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Stanford University Partners with Kheiron Medical Technologies to Pioneer Use of AI in New Areas of Oncology

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."

Henlius Novel Anti PD-L1/TIGIT Bispecific Antibody Received Clinical Trial Approval in Australia

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.

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 Target Laboratories Announces FDA Approval of CYTALUX™ (pafolacianine) injection for Identification of Ovarian Cancer During Surgery

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.

"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.

Applied BioMath, LLC Announces Participation at the Cytokine-Based Cancer Immunotherapies Summit

On November 29, 2021 Applied BioMath (www.appliedbiomath.com), the industry-leader in providing model-informed drug discovery and development (MID3) support to help accelerate and de-risk therapeutic research and development (R&D), reported their participation at the Cytokine-Based Cancer Immunotherapies Summit occurring November 30th to December 2nd, 2021 in Boston, MA (Press release, Applied BioMath, NOV 29, 2021, View Source [SID1234596215]).

Fei Hua, PhD, VP of Modeling and Simulation Services at Applied BioMath will present "Application of Quantitative Systems Pharmacology (QSP) Models in the Development of Immunocytokines" at the conference on Thursday, December 2nd at 3:00 p.m. In the presentation, Dr. Hua will discuss how QSP models can be used to help understand pharmacokinetic (PK) and pharmacodynamic (PD) complexities of immunocytokines and accelerate R&D.

"Understanding complex modalities such as immunocytokines is extremely resource intensive and difficult to do without the use of mathematical models," said John Burke, PhD, Co-founder, President and CEO of Applied BioMath. "Mechanistic modeling approaches help project teams more quickly understand these complexities to help accelerate therapeutic design, development, and better enable translation into the clinic and provide clinical support."

Applied BioMath’s solutions, which focus on quantitatively integrating knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms, are leveraged across the entire R&D spectrum from early research through all phases of clinical trials. Their approach involves working with clients to develop the appropriate mathematical strategy for each unique project, with common biosimulation software and services strategies including systems pharmacology, mechanistic modeling, PKPD, bioinformatics, and clinical pharmacology.

SQZ Biotechnologies to Present at the 4th Annual Evercore ISI HealthCONx Conference

On November 29, 2021 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported that management will be presenting at the 4th Annual Evercore ISI HealthCONx Conference on December 1st (Press release, SQZ Biotech, NOV 29, 2021, View Source [SID1234596214]). Armon Sharei, Ph.D., Chief Executive Officer, will present a corporate overview and the company will be hosting one-on-one meetings.

PRESENTATION DETAILS

Wednesday, December 1
4th Annual Evercore ISI HealthCONx Conference
Fireside Chat
9:15-9:35 am ET
Webcast

Specific conference webcast details and the company’s corporate overview presentation will be available on the Investors & Media section of the SQZ website. The webcast will be available for 90 days following the presentation.