On November 8, 2018 ArQule, Inc. (Nasdaq: ARQL) reported that it will be presenting clinical and preclinical data on the company’s next generation AKT inhibitor, ARQ 751, in three poster presentations at the 30th EORTC/AACR/NCI Symposium to be held from November 13 to 16, 2018 in Dublin, Ireland (Press release, ArQule, NOV 8, 2018, View Source [SID1234530928]).

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Presentation Details

Title: A Phase 1 Dose Escalation Study of ARQ 751 in Adult Patients with Advanced Solid Tumors with AKT1, 2, 3 Genetic Alterations, Activating PI3K Mutations, PTEN-null, or Other Known Actionable PTEN Mutations
Abstract #:

395
Session:

Molecular Targeted Agents – PART II
Date:

Friday, November 16, 2018
Time:

10:00-14:00 PM CET
Location:

Exhibition Hall

Title:

Combination of the AKT inhibitor ARQ 751 with Immune Checkpoint Inhibitor and Other Therapeutic Agents
Abstract #:

371
Session:

Molecular Targeted Agents – PART II
Date:

Friday, November 16, 2018
Time:

10:00-14:00 PM CET
Location:

Exhibition Hall

Title:

Miransertib and ARQ 751 exhibit superior cell-death-inducing properties compared to other AKT inhibitors and can overcome resistance to other allosteric AKT inhibitors
Abstract #:

442
Session:

Molecular Targeted Agents – PART II
Date:

Friday, November 16, 2018
Time:

10:00-14:00 PM CET
Location:

Exhibition Hall

About ARQ 751
ARQ 751 is an orally bioavailable, selective small molecule inhibitor of the AKT serine/threonine kinase. The AKT pathway when abnormally activated is implicated in multiple oncogenic processes such as cell proliferation and apoptosis. This pathway has emerged as a target of potential therapeutic relevance for compounds that inhibit its activity, which has been linked to a variety of cancers as well as to select non-oncology indications. ARQ 751 is currently in a Phase 1 study in adult patients with refractory and/or metastatic tumors that harbor genetic alterations along the AKT pathway.

About Miransertib
Miransertib (ARQ 092) is an orally available, selective, pan-AKT (protein kinase B) inhibitor that potently inhibits AKT1, 2 and 3 isoforms. Dysregulation of AKT has been implicated in a variety of rare overgrowth diseases and cancers; however, there are currently no approved inhibitors of AKT. AKT inhibitors, either as single agent or combination therapy, show significant promise in molecularly defined patient populations. Miransertib is currently in a Phase 1/2 company-sponsored study for PIK3CA-Related Overgrowth Spectrum (PROS), a Phase 1 study for ultra-rare Proteus syndrome conducted by the National Institutes of Health (NIH/NHGRI), and a Phase 1b study in combination with the hormonal therapy, anastrozole, in patients with advanced endometrial cancer with AKT and PI3K mutations. Miransertib has been granted Rare Pediatric Disease Designation and Fast Track Designation by the U.S. Food and Drug Administration (FDA), as well as Orphan Designation by the FDA and European Medicines Agency in the rare overgrowth disease, Proteus syndrome.

On November 8, 2018 Genomic Health, Inc. (NASDAQ: GHDX) reported that it will present at the 2018 Canaccord Genuity Medical Technologies and Diagnostics Forum in New York City on Thursday, November 15, 2018 at 9:30 a.m. Eastern Time (Press release, Genomic Health, NOV 8, 2018, View Source;diagnostics-forum-300746203.html [SID1234531043]).

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To access the live and subsequently archived webcast of the presentation, go to the Investor Relations section of the company’s web site at View Source Please connect to the web site at least 15 minutes prior to the presentation to allow for any software download that may be necessary. An archived replay will be available for three months beginning 24 hours after the live presentation.

On November 8, 2018 Sesen Bio, Inc. (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of people with cancer, reported operating results for the third quarter ended September 30, 2018 and recent highlights from its development program for Vicinium for patients with high-grade non-muscle invasive bladder cancer (NMIBC) (Press release, Eleven Biotherapeutics, NOV 8, 2018, View Source [SID1234531409]).

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"2018 has been a year of focused execution for Sesen Bio, led by the advancement of the Phase 3 program for Vicinium for patients with NMIBC," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "NMIBC is a devastating disease and there remains just one recommendation for patients who do not respond or become refractory to today’s standard-of-care treatment: complete bladder removal. Our goal is to help save this essential organ and provide a meaningful treatment option for patients with BCG-unresponsive NMIBC. Our Phase 3 registration clinical trial is well-designed and preliminary data reported earlier this year suggest that Vicinium is active and has a favorable safety profile, consistent with our Phase 2 experience. We look forward to assessing six-month data from the trial next month and twelve-month data in mid-2019. If the VISTA Trial is successful, we believe Viciniumcould change the treatment outlook for patients with NMIBC, bringing us closer to achieving our mission of saving and renewing the lives of patients with cancer."

Recent Highlights

In September 2018, at the Global Congress on Bladder Cancer 2018, Sesen Bio presented a biomarker update from its Phase 3 VISTA Trial data showing that all screened patient samples expressed EpCAM, the molecular target of Vicinium.
In October 2018, the company entered into an agreement with FUJIFILM Diosynth Biotechnologies U.S.A., Inc. to provide supply services in support of the manufacturing of Vicinium for the treatment of high-grade NMIBC. The Agreement facilitates a transfer of manufacturing technology from Sesen Bio to Fujifilm.
Upcoming Events

Sesen Bio anticipates reporting six-month data from the ongoing Phase 3 VISTA Trial in December 2018. A conference call will be held to review the data, with details to follow.
Third Quarter 2018 Financial Results

Cash Position: Cash and cash equivalents were $57.9 million as of September 30, 2018, compared to $11.3 million as of September 30, 2017.
Revenue: There was no revenue for the three-month periods ended September 30, 2018 and 2017, respectively, as no revenue triggering milestones were achieved during either period under the company’s license agreement with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche).
R&D Expenses: Research and development expenses were $3.4 million for the three months ended September 30, 2018, compared to $3.6 million for the same period in 2017. The decrease was due primarily to a reduction in Vicinium-related development expenses.
G&A Expenses: General and administrative expenses were $3.8 million for the three months ended September 30, 2018, compared to $1.6 million for the same period in 2017. The increase was due primarily to an increase in professional fees as well as higher personnel-related expenses.
Net Loss: Net loss was $14.0 million, or $0.18 per share, for the three months ended September 30, 2018, compared to net loss of $9.1 million, or $0.37 per share, for the same period in 2017. The increase was due primarily to the change in the fair value of contingent consideration and increased general and administrative expenses.
Financial Guidance: Based on current operating plans, Sesen Bio believes it will have capital sufficient to fund its current operating plans into 2020.

On November 8, 2018 IntelGenx Technologies Corp. (TSX-V: IGX) (OTCQX: IGXT) (the "Company" or "IntelGenx") reported financial results for the third quarter ended September 30, 2018 (Press release, IntelGenx, NOV 8, 2018, View Source [SID1234531028]). All dollar amounts are expressed in U.S. currency and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

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2018 Third Quarter Financial Highlights:

Total revenue was $700,000, which reflected decreases in deferred revenues on monetization of $972,000, offset by an increase in R&D revenues of $418,000 vs same period last year.
Negative adjusted EBITDA was ($2.3 million), compared to negative adjusted EBITDA of ($340,000) in the same period last year.
Cash and short-term investments totalled $2.2 million as at September 30, 2018, which did not include $499,000 in proceeds from the exercise of previously issued common share purchase warrants, nor gross proceeds of $12 million raised by the Company in its October 2018 equity offering, nor gross proceeds of $633,000 from the exercise of over-allotment options.
Recent Developments:

Announced that an Abbreviated New Drug Application ("ANDA") for a generic buccal film product was submitted to the US Food and Drug Administration ("FDA") by its partner, Insud Pharma (formerly Chemo Group).
Commenced patient recruitment in Phase 2a study with Montelukast VersaFilm in patients with mild to moderate Alzheimer’s Disease ("AD").
Announced successful results from a bioequivalence study for RIZAPORT, its proprietary anti-migraine VersaFilm product, demonstrating that RIZAPORT is bioequivalent to the U.S. reference, Maxalt-MTL, as well as the European reference, Maxalt-Lingua.
Executed a definitive world-wide agreement with Tilray, a global leader in cannabis research, cultivation, production and distribution, to co-develop and commercialize oral film products infused with recreational and medical cannabis ("cannabis-infused VersaFilm").
"This was a landmark quarter, where the Company continued to push the frontiers of oral film drug development," commented Dr. Horst G. Zerbe, President and CEO of IntelGenx. "From the initiation of AD patient recruitment for the Phase 2a Montelukast VersaFilm study, to the generic buccal film product ANDA submission, to executing our definitive agreement with Tilray, many important milestones were achieved as we continue to advance toward bringing multiple exciting VersaFilm products to market."

Financial Results:

Total revenues for the three-month period ended September 30, 2018 amounted to $700,000, compared to $1.3 million for the three-month period ended September 30, 2017. The decrease for the three-month period ended September 30, 2018 compared to last year’s corresponding period is mainly attributable to a decrease in deferred revenues on monetization of $972,000 offset by an increase in R&D revenues of $418,000.

Operating costs and expenses were $3.3 million for the third quarter ended September 30, 2018, versus $1.8 million for the corresponding quarter in 2017. The increase for the three-month period ended September 30, 2018 is mainly attributable to a $874,000 increase in Research and Development expenses mainly attributable to an increase in clinical study costs and a $750,000 increase in Selling, General and Administrative expenses mainly attributable to an increase in manufacturing costs.

For the third quarter ended September 30, 2018, the Company had an operating loss of $2.6 million, compared to an operating loss of $569,000 for the comparable period of 2017.

Net comprehensive loss was $2.9 million, or $0.04 on a basic and diluted per share basis, for the three-month period ended September 30, 2018, compared to a net comprehensive loss of $586,000, or $0.01 on a basic and diluted per share basis, for the comparable period of 2017.

As at September 30, 2018, the Company’s cash and short-term investments totalled $2.2 million, which did not include $499,000 in recently reported proceeds from the exercise of previously issued common share purchase warrants, nor gross proceeds of $12 million raised by the Company in its October 2018 equity offering, nor gross proceeds of $633,000 from the exercise of over-allotment options.

Conference Call Details:

IntelGenx will host a conference call to discuss its third quarter 2018 financial results today, November 8, 2018, at 4:30 p.m. ET. The dial-in number for the conference call is (833) 231-8269 (Canada and United States) or (647) 689-4114 (International), conference ID 8659745. The call will also be webcast live and archived for twelve months at www.intelgenx.com.

On November 8, 2018 FibroGen, Inc. (NASDAQ: FGEN), a leading biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics, reported financial results for the third quarter of 2018 and provided an update on the company’s recent developments (Press release, FibroGen, NOV 8, 2018, View Source;p=irol-newsArticle&ID=2376324 [SID1234531045]).

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"With new drug applications for roxadustat in anemia associated with chronic kidney disease supported by positive Phase 3 results and under review in China and Japan, we look forward to the upcoming reporting of topline clinical results, pooled safety data and submitting our U.S. NDA," said Thomas B. Neff, FibroGen’s Chief Executive Officer. "For pamrevlumab, our proprietary anti-fibrotic and anti-fibroproliferative therapeutic candidate, we are initiating Phase 3 studies in idiopathic pulmonary fibrosis, and in unresectable locally advanced pancreatic cancer, in the first quarter of 2019."

Recent Developments and Highlights
Roxadustat for Anemia in Chronic Kidney Disease (CKD) in the U.S./EU

Topline Phase 3 clinical results anticipated for the fourth quarter of this year
Pooled MACE analysis results and submission of New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) anticipated in the first half of 2019
Astellas reported positive topline efficacy and safety results from the first global trial, ALPS, a Phase 3 placebo-controlled study evaluating roxadustat in non-dialysis-dependent CKD anemia patients in September 2018
Astellas also completed its global trial, PYRENEES, a Phase 3 study in dialysis patients
Roxadustat for Anemia in CKD in China

Roxadustat NDA approval for the treatment of dialysis-dependent CKD is anticipated by year-end 2018, followed by approval in CKD non dialysis
Clinical results from two Phase 3 studies conducted in China were presented at the American Society of Nephrology (ASN) Kidney Week 2018 annual meeting in October
Roxadustat for Anemia in CKD in Japan

Astellas NDA for roxadustat was filed with the Pharmaceuticals and Medical Devices Agency (PMDA) for anemia associated with dialysis-dependent CKD, triggering a $15 million milestone payment to FibroGen
Astellas announced positive topline results from the four Phase 3 dialysis-dependent studies that support the Japan NDA
Clinical results from two of the four Japan Phase 3 trials in dialysis-dependent patients were presented at the ASN Kidney Week 2018:
A Phase 3 trial in peritoneal dialysis patients was presented in an oral session
A Phase 3 darbepoetin alfa controlled study in stable hemodialysis patients previously treated with ESA was presented in a clinical late-breaking poster session
One of two non-dialysis-dependent Phase 3 studies supporting approval for non-dialysis is now completed
Pamrevlumab for Idiopathic Pulmonary Fibrosis (IPF)

Clinical and preclinical data presented at the European Respiratory Society International Congress (ERS) 2018 and 20th International Colloquium on Lung and Airway Fibrosis (ICLAF) 2018
Fast Track designation received from the FDA
Plan to start a randomized, double-blind, placebo-controlled Phase 3 clinical trial with a primary endpoint of change in forced vital capacity (FVC) from baseline in approximately 500 patients, in the first quarter of 2019
Pamrevlumab for Pancreatic Cancer

On track to start a randomized, double-blind, placebo-controlled Phase 3 study evaluating pamrevlumab in combination with gemcitabine and nab-paclitaxel as a neoadjuvant therapy for unresectable locally advanced pancreatic cancer (LAPC) in approximately 260 patients in the first quarter of 2019
Corporate and Financial

Net loss for the third quarter was $42.6 million, or ($0.50) per share, compared to $24.5 million, or ($0.32) per share, for the same period in 2017
At September 30, 2018, FibroGen had $722.6 million of cash, cash equivalents, investments, restricted time deposits, and receivables
The weighted average number of common shares used to calculate net loss per share was 84.5 million shares and 75.9 million shares for the third quarters of 2018 and 2017, respectively.
Total shares outstanding as of September 30, 2018 were 84.8 million shares
Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Thursday, November, 8, 2018, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (888) 771-4371 (U.S. and Canada) or 1 (847) 585-4405 (international), reference the FibroGen third quarter 2018 financial results conference call, and use passcode 47780296. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial 1 (888) 843-7419 (domestic) or 1 (630) 652-3042 (international), and use passcode 4778 0296#.

About Roxadustat
Roxadustat (FG-4592) is a first-in-class, orally administered small molecule currently in global Phase 3 clinical development as a potential therapy for anemia associated with chronic kidney disease (CKD). Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) that promotes erythropoiesis through increasing endogenous erythropoietin, improving iron regulation, and reducing hepcidin. Administration of roxadustat has been shown to induce coordinated erythropoiesis – increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range in multiple subpopulations of CKD patients, including in the presence of inflammation and without a need for supplemental intravenous iron.

FibroGen and collaboration partners are pursuing four approval pathways in major jurisdictions to prepare for commercialization worldwide:

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa.
AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in the U.S., China, and other markets in the Americas and in Australia/New Zealand as well as Southeast Asia.
FibroGen and its partners have completed 35 Phase 1 and Phase 2 studies. The Phase 2 clinical studies have consistently demonstrated anemia correction and maintenance of hemoglobin levels in multiple subpopulations across a wide spectrum of CKD patients.

Globally, the Phase 3 program encompasses a total of 15 Phase 3 studies of roxadustat in both non-dialysis-dependent and dialysis-dependent CKD patients to support independent regulatory approvals in the U.S., Europe, Japan, and China. To date, positive topline results have been announced for seven of the Phase 3 studies, with two supporting the China NDA for treatment of anemia in CKD patients on dialysis and not on dialysis, four supporting the Japan NDA for treatment of anemia in CKD patients on dialysis, and one supporting the U.S./EU submissions. The China and Japan NDAs are both under review by the respective regulatory agencies.

Roxadustat is currently in Phase 3 clinical development for the treatment of anemia associated with myelodysplastic syndromes (MDS) in the U.S. and in Phase 2/3 development for MDS in China.

About Pamrevlumab
Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Pamrevlumab is advancing towards Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer, has been granted Orphan Drug Designation (ODD) in each of these indications, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). Pamrevlumab has received Fast Track designation from the U.S. Food and Drug Administration for the treatment of patients with locally advanced unresectable pancreatic cancer. Across all trials, pamrevlumab has consistently demonstrated a good safety and tolerability profile to date. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.