On February 6, 2019 Arch Oncology, Inc., a clinical-stage immuno-oncology company focused on the discovery and development of next-generation anti-CD47 antibody therapies for cancer, reported the initiation of a new Phase 1 clinical trial of AO-176 in select solid tumors with the first patient dosed (Press release, Arch Oncology, FEB 6, 2019, View Source [SID1234533100]). AO-176 is an anti-CD47 antibody with a best-in-class profile that works by blocking the "don’t eat me" signal and also by directly killing tumor cells, with preferential binding to tumor versus normal cells.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Dosing the first patient in this new trial is a significant milestone for our Company," said Julie M. Cherrington, Ph.D., President and Chief Executive Officer of Arch Oncology. "AO-176 is an anti-CD47 antibody with a best-in-class profile and we are excited to be part of the effort to advance this new class of therapeutics. Our team has worked diligently to bring AO-176 into the clinic, and our aim is to develop this antibody as a new treatment approach for patients with cancer."

Howard A. "Skip" Burris, III, M.D., President, Clinical Operations, Chief Medical Officer, and Principal Investigator, Sarah Cannon Research Institute, commented, "There is a growing body of research on AO-176, which has demonstrated in preclinical studies a highly differentiated mechanism among the anti-CD47 agents. With greater insights into the number of tumors that overexpress CD47, we are excited to participate in this study to assess this next-generation anti-CD47 antibody’s safety and preliminary efficacy profile."

Sarah Cannon Research Institute dosed the first patient in the Phase 1 clinical trial of AO-176. The multicenter, open-label, dose-escalation and dose-expansion study is evaluating the safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of AO-176 in patients with select solid tumors.

About AO-176

AO-176 is a humanized anti-CD47 IgG2 antibody with a best-in-class profile. Arch Oncology’s next-generation anti-CD47 antibody AO-176 is highly differentiated, with the potential to improve upon the safety and efficacy profile relative to other agents in this class of checkpoint inhibitors. AO-176 works by blocking the "don’t eat me" signal, the standard mechanism of anti-CD47 antibodies. Beyond blocking this signal, AO-176 also works by directly killing tumor cells. Importantly, AO-176 binds preferentially to tumor cells, instead of to normal cells, and binds even more potently to tumors in their acidic microenvironment (low pH). AO-176 is in a Phase 1 clinical trial for the treatment of patients with select solid tumors.

Data presented on AO-176 at recent medical and scientific meetings can be found at View Source

On February 6, 2019 KIYATEC, Inc., reported that Oregon Health & Science University (OHSU) Knight Cancer Institute has initiated patient enrollment into KIYATEC’s clinical study, 3D-PREDICT, to validate the company’s test as a patient-specific predictor of response to cancer therapies for solid tumors (Press release, KIYATEC, FEB 6, 2019, View Source [SID1234533099]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In this clinical study, the test analyzes a patient’s live cancer cells, grown in KIYATEC’s laboratory within a biologically-relevant 3D microenvironment, to determine whether or not those cells respond to guideline-recommended cancer drugs. Evidence from the company’s earlier pilot study established a correlation between patient-specific predicted tumor response and actual patient clinical response to cancer therapy. The 3D-PREDICT study is a fully prospective, multi-institutional effort to validate the predictive accuracy of the test and correlate response predictions to clinical outcomes among patients with newly diagnosed and relapsed ovarian cancer, glioblastoma and certain rare tumors.

At present, the OHSU Knight Cancer Institute is enrolling newly diagnosed and relapsed ovarian cancer patients into the 3D-PREDICT Study.

"As a pioneer in personalized cancer care, the OHSU Knight Cancer Institute is deeply committed to optimizing appropriate therapy for our patients as early as possible following diagnosis, when the disease is most treatable," said Dr. Koen De Geest, lead investigator of the clinical trial at OHSU. "Five-year survival among high-grade ovarian cancer patients is 30%, and we believe this test has the potential to help improve outcomes in the clinic."

"With cancer treatment, and especially ovarian cancer, time is of the essence and being able to measure patient-specific evidence of response and non-response before treatment begins can truly change the future of cancer care," said Matthew Gevaert, CEO of KIYATEC. "We welcome OHSU to our clinical study and their participation will be integral as we work to deliver accurate predictions of patient response to cancer therapies, reducing the need for patients to undergo treatments that may not work."

The 3D-PREDICT study is anticipated to continue through 2022. Details on the trial can be found on View Source

On February 6, 2019 Blue Earth Diagnostics, a molecular imaging diagnostics company, reported the upcoming presentation of additional analyses from the LOCATE clinical trial (NCT02680041) (Press release, Blue Earth Diagnostics, FEB 6, 2019, View Source [SID1234533098]). The LOCATE trial is a prospective, U.S., multicenter, open-label study investigating the impact of 18F fluciclovine PET/CT imaging on patient management of biochemically recurrent prostate cancer after initial prostate cancer treatment and negative or equivocal findings on standard-of-care imaging. The presentation will be made at the ASCO (Free ASCO Whitepaper) 2019 Genitourinary Cancers Symposium (ASCO GU), from February 14-16, 2019 in San Francisco, Ca. Details of the presentation to be given by Blue Earth Diagnostics collaborators is listed below.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Date: Thursday, February 14, 2019
Presentation: Identification of bone involvement in patients with prostate cancer recurrence using 18F-fluciclovine PET/CT and impact on subsequent management
Abstract Number: 248

Presenter: Michael S Kipper, MD, Genesis Healthcare, on behalf of the LOCATE study group
Session Title & Times: Poster Session A: Prostate Cancer
11:30 AM-1:00 PM and 5:30 PM-6:30 PM PT
Location: Moscone West Building, San Francisco, Ca.

Blue Earth Diagnostics invites participants at the ASCO (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium 2019 to attend the above presentation and to learn more about the company at Exhibit 36.

U.S. 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.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full Axumin prescribing information is available at www.axumin.com.

About Axumin (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 prior treatment. 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 F 18 for PET imaging. Fluciclovine F 18 was invented at Emory University in Atlanta, Ga., with much of the fundamental clinical development work carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences. Axumin was approved by the U.S. Food and Drug Administration in May 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.

On February 6, 2019 Cofactor Genomics, pioneers in the field of Predictive Immune Modeling, reported a $100,000 grant program to reward innovations with the Cofactor ImmunoPrismTM Assay (Press release, Cofactor Genomics, FEB 6, 2019, View Source [SID1234533097]). The program was unveiled at the 2019 Immuno-Oncology 360° Conference in New York.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In December 2018, Cofactor made available the use of its proprietary database of Health Expression Models (HEMs). The Health Expression Models leveraged in the ImmunoPrism Assay enable quantification of immune cells and subtypes in solid tumor tissue, shown to be important in predicting response to immunotherapies. Built using machine-learning, these models have been demonstrated to provide measurable improvements to sensitivity and specificity over single-gene approaches currently used by the field. Access to Cofactor’s database of Health Expression Models has empowered translational and clinical scientists, along with drug development companies to utilize multidimensional biomarkers in their cancer research and clinical trials. Early adopters of Cofactor’s Predictive Immune Modeling technologies include the Fred Hutchinson Cancer Research Center, National Cancer Institute, and Genocea Biosciences.

"We are sitting on the 10 year anniversary of RNA-seq with shelves stuffed full of samples and data, created by cell profiling and analysis, yet we still can’t answer the fundamental question of predicting which immunotherapy will work with a specific patient or certain type of cancer," said Jarret Glasscock, Cofactor CEO and founder. "The new Predictive Immune Modeling Grant is designed to inspire the science, research, and clinical communities to take a different approach to producing highly predictive multidimensional biomarkers to ultimately solve this massive problem."

Cofactor Genomics will be showcasing its Predictive Immune Modeling technology during the Immuno-Oncology 360 conference with a talk in the "Transactional Science & Emerging Biomarkers" track and the panel on "Next Generation Biomarker and Companion Diagnostics for Predicting Response."

Applications for the Grant Program will be accepted through April 15, 2019 and more details may be found here: View Source

On February 6, 2019 Advaxis, Inc. (NASDAQ:ADXS), (the Company) a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported the presentation of the progression of its Lm platform from discovery to clinical application, and the unique opportunity the platform affords Advaxis in its pursuit of innovative new cancer therapeutics (Press release, Advaxis, FEB 6, 2019, View Source [SID1234533096]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The presentation is being made today by Robert G. Petit, Ph.D., the Company’s Chief Scientific Officer and Executive Vice President and Andres A. Gutierrez, M.D., Ph.D., the Company’s Chief Medical Officer and Executive Vice President, during a plenary session at the Immuno-Oncology 360° Conference at the Crowne Plaza Times Square in New York City. The session begins at 4:00 p.m. ET and the Company’s presentation begins at 4:55 p.m. ET.

Drs. Petit and Gutierrez will provide an overview of the Company’s proprietary Lm platform, including the following features that have been observed:

Ability to generate CD8+ T cells rapidly and against large percentage of peptides/neoantigens targets;
Excellent priming without adding adjuvant, systemic pro-inflammatory immune "macroenvironment";
Antigen spreading demonstrated in clinical trials including our neoantigen-directed drug constructs;
No neutralizing antibodies allowing for repeat boosting;
Efficacy signals include single agent complete responses in late stage cancer and improved survival; and
Manageable safety profile – nearly 500 patients treated to date, mostly grade 1 or grade 2 treatment related adverse events.
Drs. Petit and Gutierrez will also present an overview of the Company’s neoantigen-directed therapy programs, ADXS-NEO (customized, personalized neoantigens) and ADXS-HOT (off-the-shelf, hotspot or shared neoantigens and other antigens). The presentation will be available on the Company’s website, www.advaxis.com.

"We are looking forward to presenting an overview of our proprietary Lm platform which, over the last several years, has accumulated a large amount of data supporting immune response, clinical activity and safety in the treatment of multiple cancers. Leveraging the knowledge gained from our single-antigen targeting constructs, we have further optimized our Lm vector in the development of our multiple-antigen targeting constructs. Our discussion today will provide insight into immunological activity that we’ve observed in our ADXS-NEO clinical trial," said Dr. Petit. He concluded, "These preliminary data suggest our approach may be among the best-in-class for CD8+ T cell response which we believe is important for successful clinical outcomes."

"We have a broad pipeline of drug candidates being evaluated for multiple cancer types at various stages of development. We anticipate our first drug construct from our ADXS-HOT program, ADXS-503 for non-small cell lung cancer, to enter the clinic later this quarter." said Dr. Gutierrez. He added, "We believe that our neoantigen-directed drug candidates will likely be used in combination with checkpoint inhibitors and have the potential to significantly impact the cancer treatment paradigm." He concluded, "The preliminary clinical data from our ADXS-NEO Phase 1 study demonstrate broad and rapid anti-tumor immunity. We are looking forward to providing clinical data read-outs from several studies throughout 2019."

ADXS-NEO, the Company’s personalized neoantigen program, is in an ongoing Phase 1 dose-escalation study to treat a variety of cancers. ADXS-HOT is the Company’s off-the-shelf program and consists of several different drug constructs that target hotspot or shared neoantigens, and other antigens. We expect the first drug construct from this program, ADXS-503, or HOT-Lung, will enter the clinic this quarter.