On June 14, 2021 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that the Investigational New Drug (IND) application for the company’s novel Bcl-2 inhibitor, lisaftoclax (APG-2575), has been cleared by the US Food and Drug Administration (FDA) and the company is poised to initiate a clinical study of lisaftoclax as a single agent or in combination with other antitumor therapies for the treatment of patients with advanced estrogen receptor-positive (ER+) breast cancer or other solid tumors (Press release, Ascentage Pharma, JUN 14, 2021, View Source [SID1234583975]).

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This global multicenter, open-label Phase Ib/II clinical study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of lisaftoclax as a single agent in patients with advanced solid tumors, or in combination with palbociclib in patients with metastatic ER+ and human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer relapsed or refractory to prior treatment with cyclin–dependent kinase 4/6 (CDK4/6) inhibitors.

Breast cancer is one of the most common malignancies in women. About 75% of all breast cancer cases are hormone receptor positive (HR+)1, mainly estrogen receptor positive (ER+), and the antiapoptotic protein Bcl-2 is overexpressed in around 85% of this subset2. Endocrine therapy is the standard of care treatment for patients with early-stage or metastatic HR+/HER2- breast cancer. In the first-line treatment of metastatic ER+ breast cancer, an CDK4/6 inhibitor (palbociclib, ibociclib, or abemaciclib) in combination with endocrine therapy can offer longer progression-free survival (PFS) and overall survival (OS), as compared to endocrine therapy alone3,4. In the second-line setting, phosphoinositide 3-kinase (PI3K) inhibitor plus fulvestrant, and everolimus plus endocrine therapy can effectively target the PI3K-AKT-mTOR pathway, thus offering additional treatment options for patients who failed first-line treatments3. However, patients treated with endocrine therapies and targeted therapies commonly develop drug resistances, eventually necessitating chemotherapies. Therefore, there is an urgent clinical need for novel targeted therapies that can effectively blockade mutational pathways and delay chemotherapies.

Lisaftoclax is a novel, orally administered small-molecule Bcl-2‒selective inhibitor being developed by Ascentage Pharma. Lisaftoclax is designed to treat hematologic malignancies and solid tumors by selectively blocking antiapoptotic protein Bcl-2 to restore the normal apoptosis process in cancer cells. Lisaftoclax is the first China-developed Bcl-2 inhibitor entering clinical development in China. Previously, lisaftoclax had received clearances and approvals for multiple Phase Ib/II clinical studies in China, Australia, the US, and Europe, and is currently being developed in a range of hematologic malignancies globally. As a single agent, lisaftoclax has potent antitumor activity in Bcl-2-dependent tumor cell lines, and has shown broad antitumor effects when combined with other antitumor therapies.

Preclinical data of lisaftoclax in combination with palbociclib showed that palbociclib can induce cell cycle arrest and apoptosis, while lisaftoclax can bolster the expression of proapoptotic proteins such as BIM and downregulate ER levels, while lowering the levels of phosphorylated Rb protein, and the cyclin D1 and E. Therefore, Bcl-2 inhibitors combined with CDK4/6 inhibitors can synergistically enhance cell cycle arrest while inducing the cell death of ER+ tumors.

"Lisaftoclax is a core drug candidate in our apoptosis-targeted pipeline. This IND clearance by the US FDA for lisaftoclax in patients with solid tumors marks another major milestone for this drug candidate," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "As the first China-developed Bcl-2 inhibitor entering clinical development in China, lisaftoclax has enormous therapeutic potential, both as a single agent and in combinations. Lisaftoclax has shown promising clinical activity and favorable tolerability in hematologic malignancies, and we look forward to expanding and deepening our investigation of lisaftoclax in solid tumors. We are now advancing the clinical development of this drug candidate globally in the hope of soon benefiting patients in China and around the world."

On June 14, 2021 Asieris Pharmaceuticals (Asieris) reported that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application of oral APL-1202 in combination with BeiGene’s tislelizumab as neoadjuvant therapy in patients with muscle invasive bladder cancer (MIBC) (Press release, Asieris Pharmaceuticals, JUN 14, 2021, View Source [SID1234583974]). Asieris will accelerate the initiation of the clinical trial enrollment in the U.S. and also file a Clinical Trial Application (CTA) to the National Medical Products Administration (NMPA) of China in the near future.

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This is an open-label, multi-center Phase I/II clinical study with the following objectives: to evaluate the safety in MIBC patients; to determine the RP2D (recommended Phase 2 dose), and to assess efficacy as neoadjuvant therapy for MIBC.

APL-1202 is an orally available reversible MetAP2 Inhibitor with anti-angiogenic, anti-tumor activities and can also modulate tumor immune microenvironment. It is currently in Phase III/pivotal clinical trials in China, either as single agent as first-line treatment for patients with intermediate-risk non-muscle invasive bladder cancer (NMIBC), or in combination with a chemotherapy as second-line treatment in patients with intermediate and high-risk chemo-refractory NMIBC. Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. The China National Medical Products Administration (NMPA) has granted tislelizumab approval in three indications, including full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy; and conditional approval for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies and for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

According to the 2020 Chinese Society of Clinical Oncology (CSCO) Guidelines for Diagnosis and Treatment of Urothelial Carcinoma, the Level I recommendation for MIBC is that patients who tolerate cisplatin undergo radical cystectomy (RC) after neoadjuvant chemotherapy. The commonly used chemotherapy regimen is gemcitabine plus cisplatin (GC). However, cisplatin can cause serious side effects such as renal dysfunction, peripheral neuropathy, and bone marrow suppression, and some patients are intolerant. Patients with intolerance to cisplatin don’t have any preoperative/neoadjuvant therapy that can bring survival benefits.

"We are very pleased that FDA approved the IND application for oral APL-1202 in combination with tislelizumab as a neoadjuvant therapy in MIBC patients," said Dr. Xue Yong, MD, PhD, Chief Medical Officer at Asieris. "The approval is expected to accelerate the clinical development, and Asieris will conitnue to explore cutting-edge technologies and therapeutics in our focused areas to meet the urgent medical needs and establish an outstanding portfolio that covers diagnosis and treatment to benefit more patients. "

On June 14, 2021 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported the launch of TelixU, a new educational platform focused on radiopharmaceutical research in partnership with leading medical imaging journal, Applied Radiology (Press release, Telix Pharmaceuticals, JUN 14, 2021, View Source [SID1234583973]). This website is specifically designed for healthcare professionals such as physicians and technologists, and features case studies, webinars, and technologist education.

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The launch of TelixU coincides with this year’s Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, and with over 20 sessions on gallium-68 (68Ga), the website will be a welcome resource for those looking for more information about prostate specific membrane antigen (PSMA) targeted radiopharmaceuticals. "We are proud to support SNMMI and their endeavors to educate physicians and their membership," says Colin Hayward, MBBS FFPM, Chief Medical Officer, Telix Pharmaceuticals. "Our participation in this year’s Virtual Annual Meeting is an ideal platform to introduce this valuable resource."

The Case Studies section provides peer-to-peer insight about PSMA PET/CT1 imaging, whilst ‘Technologist Education’ is a wide-ranging resource for anyone delivering PSMA imaging services and includes patient considerations, PET/CT imaging protocols, and operational and workflow resources.

"Applied Radiology is delighted to support Telix in this endeavor," said Kieran Anderson, Vice President and Group Publisher at Anderson Publishing Ltd., publishers of Applied Radiology and Applied Radiation Oncology. "We have a long history of working closely with key opinion leaders and industry. We develop high-quality, informative, and engaging content, and TelixU is the latest example, as it builds on our continued commitment to the medical imaging community."

TelixU is intended for healthcare professionals only.

About Anderson Publishing

Anderson Publishing, Ltd. is a leading medical communications and publishing company dedicated to producing high-quality, informative, and engaging content for the medical imaging and radiation oncology communities. Its primary brands include Applied Radiology, in publication since 1971, and Applied Radiation Oncology, in publication since 2012. Together, they reach a global audience of over 60,000 radiologists, nuclear medicine physicians, radiation oncologists, physicists, radiation therapists, nuclear medicine technologists, radiologic technologists, radiology administrators, and related imaging professionals.

On June 14, 2021 SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high potency, fully-human polyclonal antibodies at scale, reported that Eddie J. Sullivan, PhD, co-founder, president, CEO, will serve as an expert panelist during BIO Digital 2021 (Press release, SAB Biotherapeutics, JUN 14, 2021, View Source [SID1234583972]). The panel, "One Health Preparedness and Response: Translating Surveillance of Emerging Zoonotic Diseases into Biotechnology," will be moderated by Catherine Machalaba, MPH, PhD, senior policy advisor and senior scientist at EcoHealth Alliance. The panel is scheduled on Monday, June 14, 2021, from 11:05 AM to 11:50 AM EDT.

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One Health, or the concept that animal, human, and environmental health are interconnected, has been made readily apparent by the recent COVID-19 pandemic. The World Health Organization estimates that more than 60% of human diseases are zoonotic and that 75% of diseases discovered over the past decade originate in animals. The panelists, who include public health experts and Company leaders, will examine how the biotechnology industry can contribute to solutions to ensure the world is prepared for continuing zoonotic threats to human health.

Dr. Sullivan commented, "We have spent nearly two decades at SAB developing and optimizing our unique platform that leverages transgenic cows to rapidly produce large quantities of highly potent, fully-human therapeutic polyclonal antibodies targeted at specific diseases. Responding to the COVID-19 pandemic has provided us the opportunity to fully integrate and accelerate scale-up of our drug development, regulatory and production capabilities. We look forward to sharing what we have learned and providing a model for future response with our colleagues committed to applying 21st century biotechnology to combat these ongoing threats to global well-being."

About BIO:

BIO is the world’s largest advocacy association representing member companies, state biotechnology groups, academic and research institutions, and related organizations across the United States and in 30+ countries. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products. For more information on BIO Digital 2021, visit www.bio.org/events/bio-digital.

On June 14, 2021 Lantheus Holdings, Inc. (the "Company") (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions, reported that data from the piflufolastat F 18 (formerly known as 18F-DCFPyL) CONDOR pivotal trial will be presented at the Virtual Society of Nuclear Medicine and Molecular Imaging (SNMMI) annual meeting (Press release, Lantheus Medical Imaging, JUN 14, 2021, View Source [SID1234583971]).

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Dr. Steven Rowe, Associate Professor of Radiology and Radiological Science at Johns Hopkins University, will deliver an oral presentation entitled: "A Phase 3 study of 18F-DCFPyL-PET/CT in Patients with Biochemically Recurrent Prostate Cancer (CONDOR): An Analysis of Disease Detection Rate and Positive Predictive Value (PPV) by Anatomic Region" on Tuesday, June 15, 2021. The presentation was also selected to be included in the Henry N. Wagner, Jr., MD Highlights Symposium plenary session.

In the CONDOR trial, piflufolastat F 18 detected and localized metastatic lesions with high positive predictive value (PPV) regardless of anatomic region in men with biochemically recurrent prostate cancer where standard imaging was uninformative. The median detection rates for prostate/prostate bed, lymph nodes and extra-pelvic region were: 20.2% (CI: 14.7-25.6%), 35.1% (CI: 28.6-41.6%) and 26.4% (CI: 20.4-32.4%), respectively. The median PPV (≥1 lesion confirmed) by anatomic region was: 79.5% (CI: 66.8-92.2%) for the prostate/prostate bed, 70.9% (CI: 58.9-82.9%) for pelvic lymph nodes and 67.4% (CI: 53.8-80.9%) for the extra-pelvic region.

Oral Presentation Details are as follows:
Title: A Phase 3 study of 18F-DCFPyL-PET/CT in Patients with Biochemically Recurrent Prostate Cancer (CONDOR): An Analysis of Disease Detection Rate and Positive Predictive Value (PPV) by Anatomic Region
Lead Author: Steven Rowe, Johns Hopkins University
Session Date and Time: June 15, 2021 2:00 – 3:00 PM ET
Session Title: Advances in PET Imaging for Cancer: Highlights of Clinical Diagnostics in Oncology

About PYLARIFY (piflufolastat F 18) Injection

PYLARIFY (piflufolastat F 18) injection (also known as 18F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope5 for superior diagnostic performance. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.1-6

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States — an estimated one in eight men will be diagnosed with prostate cancer in their lifetimes. The American Cancer Society estimates that in 2021, almost 250,000 new cases of prostate cancer will be diagnosed, and more than 30,000 men will die of the disease. Approximately 3.1 million men in the United States currently count themselves as prostate cancer survivors.7

PYLARIFY (piflufolastat F 18) Injection

Indication

PYLARIFY (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

with suspected metastasis who are candidates for initial definitive therapy.
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
Important Safety Information

Contraindications

None.

Warnings and Precautions

Risk of Image Misinterpretation

Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Hypersensitivity Reactions

Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

Radiation Risks

Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

Adverse Reactions

The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

Drug interactions

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.