Helix BioPharma Corp. to initiate new L-DOS47 clinical program in pancreatic cancer

On November 1, 2018 Helix BioPharma Corp. (TSX: HBP), (FSE: HBP) ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported that it will initiate a new clinical program in pancreatic cancer which will be led by Dr. Daniel D. Von Hoff. Dr. Von Hoff is Physician-in-Chief at the Translational Genomics Research Institute ("TGen") and Professor of Medicine at both the Mayo Clinic and the University of Arizona College of Medicine (Press release, Helix BioPharma, NOV 1, 2018, View Source [SID1234531237]).

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Pancreatic cancer is the third leading cause of cancer death in the United States and is very difficult to treat. Treatment options for advanced pancreatic cancer patients are mostly limited to chemotherapy and in certain cases, radiotherapy and surgery. Immunotherapy such as check-point inhibitors, are not widely available as most drug candidates are still in clinical development. It has been speculated that since pancreatic tumours can have a very acidic profile, the application of immunotherapy may be limited.

Based on preliminary but very encouraging internal and collaborative research work with Dr. Robert Gillies of the Moffitt Cancer Center, on animal pancreatic cancer, the Company believes L-DOS47 with its purported action of combating tumour acidity, may contribute significantly to the treatment of pancreatic cancer.

The Company is very excited to work with Dr. Von Hoff on this new clinical program. Dr. Von Hoff is a pioneer in developing new cancer drugs and a prominent opinion leader in the treatment of pancreatic cancer. Dr. Von Hoff’s clinical trial work has led to the approval of three pancreatic cancer drugs by the U.S. Food and Drug Administration ("FDA") for the treatment of patients with advanced pancreatic cancer.

The first clinical study being planned by the Company is a U.S. Phase I/II study of L-DOS47 in combination with Doxorubicin for the treatment of metastatic pancreatic cancer. The Company is currently completing the study protocol and will be looking to submit to the FDA, in the coming months, an investigational new drug ("IND") application.

Given Dr. Von Hoff’s new role in leading this new clinical program, he will be stepping down as a member of the Company’s Advisory Board, effective November 1, 2018. The Company thanks Dr. Von Hoff for his contribution on the Advisory Board and is very much looking forward to Dr. Von Hoff’s valuable ontributions in the Companies pancreatic cancer clinical program.

"We are privileged to work with Dr. Von Hoff and his team on this new clinical program" said Heman Chao,
Helix’s Chief Executive Officer. "Once approved by the FDA, L-DOS47 would be tested in two different
indications, lung and pancreatic cancer. I look forward to starting this new study and am very excited about
expanding the indications of L-DOS47."

Syros to Present Initial Clinical Data from Combination Cohorts in Its Ongoing Phase 2 Trial of SY-1425 at ASH Annual Meeting

On November 1, 2018 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported that the Company will present initial clinical data from both combination cohorts in its ongoing Phase 2 trial of SY-1425, its first-in-class selective retinoic acid receptor alpha (RARα) agonist, in genomically defined subsets of patients with acute myeloid leukemia (AML) and higher-risk myelodysplastic syndrome (MDS) at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place December 1-4 in San Diego (Press release, Syros Pharmaceuticals, NOV 1, 2018, View Source [SID1234530479]).

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The data will include initial assessments of safety and efficacy of SY-1425 in combination with azacitidine in RARA and IRF8 biomarker-positive patients with newly diagnosed AML who are not suitable candidates for standard chemotherapy, and in combination with daratumumab in biomarker-positive patients with relapsed or refractory AML and higher-risk MDS. Additionally, for the daratumumab cohort, the presentation will include data on the level of CD38 induction observed in patients.

The abstract for the presentation is now available online on the ASH (Free ASH Whitepaper) conference website at View Source

Details on the presentation are as follows:

Presentation Title: Early Results from a Biomarker-Directed Phase 2 Trial of SY-1425 in Combination with Azacitidine or Daratumumab in Non-APL Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
Date & Time: Sunday, December 2, 6:00-8:00 p.m. PT (9:00-11:00 p.m. ET)
Session Title: Poster Session II
Session Category: 616. Acute Myeloid Leukemia: Novel Therapy Excluding Transplantation
Presenter: Rachel J. Cook, M.D., Oregon Health Science University
Abstract Number: 2735
Location: Hall GH, San Diego Convention Center

IntelGenx to Report Third Quarter 2018 Financial Results on November 8, 2018 – Conference Call to Follow

On November 1, 2018 IntelGenx Technologies Corp. (TSX VENTURE:IGX) (OTCQX:IGXT) reported that it will release its third quarter 2018 financial results after market close on November 8, 2018 (Press release, IntelGenx, NOV 1, 2018, View Source;Conference-Call-to-Follow/default.aspx [SID1234530515]).

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An accompanying conference call will be hosted by Dr. Horst G. Zerbe, President and Chief Executive Officer, and Mr. Andre Godin, Executive Vice-President and Chief Financial Officer, to discuss the results and provide a business update. Details of the conference call and webcast are below:

Date: Thursday, Nov 8, 2018

Time: 4:30 p.m. ET

Conference dial-in: (833) 231-8269

International dial-in: (647) 689-4114

Conference ID: 8659745

Webcast Registration: Click here

Following the live call, a replay will be available on the Company’s website, www.intelgenx.com, under "Investor Relations".

Syndax Pharmaceuticals Announces Presentations at the 60th American Society of Hematology Annual Meeting

On November 1, 2018 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that the Company’s Menin-MLLr program will be featured during two presentations at the 60thAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held December 1-4, 2018 in San Diego, California (Press release, Syndax, NOV 1, 2018, View Source [SID1234530531]).

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Oral Presentation Details:

Title: MLL-Menin Inhibition Reverses Pre-Leukemic Progenitor Self-Renewal Induced By NPM1 Mutations and Prevents AML Development
Presenter: Hannah Uckelmann, Ph.D., Dana-Farber Cancer Institute
Session Name: 602. Disordered Gene Expression in Hematologic Malignancy, including Disordered Epigenetic Regulation: Single Cell Profiling/Actionable Leukemia Targets
Session Date: Monday, December 3, 2018
Session Time: 7:00 a.m. – 8:30 a.m. PT
Presentation Time: 8:15 a.m. PT
Publication Number: 546
Location:San Diego Convention Center, Room 9

Scientific Spotlight Session Details:

Title: Targeting Chromatin Complexes in MLL Rearranged Leukemia
Presenter: Scott Armstrong, M.D., Ph.D., Dana-Farber Cancer Institute
Session Name: Biochemical and Genetic Insights Into MLL/11q23 Translocation Leukemia
Session Date: Sunday, December 2, 2018
Session Time: 4:30 p.m. – 6:00 p.m. PT
Location: San Diego Convention Center, Room 9

About MLL Rearranged Leukemias

Rearrangements of the MLL gene give rise to an acute leukemia, MLL-r. MLL-r occurs in ~80% of infant acute leukemias and up to 10% of adult acute leukemias. It is associated with a poor prognosis, with less than 40% of infants with MLL-r surviving past 5 years. MLL rearrangements produce fusion proteins that require interaction with a protein called Menin in order to drive leukemic cancer growth. Disruption of the Menin-MLL-r interaction has been shown to halt the growth of MLL-r leukemic cells. MLL-r leukemias are routinely diagnosed through currently available cytogenetic screening techniques in leukemic cells, but there are currently no approved therapies indicated for MLL-r leukemias.

About NPM1c Acute Myeloid Leukemia

NPM1c represents another discrete form of acute myeloid leukemia (AML) distinguished by point mutations in the NPM1 gene that drives the leukemic phenotype. NPM1c is the most common type of cytogenetically normal AML and represents ~30% of all diagnosed AML. This subtype of AML has a poor prognosis, with a 5-year overall survival rate of ~50%. Similar to MLL-r leukemias, NPM1c AML is highly dependent on the expression of specific developmental genes, shown to be negatively impacted by inhibitors of the menin-MLL1 interaction. NPM1c AML is routinely diagnosed through currently available screening techniques in leukemic cells, but there are currently no approved therapies indicated for NPM1c AML.

Intrexon to Announce Third Quarter 2018 Financial Results on November 8th

On November 1, 2018 Intrexon Corporation (NASDAQ: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, reported it will release third quarter 2018 financial results after the market closes on Thursday, November 8th, 2018 (Press release, Intrexon, NOV 1, 2018, View Source [SID1234530547]). The Company will host a conference call that day at 5:30 PM ET to discuss the results and provide a general business update.

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The conference call may be accessed by dialing 1-888-317-6003 (Domestic US), 1-866-284-3684 (Canada), and 1-412-317-6061 (International) and providing the number 8225818 to join the Intrexon Corporation Call. Participants may also access the live webcast through Intrexon’s website in the Investors section at View Source