Dose-Escalation, Pharmacokinetic, and Pharmacodynamic Study of the Safety and Efficacy of CAR2 Anti-CD38 A2 CAR-T Cells in Patients with Relapsed or Refractory Multiple Myeloma (www.clinicaltrials.gov : NCT03464916). IND filing completed. Study cleared for patient enrollment.

The companies’ CD38 CAR-T program is their most advanced program targeting this difficult-to-treat condition. This trial is currently the only active US-based clinical trial targeting CD38 using a CAR-T cell therapy.

The first investigational site at Roger Williams Medical Center, RI, is actively engaged in the clinical study execution, with additional sites to be included.

"Our CD38 CAR-T program has now officially entered clinical stage and will be treating patients as well as collecting valuable data in the upcoming months. This represents a major milestone for Sorrento and Celularity that clearly demonstrates our keen focus on advancing our therapeutics assets as well as our ability to deliver on the timelines we previously communicated" stated Dr. Henry Ji, Chairman and CEO of Sorrento before adding, "we expect to share initial clinical data from this study as soon as it becomes available".

"We are extremely pleased that we can begin this study in our ongoing efforts to improve treatment options for this and other serious diseases. Celularity, created through the contributions from Celgene Corporation, United Therapeutics, Human Longevity Inc., and founding strategic partner Sorrento, is uniquely positioned to combine its platform cellular technology with the vast tool set accessible from Sorrento," said Dr. Robert Hariri, Chairman and CEO of Celularity. "Celularity is building a deep pipeline of immunotherapeutic products from our proprietary placental cells including ‘off-the-shelf’ CAR-T and CAR-NK cell therapies," added Dr. Hariri.

Utilizing available cGMP manufacturing, Sorrento and Celularity estimate they can produce up to 300 patient treatments per year. These existing capacities easily cover the needs of the Phase 1 clinical study and would be sufficient to meet the requirements for subsequent advanced pivotal clinical studies.

Full details about the study available on www.clinicaltrials.gov

About Sorrento Therapeutics, Inc.

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. Sorrento’s multimodal multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies ("G-MAB library"), clinical stage immuno-cellular therapies ("CAR-T"), intracellular targeting antibodies ("iTAbs"), antibody-drug conjugates ("ADC"), and clinical stage oncolytic virus ("Sephrevir").

Sorrento’s commitment to life-enhancing therapies for cancer patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule in Resiniferatoxin ("RTX") and ZTlido. Resiniferatoxin is completing a phase IB trial in terminal cancer patients. ZTlido was approved by the FDA on 02/28/18.

For more information visit www.sorrentotherapeutics.com