On July 8, 2021 Oncopeptides, a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, reported updated results and safety measures based on the head-to-head phase 3 OCEAN study evaluating the efficacy and safety of melflufen (INN melphalan flufenamide) plus dexamethasone versus pomalidomide plus dexamethasone in patients with relapsed refractory multiple myeloma who have received 2 – 4 prior lines of therapy (Press release, Oncopeptides, JUL 8, 2021, View Source [SID1234646792]). The randomized study was initiated in 2017 and includes 495 patients from more than 100 hospitals in 21 countries around the world. The topline results were announced on May 25[th].
The updated OCEAN results follow a blinded reassessment by the Independent Review Committee (IRC). During the preparations of the clinical study report and regulatory documents it became apparent that the IRC was not provided with all the information available in the clinical database during the time of their initial assessment. This led to a thorough investigation of all 495 patients where a comparison was made between the data provided to the IRC and what data was available in the clinical database. Consequently, data from 29 patients had to be reassessed. In the final analysis melflufen met the primary endpoint of superior Progression Free Survival (PFS) compared to pomalidomide with a Hazard Ratio (HR) of 0.792 (95% CI 0.640-0.979, p-value 0.0311) as determined by the IRC.

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Overall Survival (OS) was a key secondary endpoint in the OCEAN study. The OS HR was 1.104 (0.846-1.441) in favor of pomalidomide for the Intention to Treat population. Oncopeptides has performed analyses of the OS data and the Company believes that the OS results are primarily explained by substantial HR differences between pre-specified subgroups in both directions.

Based on the observed large differences in overall survival in pre-specified subgroups, the FDA has requested a partial clinical hold of all clinical studies with melflufen, pending further investigation. Oncopeptides will co-operate closely with the FDA to expeditiously perform necessary analysis to fully understand the benefit/risk profile of melflufen and to identify what patients do benefit from treatment with melflufen in earlier lines of therapy in relapsed refractory multiple myeloma.

This update and measures will be presented at a webcast on July 8, 2021, at 11:00 (CET), log in details is available below.

For more information, please contact:

Rolf Gulliksen, Global Head of Corporate Communications, Oncopeptides AB (publ)
E-mail: [email protected]
Cell phone: + 46 70 262 96 28

Linda Holmström, Director of Investor Relations, Oncopeptides AB (publ)
E-mail: [email protected]
Cell phone: +46 70 873 40 95

The information in the press release is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons above, on July 8, 2021, at 07:30 (CET).

On July 7, 2021 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will report its second quarter 2021 financial and operating results on Thursday, August 5, 2021, before the U.S. financial markets open (Press release, Regeneron, JUL 7, 2021, View Source [SID1234584659]). The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

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Conference Call Information
To access this call, dial (888) 660-6127 (U.S.) or (973) 890-8355 (International), conference ID 9098036. A link to the webcast may be accessed from the ‘Investors and Media’ page of Regeneron’s website at View Source A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

On July 7, 2021 ViewRay, Inc. (NASDAQ: VRAY) reported that the Miami Cancer Institute, part of Baptist Health South Florida, has enrolled the first patients in its "Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction for Inoperable Primary or Metastatic Carcinoma" clinical study – referred to as the SMART ONE trial (NCT#04939246) (Press release, ViewRay, JUL 7, 2021, View Source [SID1234584675]). This single-arm prospective study that was developed and led by Dr. Michael Chuong, MD, FACRO, radiation oncologist and Medical Director of Proton Therapy and MR-guided Therapy at Miami Cancer Institute, is exploring the feasibility and tolerability of single-fraction stereotactic ablative body radiation therapy (SABR) for primary or metastatic carcinoma involving the lung, liver, adrenal gland, abdominal/pelvic lymph node, pancreas, and kidney.*

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The use of MRI instead of CT for daily image guidance offers several important advantages in the delivery of SABR including superior visualization of the internal anatomy prior to and uniquely continuously during treatment delivery.

SABR is an advanced and technically complex procedure in which very high radiation dose is delivered using steep dose gradients with millimeter precision and accuracy. The most common delivery schedule is daily treatment for five total days to each targeted tumor. While completing treatment in only one day may be possible, it is not commonly done using CT-guided radiation delivery machines because of safety concerns due to limitations in visual confirmation of tumor and nearby critical organ position throughout treatment.

MRIdian’s design allows clinicians the ability to safely deliver an ablative dose and expand single-fraction SABR to tumors that would not have been previously considered. The design includes diagnostic-quality anatomic imaging prior to treatment delivery, the ability to perform on-table adaptive planning and continuous intrafraction visualization, soft tissue tracking and automatic beam gating. These features facilitate tighter planning target volume margins to spare healthy tissue, especially in immediate proximity to the target, which allow for reduction or elimination of higher-grade toxicities often associated with SABR dose delivery.

"With MRIdian, we’re giving clinicians the clinical confidence to safely deliver ablative radiation doses while also reducing the number of treatments," said Martin Fuss, M.D., chief medical officer at ViewRay. "MRI-guidance and on-table adaptive delivery ensure that these powerful radiation doses are reaching the target but avoid highly sensitive surrounding critical structures. We believe this treatment concept has the potential to alleviate toxicity risks associated with SABR while improving outcomes for cancer patients around the world."

A growing body of clinical literature has led to the initiation of the SMART ONE trial design. This evidence describes favorable outcomes of image-guided SABR for various cancers, including tumors in the pancreas, liver, lung, breast, adrenal gland, kidney, lymph nodes, and prostate; however, the peer-reviewed, published body of data has nearly exclusively been based on multi-fraction SABR.

"Published experience suggests that delivery of single-fraction SABR using MRIdian should be at least isotoxic and isoeffective as compared to multi-fraction SABR, as supported by its on-table adaptive planning capabilities and continuous soft-tissue tracking with automatic beam gating," said Dr. Chuong. "We believe the study will demonstrate the feasibility to safely and effectively deliver SABR in only one fraction across these indications that will not only shorten overall treatment time, but also reduce cost and improve increase patient convenience."

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 nearby organs-at-risk 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 surrounding healthy tissues, 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.

More than 12,500 patients have been treated with MRIdian. Currently, 44 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

*ViewRay has provided grant funding to Miami Cancer Institute in support of the SMART ONE trial.
Dr. Michael Chuong has served on advisory boards of, and received honoraria from, ViewRay.

On July 7, 2021 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that Dmitri Wiederschain, Ph.D., Chief Scientific Officer will participate in a panel discussion at the William Blair’s Biotech Focus Conference taking place virtually on Wednesday, July 14, 2021 at 4:20 PM ET (Press release, Jounce Therapeutics, JUL 7, 2021, View Source [SID1234584643]).

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A webcast of the panel will be available by visiting "Events and Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. A replay of the webcast will be archived for 30 days following the presentation.

On July 7, 2021 Replimune Group, Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported that Robert Coffin, Ph.D., President and Chief Research & Development Officer of Replimune, will participate in a panel titled "Novel Mechanisms and Strategies for Addressing PD-(L)1 Refractory/Resistant Tumors" at the William Blair Biotech Focus Conference 2021 taking place virtually on Wednesday, July 14, 2021 at 4:20 PM ET (Press release, Replimune, JUL 7, 2021, View Source [SID1234584660]).

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A simultaneous webcast will be available in the Investors section of Replimune’s website at www.replimune.com. A replay will be available for approximately 90 days following the conference.