Foundation Medicine Announces Strategic Collaboration with Major Pharmaceutical Company

On October 17, 2018 Foundation Medicine, Inc. reported a strategic collaboration with Novartis allowing the development of companion diagnostic (CDx) tests for the Novartis portfolio of targeted oncology and immuno-oncology therapeutics (Press release, Foundation Medicine, OCT 17, 2018, View Source [SID1234529950]). The collaboration structure allows for multiple therapy programs and includes development, regulatory support and commercialization of CDx tests for inclusion on FoundationOne CDx. FoundationOne CDx is Foundation Medicine’s FDA-approved comprehensive genomic profiling (CGP) assay for all solid tumors that incorporates multiple companion diagnostics.

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!

"It is imperative that we collaborate with all of the key stakeholders in oncology to accelerate patient access to personalized medicine," said Melanie Nallicheri, chief business officer and head of biopharma at Foundation Medicine. "Novartis shares this mission and we look forward to working with them to develop companion diagnostics across multiple therapies. This collaboration reaffirms our commitment to expedite biomarker-driven development and ultimately bring more personalized treatment options to patients."

The agreement also allows for global expansion in ex-US markets including Japan, where in partnership with Chugai, Foundation Medicine has submitted FoundationOne CDx for regulatory approval from the Ministry of Health, Labour and Welfare (MHLW). If approved in Japan, FoundationOne CDx would enable access to MHLW-approved targeted therapies and immunotherapies, as well as clinical trials, for patients with cancer in Japan.

TAPIMMUNE AND MARKER THERAPEUTICS ANNOUNCE SUCCESSFUL CLOSING OF
PREVIOUSLY ANNOUNCED MERGER AND FINANCING

On October 17, 2018 TapImmune Inc. (NASDAQ: TPIV), reported the closing of the previously announced merger with privately-held Marker Therapeutics, Inc. In connection with the merger, TapImmune Inc. changed its name to Marker Therapeutics, Inc., and reincorporated from Nevada into Delaware (Press release, TapImmune, OCT 17, 2018, View Source [SID1234530399]). The combined company will focus on the continued development and commercialization of T cell therapies. Beginning Thursday, October 18, 2018, the Company’s stock will begin trading under the new ticker symbol "MRKR" on the Nasdaq Capital Market and will have a new CUSIP number, 57055L 107.

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 closing of this merger marks a significant milestone, since the combined company is well-positioned to become a leader in cancer immunotherapy, with potentially transformative therapies," said Peter L. Hoang, CEO of Marker Therapeutics, Inc. "The combined company will have exponentially superior capabilities and resources than either company had alone. With the transaction completed, we can now push our clinical trials forward more efficiently with the full resources available to the combined company. We are confident that our therapies can fundamentally improve therapeutic outcomes for patients with life-threatening diseases, and drive life-changing results for patients suffering from a variety of terrible cancers."

Mr. Hoang continued, "In connection with the merger, we welcome to our Board of Directors, John Wilson, Dr. Juan Vera and David Eansor, whose participation and future contributions will enhance the future prospects of the combined company."

"This merger provides Marker’s unique and highly promising T cell therapies with an excellent combination of financial support, management capacity, and scientific expertise that is expected to expedite a fundamental change in the lives of cancer patients," said John Wilson, CEO of the former Marker Therapeutics, Inc., which changed its name to Marker Cell Therapy, Inc. in connection with the merger. "Our belief that this merger provides the best path forward has been reinforced by events surrounding the transaction, including the significant capital contribution made by highly discerning healthcare investors, led by New Enterprise Associates, the exclusive license with Baylor College of Medicine that will allow us to leverage the vast capabilities of their Center for Cell and Gene Therapy going forward, and by the willingness of Dr. James Allison (2018 Nobel Prize of Medicine recipient) and Dr. Padmanee Sharma (2018 Coley Award in Tumor Immunology recipient) to join our internationally acclaimed founders (Drs. Malcolm Brenner, Cliona Rooney, and Helen Heslop) on Marker’s Scientific Advisory Board."

As a result of the merger, 13,914,255 shares of common stock of the Company, and warrants to purchase 5,046,003 shares of common stock at an exercise price of $2.99 per share with a five-year term, were issued to the prior stockholders of the former Marker Therapeutics, Inc., which will become a subsidiary of the combined company and renamed Marker Cell Therapy, Inc.

Concurrent with the merger, the Company closed on the previously announced private placement financing (the "Financing"). The aggregate offering size, before deducting the placement agent fees and other offering expenses, was $70 million. The Company issued 17,500,000 shares of its common stock and issued warrants to purchase 13,125,000 shares of common stock at an exercise price of $5.00 per share that will be exercisable for a period of five years. The closing of the merger and the Financing were subject to the approval of TapImmune’s stockholders as required by NASDAQ Stock Market Rules. TapImmune’s stockholders approved the issuance of the merger and Financing shares and warrants at TapImmune’s annual meeting which occurred on October 16, 2018.

The Financing proceeds will be used to advance the combined company’s novel T cell therapies into multiple Phase 2 clinical studies, build out infrastructure to support clinical and manufacturing capabilities, and other corporate and general purposes.

Piper Jaffray & Co. served as sole lead placement agent for the private placement, and Nomura Securities International, Inc. served as co-placement agent and exclusive financial advisor in conjunction with the merger.

The securities issued in the merger and sold in the Financing (together the "Securities") have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the Securities and Exchange Commission covering the resale of the Securities, including the shares of common stock issuable upon exercise of the warrants. If any of the Securities are unable to be included on the initial registration statement, the Company has agreed to file subsequent registration statements until all the Securities have been registered.

As a result of the closing of the merger and the Financing, the former Marker stockholders, after taking into account the issuance of shares in the Financing occurring concurrently with the merger, now own, on a fully-diluted basis (assuming the exercise of all outstanding warrants and options), approximately 27.5%, and TapImmune’s current stockholders now own approximately 27.5%, of the Company’s common stock.

Frederick Wasserman, who was appointed Chairman of Marker’s Board upon closing of the merger said, "The completion of the merger and financing provide a strong foundation for Marker’s future growth initiatives. We are now better positioned to develop new therapies for patients and create value for our shareholders." Mr. Wasserman continued and noted, "We look forward to working with our three new directors who are joining our Board. We also wish to recognize our former board members who left the Board in connection with the merger (Glynn Wilson, Sherry Grisewood, Mark Reddish and Joshua Silverman) for their many contributions in helping the Company reach this milestone event."

The Company will be relocating its corporate headquarters to Houston, Texas to facilitate its collaboration with the research team at the Baylor College of Medicine. In conjunction with its move, the Company plans to open a facility in Houston to conduct its operations and oversee its clinical trials.

President & Chief Executive Officer Peter L. Hoang, accompanied by the senior management team and Board of Directors, will ring the Nasdaq Closing Bell to mark the end of trading for today, October 17th.

The ceremony, which will take place between 3:45 p.m. and 4:15 p.m. Eastern Time, will stream live online at View Source

Blue Earth Diagnostics Announces Fluciclovine F 18 Research Presentations at Upcoming ASTRO Annual Meeting

On October 17, 2018 Blue Earth Diagnostics, a molecular imaging diagnostics company, reported that oral and poster presentations related to the clinical use of fluciclovine F 18 injection will be occurring at the 2018 American Society for Radiation Oncology (ASTRO) Annual Meeting, from October 21 – 24, 2018 in San Antonio, Texas (Press release, Blue Earth Diagnostics, OCT 17, 2018, View Source [SID1234529951]).

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!

Some of the oral and poster presentations listed below highlight investigational uses of fluciclovine F 18. Axumin (fluciclovine F 18) injection is FDA-approved 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. Presentations noted by "*" describe investigational uses of fluciclovine F 18 for which the safety and efficacy have not been established.

Sunday, October 21, 2018

ePoster Discussions

Session Title: GU 1 – ePoster Discussion – New Data on PET, MRI and Protons for Treating Prostate Cancer
Presentation Title:
Positive Findings on 18F-fluciclovine PET/CT in Patients with Suspected Recurrent Prostate Cancer and PSA levels ≤0.5 and ≤0.3 ng/ml

Presenter: Petra Lovec, MD, Loyola University Medical Center
Presentation Number: 1001
Presentation Time: 1:21 – 1:27 p.m. CT
Location: Room 217 A/B

Session Title: GU 1 – ePoster Discussion – New Data on PET, MRI and Protons for Treating Prostate Cancer
Presentation Title:
The Impact of 18F-Fluciclovine Positron Emission Tomography on Salvage Radiation Therapy Decisions for Patients with Post-Radical Prostatectomy Recurrence of Prostate Cancer: Results from LOCATE

Presenter: Abhishek Solanki, MD, MS, Loyola University Medical Center
Presentation Number: 1000
Presentation Time: 1:15 – 1:21 p.m. CT
Location: Room 217 A/B

Poster Viewings

Session Title: Poster Viewing Q&A 1
Presentation Title:
Application of 18-F Fluciclovine PET/CT in Guiding Salvage Radiation Therapy for Recurrent Prostate Cancer*

Presenter: Jalal Ahmed, MD, PhD, BS, Icahn School of Medicine at Mt Sinai
Session Time: 1:15 – 2:45 p.m. CT
Location: Innovation Hub, Exhibit Hall 3
Presentation No.: SU_22_2227

Tuesday, October 23, 2018

Poster Viewings

Session Title: Poster Viewing Q&A 3
Title:
Design and Evaluation of a Semi-Automated Algorithm for Segmentation of Anti-[18F]FACBC (Fluciclovine F18] PET Images for Post-Prostatectomy Radiation Therapy*

Presenter: Eduard Schreibmann, PhD, DABR, Emory University
Presentation Time: 1:00 – 2:30 p.m. CT
Location: Innovation Hub, Exhibit Hall 3
Presentation No.: TU_20_3312

Blue Earth Diagnostics invites participants at the 2018 ASTRO Annual Meeting to visit the company at Exhibit Booth 2163. The company is also hosting an Industry-Expert Theater event, "Detecting and Localizing Recurrent Prostate Cancer with Axumin (Fluciclovine F 18) Injection," with invited speaker Dr. Rodney Ellis, MD FACRO, Vice Chairman, Strategic Affairs, Radiation Oncology, University Hospital Cleveland Medical Center, Associate Professor, Radiation Oncology and Urology, Case Western Reserve University School of Medicine, Cleveland, Ohio, which will be held on Sunday, October 21, 2018, from 12:15 – 1:15 p.m. CT, in Theater 1, Innovation Hub.

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.

Castle Biosciences’ Cutaneous Squamous Cell Carcinoma Prognostic Test Development Progress Highlighted in Oral Presentation at American Society for Dermatologic Surgery Annual Meeting

On October 17, 2018 Castle Biosciences, Inc., the skin cancer diagnostics company providing molecular diagnostics to improve cancer management decisions, reported the presentation of data demonstrating progress in the development of a prognostic gene expression profile test for cutaneous squamous cell carcinoma (cSCC), one of the most common types of cancer (Press release, Castle Biosciences, OCT 17, 2018, View Source [SID1234529966]). The goal of the research program is to validate a gene expression profile test that improves upon current staging systems and identifies patients with cSCC with a high risk for recurrence, enabling more informed clinical management decisions. Aaron Farberg, M.D., Icahn School of Medicine at Mount Sinai, New York, presented the study last week during the Reconstructive, Skin Cancer and Mohs Micrographic Surgery session of the 2018 American Society for Dermatologic Surgery Annual Meeting held in Phoenix.

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 multi-center development study, more than 500 primary cSCC specimens were accrued from 14 centers, and gene expression analysis of candidate genes selected based on literature and pathway analysis was performed through reverse transcription polymerase chain reaction (RT-PCR). Predictive modeling with machine learning was performed on a preliminary development set that included both non-recurrent and recurrent cases with verified clinical data and outcomes.

Researchers successfully identified genes that exhibited significant differential expression between non-recurrent and recurrent cases, including several specific to regional/distant metastasis (p<0.05). An average of the top performing preliminary models for predicting metastasis or local recurrence had higher sensitivity and positive predictive value when compared to current staging methods, and maintained or improved comparable specificity and negative predictive value.

In addition to candidate genes selected from the literature, microarray analysis on 80 recurrent and non-recurrent cases permitted an unbiased, genome-wide approach for selection of additional genes through machine learning for validation.

"These study findings demonstrate continued progress in the development of a prognostic test for cSCC that can identify patients with a risk of metastasis more accurately than currently used staging systems," commented Chrysalyne D. Schmults, M.D., Brigham and Women’s Hospital, Boston, an investigator in the study. "Successful validation and clinical application of a test such as this could help inform clinical decision-making regarding the potential need for adjuvant therapy."

Based on demonstrated progress with initial development work, collaborative site recruitment and clinical study activities are actively continuing.

About Cutaneous Squamous Cell Carcinoma

Cutaneous squamous cell carcinoma (cSCC), a non-melanoma skin cancer, is one of the most common cancers with an estimated incidence of more than 1,000,000 cases in the U.S. each year. Approximately 20% of patients have high-risk features based on tumor depth, histology, anatomic location and/or immunosuppression. Most patients have a favorable prognosis, but a subset of patients will develop metastasis and up to 15,000 patients each year die from their disease. As current staging parameters have a low positive predictive value, many more patients are considered high risk than actually develop metastatic disease. Conversely, many patients that develop metastatic disease are misidentified as low risk. This leads to over and undertreatment of a substantial number of cSCC patients. To address this clinical need, Castle Biosciences is developing a gene expression profile test to improve upon current staging systems and identify patients with cSCC at high risk for metastasis and death, enabling more informed clinical decisions regarding adjuvant therapy and other management options.

First patient treated with Transgene TG6002 oncolytic virus in a Phase 1/2 trial in patients with advanced gastrointestinal tumors

On October 17, 2018 Transgene (Paris: TNG) (Euronext Paris: TNG), a biotechnology company that designs and develops viral vector-based immunotherapies, reported the treatment of the first patient in the TG6002 Phase 1/2 trial in patients with advanced gastrointestinal tumors such as colon cancer, in the Léon Bérard center (Lyon) (Press release, Transgene, OCT 17, 2018, View Source [SID1234529952]). This multicenter trial is authorized in France, Belgium and Spain. It will include up to 59 patients.

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!

TG6002 is a new generation multi-functional oncolytic virus that can be administered intravenously and combines several mechanisms of action . It was designed to combine the mechanism of oncolysis (destruction of the cancer cell) with local production of chemotherapy (5-FU), directly into the tumor. Induction of an immune response against tumor cells is another expected effect. TG6002 expresses the patented FCU1 gene in tumor cells that it has infected, leading to the local conversion of 5-FC (administered orally) to 5-FU. This is particularly important because of the sensitivity of most gastrointestinal tumors to 5-FU.

TG6002 has demonstrated in preclinical its ability to induce a response in the primary tumor as well as a distant effect on metastases by causing immunogenic cell death.

Dr. Philippe Cassier, PhD, principal investigator of the trial and head of the early phase trial unit at the Léon Bérard Center, explains: "Despite the improved prognosis of patients over the last 20 years, the median survival of metastatic colorectal cancer (CRC) patients remains below three years. Patients receive up to four successive treatment lines, which can be associated with significant side effects. In addition, the majority of these do not respond to immune checkpoint inhibitors. For this reason, 5-FU-based chemotherapy remains the standard treatment for this disease. TG6002, an oncolytic virus that destroys cancer cells and produces 5-FU at the heart of the tumor, is a promising therapy with the potential to be more effective and better tolerated by patients. "

Dr. Maud Brandely, PhD, Director, Clinical Development, Clinical Operations & Regulatory Affairs at Transgene, adds, "With its multiple mechanisms of action, TG6002 is an extremely promising oncolytic virus that is administered intravenously in this trial. The destruction of cancer cells, the production of chemotherapy in the tumor and the induction of a targeted immune response are all complementary approaches to better attack this disease. We look forward to the results that the oncolytic virus TG6002 will generate in this clinical trial. "

This half-open, single-arm trial is being conducted in Europe. It evaluates the safety and tolerability of multiple and increasing doses of intravenously administered TG6002 in combination with orally administered 5-FC. 5-FC is a non-cytotoxic precursor that can be converted to 5-FU. The primary endpoint of the Phase 1 part of the trial is safety; that of Phase 2 is efficiency. This trial will also evaluate the pharmacokinetic properties and biodistribution of TG6002, as well as the immune modulation of the tumor microenvironment.

About TG6002 A
new generation of oncolytic immunotherapy, TG6002 has been designed to induce the destruction of cancer cells (oncolysis) and to allow the production of 5-FU directly in the tumor. TG6002 is a modified, double-deleted Vaccinia virus (TK-RR-), expressing the patented FCU1 gene in tumor cells that it has infected in order to locally convert 5-FC (flucytosine), into 5-FU, a chemotherapy commonly used. Oncolytic virus TG6002 has shown its efficacy and good tolerability profile in several preclinical models. For Transgene, TG6002 represents a new therapeutic option for patients with recurrent solid tumors.
Another trial of TG6002 is underway in France in recurrent glioblastoma.

About gastrointestinal tumors
Gastrointestinal cancers include several forms of cancers of the digestive system. They include cancers of the esophagus, gall bladder, liver, pancreas, stomach, small bowel, colon, rectum and anus. Colorectal cancer (CRC) is the second most frequently diagnosed cancer in Europe and one of the leading causes of death in Europe and worldwide. In 2012, 447,000 new cases of CRC were reported in Europe, with 215,000 deaths. Worldwide, this represented 1.4 million new cases and 694,000 deaths (Ferlay J. et al., 2013, Ferlay J. et al., 2015). Over the last decade, the prognosis of patients with metastatic CRC has improved