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BioAtla and Context Therapeutics Announce Exclusive Worldwide License Agreement to Develop and Commercialize BA3362, a Nectin-4 x CD3 T Cell Engaging Antibody

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BioAtla and Context Therapeutics have entered into an exclusive worldwide license agreement for the development and commercialization of BA3362, a Nectin-4 x CD3 T Cell Engaging Antibody. Key points include:

1. Context obtains exclusive rights to BA3362
2. BioAtla to receive $15.0 million in upfront and near-term milestones
3. Potential for up to $118.5 million in additional clinical, regulatory, and commercial milestones, plus royalties on net sales
4. Context anticipates IND filing for BA3362 in mid-2026

This agreement allows BioAtla to focus on its lead clinical CAB programs while potentially advancing BA3362 under Context's leadership. The transaction aligns with Context's strategy of building a pipeline of TCE assets through strategic in-licensing or acquisition.

BioAtla e Context Therapeutics hanno sottoscritto un accordo di licenza esclusiva mondiale per lo sviluppo e la commercializzazione di BA3362, un anticorpo che impegna le cellule T Nectin-4 x CD3. I punti chiave includono:

1. Context ottiene diritti esclusivi su BA3362
2. BioAtla riceverà 15,0 milioni di dollari in pagamenti iniziali e traguardi a breve termine
3. Potenziale fino a 118,5 milioni di dollari in traguardi clinici, normativi e commerciali aggiuntivi, oltre a royalty sulle vendite nette
4. Context prevede di presentare la domanda IND per BA3362 a metà del 2026

Questo accordo consente a BioAtla di concentrarsi sui suoi programmi clinici principali mentre potenzialmente sviluppa BA3362 sotto la guida di Context. La transazione si allinea alla strategia di Context di costruire un portafoglio di asset TCE attraverso licenze strategiche o acquisizioni.

BioAtla y Context Therapeutics han firmado un acuerdo de licencia exclusivo a nivel mundial para el desarrollo y la comercialización de BA3362, un anticuerpo que une células T Nectin-4 x CD3. Los puntos clave incluyen:

1. Context obtiene derechos exclusivos sobre BA3362
2. BioAtla recibirá 15,0 millones de dólares en pagos iniciales y hitos a corto plazo
3. Posibilidad de hasta 118,5 millones de dólares en hitos clínicos, regulatorios y comerciales adicionales, además de regalías sobre las ventas netas
4. Context anticipa la presentación de la solicitud IND para BA3362 a mediados de 2026

Este acuerdo permite a BioAtla centrarse en sus programas clínicos principales mientras potencialmente avanza en BA3362 bajo el liderazgo de Context. La transacción se alinea con la estrategia de Context de construir un portafolio de activos TCE a través de licencias estratégicas o adquisiciones.

BioAtlaContext TherapeuticsBA3362, 즉 Nectin-4 x CD3 T 세포 결합 항체의 개발 및 상용화를 위한 독점적인 전세계 라이선스 계약을 체결했습니다. 주요 사항은 다음과 같습니다:

1. Context가 BA3362에 대한 독점 권리를 얻음
2. BioAtla는 1500만 달러의 초기 비용 및 단기 이정표를 받음
3. 추가 임상, 규제 및 상업적 이정표에 대해 최대 1억 1850만 달러의 잠재력 및 순매출에 대한 로열티
4. Context는 2026년 중반 BA3362에 대한 IND 청원을 예상함

이번 계약은 BioAtla가 주요 임상 CAB 프로그램에 집중하고, Context의 지휘 하에 BA3362를 발전시킬 수 있는 가능성을 제공합니다. 이 거래는 Context의 전략인 전략적 라이센스 또는 인수를 통해 TCE 자산 포트폴리오를 구축하는 것과 일치합니다.

BioAtla et Context Therapeutics ont conclu un accord de licence exclusif mondial pour le développement et la commercialisation de BA3362, un anticorps engageant les cellules T Nectin-4 x CD3. Les points clés incluent :

1. Context obtient des droits exclusifs sur BA3362
2. BioAtla recevra 15,0 millions de dollars en paiements initiaux et en jalons à court terme
3. Potentiel allant jusqu'à 118,5 millions de dollars en jalons cliniques, réglementaires et commerciaux supplémentaires, plus des redevances sur les ventes nettes
4. Context prévoit de déposer une demande IND pour BA3362 au milieu de 2026

Ce contrat permet à BioAtla de se concentrer sur ses principaux programmes cliniques CAB tout en faisant avancer potentiellement BA3362 sous la direction de Context. La transaction s'inscrit dans la stratégie de Context de constituer un portefeuille d'actifs TCE par le biais de licences stratégiques ou d'acquisitions.

BioAtla und Context Therapeutics haben eine exklusive weltweite Lizenzvereinbarung für die Entwicklung und Vermarktung von BA3362, einem Nectin-4 x CD3 T-Zellen bindenden Antikörper, abgeschlossen. Die wichtigsten Punkte sind:

1. Context erhält exklusive Rechte an BA3362
2. BioAtla wird 15,0 Millionen Dollar an Vorauszahlungen und kurzfristigen Meilensteinen erhalten
3. Potenzial für bis zu 118,5 Millionen Dollar an zusätzlichen klinischen, regulatorischen und kommerziellen Meilensteinen sowie Lizenzgebühren auf den Nettoumsatz
4. Context rechnet mit einer IND-Einreichung für BA3362 Mitte 2026

Durch diese Vereinbarung kann sich BioAtla auf seine führenden klinischen CAB-Programme konzentrieren und gleichzeitig die Möglichkeit nutzen, BA3362 unter der Leitung von Context voranzubringen. Die Transaktion passt zur Strategie von Context, ein Portfolio von TCE-Assets durch strategisches In-Licensing oder Akquisitionen aufzubauen.

Positive
  • BioAtla to receive $15.0 million in upfront and near-term milestones
  • Potential for additional $118.5 million in clinical, regulatory, and commercial milestones
  • BioAtla eligible for tiered royalties on net sales of BA3362
  • Non-dilutive funding for BioAtla through licensing agreement
  • Potential for multiple future collaborations, including a targeted collaboration for a Phase 2 asset
Negative
  • BioAtla relinquishes control over development and commercialization of BA3362

Context to obtain exclusive development and commercialization rights to BA3362

BioAtla to receive $15.0 million in upfront and near-term milestones, and further potential clinical, regulatory and commercial milestones of up to $118.5 million, plus royalties on net sales

Context anticipated IND filing for BA3362 in mid-2026

SAN DIEGO and PHILADELPHIA, Sept. 23, 2024 (GLOBE NEWSWIRE) -- BioAtla, Inc. (“BioAtla”) (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (“CAB”) antibody therapeutics for the treatment of solid tumors, and Context Therapeutics Inc. (“Context”) (Nasdaq: CNTX), a biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies for solid tumors, today announced that the companies have entered into an agreement under which Context has obtained from BioAtla an exclusive, worldwide license to develop, manufacture and commercialize BA3362, BioAtla’s Nectin-4 x CD3 TCE. Context will assume and fund all development and commercialization activities.

“With the successful out-licensing of BA3362 to Context, we will continue to focus on execution of our lead clinical CAB programs, while ensuring the potential advancement of BA3362 under the leadership of a seasoned team,” said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla. “We believe this transaction marks the first of multiple collaborations, including a targeted collaboration for one of our Phase 2 assets over the coming months, thereby increasing shareholder value through non-dilutive means.”

“This transaction is consistent with our focus on building a pipeline of TCE assets through strategic in-licensing or acquisition,” said Martin Lehr, CEO of Context. “Nectin-4 is a priority target for Context given the target’s high prevalence in solid tumors and the unmet need to address potential resistance to Nectin-4 antibody-drug conjugates. We identified BioAtla's Nectin-4 TCE antibody as a potentially best-in-class asset. BA3362 is built from BioAtla’s compelling CAB platform technology that uses pH-dependency to drive selective Nectin-4 binding and T cell activation within the tumor microenvironment.”

Under the terms of the agreement, BioAtla is eligible to receive up to $133.5 million in aggregate payments, including $15.0 million in upfront and near-term milestones with additional potential clinical, development and commercial milestones totaling $118.5 million, as well as tiered royalties on net sales.

Tungsten Advisors served as the exclusive financial advisor to BioAtla. Orrick, Herrington & Sutcliffe LLP served as legal counsel to BioAtla. Piper Sandler served as sole financial advisor to Context. Goodwin Procter LLP served as legal counsel to Context.

About BA3362 (Nectin-4 x CD3 T cell engaging bispecific antibody)
BA3362 targets Nectin cell adhesion protein 4 (“Nectin-4”), which is highly and frequently overexpressed in a variety of cancers. Nectin-4 is a clinically-validated target for cancer therapy using a traditional antibody-drug conjugate (ADC), but it is also associated with certain adverse events, including neuropathy and rash. BA3362 is a CAB T cell engager that is designed to be preferentially active within the tumor microenvironment.

About BioAtla® 
BioAtla, Inc. is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through its contractual relationship with BioDuro-Sundia, a provider of preclinical development services. Utilizing its proprietary Conditionally Active Biologics (CAB) technology, BioAtla develops novel, reversibly active monoclonal and bispecific antibodies and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB technology and products with greater than 765 active patent matters, more than 500 of which are issued patents. Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. BioAtla has two first-in-class CAB programs currently in Phase 2 clinical testing, mecbotamab vedotin, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and ozuriftamab vedotin, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). The Phase 2 stage CAB-CTLA-4 antibody, evalstotug, is a novel CTLA-4 inhibitor designed to reduce systemic toxicity and potentially enable safer combination therapies with checkpoint inhibitors such as anti-PD-1 antibody. The company’s first dual CAB bispecific T-cell engager antibody, BA3182, is currently in Phase 1 development. BA3182 targets EpCAM, which is highly and frequently expressed on many adenocarcinomas while engaging human CD3 expressing T cells. BioAtla maintains an FDA-cleared IND for its next-gen CAB-Nectin4-ADC, BA3361, the Company’s first glycoconjugate. To learn more about BioAtla, Inc. visit www.bioatla.com

About Context Therapeutics®
Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies for solid tumors. Context is building an innovative portfolio of TCE bispecific therapeutics, including CTIM-76, a Claudin 6 x CD3 bispecific antibody, CT-95, a Mesothelin x CD3 bispecific antibody, and CT-202 (formerly BA3362), a Nectin-4 x CD3 bispecific antibody. Context is headquartered in Philadelphia. For more information, please visit www.contexttherapeutics.com or follow the Company on X (formerly Twitter) and LinkedIn.

Forward-looking Statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding strategy, future operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,” “look forward,” “plan,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are forward-looking statements. These include, without limitation, statements regarding (i) the success of BioAtla’s outlicense to Context, (ii) Context’s ability to build a pipeline of TCE assets, (iii) Context’s expectation to file an IND for BA3362 in mid-2026, (iv) the potential benefits, characteristics, safety and side effect profile of BioAtla’s or Context’s product candidates, (v) the ability of BioAtla’s or Context’s product candidates to have benefits, characteristics, manufacturability, and a side effect profile that is differentiated and/or better than third party product candidates, (vi) the likelihood data will support future development of BioAtla’s or Context’s product candidates, (vii) the likelihood of obtaining regulatory approval for BioAtla’s or Context’s product candidates; and (viii) the ability of BioAtla to enter into future collaborations and their impact on BioAtla’s shareholder value. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and BioAtla and Context therefore cannot assure you that their respective plans, intentions, expectations, or strategies will be attained or achieved. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in BioAtla’s and Context’s respective filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as otherwise required by law, BioAtla and Context respectively disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise.

  
BioAtlaContext Therapeutics
  
Investor Relations Contact:Investor Relations Contact:
Richard WaldronJennifer Minai-Azary
Chief Financial OfficerChief Financial Officer
BioAtla, Inc.Context Therapeutics Inc.
rwaldron@bioatla.comIR@contexttherapeutics.com 
  
Media Contact: 
Bruce Mackle 
LifeSci Advisors, LLC 
bmackle@lifesciadvisors.com 



FAQ

What is the financial value of the licensing agreement between BioAtla (BCAB) and Context Therapeutics?

The licensing agreement is worth up to $133.5 million in total, including $15.0 million in upfront and near-term milestones, and potential additional payments of $118.5 million in clinical, regulatory, and commercial milestones. BioAtla is also eligible for tiered royalties on net sales.

When is Context Therapeutics expected to file an IND for BA3362?

Context Therapeutics anticipates filing an Investigational New Drug (IND) application for BA3362 in mid-2026.

What type of antibody is BA3362 that BioAtla (BCAB) licensed to Context Therapeutics?

BA3362 is a Nectin-4 x CD3 T Cell Engaging (TCE) antibody, developed using BioAtla's Conditionally Active Biologic (CAB) platform technology.

How does the licensing agreement for BA3362 align with BioAtla's (BCAB) business strategy?

The agreement allows BioAtla to focus on its lead clinical CAB programs while potentially advancing BA3362 under Context's leadership. It also represents a strategy to increase shareholder value through non-dilutive means and may lead to future collaborations.

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