An Open Label, Phase 1b Safety, Dose-finding, Brain Tumor Delivery, and Pharmacokinetics Study of Intranasal NEO100 in Patients With Pediatric-type Select Brain Tumors

This is an open label, Phase 1b safety, dose-finding, brain tumor delivery, and pharmacokinetics study of intranasal NEO100 in patients with pediatric-type diffuse high grade gliomas. Patients will receive IN NEO100 that will follow a dose titration design, followed by a standard dose escalation design to establish safety. Brain tumor delivery of NEO100 will be confirmed in each disease sub-type by surgical resection/needle biopsy only if clinically indicated and scheduled for clinical purposes and testing with residual tissue for NEO100 and the major metabolite of NEO100 (Perillic Acid).

Start Date01 May 2024

Sponsor / Collaborator

NeOnc Technologies, Inc.

KCT0009442 / RecruitingNot ApplicableIIT

A human study to evaluate safety and effectiveness of Perilla oil on blood flow

Start Date20 Jan 2024

Sponsor / Collaborator

Seoul National University of Science & Technology

NCT05023018 / RecruitingPhase 2

An Open-Label, Phase 2 Study of NEO100 in Participants With Residual, Progressive or Recurrent High-Grade Meningioma

This multi-site, Phase 2 clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO100 (perillyl alcohol) for the treatment of patients with residual high-grade meningioma following resection surgery, radiographically-confirmed progression of high-grade meningioma or recurrent high-grade meningioma. There will be up to 30 patients enrolled in this study to have 29 evaluable patients. NEO100 will be self-administered four times daily on a 28-day treatment cycle for up to twelve cycles, until disease progression or death, whichever occurs first. Following the completion of cycle twelve, patients receiving benefit will be given the option to continue receiving compassionate use treatment with NEO100.

Start Date01 Jul 2022

Sponsor / Collaborator

NeOnc Technologies, Inc.

100 Clinical Results associated with Perillyl alcohol

100 Translational Medicine associated with Perillyl alcohol

100 Patents (Medical) associated with Perillyl alcohol

512

Literatures (Medical) associated with Perillyl alcohol

08 Jan 2024·Current medicinal chemistry

Perillyl Alcohol Promotes Relaxation in Human Umbilical Artery

Article

Author: Batista, Paulo Ricardo ; Pereira de Morais, Luis ; Araújo Delmondes, Gyllyandeson ; Sena Bastos, Carla Mikevely ; Menezes Dantas, Débora de ; Silva, Andressa de Alencar ; Lima Gomes, Maria Franciele ; Rodrigues da Silva, Renata Evaristo ; Alencar de Menezes, Irwin Rose ; Barbosa, Roseli

Background::

Perillyl alcohol (POH) is a monoterpenoid found in plant essential oils and has been shown to relax murine vessels, but its effect on human vessels remains poorly studied.

Objective::

The study aimed to characterize the effect of POH on human umbilical arteries (HUA).

objective::

This study aims to evaluate the effect of POH on smooth muscle of human umbilical arteries (HUA).

Methods::

Rings of HUA were obtained from uncomplicated patients and suspended in an organ bath for isometric recording. The vasorelaxant effect of POH in HUA was evaluated on basal tone and electromechanical or pharmacomechanical contractions, and possible mechanisms of action were also investigated.

Results::

POH (1-1000 μM) altered the basal tone of HUA and completely relaxed HUA rings precontracted with KCl (60 mM) or 5-HT (10 μM), obtaining greater potency in the pharmacomechanical pathway (EC50 110.1 μM), suggesting a complex interference in the mobilization of extra- and intracellular Ca2+. POH (1000 μM) inhibited contractions induced by BaCl2 (0.1-30 mM) in a similar way to nifedipine (10 μM), indicating a possible blockade of L-type VOCC. In the presence of potassium channel blockers, tetraethylammonium (1 mM), 4-aminopyridine (1 mM), or glibenclamide (10 μM), an increase in the EC50 value of the POH was observed, suggesting a modulation of the activity of BKCa, KV, and KATP channels.

Conclusion::

The data from this study suggest that POH modulates Ca2+ and K+ ion channels to induce a relaxant response in HUA.

other::

31 Dec 2023·Oncoimmunology

Daratumumab induces cell-mediated cytotoxicity of primary effusion lymphoma and is active against refractory disease

Article

Author: Davis, David A. ; Wang, Hao-Wei ; Shrestha, Prabha ; Astter, Yana ; Yarchoan, Robert ; Ramaswami, Ramya ; Zhou, Ting ; Yuan, Constance M. ; Lurain, Kathryn

Primary effusion lymphoma (PEL), an aggressive non-Hodgkin lymphoma caused by Kaposi sarcoma-associated herpesvirus (KSHV), lacks standard therapy and has a median survival of 10-22 months with combination chemotherapy. PEL is a tumor of plasmablast-like B cells generally expressing CD38, the target of daratumumab (Dara). Initially, we assessed PEL cells from eight patients and established that each expressed high levels of CD38 by flow cytometry. PEL cell lines were also evaluated and most had high CD38 expression. We then assessed Dara's effects on complement-dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity (ADCC) of PEL cell lines as well as its clinical benefits on two patients with PEL. Despite high CD38 expression, Dara did not induce CDC of PEL cell lines, due in part to high levels of the complement-inhibitory proteins, CD55 and CD59. However, Dara induced significant and dose-dependent increases in ADCC, particularly in those lines with high CD38 levels. Two FDA-approved drugs, all trans-retinoic acid (ATRA) and pomalidomide (Pom), significantly increased surface CD38 levels in low-CD38 expressing PEL cell lines, resulting in increased Dara-induced ADCC. Two patients with refractory PEL were treated with Dara alone or in combination with Pom. One patient with leptomeningeal PEL had a complete response to Dara and Pom combination treatment. Others had improvement in performance status and resolution of malignant ascites with Dara alone. Together, these data support the use of Dara monotherapy or in combination with ATRA or Pom as a potential therapeutic option for PEL.

01 Dec 2023·Journal of neurosurgery

Enhancing brain entry and therapeutic activity of chimeric antigen receptor T cells with intra-arterial NEO100 in a mouse model of CNS lymphoma

Article

Author: Wang, Weijun ; Chen, Ligang ; Cho, Hee-Yeon ; Zheng, Long ; He, Haiping ; Stathopoulos, Apostolos ; Zeng, Shan ; Schönthal, Axel H ; Kouhi, Aida ; Chen, Thomas C ; Khawli, Leslie A ; Epstein, Alan L

OBJECTIVE:

Malignancies of the CNS are difficult to treat because the blood-brain barrier (BBB) prevents most therapeutics from reaching the intracranial lesions at sufficiently high concentrations. This also applies to chimeric antigen receptor (CAR) T cells, for which systemic delivery is inferior to direct intratumoral or intraventricular injection of the cells. The authors previously reported on a novel approach to safely and reversibly open the BBB of mice by applying intra-arterial (IA) injections of NEO100, a pharmaceutical-grade version of the natural monoterpene perillyl alcohol. The authors hypothesized that this method would enable enhanced brain entry and therapeutic activity of intravenously delivered CAR T cells, which the authors tested in a mouse model of CNS lymphoma.

METHODS:

Human Raji lymphoma cells were implanted into the brains of immune-deficient mice. After tumor uptake was confirmed with bioluminescent imaging, 0.3% NEO100 was injected intra-arterially, which was followed by intravenous (IV) delivery of CD19-targeted CAR T cells. After this single intervention, tumor growth was monitored with imaging, long-term survival of mice was recorded, and select mice were euthanized to analyze the distribution of CAR T cells in brain tissue.

RESULTS:

Intravenously injected CAR T cells could be readily detected in brain tumor areas after IA injection of NEO100 but not after IA injection of the vehicle (without NEO100). Although all untreated control animals died within 3 weeks, all mice that received IA NEO100 followed by IV CAR T cells survived and thrived for 200 days, when the experiment was terminated. Of the mice that received IV CAR T cells without prior IA NEO100, 3 died within 3 weeks and 2 survived long-term.

CONCLUSIONS:

BBB opening by IA NEO100 facilitates brain entry of intravenously delivered CD19 CAR T cells. The long-term survival of all mice with CNS lymphoma, along with the disappearance of the tumor as determined with imaging, suggests that this one-time therapeutic intervention was curative. BBB opening by IA NEO100 may offer a novel option to increase brain access by CAR T cells.

News (Medical) associated with Perillyl alcohol

18 Jan 2024

·www.fiercebiotech.com

CG Oncology aims for $209M IPO, as more biotechs eye path to public markets

If underwriters jump at the opportunity to buy a further 1.77 million shares then the haul would rise to $209 million. CG Oncology is hoping to raise $209 million from its upcoming IPO, blazing a trail to the public markets that seems to be enticing more biotechs in the first month of the year. Bladder cancer-focused CG kicked off 2024 by outlining plans to go public, although the company didn’t offer any figures at the time. Now, the biotech has said it is looking to sell 11.8 million shares at a price of between $16 and $18 apiece. Assuming that the final share price falls in the middle of this range, CG said it expects to rake in $181.1 million from the IPO. However, if underwriters jump at the opportunity to snap up a further 1.77 million shares then the haul would rise to $209 million, the biotech explained in a Jan. 18 SEC filing. California-based CG is focused on developing cretostimogene grenadenorepvec, an oncolytic adenovirus encoding immunohematopoietic cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF). The candidate is designed to infect and replicate in tumor cells, directly killing them while also causing the release of tumor-derived antigens and GM-CSF to stimulate an immune attack. CG has initially been developing the candidate as a treatment for non-muscle invasive bladder cancer. Despite an icy IPO market last year, CG made no secret of its ambition to go public as far back as August. The company was one of the few that opted for a pre-IPO crossover funding round last year, a financing model that proved popular during the biotech boom years. Since CG set out its IPO stall, Alto Neuroscience, gene-editing company Metagenomi, Arrivent Biopharma, and CAR-T developer Kyverna Therapeutics have all followed suit. ReCode Therapeutics CEO Shehnaaz Suliman, M.D., also told a Fierce Biotech event last week that her company was mulling going public in the second half of the year. Last Friday, NeOnc Technologies filed its own plans for a Nasdaq IPO. The brain cancer-focused company didn’t offer any estimates for its share price but said it intended to allocate $23.7 million of the proceeds towards its clinical trials, along with $11.4 million going to R&D and $35 million earmarked for general corporate purposes and working capital. A further $10 million would be used to pay off a short-term loan, Neonc explained in the Jan. 12 SEC filing. NeOnc’s lead candidate is NEO100, a purified form of perillyl acid that is administered to brain cancer patients intranasaly and is currently in a phase 2 trial. NEO212, a covalently conjugated molecule of the chemotherapy drug temozolomide and perillyl alcohol, is in a phase 1/2 trial for brain tumor patients.

IPOPhase 2Immunotherapy

08 Feb 2023

·www.biospace.com

NeOnc Technologies Completes $10.0 Million Equity Funding Round

Funding has Supported Clinical Trials of NEO 100™ LOS ANGELES, Feb. 08, 2023 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc., a clinical stage medical biotechnology company, has completed a $10.0 million equity funding round at a post-money valuation of $70 million. The proceeds were used to conduct Phase 2 clinical trials of NEO 100™, an enhanced method of delivering pharma-based therapeutics to the brain designed for the treatment of brain and central nervous system (CNS) diseases. The funding participants included Eminent II Venture Capital (the investment arm of TaiAn Venture Funds), Orion BioScience, and Lin Family Office. NeOnc’s proprietary biotechnology breakthroughs are the result of more than a decade of research and development by its highly accomplished medical and scientific teams. NeOnc’s patent portfolio consists of 95 patents U.S. and international patents. NeOnc’s technology focuses on segments of the global CNS treatment market which is expected to grow from $89 billion in 2021 to $166.5 billion by 2028 at a CAGR of 9.4%, according to Future Business Insights. “The financing has helped us to advance the commercialization of NEO 100 for Grade IV Gliomas and NEO 212 for treatment of malignant gliomas,” stated NeOnc’s chairman and CEO, Thomas Chen, MD, Ph.D. “Following the success of our Phase 1 clinical trials, we have established a timeline for further trials which we believe should provide certain data required for regulatory validation and advancing to commercialization.” NEO 100 is classified as an orphan drug and is on a fast-track pathway for FDA approval. Because of the successful studies to-date of NEO 100 for treating Grade IV Gliomas, NeOnc has begun work on a pediatric rare disease indication for children with high grade Gliomas. The company currently expects to utilize NeOnc’s platform technology to launch Phase One clinical trials for its second drug, NEO 212™. The company hopes to submit NEO 212™ for approval as an investigational new drug and currently plans on filing pediatric rare disease designation by the end of 2023. The company’s funding to date (equity and NIH grants) totals approximately $14.0 million. About NeOnc Technologies Holdings Inc. NeOnc is a privately held biotechnology company focused on creating novel drugs and delivery methods for pharma-based therapeutics that target brain and central nervous system diseases. The company’s NEO 100 is its first therapeutic that completed Phase One clinical trials in April 2019. It is also developing several proprietary chemotherapy agents that have demonstrated positive effects in laboratory tests on various types of cancers. As the result of its extensive research and development efforts, the company has assembled an extensive portfolio of patented intellectual property around these proprietary chemotherapy agents. To learn more about NeOnc, visit neonctech.com. Important Cautions Regarding Forward Looking Statements All statements other than statements of historical facts included in this press release are "forward-looking statements" (as defined in the Private Securities Litigation Reform Act of 1995). Generally, such forward-looking statements include statements regarding our expectations, possible or assumed future actions, business strategies, events or results of operations, including statements regarding our expectations or predictions or future financial or business performance or conditions and those statements that use forward-looking words such as "projected," "expect," "possibility" and "anticipate," or similar expressions. The achievement or success of the matters covered by such forward-looking statements involve significant risks, uncertainties, and assumptions. Actual results could differ materially from current projections or implied results. The Company cautions that statements and assumptions made in this news release constitute forward-looking statements and make no guarantee of future performance. Forward-looking statements are based on estimates and opinions of management at the time statements are made. The information set forth herein speaks only as of the date hereof. The Company and its management are under no obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any forward-looking statements following the date of this news release, whether because of new information, future events or otherwise, except as required by law. “NEO 100” and “NEO 212” are registered trademarks of NeOnc Technologies Holdings, Inc. NeOnc Contact: Dr. Thomas Chen, Chairman and CEO NeOnc Technologies Holdings, Inc. Email Contact NeOnc Investor Relations: Ron Both CMA Investor Relations Tel (949) 432-7566 Email Contact NeOnc Media & ESG Contact: Tim Randall CMA Media Relations Tel (949) 432-7572 Email Contact

Phase 1Fast TrackOrphan DrugPhase 2

100 Deals associated with Perillyl alcohol

External Link

KEGG	Wiki	ATC	Drug Bank
-	Perillyl alcohol	-	DB15289

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Meningioma	Phase 2	US	NeOnc Technologies, Inc.	01 Jul 2022
Glioblastoma	Phase 2	US	NeOnc Technologies, Inc.	08 Apr 2016
Glioblastoma Multiforme	Phase 2	US	NeOnc Technologies, Inc.	08 Apr 2016
IDH1-mutant Glioma	Phase 2	US	NeOnc Technologies, Inc.	08 Apr 2016
Multiple Myeloma	Phase 2	US	Oncotherapeutics, Inc.	01 Aug 2014
Actinic Keratosis	Phase 2	US	National Cancer Institute	01 May 2004
Pancreatic Cancer	Phase 2	US	National Cancer Institute	01 Feb 1999
Metastatic breast cancer	Phase 2	US	National Cancer Institute	01 May 1998
Castration-Resistant Prostatic Cancer	Phase 2	US	National Cancer Institute	01 Feb 1998
Prostatic cancer metastatic	Phase 2	US	National Cancer Institute	01 Feb 1998

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00608634 (CTgov)	Phase 2	Actinic Keratosis	89	placebo (Placebo)	dllarmsjji(zynfuwdgbv) = ukyjbtubki neglonjhmn (dofsuvhgiz, ujyvlxikzd - rqqfdctcaj) View more	-	01 Apr 2015
NCT00608634 (CTgov)	Phase 2	Actinic Keratosis	89	perillyl alcohol (Low Dose POH 0.30%)	dllarmsjji(zynfuwdgbv) = yesggttbiz neglonjhmn (dofsuvhgiz, azuizsxmte - gchkkmiswl)	-	01 Apr 2015
ASCO2010	Phase 1/2	Brain Cancer	89	Intranasal administration of perillyl alcohol (POH)	xroflngseb(qvofwxsueg) = oecwmgbeja cezkqnmavl (iaemjtjavd )	Positive	20 May 2010
NCT00003219 (Pubmed \| Cancer Chemother Pharmacol)	Phase 2	Metastatic breast cancer	14	Perillyl alcohol	vkmtqohdrx(ljobpzkxeb) = erzwueruis uztuyjqlfz (zunxobuawy ) View more	Negative	01 Jun 2008
ASCO2008	Phase 1/2	Recurrent Glioma	-	Perillyl alcohol	fsvnmxkpwa(belaburhup) = loqebcfbbg cwmmtehmpc (nkgusoktjf ) View more	Positive	20 May 2008

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