On November 29, 2021 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to proceed with a Phase 1b/2 clinical trial of its anti-CTLA-4 monoclonal antibody (mAb), ADG116, in combination with the anti-PD-1 antibody, pembrolizumab (Press release, Adagene, NOV 29, 2021, View Source [SID1234596225]). The global trial (ADG116-P001 / KEYNOTE-C97) will evaluate patients with advanced/metastatic solid tumors at multiple sites in the U.S. and Asia Pacific (APAC).

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ADG116 utilizes Adagene’s proprietary NEObody platform technology and is designed to target a unique conserved epitope of CTLA-4 with enhanced efficacy by potent Treg depletion in the tumor microenvironment (TME). ADG116 is designed with a soft ligand blocking to address safety concerns associated with existing CTLA-4 therapeutics.

"The FDA clearance of this trial represents a significant milestone for our anti-CTLA-4 program as we advance our evaluation of ADG116 in combination with anti-PD-1 therapy," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "By applying NEObody technology, ADG116 can overcome existing safety limitations of anti-CTLA-4 therapies to achieve improved clinical benefit. Our exploration of ADG116 with pembrolizumab aims to unleash the dual CTLA-4/PD-1 blockade and realize the full potential of this combination therapy approach as a cornerstone of cancer treatment – balancing safety and efficacy."

The ADG116-P001 trial is expected to dose the first patient in early 2022, and is designed to evaluate the safety and tolerability, determine the maximum tolerated dose, and assess preliminary efficacy of the combination of ADG116 and pembrolizumab.

Additionally, the ongoing ADG116-1003 trial is on track to expand with two combination cohorts investigating safety and preliminary efficacy of ADG116 with either toripalimab or ADG106 in patients with advanced/metastatic solid tumors.

On November 29, 2021 Ablaze Pharmaceuticals ("Ablaze"), a clinical-stage pharmaceutical company focused on the development and commercialization of innovative targeted radiopharmaceutical therapies (TRT) against tumor targets, reported a $75 million Series A financing round (Press release, Ablaze Pharmaceuticals, NOV 29, 2021, View Source [SID1234596220]). The financing was co-led by Vivo Capital and AdvanTech Capital with participation from RAYZ Investments, Nan Fung Life Sciences, Pivotal bioVenture Partners China, venBio Partners, Samsara BioCapital and Venrock Healthcare Capital Partners.

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"Targeted radiopharmaceutical therapies represent the next foundational modality to treat cancer," said Dr. Ken Song, co-founder and Chairman of the Board of Ablaze and President and CEO of RayzeBio, Inc. "In forming Ablaze, we realized to be successful, it was critical to have a company focused on the China market and focused on radiopharmaceuticals."

With TRT gaining broader interest and adoption, Ablaze was formed to become the leading radiopharmaceutical company to introduce TRT products to the Greater China market. Led by an experienced team and a strong investor syndicate, Ablaze started on a solid footing, anchoring with a strategic RayzeBio in-licensing agreement, and a partnership with an academic institution on a clinical stage asset. Upon closure of the Series A, Ablaze is also actively exploring other potential partnerships, and building strong internal development capabilities.

"TRT is an emerging field that has already demonstrated tremendous clinical efficacy in treating cancer worldwide. We are privileged to have an opportunity to partner with Ablaze and the RayzeBio team in developing this category of potentially life-saving therapeutics for cancer patients in China." said Dr. Hongbo Lu, Managing Partner of Vivo Capital.

Proceeds from the Series A financing will be used by Ablaze to establish a leading pipeline of advanced TRT products for the treatment of solid tumors, expand the leadership team, build up infrastructure for radiopharmaceuticals and secure further strategic collaborations. The board of directors include Dr. Alex Qiao, co-founder and President and CEO of Ablaze Pharmaceuticals, Dr. Hongbo Lu, Benjamin Qiu, Partner at AdvanTech Capital, Dr. Aaron Royston, Managing Partner at venBio Partners, and Dr. Ken Song as well as Norman Tse, Vice President at Nan Fung Life Sciences as board observer.

"We believe Ablaze is bringing world class design of TRT products as well as clinical expertise to China through collaborations with global leaders in TRT, and is determined to be a leading player in China’s TRT innovations" said Mr. Benjamin Qiu.

"We are excited about this opportunity to bring a novel class of therapeutic products to benefit patients in China," said Dr. Alex Qiao. "This investment from top tier investors in China and abroad provides a strong endorsement to Ablaze’s vision and business model. We look forward to creating the best and differentiated medicines to address unmet medical needs in China."

On November 29, 2021 Kheiron Medical Technologies reported its new collaboration with researchers at Stanford University to design functional proof-of-concept deep learning models to solve clinical problems in novel ways, starting with Non-Hodgkin’s Lymphoma (NHL) (Press release, Stanford University, NOV 29, 2021, View Source [SID1234596219]). With the collaboration, Kheiron, which has pioneered the development and deployment of artificial intelligence solutions to help radiologists detect breast cancer earlier, will leverage its existing technologies and expertise to expand into new imaging modalities and cancer types. This furthers its mission of transforming cancer diagnostics through the power of deep learning.

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The collaboration aims to harness the collective expertise of the Stanford Center for Artificial Intelligence in Medicine & Imaging (AIMI Center) and Kheiron. This endeavour will be referred to as ‘The Kaplan Project’ in honor of Stanford’s former radiation oncology leader, Dr. Henry Kaplan, who in the 1960s developed some of the earliest treatments for lymphoma. The Kaplan Project aligns to the AIMI center’s mission, where interdisciplinary expertise is the foundation to help solve clinically important problems in medicine using AI.

"Projects like this one are so exciting because they capitalize on collaborations not only between clinicians and data scientists, but also between academics and industry," said Dr. Curt Langlotz, Director of the AIMI Center.

The purpose of staging lymphoma is to quantify the extent of disease, guide decisions around therapy, and provide a baseline prior to treatment. For oncological radiologists, the tasks of staging and evaluating post-treatment response on PET/CT scan images is manual and time-consuming.

The Kaplan Project will seek to apply Kheiron’s deep learning technology to FDG-PET/CT images of lymphoma patients to enhance two key radiologist outcomes: improving radiologist efficiency and improving radiologist accuracy.

"This groundbreaking project marks a new chapter in the application of AI to transform cancer diagnostics across the entire patient pathway," said Dr. Peter Kecskemethy, CEO of Kheiron. "Uniting new deep learning technologies with the clinical expertise of academic research institutions like Stanford will lead to the development of a completely new category of AI diagnostics and ultimately improve patient outcomes."

"Our project aims to improve a time-consuming and mostly qualitative process, the longitudinal assessment of whole-body FDG-PET/CT scans, using deep learning to augment imaging specialists," said Dr. Guido A. Davidzon, Clinical Associate Professor at Stanford University. "The overarching goal is to reduce the time needed to evaluate a PET scan, and by improving our throughput, ultimately increase patient access to a well-established noninvasive diagnostic imaging tool used by oncologists in the care of cancer."

On November 29, 2021 Shanghai Henlius Biotech, Inc. (2696.HK) reported that the filing of a clinical trial for HLX301, a Recombinant Humanized Anti-PDL1 and Anti-TIGIT Bispecific Antibody, in Patients with locally advanced or metastatic solid tumours has been approved by the Bellberry Human Research Ethics Committee ("HREC"), and Clinical Trial Notification ("CTN") has been acknowledged by the Therapeutic Goods Administration ("TGA"), Australia (Press release, Shanghai Henlius Biotech, NOV 29, 2021, View Source [SID1234596218]). The Phase 1 clinical study in Australia is intended to be initiated soon. No bispecific antibody targeting PD-1/PD-L1 and TIGIT has been approved for marketing globally yet.

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Immunotherapies targeting immune checkpoint protein interactions between ligands and receptors offer a novel way to attack tumour cells in recent years. PD-1/PD-L1 plays a vital role in immune suppression; PD-1 and PD-L1 inhibitors show significant effectiveness in cancer treatment. TIGIT (T cell immunoreceptor with immunoglobulin and ITIM domains) is an inhibitory receptor, mainly expressed on natural killer (NK) cells and activated T cells and T regulatory cells. TIGIT binds to the major ligand CD155 (poliovirus receptor, PVR), mainly expressed on antigen-presenting cells (APC) or tumour cells, to down-regulate T cell and NK cell functions. TIGIT can inhibit innate and adaptive responses in various mechanisms and act as a "brake" like PD-1/PD-L1 does to stop T cells from attacking tumours. Several pre-clinical studies have indicated that TIGIT blockade may be effective against multiple advanced cancers, including NSCLC, GC, melanoma, and MM.

Independently developed by Henlius, HLX301 is an innovative anti-PD-L1 and anti-TIGIT bispecific antibody. Its TIGIT binding domain is derived from VHH fragments with high affinity and specificity to TIGIT, selected from the company’s synthetic humanized llama VHH library. Pre-clinical studies reported that HLX301 can simultaneously block both PD-1/PDL1 and TIGIT/PVR pathways, restore TCR signaling, inhibit tumour growth, and has good tolerance and safety. These results suggested that HLX301 is superior to blocking either pathway alone or anti-PD-L1 + anti-TIGIT combination therapy, paving the way for further clinical development.

Underpinned by the patient-centric strategy, Henlius achieves an overall layout of the immune checkpoint products of PD-1/L1, CTLA-4, LAG-3, BRAF, etc., proactively exploring immuno-oncology combination therapy, bispecific antibodies and ADC. Looking forward, Henlius will continue strengthening the in-licensing and collaboration on external innovative assets and bringing high-quality and affordable therapies to patients worldwide.

On November 29, 2021 On Target Laboratories, Inc., a privately-held biotechnology company developing fluorescent imaging agents to target and illuminate cancer during surgery, reported that the U.S. Food and Drug Administration (FDA) has approved CYTALUX for adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions (Press release, On Target Laboratories, NOV 29, 2021, View Source [SID1234596216]). CYTALUX is the first targeted fluorescent imaging agent that illuminates ovarian cancer intraoperatively, enabling the detection of more cancer for removal. CYTALUX, administered by standard IV in as little as one hour before surgery, binds to folate receptors that are overexpressed in most epithelial ovarian cancersi and illuminates intraoperatively under near-infrared light.

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"Complete removal of all malignant tissue is the goal of ovarian cancer surgery, however identifying all lesions can be challenging," said Dr. Janos L. Tanyi, MD, PhD, Associate Professor of Obstetrics and Gynecology, University of Pennsylvania Perelman School of Medicine and Investigator on the Phase 2 and 3 studies. "In the Phase 3 study, additional cancer was detected in 27% of patients, showing great promise in the ability of CYTALUX to help surgeons identify malignant lesions that may otherwise be missed during surgery."

Ovarian cancer is the number one cause of gynecologic cancer death in the United Statesii. Cytoreductive surgery is a well-established treatment for ovarian cancer, however, a study showed that among patients reported to have undergone optimal cytoreduction, 40% were found to have measurable disease on 30-day postoperative imagingiii. CYTALUX serves as an adjunctive tool for surgeons to identify additional malignant ovarian cancer lesions that may have been missed by standard visual inspection and palpation, increasing the detection of more cancer during surgery.

Adverse reactions consisting of nausea, vomiting, abdominal pain, flushing, indigestion, chest discomfort, and itching were reported during the administration of CYTALUX (see additional Important Safety Information below).

"This FDA approval is a significant milestone towards achieving On Target’s mission to make cancer visible during surgery so it can be removed more completely," said Chris Barys, President and Chief Executive Officer of On Target Laboratories. "We are excited about the potential impact CYTALUX can have for patients in their fight against ovarian cancer. Our goal is to make CYTALUX a standard of care for ovarian cancer surgery and we look forward to exploring the use of our technology for patients suffering from other cancers."

CYTALUX received Priority Review and both Fast Track and Orphan designations from the FDA. Additionally, CYTALUX is being investigated in cancer of the lung in a Phase 3 trial under Fast Track designation.

About Fluorescence-Guided Surgery

To date, there have been limited ways for surgeons to confidently assess the location and full extent of cancerous tissue while operating. On Target Laboratories’ targeted fluorescent imaging agents are comprised of a near-infrared dye and a targeting molecule, or ligand, that binds to receptors overexpressed on cancer cells. The imaging agents illuminate the cancerous tissue, which may enable surgeons to detect more cancer that otherwise may have been left behind.

On Target’s first novel compound, CYTALUX, targets folate receptors commonly found on many cancers, such as ovarian cancer. A single dose of the agent is administered via intravenous infusion prior to surgery to help the surgeon identify additional malignant tissue during the operation using a near-infrared imaging system.