Last update 28 Nov 2024
L-9LS
Last update 28 Nov 2024
Overview
Basic Info
Drug Type Monoclonal antibody |
Synonyms VRC-MALMAB0114-00-AB, L-9LS |
Target |
Mechanism PfCSP inhibitors(Plasmodium falciparum circumsporozoite protein inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhasePhase 2 |
First Approval Date- |
Regulation- |
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Related
7
Clinical Trials associated with L-9LSA Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, and Efficacy of the Anti-Malaria Monoclonal Antibody L9LS in Infants 10 Weeks of Age in Western Kenya and to Evaluate the Impact of L9LS on Subsequent Malaria Vaccine Immunogenicity
Start Date02 Dec 2024 |
Sponsor / Collaborator- |
A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of L9LS in Infants in Mali and to Evaluate the Impact of L9LS on Subsequent R21/Matrix-MTM Vaccine Immunogenicity
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of L9LS in infants in Mali and to evaluate the impact of L9LS on subsequent R21/Matrix-MTM vaccine immunogenicity.
Start Date19 Aug 2024 |
Sponsor / Collaborator |
Safety and Efficacy of L9LS, a Human Monoclonal Antibody Against Plasmodium Falciparum, in a Randomized, Double-Blind, Placebo-Controlled Trial of Adults in Mali
The purpose of this study is to evaluate the safety and tolerability of a one time SC administration of L9LS in healthy adults in Mali, as well as its protective efficacy against naturally occurring Plasmodium falciparum (Pf) infection over a 6-month malaria season. A secondary objective is to determine if SC administration of L9LS at 900 mg (compared to placebo) mediates protection against naturally occurring Pf infection in healthy Malian adult females stratified by weight during a single malaria season.
Start Date25 May 2023 |
Sponsor / Collaborator |
100 Clinical Results associated with L-9LS
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100 Translational Medicine associated with L-9LS
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100 Patents (Medical) associated with L-9LS
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2
Literatures (Medical) associated with L-9LS01 Oct 2022·Cell reports. Medicine
Accelerated development of malaria monoclonal antibodies
Article
Author: Nekkab, Narimane ; Penny, Melissa A
L9LS, a potent and safe antimalarial monoclonal antibody, demonstrated 88% protective efficacy against infection in a phase 1 trial in healthy adults.1 These promising results are the first of many to usher in a potential new era of malaria prevention.
04 Aug 2022·The New England journal of medicineQ1 · MEDICINE
Low-Dose Subcutaneous or Intravenous Monoclonal Antibody to Prevent Malaria
Q1 · MEDICINE
Article
Author: Shi, Wei ; Capparelli, Edmund V. ; Morgan, Patricia ; Gordon, Ingelise J. ; Francica, Joseph R. ; Narpala, Sandeep R. ; Strom, Larisa ; Murphy, Jittawadee R. ; Seder, Robert A. ; Flynn, Barbara J. ; Gaudinski, Martin R. ; Lukoskie, Ashly E. ; Telscher, Shinyi ; Coates, Emily E. ; Happe, Myra ; Silva, Rosa ; Stein, Judy A. ; McDermott, Adrian ; Serebryannyy, Leonid ; Hu, Zonghui ; Wang, Lawrence T. ; Wu, Richard L. ; Hickman, Somia P. ; Beck, Allison ; Imam, Marjaan ; Plummer, Sarah H. ; Awan, Seemal F. ; Carlton, Kevin ; Pittman, Iris ; Mendoza, Floreliz ; Campos Chagas, Andrezza ; Da Silva Pereira, Lais ; Seo, Ellie ; Kong, Wing-Pui ; McDougal, Andrew J. ; Idris, Azza H. ; Ledgerwood, Julie E. ; Kisalu, Neville K. ; Mascola, John R. ; Castro, Mike ; Holman, LaSonji A. ; Vazquez, Sandra ; Gall, Jason G. ; Buettner, Christian ; Dropulic, Lesia K. ; O’Connell, Sarah ; Berkowitz, Nina M.
BACKGROUND:
New approaches for the prevention and elimination of malaria, a leading cause of illness and death among infants and young children globally, are needed.
METHODS:
We conducted a phase 1 clinical trial to assess the safety and pharmacokinetics of L9LS, a next-generation antimalarial monoclonal antibody, and its protective efficacy against controlled human malaria infection in healthy adults who had never had malaria or received a vaccine for malaria. The participants received L9LS either intravenously or subcutaneously at a dose of 1 mg, 5 mg, or 20 mg per kilogram of body weight. Within 2 to 6 weeks after the administration of L9LS, both the participants who received L9LS and the control participants underwent controlled human malaria infection in which they were exposed to mosquitoes carrying Plasmodium falciparum (3D7 strain).
RESULTS:
No safety concerns were identified. L9LS had an estimated half-life of 56 days, and it had dose linearity, with the highest mean (±SD) maximum serum concentration (Cmax) of 914.2±146.5 μg per milliliter observed in participants who had received 20 mg per kilogram intravenously and the lowest mean Cmax of 41.5±4.7 μg per milliliter observed in those who had received 1 mg per kilogram intravenously; the mean Cmax was 164.8±31.1 in the participants who had received 5 mg per kilogram intravenously and 68.9±22.3 in those who had received 5 mg per kilogram subcutaneously. A total of 17 L9LS recipients and 6 control participants underwent controlled human malaria infection. Of the 17 participants who received a single dose of L9LS, 15 (88%) were protected after controlled human malaria infection. Parasitemia did not develop in any of the participants who received 5 or 20 mg per kilogram of intravenous L9LS. Parasitemia developed in 1 of 5 participants who received 1 mg per kilogram intravenously, 1 of 5 participants who received 5 mg per kilogram subcutaneously, and all 6 control participants through 21 days after the controlled human malaria infection. Protection conferred by L9LS was seen at serum concentrations as low as 9.2 μg per milliliter.
CONCLUSIONS:
In this small trial, L9LS administered intravenously or subcutaneously protected recipients against malaria after controlled infection, without evident safety concerns. (Funded by the National Institute of Allergy and Infectious Diseases; VRC 614 ClinicalTrials.gov number, NCT05019729.).
3
News (Medical) associated with L-9LS09 May 2024
PASADENA, Calif.--(BUSINESS WIRE)-- Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and other serious diseases, today reported financial results for the first quarter ended March 31, 2024 and provided a review of recent clinical and business highlights.
“We have focused our XmAb® clinical pipeline and discovery activities on bispecific CD3 and CD28 T cell engagers, which continue to show clinical validation for their potential in treating patients with serious diseases. Our key clinical-stage oncology programs in solid tumors include XmAb819 (ENPP3 x CD3) in clear cell renal cell carcinoma, XmAb808 (B7-H3 x CD28) in prostate cancer and other cancers, and XmAb541 (CLDN6 x CD3) in ovarian cancer and other cancers, which are all now advancing in Phase 1 clinical studies. We plan to select our next T cell engager IND candidate later this year,” said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. “Additionally, Xencor’s best-in-class Xtend™ antibody half-life extension technology continues to support improved outcomes for patients, with Ultomiris® now approved in the U.S. for certain patients with NMOSD, and we are especially delighted by recently published results demonstrating an investigational antibody with Xtend was effective in preventing malaria.”
Recent Clinical and Business Highlights
First Patient Dosed in Phase 1 Study of XmAb®541 (CLDN6 x CD3): XmAb541 is a bispecific antibody being developed for patients with CLDN6-positive tumors including advanced ovarian cancer. XmAb541 is designed to engage the immune system, activating T cells for highly potent and targeted killing of tumor cells expressing Claudin-6 (CLDN6), a tumor-associated antigen. Xencor’s XmAb® 2+1 multivalent format used in XmAb541 enables greater selectivity for cells expressing CLDN6 over similarly structured Claudin family members, which may be expressed on normal tissue. The first patient was recently dosed in a Phase 1 dose-escalation study.
FDA Approves Ultomiris® (Alexion Pharmaceuticals, Inc.) for Adults with NMOSD: In March 2024, Ultomiris® (ravulizumab-cwvz), which incorporates Xencor’s Xtend™ Fc Domain, was approved in the United States as the first and only long-acting C5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). Ultomiris is also approved for certain adults with NMOSD in Japan and the European Union (EU). As part of Xencor’s recent Ultomiris royalty monetization, the Company remains eligible for certain future royalties and milestone payments. Ultomiris is a registered trademark of Alexion Pharmaceuticals, Inc.
Single Dose of Investigational Antibody with Xtend™ Confers Protection Against Malaria Infection: Results from a Phase 2 National Institutes of Health (NIH)-sponsored clinical trial published in the New England Journal of Medicine showed that a single dose of L9LS, an experimental monoclonal antibody that incorporates Xencor’s Xtend™ Fc Domain, was up to 77% effective in preventing malaria in children in Mali for six months, demonstrating the long duration of action that Xtend technology can provide.
New Chief Financial Officer Appointed: Bart Cornelissen was appointed as Xencor’s senior vice president and chief financial officer. He was most recently vice president, corporate finance at Seagen Inc.
Financial Guidance: Based on current operating plans, Xencor expects to end 2024 with between $475 million and $525 million in cash, cash equivalents and marketable debt securities, and to have cash to fund research and development programs and operations into 2027.
Financial Results for the First Quarter Ended March 31, 2024
Cash, cash equivalents and marketable debt securities totaled $646.7 million as of March 31, 2024, compared to $697.4 million on December 31, 2023.
Revenues for the first quarter ended March 31, 2024 were $12.8 million, compared to $19.0 million for the same period in 2023. Total revenues earned in the first quarter of 2024 included non-cash royalty revenue from Xencor’s Alexion and Morphosys/Incyte agreements, compared to milestone revenue earned from the J&J collaboration and royalties from the Alexion agreement in the first quarter of 2023.
Research and development expenses for the first quarter ended March 31, 2024 were $56.9 million, compared to $65.6 million for the same period in 2023. Decreased research and development spending for the first quarter of 2024 compared to 2023 reflects changes in spending across multiple clinical-stage programs and wind-down costs on terminated programs.
General and administrative expenses for the first quarter ended March 31, 2024 were $13.8 million and were in line with $14.2 million for the same period in 2023.
Other expense, net, for the first quarter ended March 31, 2024 was $10.8 million, compared to $0.02 million for the same period in 2023. Increased other expense for the first quarter of 2024 compared to 2023 reflects impairment charge on equity investments, partially offset by interest income earned on investments and unrealized gain on equity investments.
Non-cash, stock-based compensation expense for the first quarter ended March 31, 2024 was $11.4 million, compared to $12.6 million for the same period in 2023.
Net loss for the first quarter ended March 31, 2024 was $68.0 million, or $(1.11) on a fully diluted per share basis, compared to $60.8 million, or $(1.02) on a fully diluted per share basis, for the same period in 2023.
The total shares outstanding were 61,634,685 as of March 31, 2024, compared to 60,381,600 as of March 31, 2023.
Upcoming Investor Conferences
Company management will participate at multiple upcoming investor conferences:
RBC Capital Markets Global Healthcare Conference
Date: Tuesday, May 14, 2024
Presentation Time: 2:05 p.m. ET / 11:05 a.m. PT
Location: New York City
BofA Securities Health Care Conference
Date: Wednesday, May 15, 2024
Presentation Time: 4:40 p.m. ET / 1:40 p.m. PT
Location: Las Vegas
Live webcasts of the presentations will be available under “Events & Presentations” in the Investors section of the Company’s website located at . Replays of the events will be available on the Xencor website for at least 30 days following the presentations.
About Xencor
Xencor is a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of patients with cancer and other serious diseases. More than 20 candidates engineered with Xencor's XmAb® technology are in clinical development, and three XmAb medicines are marketed by partners. Xencor's XmAb engineering technology enables small changes to a proteins structure that result in new mechanisms of therapeutic action. For more information, please visit .
Forward-Looking Statements
Certain statements contained in this press release may constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include statements that are not purely statements of historical fact, and can generally be identified by the use of words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” and similar terms, or by express or implied discussions relating to Xencor’s business, including, but not limited to, statements regarding planned presentations of clinical data, planned clinical trials, projected financial resources, the quotations from Xencor's president and chief executive officer, and other statements that are not purely statements of historical fact. Such statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Xencor and are subject to significant known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements and the timing of events to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Such risks include, without limitation, the risks associated with the process of discovering, developing, manufacturing and commercializing drugs that are safe and effective for use as human therapeutics and other risks, including the ability of publicly disclosed preliminary clinical trial data to support continued clinical development and regulatory approval for specific treatments, in each case as described in Xencor's public securities filings. For a discussion of these and other factors, please refer to Xencor's annual report on Form 10-K for the year ended December 31, 2023 as well as Xencor's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended to date. All forward-looking statements are qualified in their entirety by this cautionary statement and Xencor undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.
Xencor, Inc.
Selected Consolidated Balance Sheet Data
(in thousands)
March 31,
December 31,
2024
2023
(Unaudited)
Cash, cash equivalents and marketable debt securities - current
$
491,401
$
551,515
Other current assets
70,851
71,645
Marketable debt securities - long term
155,342
145,892
Other long term assets
166,661
183,640
Total assets
$
884,255
$
952,692
Total current liabilities
79,402
84,709
Deferred income - long term
113,367
125,183
Other long term liabilities
79,299
73,667
Total liabilities
272,068
283,559
Total stockholders' equity
612,187
669,133
Total liabilities and stockholders’ equity
$
884,255
$
952,692
Xencor, Inc.
Consolidated Statements of Loss and Comprehensive Loss
(in thousands, except share and per share data)
Three months Ended March 31,
2024
2023
(Unaudited)
Revenue
$
12,805
$
18,962
Operating expenses
Research and development
56,873
65,552
General and administrative
13,787
14,154
Total operating expenses
70,660
79,706
Loss from operations
(57,855
)
(60,744
)
Other income (expense), net
(10,854
)
(19
)
Loss before income tax
(68,709
)
(60,763
)
Income tax expense
—
—
Net loss
(68,709
)
(60,763
)
Net loss attributable to non-controlling interest
(676
)
—
Net loss attributable to Xencor, Inc.
(68,033
)
(60,763
)
Other comprehensive income (loss):
Net unrealized gain (loss) on marketable debt securities available-for-sale
(1,445
)
3,327
Comprehensive loss attributable to Xencor, Inc.
$
(69,478
)
$
(57,436
)
Net loss per common share attributable to Xencor, Inc.:
Basic and Diluted
$
(1.11
)
$
(1.02
)
Weighted average common shares used to compute net loss per share attributable to Xencor, Inc.
Basic and Diluted
61,212,324
59,771,674
Phase 1Phase 2Drug ApprovalClinical ResultFinancial Statement
01 Nov 2022
One dose of an antibody drug safely protected healthy, non-pregnant adults from malaria infection during an intense six-month malaria season in Mali, Africa, a National Institutes of Health clinical trial has found. The antibody was up to 88.2% effective at preventing infection over a 24-week period, demonstrating for the first time that a monoclonal antibody can prevent malaria infection in an endemic region.
One dose of an antibody drug safely protected healthy, non-pregnant adults from malaria infection during an intense six-month malaria season in Mali, Africa, a National Institutes of Health clinical trial has found. The antibody was up to 88.2% effective at preventing infection over a 24-week period, demonstrating for the first time that a monoclonal antibody can prevent malaria infection in an endemic region. These findings were published today in The New England Journal of Medicine and presented at the American Society of Tropical Medicine & Hygiene 2022 Annual Meeting in Seattle.
"We need to expand the arsenal of available interventions to prevent malaria infection and accelerate efforts to eliminate the disease," said Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH. "These study results suggest that a monoclonal antibody could potentially complement other measures to protect travelers and vulnerable groups such as infants, children, and pregnant women from seasonal malaria and help eliminate malaria from defined geographical areas."
NIAID sponsored and funded the trial, which was led by Peter D. Crompton, M.D., M.P.H., and Kassoum Kayentao, M.D., M.P.H., Ph.D. Dr. Crompton is chief of the Malaria Infection Biology and Immunity Section in the NIAID Laboratory of Immunogenetics, and Dr. Kayentao is a professor at the University of Sciences, Techniques and Technologies (USTTB) of Bamako, Mali.
An estimated 241 million cases of malaria occurred worldwide in 2020, according to the World Health Organization (WHO), resulting in an estimated 627,000 deaths, mostly in children in sub-Saharan Africa. These cases included more than 11 million pregnant women in Africa, resulting in an estimated 819,000 newborns with low birthweight and thus at increased risk for illness and death.
The only malaria vaccine currently recommended by WHO, called RTS,S (Mosquirix), provides partial protection against clinical malaria during the early years of life when given to children aged 5 to 17 months in four doses over a 20-month period. Other drugs consisting of small chemical compounds that effectively prevent malaria infection are also available for infants and young children as well as travelers. The requirement for frequent dosing of these drugs can limit adherence, however, and the emergence of drug resistance may also limit their usefulness. Thus, there is an urgent need for new, fast-acting, infrequently dosed interventions that safely provide strong protection against malaria infection.
Malaria is caused by Plasmodium parasites, which are transmitted to people through the bite of an infected mosquito. The mosquito injects the parasites in a form called sporozoites into the skin and bloodstream. These travel to the liver, where they mature and multiply. Then the mature parasite spreads throughout the body via the bloodstream to cause illness. P. falciparum is the Plasmodium species most likely to result in severe malaria infections, which, if not promptly treated, may lead to death.
The Phase 2 NIAID-USTTB trial evaluated the safety and efficacy of a one-time, intravenous infusion of a monoclonal antibody called CIS43LS. This antibody was previously shown to neutralize the sporozoites of P. falciparum in the skin and blood before they could infect liver cells. Researchers led by Robert A. Seder, M.D., isolated a naturally occurring form of this antibody from the blood of a volunteer who had received an investigational malaria vaccine, and then modified the antibody to extend the length of time it would remain in the bloodstream. Dr. Seder is the acting chief medical officer and acting associate director of the NIAID Vaccine Research Center (VRC) and chief of the VRC's Cellular Immunology Section.
The study team for the Phase 2 trial enrolled 369 healthy, non-pregnant adults aged 18 to 55 years in the rural communities of Kalifabougou and Torodo in Mali, where intense P. falciparum transmission typically occurs from July through December each year.
The first part of the trial assessed the safety of three different doses of CIS43LS -- 5 milligrams per kilogram of body weight, 10 mg/kg and 40 mg/kg -- administered by intravenous infusion in 18 study participants, with six participants per dose level. The study team followed these participants for 24 weeks and found the antibody infusions were safe and well-tolerated.
The second part of the trial assessed the efficacy of two different doses of CIS43LS compared to a placebo. Three hundred and thirty participants were assigned at random to receive either 10 mg/kg of the antibody, 40 mg/kg, or a placebo by intravenous infusion. No one knew who was assigned to which group until the end of the trial. The study team followed these individuals for 24 weeks, testing their blood for P. falciparum weekly for the first 28 days and every two weeks thereafter. Any participant who developed symptomatic malaria during the trial received standard treatment from the study team.
The investigators analyzed the efficacy of CIS43LS two ways. Based on the time to first P. falciparum infection over the 24-week study period, the high dose (40 mg/kg) of CIS43LS was 88.2% effective at preventing infection and the lower dose (10 mg/kg) was 75% effective. An analysis of the proportion of participants infected with P. falciparum at any time over the 24-week study period found the high dose was 76.7% at preventing infection and the lower dose was 54.2% effective.
"These first field results demonstrating that a monoclonal antibody safely provides high-level protection against intense malaria transmission in healthy adults pave the way for further studies to determine if such an intervention can prevent malaria infection in infants, children, and pregnant women," Dr. Seder said. "We hope monoclonal antibodies will transform malaria prevention in endemic regions."
Dr. Seder and colleagues have developed a second antimalarial monoclonal antibody, L9LS, that is much more potent than CIS43LS and therefore can be administered in a smaller dose as an injection under the skin (subcutaneously), rather than by intravenous infusion. An early-phase NIAID trial of L9LS in the United States found that the antibody was safe and prevented malaria infection for 21 days in 15 out of 17 healthy adults exposed to P. falciparum in a carefully controlled setting. Two larger, NIAID-sponsored Phase 2 trials assessing the safety and efficacy of L9LS in infants, children and adults are underway in Mali and Kenya.
Additional information about the Phase 2 trial of CIS43LS is available at ClinicalTrials.gov under study identifier NCT04329104.
AntibodyVaccine
04 Aug 2022
One injection of a candidate monoclonal antibody (mAb) known as L9LS was found to be safe and highly protective in U.S. adults exposed to the malaria parasite, according to new results. Additional clinical trials evaluating if L9LS can prevent malaria over six to 12 months against seasonal and perennial transmission are underway in infants and children in Mali and Kenya, where malaria is endemic.
One injection of a candidate monoclonal antibody (mAb) known as L9LS was found to be safe and highly protective in U.S. adults exposed to the malaria parasite, according to results from a National Institutes of Health Phase 1 clinical trial published in The New England Journal of Medicine. Additional clinical trials evaluating if L9LS can prevent malaria over six to 12 months against seasonal and perennial transmission are underway in infants and children in Mali and Kenya, where malaria is endemic. The trial was sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH.
"These early clinical trial results demonstrating that a monoclonal antibody administered subcutaneously can protect people from malaria are highly encouraging," said NIAID Director Anthony S. Fauci, M.D. "A one-time intervention that protects against malaria for six months to a year could significantly reduce morbidity and mortality among children in malaria-endemic regions and offer an effective preventive tool for health care workers, military personnel and travelers to these areas."
Malaria is a mosquito-borne disease caused by Plasmodium parasites. The World Health Organization estimates that in 2020, about 240 million people had malaria and about 627,000 of them died. A disproportionate burden of malarial disease is seen in Sub-Saharan Africa, where children under age 5 account for approximately 80% of all malaria deaths. A vaccine to prevent malaria is now available; however, its variable efficacy underscores the need for new interventions that offer high-level protection against disease.
Scientists from NIH's Vaccine Research Center (VRC), part of NIAID, developed L9LS and led the Phase 1 clinical trial. L9LS is a laboratory-made version of a naturally occurring antibody called L9, derived from the blood of a volunteer who had received an investigational malaria vaccine. The antibody prevents malaria by neutralizing the parasites in the skin and blood before they can infect liver cells.
L9LS is similar to a candidate anti-malarial antibody known as CIS43LS that the VRC developed and found to be highly protective in a small trial when administered by the intravenous route. However, L9LS is two to three times more potent. Increasing the potency allowed for subcutaneous injection, a more cost-effective and feasible route of administration than intravenous infusion.
The Phase 1 study was conducted from Sept. 13 to Nov. 16, 2021, at the NIH Clinical Center in Bethesda, Maryland, and the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. The trial involved 18 volunteer participants receiving various doses of L9LS subcutaneously or intravenously. After tolerating the injection and experiencing no safety concerns, the participants allowed mosquitoes carrying the malaria parasite to bite their forearm five times, starting from two to six weeks after receiving the mAb candidate. This took place in a carefully controlled setting, known as controlled human malaria infection (CHMI). As part of this approach, which has been used for decades in malaria research, medical staffers closely monitor participants and provide proper treatment if they become infected. L9LS fully protected 15 of 17 (88%) participants from malaria infection during the 21-day challenge period. All volunteers in the control group that underwent CHMI, but did not receive L9LS, became infected and were promptly treated without complications. Encouragingly, four of the five participants who received a low, subcutaneous dose of the mAb were protected from malaria.
"This is the first demonstration that a monoclonal antibody can provide protection when given by the subcutaneous route, with important implications for widespread clinical use and reaching the goal of eliminating malaria," said Robert Seder, M.D., chief of the Cellular Immunology Section in the VRC, who led the development of L9LS. "We look forward to results in larger field studies that will help establish an effective dose."
Lt. Cmdr. Richard Wu, M.D., staff clinician in the VRC's Clinical Trials Program, led the Phase 1 trial. Study collaborators included scientists from the U.S. Public Health Service Commissioned Corps; the Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard University; NIAID'S Biostatistics Research Branch; WRAIR; and the University of California at San Diego.
VaccineAntibody
100 Deals associated with L-9LS
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R&D Status
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Malaria, Falciparum | Phase 2 | ML | 25 May 2023 | |
| Malaria | Phase 2 | KE | 14 Sep 2022 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 2 | 365 | (Adult Dose-escalation Study: Arm 1: 300 mg of L9LS) | asnbufuzkz(ujcfszmuom) = lswncczpxu grcydzwaua (riezhnwdck, dimzrjjgek - bssvsakkwo) View more | - | 10 Jul 2024 | ||
(Adult Dose-escalation Study: Arm 2: 600 mg of L9LS) | asnbufuzkz(ujcfszmuom) = yczodgzacc grcydzwaua (riezhnwdck, acnzvrhswd - cggkfttsge) View more | ||||||
NCT05304611 (Pubmed) Manual  | Phase 2 | 225 | ofczaseutf(ygofanhhmc) = smlcpfvwgw spsydmbrjr (dcodgkoznj ) View more | Positive | 26 Apr 2024 | ||
ofczaseutf(ygofanhhmc) = qcxopiwjcv spsydmbrjr (dcodgkoznj ) View more | |||||||
Phase 1 | 32 | Plasmodium falciparum (P. falciparum) sporozoite challenge+VRC-MALMAB0114-00-AB (Group 1: L9LS (1 mg/kg IV)) | snesqwcpov(bqwqftotop) = strxsehnhr trffembjoz (ypjfwthbst, svhjqaegsj - tpetbrwcug) View more | - | 13 Oct 2023 | ||
Plasmodium falciparum (P. falciparum) sporozoite challenge+VRC-MALMAB0114-00-AB (Group 2: L9LS (5 mg/kg IV)) | snesqwcpov(bqwqftotop) = poauphfwdv trffembjoz (ypjfwthbst, rtzxtkcgvz - uqxqqggzam) View more |
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