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Interim Findings from MIRAGE Phase III Randomized Trial Signal Superiority of MRIdian® MRI-guidance in Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer

On February 15, 2022 ViewRay, Inc. (NASDAQ: VRAY) reported that interim data from the single center Phase III randomized MIRAGE trial, led by UCLA, comparing MRIdian MRI-guided vs. CT-guided SBRT for localized prostate cancer, will be featured at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium, held February 17-19 in San Francisco (Press release, ViewRay, FEB 15, 2022, View Source [SID1234608154]). Interim analysis of the primary endpoint signaled superiority of MRIdian MRI-guided SBRT with a significant reduction in acute grade ≥2 GU toxicity in men receiving MRI-guided SBRT over those receiving CT-guided SBRT.

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The poster, titled "Magnetic resonance imaging-guided versus computed tomography-guided stereotactic body radiotherapy for prostate cancer (MIRAGE): Interim analysis of a phase III randomized trial" and authored by Amar Kishan, MD., Associate Professor and Chief of the Genitourinary Oncology Service at UCLA, will be showcased on Thursday, February 17 from 11:30 AM PT to 1:00 PM PT as part of the Prostate Cancer poster session. Following the poster session, Dr. Kishan (@AmarUKishan) will host a LIVE Twitter Q&A to answer questions about the interim findings. Those interested can join the conversation and post their questions using #MIRAGEQ&A.

The interim analysis of data from 100 patients eligible for evaluation (51 in the CT group and 49 in the MRI group) showed a statistically significant reduction in acute grade ≥2 GU toxicity in men receiving MRI-guided SBRT (47.1 percent in the CT group vs. 22.4 percent in the MRI group) and a significant reduction in acute grade ≥2 gastrointestinal (GI) toxicity in men receiving MRI-guided SBRT (13.7 percent in the CT group vs. 0 percent in the MRI group). Acute grade ≥2 GU toxicity can include adverse events range from frequent, urgent, or painful urination to pelvis pain, bladder spasms, or blood in the urine. Acute grade ≥2 GI toxicity can include adverse events ranging from diarrhea, discharge, or rectal/abdominal pain to abdominal distention or obstruction.

Patient-reported outcomes were measured using the International Prostate Symptom Score (I-PSS) and Expanded Prostate cancer Index Composite (EPIC-26). Patient reported urinary and bowel function metrics were better preserved at the 1-month time point with MRI-guidance, though this difference dissipates at the 3-month time point, potentially due to management of side effects.

"Beyond a reduction in the standardized metric of physician-scored toxicity, we also saw differences in one-month patient-reported urinary and bowel function metrics favoring the MRI-guidance arm. These data are highly indicative of less radiation dose being delivered to sensitive structures, such as the bladder, urethra, and rectum, with MRI-guidance," said Dr. Kishan. "Potential explanations for the magnitude of these results can be attributed to the real-time tissue tracking of actual anatomy and automatic gating of beam delivery, which thereby allows for tighter contours and treatment of smaller volumes. The high dose regions are significantly smaller for patients receiving MRI-guided SBRT."

Given the large primary endpoint signal seen, the study protocol was amended to reduce the projected sample size from 300 to 154, requiring half the number of patients while still maintaining 89 percent power to demonstrate superiority. Accrual of the MIRAGE trial (NCT04384770) was completed as of October 2021 and a final analysis for the primary endpoint is anticipated in early 2022.

"While the final results are still being analyzed, it is evident from our interim analysis that the benefit provided by MRI-guidance over CT-guidance for the delivery of SBRT for localized prostate cancer is projected to be large enough that we were able to cut the projected size of our trial in half. In fact, by the time this interim analysis was done, we had already enrolled enough patients to close the trial successfully," said Dr. Kishan. "In anticipation of the highly positive result implied by this interim analysis, we have now shifted to routinely offering MRI-guided SBRT at UCLA."

The MRIdian system provides oncologists outstanding anatomical visualization through diagnostic-quality MR images and the ability to adapt a radiation therapy plan to the targeted cancer with the patient on the table. This combination allows physicians to define tight treatment margins to avoid unnecessary radiation exposure of vulnerable organs-at-risk and healthy tissue and allows the delivery of ablative radiation doses in five or fewer treatment sessions, without relying on implanted markers. By providing real-time continuous tracking of the target and organs-at-risk, MRIdian enables automatic gating of the radiation beam if the target moves outside the user-defined margins. This allows for delivery of the prescribed dose to the target, while sparing surrounding healthy tissue and critical structures, which results in minimizing toxicities typically associated with conventional radiation therapy.

Nearly 18,000 patients have been treated with MRIdian. Currently, 48 MRIdian systems are installed at hospitals around the world where they are used to treat a wide variety of solid tumors and are the focus of numerous ongoing research efforts. MRIdian has been the subject of hundreds of peer-reviewed publications, scientific meeting abstracts, and presentations. For a list of treatment centers, please visit: View Source

Disclaimer:
The opinions and clinical experiences discussed herein are specific to the featured physicians and are for information purposes only. Nothing in this material is intended to provide specific medical advice or to take the place of written law or regulations. Results of treatment presented in this press release are not indicative of typical or future results.

Safety Statement
The MRIdian Linac System is not appropriate for all patients, including those who are not candidates for magnetic resonance imaging. Radiation treatments may cause side effects that can vary depending on the part of the body being treated. The most frequent ones are typically temporary and may include, but are not limited to, irritation to the respiratory, digestive, urinary or reproductive systems; fatigue; nausea; skin irritation; and hair loss. In some patients, side effects can be severe. Treatment sessions may vary in complexity and duration. Radiation treatment is not appropriate for all cancers. You should discuss the potential for side effects and their severity as well as the benefits of radiation and magnetic resonance imaging with your doctor to make sure radiation treatment is right for you.

Conflicts of Interest: Amar Kishan, M.D. discloses research funding from the Department of Defense, the National Institutes of Health, the Jonsson Comprehensive Cancer Foundation, the Prostate Cancer Foundation, and the American Society for Radiation Oncology. He also discloses research support, not related to this study, from ViewRay, Inc. AUK discloses consulting fees from ViewRay, Inc. and Varian Medical Systems, Inc. Dr. Kishan also discloses low-value stock held in ViewRay Inc.

ZielBio Announces First Patient Dosed in Phase 1/2 Clinical Trial of ZB131, Its Novel Monoclonal Antibody Targeting Cancer Specific Plectin

On February 15, 2022 ZielBio, Inc., a clinical stage biotechnology company discovering new treatments for cancer through its innovative ZielFind drug discovery platform, reported the first patient dosed in its Phase 1/2 clinical trial (Press release, ZielBio, FEB 15, 2022, View Source [SID1234608153]). The study will evaluate ZB131 in patients with solid tumors who are either non-responsive to or ineligible for the standard of care . ZB131 is a monoclonal antibody with a high affinity and specificity for cancer specific plectin (CSP), a cell surface protein identified in a wide range of cancers that correlates with poor prognosis and aggressive tumors.

"Having the first patient dosed in the ZB131 trial represents an important milestone for the company and for unserved patients, including those with cholangiocarcinoma, pancreatic, and ovarian cancers," said Kimberly Kelly, Ph.D., founder and CEO of ZielBio. "These types of cancers are difficult to treat with current therapies, but preclinical research suggests that ZB131 is able to bind to CSP located on the surface of cancer cells, resulting in profound tumor regression."

The ZB131 clinical trial is a Phase 1/2, first-in-human, open-label, dose escalation study of a CSP-targeting functional antibody (ZB131) in tumors likely to express CSP. The primary objective of the Phase 1 dose escalation is to evaluate the safety and tolerability of ZB131 as a monotherapy. Once the recommended Phase 2 dose (RP2D) has been established, the dose expansion stage of the trial will begin enrolling patients to receive ZB131 in at least three pre-defined cohorts in cholangiocarcinoma, pancreatic, and ovarian cancers. The clinical trial is open and enrolling with additional study details available at clinicaltrials.gov with the trial identifier NCT05074472.

"The beginning of our clinical trial is an important step toward our goal of designing and offering safer, better therapies for patients who need them," said Brian Schwartz, MD, and CMO of ZielBio. "By identifying new targets for treatment, we are expanding what is possible for the future of patient care and delivering new hope to a group of individuals who have not responded to or qualified for treatments previously."

"CSP represents one out of countless novel cancer targets, many of which remain undiscovered," said Dr. Kelly. "With ZielFind, we have the ability to bring forth the next evolution in target identification by interrogating cell proteins in their native context. This leads us to actionable targets and in turn, better therapies for unserved patients."

Kairos Pharma Announces FDA Clearance of Investigational New Drug (IND) for ENV105 for the Treatment of Prostate Cancer

On February 15, 2022 Kairos Pharma, Ltd. ("Kairos"), a privately held clinical stage biotechnology company focused on drug resistance and immunotherapy for cancer, reported that it has received FDA approval to proceed with a Phase 2 clinical trial of ENV105 with apalutamide for the treatment of metastatic castration-resistant prostate cancer (Press release, Kairos Pharma, FEB 15, 2022, View Source [SID1234608152]). The phase II trial is sponsored by Enviro Therapeutics, a wholly-owned subsidiary of Kairos Pharma.

Kairos CEO John Yu, M.D. commented, "This IND acceptance establishes the first of many substantial clinical milestones that Kairos is working toward in 2022. We will roll out our Phase 2 clinical trial with the goal of verifying the benefit of our transformative technologies to reverse the normal course of drug resistance in patients with prostate cancer, lung cancer, and breast cancer."

ENV105 has been demonstrated to complement standard of care androgen targeted therapy with non-steroidal anti-androgens such as XTANDI (enzalutamide) and Zytiga (abiraterone acetate) in limiting therapeutic resistance to these drugs in a previous Phase II trial. These encouraging results is the premise for this randomized, multi-center phase II trial enrolling 100 patients. Prostate cancer patients failing to respond to androgen targeted therapy interventions will be randomized to receive the combination of ENV105 and a third-generation androgen receptor antagonist, apalutamide or apalutamide alone. Interruption of the BMP/CD105 signaling between cancer cells and surrounding non-cancer cells with ENV105 sensitizes prostate tumors to androgen targeted therapy through a novel mechanism of action. Three academic medical centers will participate in the randomized trial including Cedars Sinai Medical Center, University of Utah, and City of Hope.

Kairos Chief Scientific Officer Neil Bhowmick, Ph.D. added, "This achievement represents the next major step in testing the degree of potential clinical benefit of ENV105 for patients with androgen resistant prostate cancer."

In addition to the upcoming Phase 2 trial of ENV105 with apalutamide, a Phase 1 trial of ENV105 with Tagrisso (AstraZeneca) for lung cancer is planned to start in 2022, and a Phase 1 trial of activated T cell therapy for KROS 201 in patients with glioblastoma will enter Phase 1 clinical trials in 2022.

Jazz Pharmaceuticals to Report 2021 Fourth Quarter and Full Year Financial Results on March 1, 2022

On February 15, 2022 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it will report its 2021 fourth quarter and full year financial results on Tuesday, March 1, 2022, after the close of the U.S. financial markets (Press release, Jazz Pharmaceuticals, FEB 15, 2022, View Source [SID1234608151]). Company management will host a live audio webcast at 4:30 p.m. ET / 9:30 p.m. GMT to discuss 2021 fourth quarter and full year financial results and provide a business and financial update.

Interested parties may access the live audio webcast via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharma.com.

TC Biopharm Announces Closing of $17.5 Million Initial Public Offering

On February 15, 2022 TC Biopharm (Holdings) PLC ("TC Biopharm" or the "Company") (NASDAQ: TCBP) (NASDAQ: TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and viral indications, reported the closing of its previously announced initial public offering of 4,117,648 American Depositary Shares (the "ADSs") and warrants (the "Warrants") to purchase up to 8,235,296 ADSs. In connection with the initial public offering, the underwriters have partially exercised their option to purchase an additional 1,235,294 warrants at an exercise price of $4.25 per warrant (Press release, TC Biopharm, FEB 15, 2022, View Source [SID1234608150]). In total, the Company received aggregate gross proceeds of approximately $17.5 million, prior to deducting underwriting discounts, commissions, and other offering expenses. The issuance and sale of these additional ADSs also closed today.

Each ADS represents one ordinary share, and each Warrant represents the right to purchase one ADS. The ADSs and Warrants will be separately issued but the ADSs and Warrants will be sold to purchasers only in a combination of one ADS and two Warrants, for a combined aggregate offering price of $4.25. Each Warrant will be immediately exercisable for one ordinary share, that will then be deposited with the custodian for the issuance of a corresponding ADS at an exercise price of $4.25 per ADS and expire six years after the issuance date.

The Company intends to use the net proceeds from the offering to finance the cost of treating patients under our proposed clinical trials OmnImmune (TCB 008-001), a phase 2b-into-pivotal (phase 3) trial for the treatment of acute myeloid leukemia) and ImmuniStim (TCB 008-002) (for the treatment of COVID-19 infections) and to continue the research and development of our proposed GD-T CAR therapies to treat sold cancers, as well as financing our operating overhead costs, capital expenditure and limited repayment of convertible loan notes.

EF Hutton, division of Benchmark Investments, LLC, acted as sole book-running manager for the offering.

A registration statement on Form F-1, as amended (File No. 333-260492), was filed with the Securities and Exchange Commission ("SEC") and was declared effective on February 10, 2022. A final prospectus relating to the offering was filed with the SEC and will be available on the SEC’s website at View Source Electronic copies of the final prospectus relating to this offering may be obtained from EF Hutton, division of Benchmark Investments, LLC, 590 Madison Avenue, 39th Floor, New York, NY 10022, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 404-7002.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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.