On February 27, 2019 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported two oral presentations at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held March 29 – April 3, 2019 in Atlanta, Georgia (Press release, Syndax, FEB 27, 2019, View Source [SID1234533761]).

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Oral Presentation Details

Title: Identification of gene signatures associated with response in a Phase 2 trial of entinostat (ENT) plus pembrolizumab (PEMBRO) in non-small cell lung cancer (NSCLC) patients whose disease has progressed on or after anti-PD-(L)1 therapy
First author: Peter Ordentlich, Ph.D.
Session: Advances in Novel Immunotherapeutics (Clinical Trials Minisymposium)
Abstract Number: 7822
Location: Georgia World Congress Center, Building A, Room 411
Date and Time: Sunday, March 31, 2019; 3:00 p.m. – 5:00 p.m. ET

Title: Efficacy and safety of entinostat (ENT) and pembrolizumab (PEMBRO) in patients with melanoma previously treated with anti-PD1 therapy
First author: Ryan Sullivan, M.D.
Session: Optimizing PD-1/PD-L1 Immune Checkpoint Inhibitor Therapy (Clinical Trials Plenary Session)
Abstract Number: 7449
Location: Georgia World Congress Center, Building A, Marcus Auditorium
Date and Time: Monday, April 1, 2019; 10:30 a.m. – 12:30 p.m. ET

All accepted abstracts will be published in the 2019 Proceedings of the AACR (Free AACR Whitepaper). Session information is available online via the Annual Meeting Itinerary Planner through the AACR (Free AACR Whitepaper) website at www.aacr.org.

On February 27, 2019 Turning Point Therapeutics, Inc., a clinical-stage precision oncology company developing novel drugs that address treatment resistance, reported that it will present preclinical data next month highlighting the potent activity of its kinase inhibitors against targeted oncogene drivers and their mutations (Press release, Turning Point Therapeutics, FEB 27, 2019, View Source [SID1234533755]).

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Four studies were accepted for presentation during poster sessions at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place March 29 to April 3 in Atlanta, including two presentations that further characterize lead clinical asset, repotrectinib, in tumor cells with clinically reported ROS1 and NTRK fusions and their corresponding mutations.

"The pervasive challenge of kinase mutations that lead to treatment resistance has limited the effectiveness of approved and investigational kinase inhibitors," said Athena Countouriotis, M.D., chief executive officer. "Our team has developed a pipeline of novel, small compact kinase inhibitors that have demonstrated early preclinical and clinical effectiveness against targeted gene fusions and their mutations. We are pleased to share several of our preclinical studies at AACR (Free AACR Whitepaper) as we continue to generate clinical evidence for our lead asset repotrectinib in our ongoing Phase 1/2 TRIDENT-1 study."

The preclinical antitumor activities of Turning Point’s TPX-0022, a MET/CSF1R/SRC inhibitor, will be presented for the first time in two poster presentations. TPX-0022 was designed to target not only MET-driven tumor cells by potent inhibition of MET/SRC signaling, but also modulate the tumor microenvironment by inhibition of CSF1R. This dual modulation has demonstrated significant tumor growth inhibition in preclinical models.

The four studies to be presented are:

Title: Repotrectinib, a next generation TRK inhibitor, overcomes TRK resistance mutations including solvent front, gatekeeper and compound mutations
Session: Sunday Mar 31, 2019, 1:00 PM – 5:00 PM
Abstract Number: 4000

Title: Repotrectinib, a new generation ROS1 inhibitor, is highly potent against fusion ROS1s and emerging resistance mutations
Session: Monday April 1, 2019, 8:00 AM – 12:00 PM
Abstract Number: 4832

Title: TPX-0022, a polypharmacology inhibitor of MET/CSF1R/SRC for treatment of cancers with abnormal HGF/MET signaling
Session: Monday April 1, 2019, 8:00 AM – 12:00 PM
Abstract Number: 3719

Title: TPX-0022, a polypharmacology inhibitor of MET/CSF1R/SRC inhibits tumor growth by promoting anti-tumor immune responses
Session: Monday April 1, 2019, 8:00 AM – 12:00 PM
Abstract Number: 3749

Turning Point Therapeutics lead drug candidate, repotrectinib, is being evaluated for the treatment of patients with ROS1+ advanced non-small-cell lung cancer (NSCLC) and patients with ROS1+, NTRK+ or ALK+ advanced solid tumors. A multi-cohort Phase 2 registrational study is planned for the second half of 2019. The company is also developing two multi-targeted kinase inhibitors — TPX-0046, a novel RET/SRC inhibitor, and TPX-0022, a novel MET/CSF1R/SRC inhibitor — and next-generation ALK inhibitors.

About Repotrectinib
Repotrectinib (TPX-0005) is a potent and orally bioavailable investigational small molecule kinase inhibitor of ROS1, TRKs and ALK. The clinical benefits of targeting ROS1, TRK, or ALK fusion kinases have been demonstrated with multiple kinase inhibitors already approved or in clinical studies. The successes of these therapies are often overshadowed by the development of acquired resistance. The acquired solvent front mutations including ROS1 G2032R, TRKA G595R and TRKC G623R, and ALK G1202R render common clinical resistance to the current ROS1, TRK, and ALK inhibitors.

Repotrectinib has demonstrated potency against wildtype and mutated ROS1, TRK and ALK kinases, especially the clinically significant solvent front mutations, gatekeeper mutations, and emerging compound mutations after multiple lines of treatment. Repotrectinib may provide a new opportunity to inhibit the abnormal signaling of ROS1, TRK or ALK in solid malignancies, and overcome multiple resistance mechanisms seen in resistant patients. Repotrectinib is currently being evaluated in a Phase 1/2, open-label, multi-center, first-in-human study of the safety, tolerability, pharmacokinetics and anti-tumor activity in patients with advanced solid tumors harboring ALK, ROS1, or NTRK1-3 rearrangements TRIDENT-1 study (www.clinicaltrial.gov number NCT03093116). Interested patients and physicians can also contact the TP Therapeutics Oncology Clinical Trial Hotline at 1-858-276-0005 or email clinical@tptherapeutics.com.

On February 27, 2019 Ipsen (Euronext: IPN; ADR: IPSEY) reported that they are looking forward to revealing 17 presentations that detail their research into neuroendocrine tumors (NETs) at the 16th European Neuroendocrine Tumor Society (ENETS) Annual Conference, which is taking place in Barcelona, Spain between 6th-8th March 2019 (Press release, Ipsen, FEB 27, 2019, View Source [SID1234533754]).

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One of the key presentations, titled (Abstract #H14) ‘Development of a new and improved delivery system for lanreotide autogel/depot to further enhance care for patients with NETs and acromegaly’, reports results from five separate, but complementary studies designed to inform and test enhancements to the existing Somatuline Autogel (lanreotide) pre-filled syringe.1

Input from patients and their caregivers, as well as nurses and other healthcare professionals, was used to design a new pre-filled syringe1 that was submitted to the European Union as a type II variation via a work-sharing procedure with HPRA (Ireland) as the reference country. Following a positive outcome of the work-sharing procedure, each member state would consider a national approval. Notable new features are modified ergonomics and handling, a needle shield removal system, an injection process with plunger support and heightened ease of use.1

"It is our mission to ensure patients continue to receive optimized care as they navigate the challenges of living with NETs and acromegaly," said Sotirios Stergiopoulos, Chief Medical Officer at Ipsen. "The data we are sharing at this year’s ENETS conference underscores our commitment to understanding the patient experience and to supporting a multidisciplinary treatment approach to make treatment administration as simple as possible whether in hospital or at home."

"For nurses and other healthcare practitioners treating patients with NETs or acromegaly, the value of innovation across the entire treatment landscape supports our ability to provide the best care for our patients," said Daphne T Adelman, Clinical Nurse Specialist from Northwestern University in Chicago, U.S. and one of the authors of the study. "As a nurse who administers treatments to patients often, efficient pre-filled syringes allow me to save time and focus on patients and their needs."

Also, being highlighted are results from:

(Abstract #H18) Tumour growth rate (TGR) to monitor growth/predict response to lanreotide autogel (LAN) use before, during and after peptide receptor radionuclide therapy (PRRT) in advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs): data from PRELUDE

This abstract has been selected for a poster walk during ENETS’ scientific program and will report effectiveness data and post-hoc analyses of tumor growth rate (TGR) as a measure of response to LAN–PRRT (lanreotide autogel – peptide receptor radionuclide therapy).

(Abstract #M03) ATLANT, phase 2 study combination trial between long acting somatostatin analogue (SSA) lanreotide (LAN) and temozolomide (TMZ) in progressive thoracic (lung / thymus) well differentiated NET (carcinoid) (TNETS).

(Abstract #F22) Exploratory assessment of the clinical value of baseline (BL) circulating tumour cells (CTC) to predict symptomatic response in pts with functioning midgut neuroendocrine tumours (NETs) receiving lanreotide autogel (LAN): CALM-NET study results

In addition to these posters, Ipsen will share data from the following 13 company sponsored or supported studies and literature reviews:

(Abstract #H17) Safety and Efficacy of 14-Day Dosing Interval of Lanreotide Autogel/Depot (LAN) For Patients With Pancreatic or Midgut Neuroendocrine Tumours (NETs) Progressing on LAN Every 28 Days: The Prospective, Open-label, International, Phase 2 CLARINET FORTE Study

(Abstract #P04) Lanreotide autogel 120mg (LAN) in patients (pts) with locally advanced or metastatic gastroenteropancreatic neuroendocrine tumours (GEP-NETs): prospective observational NETways study

(Abstract #D13) Satisfaction Survey of Administration Modes for Long-Acting (LA) Somatostatin Analog (SSA) Therapy in Patients (pts) with Neuroendocrine Tumuors (NETs): Results of Cognitive Interviews With Patients and Nurses

(Abstract #J15) The Effect of Carcinoid Syndrome Diarrhea (CSD) Interventions on Patient Experience Outcomes: a Systematic Literature Review (SLR)

(Abstract #J08) Differential Diagnosis (DDx) of Carcinoid Syndrome Diarrhea (CSD): a Systematic Literature Review (SLR)

(Abstract #H25) Evaluation of the use of resources and costs associated with Uncontrolled or Controlled Carcinoid Syndrome (CS) in patients (pts) with Neuroendocrine Tumours (NETs) in Spain: RECOSY study

(Abstract #F10) Relationship between biomarkers and number of liver metastases at the time of diagnosis of small intestinal neuroendocrine tumors

(Abstract #A11) Evaluation of gene expression changes associated with response to somatostatin analogues (SSAs) in gastrointestinal (GI) neuroendocrine tumors (NETs)

(Abstract #J07) Long-term Treatment with Telotristat Ethyl (TE) in Patients with Carcinoid Syndrome (CS) Symptoms: Results from TELEPATH Study

(Abstract #P05) TELEFIRST: A randomized phase III clinical trial of Lanreotide (LAN) combined with Telotristat ethyl (TE) or placebo (PBO) for the First-line treatment in patients (pts) with advanced well-differentiated (wd) small intestinal neuroendocrine tumours (siNET) with highly-functioning carcinoid syndrome (CS)

(Abstract #K30) OPS-C-001: A Phase I/II Study To Investigate Safety, Tolerability, Biodistribution, Dosimetry and Preliminary Efficacy of 177Lu-OPS201 for the Therapy of Somatostatin Receptor (SSTR)-Positive Neuroendocrine Tumours (NETs)

(Abstract #P08) Study to evaluate the optimal dose of 68Ga-OPS202 as a PET imaging agent in patients with GEP-NETs

(Abstract #D33) Establishment of a NET data base in a German tertiary referral center; preliminary results

About SOMATULINE2

Somatuline Autogel is made of the active substance lanreotide, which is a long-acting somatostatin analogue that inhibits the secretion of growth hormone and certain hormones secreted by the digestive system. The main indications of Somatuline and Somatuline Autogel are:2

The treatment of individuals with acromegaly when the circulating levels of Growth Hormone (GH) and/or Insulin-like Growth Factor-1 (IGF-1) remain abnormal after surgery and/or radiotherapy, or in patients who otherwise require medical treatment.
The treatment of grade 1 and a subset of grade 2 (Ki-67 index up to 10%) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) of midgut, pancreatic or unknown origin where hindgut sites of origin have been excluded, in adult patients with unresectable locally advanced or metastatic disease.
The treatment of symptoms associated with neuroendocrine (particularly carcinoid) tumors.
Important Safety Information

The detailed recommendations for the use of Somatuline Autogel are described in the Summary of Product Characteristics (SmPC), available here.
About XERMELO3

Xermelo is a novel, orally administered, inhibitor of the enzyme tryptophan hydroxylase (TPH). Through inhibition of TPH, the rate-limiting step in the synthesis of serotonin, Xermelo was designed to reduce the production of serotonin within neuroendocrine tumors.

Xermelo (telotristat ethyl) is commercialized by Ipsen in all territories excluding the United States and Japan, where Lexicon retains the rights. Lexicon has approval for Xermelo in the U.S. as a first and only orally administered therapy for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.

Xermelo is approved in Europe for the treatment of carcinoid syndrome diarrhea in patients inadequately controlled by somatostatin analogue therapy.

Important Safety Information

The detailed recommendations for the use of Xermelo are described in the Summary of Product Characteristics (SmPC), available here.
References
1 Data on File. ENETS ‘19
2 Somatuline Autogel SmPC. November 2018
3 Xermelo SmPC. January 2019

On February 27, 2019 Celularity, Inc., a clinical-stage cell therapeutics company developing allogeneic cellular therapies harnessed from human placentas, reported it will present first-ever clinical and pre-clinical results from its comprehensive placental hematopoietic stem cell derived natural killer (PNK) cells oncology program at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held from March 29 – April 3, 2019 in Atlanta, Georgia (Press release, Celularity, FEB 27, 2019, View Source [SID1234533753]). Investigational PNK-007 is a fully allogeneic, off-the-shelf cell therapy product developed as a potential treatment option for various hematological cancers and solid tumors.

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"Combining the unique biologic properties of placental-derived cells with our proprietary IMPACT cell therapy development platform, Celularity is working to develop next-generation, off-the-shelf immunotherapies that could be safer, more accessible, and more affordable than currently available approaches," said Robert J. Hariri, M.D., Ph.D., Celularity’s Founder, Chairman and CEO. "These data are an important and validating milestone of our IMPACT platform. We believe the emergent positive profile marks the unveiling of a potential new immuno-oncology option, one capable of turning cells from this abundant, highly scalable and versatile source—the placenta leftover after a healthy birth—into meaningful therapies for patients with cancer and other serious diseases."

Data highlights at AACR (Free AACR Whitepaper) include:

Presentation (Abstract #CT108): A Phase I study of PNK‐007, allogeneic, off the shelf NK cell, post autologous transplant in multiple myeloma. Monday, April 1, 1:00pm – 5:00pm EST. Location: Georgia World Congress Center, Exhibit Hall B, Poster Board Number 7.

Presentation (Abstract #CT079): A Phase 1 Study of PNK-007, Allogeneic, Off the Shelf NK Cell in Relapsed/Refractory AML. Monday, April 1, 1:00pm – 5:00pm EST. Location: Georgia World Congress Center, Exhibit Hall B, Poster Board Number 3.

Poster Presentation (Abstract #LB-070): Immune monitoring of PNK-007, an allogeneic, off the shelf NK cell in a Phase I study of acute myeloid leukemia. W. van der Touw, Ph.D. Monday, April 1, 8:00am – 12:00pm EST. Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 41, Poster Board Number 15.

Oral Presentation (Abstract #5318): Genetic modification potentiates the anti-tumor activity of human placental CD34+ cells-derived NK cells. J. Li, Ph.D. Sunday, March 31, 3:00pm – 5:00pm EST. Location: Georgia World Congress Center, Room B405.

About PNK-007

PNK‐007 is the only allogeneic, off-the-shelf NK cell therapy being developed from placental hematopoietic stem cells as a potential treatment option for various hematological cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. When derived from the placenta, these cells offer intrinsic safety and versatility, allowing potential use across a range of organs and tissues. PNK cells are currently being investigated for patients with acute myeloid leukemia (AML) and multiple myeloma (MM).

On February 27, 2019 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported that it will present new preclinical data on SY-1365, its first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor currently in a Phase 1 clinical trial focused on ovarian and breast cancers, and on SY-5609, its selective oral CDK7 inhibitor that the company has named as its next development candidate, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place March 29-April 3 in Atlanta (Press release, Syros Pharmaceuticals, FEB 27, 2019, View Source [SID1234533752]).

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The presentation on SY-1365 will highlight data showing that alterations in the RB pathway are predictive of response to SY-1365 in patient-derived xenograft models of high-grade serous ovarian cancer, supporting exploration of RB alterations as potential biomarkers of response to SY-1365. The presentation on SY-5609 will describe in vitro and in vivo data on the selectivity, potency and anti-tumor activity of SY-5609 that supported its advancement into investigational new drug application (IND)-enabling preclinical studies.

The abstracts for these presentation are now available online on the AACR (Free AACR Whitepaper) website at View Source

Details on the presentation are as follows:

Presentation Title: Prospective identification of RB pathway alterations predict response to SY-1365, a selective CDK7 inhibitor, in a panel of high-grade serous ovarian cancer (HGSOC) patient derived xenograft (PDX) models
Date & Time: Tuesday April 2, 1:00 – 5:00 p.m. ET
Session Title: Targeting the Cell Cycle: Development of Preclinical Models and Therapeutic Targets
Session Category: Molecular and Cellular Biology/Genetics
Presenter: Nan Ke, Syros
Abstract Number: 4409
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 37

Presentation Title: SY-5609, an orally available selective CDK7 inhibitor, demonstrates broad anti-tumor activity in vivo
Date & Time: Tuesday April 2, 1:00 – 5:00 p.m. ET
Session Title: Targeting the Cell Cycle: Development of Preclinical Models and Therapeutic Targets
Session Category: Molecular and Cellular Biology/Genetics
Presenter: Shanhu Hu, Ph.D., Syros
Abstract Number: 4421
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 37