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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
4. BioAtla eligible for tiered royalties on net sales
5. Context anticipates IND filing for BA3362 in mid-2026

This agreement allows BioAtla to focus on its lead clinical CAB programs while advancing BA3362 under Context's leadership. Context views Nectin-4 as a priority target for solid tumors and sees BA3362 as a potentially best-in-class asset.

BioAtla e Context Therapeutics hanno stipulato un accordo di licenza esclusiva mondiale per lo sviluppo e la commercializzazione di BA3362, un anticorpo che interagisce con Nectin-4 e CD3 sulle cellule T. 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 di fino a 118,5 milioni di dollari in ulteriori traguardi clinici, normativi e commerciali
4. BioAtla è idonea a ricevere royalties scalari sulle vendite nette
5. Context prevede di presentare la domanda IND per BA3362 a metà del 2026

Questo accordo consente a BioAtla di concentrarsi sui suoi principali programmi clinici CAB mentre prosegue lo sviluppo di BA3362 sotto la guida di Context. Context considera Nectin-4 come un obiettivo prioritario per i tumori solidi e vede BA3362 come un potenziale asset di eccellenza nella categoria.

BioAtla y Context Therapeutics han firmado un acuerdo de licencia exclusivo mundial para el desarrollo y la comercialización de BA3362, un anticuerpo que se une a Nectin-4 y CD3 en células T. 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. Potencial de hasta 118,5 millones de dólares en hitos clínicos, regulatorios y comerciales adicionales
4. BioAtla será elegible para recibir regalías en función de las ventas netas
5. Context anticipa presentar la solicitud IND para BA3362 a mediados de 2026

Este acuerdo permite a BioAtla centrarse en sus principales programas clínicos CAB mientras avanza BA3362 bajo el liderazgo de Context. Context considera a Nectin-4 como un objetivo prioritario para tumores sólidos y ve a BA3362 como un posible activo líder en su clase.

BioAtla와 Context Therapeutics는 전세계 독점 라이선스 계약을 체결하여 BA3362, Nectin-4와 CD3에 결합하는 T세포 유도 항체의 개발 및 상용화를 진행합니다. 주요 사항은 다음과 같습니다:

1. Context는 BA3362에 대한 독점 권리를 획득합니다.
2. BioAtla는 1,500만 달러의 선불 및 단기 이정표에 대한 지급을 받게 됩니다.
3. 최대 1억 1,850만 달러의 추가 임상, 규제 및 상용화 이정표의 가능성
4. BioAtla는 순매출에 대한 단계별 로열티를 받을 자격이 있습니다.
5. Context는 2026년 중반에 BA3362의 IND를 제출할 것으로 예상합니다.

이번 계약을 통해 BioAtla는 Context의 주도 하에 BA3362를 개발하는 동안 주요 임상 CAB 프로그램에 집중할 수 있게 됩니다. Context는 Nectin-4를 고형 종양에 대한 우선 목표로 보고 있으며 BA3362를 가능성 있는 최고의 자산으로 보고 있습니다.

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 avance et lors des étapes imminentes
3. Potentiel de jusqu'à 118,5 millions de dollars en étapes cliniques, réglementaires et commerciales supplémentaires
4. BioAtla éligible à des redevances par paliers sur les ventes nettes
5. Context prévoit de soumettre la demande IND pour BA3362 à la mi-2026

Ce contrat permet à BioAtla de se concentrer sur ses principaux programmes cliniques CAB tout en faisant avancer BA3362 sous la direction de Context. Context considère Nectin-4 comme une cible prioritaire pour les tumeurs solides et voit en BA3362 un actif potentiellement de première classe.

BioAtla und Context Therapeutics haben einen exklusiven weltweiten Lizenzvertrag für die Entwicklung und Vermarktung von BA3362, einem Nectin-4 x CD3 T-Zell-bindenden Antikörper, abgeschlossen. Die wichtigsten Punkte sind:

1. Context erhält exklusive Rechte an BA3362
2. BioAtla erhält 15,0 Millionen Dollar zu Beginn und bei kurzfristigen Meilensteinen
3. Potenzial für bis zu 118,5 Millionen Dollar an zusätzlichen klinischen, regulatorischen und kommerziellen Meilensteinen
4. BioAtla hat Anspruch auf gestaffelte Lizenzgebühren auf Nettoverkäufe
5. Context plant, den IND-Antrag für BA3362 mitte 2026 einzureichen

Diese Vereinbarung ermöglicht es BioAtla, sich auf seine führenden klinischen CAB-Programme zu konzentrieren, während BA3362 unter der Führung von Context vorangetrieben wird. Context betrachtet Nectin-4 als ein prioritäres Ziel für solide Tumoren und sieht in BA3362 ein potenziell erstklassiges Asset.

Positive
  • BioAtla to receive $15.0 million in upfront and near-term milestones
  • Potential for up to $118.5 million in additional clinical, regulatory, and commercial milestones
  • BioAtla eligible for tiered royalties on net sales
  • Non-dilutive funding for BioAtla through licensing agreement
  • Context gains rights to a potentially best-in-class Nectin-4 TCE antibody
Negative
  • BioAtla relinquishes control over BA3362 development and commercialization
  • Context assumes financial burden of BA3362 development and commercialization

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:
Richard Waldron
Chief Financial Officer
BioAtla, Inc.
rwaldron@bioatla.com
858.356.8945
Investor Relations Contact:
Jennifer Minai-Azary
Chief Financial Officer
Context Therapeutics Inc.
IR@contexttherapeutics.com 

  
Media Contact: 
Bruce Mackle
LifeSci Advisors, LLC
bmackle@lifesciadvisors.com
 

FAQ

What is the financial value of the licensing agreement between BioAtla and Context Therapeutics for BA3362?

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

When does Context Therapeutics (CNTX) anticipate filing 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 and what is its target?

BA3362 is a Nectin-4 x CD3 T Cell Engaging (TCE) bispecific antibody, targeting Nectin-4 in solid tumors.

How does the BA3362 licensing agreement benefit BioAtla's strategy?

The agreement allows BioAtla to focus on its lead clinical CAB programs while ensuring the potential advancement of BA3362. It also provides non-dilutive funding through licensing, potentially increasing shareholder value.

Context Therapeutics Inc.

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