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Prime Medicine Announces Pricing of Upsized Initial Public Offering

On October 19, 2022 Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, reported the pricing of its upsized initial public offering of 10,294,118 shares of its common stock at a price to the public of $17.00 per share (Press release, Prime Medicine, OCT 19, 2022, View Source [SID1234622217]). All of the shares are being offered by Prime Medicine. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Prime Medicine, are expected to be $175.0 million. In addition, the underwriters have a 30-day option to purchase up to 1,544,117 additional shares of common stock at the initial public offering price less underwriting discounts and commissions.

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The shares are expected to begin trading on the Nasdaq Global Market on October 20, 2022 under the ticker symbol "PRME." The offering is expected to close on October 24, 2022, subject to the satisfaction of customary closing conditions.

J.P. Morgan, Goldman Sachs & Co. LLC, Morgan Stanley and Jefferies are acting as joint book-running managers for the offering.

A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on October 19, 2022. The offering is being made only by means of a prospectus. When available, copies of the final prospectus relating to the offering may be obtained from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at 866-803-9204 or by email at [email protected]; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, via telephone: (866) 471-2526, or via email: [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, by telephone at (866) 718-1649 or by e-mail to [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at 877-821-7388 or by email at [email protected].

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

MRIdian Clinical Studies and Initial MRIdian A3i Clinical Experience to be Highlighted at ASTRO 2022

On October 19, 2022 ViewRay, Inc. (NASDAQ: VRAY) reported that the company’s MRIdian MRI-Guided Radiation Therapy System will be featured at the 64th Annual Meeting of the American Society for Radiation Oncology (ASTRO), being held October 23-26, 2022, at the Henry B. González Convention Center in San Antonio, Texas (Press release, ViewRay, OCT 19, 2022, View Source [SID1234622207]). The meeting will feature numerous presentations and posters highlighting MRIdian’s cutting-edge Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) technology, including oral presentations providing results of the multi-center SMART Pancreas study and MIRAGE, a Phase III randomized controlled prostate trial. In addition, initial clinical experience using MRIdian A3i will be highlighted during the conference.

On Tuesday, October 25, 2022, at 3:00 p.m. CT, Dr. Parag Parikh from Henry Ford Health System will provide an oral presentation titled "Stereotactic MR-Guided On-Table Adaptive Therapy (SMART) for Patients with Borderline or Locally Advanced Pancreatic Cancer: Primary Endpoint Outcomes of a Prospective Phase II Multi-Center International Trial." The SMART study (NCT03621644) is a prospective clinical study exploring the clinical benefits of ablative MR-guided radiation therapy in the treatment of borderline resectable or inoperable locally advanced pancreatic cancer.

On Wednesday, October 26, 2022, at 11:00 a.m. CT, Dr. Amar Kishan from UCLA will provide an oral presentation titled "Magnetic Resonance Imaging-Guided vs. Computed Tomography-Guided Stereotactic Body Radiotherapy for Prostate Cancer (MIRAGE): Primary Endpoint Analysis of a Phase III Randomized Trial". This clinical study compared MRIdian MRI-guided SBRT vs. CT-guided SBRT for localized prostate cancer. At ASCO (Free ASCO Whitepaper) GU 2022, Dr. Kishan reported the interim findings and analysis of the primary endpoint that signaled superiority of MRIdian MRI-guided SBRT compared to CT-guided SBRT. During this presentation, he will be presenting the final results of acute GU and GI toxicity.

In addition, there will be dozens of scientific session presentations and posters highlighting the important role of MRIdian in cancer care treatment, including data supporting its clinical value in the treatment of cancers including pancreas, prostate, bladder, liver, kidney, and lung including ultra-central lung lesions, as well as oligometastatic disease. There will also be presentations focused on MRIdian’s benefits in delivering reirradiation and on-table adaptive therapy.

On Monday, October 24, 2022, at 4:00 p.m. CT, ViewRay will host an Industry Expert Theater titled "MRIdian A3i – Newest Innovation of MRgRT for Prostate, Pancreas, and Brain" featuring experts from Henry Ford Health System and Miami Cancer Institute sharing their initial clinical experience treating patients with MRIdian A3i.

The new MRIdian A3i features enable clinicians to collaborate simultaneously and connect remotely during patient treatment. The new automated workflow steps and contouring tools are designed to minimize clinician time and increase patient throughput. MRIdian A3i also expands existing real-time tissue tracking and automated beam gating functionalities to include multiplanar, 3D tracking and gating in up to three planes.

On Sunday night, October 23, 2022, at 6:30 p.m. CT, ViewRay will host an evening reception with special guest and cancer advocate Katie Couric, as part of ViewRay’s previously announced national awareness campaign and partnership with Katie Couric Media to educate patients and clinicians about MRIdian SMART. Couric will moderate a discussion with ViewRay’s CEO, Scott Drake, and radiation oncologists treating patients on MRIdian.

ViewRay will also host customer presentations throughout the conference in the company’s booth #3770, where customers will highlight their clinical experience treating patients on MRIdian.

MRIdian provides radiation 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.

To date, over 25,000 patients have been treated with MRIdian. Currently, 54 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

IceCure Files De Novo Classification Request with the FDA for Marketing Authorization of ProSense® with Breakthrough Indication: Early-Stage Low-Risk Breast Cancer Patients at High Risk to Surgery

On October 19, 2022 IceCure Medical Ltd. (Nasdaq: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense System that destroys tumors by freezing, reported it submitted a regulatory filing (De Novo Classification Request) with the U.S. Food and Drug Administration ("FDA") for marketing authorization based on ICE3 clinical trial ("ICE3") interim analysis of ProSense for the indication of early-stage (Luminal A T1 invasive) low-risk breast cancer in patients who are at high risk to surgery (not suitable for surgical alternatives), representing approximately 43,000 women in the U.S. annually (Press release, IceCure Medical, OCT 19, 2022, View Source [SID1234622206]). The specific indication filed is based on interim data and is in accordance with discussions IceCure has had with the FDA, which granted ProSense Breakthrough Device Designation, enabling closer communications regarding its regulatory filing.

ICE3 is the largest controlled, multicenter clinical trial ever performed in the U.S. for liquid nitrogen-based cryoablation of small, low-risk, early-stage malignant breast tumors. To date, there have been six cases of ipsilateral breast tumor recurrence ("IBTR") out of 194 patients, or 3.09%. The survival-based estimate for the 5-year IBTR is 4.3% with a one-sided 95% confidence level, upper bound of 8.4% for the entire study population. Final ICE3 5-year follow-up data are expected in the first half of 2024, at which time IceCure plans to file with the FDA for a broader indication reflecting the entire study population—early-stage (Luminal A T1 invasive) low-risk breast cancer for patients age 60 and over, representing approximately 65,000 women in the U.S. annually.

The total group of Luminal A breast cancer for women in all ages, is estimated at 144,000 cases annually in the U.S. In the future, IceCure intends to explore more indications for additional sub groups that are part of the total group of Luminal A breast cancer.

Approximately 66% of the ICE3 patients were determined to be at high risk to surgery due to factors including age and co-morbidities. For these patients, their doctors, and insurers, cryoablation may offer significant benefits as compared to lumpectomy, the current standard of care, including less risk of complications, lower cost, superior cosmetic results, rapid recovery, higher physician and patient satisfaction, and the convenience of a fast and simple in-office procedure.

Data suggests the use of ProSense cryoablation in breast procedures eliminates the risk of re-excision (a second surgery). Between 14% – 20% of breast cancer surgeries result in re-excision due to the practice of requiring a margin of normal breast tissue beyond the involved malignant tissue. This is associated with greater morbidity, patient anxiety, poorer cosmetic outcomes, and increased cost.

"We are very pleased to be in a position to file for regulatory approval with the FDA in this specific breast cancer indication prior to our full study read out expected in 2024 and backed by what we believe is the most extensive data available in the field of breast cancer cryoablation. Following our pre-submission package to the FDA last year, we have been in discussions with the regulatory body regarding this two-step approach for the specific indications for which we are applying. While we await the full study read out of the ICE3 trial, we believe that our first submission makes a strong case for approval based on our interim analyses of the ICE3 data, highly favorable patient outcomes, and improved healthcare economics," stated IceCure CEO Eyal Shamir. "We hope to give women a new option that is just as effective as lumpectomy, without the risk of surgery in the U.S. and globally. If the FDA grants the De Novo Request for ProSense in breast cancer, this may support our global commercialization efforts, as doctors, distributors, and regulatory agencies around the world tend to consider a device’s FDA status in their decision-making."

IceCure is committed to making ProSense widely available and affordable upon regulatory approval by elucidating the procedure’s healthcare economics and through reimbursement and CPT codes. The Company will continue to follow the development of CMS’s new pathway for coverage of innovative new devices, Transitional Coverage of Emerging Technology ("TCET"), which is replacing the repealed Medicare Coverage of Innovative Technologies ("MCIT") rule. CMS is expected to share more about TCET with the public for comments after April 2023.

In addition, IceCure continues to work closely with the ASBrS toward a potential registry trial targeting ASBrS treatment guideline amendments following trial results.

About ICE3

ICE3 is the largest controlled multi-location clinical trial ever performed for liquid nitrogen (LN2) –based cryoablation of small, low-risk, early-stage malignant breast tumors without subsequently removing them. The trial began in 2014 and has completed recruitment of 206 patients (of which 194 were eligible for cryoablation) in 19 hospitals and medical centers across the U.S., including Columbia University Medical Center and Mount Sinai Beth Israel.

Avenge Bio to Present Preclinical Data at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting

On October 19, 2022 Avenge Bio, Inc. ("Avenge" or the "Company"), a biotechnology company developing the LOCOcyte Immunotherapy platform for the precision administration of potent immune effector molecules to treat solid tumors, reported that three abstracts were selected for presentation as posters at the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting on November 10-11, 2022, at the Boston Convention & Exhibition Center – Exhibit Hall C, Boston, MA (Press release, Avenge Bio, OCT 19, 2022, View Source [SID1234622205]).

Avenge’s most advanced product candidate, AVB-001, produces native IL-2 immunotherapy and is initially being studied in metastatic peritoneal cancers such as ovarian cancer. AVB-001, developed in the LOCOcyte platform, consists of proprietary engineered human cells. The cells are encapsulated in a pro-inflammatory biomaterial that are delivered to the local tumor environment and generate high, sustained concentrations of native IL-2. The encapsulated cells initiate a robust, local, and durable systemic immune response while avoiding toxicities associated with systemic immunotherapies. Avenge has additional pipeline candidates for the treatment of a wide range of cancers including pancreatic, lung and breast cancers. In July 2022, Avenge announced that Food and Drug Administration ("FDA") cleared the Investigational New Drug ("IND") application for AVB-001 for the treatment of platinum resistance ovarian cancer. The Phase 1, multicenter clinical trial is expected to be initiated in Q4 2022.

Details on Avenge’s presentations at SITC (Free SITC Whitepaper) are as follows:

Abstract #: 363
Poster Title: Localized interleukin-2 cytokine factories eradicate mesothelioma tumors via activation of adaptive and innate immune cells
Presenting Author: Samira Aghlara-Fotovat, BA (Rice University)
Location: Poster Hall C
Date: Thursday, November 10, 2022
Time: 11:40 AM-1:10 PM ET & 7:30-9:00 PM ET

Abstract #: 1095
Poster Title: IL-12-Based Cytokine Factories Modulate Tumor Microenvironment to Eradicate Pancreatic Tumors in Mice and are Well Tolerated in Non-human Primate
Presenting Author: Amanda Nash, BS (Rice University)
Location: Poster Hall C
Date: Thursday, November 10, 2022
Time: 11:40 AM-1:10 PM ET & 7:30-9:00 PM ET

Abstract #: 1094
Poster Title: Favorable preclinical efficacy and safety profile of AVB-001 a novel IL-2 cell-based immunotherapy that eradicates ovarian cancer in mouse tumor models and supports first in human clinical development
Presenting Author: Guillaume Carmona, PhD (Avenge Bio, Inc.)
Location: Poster Hall C
Date: Friday, November 11, 2022
Time: 11:55 AM-1:25 PM ET & 7:00-8:30 PM ET

The posters will be available on the Presentations and Publications section of www.avengebio.com following the conference.

About LOCOcyte Platform
Our LOCOcyte allogeneic cell-based immunotherapy platform enables potent localized modulation of the immune system which also precipitates a systemic immune response, allowing us to treat previously intractable cancers. The technology leverage three unique advantages:

Potent immune effector molecules are generated by synthetically engineering allogeneic cells creating a ready-to-use therapy,
Therapy is localized in proximity to the primary tumor site and generates innate and adaptive immune response, and
The immunomodulator trains the patient’s immune system generating a robust immune response that seeks and eradicates distal metastasis without systemic toxicity.

SeekIn Presents New Data Supporting its Pan-cancer Early Detection Test at the Early Detection of Cancer Conference 2022

On October 19, 2022 SeekIn Inc, a leader in blood-based cancer early detection and monitoring technology, reported the results of pan-cancer early detection test SeekInCare were presented at The 2022 Early Detection of Cancer Conference in Portland, Oregon (Press release, SeekIn, OCT 19, 2022, View Source [SID1234622204]).

At present, the majority of deadly cancers do not have standard-of-care screening paradigms available and the existing screenings have challenges in patient compliance due to the invasive procedures endured from the tests. As a result, most cancers are detected until they have progressed to late stages when chances of survival are much lower.

"Currently, the five-year survival rate for cancer patients in China is 39%, compared with 68% in the United States. The key to the difference in the survival rates between China and the United States is cancer screening, which reduces disease- and treatment-related morbidity, increases the likelihood of treatment success, improves quality of life, and reduces treatment cost and complexity," said Mao Mao, M.D., Ph.D., SeekIn’s founder and CEO. "SeekInCare, a blood-based pan-cancer detection approach, holds promise for identifying asymptomatic cancer patients from general population through a single blood draw."

SeekInCare, a novel multidimensional cancer risk score (CRS) model, incorporating copy number aberrations (CNA), fragment size (FS), end motifs and cancer related viruses via shallow whole genome sequencing (sWGS) from cell-free DNA (cfDNA), and seven plasma tumor markers (PTMs). The case-control study included 616 stage I-IV cancer patients that cover 8 common cancers and 19 other types, and 898 healthy subjects. SeekInCare identified 419 cancer patients with 68.0% sensitivity at 98.0% specificity, resulting in an AUC (area under the curve) of 0.916. Compared with multi-cancer detection in the retrospective validation cohorts from GRAIL and Exact Sciences, SeekInCare had a similar performance if not better. Moreover, the sensitivities were 49.0%, 61.3%, 72.5% and 85.4% in stages I, II, III and IV respectively.

To further assess SeekInCare’s performance, it was evaluated in a real-world cohort consisting of 604 subjects (median follow-up time: 404 days). 12 cancer cases were detected while nine subjects tested positive but without cancer. Only one subject was tested negative and subsequently diagnosed with stage I thyroid cancer. Thus, SeekInCare achieved 92.3% sensitivity, 97.7% specificity, 57.1% PPV and 99.7% NPV in the real-world cohort. These data demonstrated that the performance of SeekInCare is similar to the data generated by GRAIL and Johns Hopkins University in prospective setting.

"There are different technical approaches for blood-based pan-cancer/multi-cancer early detection. These clinical studies demonstrated the solid performance of our technology," said Dr. Mao, "In addition, SeekInCare had received CE-IVD Mark approval which represents a significant milestone for SeekIn in bringing SeekInCare test to the other countries besides China, allowing more people to access the cutting-edge, convenient, non-invasive and cost-effective cancer early detection technology."