Delving into the Latest Updates on Ivonescimab with Synapse

Overview

Basic Info

Drug Type

Bispecific antibody

Synonyms

ivonescimab

+ [4]

Target

PD-1 x VEGF-A

Mechanism

PD-1 inhibitors(Programmed cell death protein 1 inhibitors), VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors)

Therapeutic Areas

NeoplasmsRespiratory DiseasesDigestive System Disorders+ [5]

Active Indication

EGFR positive Non-squamous non-small cell lung cancerPD-L1 positive Non-Small Cell Lung CancerRecurrent Squamous Cell Carcinoma of the Head and Neck+ [28]

Inactive Indication-

Originator Organization

Akeso Biopharma Co., Ltd.

Active Organization

Akeso Biopharma Co., Ltd.Akeso-Sino Pharma Co., Ltd.Summit Therapeutics, Inc.

+ [2]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (21 May 2024),

EGFR positive Non-squamous non-small cell lung cancer

RegulationFast Track (US), Priority Review (CN), Breakthrough Therapy (CN)

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Gene Sequence

Sequence Code 41637

Source: *****

Sequence Code 616715490

Source: *****

The goal of Phase 1 of this clinical research study is to find the highest tolerable dose and the recommended Phase 2 dose of ivonescimab that can be given to patients who have recurrent glioblastoma.
The goal of Phase 2 of this clinical research study is to learn if the recommended Phase 2 dose of ivonescimab found in Phase 1 can help to control the disease.

Start Date01 Apr 2025

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+1]

NCT06567314 / Not yet recruitingPhase 2IIT

Phase 2 Study of Ivonescimab in Patients With Cutaneous Squamous Cell Carcinoma

To learn if ivonescimab can help to control advanced cSCC. The safety and effects of ivonescimab will also be studied.

Start Date28 Feb 2025

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+1]

NCT06529718 / Not yet recruitingPhase 2IIT

A Randomised, Phase II Trial to Evaluate the Efficacy of Ivonescimab, a PD 1/VEGF Bispecific Antibody, Versus FOLFOX as Second Line Therapy for Locally Advanced/Metastatic Biliary Cancers

The object of this trial is to test whether ivonescimab is superior to standard chemotherapy (FOLFOX regimen) for the treatment of patients with advanced biliary tract cancer after failure of a first line of chemotherapy. It is only open to patients who participated in the SAFIR-ABC10 trial (NCT05615818) but did not receive experimental treatment.
Eligible patients will be randomised (2:1) to receive either ivonescimab or FOLFOX. Treatment will be continued until disease progression, or a maximum of 34 cycles of ivonescimab (experimental arm), whichever occurs first.

Start Date30 Jan 2025

Sponsor / Collaborator

UNICANCER

[+2]

100 Clinical Results associated with Ivonescimab

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100 Translational Medicine associated with Ivonescimab

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100 Patents (Medical) associated with Ivonescimab

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9

Literatures (Medical) associated with Ivonescimab

31 Dec 2024·mAbs

Antibodies to watch in 2024

Article

Author: Kaplon, Hélène ; Reichert, Janice M. ; Crescioli, Silvia ; Chenoweth, Alicia ; Visweswaraiah, Jyothsna ; Wang, Lin

The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.

01 Oct 2024·Journal of Thoracic Oncology

Brief report: Ivonescimab combined with etoposide plus carboplatin as first-line treatment for extensive-stage small-cell lung cancer: results of a phase Ib clinical trial

Article

Author: Yu, Yan ; Liu, Xianling ; Lu, Shun ; Wang, Qiaoyun ; Li, Lin ; Chen, Zhiwei ; Li, Yan ; Li, Tao ; Ma, Rui ; Xu, Xiao ; Zhao, Wei ; Song, Xia ; Wang, Qiming ; Wu, Lin

INTRODUCTIONIvonescimab is a humanized IgG1 bispecific anti-PD-1/VEGF antibody. This study aimed to evaluate the safety and tolerance of ivonescimab combined with etoposide and carboplatin as first-line treatment in patients with extensive-stage small cell lung cancer (ES-SCLC) and explore the primary efficacy of this regimen.METHODSEligible patients received intravenous ivonescimab 3 mg/kg, 10 mg/kg, or 20 mg/kg every 3 weeks combined with etoposide and carboplatin for up to 4 cycles, followed by ivonescimab as maintenance. The primary endpoints were safety and objective response rate (ORR).RESULTSBetween April 23, 2021 and December 2, 2021, 35 patients were enrolled. At data cutoff (October 25, 2023), the median follow-up was 13.3 months (range, 0.3-28.5). For all patients, the confirmed ORR and disease control rate were 80% and 91.4%, respectively. The ORR was 66.7%, 90.9%, and 76.2% at the dose of 3 mg/kg, 10 mg/kg, and 20 mg/kg, respectively. Grade ≥3 treatment-related adverse events (TRAEs) were observed in 21 patients (60%), and the most frequent toxicities were decreased neutrophil count (n=8, 22.9%), decreased white blood cell count (n=5, 14.3%), and anemia (n=5, 14.3%). Grade ≥3 TRAEs occurred in 66.7%, 54.5%, and 61.9% of patients in 3, 10, and 20 mg/kg groups, respectively. TRAEs leading to death were reported in 2 patients (5.7%). Adverse events with potential immunologic etiology, most of them grade 1 or 2, occurred in 14 patients (40.0%).CONCLUSIONSIvonescimab in combination with etoposide and carboplatin was well-tolerated and showed promising antitumor activity in ES-SCLC.

01 Sep 2024·Med

EGFR-mutated NSCLC: A roadmap to treatment sequences

Article

Author: Girard, Nicolas

Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are the standard of care for the management of EGFR-mutated non-small cell lung cancer. Recent results from the HARMONi-A trial lead to considering ivonescimab-a first-in-class, bispecific antibody targeting PD-1 and VEGF-plus chemotherapy as a new second-line option following third-generation TKIs.

140

News (Medical) associated with Ivonescimab

16 Nov 2024

·endpts.com

Trump picks RFK Jr. for HHS; AbbVie's psych implosion; Merck tries staving off Summit; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here . President-elect Donald Trump made good on his pledge to let Robert F. Kennedy Jr. “go wild on health,” nominating him as HHS secretary. For more on what this will mean for biopharma, read below, and keep checking back at Endpoints where our reporters will continue to have the latest. — Max Gelman RFK Jr. picked to lead HHS As Trump picked Robert F. Kennedy Jr. to be the next HHS secretary, Kennedy, a longtime anti-vaccine advocate, has said he will push for big changes at the FDA and NIH. At an event earlier this week, current FDA Commissioner Rob Califf weighed in on how the agency may be affected by the next administration, making pointed remarks about risks to its authority and workforce. When asked who might replace him, Califf said, “Hopefully it’ll be someone who understands the really critical role of high-quality evidence in everything we do.” AbbVie has a bad Monday The centerpiece of AbbVie’s $8.7 billion Cerevel buyout imploded on Monday, with the schizophrenia drug emraclidine registering not one, but two pivotal trial failures. Emraclidine had been expected to compete with Cobenfy , the newly approved drug from Bristol Myers Squibb and Karuna , but now it appears Cobenfy will have more of the market to itself. The news sent AbbVie’s stock down more than 12%, while BMS shares rose roughly 10%. Merck aims to keep Summit at arm’s length With Summit Therapeutics hot on its heels, the Keytruda developer spent $588 million upfront to get an exclusive global license to a PD-1/VEGF combination therapy called LM-299 , currently in Phase 1. The asset comes from LaNova Medicines , a startup based in Shanghai that can receive up to $2.7 billion in biobucks from the deal. Merck is attempting to stay in front of Summit and Akeso’s ivonescimab , which beat Keytruda in a Phase 3 lung cancer study earlier this year. 23andMe shuts down therapeutics division DNA testing company 23andMe announced this week that it’s closing its therapeutics division and winding down ongoing clinical trials. It’s also cutting 40% of its workforce or more than 200 employees. The move is the latest in a string of setbacks for 23andMe, including a data breach last year that affected millions of customers. The company said it’s exploring a range of options for offloading its therapeutic programs, including licensing agreements, asset sales or other deals. Aurion and its investor Alcon enter legal battle Cell therapy startup Aurion and its investor Alcon are engaged in an unusual legal spat after Alcon sued the biotech as it prepares to go public. While Alcon claimed its shareholder rights were being violated, Aurion argued in a counterclaim that Alcon “opposes the IPO because it interferes with Alcon’s plans to acquire Aurion at a discount.” The stakes are high for Aurion, which said its cash runway only extends to March, putting urgency on its plan to go public in January. SPOTLIGHT MORE IN R&D MORE IN PHARMA MORE IN FDA+ MORE IN STARTUPS MORE IN PEOPLE MORE IN MANUFACTURING MORE IN HEALTH TECH

AcquisitionPhase 3Vaccine

14 Nov 2024

·endpts.com

Merck buys into PD-1/VEGF space as Summit comes for Keytruda

Summit Therapeutics and its Chinese partner Akeso have a few competitors now. Merck, the maker of the drug they’re trying to beat, is entering the PD-1/VEGF space by handing down $588 million upfront to get the exclusive global license to a Phase 1 asset from LaNova Medicines. The New Jersey pharma giant could dish out up to another $2.7 billion in biobucks to Shanghai-based LaNova. Last month, the five-year-old startup said it started a Phase 1 in China for the experimental medicine, dubbed LM-299. It also said it planned to file an IND in the US in the second half of the year after securing $42 million in a Series C1. Merck has been one of the most acquisitive pharmas in recent years in an attempt to shore up the looming patent cliff for the world’s best-selling medicine, the immunotherapy Keytruda. It’s bought three companies this year — EyeBio, Abceutics and Harpoon Therapeutics — and paid $700 million for a bispecific antibody from Curon. Summit and Akeso made waves at the year’s two biggest cancer confabs, ASCO and ESMO, with data on their PD-1/VEGF bispecific called ivonescimab, which was found to be better than Keytruda in a head-to-head trial in China . The partners are running multiple studies in the US and elsewhere. “If it’s good for patients, it’s good for me. I’m happy with that,” Merck chief medical officer Eliav Barr told Endpoints News at the time of Summit’s initial press release in May, in which no hard data were disclosed. After Summit released more data, Barr told Endpoints on the sidelines of ESMO: “If you look at the data that they’ve shown so far, they’ve shown some really exciting data, but where there’s somewhat less efficacy, you start to see that catch-up with the toxicity, or at least what seems like it.” Multiple other parties are intrigued. BioNTech further delved into the space this week by buying out its near-term Phase 3 partner Biotheus for $800 million upfront . Former Seagen CEO David Epstein is also a figure in the field with his new leadership post at preclinical-stage Ottimo Pharma. Merck and LaNova expect the deal to close this quarter. LaNova has inked partnerships with other pharmas, including an ADC pact with AstraZeneca .

Phase 3License out/inAcquisitionImmunotherapyADC

14 Nov 2024

·firstwordpharma.com

Merck & Co. vies to keep oncology lead with Chinese PD-1/VEGF deal

Oncology heavyweight Merck & Co. became the latest to throw its hat into the PD-1/VEGF bispecific antibody ring through a licensing deal with Chinese biotech LaNova Medicines. The agreement to develop LM-299 includes an upfront payment of $588 million, with LaNova eligible for further milestones of up to $2.7 billion."We continue to assemble a strong and diversified oncology pipeline spanning differentiated mechanisms and multiple modalities," remarked Dean Li, president of Merck Research Laboratories, with the company aiming to advance LM-299 "with speed and rigor."According to Merck, LM-299 has a differentiated molecular design, comprising an anti-VEGF antibody linked to two C-terminal single domain anti-PD-1 antibodies. A Phase I study for LM-299 kicked off in China last month, with LaNova noting at the time that an IND application in the US was planned to be filed by year-end.Summit leads raceThe space around bispecific antibodies targeting PD-(L)1/VEGF has been abuzz since Summit Therapeutics announced in May that its candidate, dubbed ivonescimab, improved progression-free survival over Merck's blockbuster PD-1 inhibitor Keytruda (pembrolizumab) in patients with PD-L1-positive, locally advanced or metastatic non–small-cell lung cancer. Results showed that ivonescimab reduced the risk of disease progression or death by 49% compared with Keytruda when used as a first-line treatment.With doctors keen to prescribe ivonescimab over Keytruda — according to recent findings from a FirstWord poll — Merck is looking to defend its oncology franchise. And it is not only Summit's effort the company needs to keep an eye on: yesterday, BioNTech agreed to spend $800 million upfront on Chinese biotech Biotheus, gaining the PD-L1/VEGF-A-targeting antibody BNT327, which is racing to registrational trials.For related analysis, see Vital Signs: BioNTech bags a bargain in a bubble for bispecifics.

Phase 1License out/inADC

100 Deals associated with Ivonescimab

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
EGFR positive Non-squamous non-small cell lung cancer	CN	Akeso-Sino Pharma Co., Ltd.	21 May 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
PD-L1 positive Non-Small Cell Lung Cancer	NDA/BLA	CN	Akeso Pharmaceuticals, Inc.	27 Jul 2024
PD-L1 positive Non-Small Cell Lung Cancer	NDA/BLA	CN	Akeso-Sino Pharma Co., Ltd.	27 Jul 2024
EGFR positive Non-squamous non-small cell lung cancer	Phase 3	US	Summit Therapeutics, Inc.	04 May 2023
EGFR positive Non-squamous non-small cell lung cancer	Phase 3	ES	Akeso Biopharma Co., Ltd.	04 May 2023
EGFR positive Non-squamous non-small cell lung cancer	Phase 3	FR	Akeso Biopharma Co., Ltd.	04 May 2023
EGFR positive Non-squamous non-small cell lung cancer	Phase 3	IT	Akeso Biopharma Co., Ltd.	04 May 2023
EGFR positive Non-squamous non-small cell lung cancer	Phase 3	ES	Summit Therapeutics, Inc.	04 May 2023
EGFR positive Non-squamous non-small cell lung cancer	Phase 3	GB	Akeso Biopharma Co., Ltd.	04 May 2023
Non-squamous non-small cell lung cancer	Phase 3	CN	Akeso Biopharma Co., Ltd.	25 Jan 2022
Hepatocellular Carcinoma	Phase 3	-	Akeso Biopharma Co., Ltd.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05227664 (ESMO2024) Manual	Phase 2	Triple Negative Breast Cancer First line \| \|	30	Ivonescimab + Paclitaxel or nab-paclitaxel	(tfwquxqlrs) = jvpqbcdrph afrzwfsclz (wtwcszgpsz ) View more	Positive	16 Sep 2024
				Ivonescimab + Paclitaxel or nab-paclitaxel (PD-L1 CPS ≥10)	(tfwquxqlrs) = djrcjxqwzd afrzwfsclz (wtwcszgpsz ) View more
NCT05229497 (ESMO2024) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck First line	30	Ivonescimab monotherapy	(wclusjrojh) = epwkabpkjs jbibvfpwqd (tffdazktjo ) View more	Positive	14 Sep 2024
				Ivonescimab plus ligufalimab	(wclusjrojh) = wmmppormzf jbibvfpwqd (tffdazktjo ) View more
NCT05382442 (ESMO2024) Manual	Phase 2	Metastatic Colorectal Carcinoma First line KRAS \| BRAF \| MSS	40	FOLFOXIRI + Ivonescimab	(rsbyacggnd) = twuqkgyume gugqqwmnkk (ahnnphignw ) View more	Positive	14 Sep 2024
				FOLFOXIRI + Ivonescimab + Ligufalimab	(rsbyacggnd) = gpohpikhfh gugqqwmnkk (ahnnphignw ) View more
NCT05499390 (HARMONi-2 \| AK112-303, WCLC2024) Manual	Phase 3	PD-L1 positive Non-Small Cell Lung Cancer First line	398	Ivonescimab 20 mg/kg	(gxgdibmyhb) = rxlsnzchbr mwneqaamwz (tfdumowdcd ) View more	Positive	08 Sep 2024
				Pembrolizumab 200 mg	(gxgdibmyhb) = lencbhhmkm mwneqaamwz (tfdumowdcd ) View more
NCT05247684 (WCLC2024) Manual	Phase 2	Resectable Lung Non-Small Cell Carcinoma	60	Ivonescimab 20 mg/kg	(bfktciovrw) = The most common TRAEs (incidence ≥5%) of grade 3 or higher were decreased neutrophil count and decreased white blood cell count nucrdwqghy (xcwrlxqfbf ) View more	Positive	08 Sep 2024
				Ivonescimab plus chemotherapy
NCT05499390 (AK112-303 \| HARMONi-2, NEWS) Manual	Phase 3	PD-L1 positive Non-Small Cell Lung Cancer First line	398	依沃西	(rwhhsahjaq) = 在意向治疗人群(ITT)中，依沃西组相较于帕博利珠组显著延长了患者无进展生存期（PFS），风险比（HR）显著优于预期 rlsubanavf (olinbwawny ) Met	Superior	31 May 2024
				帕博利珠
NCT05184712 (Pubmed)	Phase 3	EGFR C797S Mutation Non-small Cell Lung Cancer epidermal growth factor receptor (EGFR) variant	322	Ivonescimab plus pemetrexed and carboplatin	biiycpjilh(hzbbcgfbik) = occurred in 10 patients (6.2%) in the ivonescimab group vs 4 (2.5%) in the placebo group govouvicei (lqjjttewws ) View more	Positive	31 May 2024
				Placebo plus pemetrexed and carboplatin
NCT05184712 (HARMONi-A, ASCO2024) Manual	Phase 3	EGFR positive Non-squamous non-small cell lung cancer	322	Ivonescimab + Chemotherapy	(cpelfaqknu) = docvymjciw swixgqucbp (xnqobiqubh, 5.85 - 8.74) View more	Positive	24 May 2024
				Placebo + Chemotherapy	(cpelfaqknu) = dgurztafqe swixgqucbp (xnqobiqubh, 4.21 - 5.55) View more
NCT04047290 (Pubmed) Manual	Phase 1	Advanced Malignant Solid Neoplasm PD-1 \| VEGF-A	51	Ivonescimab	(klkvwsdkrb) = ylfesrckwh fhklvrhgjm (mvluycpfhl ) View more	Positive	19 Apr 2024
NCT04736823 (ESMO_ELCC2024) Manual	Phase 2	Squamous non-small cell lung cancer First line	63	Ivonescimab	(vxzgiphkat) = kojxjcgnby kijpyvhagf (oythusxwam ) View more	Positive	20 Mar 2024