This study is an open-label, international, multi-center, Phase 2 study in adult patients with recurrent, locally-advanced or metastatic solid tumors, which harbor the NRG1 gene fusion.

Start Date28 Feb 2024

Sponsor / Collaborator

Elevation Oncology, Inc.

NCT03241810 / TerminatedPhase 2

Randomized Phase 2 Trial of Seribantumab Plus Fulvestrant in Postmenopausal Women With Hormone Receptor-positive, Heregulin Positive (HRG+), HER2 Negative Metastatic Breast Cancer (Merrimack Pharmaceuticals Inc.)

This study is a multi-center, randomized, double-blind, placebo-controlled, Phase 2 study in postmenopausal women with heregulin positive, hormone receptor positive, HER2 negative metastatic, unresectable breast cancer.

Start Date15 Aug 2017

Sponsor / Collaborator

Elevation Oncology, Inc.

NCT02538627 / TerminatedPhase 1

A Phase 1 Multi Arm Study Evaluating the Safety, Pharmacology and Preliminary Activity of the Co-Administration of MM-151 With Seribantumab (MM-121), Istiratumab (MM-141), or Trametinib in Biomarker-selected Cancer Patients

This is a Phase 1 open-label, dose-escalation trial using "3+3" design, evaluating MM-151 co-administration with MM-121, MM-141, and trametinib at varying dose levels.

Start Date01 Aug 2015

Sponsor / Collaborator

Merrimack Pharmaceuticals, Inc.

100 Clinical Results associated with Seribantumab

100 Translational Medicine associated with Seribantumab

100 Patents (Medical) associated with Seribantumab

Literatures (Medical) associated with Seribantumab

05 Nov 2024·Circulation

ErbB3 Governs Endothelial Dysfunction in Hypoxia-Induced Pulmonary Hypertension

Article

Author: Zhang, Junting ; Chen, Yuan ; Yang, Xusheng ; Li, Yiying ; Deng, Lin ; Chen, Rongchang ; Nie, Xiaowei ; Bian, Jin-Song ; Tan, Jianxin ; Chen, Jingyu

BACKGROUND::

Pulmonary hypertension, characterized by vascular remodeling, currently lacks curative therapeutic options. The dysfunction of pulmonary artery endothelial cells plays a pivotal role in the initiation and progression of pulmonary hypertension (PH). ErbB3 (human epidermal growth factor receptor 3), also recognized as HER3, is a member of the ErbB family of receptor tyrosine kinases.

METHODS::

Microarray, immunofluorescence, and Western blotting analyses were conducted to investigate the pathological role of ErbB3. Blood samples were collected for biomarker examination from healthy donors or patients with hypoxic PH. The pathological functions of ErbB3 were further validated in rodents subjected to chronic hypoxia- and Sugen-induced PH, with or without adeno-associated virus-mediated ErbB3 overexpression, systemic deletion, or endothelial cell–specific ErbB3 knockdown. Primary human pulmonary artery endothelial cells and pulmonary artery smooth muscle cells were used to elucidate the underlying mechanisms.

RESULTS::

ErbB3 exhibited significant upregulation in the serum, lungs, distal pulmonary arteries, and pulmonary artery endothelial cells isolated from patients with PH compared with those from healthy donors. ErbB3 overexpression stimulated hypoxia-induced endothelial cell proliferation, exacerbated pulmonary artery remodeling, elevated systolic pressure in the right ventricle, and promoted right ventricular hypertrophy in murine models of PH. Conversely, systemic deletion or endothelial cell–specific knockout of ErbB3 yielded opposite effects. Coimmunoprecipitation and proteomic analysis identified YB-1 (Y-box binding protein 1) as a downstream target of ErbB3. ErbB3 induced nuclear translocation of YB-1 and subsequently promoted hypoxia-inducible factor 1/2α transcription. A positive loop involving ErbB3-periostin-hypoxia–inducible factor 1/2α was identified to mediate the progressive development of this disease. MM-121, a human anti-ErbB3 monoclonal antibody, exhibited both preventive and therapeutic effects against hypoxia-induced PH.

CONCLUSIONS::

Our study reveals, for the first time, that ErbB3 serves as a novel biomarker and a promising target for the treatment of PH.

15 Jan 2024·Current medicinal chemistry

The Therapeutic Significance of HER3 in Non-small Cell Lung Cancer (NSCLC): A Review Study

Article

Author: Ding, Ke ; Zhang, Jinwei ; Trinder, Amelia

Abstract::

HER3 (Human Epidermal Growth Factor Receptor 3) is frequently overexpressed in various cancers, including non-small cell lung cancer (NSCLC), with a prevalence of 83% in primary tumors. Its involvement in tumorigenesis and resistance to targeted therapies makes HER3 a promising target for cancer treatment. Despite being initially considered “undruggable” due to its lack of catalytic activity, significant progress has been made in the development of anti-HER3 therapeutics. Monoclonal antibodies such as lumretuzumab, seribantumab, and patritumab have shown potential in targeting HER3 to overcome resistance to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs). Additionally, antibody-drug conjugates (ADCs) like HER3-DXd (patritumab deruxtecan) are new drug candidates that have demonstrated selective delivery of cytotoxic chemicals to NSCLC cells by exploiting HER3's widespread expression, minimizing cytotoxicity. This review aims to evaluate the efficacy of current HER3 therapeutics in development and their therapeutic potential in NSCLC, incorporating evidence from clinical trials.

01 Nov 2022·JCO precision oncology

Clinical Response to Seribantumab, an Anti–Human Epidermal Growth Factor Receptor-3 Immunoglobulin 2 Monoclonal Antibody, in a Patient With Metastatic Pancreatic Ductal Adenocarcinoma Harboring an NRG1 Fusion

Article

Author: Thavaneswaran, Subotheni ; Deegan, Maegan ; Chan, Wei Yen ; Jansen, Valerie M. ; Grady, John P. ; Asghari, Ray ; Thomas, David M.

News (Medical) associated with Seribantumab

08 Apr 2024

·www.biospace.com

Elevation Oncology Presents Preclinical Proof-of-Concept Data for HER3-ADC Program at AACR Annual Meeting 2024

-- On-track to nominate development candidate in 2024 -- BOSTON, April 8, 2024 /PRNewswire/ -- Elevation Oncology Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, today announced new preclinical data demonstrating proof-of-concept for its differentiated HER3-ADC program. The data will be presented in a poster session at the American Association for Cancer Research (AACR) Annual Meeting 2024, being held April 5-10 in San Diego, California. "We are pleased to share the first preclinical proof-of-concept data for our HER3-ADC program, reinforcing our commitment to advancing a portfolio of differentiated ADC-based therapies that may deliver better outcomes for patients," said David Dornan, Ph.D., Chief Scientific Officer of Elevation Oncology. "With our HER3-ADC program, we set out to design a differentiated ADC which selectively binds to HER3 and is internalized to potentially attack HER3-expressing cancerous cells while minimizing systemic exposure. Preclinical data with our proof-of-concept HER3-ADC shows HER3-dependent cell killing and robust anti-tumor activity in vivo where HER3 is expressed at high levels. We look forward to nominating a development candidate from our HER3 program later this year and, subsequently, advancing our program closer to the clinic." HER3 is a clinically validated oncology and antibody-drug conjugate (ADC) target, which is overexpressed in a range of solid tumors, including breast cancer, EGFR-mutant non-small cell lung cancer and pancreatic cancer, and is often associated with poor clinical outcomes. Elevation Oncology's HER3-ADC program conjugated seribantumab, its anti-HER3 monoclonal antibody, with a cleavable valine-citrulline linker and monomethyl auristatin E (MMAE) payload to yield HER3-ADC1, a proof-of-concept molecule with an average drug-antibody ratio (DAR) of 4. In a poster titled, "Therapeutic potential of a HER3 antibody-drug conjugate for the treatment of HER3-expressing cancers," Elevation Oncology scientists presented in vitro and in vivo data of a seribantumab-based ADC for patients with HER3-expressing cancers. The data showed: HER3-ADC1 binding to cancer cells, endocytosis, MMAE release and inhibition of proliferation were dependent on HER3 expression. In cytotoxicity assays, HER3-ADC1 displayed HER3-dependent cell killing and outperformed a benchmark HER3-ADC with a deruxtecan payload, which is currently in clinical development. In a patient derived xenograft (PDX) model of pancreatic cancer with high HER3 expression, HER3-ADC1 induced tumor regression, whereas an isotype-MMAE control and a benchmark HER3-ADC with a deruxtecan payload had only a modest effect. The poster presentation is now available in the "Publications" section of Elevation Oncology's website: . About Elevation Oncology, Inc. Elevation Oncology is an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs. We are leveraging our antibody-drug conjugate (ADC) expertise to advance a novel pipeline, initially targeting two clinically validated targets in oncology, Claudin 18.2 and HER3. Our lead candidate, EO-3021, is a potential best-in-class ADC designed to target Claudin 18.2 and is currently being evaluated in a Phase 1 trial (NCT05980416) in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or esophageal cancers. Additionally, we expect to nominate a development candidate for our second program, a HER3-targeting ADC for the treatment of patients with solid tumors that overexpress HER3, in 2024. For more information, visit . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated clinical and preclinical development activities, expected timing of announcements regarding development activities, potential benefits of Elevation Oncology's product candidates, potential market opportunities for Elevation Oncology's product candidates and the ability of Elevation Oncology's product candidates to treat their targeted indications. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "possible," "potential," "will," "would," and other words and terms of similar meaning. Although Elevation Oncology believes that the expectations reflected in such forward-looking statements are reasonable, Elevation Oncology cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval are inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause Elevation Oncology's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Elevation Oncology's ability to advance its product candidates, the timing and results of preclinical studies and clinical trials, approvals and commercialization of product candidates, the receipt and timing of potential regulatory designations, Elevation Oncology's ability to fund development activities and achieve development goals, Elevation Oncology's ability to protect intellectual property, Elevation Oncology's ability to establish and maintain collaborations with third parties, and other risks and uncertainties described under the heading "Risk Factors" in documents Elevation Oncology files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Elevation Oncology undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. Elevation Oncology Investor and Media Contact Candice Masse, 978-879-7273 Senior Director, Corporate Communications & Investor Relations cmasse@elevationoncology.com Company Codes: NASDAQ-NMS:ELEV

Phase 1ADCAACR

14 Feb 2024

·firstwordpharma.com

Merrimack to close out and cash in after $225M milestone

Hours after becoming eligible for a hefty milestone payment, Merrimack Pharmaceuticals announced plans on Tuesday to dissolve the company and distribute the windfall among shareholders. Merrimack is set to receive $225 million from Ipsen after the FDA approved a four-drug regimen featuring Onivyde (irinotecan liposome injection) to treat first-line metastatic pancreatic adenocarcinoma. Ipsen acquired US rights to Onivyde from Merrimack in 2017. For more, see ViewPoints: Ipsen success provides epitaph for Merrimack.The only other licensing deal Merrimack has is with Elevation Oncology, which has rights to anti-HER3 antibody seribantumab under a 2019 deal. However, Elevation paused development of the experimental cancer treatment last year until it could find a partner.Given that Merrimack doesn’t expect to receive any additional milestone payments, the company plans to shutter operations and pay investors a cash dividend between $14.65 and $15.35 per share, pending a shareholder meeting scheduled for May. Shares in Merrimack ticked down 2% on Wednesday to close at $14.67. Merrimack is the second company this week to close shop and cash out. LianBio said Tuesday it plans to wind down operations, sell its remaining pipeline assets, and pay investors a cash dividend of $4.80 per share. The move comes just months after the company pocketed $350 million from selling off certain Asia rights for cardiac myosin inhibitor mavacamten to Bristol Myers Squibb.

License out/inDrug ApprovalPhase 3Acquisition

02 Nov 2023

·www.biospace.com

Merrimack Reports Third Quarter 2023 Financial Results

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [(“Merrimack” or the “Company”)] today announced its third quarter 2023 financial results for the period ended September 30, 2023. “During the third quarter we saw interest income on our cash and short term investments offset a significant portion of our operating expenses” said Gary Crocker, Chairman of Merrimack's Board of Directors. “We continue to monitor developments in Ipsen’s Onivyde® (irinotecan liposomal injection) program and Elevation’s seribantumab program.” Third Quarter 2023 Financial Results Merrimack reported a net loss of $279 thousand for the third quarter ended September 30, 2023, or $0.02 per basic and diluted share on a fully diluted basis, compared to a net loss of $442 thousand, or $0.03 per basic and diluted share on a fully diluted basis, for the same period in 2022. General and administrative expenses for the third quarter ended September 30, 2023, were $531 thousand, compared to $504 thousand for the same period in 2022. As of September 30, 2023, Merrimack had short term investments and cash and cash equivalents of $18.9 million, compared to $19.4 million as of December 30, 2022. As of September 30, 2023, Merrimack had 14.3 million shares of common stock outstanding. Updates on Programs Underlying Potential Milestone Payments Ipsen - In June 2023, Ipsen announced that the U.S. Food and Drug Administration (FDA) had accepted its supplemental new drug application (sNDA) Onivyde® (irinotecan liposome injection) plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen) as a potential first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC) and that the FDA had provided a Prescription Drug User Fee Act goal date of 13 February 2024 for review of the application. This guidance was reiterated in Ipsen’s September, 2023 investor presentation. Elevation Oncology - In January 2023, Elevation announced it is pausing further investment in the clinical development of seribantumab and intends to pursue further development only in collaboration with a partner. About Merrimack Merrimack Pharmaceuticals, Inc. is a biopharmaceutical company based in Cambridge, Massachusetts that is entitled to receive up to $450.0 million in contingent milestone payments related to its sale of ONIVYDE® to Ipsen S.A. in April 2017. These milestone payments would be payable by Ipsen upon approval by the U.S. Food and Drug Administration (“FDA”) of ONIVYDE for certain additional clinical indications. ONIVYDE® is already approved by the FDA in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. This existing approval is unrelated to any future potential milestone payments. Merrimack’s agreement with Ipsen does not require Ipsen to provide Merrimack with any information on the progress of ONIVYDE clinical trials that is not publicly available. Merrimack is also entitled to receive up to $54.5 million in contingent milestone payments related to its sale of anti-HER3 programs to Elevation Oncology (formerly 14ner Oncology, Inc.) in July 2019. Forward Looking Statements To the extent that statements contained in this press release are not descriptions of historical facts, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include any statements about Merrimack’s strategy, future operations, future financial position, future revenues and future expectations and plans and prospects for Merrimack, and any other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue” and similar expressions. In this press release, Merrimack’s forward-looking statements include, among others, Merrimack’s rights to receive payments related to certain milestone events from Ipsen and/or Elevation Oncology or whether such milestones will be achieved, if at all, the sufficiency of Merrimack’s cash resources and Merrimack’s strategic plan, including any potential distribution of additional cash. Such forward-looking statements involve substantial risks and uncertainties that could cause Merrimack’s future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others: Positive information about pre-clinical and early stage clinical trial results does not ensure that later stage or larger scale clinical trials will be successful. For example, Onivyde® may not demonstrate promising therapeutic effect or appropriate safety profiles in current or later stage or larger scale clinical trials as a result of known or as yet unanticipated side effects. The results achieved in later stage trials may not be sufficient to meet applicable regulatory standards or to justify further development. Problems or delays may arise prior to the initiation of planned clinical trials, during clinical trials or in the course of developing, testing or manufacturing that could lead Ipsen and Elevation Oncology and their partners and collaborators to fail to initiate or to discontinue development. Even if later stage clinical trials are successful, unexpected concerns may arise from subsequent analysis of data or from additional data. Obstacles may arise or issues may be identified in connection with review of clinical data with regulatory authorities. Regulatory authorities may disagree with Ipsen and Elevation Oncology’s view of the data or require additional data or information or additional studies. In addition, the planned timing of initiation and completion of clinical trials based upon Onivyde® and the anti-HER Program are subject to the ability of each of Ipsen and Elevation Oncology, respectively, to enroll patients, enter into agreements with clinical trial sites and investigators, and overcome technical hurdles and other issues related to the conduct of the trials for which each of them is responsible. Additionally, each of Ipsen and Elevation Oncology are subject to the risk that they may not successfully commercialize these development programs. Merrimack is also subject to the risk that it may not have funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements. In addition, press releases and other public statements by Ipsen and Elevation Oncology may contain forward-looking statements. Merrimack undertakes no obligation to update or revise any forward-looking statements. Forward-looking statements should not be relied upon as representing Merrimack’s views as of any date subsequent to the date hereof. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Merrimack’s business in general, see the “Risk Factors” section of Merrimack’s Annual Report on Form 10-K filed with the SEC on March 9, 2023, any subsequent quarterly report on Form 10-Q filed by Merrimack and the other reports Merrimack files with the Securities and Exchange Commission. View source version on businesswire.com: Contacts Tim Surgenor ir@merrimack.com Source: Merrimack Pharmaceuticals, Inc. View this news release online at:

Financial StatementNDALicense out/in

100 Deals associated with Seribantumab

External Link

KEGG	Wiki	ATC	Drug Bank
D11777	Seribantumab	-	DB11857

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bile Duct Neoplasms	Phase 2	US	Elevation Oncology, Inc.	28 Feb 2024
Bile Duct Neoplasms	Phase 2	AU	Elevation Oncology, Inc.	28 Feb 2024
Bile Duct Neoplasms	Phase 2	CA	Elevation Oncology, Inc.	28 Feb 2024
Bile Duct Neoplasms	Phase 2	KR	Elevation Oncology, Inc.	28 Feb 2024
Bladder Cancer	Phase 2	US	Elevation Oncology, Inc.	28 Feb 2024
Bladder Cancer	Phase 2	AU	Elevation Oncology, Inc.	28 Feb 2024
Bladder Cancer	Phase 2	CA	Elevation Oncology, Inc.	28 Feb 2024
Bladder Cancer	Phase 2	KR	Elevation Oncology, Inc.	28 Feb 2024
Breast Cancer	Phase 2	AU	Elevation Oncology, Inc.	28 Feb 2024
Breast Cancer	Phase 2	KR	Elevation Oncology, Inc.	28 Feb 2024

Clinical Result

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Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


WCLC2024	Not Applicable	NRG1 Fusion Positive non-small cell lung cancer	-	Seribantumab	lguhleccgj(bfgoacuskc) = mjeoxarvla qyclmmqtcx (cxhjxynenu )	-	09 Sep 2024
NCT04383210 (CRESTONE, AACR2023) Manual	Phase 2	Solid tumor Second line NRG1 Expression	51	seribantumab 3g	ehjytqohhk(cjhnalyiio) = feoangshza bahkejksmu (fuxiubaznt ) View more	Positive	14 Apr 2023
NCT04383210 (CRESTONE, ASCO2022)	Phase 2	Sarcoma \| Metastatic Solid Tumor \| NRG1 Fusion Positive Solid Tumors ... View more	12	Seribantumab 3g QW	megttkyepk(ynfbajdjed) = kkwkccvgzg gdfkhxlwfg (rupzusupsa )	-	02 Jun 2022
NCT00734305 (Pubmed) Manual	Phase 1	Solid tumor	44	Seribantumab (dose escalation)	mcxkkoanaz(flbafaqomg) = maximum tolerated dose was not reached. oepmazgyaf (ppzvmjmlyq ) View more	Positive	01 Dec 2021
				Seribantumab (dose expansion)
NCT02387216 (SHERLOC, CTgov)	Phase 2	Adenocarcinoma \| metastatic non-small cell lung cancer	153	Docetaxel+MM-121 (Arm A (Experimental): MM-121 in Combination With Docetaxel)	kwlnluqzrf(mlstiraahx) = ccltlhuqzx phvxqedint (wgntvcuqdz, tuieagrqer - jqbdpahufe) View more	-	12 Oct 2021
				Docetaxel (Arm B (Comparator): Docetaxel Alone)	kwlnluqzrf(mlstiraahx) = cjuhqhfkzy phvxqedint (wgntvcuqdz, jaysmsinaj - huwgknywxl) View more
NCT03241810 (SHERBOC, CTgov)	Phase 2	Metastatic breast cancer \| Hormone receptor positive HER2 negative breast cancer	22	Fulvestrant+Seribantumab (Arm A (Experimental): Seribantumab and Fulvestrant)	ybdxeohsov(oygevxpitg) = pcnzoomhzg kfyyihcapo (vvzupwitng, mgbsjhwxue - kwzbwliwpc) View more	-	02 Sep 2020
				Placebo+Fulvestrant (Arm B (Control): Placebo and Fulvestrant)	ybdxeohsov(oygevxpitg) = zrybdvdtxk kfyyihcapo (vvzupwitng, icdauqftye - lqmcplwqvd) View more
NCT02387216 (Pubmed \| Oncologist)	Phase 2	EGFR-mutated non-small Cell Lung Cancer	153	Seribantumab + Erlotinib	hptwbyosjj(yzsholzpvs) = ofhrtulbxe kemhqelpgn (szmedmerev ) View more	-	01 Aug 2019
				Erlotinib alone	hptwbyosjj(yzsholzpvs) = lwshppvlla kemhqelpgn (szmedmerev ) View more
NCT02387216 (SHERLOC, ASCO2019) Manual	Phase 2	Non-Small Cell Lung Cancer HRG positive	108	docetaxel 75 mg+MM-121 3000 mg	jgnstvenii(vkszsitvjm) = ofnxgfmahd gftrwqwbgf (owacegkgln ) View more	Negative	02 Jun 2019
				docetaxel 75 mg	jgnstvenii(vkszsitvjm) = vjzahnloep gftrwqwbgf (owacegkgln ) View more
NCT01447706 (CTgov)	Phase 2	Peritoneal Neoplasms \| Ovarian Epithelial Carcinoma \| Platinum-Resistant Ovarian Carcinoma ... View more	223	Paclitaxel	ifhslxazvm(bmcuqsqrvd) = nvfafbpygb rykawqbxqf (ukohysyyfs, jpinjmokkp - gdrgcqjanh) View more	-	12 May 2016
NCT01151046 (CTgov)	Phase 2	HER2-negative breast cancer	118	Placebo+Exemestane	tjesadpxzf(yrhdmwxhzs) = aenplybwbo jioyxwwnyx (akuqxfgejz, abxcwlsnbn - gekbfejekf) View more	-	12 May 2016

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