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Domain Therapeutics to progress into clinical trials with its EP4R antagonist DT-9081 in solid tumors

On October 19, 2022 Domain Therapeutics ("Domain" or "the Company"), a drug discovery and development company focused on G Protein-Coupled Receptors (GPCRs) in immuno-oncology (IO), reported that its proprietary IO candidate, DT-9081, has cleared its clinical trial applications (CTA) by the ANSM (Agence Nationale de Sécurité du Médicament et des produits de santé) in France and the AFMPS (Agence Fédérale des Médicaments et des Produits de Santé) in Belgium, enabling Domain to start its Phase I clinical trial (Press release, Domain Therapeutics, OCT 19, 2022, View Source [SID1234622445]). The first-in-human clinical trial is on track to initiate by the end of the year .

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DT-9081 is an oral small molecule drug candidate, which is able to reverse the prostaglandin E2 (PGE2)-mediated immunosuppression triggered by some tumors to bypass the immune system, by blocking the EP4 receptor present on immune cells. Given the high concentrations of PGE2 exhibited by a range of different solid tumors, Domain Therapeutics develops an extensive biomarker strategy, enabling optimal selection of tumor types and patient subpopulations and monitoring the target engagement in future clinical trials. Furthermore, this approach will help in finalizing the design of future clinical trials, in combination with standard of care including immune checkpoint inhibitors (such as anti-PD1).

Dr. Pascal Neuville, CEO of Domain Therapeutics, commented: "Today’s news marks a pivotal moment for Domain as we progress our first fully-owned immuno-oncology drug candidate towards the clinic. Our proprietary assets in immuno-oncology are selected through a rigorous approach that utilizes our unrivalled expertise of GPCRs. We believe that DT-9081 has the potential to be a best-in-class therapeutic with multi-tumor applications. We look forward to dosing our first patient by the end of this year."

Dr. Asmaa Boudribila, Medical Director at Domain Therapeutics, commented: "DT-9081 is a promising new candidate with the potential to treat a wide range of cancers. The signals and strong synergies with immune checkpoint inhibitors observed in preclinical studies strengthen our belief that DT-9081 could potentially be a game-changer in immuno-oncology therapies for cancer patients and we now look forward to progressing our first clinical milestone."

Hrain Biotech Plans $352 Million Shanghai STAR IPO for Novel CAR Candidates

On October 19, 2022 Shanghai Hrain Biotechnology reported that it will stage an IPO on Shanghai’s STAR board that is expected to raise $352 million for its cell therapy programs (Press release, ChinaBio, OCT 19, 2022, View Source [SID1234622252]). The company used CAR-T, CAR-NK and TCR-T technology to develop a portfolio of 11 candidates. Three of Hrain’s self-developed CAR-T candidates have started clinical trials, while its BCMA T-cell injection HR003 was granted China breakthrough therapy. The company expects to file an NDA for its lead product, a CD19-targeted CAR-T HR001, in 2023, which will be reviewed under priority rules.

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.

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.