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.

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.