On June 9, 2016 Aptose Biosciences reported it will co-develop CrystalGenomics’ preclinical cancer drug candidate CG026806, the companies said, under an exclusive global option and license agreement that could generate up to $303 million-plus for CrystalGenomics (Press release, CrystalGenomics, JUN 9, 2016, View Source;id=1465&page=4&num=94&nowpos=510&type=&sermun=&qu=&tb_name=eng_news&rt_page=/en/news/news.php [SID1234539167]).

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Aptose said it expects to undertake IND-enabling studies immediately, and, if it exercises an option under the agreement, to launch a Phase I clinical trial by mid-2017. Upon exercise of that option, Aptose will own global rights to develop and commercialize CG026806 outside of South Korea and China.

"We are impressed by the ability of once-daily oral dosing of CG026806 to demonstrate tumor eradication in the absence of toxicity in murine xenograft models of human hematologic malignancies," William G. Rice, Ph.D., Aptose’s Chairman, President and CEO, said in a statement.

The companies said their deal was valued at $303 million, with Aptose agreeing to pay CrystalGenomics payments tied to achieving development, regulatory, and commercial-based milestones. CrystalGenomics is also eligible to receive a single-digit royalty on sales worldwide except China and South Korea.

CG026806 is a first-in-class, noncovalent, small molecule inhibitor of Bruton’s tyrosine kinase (BTK), FMS-like tyrosine kinase 3 (FLT3), and Aurora kinases (AURK). The candidate is CrystalGenomics’ lead compound among BTK/FLT3/AURK inhibitors.

Oncology is one of CrystalGenomics’ therapeutic areas, along with infectious disease and inflammation. The company won approval in February from the Korean Ministry of Food and Drug Safety (MFDS) for its osteoarthritis drug Acelex (polmacoxib). Aptose specializes in cancer drugs and diagnostics.

The companies envision CG026806 fighting multiple forms of cancer, particularly those resistant to current BTK inhibitors or those that possess the FLT3-internal tandem duplication (ITD) alteration.

BTK plays a key role in B-cell hematologic malignancies, such as chronic lymphocytic leukemia and mantle cell lymphoma, as well as some autoimmune diseases. FLT3, including the ITD, a mutation of the FLT3 gene, occurs in approximately 30–35% of patients with acute myeloid leukemia. AURK participate in the epigenetic phosphorylation of histones and are key drivers in a series of hematologic malignancies and solid tumors.

On June 9, 2016 argenx (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, reported the presentation of efficacy and safety data from its Phase 1 expansion study of ARGX-110 in patients with T-cell lymphoma (TCL) during an e-poster session at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress (Copenhagen, Denmark) (Press release, arGEN-X, JUN 9, 2016, View Source [SID:1234513200]).

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The data from the Phase 1 expansion study show evidence of clinical and/or biological anti-tumor activity with ARGX-110 in highly refractory cutaneous TCL & peripheral TCL patients with confirmed overexpression of CD70. The abstract can be accessed here.

"The data presented today during EHA (Free EHA Whitepaper) 2016 are very encouraging and further support the important role of CD70 in the TCL patient population. We are seeing signs of biological activity in both CTCL and PTCL patients that have failed standard therapy, as well as favourable safety profiles, so we are eager to present the full data set later this year in this critical indication," said Tim van Hauwermeiren, Chief Executive Officer of argenx. "We remain on track with patient recruitment, which we expect to complete by mid 2016."

About ARGX-110

ARGX-110 is a SIMPLE Antibody targeting CD70, an immune checkpoint target involved in hematological malignancies, several solid tumors and severe autoimmune diseases. ARGX-110 works in three ways: i) blocks growth of tumor cells, ii) kills cancer cells and iii) restores immune surveillance against tumors (Silence K. et al. mAbs 2014; 6 (2):523-532). ARGX-110 is currently being evaluated in both hematological and solid tumors.

On June 0, 2016 Blue Earth Diagnostics, a molecular imaging diagnostics company, reported the presentation of results from Axumin (fluciclovine F 18) injection studies in biochemically recurrent prostate cancer at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting (SNMMI), from June 11-15, 2016 in San Diego, Ca Blue Earth Diagnostics Announces AxuminTM (Fluciclovine F 18) Presentations at Upcoming Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting
(Press release, Blue Earth Diagnostics, JUN 9, 2016, View Source [SID:1234513170]). The Company will also participate in a panel presentation on new imaging agents. Details of Axumin presentations by Blue Earth Diagnostics and its collaborators are listed below.

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Date: Sunday, June 12, 2016
Presentation:
Fluciclovine F18 (FACBC): An Amino Acid Tracer for the Staging of Recurrent Prostate Cancer
Session Title: New Imaging and Therapeutic Agents on the Horizon for Routine Clinical Use
Presenter: Jonathan Allis, D. Phil.
Presentation Time: 12:30 PM – 2:00 PM PT
Location: 25 A

Date: Monday, June 13, 2016
Poster Title:
Evidence of the effectiveness of reader training for the staging of biochemically recurrent prostate cancer using fluciclovine F18 PET-CT
Session Title: Prostate/GU: poster session
Presenter: Matthew P. Miller, Ph.D.
Presentation Time:
3:00 PM – 4:30 PM PT
Location: Exhibit Hall G
Publication No.: 1556

In addition, the following presentation will be part of an independent continuing education program at SNMMI.

Date: Tuesday, June 14, 2016
Presentation:
Fluciclovine F18: A New Option for Biochemical Recurrence in Prostate Cancer
Session Title: CE79 Imaging Prostate Cancer
Presenter: Trond V. Bogsrud, M.D., Ph.D.
Presentation Time: 2:45 PM – 4:15 PM PT
Location: 20 BC

Blue Earth Diagnostics invites participants at this year’s SNMMI Annual Meeting to visit the Company at Exhibit Booth 337.

About AxuminTM (fluciclovine F 18)

Axumin (fluciclovine F 18) injection is a novel product indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men. Recurrence of prostate cancer is suspected by an increase in prostate specific antigen (PSA) levels following initial therapy. PET imaging with Axumin may identify the location and extent of such recurrence. Axumin was developed to enable visualization of the increased amino acid transport that occurs in many cancers, including prostate cancer. It consists of a synthetic amino acid that is preferentially taken up by prostate cancer cells compared with surrounding normal tissues, and is labeled with the radioisotope F18 for PET imaging. Axumin was approved by the U.S. Food and Drug Administration on May 27, 2016 following Priority Review, and is the first product commercialized by Blue Earth Diagnostics, which licensed the product from GE Healthcare. The molecule is being investigated by Blue Earth Diagnostics for other potential cancer indications, such as glioma.

Indication and Important Safety Information About Axumin

INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.

On June 9, 2016 Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Afferent Pharmaceuticals reported that the two companies have signed a definitive agreement under which Merck will acquire this privately held pharmaceutical company (Press release, Merck & Co, JUN 9, 2016, View Source [SID:1234513169]). Afferent Pharmaceuticals is a leader in the development of therapeutic candidates targeting the P2X3 receptor for the treatment of common, poorly-managed, neurogenic conditions. Afferent’s lead investigational candidate, AF-219, is a selective, non-narcotic, orally-administered P2X3 antagonist currently being evaluated in a Phase 2b clinical trial for the treatment of refractory, chronic cough as well as in a Phase 2 clinical trial in idiopathic pulmonary fibrosis (IPF) with cough.

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"Afferent has pioneered the clinical development of novel investigational candidates selectively targeting the P2X3 receptor, an exciting area of research," said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. "We look forward to advancing these innovative molecules for patients with conditions like chronic cough, an area of significant unmet medical need."

Under terms of the agreement, Merck, through a subsidiary, will acquire all outstanding stock of Afferent in exchange for an upfront payment of $500 million in cash. Also, Afferent shareholders will be eligible to receive a total of up to an additional $750 million associated with the attainment of certain clinical development and commercial milestones for multiple indications and candidates, including AF-219.

"This achievement is a reflection of the talent and hard work of the experienced Afferent team in advancing the science of P2X3 receptors and the clinical development of our novel therapeutic candidates," said Kathleen Sereda Glaub, chief executive officer, Afferent Pharmaceuticals. "We are very pleased to enter into this agreement given Merck’s reputation for maximizing opportunities around novel mechanisms. This agreement with Merck creates significant value for Afferent shareholders while enhancing the potential of our portfolio to provide meaningful benefits to patients globally."

Data on cough frequency from the first cohort of a Phase 2b dose-escalation clinical trial of AF-219 in patients with chronic cough were presented at the 2016 American Thoracic Society (ATS) International Conference. The results of the second cohort, which is examining lower doses, are expected to be presented at a future scientific congress.

The closing of the transaction will be subject to certain conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The companies anticipate the transaction will close in the third quarter of 2016.

About P2X3 Receptor-Mediated Sensitization

Afferent’s clinical candidates, AF-219 and AF-130, are orally available investigational candidates that selectively block P2X3 receptors. P2X3 receptors are believed to play a key role in the sensitization of certain sensory nerves, notably C-fiber afferents. These nerves become activated and sensitized under pathological conditions mediated by a common cellular signal, ATP, when it is released in high concentrations due to cellular distress following injury or infection. Afferent’s compounds are designed to selectively block ATP activation of P2X3 channels, potentially reducing a range of sensory signs and symptoms.

About Chronic Cough

The prevalence of chronic cough (a cough lasting more than 8 weeks) is estimated to be approximately 10 percent of adults in the U.S. While an underlying condition may contribute to cough in many of these patients, in 20-40 percent of cases no underlying condition can be identified and hence these patients are typically not responsive to symptomatic treatment. Additionally, many treatment-responsive patients are not well-controlled for their cough. There are currently no approved therapies for the treatment of chronic cough.

On June 9, 2016 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported key corporate objectives as well as financial results for the third quarter and year to date ended April 30, 2016 (Press release, OncoSec Medical, JUN 9, 2016, View Source [SID:1234513168]).

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"As we enter the next quarter, we are confident in our team’s mission to deliver safer and more effective intratumoral immunotherapies to provide long-term benefits for cancer patients. We believe the advancements in our technology as well as the preclinical and clinical data generated to date hold the greatest potential to provide meaningful benefit to patients and investment value to OncoSec’s shareholders," said Punit Dhillon, President and CEO of OncoSec. "We have sufficient funds to advance our development efforts for the combination of ImmunoPulse IL-12 with anti-PD-1/PD-L1 in melanoma as well as our next ImmunoPulse product."

FINANCIAL RESULTS
For the third quarter of fiscal 2016 and the nine months ended April 30, 2016, OncoSec reported a net loss of $6.3 million and $20.3 million, or $0.37 per share and $1.27 per share, respectively, compared to a net loss of $6.0 million and $14.7 million, or $0.48 per share and $1.19 per share, respectively, for the same periods last year. The increase in net loss for the three months ended April 30, 2016, compared with the same period in 2015, resulted primarily from an increase of $1.0 million in personnel costs, inclusive of non-cash stock-based compensation, offset by a decrease in engineering costs, outside services and bonuses as compared to the prior year. The increase in net loss for the nine months ended April 30, 2016, compared with the same period in 2015, resulted primarily from (i) an increase of $3.5 million in personnel costs, inclusive of non-cash stock-based compensation; and (ii) an increase of $1.2 million in patient treatment costs related to our clinical trials. There were no revenues for the three and nine months ended April 30, 2016 or April 30, 2015.

Research and development expenses were $3.4 million and $11.1 million for the third quarter of fiscal 2016 and the nine months ended April 30, 2016, respectively, compared to $3.9 million and $9.3 million for the same periods in 2015. General and administrative expenses were $2.9 million and $9.2 million for the third quarter of fiscal 2016 and the nine months ended April 30, 2016, compared to $2.1 million and $5.4 million for the same periods in 2015.

At April 30, 2016, OncoSec had $24.0 million in cash and cash equivalents, as compared to $32.0 million of cash and cash equivalents at July 31, 2015; however, OncoSec raised an additional $9.1 million in net proceeds from a registered direct offering on May 26, 2016. OncoSec expects these funds to be sufficient to allow it to continue to operate its business for at least the next 12 months.