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.

On September 27, 2022 Thermo Fisher Scientific reported The U.S. Food and Drug Administration (FDA) has granted approval to it’s Oncomine Dx Target Test as a companion diagnostic (CDx) to aid in selection of patients with RET-fusion positive locally advanced or metastatic non-small cell lung cancer (NSCLC), RET-fusion positive advanced or metastatic thyroid cancer and RET-mutation positive advanced or metastatic medullary thyroid cancer (MTC) who may be eligible for treatment with Lilly’s Retevmo (selpercatinib) (Press release, Thermo Fisher Scientific, SEP 27, 2022, View Source [SID1234621479]). This marks the Oncomine Dx Target Test’s first approval as a CDx for a therapy targeting RET-positive thyroid cancer and second approval associated with RET-positive NSCLC.

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Initially approved in 2020, Retevmo is a selective RET kinase inhibitor and was the first therapy approved for patients with advanced RET-driven lung and thyroid cancers. RET (rearranged during transfection) alterations are found in approximately 2% of patients with NSCLC, which is the leading cause of adult cancer death in the United Statesi, 60% of patients with MTC and 20% in other thyroid cancers.ii

The Oncomine Dx Target test is a next-generation sequencing (NGS)-based test that can detect multiple alterations at once from a small sample size, helping to quickly match patients with the appropriate targeted therapy. It is also approved in Japan as a companion diagnostic for Retevmo in the same indications. The test is the only globally distributable NGS CDx solution that has received regulatory approval in 17 countries for 15 targeted therapies, covering more than 550 million lives globally.

Garret Hampton, president, clinical next generation sequencing and oncology at Thermo Fisher Scientific in his statement regarding the approval said, "Following the Oncomine Dx Target Test’s first approval in 2017, we have worked to advance access to companion diagnostics for targeted therapies on a global scale." He also added, "As we continue to pursue additional approvals alongside our biopharma partners, we remain committed to broadening access to NGS-based testing to ensure patients and clinicians everywhere can benefit from it."

On September 27, 2022 Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported that data from the ongoing Phase 2 trial evaluating the safety and efficacy of suprachoroidal (SC) administration using its first VDC product candidate, belzupacap sarotalocan (AU-011), for the first-line treatment of patients with early-stage choroidal melanoma [indeterminate lesions and small choroidal melanoma (IL/CM)] will be presented at the upcoming American Academy of Ophthalmology (AAO) 2022 Annual Meeting being held September 30-October 3, 2022, in Chicago (Press release, Aura Biosciences, SEP 27, 2022, View Source [SID1234621478]). The Company will also host a virtual Investor Day on Monday, October 3, 2022, from 11:30 a.m. to 1:00 p.m. Eastern Time. Aura Biosciences’ executive management team will be joined by three distinguished ocular oncology thought leaders:

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Carol Shields, MD, Chief of the Ocular Oncology Service at Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University (USA)
Ivana Kim, MD, MBA, Director of the Ocular Melanoma Center, Massachusetts Eye and Ear & Associate Professor of Ophthalmology, Harvard Medical School (USA)
Martine Jager, MD, PhD, Professor of Ophthalmology, Leiden University, (Netherlands) & Past President of the International Society of Ocular Oncology and the Association for Research in Vision and Ophthalmology
The program will include:

Safety and efficacy results from the ongoing Phase 2 trial evaluating suprachoroidal administration of belzupacap sarotalocan for the potential first-line treatment of patients with early-stage IL/CM
Two-year visual acuity data from the retrospective matched case control study of belzupacap sarotalocan vs. plaque radiotherapy
Preclinical data from a research collaboration with the University of Leiden (Netherlands) highlighting the possibility of using belzupacap sarotalocan in combination with immune checkpoint inhibitors to treat primary and distant lesions by an abscopal effect
Details for the Presentation at AAO:

To access the virtual Investor Day, please dial (888) 660-6585 (U.S. and Canada) or (929) 203-0858 (international) at least 10 minutes prior to the start time and refer to conference ID 9748492. A live video webcast will be available in the Investor section of the Company’s website at View Source A webcast replay will also be available on the corporate website at the conclusion of the call.

On September 27, 2022 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported that the U.S. Food and Drug Administration (FDA) has accepted its filing for a New Drug Application (NDA) for 18F-rhPSMA-7.3, an investigational radiohybrid Prostate-Specific Membrane Antigen-targeted (PSMA) PET imaging agent (Press release, Blue Earth Diagnostics, SEP 27, 2022, View Source [SID1234621477]). The submission is for the use of 18F-rhPSMA-7.3 PET for diagnostic imaging of prostate cancer.

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"This event marks a significant milestone in advancing our robust prostate cancer portfolio, and we are very pleased that the FDA has accepted our NDA submission for the use of 18F-rhPSMA-7.3 PET imaging in prostate cancer patients," said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. "We look forward to working with the Agency throughout the review process, with the goal of having an approved product that is widely available and accessible across the United States. Subject to FDA approval, we believe that 18F-rhPSMA-7.3 PET imaging may be clinically useful in the management of men affected by prostate cancer across the care continuum. All of us at Blue Earth want to express our sincere gratitude to the many patients, physicians, clinical trial sites and collaborators who have worked closely with us to progress 18F-rhPSMA-7.3, and to having successfully completed our Phase 3 clinical trials despite all the challenges presented by the COVID-19 pandemic."

The submission is supported by clinical data from one prospective Phase 1 study and two prospective Phase 3 clinical trials sponsored by the Company. Blue Earth Diagnostics’ Phase 3 LIGHTHOUSE trial assessed the safety and diagnostic performance of 18F-rhPSMA-7.3 PET in men with newly diagnosed prostate cancer in 356 patients. Key results from the LIGHTHOUSE trial will be presented at an upcoming medical conference. The Phase 3 SPOTLIGHT trial evaluated the use of 18F-rhPSMA-7.3 in 391 men with suspected prostate cancer recurrence based on elevated PSA level. Results from the SPOTLIGHT study have been presented at medical meetings earlier this year. Further clinical support for the submission included results published by the Technical University of Munich.

"Prostate cancer is a leading cause of male cancer-related death worldwide, and accurate localization and staging of the disease is critical in establishing optimal medical management strategies," said Eugene Teoh, MBBS, MRCP, FRCR, D.Phil., Chief Medical Officer of Blue Earth Diagnostics. "We believe that the performance of 18F-rhPSMA-7.3, its high PSMA binding affinity and potential for low bladder activity will make it a valuable diagnostic tool that is radiolabeled with 18F for high image quality and readily available patient access."

About Prostate Cancer
Prostate cancer is the second most frequently diagnosed cancer in men and the fifth leading cause of death worldwide. It is most commonly diagnosed in men aged 65 years and over. In its early stages, it is largely asymptomatic and tumors are detected by increased prostate-specific antigen (PSA) levels in the blood. Effective staging of newly diagnosed prostate cancer − determining its extent and whether it may have metastasized − is critical in assessing a patient’s prognosis and informing individual clinical management strategies. Up to 25% of prostate cancer patients may have detectable lymph node metastases, which are correlated with a risk for recurrence and decreased overall survival. Regardless of initial therapy, there is potential for recurrence of prostate cancer. Up to one-third of men treated for primary prostate cancer will experience a biochemical recurrence (BCR) within 10 years, and one-third of men experiencing recurrence will develop metastatic disease within 8 years. Up to 40% of patients who undergo radical prostatectomy, and up to 50% of patients who undergo radiation therapy will develop local or distant recurrences within 10 years. Recurrent prostate cancer is clinically challenging, given that its natural history is highly variable.

About 18F-rhPSMA-7.3 and Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)
18F-rhPSMA-7.3 is an investigational agent that consists of a radiohybrid Prostate-Specific Membrane Antigen (PSMA)-targeted receptor ligand which attaches to and is internalized by prostate cancer cells, and is labeled with the 18F radioisotope for PET imaging. rhPSMA compounds are referred to as radiohybrid ("rh"), as each molecule possesses three distinct domains. The first consists of a Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells. It is attached to two labelling moieties which may be radiolabeled with either 18F for PET imaging, or with isotopes such as 177Lu or 225Ac for therapeutic use – creating a true theranostic technology. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Currently, rhPSMA compounds are investigational and have not received regulatory approval.

About the Phase 3 LIGHTHOUSE Clinical Trial for 18F-rhPSMA-7.3
The Phase 3 LIGHTHOUSE clinical trial was a prospective, Phase 3, multi-center, single-arm, imaging study investigating the safety and diagnostic performance of 18F-rhPSMA-7.3 Positron Emission Tomography (PET) in men with newly diagnosed prostate cancer. The study evaluated 356 patients at clinical sites in the United States and Europe. Additional information about the Phase 3 LIGHTHOUSE trial is available at www.clinicaltrials.gov (NC04186819).

About the Phase 3 SPOTLIGHT clinical trial for 18F-rhPSMA-7.3
The SPOTLIGHT Phase 3 clinical trial was a prospective, Phase 3, multi-center, single-arm, imaging study investigating the safety and diagnostic performance of 18F-rhPSMA-7.3 Positron Emission Tomography (PET) in men with suspected prostate cancer recurrence based on elevated Prostate-Specific Antigen (PSA) following prior therapy. The study evaluated 391 patients at clinical sites in the United States and Europe. Additional information about the Phase 3 SPOTLIGHT trial is available at www.clinicaltrials.gov (NCT04186845).