Akt-1 inhibitors(Serine/threonine-protein kinase AKT inhibitors), CLPP agonists(caseinolytic mitochondrial matrix peptidase proteolytic subunit agonists), D2 receptor antagonists(Dopamine D2 receptor antagonists)

Therapeutic Areas

NeoplasmsNervous System DiseasesOther Diseases+ [6]

Active Indication

Diffuse midline glioma, point mutation K27M in histone H3Diffuse Intrinsic Pontine GliomaRecurrent Glioma+ [16]

Inactive Indication

Advanced cancerAdvanced Colorectal AdenocarcinomaAdvanced Endometrial Carcinoma+ [21]

Originator Organization

Oncoceutics, Inc.

Active Organization

Oncoceutics, Inc.

Chimerix, Inc.

National Institute of Neurological Disorders & Stroke

+ [8]

Inactive Organization

Icahn School of Medicine at Mount SinaiSanjiu Healthy World Co., Ltd.Jonsson Comprehensive Cancer Center

+ [1]

Drug Highest PhaseNDA/BLA

First Approval Date-

RegulationFast Track (United States), Rare Pediatric Disease (United States), Orphan Drug (European Union), Orphan Drug (Australia), Priority Review (United States)

Structure/Sequence

Molecular FormulaC24H26N4O

InChIKeyVLULRUCCHYVXOH-UHFFFAOYSA-N

CAS Registry1616632-77-9

Clinical Trials associated with Dordaviprone

NCT06012929

/ SuspendedPhase 2IIT

A Pilot Study, Open-Label Study of ONC201 for Refractory Meningioma

The goal of this clinical trial is to learn about treatment for a type of brain tumor called a meningioma. This study will enroll two groups of people. One group will be for people who will receive surgery to remove their brain tumor. The other group will be for people who have previously received treatment for their brain tumor but do not have any other available options for treatment.
The primary goals of this study are:
1. To measure how much of the study drug is present in tumor tissue taken from patients during surgery to remove their brain tumor
2. To measure the length of time between a study participant's first dose of study treatment until the time when their brain tumor gets worse or their death

Start Date01 Dec 2025

Sponsor / Collaborator

University of Nebraska

[+1]

NCT05630794

/ Not yet recruitingPhase 1IIT

Phase 1 Trial of ONC201 for Chemoprevention of Colorectal Cancer

This phase I trial tests the safety, side effects, and best dose of Akt/ERK Inhibitor ONC201 (ONC201) in preventing colorectal cancer in patients with familial adenomatous polyposis (FAP) or a history of multiple polyps. ONC201 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Start Date30 Mar 2025

Sponsor / Collaborator

National Cancer Institute

NCT04629209

/ WithdrawnPhase 2IIT

A Phase II, Open Label Study of ONC201 in Adults With EGFR-low Glioblastoma

This is an open-label, two arm study. The trial will enroll a total of up to 36 patients. Arm A will enroll up to a total of 6 evaluable patients and Arm B will enroll up to a total of 30 evaluable patients. Arm A will explore the intra-tumoral ONC201 concentrations and pharmacodynamic activity in adult EGFR-low glioblastoma patients. Arm B will determine the radiographic efficacy of ONC201 in adult recurrent EGFR-low glioblastoma patients. All patients will be treated with oral ONC201 (625 mg) twice weekly, 2 consecutive days on and 5 days off per week schedule.

Start Date28 Jun 2024

Sponsor / Collaborator

University of Minnesota Masonic Cancer Center

[+1]

100 Clinical Results associated with Dordaviprone

100 Translational Medicine associated with Dordaviprone

100 Patents (Medical) associated with Dordaviprone

243

Literatures (Medical) associated with Dordaviprone

22 Apr 2025·PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Mechanism of allosteric activation in human mitochondrial ClpP protease

Article

Author: Kim, Angelina S. ; Vahidi, Siavash ; Feng, Yue ; Velyvis, Algirdas ; Uday, Adwaith B. ; Forrester, Taylor J. B. ; Kimber, Matthew S. ; Jitkova, Yulia ; Currie, S. Quinn W. ; Schimmer, Aaron D. ; Harkness, Robert W. ; Zeytuni, Natalie ; Goncalves, Monica M.

Human ClpP protease contributes to mitochondrial protein quality control by degrading misfolded proteins. ClpP is overexpressed in cancers such as acute myeloid leukemia (AML), where its inhibition leads to the accumulation of damaged respiratory chain subunits and cell death. Conversely, hyperactivating ClpP with small-molecule activators, such as the recently discovered ONC201, disrupts mitochondrial protein degradation and impairs respiration in cancer cells. Despite its critical role in human health, the mechanism underlying the structural and functional properties of human ClpP remains elusive. Notably, human ClpP is paradoxically activated by active-site inhibitors. All available structures of human ClpP published to date are in the inactive compact or compressed states, surprisingly even when ClpP is bound to an activator molecule such as ONC201. Here, we present structures of human mitochondrial ClpP in the active extended state, including a pair of structures where ClpP is bound to an active-site inhibitor. We demonstrate that amino acid substitutions in the handle region (A192E and E196R) recreate a conserved salt bridge found in bacterial ClpP, stabilizing the extended active state and significantly enhancing ClpP activity. We elucidate the ClpP activation mechanism, highlighting a hormetic effect where substoichiometric inhibitor binding triggers an allosteric transition that drives ClpP into its active extended state. Our findings link the conformational dynamics of ClpP to its catalytic function and provide high-resolution structures for the rational design of potent and specific ClpP inhibitors, with implications for targeting AML and other disorders with ClpP involvement.

01 Apr 2025·JOURNAL OF CLINICAL PHARMACOLOGY

Relative Bioavailability of Dordaviprone (ONC201) is Not Affected by Co‐Administration of the Proton‐Pump Inhibitor Rabeprazole

Article

Author: Mullin, Mark J. ; Morrison, Marion ; Faison, Shamia L. ; Batonga, Joelle ; Naderer, Odin ; Bartkus, Angela ; Arumugham, Thangam ; Tippin, Tim

Abstract:

Dordaviprone (ONC201) is a novel, orally administered, anti‐cancer, small molecule imipridone with demonstrated antitumor effects in patients with glioma. Dordaviprone in vitro solubility is significantly reduced at pH >4.5. Concomitant use of acid reducing agents (ARAs) may therefore impact dordaviprone solubility and bioavailability. This open‐label, single‐sequence, three‐period crossover study evaluated the effect of proton‐pump inhibitor rabeprazole on dordaviprone pharmacokinetics (PK). Periods were consecutive and comprised of period 1 (days 1‐3), period 2 (days 4‐9), and period 3 (days 10‐13). In period 1, participants received a single oral 625 mg dose of dordaviprone on day 1. In period 2, participants received six consecutive days of QD 20 mg rabeprazole alone. In period 3, patients received one oral dose of 20 mg rabeprazole (the seventh consecutive daily dose), followed 2 h later by a single 625 mg dordaviprone oral dose. PK blood samples were collected and analyzed from pre‐dose 72 h following dordaviprone administration in periods 1 and 3. Dordaviprone exposure PK parameters were similar following administration of dordaviprone alone or with rabeprazole. Geometric mean ratios and 90% CIs for dordaviprone exposure parameters with and without rabeprazole following dordaviprone administration fell within bioequivalence limits of 80.00%‐125.00% for Cmax (97.19% [86.43‐109.28]), AUClast (102.21% [95.19‐109.75]), and AUCinf (102.27% [95.21‐109.86]), indicating no effect of multiple oral doses of rabeprazole on dordaviprone relative bioavailability. Six of the 16 participants reported treatment‐emergent adverse events (TEAEs); dordaviprone‐related TEAEs were reported by three participants and were limited to mild nausea and dizziness. No dordaviprone dose adjustment or ARA treatment modification is warranted.

01 Apr 2025·ACS Omega

A Novel Self-Healing Anticorrosive Inhibitor for Pipeline Corrosion Protection in Geothermal Well Systems

Article

Author: Jin, Xiaoguang ; Ma, Jiayun ; Wang, Lei ; Cao, Linglong ; Deng, Song ; Yan, Xiaopeng

The growing demand for energy coupled with the need for environmental sustainability underscores the importance of advancing renewable energy technologies. Among these, geothermal energy stands out as a clean and sustainable resource with substantial potential for heating and power generation. However, the corrosion of materials in geothermal facilities presents a significant operational challenge. This study explores the development of a self-healing anticorrosive coating based on microcapsule technology to address this issue. The proposed coating releases corrosion inhibitors from the microcapsules upon damage, enabling autonomous repair. Microcapsules were fabricated with an oil-soluble imidazoline oleate corrosion inhibitor encapsulated in urea-formaldehyde resin and incorporated into an epoxy resin matrix. The resulting composite coating demonstrated enhanced self-healing properties. Key parameters, including the core-to-wall ratio, healing duration, and microcapsule concentration, were systematically examined for their influence on self-healing efficiency. The performance of the composite was rigorously evaluated through simulated geothermal water corrosion tests under conditions representative of geothermal systems. The results indicate that microcapsules with a core-to-wall ratio of 3:1, using OP-10 as an emulsifier at 0.5 wt % of the core material, exhibited optimal structural integrity and encapsulation efficiency (74.6% core content, 85.7% coating efficiency). Additionally, epoxy resin composites with microcapsule concentrations greater than 20 wt % exhibited effective self-healing of artificially induced damage, demonstrating superior anticorrosive properties crucial for geothermal applications. These findings suggest that the developed self-healing composite holds great potential for mitigating corrosion in geothermal energy systems, contributing to the durability and efficiency of geothermal facilities.

118

News (Medical) associated with Dordaviprone

21 Apr 2025

·investor.jazzpharma.com

Jazz Pharmaceuticals Completes Acquisition of Chimerix

- Addition of dordaviprone strengthens Jazz's late-stage oncology pipeline and reinforces commitment to addressing rare diseases with significant unmet need - DUBLIN, April 21, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) ("Jazz" or the "Company") today announced the successful completion of its acquisition of Chimerix, Inc. ("Chimerix") for approximately $935 million in cash. Chimerix is now a wholly owned subsidiary of Jazz. "Bringing Chimerix into Jazz adds a novel medicine to our oncology portfolio and advances our efforts to address unmet patient needs," said Bruce Cozadd, chairman and chief executive officer of Jazz. "Dordaviprone has the potential to become the first and only FDA-approved therapy for patients with H3 K27M-mutant diffuse glioma and offers a promising near-term commercial opportunity, if approved. We are excited to welcome Chimerix's talented team as we collectively continue to advance dordaviprone, leveraging our development and commercial capabilities to deliver this therapy to patients as soon as the second half of this year." The addition of dordaviprone, a novel first-in-class small molecule treatment in development for H3 K27M-mutant diffuse glioma, further diversifies and adds near-term commercial opportunity to Jazz's oncology pipeline. Dordaviprone is currently under Priority Review by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) action date set for August 18, 2025. If approved in the U.S., the therapy may be eligible for a Rare Pediatric Disease Priority Review Voucher (PRV). Dordaviprone is also being studied in the ongoing Phase 3 ACTION trial to evaluate its use in newly diagnosed, non-recurrent H3 K27M-mutant diffuse glioma patients following radiation treatment, potentially extending its use into the first-line setting. Transaction Details Jazz's tender offer for all outstanding shares of common stock, par value $0.001 per share, of Chimerix expired at one minute after 11:59 p.m., Eastern Time, on April 17, 2025. Jazz has accepted for payment of $8.55 per share, in cash, without interest and subject to reduction for any applicable withholding taxes, all shares that were validly tendered and not validly withdrawn. Following its acceptance of the tendered shares, Jazz completed the acquisition of Chimerix through the merger of Pinetree Acquisition Sub, Inc., a Delaware corporation, an indirect wholly owned subsidiary of Jazz ("Purchaser") with and into Chimerix (the "Merger"). As a result of the Merger, the separate existence of Purchaser ceased, and Chimerix continued as the surviving corporation and an indirect wholly owned subsidiary of Jazz. Additional details regarding the tender can be found in a form 8-K filed by Jazz today with the SEC. About Dordaviprone Dordaviprone (ONC201) is a novel first-in-class small molecule imipridone that selectively targets the mitochondrial protease ClpP and dopamine receptor D2 (DRD2). Dordaviprone's unique mechanism of action includes alterations of key epigenetic modifications such as reversal of H3 K27me3-loss, which is the hallmark of H3 K27M-mutant gliomas. About Jazz Pharmaceuticals Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Caution Concerning Forward-Looking Statements This communication contains forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Jazz and Chimerix, including statements regarding the prospective benefits of the acquisition, including benefits from dordaviprone's potential to become the first and only FDA-approved therapy for patients with H3 K27M-mutant diffuse glioma and its potential to offer a promising near-term commercial opportunity; the potential for a near-term commercial launch of dordaviprone in the U.S. if approved; the potential of the ongoing Phase 3 ACTION trial to confirm clinical benefit of dordaviprone in recurrent H3 K27M-mutant diffuse glioma and extend its use in first-line patients; dordaviprone potentially being eligible for a Rare Pediatric Disease PRV; and other statements that are not historical facts. Actual results could differ materially from those anticipated in these forward-looking statements. Risks that may cause these forward-looking statements to be inaccurate include, without limitation: uncertainties as to the difficulty of predicting the timing or outcome of regulatory approvals or actions, if any; risks related to the ability to realize the anticipated benefits of the acquisition, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period and that Jazz and Chimerix will not be integrated successfully or that such integration may be more difficult, time-consuming or costly than expected; the effects of the transaction on relationships with employees, customers, suppliers, other business partners or governmental entities; significant transaction costs; unknown or inestimable liabilities; the risk of litigation and/or regulatory actions related to the acquisition; effectively launching and commercializing products and product candidates such as dordaviprone, if approved; the successful completion of development and regulatory activities with respect to dordaviprone; obtaining and maintaining adequate coverage and reimbursement for Jazz's products; the time-consuming and uncertain regulatory approval process, including the risk that Chimerix's NDA for dordaviprone seeking accelerated approval for treatment of H3 K27M-mutant diffuse glioma in adult and pediatric patients with progressive disease following prior therapy may not be approved by FDA in a timely manner or at all, and that Chimerix and/or Jazz may not receive a Rare Pediatric Disease PRV upon potential approval of dordaviprone; the costly and time-consuming pharmaceutical product development and the uncertainty of clinical success, including risks related to failure or delays in successfully initiating or completing clinical trials and assessing patients, including with respect to current and planned future clinical trials of dordaviprone; global economic, financial, and healthcare system disruptions and the current and potential future negative impacts to Jazz's business operations and financial results; and other risks and uncertainties affecting Jazz, including those described from time to time under the caption "Risk Factors" and elsewhere in its filings and reports with the U.S. Securities and Exchange Commission, including Jazz's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and future filings and reports. Other risks and uncertainties of which the Company is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements made in this press release are made only as of the date hereof, even if they are subsequently made available by the Company on its website or otherwise. The Company undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made. Contacts Investors: Jeff Macdonald Executive Director, Investor Relations Jazz Pharmaceuticals plc InvestorInfo@jazzpharma.com Ireland +353 1 634 3211 U.S. +1 650 496 2717 Media: Kristin Bhavnani Head of Global Corporate Communications Jazz Pharmaceuticals plc CorporateAffairsMediaInfo@jazzpharma.com Ireland +353 1 637 2141 U.S. +1 215 867 4948 View original content to download multimedia:https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-completes-acquisition-of-chimerix-302433612.html SOURCE Jazz Pharmaceuticals plc

Phase 3Drug ApprovalAcquisitionPriority Review

04 Apr 2025

·www.prnewswire.com

March Recap: 15 Top Health Press Releases

A roundup of the most newsworthy healthcare press releases from PR Newswire, including Novo Nordisk's affordable semaglutide initiative and the fifth anniversary of COVID-19. NEW YORK, April 4, 2025 /PRNewswire/ -- With thousands of press releases published each month, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the month's most popular releases and newsworthy trends, here's a recap of some of the past month's most read- and engaged-with stories. The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download. Continue Reading PR Newswire Monthly Health Press Release Roundup, March 2025. Photos provided by iHealth Labs, Inc., Garmin International, Inc. and Eggland's Best. Novo Nordisk introduces NovoCare® Pharmacy, lowering cost of all doses of FDA-approved Wegovy® (semaglutide) to $499 per month and offering easy home delivery for cash-paying patients Amidst the dangers of fake or illegitimate compounded "semaglutide," NovoCare® Pharmacy offers reliable access to authentic, FDA-approved Wegovy® in a once-weekly, single-dose pen. National Resident Matching Program® Releases the 2025 Main Residency Match® Results, Celebrates the Next Generation of Physicians A record number of 52,498 applicants registered for the Match (a 4.1% increase from 2024) to learn where they will begin their medical training. The Cigna Group Completes Sale of Medicare Businesses to HCSC The transaction is not expected to disrupt coverage or service for customers, clients, providers, or brokers of the Medicare or CareAllies businesses. Pleio Unveils OLLIE™: AI That Listens, Learns, and Guides To Elevate Human Connection in Patient Medication Journeys Powered by AI, OLLIE™ analyzes conversations to deliver critical information about patient sentiment, confidence levels, and emotional barriers that impact medication adherence — a challenge that contributes to up to 69% of all medication-related hospitalizations in the U.S. Capstan Medical Achieves Milestone: World's First Robotic Catheter Mitral Valve Replacements Successfully Completed The landmark completion is the first time a minimally invasive robotic structural heart platform has been used in clinical practice, successfully delivering a novel mitral valve into two human patients. Labcorp Announces Acquisition of Select Assets of BioReference Health's Innovative Oncology and Related Clinical Testing Services Businesses Labcorp will acquire BioReference Health's laboratory testing businesses focused on oncology and oncology-related clinical testing services across the United States. The assets that Labcorp will be acquiring currently generate approximately $85 million to $100 million in annual revenue. Ajax Health and KKR Form New Platform to Develop System for Treating Heart Failure The new entity, FlowMod, intends to accelerate the creation, clinical validation, and regulatory approval for a system treating heart failure, a condition that affects pumping action of the heart muscles and currently impacts 64 million people worldwide. Boston Scientific announces agreement to acquire SoniVie Ltd. The TIVUS™ system was developed by SoniVie to treat a variety of hypertensive disorders, including renal artery denervation (RDN) for hypertension, and is expected to further expand Boston Scientific's interventional portfolio. AbbVie and Gubra Announce License Agreement to Develop an Amylin Analog for the Treatment of Obesity The partnership marks AbbVie's entrance into the obesity field. Robert A. Michael, chief executive officer, AbbVie, said, "At AbbVie, we are focused on transforming the future of patient care in areas where significant unmet need persists." Mallinckrodt and Endo to Combine to Create a Global, Scaled, Diversified Pharmaceuticals Leader "The combination of Mallinckrodt and Endo brings together two essential pharmaceuticals organizations to accelerate value creation for our shareholders, customers, employees, the patients we serve and our other stakeholders," said Siggi Olafsson, President and Chief Executive Officer of Mallinckrodt. Abbott Receives CE Mark for its Volt™ Pulsed Field Ablation System to Treat Patients with Abnormal Heart Rhythms Pulsed field ablation (PFA) uses high energy electrical pulses for ablation procedures that may offer benefits to targeting and treating tissue in the heart. Designed to overcome limitations of existing systems, Abbott's Volt™ PFA System provides a new therapy option for people battling heart rhythm disorders. Sun Pharma to Acquire Checkpoint Therapeutics "We are excited to enter this transaction with Sun Pharma as the next step to bringing UNLOXCYT to cSCC [metastatic cutaneous squamous cell carcinoma] patients in need of a differentiated immunotherapy treatment option," said James Oliviero, President and Chief Executive Officer of Checkpoint. RamSoft Partners with Alpha Nodus to Automate Prior Authorizations Using AI This collaboration will provide RamSoft's over 750 global healthcare sites access to Alpha Nodus's AI-powered tools, including automated document processing, cost estimates, prior authorizations, and scheduling. Amgen and Kyowa Kirin Provide Top-Line Results from Rocatinlimab Phase 3 IGNITE Study in Adults with Moderate to Severe Atopic Dermatitis The IGNITE study, which evaluated two dose strengths of rocatinlimab, met its co-primary endpoints and all key secondary endpoints, achieving statistical significance for both rocatinlimab dose strengths versus placebo. Jazz Pharmaceuticals to Acquire Chimerix, Further Diversifying Oncology Portfolio "If approved, dordaviprone [Chimerix's lead clinical asset] has the potential to rapidly become a standard of care for a rare oncology disease and also contribute durable revenue beginning in the near-term," said Bruce Cozadd, chairman and chief executive officer, Jazz Pharmaceuticals. For more news like this, check out all of the latest health-related releases from PR Newswire. Trending Topics In addition to the newsworthy headlines above, the PR Newswire team identified several trends shaping health industry news in March: COVID-19 Five-Year Milestone: It may be five years since the pandemic's onset, but medical research shows no signs of slowing down when it comes to the treatment and prevention of COVID-19. Pharmaceutical companies like Soligenix and Inovio presented breakthrough findings showcasing their ongoing efforts to develop more effective booster treatments and monoclonal antibodies. Diving deeper into clinical impacts, CalciMedica reported critical data for severe COVID-19 pneumonia patients. Consumer health preparedness also remained a priority with iHealth's at-home testing making health monitoring easier than ever. World Sleep Day: Did you snooze your alarm on World Sleep Day, March 14? If so, catch up with these dream-worthy insights. The National Sleep Foundation shed light on the critical intersection of sleep health and overall well-being. New research also highlighted a concerning statistic: 31% of Americans diagnosed with sleep apnea are not receiving treatment. Brands like Garmin and Love to Dream leveraged the awareness day to promote innovative sleep solutions, showcasing that a good night's rest isn't just a luxury, it's a necessity. National Nutrition Month: From grocery carts to fitness apps, press releases in March were geared towards making healthy eating more accessible. Celebrating National Nutrition Month, the American Diabetes Association and Instacart simplified nutritious shopping, while MyFitnessPal revealed surprising nutritional blind spots and Eggland's Best partnered with Club Pilates. From CVS's innovative weight management program to GENYOUth's mission to secure student nutrition, we noticed nutrition awareness becoming increasingly personalized, making healthy eating less of a puzzle. Looking ahead: April is full of must-follow awareness initiatives including World Health Day (April 7) and National Minority Health Month. April 1 also marks the beginning of National Autism Awareness Month and National Stress Awareness Month. We anticipate significant wire activity around these initiatives, with releases likely spotlighting health equity, innovative medical technologies and mental health and wellness. Do you have a health press release to distribute? Sign up with PR Newswire to share your story with the audiences who matter most. Helping Journalists Stay Up to Date on Industry News These are just a few of the recent press releases that consumers and the media should know about. To be notified of releases relevant to their coverage area, journalists can set up a custom newsfeed with PR Newswire for Journalists. Once they're signed up, reporters, bloggers, and freelancers have access to the following free features: Customization: Users can create customized newsfeeds that will deliver relevant news right to their inbox. Newsfeed results can be targeted by keywords, industry, subject, geography, and more. Photos and Videos: Thousands of multimedia assets are available to download and include in a journalist or blogger's next story. Subject Matter Experts: Journalists will have access to ProfNet, a database of industry experts to connect with as sources or for quotes in their articles. Related Resources: Our journalist- and blogger-focused blog, Beyond Bylines, features regular media news roundups, writing tips, upcoming events, and more. About PR Newswire PR Newswire is the industry's leading press release distribution partner with an unparalleled global reach of more than 440,000 newsrooms, websites, direct feeds, journalists and influencers and is available in more than 170 countries and 40 languages. From our award-winning Content Services offerings, integrated media newsroom and microsite products, Investor Relations suite of services, paid placement and social sharing tools, PR Newswire has a comprehensive catalog of solutions to solve the modern-day challenges PR and communications teams face. For 70 years, PR Newswire has been the preferred destination for brands to share their most important news stories across the world. For questions, contact the team at [email protected]. SOURCE PR Newswire WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3AcquisitionImmunotherapy

21 Mar 2025

·www.fiercebiotech.com

Chimerix engaged with 7 other biopharmas before choosing Jazz\'s $935M deal—here\'s why it won

Chimerix engaged with numerous biopharmas—termed parties A through G—about potential strategic transactions related to its oncology candidate.\n Before Jazz Pharmaceuticals inked a $935 million deal for Chimerix earlier this month, the biotech had been in talks with six other pharmas and one biotech about several different potential offers.Ultimately, Chimerix’s board went with Jazz’s offer due to its cash payable nature and the recent downward trend in biopharma financial markets, plus a general volatility tied to escalating political and global trade tensions, according to Securities and Exchange Commission documents filed Friday. Buying Chimerix gives Jazz control of the brain cancer drug candidate dordaviprone, also known as ONC201, a small molecule designed to treat recurrent H3 K27M-mutant diffuse glioma.But Jazz wasn’t first on site. Since August 2023, Chimerix had been in discussions about potential licensing deals for ONC201 with a “global pharmaceutical company,” known as “party A” in the filings. Chimerix steadily entered discussions with more companies—termed parties B through G—about potential strategic transactions related to the oncology candidate, per the docs.Jazz was one of the last contenders to enter the scene, reaching out after Chimerix publicly announced on Dec. 9, 2024, its plan to submit a new drug application seeking accelerated approval for ONC201 before the year ended. On Dec. 18 and Dec. 19, Chimerix’s board reviewed its offers from several different companies, including a potential equity financing, a possible ex-U.S. licensing transaction for ONC201 and a potential acquisition. The board ultimately decided to move forward with multiple options at the same time. On the same day—Dec. 19—party A submitted a proposal to acquire ONC201 and related assets for an upfront payment of $350 million and a contingent payment of $100 million upon FDA approval. Chimerix management reached out to the pharma and said the proposal was insufficient.Less than a month later, party A tried again, submitting a new proposal to acquire Chimerix for an upfront payment of $6.50 per share and one contingent value right (CVR) per share, representing the right to receive a one-time payment of $1.50 upon FDA approval of ONC201 no later than June 2027, plus a one-time payment of $1.50 once ONC201 achieved yearly net sales in the U.S. above $700 million at a date before 2030.According to the filing, Chimerix’s board directed management to discuss transaction terms with party A in a way designed to increase the economic value and certainty of that proposal, with the view that alternative offers from other potential counterparties could be increased if they had a better nonbinding indication from party A.Meanwhile, bidders started dropping. Party F lost interest after Chimerix told the company that it had received a proposal with a higher value than party F’s offer of around $5 per share. And party G—a biotech—discontinued conversations regarding a potential acquisition on the belief that it wouldn’t be able to compete with other interested parties. On Jan. 26, party A came back again with a revised proposal to acquire Chimerix on the same terms as before but with the deadlines to hit the payment-triggering milestones removed.Chimerix management told party A on Jan. 30 that the revised offer was still not good enough.On Feb. 6, Jazz outlined an acquisition offer for an upfront payment of $5.50 per share and one CVR per share representing the right to receive one-time payments of $1 upon FDA approval, 25 cents upon receipt of pricing approval in at least three major European markets and $1.50 once global net sales of ONC201 were above $500 million in a calendar year.Chimerix told Jazz the offer was insufficient but that Chimerix would provide additional due diligence materials so Jazz could increase its offer.Ten days later, Chimerix publicly announced that the FDA had accepted its new drug application seeking accelerated approval, with the application receiving priority review and a decision expected by Aug. 18 of this year.On March 3, Jazz submitted its final proposal: $8.55 per share in all cash. On the same day, party A shared a proposal to acquire Chimerix for an upfront payment of $7.50 per share and one CVR per share representing the right to receive a one-time payment of $2, payable if ONC201 received full approval by the FDA before Aug. 31, 2032. The CVR would not be payable if the primary endpoint of Chimerix’s ongoing phase 3 study was not achieved or if Chimerix received a complete response letter.That night, the board met to review the two offers and determined Jazz to be the winning bidder. The next afternoon, Chimerix’s board unanimously decided that Jazz’s offer was in the best interests of its stockholders. The board took into account several different factors when reaching its recommendation that stockholders accept the proposal, according to the documents.One consideration was that Jazz’s offer price represented a 70% premium over Chimerix’s closing price per share on March 3 and an 89% premium over the weighted average price of shares during the preceding 30-day trading period.The biotech board also considered the fact that the offer was payable fully in cash, allowing stockholders to realize immediate value.Furthermore, they weighed the risks of remaining a standalone company and general risks tied to market conditions. Among the potential risks identified were “the challenges faced by the biopharmaceutical industry,” including potential competition; “complex regulatory and political regimes”; and an “evolving pricing environment,” particularly in light of “the increasing scrutiny of pharmaceutical pricing and proposals to address the perceived high cost of pharmaceuticals.”Another consideration was “the current state of the U.S. and global economies, including the recent downward trend in the biopharmaceutical financial markets, U.S. trade policies and tariffs.” The board also cited rising inflation and volatility resulting from escalating political and global trade tensions in its ultimate decision.

AcquisitionPhase 3Priority ReviewLicense out/in

100 Deals associated with Dordaviprone

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB14844

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Diffuse midline glioma, point mutation K27M in histone H3	NDA/BLA	United States	Chimerix, Inc.	30 Dec 2024
Diffuse Intrinsic Pontine Glioma	Phase 3	Denmark	Chimerix, Inc.	29 Sep 2022
Diffuse Intrinsic Pontine Glioma	Phase 3	France	Chimerix, Inc.	29 Sep 2022
Diffuse Intrinsic Pontine Glioma	Phase 3	Spain	Chimerix, Inc.	29 Sep 2022
Diffuse Intrinsic Pontine Glioma	Phase 3	Sweden	Chimerix, Inc.	29 Sep 2022
Meningioma	Phase 2	United States	Chimerix, Inc.	01 Dec 2025
Recurrent Glioma	Phase 2	United States	National Institute of Neurological Disorders & Stroke	20 Oct 2021
Recurrent Glioma	Phase 2	Australia	National Institute of Neurological Disorders & Stroke	20 Oct 2021
Recurrent Glioma	Phase 2	Israel	National Institute of Neurological Disorders & Stroke	20 Oct 2021
Recurrent Glioma	Phase 2	Netherlands	National Institute of Neurological Disorders & Stroke	20 Oct 2021

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03485729 (CTgov)	Phase 2	Recurrent Endometrial Cancer	27	Dordaviprone (Arm B)	jcwkbtupnj = zcadbwvcpx jfhezpmnle (vdklphessc, euilxsebxv - rqioqjmjmv) View more	-	24 Dec 2024
				Dordaviprone (Arm A)	hnvigpwdxz(oefftkpefl) = hyrwomiiix vkddcbxitm (wxglncrgpn, uozdbtncyt - pwqsvasvkg) View more
NCT02525692 (PATH-25 \| ACTR-51, CTgov)	Phase 2	Diffuse midline glioma, point mutation K27M in histone H3 \| Basal Ganglia Diseases \| Recurrent Glioblastoma	84	Dordaviprone (Arm A)	qtuzydtero = xafwleqkda lvdjfbvadg (ypbgnvxgll, tbkpwxknrn - afqekdjxxt) View more	-	24 Dec 2024
				Dordaviprone (Arm B)	qtuzydtero = grrwaugunw lvdjfbvadg (ypbgnvxgll, hpqifpzhxs - nrmyfikooo) View more
NCT03034200 (CTgov)	Phase 2	Neuroendocrine Tumors \| Pheochromocytoma	30	ONC201 (Arm A: Metastatic PC-PG)	wqtywxcale(fptnrqrxjp) = bkgtdhbfyz ihfbhmlnnj (tiwxrmnhhw, ikifqvypus - uyvyvcxbfi) View more	-	26 Nov 2024
				ONC201 (Arm B: Other NETs)	wqtywxcale(fptnrqrxjp) = pigzugkmrv ihfbhmlnnj (tiwxrmnhhw, fgftimeprm - gocvyfxktl) View more
NCT05580562 (ACTION, ASTRO2024)	Phase 3	Diffuse midline glioma, point mutation K27M in histone H3	50	ONC201	cgttzbvegh(yamxyntaub) = qkuqeesjqu zyaxihoamc (vwhdkvdgiu )	Positive	01 Oct 2024
				Standard Radiotherapy Dosing Regimens	cgttzbvegh(yamxyntaub) = bjjeffjatd zyaxihoamc (vwhdkvdgiu )
NCT02863991 (CTgov)	Phase 1/2	Relapse multiple myeloma	17	ONC201+Dexamethasone (Phase 1: 375 mg ONC201 + 20 mg Dexamethasone)	rfujnfdcri = ziinyiuprr cafmjziotg (bruqwldxvc, wbzsyctand - ytkaivmucv) View more	-	03 Jul 2024
				ONC201+Dexamethasone (Phase 2: 625 mg ONC201 + 20 mg Dexamethasone)	rfujnfdcri = gfelaqbpte cafmjziotg (bruqwldxvc, akllijkadd - dqdprdibpx) View more
NCT05009992 (Biospace) Manual	Phase 2	Diffuse Midline Glioma First line	132	paxalisib in combination with ONC201 (Cohort 1)	etdiiyxknt(vgeobupxnf) = szmhwwbmuz rbbzhwrncd (hlksscnjqg )	Positive	27 Jun 2024
				paxalisib in combination with ONC201 (Cohort 2)	etdiiyxknt(vgeobupxnf) = xxojislaqh rbbzhwrncd (hlksscnjqg )
NCT05009992 (SNO2023) Manual	Phase 2	Diffuse Midline Glioma	68	ONC201+paxalisib	hbryzxyfnt(gpbcahgybu) = yvbddookok qufluwadqg (gxdtrzggqp, lower 11.6) View more	Positive	10 Nov 2023
TMET-02 (SNO2023)	Not Applicable	Brain Stem Glioma H3K27M-mutant	71	ONC201 monotherapy	pdpzpxqxzs(yyucvdrzah) = jxonecswje toosdivthi (fjhawufjyb ) View more	Positive	10 Nov 2023
NCT03394027 (Pubmed)	Phase 2	Metastatic breast cancer \| Advanced Endometrial Carcinoma	30	ONC201	iiholanugd(dqhqhvznvy) = all patients experienced bkffcswvdv (dmpotdmhcy )	Negative	05 Jun 2023
NCT03416530 \| NCT03134131 (CTNI-61, SNO2022)	Phase 2	Brain Stem Glioma EGFR mutation \| EGFR expression \| MAPK-pathway alterations ... View more	75	ONC201	micvnzrpcp(qeeetyefin) = high EGFR expression as a marker of resistance and improved response in tumors with MAPK-pathway alterations pdmsjaielx (otcfsiyxdx ) View more	Positive	14 Nov 2022
				ONC201 (Historical Control)

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