Ginkgo Bioworks Completes Acquisition of Zymergen

On October 19, 2022 Ginkgo Bioworks, the leading horizontal platform for cell programming, and Zymergen (Nasdaq: ZY) reported that Ginkgo has completed its previously announced acquisition of Zymergen (Press release, Ginkgo Bioworks, OCT 19, 2022, View Source [SID1234635829]). The acquisition is expected to significantly enhance Ginkgo’s platform by integrating strong automation and software capabilities as well as a wealth of experience across diverse biological engineering approaches.

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"Today marks an important step in our long-term growth as we complete the Zymergen acquisition and welcome their world-class team to Ginkgo," said Jason Kelly, CEO and co-founder of Ginkgo Bioworks. "We are excited to integrate Zymergen’s capabilities into our platform and explore new and expanded partnerships and opportunities for their diverse array of product concepts currently under development."

Under the terms of the merger agreement entered into on July 24, 2022, Zymergen stockholders received, for each share of Zymergen common stock, 0.9179 shares of Ginkgo Class A common stock. Zymergen shares will no longer be traded on Nasdaq. Ginkgo Class A common stock will continue to trade on NYSE under the ticker symbol DNA.

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.

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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.

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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