On September 21, 2021 HALO Diagnostics (HALO Dx) reported that now offers men with suspected metastatic and recurrent prostate cancer another groundbreaking advanced imaging option (Press release, HALO Diagnostics, SEP 21, 2021, View Source [SID1234590104]).

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!

HALO Diagnostics, known for pioneering MRI-guided Laser Focal Therapy for the treatment of prostate cancer, reported the adoption of imaging agent, PYLARIFY (piflufolastat F-18) Injection for use with targeted positron emission tomography (PET) imaging.

"PYLARIFY is a game-changer for early detection of metastasis and recurrence in men previously treated for the disease."

PYLARIFY, developed by Lantheus, targets a prostate-specific membrane antigen (PSMA) protein overexpressed on the surface of 95 percent of prostate cancer cells circulating in a man’s blood. It is the first commercially available, FDA approved PSMA PET imaging agent for prostate cancer.

"PYLARIFY is a molecular imaging game changer for early detection of metastasis in newly diagnosed prostate cancer patients, and for recurrence in men previously treated for the disease," said Dr. John Feller, HALO Diagnostics Chief Medical Officer. "Early and more precise detection gives patients multiple treatment options."

Prostate cancer is the second most common form of cancer affecting American men. An estimated one in eight will be diagnosed in their lifetime.

Of men with localized prostate cancer who undergo initial treatment, as many as 50 percent may experience recurrence within ten years. Recurrent disease is often detected by rising PSA levels; however, conventional imaging, especially at low PSA levels, is not able to identify the location and extent of the disease in most cases.

PYLARIFY enables visualization of microscopic amounts of cancer that have metastasized beyond the prostate by binding to PSMA and causing the cancer cells to "light up" on a PET scan, allowing the reader to better detect and locate the disease. Early detection saves lives.

The radiotracer is now included in the National Comprehensive Cancer Network (NCCN) guidelines for imaging prostate cancer.

To make an appointment with a HALO Diagnostics doctor, visit HALODx.com.

On September 21, 2021 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development reported their participation at the World Bispecific Summit occurring virtually September 29 – October 1, 2021 (Press release, Applied BioMath, SEP 21, 2021, View Source [SID1234590099]).

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!

Alison Betts, PhD, Vice President of Scientific Collaborations and Fellow of Modeling & Simulation at Applied BioMath will present "Mechanistic Strategies for Modeling Avidity: Application in the Design of Tumor Selective Bispecific Antibodies in Oncology" on Thursday, September 30th at 8:50 a.m. ET. In this presentation, Dr. Betts will discuss the importance of avidity in designing tumor selective bispecific antibodies and how modeling can help interpret titration curves and optimize single-site binding affinities. She will also explain a case study about optimizing a 2+1 format T-cell engager for binding selectivity to tumor cells.

"Mechanistic modeling strategies can help understand complexities innate in bispecific design that are not often straightforward or intuitive," said John Burke, PhD, Co-founder, President and CEO of Applied BioMath. "Dr. Betts will explain how an avidity binding systems pharmacology model provided guidance about bispecific molecules and how the model was expanded and translated into a collaboration."

Learn more about Applied BioMath’s work in bispecifics at View Source

On September 21, 2021 LIPAC Oncology LLC., a pharmaceutical company utilizing its liposome-bound nano-technology platform to provide precision targeted cancer drugs for the treatment of multiple tumor types, reported that management will participate in the following investor conferences, which will all be held virtually:

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!

Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on Thursday, September 23, 2021 at 2:55 p.m. E.T.
A.G.P. Biotech & Specialty Pharma Conference on Wednesday, October 13, 2021
BMO Life Sciences Private Company Showcase on Thursday, October 14, 2021 at 9:00 a.m. E.T.
A live webcast of the Oppenheimer and BMO presentations can be accessed by visiting the home page of the Company’s website: View Source

About LiPax

LiPax is a precision targeted, locally delivered taxane in Phase 2b development for intravesical instillation in the treatment of non-muscle invasive bladder cancer (NMIBC). Its liposome-bound nano-technology platform achieves targeted tissue penetration with undetectable systemic exposure, toxicity or chemo-related side-effects. NMIBC is the lead program with additional orphan indications in upper tract urothelial cancer (UTUC), thoracic cancers (mesothelioma and malignant pleural effusion) and peritoneal and ovarian cancers. LiPax is designed to enhance the standard of care of outpatient endoscopic tumor removal followed by intravesical instillation using a typical urinary catheter. LIPAC Oncology completed a Phase 2a clinical trial in August 2020 and intends to initiate a Phase 2b study in the second half of 2021 to further investigate LiPax in the treatment of this condition.

On September 21, 2021 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that Barry Quart, Pharm.D., Chairman and Chief Executive Officer, and John Poyhonen, President and Chief Commercial Officer, will participate in a fireside chat at the 2021 Cantor Virtual Global Healthcare Conference on Monday, September 27, 2021 at 1:20 pm ET (Press release, Heron Therapeutics, SEP 21, 2021, View Source [SID1234590095]).

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!

A live webcast of the fireside chat will be available on the Company’s website at www.herontx.com in the Investor Resources section. A replay of the event will be archived on the site for 60 days.

On September 21, 2021 HUYABIO International (HUYABIO), the leader in accelerating global development of China’s pharmaceutical innovations, reported the first patient treated in a pivotal trial designed to measure the safety and efficacy of HBI-8000 combined with Bristol Myers Squibb’s anti-PD-1, antibody Opdivo (nivolumab), in patients with unresectable or metastatic melanoma (Press release, HUYA Bioscience, SEP 21, 2021, View Source [SID1234590092]). The multicenter, randomized, double blinded, placebo-controlled Phase 3 trial entitled, "Study Comparing the Investigational Drug HBI-8000 Combined with Opdivo vs. Opdivo in Patients with Advanced Melanoma," will have a primary outcome of objective response rate and progression-free survival. Secondary outcomes include safety and overall survival. Opdivo is a trademark of Bristol-Myers Squibb Company.

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!

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, "The initiation of the Phase 3 trial represents another significant milestone for HBI-8000 following the recent approval for the drug as monotherapy for the treatment of ATLL in Japan. The Company has taken another important step in expanding the clinical indications for our lead oncology asset in solid tumors. The results from our Phase 2 trial of HBI-8000 combined with Opdivo in solid tumors pointed to the important immunomodulatory activity for our drug. We are pleased to begin this global study in collaboration with Bristol Myers Squibb."

The pivotal multi-national trial will enroll 480 patients from the United States, Europe, Australia, New Zealand and Japan. In the US Phase 2 trial, the combination of HBI-8000 with Opdivo was well tolerated with a favorable safety profile in checkpoint naïve melanoma patients who achieved a promising clinical response.

"Australia has one of the highest rates of melanoma in the world, especially relevant to the Sunshine Coast and Queensland", said Principal Investigator Dr. Hong Shue, who treated the first patient and is from Sunshine Coast Haematology and Oncology Clinic and University of the Sunshine Coast Clinical Trials Unit. "We are really excited to participate in this HUYABIO International sponsored Phase 3 registrational clinical trial. This trial potentially offers a practice-changing, effective combination treatment of HBI-8000 with Opdivo to our patients on the Sunshine Coast. This study, if positive, may provide an additional treatment option and significant change in the metastatic melanoma treatment paradigm."

About HBI-8000

HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. This oral agent targets class I histone deacetylases causing cell cycle arrest and tumor cell death as the mechanism underlying its single agent activity against lymphoma. The drug also has immunomodulatory impact by increasing the efficacy of checkpoint inhibitors in preclinical animal models. The Company recently reported results from its ongoing Phase 2 study for the Opdivo combination demonstrating an overall objective response rate of approximately 70% with a disease control rate over 90% in a cohort of checkpoint naïve patients with melanoma.