On October 7, 2020 OncoNano Medicine, Inc. reported positive results from its ongoing Phase 2a study of ONM-100, an innovative imaging agent used in intraoperative surgical resection of solid tumors (Press release, OncoNano Medicine, OCT 7, 2020, View Source [SID1234568201]). The data, presented today at the World Molecular Imaging Congress (WMIC) Virtual 2020, demonstrate successful imaging of various solid tumors.

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!

"As low pH is a hallmark of all solid tumors, our novel imaging agent ONM-100 has the potential to become a useful tool for successful tumor resection surgeries," said Ravi Srinivasan, Ph.D., President of OncoNano Medicine. "These data indicate that ONM-100 was well-tolerated and was able to visualize various solid tumor types. We are encouraged by these findings and are excited to continue developing ONM-100 to address this persistent and challenging unmet need in detection of cancer."

OncoNano is currently enrolling patients in the Phase 2a trial to further evaluate the safety and pharmacokinetic/pharmacodynamic (PK/PD) profile of ONM-100. More information can be found at ClinicalTrials.gov

Presentation Overview

TITLE: Image Guided Robotic Prostatectomy Using the pH-Activated Micellar Imaging Agent ONM-100 – A Phase 2 Study of Tumor and Camera Agnostic Detection of Solid Cancers

PRESENTER: Aditya Bagrodia, M.D., Assistant Professor, Department of Urology, University of Texas Southwestern Medical Center

Results announced today are based on 16 patients with various cancers (4 breast, 5 head and neck, 6 prostate and 1 ovarian), all of whom received a single intravenous dose of ONM-100 the same day as, or previous to the day of surgery. The findings indicate that ONM-100:

Is well tolerated at doses 3X higher than doses administered in Phase 1
Detects pathologically confirmed tumor regions through the prostatic capsule, indicating imaging feasibility during robotic prostatectomy
Demonstrates ability to provide fluorescence signals even within a few hours after dosing, which combined with a half-life > 55 hours enables a wide imaging window
Can feasibly image breast, head and neck, prostate, and ovarian cancers.
About ONM-100

ONM-100 is OncoNano’s lead product candidate under development. ONM-100 utilizes a proprietary pH-sensitive micelle platform to encapsulate a fluorescent tag and exploit a universal biomarker of all solid cancers – the relatively acidic pH of the tumor microenvironment – to intraoperatively image tumors. ONM‑100 micelles remain inactive at normal physiological pH until exposure to the acidic tumor microenvironment triggers micelle dissociation and fluorescent tag activation. This has the potential to make tumors visible during surgery with standard surgical imaging equipment. ONM-100 is currently in Phase 2 clinical trials. ONM-100 was partially funded for clinical research by the Cancer Prevention and Research Institute of Texas (CPRIT).

On October 7, 2020 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that it was selected to present at the 2020 BIO Investor Forum conference to be held virtually from October 13-15, 2020 and will be participating at the BIO-Europe partnering conference to be held virtually from October 26-29, 2020 (Press release, Greenwich LifeSciences, OCT 7, 2020, View Source [SID1234568200]).

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!

At the BIO Investor Forum, Snehal Patel, CEO of Greenwich LifeSciences will present and will be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference. The presentation will highlight the Company’s GP2 program and its plans to commence a Phase III clinical trial, will include a pre-recorded audio track available to conference attendees on demand, and will be simultaneously made available on the investor section of the Company’s website at: View Source

At the BIO-Europe partnering conference, the Company will seek to meet with international pharmaceutical companies seeking to license marketing rights for promising therapeutics for their respective regions. The Company previously initiated a global and regional out-licensing process with industry leading advisor, Torreya Partners, which is expected to continue as the upcoming GP2 Phase III trial commences.

About BIO Investor Forum

The 19th annual BIO Investor Forum is an international biotech investor conference focused on early and established private companies as well as emerging public companies. The event features plenary sessions, business roundtables and therapeutic workshops, company presentations, and scheduled one-to-one meetings. For more information, please visit the conference website at: View Source

About BIO-Europe

The 26th annual BIO-Europe global life sciences partnering conference includes access to company pitches, program sessions, and sponsor and showcase company content. The event is expected to bring together over 4,000 executives from more than 2,000 life sciences companies spanning an estimated 60+ countries. Program content includes business development, therapeutic areas, startup innovations, digital health, and scheduled one-to-one meetings. For more information, please visit the conference website at: https://informaconnect.com/bioeurope/

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On October 7, 2020 Pulse Biosciences, Inc. (Nasdaq: PLSE) a novel bioelectric medicine company progressing Nano-Pulse Stimulation (NPS) technology, reported that clinical results from studies spanning the Company’s dermatologic application portfolio will be presented at the American Society for Dermatologic Surgery (ASDS) virtual annual meeting on October 9-11, 2020 (Press release, Pulse Biosciences, OCT 7, 2020, View Source [SID1234568199]). Positive study results generated using the Company’s innovative cellular-specific Nano-Pulse Stimulation mechanism performed with its CellFX System for the treatment of sebaceous hyperplasia lesions, cutaneous non-genital warts, plantar warts, and basal cell carcinoma will be presented in two oral presentations and two e-posters.

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!

These newest published results from NPS clinical studies provide further evidence of the unique CellFX cellular mechanism of action for multiple applications across the lesion treatment spectrum. These recent findings were also the basis for the recently initiated multicenter clinical study to compare NPS technology to RF electrodessication in clearing sebaceous hyperplasia lesions. Treatment of the first study patient was previously announced by the Company on October 1, 2020.

"The positive results being shared at this year’s ASDS meeting add to the growing body of evidence in support of using Nano-Pulse Stimulation technology delivered by the CellFX System to treat a broad range of dermatology applications for which targeted clearance of cellular lesions or structures is medically or cosmetically desirable," said Darrin Uecker, President and CEO of Pulse Biosciences. "These data underscore our persistent dedication to providing dermatologists a highly differentiated non-thermal solution with vast opportunity."

Highlights from this meeting of leading dermatologic surgeons demonstrate:

Successful use of lower NPS energy levels to maintain high levels of effectiveness in clearing sebaceous hyperplasia lesions with greatly improved cosmesis and high subject satisfaction
Favorable clearance rate for warts on the hands, leg, knee, neck; no plume detected in a subset of NPS procedures
Encouraging findings of biopsy-confirmed elimination of residual BCC in the known NPS treatment zone for 8 nodular BCCs and 21 superficial BCCs, indicating promising potential for NPS treatment of both BCC-subtypes
Strong clearance rate of difficult-to-treat, recalcitrant plantar warts in a single treatment session
Dr. Ted Lain, author of the non-genital cutaneous wart study, said: "We are pleased to present conclusive evidence of consistently high rates of clearance across a variety of anatomical areas in one to two NPS treatments. Compared to today’s standard wart treatments, which typically require two to four visits to clear common cutaneous warts, these NPS results represent a much more convenient approach for the patient and the physician." Dr. Lain is Chief Medical Officer of Sanova Dermatology in Austin, TX.

Members of the dermatologic surgery community who have registered for the virtual meeting can gain access to accepted video presentations and posters at the ASDS meeting portal. The listed dates and times below are subject to change.

Title

Lead Author Session Information
A Prospective, Non-Randomized, Multicenter Pivotal Study of Nano-Pulse Stimulation (NPS) for Treatment of Cutaneous Non-Genital Warts

Edward (Ted) Lain, MD,
Chief Medical Officer of Sanova Dermatology, Austin, TX

Oral Presentation
(narrated video slide set)

Friday, October 9th at

11:15am ET

General Derm Track

Nano-Pulse Stimulation (NPS) Procedure to Treat Sebaceous Hyperplasia – A Dose-Ranging, Multi-Center, Pivotal Study

Girish (Gilly) Munavalli, MD,
Medical Director of Dermatology, Laser & Vein Specialists of the Carolinas, Charlotte, NC.

Oral Presentation
(narrated video slide set)

Saturday, October 10th at

11:00 to 11:45am ET

Cosmetic Track

A Prospective, Non-Randomized, Multicenter Pivotal Study of Nano-Pulse Stimulation (NPS) Technology for Cutaneous Warts on the Feet

Brenda LaTowsky, MD,
Clear Dermatology& Aesthetics Center, Scottsdale, AZ

Poster Presentation
A first human feasibility study of Nano-Pulse Stimulation (NPS) to evaluate the potential elimination of a biopsy-confirmed nodular or superficial BCC in a short-term treat and resect study design

Christopher B. Harmon, MD,
Mohs surgeon and founder of Surgical Dermatology Group, Birmingham, AL

Poster Presentation
"We are thrilled to showcase our latest research and congratulate the American Society for Dermatology Surgery for hosting this important scientific exchange with aesthetic and surgical dermatology professionals as we work toward commercial introduction of our CellFX System powered by Nano-Pulse Stimulation technology," said Ed Ebbers, Pulse’s Executive Vice President and General Manager, Dermatology.

On October 7, 2020 Brainlab, the digital medical technology company, reported the planned delivery of 10 new ExacTrac Dynamic systems to GenesisCare, offering US cancer patients and physicians access to the latest treatment technologies on the market (Press release, GenesisCare, OCT 7, 2020, View Source [SID1234568198]). This follows GenesisCare’s acquisition of major integrated cancer care provider, 21st Century Oncology, increasing access to advanced cancer care for patients across US communities.

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!

ExacTrac Dynamic, a patient positioning and position monitoring device, received FDA 510(k) clearance in July 2020 and supports the delivery of precision radiotherapy with surface and thermal tracking combined with real-time X-Ray monitoring. ExacTrac Dynamic will allow GenesisCare physicians to deliver stereotactic radiosurgery, a non-invasive form of radiation therapy which delivers precisely targeted radiation in fewer high-dose treatments than traditional therapies.

Australian-headquartered GenesisCare is one of the largest networks of integrated oncology care in the world, with treatment centers and clinics across Australia, the UK, Spain and now the US. ExacTrac Dynamic systems have already been rolled out in Australia and the UK, providing patients access to the latest advancements in radiation therapy, including stereotactic radiosurgery and tattoo-free treatment.

"During COVID-19, we have remained steadfastly committed to ensuring all cancer patients in local communities across the United States and globally receive rapid access to world-class cancer care. Our investment in these cutting-edge ExacTrac Dynamic systems will help us deliver on our vision to ensure as many cancer patients as possible are able to receive the right treatment, at the right time, closer to home. Our partnership with Brainlab will allow our physicians in the US to automate precise patient monitoring during the delivery of faster, more personalized radiotherapy treatments in our 290 centers across the country," said Dan Collins, Founder and Global Chief Executive Officer, GenesisCare."

Building upon the first generation ExacTrac X-Ray, the new ExacTrac Dynamic system expands clinical workflows beyond traditional stereotactic capabilities with new surface-guided and thermal technology. These high-precision tracking and verification capabilities enable the delivery of effective prescription target doses, with less radiation to normal healthy tissues, for a wide range of treatment locations in the body. The system allows for:

Surface guided patient setup without tattoos or markings
Submillimetric patient monitoring using integrated surface, thermal, and X-Ray imaging at all couch angles
Real-time motion management with automatic beam-hold enabling future applications such as Deep Inspiration Breath Hold (DIBH) gated treatments*
"It’s exciting for Brainlab to continue to work with GenesisCare as they expand their presence in the United States," said Stefan Vilsmeier, President and CEO, Brainlab. "We have long partnered with GenesisCare in Australia and the UK and share their vision to make precision radiotherapy more accessible on a global scale."

First deliveries are planned for November 2020.

On October 7, 2020 Epizyme, (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported that The Lancet Oncology published results of the company’s Phase 2 trial cohorts evaluating TAZVERIK (tazemetostat) for the treatment of epithelioid sarcoma and relapsed/refractory follicular lymphoma (Press release, Epizyme, OCT 7, 2020, View Source [SID1234568197]). Data included in these publications supported the accelerated approval of TAZVERIK by the U.S. Food and Drug Administration (FDA) for the treatment of epithelioid sarcoma in January 2020, and the accelerated approval of TAZVERIK by the FDA for the treatment of relapsed/refractory follicular lymphoma in June 2020.

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 two publications in such a highly regarded, peer-reviewed journal as the Lancet are the culmination of years of hard work by our team, and the significant contributions by the patients and physicians who participated in our clinical trials," said Dr. Shefali Agarwal, chief medical officer of Epizyme. "In our Phase 2 trials, TAZVERIK demonstrated durable clinical responses in both patient populations, including in patients with advanced disease who had previously received multiple therapeutic regimens. In addition, we observed consistently favorable safety with TAZVERIK, which we view as one of its most attractive features. These publications provide important support for TAZVERIK’s novel epigenetic approach, and I am very proud that we are able to offer it as an approved therapy for both patient populations."

"Based on its compelling clinical data and first-in-class mechanism, we believe TAZVERIK has a pipeline in-a-product opportunity that we hope may offer benefit to patients with a wide range of cancers," said Robert Bazemore, president and chief executive officer of Epizyme. "The two FDA accelerated approvals this year highlight the therapeutic impact TAZVERIK could have for patients, and we look forward to continuing to explore its potential in additional tumor types and combinations to reach as many patients as possible."

The publications can be accessed at the following link:
https://www.thelancet.com/journals/lanonc/onlinefirst

About TAZVERIK

TAZVERIK is a methyltransferase inhibitor indicated for the treatment of:

Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

Dosage and Administration

The recommended dosage of TAZVERIK is 800 mg taken orally twice daily with or without food.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Secondary Malignancies

The risk of developing secondary malignancies is increased following treatment with TAZVERIK. Across clinical trials of 729 adults who received TAZVERIK 800 mg twice daily, myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) occurred in 0.7% of patients. One pediatric patient developed T-cell lymphoblastic lymphoma (T LBL). Monitor patients long-term for the development of secondary malignancies.
Embryo-Fetal Toxicity

Based on findings from animal studies and its mechanism of action, TAZVERIK can cause fetal harm when administered to pregnant women. There are no available data on TAZVERIK use in pregnant women to inform the drug-associated risk. Administration of tazemetostat to pregnant rats and rabbits during organogenesis resulted in dose-dependent increases in skeletal developmental abnormalities in both species beginning at maternal exposures approximately 1.5 times the adult human exposure (area under the plasma concentration time curve [AUC0-45h]) at the 800 mg twice daily dose.
Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAZVERIK and for 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with TAZVERIK and for 3 months after the final dose.
Adverse Reactions

Epithelioid Sarcoma

In 62 clinical study patients with epithelioid sarcoma receiving TAZVERIK 800 mg twice daily: Serious adverse reactions occurred in 37% of patients who received TAZVERIK. Serious adverse reactions occurring in ≥3% were hemorrhage, pleural effusion, skin infection, dyspnea, pain, and respiratory distress. The most common (≥20%) adverse reactions were pain (52%), fatigue (47%), nausea (36%), decreased appetite (26%), vomiting (24%), and constipation (21%).
Relapsed or Refractory Follicular Lymphoma

In 99 clinical study patients with relapsed or refractory follicular lymphoma receiving TAZVERIK 800 mg twice daily: Serious adverse reactions occurred in 30% of patients who received TAZVERIK. Serious adverse reactions occurring in ≥2% were general physical health deterioration, abdominal pain, pneumonia, sepsis, and anemia. The most common (≥20%) adverse reactions were fatigue (36%), upper respiratory tract infection (30%), musculoskeletal pain (22%), nausea (24%), and abdominal pain (20%).
Drug Interactions

Avoid coadministration of strong or moderate CYP3A inhibitors with TAZVERIK. If coadministration of moderate CYP3A inhibitors cannot be avoided, reduce TAZVERIK dose.
Avoid coadministration of moderate and strong CYP3A inducers with TAZVERIK, which may decrease the efficacy of TAZVERIK.
Coadministration of TAZVERIK with CYP3A substrates, including hormonal contraceptives, can result in decreased concentrations and reduced efficacy of CYP3A substrates.
Lactation

Because of the potential risk for serious adverse reactions from TAZVERIK in the breastfed child, advise women not to breastfeed during treatment with TAZVERIK and for one week after the final dose.