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]

On September 27, 2022 ZAP Surgical Systems, Inc. reported that the Institut du Cancer Courlancy (ICC) in Reims, France will add the latest advancement in non-invasive brain tumor treatments, the ZAP-X Gyroscopic Radiosurgery platform, to its current portfolio of cancer treatment technologies (Press release, ZAP Surgical Systems, SEP 27, 2022, View Source [SID1234621481]).

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In a collaboration between the radiation oncology and neurosurgery teams, the site looks to solidify their status as a regional oncology center-of-excellence by dedicating ZAP-X to the treatment of cranial-based indications, thereby complementing the institute’s existing modern fleet of radiation delivery systems optimized for the treatment of lung, breast, prostate, and other cancers of the body.

Radiosurgery, also referred to as SRS, is a well-studied and effective treatment for many brain cancers including primary and metastatic brain tumors. For eligible indications, SRS is a completely non-invasive and pain-free alternative to expensive and often debilitating surgeries.

Tailor made for cranial radiosurgery, the recently introduced ZAP-X system relies on the latest surgical robotic technology and novel gyroscopic mobility to concentrate high-intensity radiation on tumor targets while minimizing incidental radiation exposure to normal brain tissue and nearby healthy organs.

"Differing from conventional body radiotherapy, cranial SRS requires exacting precision to preserve patient neuro-cognitive function as well as protect radio-sensitive organs such as the eyes, optic nerves, and brain stem," says Dr. Philippe Colin, ICC radiation oncologist specializing in neurosurgical applications and lead clinician for the ZAP-X program. "These meticulous demands are best served by purpose-built SRS technologies such as ZAP-X, which aim to offer greater control and accuracy of radiation delivery."

"The team looks to treat approximately 500 SRS patients per year, focused primarily on the treatment of metastatic and benign brain tumors," added Pr. Claude-Fabien Litre, neurosurgeon at Centre Hospitalier Universitaire de Reims. "We also plan to reinforce our expertise in functional radiosurgery, including radiosurgical thalamotomy, having delivered more than 300 frameless trigeminal neuralgia treatments in the past."

The ZAP-X system is the first new dedicated cranial radiosurgery platform in nearly half a century. Prior to ZAP-X, state-of-the-art SRS often required hospitals to manage large quantities of expensive and volatile Cobalt-60 for radiosurgery beam generation. ZAP-X eliminates this historical requirement by using leading-edge linear accelerator technology, and thus removes the burdens of perpetual source decay and costs of recurring isotope replacement.

On September 27, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the global leader in the development of NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases, reported the launch of a follow-on public offering of its ordinary shares (Press release, Gamida Cell, SEP 27, 2022, View Source [SID1234621480]). In addition, Gamida Cell expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the ordinary shares to be sold in the offering on the same terms and conditions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed. All of the shares in the offering are to be sold by Gamida Cell.

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Gamida Cell intends to use the net proceeds from this offering, together with its existing cash and cash equivalents and trading financial assets: to fund (i) commercial readiness activities to support potential launch of omidubicel, if approved; (ii) the continued clinical development of its NK product candidates, including GDA-201; and (iii) general corporate purposes, including general and administrative expenses and working capital.

Piper Sandler & Co. and JMP Securities, a Citizens Company, are acting as joint book-running managers for this offering.

A registration statement on Form S-3 (File No. 333-259472) relating to the ordinary shares has been filed with the Securities and Exchange Commission and declared effective on April 1, 2022. This offering will be made only by means of a prospectus supplement. Copies of the preliminary prospectus supplement and the accompanying prospectus related to this offering may be obtained, when available, from: Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at [email protected], or JMP Securities LLC, 600 Montgomery Street, Suite 1100, San Francisco, California 94111, Attention: Prospectus Department, by calling (415) 835-8985, or by e-mail at [email protected]. Investors may also obtain these documents at no cost by visiting the SEC’s website at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.