<SEC-DOCUMENT>0001776985-22-000039.txt : 20220623
<SEC-HEADER>0001776985-22-000039.hdr.sgml : 20220623
<ACCEPTANCE-DATETIME>20220623163409
ACCESSION NUMBER:		0001776985-22-000039
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20220623
FILED AS OF DATE:		20220623
DATE AS OF CHANGE:		20220623

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			BioNTech SE
		CENTRAL INDEX KEY:			0001776985
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			2M
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-39081
		FILM NUMBER:		221035917

	BUSINESS ADDRESS:	
		STREET 1:		AN DER GOLDGRUBE 12
		CITY:			MAINZ
		STATE:			2M
		ZIP:			55131
		BUSINESS PHONE:		0049613190847081

	MAIL ADDRESS:	
		STREET 1:		AN DER GOLDGRUBE 12
		CITY:			MAINZ
		STATE:			2M
		ZIP:			55131
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>form6-kbnt211primeema23jun.htm
<DESCRIPTION>6-K
<TEXT>
<!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN" "http://www.w3.org/TR/html4/loose.dtd"><html><head>
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<title>Document</title></head><body><div id="ic6a9805549b342908101c877f9b04e11_1"></div><div style="min-height:54pt;width:100%"><div><font><br></font></div></div><div style="text-align:center"><font><br></font></div><div style="text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:20pt;font-weight:700;line-height:120%">UNITED STATES</font></div><div style="text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:20pt;font-weight:700;line-height:120%">SECURITIES AND EXCHANGE COMMISSION</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:20pt;font-weight:400;line-height:120%"> </font></div><div style="margin-bottom:12pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:700;line-height:120%">Washington, D.C. 20549</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:120%"> </font></div><div style="margin-bottom:12pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:20pt;font-weight:400;line-height:120%"><br></font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:20pt;font-weight:700;line-height:120%">FORM 6-K</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:20pt;font-weight:400;line-height:120%"> </font></div><div><font><br></font></div><div style="text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:700;line-height:120%">REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a&#8209;16 OR 15d&#8209;16</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:120%"> </font></div><div style="margin-bottom:12pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:700;line-height:120%">UNDER THE SECURITIES EXCHANGE ACT OF 1934</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:120%"> </font></div><div style="margin-bottom:12pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:700;line-height:120%">FOR THE MONTH OF JUNE 2022</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:120%"> </font></div><div><font><br></font></div><div style="margin-bottom:12pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:700;line-height:120%">COMMISSION FILE NUMBER 001-39081 </font></div><div style="margin-bottom:12pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:20pt;font-weight:700;line-height:120%">BioNTech SE<br></font><font style="color:#333333;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">(Translation of registrant&#8217;s name into English)</font></div><div style="text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:700;line-height:120%">An der Goldgrube 12</font></div><div style="text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:700;line-height:120%">D-55131 Mainz</font></div><div style="text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:700;line-height:120%">Germany</font></div><div style="margin-bottom:12pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:700;line-height:120%">+49 6131-9084-0<br></font><font style="color:#333333;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">(Address of principal executive offices)</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:120%"> </font></div><div><font><br></font></div><div style="margin-bottom:12pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:120%">Indicate by check mark whether the registrant files or will file annual reports under cover Form 20&#8209;F or Form 40&#8209;F&#58; Form 20&#8209;F </font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:12pt;font-weight:400;line-height:120%">&#9746;</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:120%"> Form 40&#8209;F </font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:12pt;font-weight:400;line-height:120%">&#9744;</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:120%"> </font></div><div style="margin-bottom:12pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:120%">Indicate by check mark if the registrant is submitting the Form 6&#8209;K in paper as permitted by Regulation S&#8209;T Rule 101(b)(1)&#58; </font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:12pt;font-weight:400;line-height:120%">&#9744;</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:120%"> </font></div><div style="margin-bottom:12pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:120%">Indicate by check mark if the registrant is submitting the Form 6&#8209;K in paper as permitted by Regulation S&#8209;T Rule 101(b)(7)&#58; </font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:12pt;font-weight:400;line-height:120%">&#9744;</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:120%"> </font></div><div style="text-align:center"><font><br></font></div><div style="height:54pt;position:relative;width:100%"><div style="bottom:0;position:absolute;width:100%"><div><font><br></font></div></div></div><hr style="page-break-after:always"><div style="min-height:54pt;width:100%"><div><font><br></font></div></div><div style="text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:700;line-height:120%">DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K</font></div><div style="text-align:center"><font><br></font></div><div><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:112%">On June 23, 2022, BioNTech SE (the &#8220;Company&#8221;) today announced that that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to BioNTech&#8217;s fully owned product candidate BNT211 for the third- or later-line treatment of testicular germ cell tumors. The press release is attached hereto as Exhibit 99.1.</font></div><div style="text-align:center"><font><br></font></div><div style="margin-bottom:12pt;text-align:justify"><font><br></font></div><div style="margin-bottom:12pt;text-align:justify"><font><br></font></div><div style="height:54pt;position:relative;width:100%"><div style="bottom:0;position:absolute;width:100%"><div><font><br></font></div></div></div><hr style="page-break-after:always"><div style="min-height:54pt;width:100%"><div><font><br></font></div></div><div style="margin-bottom:12pt;text-align:justify"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:700;line-height:120%">SIGNATURE</font></div><div style="margin-bottom:12pt;text-align:justify;text-indent:36pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:120%">Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. </font></div><div style="margin-bottom:6pt"><table style="border-collapse:collapse;display:inline-table;margin-bottom:5pt;vertical-align:text-bottom;width:100.000%"><tr><td style="width:1.0%"></td><td style="width:49.493%"></td><td style="width:0.1%"></td><td style="width:1.0%"></td><td style="width:3.647%"></td><td style="width:0.1%"></td><td style="width:1.0%"></td><td style="width:43.560%"></td><td style="width:0.1%"></td></tr><tr><td colspan="3" style="padding:0 1pt"></td><td colspan="6" style="padding:2px 1pt 2px 1.37pt;text-align:left;vertical-align:bottom"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:700;line-height:125%">BioNTech SE</font></td></tr><tr style="height:13pt"><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td></tr><tr style="height:13pt"><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td></tr><tr><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:2px 1pt 2px 1.37pt;text-align:left;vertical-align:bottom"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:125%">By&#58;</font></td><td colspan="3" style="padding:2px 1pt 2px 1.37pt;text-align:left;vertical-align:bottom"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:125%">&#47;s&#47; Dr. Sierk Poetting</font></td></tr><tr><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="border-top:1pt solid #000000;padding:2px 1pt 2px 1.37pt;text-align:left;vertical-align:bottom"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:125%">Name&#58; Dr. Sierk Poetting</font></td></tr><tr><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:2px 1pt 2px 1.37pt;text-align:left;vertical-align:bottom"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:125%">Title&#58;   Chief Operating Officer</font></td></tr></table></div><div><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:120%">Date&#58; June 23, 2022 </font></div><div style="margin-bottom:12pt;text-align:center"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:12pt;font-weight:400;line-height:120%"> </font></div><div style="height:54pt;position:relative;width:100%"><div style="bottom:0;position:absolute;width:100%"><div><font><br></font></div></div></div><hr style="page-break-after:always"><div style="min-height:54pt;width:100%"><div><font><br></font></div></div><div style="margin-bottom:12pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:700;line-height:120%">EXHIBIT INDEX </font></div><div style="margin-bottom:6pt"><table style="border-collapse:collapse;display:inline-table;margin-bottom:5pt;vertical-align:text-bottom;width:100.000%"><tr><td style="width:1.0%"></td><td style="width:9.895%"></td><td style="width:0.1%"></td><td style="width:1.0%"></td><td style="width:87.905%"></td><td style="width:0.1%"></td></tr><tr style="height:13pt"><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td></tr><tr><td colspan="3" style="padding:2px 1pt 2px 1.37pt;text-align:left;vertical-align:top"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:125%;text-decoration:underline">Exhibit</font></td><td colspan="3" style="padding:2px 1pt 2px 1.37pt;text-align:left;vertical-align:top"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:125%;text-decoration:underline">Description of Exhibit</font></td></tr><tr style="height:13pt"><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td></tr><tr><td colspan="3" style="padding:2px 1pt 2px 1.37pt;text-align:left;vertical-align:top"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:125%">99.1</font></td><td colspan="3" style="padding:2px 1pt;text-align:left;vertical-align:top"><div><font style="color:#0000ff;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:120%;text-decoration:underline"><a href="ex991bnt211primeema23june2.htm" style="color:#0000ff;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:120%;text-decoration:underline">BioNTech Receives Priority Medicines (PRIME) Designation from EMA for Enhanced Regulatory Support of CAR-T Candidate  BNT211 in Testicular Cancer</a></font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:120%"> </font></div><div style="padding-left:0.35pt;padding-right:0.35pt;text-align:justify"><font><br></font></div></td></tr><tr style="height:13pt"><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td></tr><tr style="height:13pt"><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td></tr></table></div><div style="text-align:right"><font><br></font></div><div style="text-align:right"><font><br></font></div><div style="margin-bottom:8pt"><font><br></font></div><div style="height:54pt;position:relative;width:100%"><div style="bottom:0;position:absolute;width:100%"><div><font><br></font></div></div></div></body></html>
</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>ex991bnt211primeema23june2.htm
<DESCRIPTION>EX-99.1
<TEXT>
<!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN" "http://www.w3.org/TR/html4/loose.dtd"><html><head>
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<title>Document</title></head><body><div id="i6e3d18c0bf0a4afe8b8fc01344526da0_1"></div><div style="min-height:120.83pt;width:100%"><div style="text-align:right"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:700;line-height:120%">Exhibit 99.1</font></div><div><font><br></font></div><div style="margin-bottom:6pt"><table style="border-collapse:collapse;display:inline-table;margin-bottom:5pt;vertical-align:text-bottom;width:100.000%"><tr><td style="width:1.0%"></td><td style="width:49.560%"></td><td style="width:0.1%"></td><td style="width:1.0%"></td><td style="width:48.240%"></td><td style="width:0.1%"></td></tr><tr style="height:29pt"><td colspan="3" style="padding:0 1pt"><div style="padding-left:2.75pt;padding-right:2.75pt"><img alt="image_0.jpg" src="image_0.jpg" style="height:26px;margin-bottom:5pt;vertical-align:text-bottom;width:240px"></div></td><td colspan="3" style="padding:0 1pt"></td></tr></table></div><div><font style="color:#000000;font-family:'Calibri',sans-serif;font-size:11pt;font-weight:400;line-height:120%">&#160;&#160;&#160;&#160;</font></div></div><div style="text-align:center"><font><br></font></div><div style="text-align:center"><font style="background-color:#ffffff;color:#000000;font-family:'Arial',sans-serif;font-size:14pt;font-weight:700;line-height:107%">BioNTech Receives Priority Medicines (PRIME) Designation from EMA for Enhanced Regulatory Support of CAR-T Candidate  BNT211 in Testicular Cancer</font></div><div style="text-align:justify"><font><br></font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:107%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:107%;padding-left:14.15pt">First BioNTech</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:107%"> </font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:107%">product candidate to receive priority medicines (PRIME) designation by the European Medicines Agency for enhanced regulatory support facilitating the clinical development of the investigational cell therapy candidate BNT211 in the third- or later-line setting in patients with heavily pre-treated testicular cancer</font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:107%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:107%;padding-left:14.15pt">Designation follows positive interim Phase 1&#47;2 data for BNT211 demonstrating an encouraging safety profile and early signs of anti-tumor activity</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:107%"> </font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:107%">in testicular cancer patients</font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:107%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:107%;padding-left:14.15pt">BNT211 combines two innovative approaches in one regimen, an autologous chimeric antigen receptor (CAR) T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) and a CLDN6-encoding CAR-T cell amplifying RNA vaccine (CARVac) to improve persistence and functionality of the adoptively transferred cells</font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:107%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:107%;padding-left:14.15pt">The European Medicines Agency&#8217;s priority medicines status is granted to drug candidates that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options   </font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:107%">MAINZ, Germany, June 23, 2022 (GLOBE NEWSWIRE) </font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:107%">&#8211; BioNTech SE (Nasdaq&#58; BNTX, &#8220;BioNTech&#8221;) today announced that that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to BioNTech&#8217;s fully owned product candidate BNT211 for the third- or later-line treatment of testicular germ cell tumors. BNT211 is a potential first-in-class therapeutic approach which comprises a synergistic combination of two of the Company&#8217;s proprietary drug products, an autologous chimeric antigen receptor (CAR) T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) and a CLDN6-encoding CAR-T cell amplifying RNA vaccine (CARVac). The product candidate is currently being investigated in an ongoing Phase 1&#47;2 study (NCT04503278&#59; 2019-004323-20) that aims to evaluate the safety and preliminary efficacy in heavily pretreated patients with relapsed or refractory advanced solid tumors.</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:107%">&#8220;Patients with relapsed or treatment refractory testicular cancers have a poor prognosis with limited remaining treatment options. The PRIME designation underlines the potential of our approach in this high medical need setting. Our approach brings together several new elements&#58; Firstly, targeting CLDN6, a pan-cancer cell surface marker, secondly, our CAR design, and thirdly, &#8220;remote control&#8221; of CAR T cells by our uridine RNA-lipoplex based vaccine. We believe that a combination of engineered T cells and mRNA vaccines in one treatment regimen can stimulate and expand T cells. This could enable us to develop truly powerful precision immunotherapies,&#8221; said </font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:107%">Prof. &#214;zlem T&#252;reci, M.D., Co-Founder and Chief Medical Officer at BioNTech</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:107%">. &#8220;With the PRIME status and support by the EMA, we aim to expedite the further development of the BNT211 program to bring a novel therapeutic option for patients with life-threatening testicular cancer, and thus to extend the successes of CAR-T therapy also to hard-to-treat solid tumors.&#8221;</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:107%">The designation is based on positive preliminary Phase 1&#47;2 data from the ongoing study that was presented at the AACR Annual Meeting in April 2022. The results demonstrated that treatment with CLDN6 CAR-T alone or in combination with CARVac was well tolerated and showed encouraging signs of anti-tumor activity in testicular cancer patients at the first evaluated dose levels. In the study all six patients with heavily pretreated testicular cancer eligible for efficacy analysis showed clinical benefits highlighting the potential of this novel approach. One patient achieved a complete response 18 weeks after infusion. Three patients achieved a partial response and showed deepening and durability of responses (one of them in the lowest CAR-T dose level cohort in combination with CARVac). One patient had stable disease with shrinkage of target lesions. </font></div><div style="height:59.84pt;position:relative;width:100%"><div style="bottom:0;position:absolute;width:100%"><div style="text-align:center"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:9pt;font-weight:400;line-height:120%">1</font></div><div><font><br></font></div></div></div><hr style="page-break-after:always"><div style="min-height:120.83pt;width:100%"><div><font><br></font></div></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:107%">The PRIME scheme is a regulatory mechanism introduced by the EMA that provides early and proactive support to developers of promising medicines, to optimize development plans and speed up evaluations so these medicines can reach patients faster. The goal is to help patients benefit as early as possible from innovative new therapies that have demonstrated the potential to significantly address an unmet medical need. </font></div><div><font><br></font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:107%">About BNT211</font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:107%">Aiming to harness the power of cell therapies for solid cancers and to overcoming hurdles to date, BioNTech has combined their CAR-T and FixVac platform technologies to develop a highly tumor-specific CAR-T cell therapy product which is consecutively enhanced by a </font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:107%;text-decoration:underline">C</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:107%">AR-T Cell </font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:107%;text-decoration:underline">A</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:107%">mplifying </font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:107%;text-decoration:underline">R</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:107%">NA </font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:107%;text-decoration:underline">Vac</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:107%">cine (CARVac) that is based on BioNTech&#96;s mRNA-lipoplex technology and encodes for the respective CAR-T target antigen. The CARVac is based on BioNTech&#8217;s backbone-optimized uridine mRNA (uRNA)-lipoplex technology which through its inherent adjuvant function enables a potent T cell stimulation to improve persistence and functionality of the adoptively transferred CAR-T cells, thus enabling and maintaining a therapeutic effect even at low CAR-T doses. BNT211 is an investigational CAR-T cell therapy directed against the novel oncofetal antigen Claudin-6 (CLDN6), a target discovered by BioNTech founders and expressed on multiple solid tumors such as ovarian cancer, sarcoma, testicular cancer, endometrial cancer and gastric cancer. The program is currently being evaluated in a first-in-human Phase 1&#47;2 trial as a monotherapy and in combination with a CLDN6-encoding CARVac, aiming to boost persistence and functionality of the CLDN6-CAR-T cells, in patients with CLDN6-positive relapsed or refractory advanced solid tumors.</font></div><div style="text-align:justify"><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">About BioNTech</font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">Biopharmaceutical New Technologies (BioNTech) is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bispecific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma and Pfizer.</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">For more information, please visit www.BioNTech.com</font><font style="color:#3c9673;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">  </font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">BioNTech Forward-Looking Statements</font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:107%">This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to statements concerning&#58; BioNTech&#8217;s CAR-T  program candidate BNT211&#59; timing for any data readouts of the Phase 1&#47;2 trial&#59; the registrational potential of any  trial we may initiate for BNT211&#59; the nature and characterization of and timing for release of clinical data across BioNTech&#8217;s platforms, which is subject to peer review, regulatory review and market interpretation&#59; the planned next steps in BioNTech&#8217;s pipeline programs and specifically including, but not limited to, statements regarding timing or plans for initiation of clinical trials, enrollment or submission for and receipt of product approvals with respect to BioNTech&#8217;s product candidates&#59; the ability of BioNTech&#8217;s mRNA technology to demonstrate clinical efficacy outside of BioNTech&#8217;s infectious disease platform&#59; the potential safety and efficacy of our other product candidates&#59; and BioNTech&#8217;s anticipated market opportunity and size for its product candidates, the rate and degree of market acceptance of BioNTech&#8217;s </font></div><div style="height:59.84pt;position:relative;width:100%"><div style="bottom:0;position:absolute;width:100%"><div style="text-align:right"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">2</font></div><div><font><br></font></div></div></div><hr style="page-break-after:always"><div style="min-height:120.83pt;width:100%"><div><font><br></font></div></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:107%">investigational medicines, if approved. Any forward-looking statements in this press release are based on BioNTech&#8217;s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to&#58; discussions with regulatory agencies regarding timing and requirements for additional clinical trials&#59; and the ability to produce comparable clinical results in future clinical trials.</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:107%">For a discussion of these and other risks and uncertainties, see BioNTech&#8217;s Annual Report as Form 20-F for the Year Ended December 31, 2021, filed with the SEC on March 30, 2022, which is available on the SEC&#8217;s website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.</font></div><div><font><br></font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">CONTACTS</font></div><div><font><br></font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">BioNTech&#58;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%"> </font></div><div><font><br></font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">Media Relations </font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">Jasmina Alatovic </font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">+49 (0)6131 9084 1513 </font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">Media&#64;biontech.de</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">Investor Relations</font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">Sylke Maas, Ph.D. </font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">+49 (0)6131 9084 1074 </font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">Investors&#64;biontech.de</font></div><div style="text-align:justify"><font><br></font></div><div style="height:59.84pt;position:relative;width:100%"><div style="bottom:0;position:absolute;width:100%"><div style="text-align:right"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">3</font></div><div><font><br></font></div></div></div></body></html>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
