On February 15, 2022 Medivir reported that Year-End Report, January – December 2021 (Press release, Medivir, FEB 15, 2022, View Source;year-end-report-january–december-2021-301482292.html [SID1234608155])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

October – December

Financial summary for the quarter

Net turnover amounted to SEK 13.9 (1.5) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -23.5 (-10.6) million. Basic and diluted earnings per share amounted to SEK -0.44 (-0.46) and SEK -0.44 (-0.46) respectively.
Cash flow from operating activities amounted to SEK -5.4 (-1.0) million.
Liquid assets and short-term investments at the end of the period amounted to SEK 221.2 (70.0) million.
Significant events during the quarter

In October, the Board of Directors appointed Jens Lindberg as new CEO of Medivir. Jens Lindberg has extensive experience from the pharmaceutical industry and the field of Oncology. He joins from Sedana Medical where he has been VP Commercial Operations and acting CEO.
IGM Biosciences, Inc. initiated its clinical study in solid cancers with birinapant (IGM-9427) in combination with IGM’s DR5 agonist antibody IGM-8444. The purpose of this first clinical trial with the combination is to evaluate safety and tolerability.
In November, results from an investigator-initiated phase II clinical trial of remetinostat in patients with squamous cell carcinoma were published.
In December, it was announced that the first patient with hepatocellular carcinoma had started treatment with fostroxacitabine bralpamide (MIV-818) in the phase 1b / 2a combination study.
January – December

Financial summary for the period

Net turnover amounted to SEK 25.5 (13.9) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -59.5 (-38.5) million. Basic and diluted earnings per share amounted to SEK -1.20 (-1.75) and SEK -1.20 (-1.75) respectively.
Cash flow from operating activities amounted to SEK -48.7 (-58.1) million.
Liquid assets and short-term investments at the end of the period amounted to SEK 221.2 (70.0) million.
Significant events after the end of the period

In January, it was announced that the WHO had selected fostroxacitabine bralpamide as the official generic name for the patented candidate drug MIV-818, which is in clinical development in primary liver cancer.
Jens Lindberg assumed his position as CEO of Medivir on January 24, 2022.
Conference call for investors, analysts and the media

The Year-End Report January – December 2021 will be presented by Medivir’s CEO, Jens Lindberg.

The conference call will also be streamed via a link on the website: www.medivir.com

The presentation will be available on Medivir’s website after completion of the conference.

CEO’s message

On January 24, 2022, I took over as CEO of Medivir and after my first time on the job, it is clear to me why the company managed to deliver so well on business goals in 2021. We have an extremely competent and experienced team that works dedicatedly with both our cutting-edge project fostroxacitabine bralpamide (MIV-818) and with the business development for our other assets. I hope to be able to contribute to the further strengthening of our delivery capacity in the future. Under the leadership of the company’s former CEO Yilmaz Mahshid, today a board member of Medivir, and our CFO Magnus Christensen, who has been the company’s interim CEO since May, Medivir has made significant progress in 2021.

Medivir’s drug development focuses on a very promising and proprietary clinical project, fostroxacitabine bralpamide (formerly MIV-818), with a clear therapeutic target, where the unmet medical needs remain extremely large, despite recent clinical advances. Fostroxacitabine bralpamide has the potential to become the first liver-targeted and orally administered drug that can help patients with various cancers of the liver. Its unique mechanism of action means that it does not directly compete with other treatment options but instead enables combination treatments with other drug alternatives in hepatocellular carcinoma (HCC). Liver cancer is the third leading cause of cancer-related deaths worldwide and HCC is the most common form of cancer that arises in the liver. The effect of today’s medications is often limited and mortality remains at a high level.

After the end of the year, MIV-818 received the official generic name fostroxacitabine bralpamide from the World Health Organization WHO, something we see as an important step towards a product for the treatment of HCC.

The clinical development program for fostroxacitabine bralpamide has passed a number of milestones during the year. In April, it was announced that the top-line results from the monotherapy part of the phase Ib study were positive with a good safety and tolerability profile. They were later presented in more detail at the ESMO (Free ESMO Whitepaper) Congress in September and aroused great interest. In May, the design for the next step, the phase 1b/2a combination study with fostroxacitabine bralpamide for liver cancer, was presented. The regulatory approval from the British Medicines & Healthcare products Regulatory Agency (MHRA) for the study was obtained at the end of August, and from the South Korea Ministry of Food and Drug Safety (MFDS) in November.

In December, the first patient with HCC was dosed in the phase 1b/2a combination study with fostroxacitabine bralpamide, which is given in combination with two other medicines, either with Lenvima, a tyrosine kinase inhibitor, or with Keytruda, an anti-PD-1 checkpoint inhibitor. Lenvima and Keytruda (approved in the USA) are currently approved as mono therapy treatments of HCC.

The licensing agreement with IGM Biosciences, Inc., which gives IGM the global and exclusive rights to develop birinapant, could potentially provide milestone payments up to a total of approximately USD 350 million as well as tiered royalties up to "mid-teens". At the time of signing in January 2021, Medivir received USD 1 million, and when IGM in early November initiated a phase I clinical trial in solid cancers with birinapant in combination with its own DR5 agonist antibody IGM-8444, it was followed by an additional USD 1.5 million. Of course, we look forward to IGM’s continued clinical development of birinapant.

Also for remetinostat, a number of steps forward made during the year should be noted. Positive results from the investigator-initiated phase II clinical trial of remetinostat in patients with squamous cell carcinoma were published in November in the scientific journal JAMA Dermatology. Promising results from the investigator-initiated phase II study with remetinostat for basal cell carcinoma were published in August in the scientific journal Clinical Cancer Research. Through a renegotiated multi-party agreement, Medivir was able to further strengthen the business development potential for remetinostat in August.

Business development and collaborations are central to Medivir’s success. Birinapant is a good example of this and we see opportunities for remetinostat and MIV-711, but also in other smaller projects. In early 2021, a licensing agreement was entered into with Ubiquigent for the preclinical research program USP7.

Thanks to the financing that was successfully carried out at the beginning of the year and provided the company with approximately SEK 223 million before transaction costs, we are entering 2022 with resources and business development opportunities that provide good conditions for continuing the clinical development program for our cutting-edge project fostroxacitabine bralpamide. Our goal is to make it an effective drug for liver cancer that makes a real difference for patients and for healthcare, and thus also for our shareholders. I look forward to keeping you informed about Medivir’s continued development.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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."

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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