On November 14, 2018 RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on proprietary drugs for gastrointestinal diseases and cancer, reported a poster presentation on YELIVA (opaganib, ABC294640)1 for multiple myeloma at the upcoming EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium2 on Molecular Targets and Cancer Therapeutics, on Friday, November 16th in Dublin (Press release, RedHill Biopharma, NOV 14, 2018, View Source [SID1234531300]).

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The abstract3 (poster board number PB-045), which will be presented by Yubin Kang, MD, of Duke Health, is entitled "Sphingosine kinase 2 (SK2) targeting in the treatment of multiple myeloma: preclinical and phase I studies of opaganib, an SK 2 inhibitor, in multiple myeloma". The abstract describes data from preclinical studies and a Phase Ib/II study conducted by Dr. Kang with YELIVA for the treatment of multiple myeloma.

The open-label, dose escalation Phase Ib/II study evaluating YELIVA in patients with refractory or relapsed multiple myeloma that were previously treated with proteasome inhibitors and immunomodulatory drugs is ongoing at Duke University Medical Center. Enrollment for the Phase Ib portion of the study has been completed with a total of 11 patients enrolled and treated in three dose cohorts. Results from the Phase Ib portion of the study did not show any dose-limiting toxicities. Additionally, while efficacy was not the primary endpoint of the Phase I study, it was observed that out of 10 evaluable subjects, two subjects had stable disease for over four months and one patient achieved a very good partial response (VGPR).
In addition, results from preclinical studies demonstrated that SK2 is overexpressed in multiple myeloma cell lines and in human multiple myeloma specimens and plays a critical role in myeloma cell growth, proliferation and survival. Additional preclinical studies described in the abstract demonstrated that treatment with YELIVA effectively inhibited myeloma tumor growth in vitro and in vivo in mouse xenograft models. The authors conclude that YELIVA as a single agent or in combination with a B-cell lymphoma 2 (Bcl-2) inhibitor has the potential for treatment of relapsed/refractory multiple myeloma patients that were previously treated with proteosome inhibitors and immunomodulatory agents.

The Phase Ib/II study with YELIVA for multiple myeloma is supported by a $2 million grant from the National Cancer Institute (NCI) Small Business Innovation Research Program (SBIR) awarded to Apogee Biotechnology Corp., in conjunction with Duke University, with additional support provided by RedHill.

Dr. Yubin Kang, MD, associate professor in the division of hematologic malignancies and cellular therapy in the department of medicine at Duke University School of Medicine, is the lead investigator for the Phase Ib/II study with YELIVA for multiple myeloma, as well as the head of the laboratory performing the preclinical studies.

YELIVA is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor being developed by RedHill and targeting multiple oncology, inflammatory and gastrointestinal indications. A single-arm Phase IIa study evaluating the activity of YELIVA as a single agent in patients suffering from advanced, unresectable intrahepatic, perihilar and extrahepatic cholangiocarcinoma is being conducted at renowned clinical institutions in the U.S.

About YELIVA (opaganib, ABC294640):
YELIVA (opaganib, ABC294640), a new chemical entity, is a Phase II-stage, proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with anticancer and anti-inflammatory activities, targeting multiple oncology, inflammatory and gastrointestinal indications. By inhibiting SK2, YELIVA blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid-signaling molecule that promotes cancer growth and pathological inflammation. SK2 is an innovative molecular target for anticancer therapy because of its critical role in catalyzing the formation of S1P, which is known to regulate cell proliferation and activation of inflammatory pathways. YELIVA was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful preclinical studies in oncology, inflammation, GI and radioprotection models, as well as a Phase I clinical study in cancer patients with advanced solid tumors. YELIVA received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma. The development of YELIVA was funded to date primarily by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including the U.S. National Cancer Institute.

The ongoing studies with YELIVA (opaganib, ABC294640) for cholangiocarcinoma, multiple myeloma and advanced hepatocellular carcinoma (HCC) are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.

On November 14, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the submission of two Type II variation applications to the European Medicines Agency (EMA) seeking approval for the expanded use of IMBRUVICA (ibrutinib) (Press release, Johnson & Johnson, NOV 14, 2018, View Source [SID1234531316]). One application seeks to include use of ibrutinib in combination with obinutuzumab in previously untreated adults with chronic lymphocytic leukaemia (CLL) and to add long-term follow-up data from the existing label studies RESONATETM (PCYC-1112) and RESONATETM-2 (PCYC-1115). The second is for use of ibrutinib plus rituximab for the treatment of previously untreated and relapsed/refractory adults with Waldenström’s macroglobulinemia (WM).

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"Today’s news brings us one step closer to potentially offering ibrutinib in new combinations for patients where unmet needs still persist," said Dr. Catherine Taylor, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag Limited. "Ibrutinib continues to demonstrate clinical benefit over the long term for a broad group of patients living with blood cancer, and we look forward to working with relevant authorities to secure approval of these new combinations."

Ibrutinib, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, is jointly developed and commercialised by Janssen Biotech, Inc., and Pharmacyclics LLC, an AbbVie company.

The CLL submission is supported by positive results from the Phase 3 iLLUMINATE (PCYC-1130) study which investigated ibrutinib in combination with obinutuzumab versus chlorambucil plus obinutuzumab in patients with newly diagnosed CLL.1 Study findings from iLLUMINATE will also be featured as an oral presentation (abstract #691), whilst further analysis of RESONATETM and RESONATETM-2 results in comparison with real-world evidence databases (abstract #4427) will be included at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place in San Diego next month.1,2 A supplemental New Drug Application (sNDA) which was also recently submitted to the U.S. Food and Drug Administration (FDA) received Priority Review.

In WM, the submission is supported by data from the Phase 3 iNNOVATE (PCYC-1127) study evaluating ibrutinib in combination with rituximab, versus rituximab with placebo, in patients with previously untreated and relapsed/refractory WM.3 Follow-up efficacy and safety findings from the iNNOVATE study will also be presented at ASH (Free ASH Whitepaper) 2018 (abstract #149).4 In August 2018, the FDA approved ibrutinib in combination with rituximab for the treatment of WM based on the data from iNNOVATE.5

Additional information about both studies can be found at www.ClinicalTrials.gov (NCT02264574 and NCT02165397).6,7

#ENDS#

About ibrutinib

Ibrutinib is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, which works by forming a strong covalent bond with BTK to block the transmission of cell survival signals within the malignant B-cells.8 By blocking this BTK protein, ibrutinib helps kill and reduce the number of cancer cells, thereby delaying progression of the cancer.9

Ibrutinib is currently approved in Europe for the following uses:10

Chronic lymphocytic leukaemia (CLL): As a single agent for the treatment of adult patients with previously untreated CLL, and as a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy.
Mantle cell lymphoma (MCL): Adult patients with relapsed or refractory mantle cell MCL.
Waldenström’s macroglobulinemia (WM): Adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemo-immunotherapy.
The most common adverse reactions seen with ibrutinib include diarrhoea, neutropenia, haemorrhage (e.g., bruising), musculoskeletal pain, nausea, rash, and pyrexia.10

For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.

About CLL

CLL is typically a slow-growing blood cancer of the white blood cells.11 The overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year with rates amongst men and women approximately 5.87 and 4.01 cases per 100,000 persons per year, respectively.12 CLL is predominantly a disease of the elderly, with a median age of 72 years at diagnosis.13

CLL is a chronic disease; median overall survival ranges between 18 months and more than 10 years, according to the stage of disease.14 The disease eventually progresses in the majority of patients, and patients are faced with fewer treatment options with each relapse. Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.

About Waldenström’s macroglobulinemia

Waldenström’s macroglobulinemia (WM) is a rare form of non-Hodgkin’s lymphoma (NHL).15 It causes overproduction of a protein called monoclonal immunoglobulin M (IgM) antibody, which causes a thickening of the blood.16 Incidence rates among men and women in Europe are approximately 7.3 and 4.2 per million persons, respectively.17 The causes of WM are unknown, with it typically affecting older adults and being slightly more common in men than women.15,17

On November 13, 2018 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported financial results and provided a corporate update for the third quarter ended September 30, 2018 (Press release, Jounce Therapeutics, NOV 13, 2018, View Source [SID1234531231]).

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"We are pleased to announce continued advancement across our development programs including JTX-2011, JTX-4014 and JTX-8064. While we complete our biomarker and clinical data analysis on JTX-2011, safety dose escalation cohorts are proceeding as planned to enable us to pursue new combination trials. Additionally, we filed an IND for our internal PD-1 program, JTX-4014, and recently received clearance from the FDA to proceed with a Phase 1 dose escalation trial. Our lead tumor-associated macrophage program, JTX-8064, targeting LILRB2, is on track to be our third IND," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "We are committed to our vision and firmly believe there is strong promise for our translational science approach to transform the treatment of cancer. Based on this progress, we are well-positioned to advance both our clinical and discovery program efforts in 2019."

Corporate and Development Highlights:
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JTX-2011 Dose Escalation Cohorts Progressing: As previously announced, in June 2018, Jounce began the enrollment of dose escalation cohorts evaluating the safety of JTX-2011 in combination with ipilimumab and in combination with pembrolizumab, and these studies are progressing as planned.
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Newly Reported Data Confirms Mechanism of Action of JTX-2011: At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd annual meeting in November, Jounce presented new data from ICONIC patients demonstrating the agonistic properties of JTX-2011. These data are in addition to the subset analysis data presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in June demonstrating the emergence of ICOS hi CD4 T cells in the blood of all patients with ≥30% target lesion tumor reductions, both in patients treated with JTX-2011 monotherapy and in combination with nivolumab. The ICOS hi CD4 T cells were not observed in patients with primary progressive disease.
Through additional reverse translational studies, presented at SITC (Free SITC Whitepaper), Jounce established two key insights that provide the scientific foundation for the next stage of development of JTX-2011.

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First, the emergence of these ICOS hi CD4 T cells was related to JTX-2011, as it has not been detected in a separate study Jounce conducted of responding and non-responding patients that received PD-1/L1 inhibitor monotherapy treatment; and
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Second, in vitro experimental data showed that JTX-2011 only activates CD4 T cells if they already express high levels of ICOS.
Additionally, new preclinical tumor model data presented in a separate poster at SITC (Free SITC Whitepaper), strengthens Jounce’s belief that agents that induce ICOS hi CD4 T cells detectable in the bloodstream, such as anti-CTLA-4, may be attractive combination partners for JTX-2011.
•
JTX-4014 IND Filed and Cleared: Jounce filed an Investigational New Drug (IND) application for JTX-4014, its PD-1 inhibitor, in September 2018. In October 2018, the U.S. Food and Drug Administration (FDA) concluded that Jounce may proceed with a Phase 1 dose escalation trial. Jounce will initiate this trial as the next key step for this program.
•
JTX-8064 IND Filing on Track: Jounce continues to advance its first tumor-associated macrophage candidate targeting Leukocyte Immunoglobulin Like Receptor B2 (LILRB2) from its Translational Science Platform through IND-enabling studies. JTX-8064 is a selective antagonist antibody that demonstrates preclinical characteristics of reprogramming immune suppressive macrophages in the tumor microenvironment.
•
Jounce Founders Awarded 2018 Nobel Prize and Coley Award: In October 2018, Jounce founder Dr. James P. Allison was jointly awarded the 2018 Nobel Prize in Physiology or Medicine for the discovery of cancer therapy by inhibition of negative immune regulation. Also in October 2018, Jounce founder Dr. Padmanee Sharma was awarded the William B. Coley Award for Distinguished Research in Tumor Immunology for her innovative work understanding factors that enhance and hinder cancer immunotherapy.

Third Quarter 2018 Financial Results:
•
Cash Position: As of September 30, 2018, cash, cash equivalents and investments were $214.7 million, compared to $257.9 million as of December 31, 2017. Cash was utilized for operating costs incurred during the period, offset by the receipt of state and federal income tax refunds.
•
Collaboration Revenue: Collaboration revenue was $14.5 million for the third quarter of 2018, compared to $18.1 million for the same period in 2017. Collaboration revenue represents revenue recognition relating to the $225.0 million upfront payment received in July 2016 upon the execution of Jounce’s global strategic collaboration with Celgene.
•
Research and Development (R&D) Expenses: R&D expenses were $16.8 million for the third quarter of 2018, compared to $17.1 million for the same period in 2017. The decrease in R&D expenses was due to $1.5 million of decreased lab consumables offset primarily by $0.5 million of increased stock-based compensation expense, $0.3 million of increased external clinical and regulatory expenses related to the Phase 1/2 ICONIC trial and $0.4 million of increased other research expenses primarily due to license and milestone payments associated with preclinical programs.
•
General and Administrative (G&A) Expenses: G&A expenses were $6.5 million for the third quarter of 2018, compared to $5.4 million for the same period in 2017. The increase in G&A expenses was primarily due to $1.2 million of increased employee compensation costs, including $0.8 million of increased stock-based compensation expense.

jouncelogosmaller.jpg

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Net Loss: Net loss was $7.6 million for the third quarter of 2018, or a basic and diluted net loss per share attributable to common stockholders of $0.23. Net loss was $4.1 million for the same period in 2017, or a basic and diluted net loss per share attributable to common stockholders of $0.13. The increase in net loss and net loss per share attributable to common stockholders is primarily attributable to the decrease in non-cash collaboration revenue and the increase in operating expenses from the third quarter of 2017 to the third quarter of 2018.

Financial Guidance:
Jounce continues to expect to end the year with approximately $185.0 to $195.0 million in cash, cash equivalents and investments. Jounce expects its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements for at least the next 24 months.

Jounce is reiterating its 2018 collaboration revenue guidance of approximately $50.0 to $60.0 million.

Conference Call and Webcast Information:
Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 4689666. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days.

On November 13, 2018 OncoSec Medical Inc., (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported that TAVO will be featured in two poster sessions during the 2018 San Antonio Breast Cancer Symposium (SABCS) taking place December 4-8 in San Antonio, Texas (Press release, OncoSec Medical, NOV 13, 2018, View Source [SID1234531248]). Posters include data on TAVO as a monotherapy and an initial project overview for KEYNOTE-890, a Phase 2 clinical trial in combination with Merck’s KEYTRUDA (pembrolizumab) for the treatment of late stage triple negative breast cancer (TNBC).

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"We are encouraged with the preliminary clinical observations we are seeing thus far, both in a monotherapy setting and in combination with checkpoint inhibitors," said Daniel J. O’Connor, President and Chief Executive Officer of OncoSec. "Based on this, we are excited to continue on the path toward developing novel treatment options for this large unmet medical need,"

Details on the poster presentations are as follows:

Presentation Title: Intratumoral tavokinogene telseplasmid and electroporation in pre-treated inoperable locally advanced or recurrent triple-negative breast cancer
Session Date & Time: Thursday, December 6, 7:00 – 9:00 a.m. CT (8:00 – 10:00 a.m. ET)
Session Title: Poster Session 2: Treatment: Immunotherapy (clinical)
Location: Hall 1, Henry B. Gonzalez Convention Center

Presentation Title: A phase 2 study of intratumoral tavokinogene telseplasmid (tavo) plus electroporation with pembrolizumab in patients with inoperable locally advanced or metastatic triple negative breast cancer
Session Date & Time: Thursday, December 6, 5:00 – 7:00 p.m. CT (6:00 – 8:00 p.m. ET)
Session Title: Ongoing Clinical Trials: Immunotherapy
Location: Hall 1, Henry B. Gonzalez Convention Center

The abstracts for these presentations are now available online on the SABCS website at View Source

On November 13, 2018 Forty Seven Inc. (NASDAQ:FTSV), a clinical-stage, immuno-oncology company focused on developing therapies to activate macrophages in the fight against cancer, reported financial results for the third quarter ended September 30, 2018 and provided a business update (Press release, Forty Seven, NOV 13, 2018, View Source [SID1234531273]).

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"Our recent accomplishments reflect our commitment to establishing Forty Seven as a pioneer in the development of a new class of checkpoint therapies, which harness the innate immune system to help patients more effectively defeat their disease," said Mark McCamish, M.D., Ph.D., President and Chief Executive Officer of Forty Seven, Inc.
"We were pleased to have the New England Journal of Medicine publish our Phase 1b NHL data for 5F9 in combination with rituximab earlier this month, which speaks to the potential of macrophage activation for the treatment of cancer.

"In addition to progressing our ongoing clinical trials of 5F9 toward data readouts in 2019, we advanced our pipeline in the third quarter with additional efforts on FSI-189 as our next development candidate," continued Dr. McCamish. "FSI-189 is an anti-SIRPα antibody, designed to interfere with CD47 activity through a distinct modality, which enables us to more fully exploit the potential of the CD47/SIRPα pathway as a novel oncology target. We look forward to building on this momentum in the coming months, as we work together with our newly appointed SAB to advance our pipeline and maximize our impact."

Upcoming Milestones:

Forty Seven plans to present preclinical data providing new insights into the mechanism of action of its priming and maintenance dose strategy for 5F9 in a poster session at the 60th ASH (Free ASH Whitepaper) Annual Meeting, which will be held December 1-4, 2018 in San Diego, California. Also at ASH (Free ASH Whitepaper), Forty Seven will present a poster detailing new preclinical data that supports the combination of 5F9 and azacitidine for the treatment of acute myeloid leukemia (AML). Patients with AML have already been dosed with this combination based on these promising preclinical results.

Third Quarter and Recent Business Highlights:

In October 2018, Forty Seven advanced FSI-189, an anti-SIRPα antibody, as its second product candidate for the treatment of cancer. SIRPα is the cognate receptor of CD47 and, in preclinical models, FSI-189 blocked SIRPα binding to CD47 and enhanced macrophage phagocytosis of cancer cells. SIRPα is only expressed on certain cells types, including macrophages. As a result, Forty Seven believes that FSI-189 may be effective at low doses. FSI-189 is currently in preclinical development, and Forty Seven plans to initiate IND-enabling studies in 2019.

O: 650-352-4150 F: 650-618-2308 W: fortyseveninc.com A: 1490 O’Brien Drive, Suite A, Menlo Park, CA 94025, United States

In October 2018, Forty Seven announced that proof-of-concept data from the Phase 1b portion of its Phase 1b/2 clinical trial evaluating 5F9 in combination with rituximab in patients with relapsed/refractory NHL were published in the New England Journal of Medicine. In the Phase 1b portion of the study, 5F9 demonstrated signs of clinical efficacy, and was safe and well-tolerated in the patients treated.

Corporate:

In October 2018, Forty Seven announced the formation of its SAB, including the appointment of four leading scientists in the fields of immunotherapy and oncology: 2018 Nobel Laureate for Medicine, James Allison, Ph.D.; Ronald Levy, M.D.; Padmanee Sharma, M.D., Ph.D.; and Louis Weiner, M.D.

In August 2018, the European Patent Office Opposition Division ruled in favor of Forty Seven, rejecting challenges to the company’s licensed European patent, EP ‘512, which covers the use of CD47 antibodies designed to treat cancer through phagocytosis. This decision strengthens Forty Seven’s patent protection for 5F9 in Europe.

Third Quarter 2018 Financial Results:

Cash Position: As of September 30, 2018, cash, cash equivalents and short-term investments were $154.0 million, as compared to $88.1 million as of December 31, 2017. This increase reflects net proceeds of $116.3 million from Forty Seven’s initial public offering of common stock, which closed in July 2018. The company expects that its cash, cash equivalents and short-term investments will fund operating expenses and capital expenditure requirements into 2020.

R&D Expenses: R&D expenses were $18.0 million for the third quarter ended September 30, 2018, as compared to $8.8 million for the same period in 2017. This increase was primarily due to non-recurring upfront payments on two licensing deals of $6.3 million, as well as the continued advancement of the company’s clinical development efforts and preclinical and discovery programs. This increase was partially offset by $1.7 million in grant and cost-share funding recognized under the company’s grants from the California Institute of Regenerative Medicine, the Leukemia and Lymphoma Society and Merck KGaA.

G&A Expenses: G&A expenses were $4.4 million for the third quarter ended September 30, 2018, as compared to $2.1 million for the same period in 2017. This increase was primarily due to increased personnel costs and expenses incurred in connection with operating as a public company.

Net Loss: Net loss was $21.7 million for the third quarter ended September 30, 2018, or $0.71 per basic and diluted share, as compared to a net loss of $10.8 million, or $1.67 per basic and diluted share, for the same period in 2017.