On September 27, 2022 Optellum, an Oxford-based medtech company that provides a breakthrough AI platform to diagnose and treat early-stage lung cancer, reported that has raised $14 million in a Series A funding round (Press release, Optellum, SEP 27, 2022, View Source [SID1234621495]). The investment will enable Optellum to scale its base, operations, and commercial launches in the UK and USA; accelerate research and development; and expand its platform into personalized therapy decisions by integrating imaging data with molecular data, robotics, and liquid biopsies.

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Optellum is a commercial-stage lung health company providing artificial intelligence decision-support software that assists physicians in early diagnosis and optimal treatment for their patients. The company was founded so that every lung disease patient is diagnosed and treated at the earliest possible stage, when the probability of better health outcomes is highest.
Optellum is a commercial-stage lung health company providing artificial intelligence decision-support software that assists physicians in early diagnosis and optimal treatment for their patients. The company was founded so that every lung disease patient is diagnosed and treated at the earliest possible stage, when the probability of better health outcomes is highest.
This funding round was led by Mercia, with additional investors Intuitive Ventures (Sunnyvale, CA, USA) and Black Opal Ventures (New York, NY, USA). Existing investors, including St John’s College in the University of Oxford, IQ Capital, and the family office of Sir Martin & Lady Audrey Wood, also participated in this round.

Lung cancer is the most common type of cancer and the leading cause of cancer deaths in the world. Approximately 150,000 people in the United States and 1.8 million people worldwide die from lung cancer each year. The current worldwide five-year survival rate is 20 percent, primarily because most patients are diagnosed after symptoms have appeared and the disease has progressed to an advanced stage (Stage III or IV). In contrast, the survival rate for small tumors treated at Stage 1A is up to 90 percent. This disparity highlights a critical need for diagnosis and treatment at the earliest stage possible.

Optellum is the leader in AI-enabled lung cancer diagnosis, and the first and only medtech company to attain FDA clearance, CE-MDR in the EU, and UKCA in the UK for its software platform Virtual Nodule Clinic. This first-of-a-kind platform can help physicians identify and track at-risk patients, and optimally diagnose the signs of lung cancer early, so treatment can be started sooner for patients with tumors, and invasive procedures such as biopsies on benign lesions can be minimized.

Jason Pesterfield, CEO at Optellum, said: "With this strong support and commitment of highly specialized investors, we are positioned to accelerate commercial deployment in both the UK and the United States to expand our installed base. Following years of research and clinical trials that have shown the impact of our software on the diagnosis of at-risk lung nodules, we’re focused on expanding patient access to this crucial technology and identifying deadly lung cancer faster in more at-risk people. The funding will also boost our research and development with world-leading institutions and partners to progress further innovation."

Lead investor Mercia brings expertise in software technologies having a significant impact on global health issues and an existing portfolio that includes AI and machine-learning technology.

Investment Director at Mercia, Stephen Johnson, said: "Optellum is the latest in a series of companies to channel research from the UK’s world-leading universities into commercially viable products that can make a difference to the provision of medical care. Having observed Optellum achieve great milestones over the years, we are now excited to become part of their success and apply our experience with scaling up software and deep-tech companies to help accelerate Optellum’s impact on patient lives across the world."

Intuitive Ventures, the independent venture-capital arm of Intuitive (NASDAQ: ISRG), a world leader in medical robotics, including lung cancer care, was founded in 2020 to accelerate the future of minimally invasive care. The investment team supports Optellum’s ambitions to think and move beyond earlier diagnosis into decision support across the treatment pathway, integrating liquid biopsies, molecular tests, and drug therapies.

"Lung cancer is an urgent public health crisis and Optellum’s groundbreaking approach utilizing AI to accelerate early detection and intervention may fundamentally alter the healthcare community’s approach to combating this disease," said Oliver Keown, MD, managing director of Intuitive Ventures. "Optellum is uniquely positioned to align and provide considerable value to patients, providers, and payers alike. Intuitive Ventures is thrilled to provide our full arsenal of financial and strategic support to Optellum as we work towards a world of better outcomes for cancer patients."

Physician-led, female-founded fund Black Opal Ventures has a mission to build better businesses and a better future at the intersection of healthcare and technology. Its expertise in reimbursement and health economics will assist Optellum, which recently announced a New Technology Ambulatory Payment Classification for Medicare patients in the USA.

Founder Tara Bishop, MD, commented: "We value solutions that make medicine more accurate and accessible. The strong validation data that underpins the Optellum solution has demonstrated its ability to make a difference to patients. We share Optellum’s vision of making this available to every doctor in every hospital – and transform the diagnosis and treatment path for lung cancer."

Optellum’s platform was developed and clinically validated in partnership with leading universities and healthcare systems around the world. Optellum also has strategic collaborations with GE Healthcare and the Lung Cancer Initiative at Johnson & Johnson to accelerate clinical deployments and continue the advancement of the platform. In the UK, Optellum’s solution is being used to predict at-risk lung nodules in a multi-center study with NHS Trusts as part of a major investment in AI for healthcare.

On September 27, 2022 The Cancer Research Institute (CRI), a nonprofit organization dedicated to harnessing the immune system’s power to control and potentially cure all types of cancer, reported that it will confer its prestigious 2022 William B (Press release, Cancer Research Institute, SEP 27, 2022, View Source [SID1234621488]). Coley Award for Distinguished Research in Basic and Tumor Immunology on four scientists for their collective work that revealed the role of the pore-forming gasdermins in pyroptosis and promotion of anti-tumor immunity, setting the stage for targeting gasdermins in cancer therapeutics.

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Judy Lieberman, M.D., Ph.D., and Hao Wu, Ph.D., of Boston Children’s Hospital and Harvard Medical School, Feng Shao, Ph.D., of the National Institute of Biological Sciences, Beijing, and Vishva Dixit, M.D., of Genentech will receive their Coley Awards during an evening ceremony taking place Tuesday, September 27, at The New York Hilton Midtown, where CRI with its partners the European Network for Cancer Immunotherapy (ENCI) and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) will host their four-day International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper).

Gasdermins (GSDMs) are a family of proteins originally identified and named from their expression in the gastrointestinal tract and the skin. In 2015, Dixit and Shao’s groups discovered that gasdermin D (GSDMD) is a substrate of inflammatory caspases, which are activated downstream of the immune system’s inflammasomes when they sense pathogen- or damage-associated molecules. GSDMD is the key executioner of inflammasome-induced inflammatory cell death called pyroptosis in immune sentinel cells and is responsible for the secretion of IL-1 family cytokines. Pyroptosis is a highly immunogenic form of cell death, and pyroptosis in cancer in theory could result in the release of danger-associated molecules and neoantigens to alert the immune system and promote antitumor immunity.

In 2016, Lieberman and Wu, and Shao, went on to demonstrate the mechanisms by which gasdermins effect cell death. Specifically, they discovered that upon processing by inflammatory caspases, the GSDMD N-terminal domain (GSDMD-NT) binds acidic lipids and forms cell membrane pores that are responsible for cell death. These pores also release mature IL-1 family cytokines and other danger signals, including chemokines, which recruit and activate immune cells to the site of danger. The requirement for binding to acidic lipids for GSDMD pore formation and the enrichment of these lipids in the inner leaflet of the cytoplasmic membrane suggested that GSDMD kills from within the cell but does not harm bystander mammalian cells. Lieberman and Wu further showed that GSDMD kills bacteria upon activation by binding to an acidic lipid called cardiolipin on bacterial membranes. Shao developed a crystal structure of a GSDM family member, mouse GSDMA3, showing that GSDMD-NT is autoinhibited by the GSDMD C-terminal region in full-length GSDMD. Dixit and other groups subsequently published their identification of the pore-forming activity of GSDMD.

"Discovery of the pore-forming activity of GSDM proteins changed the definition of pyroptosis from a ‘fiery death’ induced by inflammasome activation to GSDM-mediated lytic cell death, opening the search for other proteolytic pathways for activating GSDMD and other GSDMs," says Frederick W. Alt, Ph.D., a Howard Hughes Medical Institute Investigator and director of the Program in Cellular and Molecular Medicine at Boston Children’s Hospital and a member of the CRI Scientific Advisory Council.

The direct relationship to cancer of another gasdermin, GSDME, became clear in a series of papers authored by Lieberman and Wu, and Shao. They showed that the expression of GSDME is often repressed or mutated to lose its function in cancers while expression of GSDME converts noninflammatory apoptosis to inflammatory pyroptosis, effectively altering immunogenically "cold" tumors that do not ignite an anticancer immune response into "hot" tumors that attract killer cytotoxic T lymphocytes and natural killer cells. Shao showed that delivery of gasdermins via cancer-targeting nanoparticles can result in cancer cell pyroptosis in mice, resulting in the suppression of entire tumor grafts, not only the targeted tumor tissue because the treatment activated an effective adaptive immune response to the tumor.

"The groundbreaking molecular and mechanistic studies carried out by Lieberman and Wu, Shao, and Dixit along with the preclinical development of effective therapeutics that can convert immunologically cold tumors to hot have made possible therapeutic interventions that specifically activate GSDMs in cancer cells to promote antitumor immunity and responsiveness to checkpoint blockade immunotherapy," said Jill O’Donnell-Tormey, Ph.D., CEO and director of scientific affairs at the Cancer Research Institute.

In addition to presenting the 2022 William B. Coley Award, the ceremony will also feature the presentation of the 2022 Frederick W. Alt Award for New Discoveries in Immunology to David Masopust, Ph.D., the McKnight University Professor and a Howard Hughes Medical Institute Faculty Scholar in the Department of Microbiology and Immunology at the University of Minnesota, for his body of research focused on T cell development and biology, primarily memory T cell development and behavior. The Alt Award is given to a former CRI postdoctoral fellow whose work has made a significant impact on the fields of immunology or tumor immunology. Masopust received CRI funding while carrying out postdoctoral research in the laboratory of renowned immunologist and virologist Rafi Ahmed, Ph.D., at Emory University, from 2002-2005.

About the William B. Coley Award for Distinguished Research in Basic and Tumor Immunology
The Cancer Research Institute established this award in 1975 in honor of Dr. William B. Coley, now regarded as the Father of Cancer Immunotherapy, whose daughter Helen Coley Nauts (1907-2001) founded the Cancer Research Institute. Considered CRI’s highest scientific accolade as well as a predictor of more widely recognized scientific honors including the Lasker Award and Nobel Prize, the Coley Award has been given to 119 immunologists and tumor immunologists including the 2022 recipients.

On September 27, 2022 LUNGevity Foundation, the nation’s leading lung cancer-focused nonprofit organization, reported the recipients of their 2022 Career Development Awards (Press release, LUNGevity Foundation, SEP 27, 2022, View Source [SID1234621487]).

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LUNGevity’s Career Development Awards (CDA), now in their 11th consecutive year, support a cohort of future research leaders who will keep the pipeline of lung cancer research energized with new ideas and novel approaches. Awardees receive funding for their research projects, coveted mentorship opportunities, and serve as non-voting members of LUNGevity’s Scientific Advisory Board for the term of the awards. They also receive training in effective science communications.

"It’s a privilege to announce the 2022 class of LUNGevity Career Development Awardees. As we just completed a systematic analysis of the lung cancer treatment landscape, we are confident these CDAs will address key unmet needs in the treatment landscape—developing immunotherapy combination approaches in the treatment of early-stage and metastatic non-small cell lung cancer, and new treatment options for rare lung cancers." says Upal Basu Roy, PhD, MPH, Executive Director of Research at LUNGevity. "By funding these early career researchers, LUNGevity helps to retain promising scientists in the lung cancer space. The CDA program encourages their continued focus on the key challenges facing the lung cancer community and contributes to a robust pipeline of dedicated lung cancer researchers."

Past recipients of these awards have developed their own independent research programs, received major grants from the NIH and other funders, and even succeeded in getting a new treatment approved by the FDA. This year, the recipients of this prestigious award are:

Kristen Marrone, MD
Johns Hopkins School of Medicine
Project: Phase 2 trial of neoadjuvant KRAS G12C directed therapy in resectable NSCLC

Dr. Marrone will conduct a phase 2 clinical trial to test whether treatment with a KRAS G12C blocking drug, adagrasib, given as a single drug or in combination with an immunotherapy drug, nivolumab, before a patient undergoes surgery, can delay or prevent recurrence in patients with early-stage non-small cell lung cancer (NSCLC) whose tumors have a KRAS G12C mutation.

Michael Offin, MD
Memorial Sloan Kettering Cancer Center
Project: Therapeutic targeting of BRAF fusion altered lung cancer

Dr. Offin will be testing a series of new drugs in pre-clinical cell lines and animal models of lung cancer that contain BRAF fusions, which are known to be powerful stimulators of lung cancer development. Currently no targeted treatment exists for cancers that harbor these BRAF fusions. The goal of this project is to identify new drugs for this unmet need that can be tested in clinical trials.

Joshua Reuss, MD
Georgetown University
Project: Combination checkpoint blockade plus VEGF inhibitor in EGFR-mutated NSCLC

Dr. Reuss is conducting a phase 2 clinical trial to test whether a regimen of two immunotherapy drugs, atezolizumab and tiragolumab, given in combination with a VEGF inhibitor, bevacizumab, is effective in controlling EGFR-positive NSCLC that has become resistant to osimertinib.

LUNGevity implements a rigorous process to carefully select awardees. Each research project is evaluated by a multidisciplinary review committee of thoracic oncology leaders, who are committed to finding lung cancer at its earliest, most treatable phase, as well as for extending and improving the lives of lung cancer survivors.

"Congratulations to these awardees. When they look back, years from now, I believe this support from LUNGevity is likely to be viewed as an important turning-point in their careers," said Charles Rudin, MD, PhD, Professor and Chief of the Thoracic Oncology Service at Memorial Sloan Kettering Cancer Center and Chair of LUNGevity’s Scientific Advisory Board. "These exceptional young investigators are poised to bring tremendous growth and improvements in our treatment of lung cancer. And I’m proud that LUNGevity Foundation is catalyzing their progress. "

LUNGevity is the only lung cancer organization with a programmatic focus on early detection and a strong Career Development Award Program. LUNGevity-funded researchers are working on finding a better way to detect lung cancer, and to better diagnose, treat, and prevent its recurrence. The Foundation’s translational research program, including the CDA awards, seeks to move the science forward to improve outcomes for people living with lung cancer.

LUNGevity’s Career Development Awards program is supported by Genentech.

On September 27, 2022 Susan G. Komen, the world’s leading breast cancer organization, reported that it is expanding its screening and diagnostics program from nine cities to 12 (Press release, Susan G Komen, SEP 27, 2022, View Source [SID1234621486]). Now, income-eligible residents from Dallas, Los Angeles, and Memphis also can access no-cost, breast cancer screening and diagnostic services . Atlanta, Chicago, Fort Worth, Houston, Madison, WI, Marshfield, WI, Philadelphia, Virginia Beach and Washington D.C. are the other cities where the program is already operating.

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"The screening and diagnostics program is critical for individuals who may have been putting off their breast cancer screening due to concerns about cost," said Victoria Wolodzko Smart, Senior Vice President of Mission at Susan G. Komen. "Early detection saves lives, and cost should not be a barrier to accessing high-quality health care services for anyone in need. Through expanding this program, we are breaking down barriers for more people."

Komen’s Patient Care Center offers no-cost, breast cancer screening and diagnostics services in 12 U.S. cities.

The Komen screening and diagnostics program is a service provided through the Komen Patient Care Center. Individuals who meet income qualifications will be able to access no-cost breast cancer screening mammograms and necessary diagnostic follow-up tests. They will receive a voucher and be connected to a local health system that has partnered with Komen to provide the services.

The local health systems that have partnered with Komen include:

City

Health System

Atlanta

Northside Hospital

Wellstar Health System

Chicago

NorthShore University HealthSystem

Dallas

Texas Health Presbyterian Hospital Dallas

Ft. Worth

Moncrief Cancer Institute

Houston

Houston Methodist Neal Cancer Center

Los Angeles

Alinea Medical Imaging

Madison, WI

University of Wisconsin Health

Marshfield, WI

Marshfield Clinic Health System

Memphis

Baptist Memorial Hospital

Philadelphia

Penn Medicine: University of Pennsylvania Health System

Virgina Beach

Chesapeake Regional Medical Center

Sentara Healthcare

Washington DC

Luminis

Breast Care for Washington

Last year, Susan G. Komen provided nearly 3,000 screening and diagnostics services. Now, with the voucher program, Komen hopes to serve another 3,000 individuals in 2023. "The screening and diagnostics program is active in the 10 metropolitan areas where the breast cancer mortality gap between Black and white women is the greatest." says Cati Diamond Stone, Vice President of Community Health at Susan G. Komen. "As part of Komen’s work to achieve health equity for all, we are eliminating barriers for people who cannot get timely, and high-quality health care they need."

Income eligible people seeking access to a breast cancer screening mammogram or diagnostic service should contact the Komen Breast Care Helpline at 1-877-465-6636 or [email protected] to learn more.

About Breast Cancer Screening
Screening mammography tests are used to find breast cancer before it causes any warning signs or symptoms. Regular screening tests along with follow-up tests and treatment, if diagnosed reduce an individual’s chance of dying from breast cancer.

Mammography is a test that uses X-rays to create images of the breast. These images are called mammograms. A radiologist trained to read mammograms studies the images and looks for signs of breast cancer.

A mammogram may show:
No signs of breast cancer
A benign (not cancer) condition or other change that does not suggest cancer
An abnormal finding that needs follow-up tests to rule out cancer
Alisa Berndt Knows the Importance of Breast Cancer Screening
Wisconsin native Alisa Berndt feels grateful for the screening voucher she received from Komen. It provided her with access to a mammogram and follow-up tests in 2020 that confirmed she had stage 2 invasive lobular carcinoma.

"I’m not the type of person that does mammograms all the time," Berndt said. "I hadn’t had one in two years, and I was about to go see my primary care doctor for my annual physical. I thought I better get my mammogram so he wouldn’t be upset with me for skipping them, and that’s how we figured out that I had breast cancer. They saw a calcification on my mammogram."

Berndt turned to Susan G. Komen for help. She called the Breast Care Helpline and applied for a voucher from Komen’s screening & diagnostics program to cover the cost of her diagnostic mammogram. The screening & diagnostics program provides income-eligible people with no-cost screening and diagnostic services like the diagnostic mammogram Alisa needed.

"I had to stop and think about what I was going to do," she said. "I called Susan G. Komen and was told that I could apply to see if they would pay for the diagnostic mammogram. I was very fortunate because, without Susan G. Komen, I wouldn’t have had my mammogram this year. I can’t afford it. Just because somebody has insurance doesn’t mean they can pay out-of-pocket for mammograms."

On September 27, 2022 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported that the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has approved a pivotal Phase III registration study that will bridge to Telix’s global Phase III ‘ZIRCON’ trial of TLX250-CDx (89Zr-girentuximab), for the imaging of clear cell renal cell carcinoma (ccRCC) with position emission tomography (PET) (Press release, Telix Pharmaceuticals, SEP 27, 2022, View Source [SID1234621484]).

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The investigational new drug (IND) application was submitted by Telix’s partner in the Greater China region, Grand Pharmaceutical Group Limited (Grand Pharma). The bridging study is required to provide "supplementary" data obtained in a Chinese population to establish that the diagnostic efficacy of this investigational product is equivalent in Chinese and Western populations. A dosimetry study enrolling 10 patients will precede the multi-centre Phase III bridging study, which is expected to enrol 100 patients.

A successful outcome from Telix’s global ZIRCON trial combined with positive data from this Phase III bridging study will support a future marketing authorisation application for TLX250-CDx in China.

Dr David N Cade, CEO Telix Asia Pacific, said "This IND is a significant milestone for Telix and our partner Grand Pharma, enabling us to proceed with a pivotal registration study and ultimately bring new options to the 73,000 people newly diagnosed with renal cell carcinoma in China each year where there is currently critical unmet medical need."

About TLX250-CDx

TLX250-CDx (89Zr-girentuximab) is an investigational product being developed by Telix for the purpose of non-invasive detection of clear cell renal cancer in patients with "indeterminate renal masses" (IDRMs), typically identified based on computed tomography (CT) or magnetic resonance imaging (MRI) imaging and are an increasing medical dilemma as more scans are performed and more IDRMs are identified.

Girentuximab is a monoclonal antibody that targets carbonic anhydrase IX (CAIX), a cell surface target that is highly expressed in several human cancers including renal, lung and oesophageal cancers. In July 2020, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy (BT) designation for TLX250-CDx,[1] reflecting the significant unmet clinical need to improve the diagnosis and staging of clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer.

About the ZIRCON Study

ZIRCON (Zirconium Imaging in Renal Cancer Oncology, NCT03849118) is a confirmatory, prospective, open-label, multi-centre phase III study to evaluate sensitivity and specificity of 89Zr-TLX250-CDx PET/CT imaging to non-invasively detect clear cell renal cell cancer (ccRCC) in adult patients with "indeterminate renal masses" (IDRMs), scheduled for partial or total nephrectomy. The study completed enrolment in July 2022 and Telix expects to report study outcomes in 2H, 2022.[2]