A Phase Two Study Evaluating Two Doses of Leronlimab (Pro 140) In Combination With Trifluridine + Tipiracil (TAS-102) + Bevacizumab in Participants With CCR5+, Microsatellite Stable (MSS), Relapsed Refractory Metastatic Colorectal Cancer (mCRC)

This is an open label, randomized, two arm, multi-center study to explore the effect of leronlimab on the overall response rate/ overall survival and safety and tolerability when used in combination with trifluridine and tipiracil + bevacizumab in patients with CCR5+, MSS, mCRC who have progressed on prior treatment before participating in the study. The main questions this study aims to answer are:
1. Can leronlimab, in combination with standard of care therapies trifluridine and tipiracil+ bevacizumab, increase the objective response rate in persons with CCR5+, MSS, mCRC who have progressed on prior treatment before participating in the study.
2. Is leronlimab safe and well tolerated in these subjects when used in combination with standard of care therapies trifluridine and tipiracil+ bevacizumab.

Start Date16 Jun 2025

Sponsor / Collaborator

CytoDyn, Inc.

[+1]

NCT05730673

/ WithdrawnPhase 2

A Phase II Study of Leronlimab (PRO 140) in Combination With Regorafenib in Patients With CCR5+, Microsatellite Stable (MSS), Metastatic Colorectal Cancer (mCRC)

This is aPhase II Study of Leronlimab (PRO 140) in combination with Regorafenib in Patients with CCR5+, Microsatellite Stable (MSS), Metastatic Colorectal Cancer (mCRC)

Start Date20 Sep 2022

Sponsor / Collaborator

CytoDyn, Inc.

[+1]

NCT04901689

/ SuspendedPhase 3IIT

A Phase 3, Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Leronlimab in Combination With Standard of Care for Patients With Coronavirus Disease 2019 (COVID-19) With Need for Mechanical Ventilation or Extracorporeal Membrane Oxygenation

Leronlimab (PRO 140) is a humanized IgG4,k monoclonal antibody (mAb) that recognizes the C-C chemokine receptor type 5 (CCR5). Disruption of the C-C chemokine ligand 5 (CCL5)-CCR5 axis via leronlimab-mediated CCR5 blockade might prevent pulmonary trafficking of pro-inflammatory leukocytes and dampen pathogenic immune activation in coronavirus disease 2019 (COVID-19).
The purpose of the study is to assess the safety and efficacy of leronlimab plus standard of care in critically ill patients hospitalized with COVID-19 pneumonia who are requiring mechanical ventilation or extracorporeal oxigenation (ECMO).

Start Date23 Oct 2021

Sponsor / Collaborator

Hospital Israelita Albert Einstein

[+1]

100 Clinical Results associated with Leronlimab

100 Translational Medicine associated with Leronlimab

100 Patents (Medical) associated with Leronlimab

Literatures (Medical) associated with Leronlimab

01 Sep 2025·JOURNAL OF MOLECULAR MODELING

Quantum chemical calculations based on 4,5-di(1,2,4-oxadiazol-3-yl)-2H-1,2,3-triazole and 3,3′ -(2H-1,2,3-triazole-4,5-diyl)-bis(1,2,4-oxadiazol-5(4H)-one) derivatives: a DFT study

Article

Author: Zhang, Peng ; Ma, Peng ; Ma, CongMing ; Chu, YuQin ; Zhu, Yang ; Jiang, Wen

CONTEXT:

1,2,3-Triazole has excellent thermal stability, and both 1,2,3-triazole and 1,2,4-oxazolium are good in structural modifiability. This study employed density functional theory (DFT) to design 24 target compounds (designated PA-1 to PA-24) based on the characteristics of these two heterocyclic systems. Using 4,5-diallyl-2H-1,2,3-triazole-3,3'-(2H-1,2,3-triazole-4,5-diyl)-bis(1,2,4-oxadiazol-5(4H)-one) as the parent compound (labeled A1), we introduced different energetic substituents at the C3 position of the oxadiazole ring and the N2 position of the triazole ring. Alternatively, using 3,3'-(2H-1,2,3-triazole-4,5-diyl)-bis(1,2,4-oxadiazol-5(4H)-one) as the parent compound (labeled A2), we introduced different energetic substituents at the N2 position of the triazole ring. The selection process considered both macroscopic properties (heat of formation and detonation performance) and microscopic factors including frontier molecular orbitals, energy gaps, weak interactions, surface electrostatic potential, and bond parameters. This approach aimed to identify energetic materials with both detonation performance and safety characteristics while investigating how introducing different substituents at these two positions affects detonation performance and safety. The research results indicate the following: First, introducing an azide group at the C3 position of the oxadiazole in A1 more effectively enhances the compound's heat of formation. PA-13 (△H_f,sold = 972.97 kJ/mol), PA-14 (△H_f,sold = 1023.62 kJ/mol), and PA-15 (△H_f,sold = 1069.24 kJ/mol), which all contain azide groups, rank among the top three in heat of formation among the 24 compounds. Second, PA-6 (D = 9.31 km/s, P = 39.93 GPa, Q = 7.39 kJ/g) exhibits the best detonation performance: its detonation pressure exceeds those of RDX (G = 36GPa), its detonation velocity and detonation heat surpass that of HMX (D = 9 km/s, Q = 6.4 kJ/g), and it achieves the ideal state of zero oxygen balance, resulting in the highest energy utilization efficiency. Third, PA-19 showed the least impact sensitivity and showed the potential of an insensitive explosive. Fourth, hydrogen bonds are common in the molecular structure of PA-8 ~ PA-12 derivatives of A2, which may contribute to the stability of the molecules. Fifth, trinitromethyl and dinitromethyl groups are more prone to fragmentation. The substituents introduced at the C3 position of the oxadiazole have almost no effect on the ring length of the oxadiazole, but introducing trinitromethyl at the N2 position of the triazole causes the triazole ring structure to expand, resulting in an increased ring length.

METHOD:

All calculations in this paper are based on density functional theory and were performed using the Gaussian16 software. Initially, the structures of PA-1 to PA-24 were optimized at the B3LYP-D3/6-311G** level. Subsequently, single-point energy calculations were conducted at the M06-2X-D3/def2-TZVPP level to determine the formation enthalpy, detonation velocity, and detonation pressure of the compounds. The Multiwfn and VMD programs were used to plot the energy gap diagrams, isosurface maps, scatter plots, and surface electrostatic potential maps for PA-1 to PA-24.

01 Jun 2025·JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES

Leronlimab Treatment for Multidrug-Resistant HIV-1 (OPTIMIZE): A Randomized, Double-Blind, Placebo-Controlled Trial

Article

Author: Dejesus, Edwin ; Sanchez, William E. ; Hansen, Scott G. ; Gathe, Joseph C. ; Meidling, Joseph ; Lalezari, Jacob P. ; Krishen, Alok ; Sacha, Jonah B. ; Ramgopal, Moti N. ; Rolle, Charlotte-Paige ; Yang, Otto O.

Background::

Leronlimab is a humanized κ-IgG4 monoclonal antibody that blocks C–C chemokine receptor type 5. We investigated leronlimab as a treatment option for people living with multidrug-resistant HIV-1.

Setting and Methods::

In a phase 2b/3, multicenter, randomized, double-blind, placebo-controlled study conducted in 21 hospital centers in the United States, treatment-experienced people living with HIV with documented drug resistance were randomly assigned once weekly leronlimab (350 mg subcutaneously) or matching placebo for 1 week overlapping existing failing antiretroviral therapy, followed by a 24-week single-arm extension with weekly leronlimab combined with a new optimized background treatment. The primary end point was achieving ≥0.5 log10 reduction in plasma HIV-1 RNA from baseline at the end of the 1-week double-blinded treatment period.

Results::

Fifty-two participants were enrolled (25 leronlimab and 27 placebo). After the 1-week randomized phase, by the intent-to-treat analysis, 64.0% (16/25) receiving leronlimab achieved ≥0.5 log10 reduction in plasma HIV-1 RNA versus 23.1% (6/26) receiving placebo (P = 0.0032), whereas by per protocol analysis, 72.7% (16/22) receiving leronlimab achieved ≥0.5 log10 reduction in plasma HIV-1 RNA versus 24.0% (6/25) receiving placebo (P = 0.0008). Leronlimab was generally well tolerated with no drug-related serious adverse events reported. Overall, 175 adverse events were reported by 34/52 participants, with 120 (68.6%) adverse events categorized as mild.

Conclusions::

Leronlimab resulted in significantly reduced plasma HIV-1 within 1 week after addition to failing antiretroviral therapy. After 24 weeks combined with an optimized background treatment, most participants had plasma HIV-1 RNA levels <50 copies per milliliter plasma, suggesting utility of leronlimab as a component of salvage therapy.

15 Apr 2025·JOURNAL OF VIROLOGY

Addition of a short HIV-1 fusion-inhibitory peptide to PRO 140 antibody dramatically increases its antiviral breadth and potency

Article

Author: Gao, Yue ; Zhu, Yuanmei ; Chen, Yue ; Su, Bin ; Gong, Yani ; Chong, Huihui ; Yan, Hongxia ; Li, Li ; He, Yuxian

ABSTRACT:

PRO 140, a humanized anti-HIV monoclonal antibody targeting the cell coreceptor CCR5, is currently under clinical trials, but it only affects CCR5-tropic viruses. In this study, we have engineered two tandem fusion proteins (2P23-PRO140SC and 2P23-PRO140-Fc) with bifunctional activity by adding short fusion-inhibitory peptide 2P23 to the single-chain fragment variable (scFv) of PRO 140 (PRO140SC) with or without the Fc domain of human IgG4. We first demonstrated that 2P23-PRO140SC and 2P23-PRO140-Fc could efficiently bind to the cell membranes through CCR5 anchoring, which did not affect the expression level of CCR5 on the cell surface. We then verified that the addition of 2P23 peptide to PRO140SC enabled a very potent activity against CXCR4-tropic HIV-1 isolates. As expected, the bispecific fusion proteins exhibited highly potent activities in inhibiting divergent HIV-1 subtypes and viral mutants that were resistant to the fusion inhibitors 2P23 and T20, and they displayed relatively low in vitro cytotoxicity. Furthermore, both the fusion proteins had robust in vivo anti-HIV activities in rats, with 2P23-PRO140-Fc much better than 2P23-PRO140SC. In conclusion, our studies have provided bispecific HIV-1 inhibitors that overcome the drawbacks of PRO 140 antibody and offered novel tools for studying the mechanisms of HIV-1 infection.

IMPORTANCE:

Given that HIV-1 evolves with high variability and drug resistance, the development of novel antivirals is important. CCR5-directed antibody PRO 140 is currently under clinical trials, but it only inhibits CCR5-tropic HIV-1 isolates. The designed fusion proteins by adding a minimum fusion-inhibitory peptide to PRO 140 enable dramatically increased activities in inhibiting both CCR5-tropic and CXCR4-tropic viruses, thus offering novel antiviral agents with a bispecific functionality that can overcome the drawbacks of PRO 140 antibody.

159

News (Medical) associated with Leronlimab

27 Jan 2026

·www.globenewswire.com

CytoDyn Announces Funding and Initiation of Expanded Access Program for Patients with Triple-negative Breast Cancer

VANCOUVER, Washington, Jan. 27, 2026 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including triple-negative breast cancer (TNBC) and metastatic colorectal cancer (mCRC), today announced that a compassionate benefactor has formally committed funding to support the Company’s Expanded Access Program (EAP) for patients with triple-negative breast cancer. The benefactor, who has chosen to remain anonymous, has a longstanding interest in patient access initiatives, the potential of leronlimab, and how the Company’s recent data and mechanism of action theories might serve to offer experimental avenues to patients who have exhausted all approved treatment options. This strategic funding initiative will enable CytoDyn to set up and administer a program to expand access to leronlimab for a group of eligible patients, as determined by the U.S. Food and Drug Administration (FDA) guidelines, with advanced disease but who do not otherwise meet the enrollment criteria for the Company’s ongoing clinical trials. “We are honored by this benefactor’s commitment to accelerating patient access to promising cancer therapies such as leronlimab,” said Jacob Lalezari, M.D., CEO of CytoDyn. “This support allows us to responsibly broaden the availability of leronlimab while continuing to advance our promising clinical programs as we generate data to inform future regulatory pathways.” With Every Patient (WEP Clinical) has been engaged to serve as the clinical research organization (CRO) for the EAP, and the Company expects to formally open the program for patient referral in March 2026, assuming FDA’s allowance of the Company's revised protocol submission. In addition to providing compassionate access to patients who have exhausted other treatment options and are otherwise unable to participate in the Company's upcoming Phase 2 trial, the EAP program will serve as another potential avenue to observe PD-L1 induction following treatment with leronlimab, and thereby – in theory – opening a treatment pathway towards sustained remission when combined with an immune checkpoint inhibitor (“ICI”). The EAP will operate under applicable FDA guidelines, and additional information for physicians and eligible patients will be available on the Company’s website (www.cytodyn.com) as the program is rolled out in the coming weeks. About CytoDyn CytoDyn is a clinical-stage oncology company dedicated to advancing leronlimab, a first-in-class humanized monoclonal antibody that targets the CCR5 receptor, a key regulator of immune function implicated in cancer, infectious diseases, and autoimmune disorders. Guided by a mission to improve patients’ quality of life through therapeutic innovation, CytoDyn is committed to integrity, responsibility, and service as it works to bring transformative treatments to patients worldwide. For more information, please visit www.cytodyn.com and follow us on LinkedIn. Note Regarding Forward-Looking Statements This news release may contain forward-looking statements relating to, among other things, mechanism of action, clinical development programs, clinical trial results, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2025, including the section captioned “Forward-Looking Statements” and in Item 1A, as well as subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments except as required by applicable law. Corporate Contact CytoDyn Inc.ir@cytodyn.com Media Contacts David Schull or Ignacio Guerrero-Ros, Ph.D. Russo Partners, LLCCytoDyn@russopartnersllc.com

ImmunotherapyPhase 2

27 Jan 2026

·www.biospace.com

CytoDyn’s Former CEO Gets Jail Time, $5.3M+ Fine for Securities Fraud

iStock, serggn Nader Pourhassan, who led CytoDyn for nearly 10 years, was convicted in December 2024 of misleading investors regarding the biotech’s investigational COVID-19 and HIV drug, which artificially inflated its share price. The Department of Justice has sentenced Nader Pourhassan, the former CEO of CytoDyn, to 30 months in prison after he was convicted of securities fraud and insider trading. Pourhassan intentionally made misleading claims about leronlimab, an experimental antibody that CytoDyn was developing for HIV and COVID-19, according to a Department of Justice release on Monday. The ex-CEO’s scheme ran from 2018 to 2021 and served to “artificially inflate” CytoDyn’s stock price and attract new investors, the DOJ stated. Pourhassan then sold 4.8 million company shares that he owned, earning $4.4 million in the process. The former top executive “exploited a deadly public health crisis to intentionally deceive investors and the public out of millions—all so that he could enrich himself,” U.S. Attorney Kelly Hayes, for the District of Maryland, said in a statement. Aside from jail time, Pourhassan was also ordered by the court to pay more than $5.3 million in restitution and surrender over $4.4 million. Leronlimab, a humanized IgG4 monoclonal antibody, was initially being developed for HIV before CytoDyn decided to pivot and propose the therapy for COVID-19. In May 2021, however, the FDA publicly contradicted these plans, noting that “the data currently available do not support the clinical benefit of leronlimab for the treatment of COVID-19.” The rebuke came after leronlimab failed a Phase III study in March 2021, unable to significantly boost survival in hospitalized COVID-19 patients versus placebo. Pourhassan nevertheless dug into the data and put a positive spin on the outcomes. “We believe these results are the best results ever achieved for this population in a Phase 3 clinical trial,” he claimed at the time. Monday’s sentencing comes after a federal jury in Maryland in December 2024 found Pourhassan guilty of four counts of securities fraud, two counts of wire fraud and three counts of insider trading. Alongside Pourhassan, the jury also found guilty Kazem Kazempour, who at the time of Pourhassan’s scheme was CEO of Amarex Clinical Research, a third-party contract research organization that ran CytoDyn’s studies. Kazempour, according to the original complaint, collaborated with Pourhassan and earned more than $340,000. Kazempour was convicted of one count of securities fraud and one of wire fraud—though these have since been vacated , according to a press announcement from the law firm representing Kazempour last Thursday. He will face a new trial, according to the statement. Pourhassan became CytoDyn’s CEO in September 2012 and held that post until January 2022, when the company’s board of directors voted to let him go and search for another executive that could better lead the commercialization of leronlimab.

Phase 3Executive Change

26 Jan 2026

·endpoints.news

Ex-CytoDyn CEO sentenced to 30 months for pump-and-dump scheme

CytoDyn’s former CEO Nader Pourhassan was sentenced Friday to 30 months in prison for misleading investors about the prospects of a potential drug and then selling his personal stock in the company at artificially inflated prices. Prior to Pourhassan’s firing in 2022, CytoDyn was known for its aggressive promotional campaigns to tout the unsubstantiated potential of its drug leronlimab for Covid-19, the Department of Justice said. Pourhassan appeared on webcasts and recorded videos to push the drug, even after the FDA rejected it as a treatment for HIV, its original indication, and the drug failed a pair of Covid-19 studies. The DOJ said Monday that between 2018 and 2021, Pourhassan intentionally misled investors about leronlimab’s prospects for approval. Pourhassan then sold his 4.8 million shares of CytoDyn stock and pocketed $4.4 million, the department said. Pourhassan was initially charged in 2022. In 2024, he was convicted at trial of four counts of securities fraud, two counts of wire fraud and three counts of insider trading. At sentencing, he was ordered to pay more than $5.3 million in restitution and to forfeit more than $4.4 million, the DOJ said.

Executive ChangePatent Infringement

100 Deals associated with Leronlimab

External Link

KEGG	Wiki	ATC	Drug Bank
D11399	Leronlimab	-	DB05941

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	NDA/BLA	United States	CytoDyn, Inc.	01 Nov 2021
COVID-19	Phase 3	United States	CytoDyn, Inc.	05 Aug 2020
Unresectable Colorectal Carcinoma	Phase 2	United States	CytoDyn, Inc.	16 Jun 2025
Metastatic Colorectal Carcinoma	Phase 2	-	CytoDyn, Inc.	20 Sep 2022
Metastatic Microsatellite Stable Colorectal Carcinoma	Phase 2	-	CytoDyn, Inc.	20 Sep 2022
Microsatellite Stable Colorectal Carcinoma	Phase 2	-	CytoDyn, Inc.	20 Sep 2022
Post Acute COVID 19 Syndrome	Phase 2	United States	CytoDyn, Inc.	01 Mar 2021
Metabolic Dysfunction Associated Steatohepatitis	Phase 2	United States	CytoDyn, Inc.	01 Dec 2020
Metastatic Solid Tumor	Phase 2	United States	CytoDyn, Inc.	01 May 2020
Triple Negative Breast Cancer	Phase 2	United States	CytoDyn, Inc.	22 Apr 2019

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04504942 (Phase 2 single-arm basket study, CTgov)	Phase 2	Metastatic Solid Tumor \| Solid tumor	16	Leronlimab	xnxwkgubvo = fscbnbbrqb xjicvlqmxs (mszyrndire, cggxlkbjgt - xumucymwhn) View more	-	23 Jan 2026
NCT03838367 (SABCS2025)	Phase 1/2	Triple Negative Breast Cancer PD-L1 \| PD-1 \| CCR5	28	Leronlimab ± immune checkpoint inhibitors (ICI) + various chemotherapies	ojbcjaenzq(ruxcnxhvdn) = hmkzdkcnpw veybdknvsb (yqvugreijk ) View more	Positive	12 Dec 2025
NCT02990858 (CTgov)	Phase 2/3	HIV Infections	43	PRO 140 (leronlimab) (PRO 140)	uoivsifriv(ialcjkcqfw) = odydmvdqnj hheeymgisg (hpjwdwvhwl, 1.11) View more	-	12 Nov 2025
NCT02990858 (CTgov)	Phase 2/3	HIV Infections	43	PRO 140 (leronlimab) (PRO 140 350 mg)	aiqarjsnvq(hivpcovefg) = rzhoymqpas dfommpgvvy (llnaspxvnv, jfrhllxolk - axvwrrbfhh) View more	-	12 Nov 2025
NCT05271370 (CTgov)	Phase 2/3	HIV Infections	56	PRO 140 350 (PRO 140 350 mg)	krxvcwbyti = ganwtulkqy neuydynrqy (cbgfzsvsjs, bqwbhibtmb - zskgkklgfo) View more	-	30 Oct 2025
NCT05271370 (CTgov)	Phase 2/3	HIV Infections	56	PRO 140 525 (PRO 140 525 mg)	krxvcwbyti = pmrcwaklye neuydynrqy (cbgfzsvsjs, neodgstcjq - icpnddinnd) View more	-	30 Oct 2025
NCT02355184 (CTgov)	Phase 2	HIV Infections	20	PRO 140	bpzhpvyqfq(vgtadjohxt) = mlqwzvanod jjuaqixtum (hrkaphqdbk, 225.6) View more	-	07 Oct 2025
NCT03902522 (CTgov)	Phase 2/3	HIV Infections	6	PRO 140	oapmehwoyb = rovtpbwxsv hyqbgdpgjt (poqttnphaf, zjdalcaxfg - lgycnrdmjm) View more	-	16 Sep 2025
NCT03838367 (CTgov)	Phase 1/2	Triple Negative Breast Cancer	10	AUC 5 Carboplatin+leronlimab (Phase II- MTD to be Established for the Combination Treatment)	tlukrngype(ompapifwcq) = xoxmkajvpo jzwnsqvysq (aqdatpgtrp, hknxrhqsmx - kzilokptoz) View more	-	09 Sep 2025
NCT03838367 (CTgov)	Phase 1/2	Triple Negative Breast Cancer	10	AUC 5 Carboplatin+350 mg leronlimab (Phase I-Cohort A: 350 mg PRO 140 SC Weekly + AUC 5 Carboplatin)	czeexarrdu = xsjlpsejjy vbdgtlapac (psjdogmwiy, sjhgwnpbhn - fgkmdwwrks) View more	-	09 Sep 2025
NCT04347239 (CTgov)	Phase 2	COVID-19	484	Placebo (Placebo)	szpzovbmxu = qnlilgublc epcnvciyrv (vbgvfawnvw, vwcatpocps - dyoddfbgva) View more	-	27 Aug 2025
NCT04347239 (CTgov)	Phase 2	COVID-19	484	Leronlimab (700mg) (700mg Leronlimab)	szpzovbmxu = jzklfthmqm epcnvciyrv (vbgvfawnvw, mcqdfzcdsz - jgqlhmduvk) View more	-	27 Aug 2025
NCT04504942 (Phase 2 single-arm basket study, ESMO_GI2025)	Phase 2	Metastatic Colorectal Carcinoma CCR5-positive tumors	5	Leronlimab	lafhnzocxh(kfbztuaxvm) = Two patients had grade 1 AEs that were deemed treatment related (infusion-related reaction and nausea) xqugqdicnc (gpgopuwimw )	Positive	03 Jul 2025
NCT03838367 \| NCT04504942 \| NCT04313075 (ESMO_BC2025)	Not Applicable	Metastatic Triple-Negative Breast Carcinoma CCR5	28	Leronlimab	fdfkpmfkwd(xqwfzuzena) = No DLTs were observed in NCT03838367 after dose escalation to 700 mg (n=10) jugysmwqpq (elhaamjhuh ) View more	Positive	14 May 2025

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