On November 8, 2018 Veracyte, Inc. (Nasdaq: VCYT) reported the publication of "real world" data showing that the Afirma Genomic Sequencing Classifier (GSC) enables even more patients to avoid unnecessary surgery in thyroid cancer diagnosis compared to the company’s flagship, original Afirma Gene Expression Classifier (GEC) (Press release, Veracyte, AUG 8, 2018, View Source [SID1234531100]). The findings are published online in Endocrine Practice, the journal of the American Association of Clinical Endocrinologists"

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 the study, researchers from Memorial Healthcare System in Hollywood, Fla., reviewed data from all patients in their practice whose thyroid nodules were deemed indeterminate (i.e., not clearly benign or cancerous) by cytopathology review and who subsequently received results from genomic testing with the Afirma GSC (n=139) or the Afirma GEC (n=481). They found that the Afirma GSC identified 47 percent more thyroid nodules as benign than the first-generation test (61.2 percent vs. 41.6 percent). Use of the next-generation test also reduced overall surgery rates among all patients with indeterminate thyroid nodules by 45 percent. The researchers determined that sensitivity for the Afirma GSC in their practice was 97 percent.

The RNA sequencing-based Afirma GSC demonstrated especially strong performance in distinguishing benign from cancerous Hürthle cells – a category of thyroid cell that has historically been challenging to diagnose by cytopathology or molecular methods. The Afirma GSC identified 64.7 percent of Hürthle cell dominant biopsies as benign compared to 17.3 percent with the original test and dramatically reduced overall surgery referrals in this group by 57.3 percent.

"Our data suggest that the Afirma GSC is helping us to further reduce unnecessary surgeries among our patients with indeterminate thyroid nodules by enhancing the original test’s specificity while maintaining its high sensitivity," said R. Mack Harrell, M.D., cofounder of the Memorial Center for Integrative Endocrine Surgery and lead author of the new study. "A key reason for this change is the Afirma GSC’s ability to rule out cancer in Hürthle-dominant thyroid nodules. This is important because Hürthle-dominant cases comprise 22 percent of the indeterminate thyroid nodules we evaluate."

Dr. Harrell’s practice began using the Afirma GEC when it was introduced in January 2011. They have been offering patients the Afirma GSC since it became available in August 2017.

"This new publication adds to the growing body of real-world data confirming the utility and consistent performance of the Afirma GSC across a variety of clinical settings," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "Developed using a novel combination of RNA sequencing and machine learning technology, the Afirma GSC helps even more patients with benign thyroid nodules get clearer answers and avoid unnecessary surgery, further benefitting them, their physicians and the healthcare system."

About Afirma

Veracyte’s Afirma solution provides a comprehensive offering in thyroid cancer diagnosis for physicians evaluating patients with thyroid nodules. The Afirma Genomic Sequencing Classifier combines RNA sequencing data with machine learning to identify patients with benign thyroid nodules among those with indeterminate cytopathology results in order to avoid unnecessary surgery and preserve the thyroid. Since the commercial introduction of Afirma in 2011, Veracyte has performed over 100,000 genomic tests, and estimates it has saved more than 40,000 patients from unnecessary thyroid surgery and removed an estimated $800 million in surgery costs from the healthcare system. The Afirma classifier is proven in over 20 published clinical studies, is included in most leading clinical guidelines and is covered as medically necessary by Medicare and all major U.S. health plans. The company’s Afirma Xpression Atlas platform, introduced in May 2018, provides extensive genomic data that may inform surgery strategy and treatment options for patients with thyroid nodules that are suspicious for cancer or cancerous. The RNA sequencing-based platform measures 761 DNA variants and 130 RNA fusions in over 500 genes shown to be associated with thyroid cancer on thyroid nodule fine needle aspiration samples.

On November 8, 2018 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary therapeutic cancer vaccine immunotherapy and targeted cancer therapies, reported its upcoming Phase 2 clinical trials of ProscaVax for prostate cancer and other corporate developments (Press release, Oncbiomune, NOV 8, 2018, http://oncbiomune.com/2018/11/08/oncbiomune-phase-2-clinical-trial-to-begin-enrollment-company-announces-other-development-and-corporate-milestones/ [SID1234531154]).

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!

Phase 2 Trial, Early-Stage Prostate Cancer

The Company’s lead Phase 2 trial of ProscaVax for prostate cancer (View Source) is being hosted by Beth Israel Deaconess Medical Center (BIDMC), a teaching hospital of Harvard University, and its affiliate hospital. The Company reported that the trial will commence on or about December 17, 2018. Enrollment is scheduled for 120 patients (80 in the ProscaVax arm, 40 in active surveillance arm).

This study will evaluate the safety and efficacy of ProscaVax, OncBioMune’s prostate cancer vaccine (a combination of prostate cancer associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF)) in patients with low-risk localized prostate cancer. The goal of the study is to determine if vaccine administration results in a change in the rate of prostate cancer progression when compared to a no-treatment control group of active surveillance patients. Active surveillance is a frequently used disease management option for patients with localized prostate cancer that elect to work with their doctor to monitor the disease for progression before taking more drastic intervention measures, such as surgery or radiotherapy that are often accompanied by unpleasant side effects, including impotence and urinary incontinence.

In the ProscaVax arm of the study, during the first 4 months of induction treatment, 6 doses of the Proscavax vaccine will be administered intradermally at weeks 1, 2, 3, 7, 11, and 15, followed by maintenance booster injections once every month which will alternate between low dose IL-2 alone (at weeks 19, 27 and 35) and Proscavax vaccine (at weeks 23, 31, 39) for 6 months.

Primary outcomes for the study are:

Prostate cancer progression measured by PSA test (Time Frame: At pre-study, every 3 months until 2 years starting at week 7 for the ProscaVax arm and at study entry for the active surveillance arm)
Prostate cancer progression measured by digital rectal examination (Time Frame: At pre-study and then every 6 months for 2 years)
Prostate cancer progression measured by prostate biopsy (Time Frame: At pre-study and then every 12-months for 2 years)
Secondary Outcomes for the study are:

PSA doubling time (Time Frame: At pre-study, and then every 3 months until 2 years, starting at week 7 for ProscaVax arm and at study entry for active surveillance arm)
Assessment of Adverse Events (Time Frame: From first injection until 30 days past the 24-month assessments)
Management anticipates providing interim results throughout the trial as they are available, tentatively beginning during the second quarter of 2019.

Phase 2 Trial, Late-Stage Prostate Cancer

This study, which is expected to get the FDA green light in the coming weeks, is being hosted by Urology Clinics of North Texas, a preeminent 10-center urology group in Texas serving the Dallas, Fort Worth, Collin, Rockwall and Tarrant County areas. The trial is similar in design to and builds upon the successfully completed Phase 1a trial of ProscaVax and will treat hormone-naïve recurrent prostate cancer patients with increasing PSA that have failed previous conventional therapies. Per protocol, following FDA approval, the trial is scheduled to enroll 30 biochemically progressing prostate cancer patients. The study is anticipated to take three years to complete.

As previously announced, OncBioMune has signed a work order with the leading Contract Research Organization Theradex Oncology for its services throughout this clinical trial. An independent Institutional Review Board (IRB) is being used for this trial, which is expected to reduce IRB review times. Once approved by the FDA and IRB, the clinical trial information will be submitted to clinicaltrials.gov, where the summary of the clinical trial will then be publicly available.

In the completed Phase 1a clinical trial, at 19 weeks post-therapy, 80 percent of the patients (n=20) treated with ProscaVax demonstrated stable disease/no prostate cancer progression. At 43 weeks post-therapy, overall survival was 100% for all 20 patients and 12 of the 17 evaluable patients (70.6%) continued to live with stable, progression-free disease.

As with the BIDMC Phase 2 trial, OncBioMune anticipates releasing interim data as available detailing the safety and efficacy data from ProscaVax therapy.

Corporate Developments

Dr. Jonathan Head, Chief Executive Officer and Chairman at OncBioMune, last week spoke about the development of ProscaVax at Oncology Meeting Innovations’ 2018 Global Summit on Genitourinary Malignancies in Banff, Alberta, Canada. Dr. Head’s presentation was well received and sparked interest in ProscaVax as a compelling experimental immunotherapeutic vaccine targeting prostate cancer at the earliest stage, where no current therapies exist, and in the late stage, where the limited number of FDA-approved therapies frequently fail. Dr. Head’s presentation will be available this week on the Company’s website on the "Investors" > "Events and Presentations" tab.

The Company recently made a significant improvement to its balance sheet with the retirement of $900,000 in debt. The Company continues to focus on improving its liquidity and strengthening its balance sheet in support of the clinical trials and additional continued development of ProscaVax. In furtherance of these efforts, OncBioMune reported that it is planning to host a shareholder conference call in December 2018. The Company expects to disclose details on the call in connection with the filing of its Form 10-Q for the quarter ended September 30, 2018.

"Our team and stakeholders have worked vigilantly to make 2018 a milestone year at OncBioMune. We believe that our concerted efforts have built considerable momentum as we look ahead to 2019," commented Dr. Head. "There is still much work to be done to meet our goal of developing the world’s first therapeutic prostate cancer vaccine, but all that we have accomplished so far this year with positioning for two significant clinical trials certainly gives us reason to be very optimistic about where we are heading for our company, our shareholders and the oncology community."

Sign up for OncBioMune email alerts at: View Source

About Prostate Cancer

According to the American Cancer Society (ACS), prostate cancer is the most common type of cancer in men other than skin cancer, with about 1 in 9 men diagnosed during their lifetime. ACS estimates that about 164,690 new cases of prostate cancer will be diagnosed during 2018 and approximately 29,430 men will die from the disease this year. Prostate cancer is the second leading cause of cancer death in men, trailing only lung cancer. Approximately 2.9 million men are living with prostate cancer today. The average age of diagnosis is 66, with the disease considered rare in men under the age of 40.

On November 8, 2018 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), reported it will present two posters highlighting preclinical data and the Phase Ib clinical trial design for ADCT-301 (camidanlumab tesirine) in advanced solid tumors at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting, which is being held November 7-11 in Washington, DC (Press release, ADC Therapeutics, NOV 8, 2018, View Source [SID1234596074]).

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!

Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President of Clinical Development at ADC Therapeutics, said, "ADCT-301 is already being evaluated in relapsed and refractory Hodgkin lymphoma, and at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting we will be updating our abstract data from June, at which time we had an overall response rate of 80.8 percent with a complete response rate of 50 percent in median 6th line patients. Based on the immune-oncology potential ADCT-301 demonstrated in preclinical studies, we are excited to be starting a clinical trial for ADCT-301 in solid tumors to see if we can make an impact and improve patient outcomes in multiple solid tumor cancers."

Patrick van Berkel, PhD, Senior Vice President of Research and Development at ADC Therapeutics, said, "ADCT-301 targets CD25, which is expressed on Tregs that infiltrate the local tumor environment. In preclinical models, a single dose of the CD25-targeted ADC induced strong and durable anti-tumor activity against established CD25 negative solid tumors with infiltrating Tregs. Moreover, re-challenged mice did not develop new tumors indicating the CD25-targeted ADC was able to induce tumor-specific protective immunity."

ADC Therapeutics’ posters will be located in Poster Hall E in the Walter E. Washington Convention Center. The Poster Hall will be open Friday, November 9 from 8 a.m. to 8 p.m. and Saturday, November 10 from 8 a.m. to 8:30 p.m. EST. Details of the posters are below.

Abstract Poster Number: P11
Title: A CD25 targeted pyrrolobenzodiazepine dimer-based antibody-drug conjugate shows potent anti-tumor activity in pre-clinical models of solid tumors either alone or in combination with a PD-1 inhibitor
Presentation Date and Time: Friday, November 9, 12:45-2:15 p.m. and 6:30-8 p.m. EST
Presenter: Francesca Zammarchi, PhD, ADC Therapeutics

Abstract Poster Number: P316
Title: Phase 1b dose-escalation and dose-expansion study to evaluate safety, tolerability, pharmacokinetics, and antitumor activity of ADCT-301 (camidanlumab tesirine) in patients with advanced solid tumors
Presentation Date and Time: Saturday, November 10, 12:20-1:50 p.m. and 7-8:30 p.m. EST
Presenter: Francesca Zammarchi, PhD, ADC Therapeutics

For more information about the SITC (Free SITC Whitepaper) 2018 Annual Meeting, please visit View Source

About ADCT-301

ADCT-301 (camidanlumab tesirine) is an antibody drug conjugate (ADC) composed of a monoclonal antibody that binds to CD25 (HuMax-TAC, licensed from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload tesirine. Once bound to a CD25-expresing cell, ADCT-301 is internalized into the cell where enzymes release the PBD-based warhead. The intra-tumor release of its PBD warhead may cause bystander killing of neighboring tumor cells. In addition, the PBD warhead will trigger immunogenic cell death, which in turn will strengthen the immune response against tumor cells. ADCT-301 is being evaluated in a Phase Ib clinical trial in solid tumors (NCT03621982), as well as ongoing Phase Ia/Ib clinical trials in patients with relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma (NCT02432235).

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, Sesen Bio, NOV 8, 2018, View Source [SID1234530922]).

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!

"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 Bio-Thera Solutions, a clinical-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, reported the company will present one poster at the 2018 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium taking place November 13 – 16, 2018 in Dublin, Ireland.

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 poster, entitled "BAT8001, a potent anti-HER2 antibody-drug conjugate with a novel stable linker for the treatment of HER2-positive gastric cancer," will present preclinical data that highlight advantages of BAT8001 as a potential treatment for breast cancer patients. An abstract of the presentation is currently available on EORTC website.

Presentation details are as follows:

Poster Session: Molecular Targeted Agents – PART I
Session Date and Time: Tuesday, November 13, 2018, 12:00 – 18:30
Location: Poster Area/Exhibition Hall

Poster Board Number: PB-084

Abstract Number 133

About BAT8001

BAT8001 is an investigational HER2-ADC being evaluated in multiple tumor types. HER2 is a naturally occurring receptor that is overexpressed in many types of cancer, including breast cancer and gastric cancer. BAT8001 is being developed for use as a single agent and in combination with other agents for the treatment of multiple cancers. BAT8001 is currently being evaluated in a Phase 3 clinical trial for the treatment of metastatic breast cancer patients (more information on the trial is available at View Source (CTR20180157)). The BAT8001 clinical study program will be expanded beyond metastatic breast cancer to other HER2-positive cancers, including gastric cancer, over the next 12 months.

About Antibody-Drug Conjugates

Antibody-drug Conjugates or ADCs are designed to harness the targeting ability of monoclonal antibodies (mAbs) to deliver cytotoxic agents selectively to tumor cells by linking the monoclonal antibody and cytotoxic agent through a chemical linker. An ideal ADC consists of: 1) a highly selective mAb for a tumor-associated antigen that has little or no expression on normal cells, 2) a potent cytotoxic agent designed to induce target cell death after being internalized in the tumor cell and released and 3) a chemical linker that is stable in circulation but releases the cytotoxic agent in target cells. By selectively delivering a cytotoxic agent directly inside a tumor cell, ADCs increase the safety and tolerability of the cytotoxic agent relative to giving the cytotoxic agent systemically to the patient.