On January 14, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported that it will present its 2025 strategic priorities and progress on the Company’s pipeline of mRNA therapeutics, immunomodulators, and targeted therapies at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, California (Press release, BioNTech, JAN 14, 2025, View Source [SID1234649700]).

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"We aim to develop BioNTech into a global immunotherapy powerhouse with the potential to improve the standard of care with innovative oncology products and prophylactic vaccines against infectious diseases​. In oncology, we are focused on addressing the full spectrum of solid tumors with investigational combination therapies in two pan-tumor technology pillars: our mRNA-based cancer immunotherapies for the early, adjuvant setting, and our differentiated anti-PD-L1/-VEGF-A bispecific antibody candidate BNT327/PM8002 for the treatment of advanced cancers. With our capabilities, we believe BioNTech is uniquely positioned to develop personalized, yet scalable cancer treatments based on mRNA," said Prof. Ugur Sahin, M.D., Co-Founder and Chief Executive Officer of BioNTech. "2025 is an important year, with data updates expected across both pillars and additional global clinical trial starts planned to generate evidence on our combination treatment concepts."

Prof. Ugur Sahin, M.D., will present strategic priorities and a pipeline update at the conference on Tuesday, January 14, 2025, at 6:00 p.m. CET/ 12:00 p.m. EST. A live webcast of the presentation will be available on the "Events & Presentations" page in the investor relations section on the Company’s website. A replay of the webcast will be archived on the Company’s website for 30 days following the conference.

Summary of selected pipeline updates

BNT327/ PM8002, an investigational bispecific antibody combining PD-L1 checkpoint inhibition with VEGF-A neutralization being developed in collaboration with Biotheus:

In December 2024, BioNTech initiated a global randomized Phase 3 clinical trial (NCT06712355) evaluating BNT327/PM8002 plus chemotherapy compared to atezolizumab plus chemotherapy in first line extensive-stage small cell lung cancer ("ES-SCLC").
In December 2024, BioNTech initiated a global randomized Phase 2/3 clinical trial (NCT06712316) evaluating BNT327/PM8002 plus chemotherapy compared to pembrolizumab and chemotherapy in first line NSCLC.
A global randomized Phase 3 clinical trial evaluating BNT327/PM8002 in first line triple-negative breast cancer ("TNBC") is on track to start in 2025.
Plan to initiate additional clinical trials exploring novel combinations of BNT327/PM8002 with ADCs BNT323/DB-1303 (trastuzumab pamirtecan), BNT324/DB-1311 and BNT326/YL202 in 2025.
Plan to present first clinical data from the ongoing global Phase 1/2 expansion cohorts (NCT05438329) evaluating BNT327/PM8002 plus BNT325/DB-1305 in multiple solid tumors in 2025.
Plan to present clinical data from the ongoing global Phase 2 dose optimization trials evaluating BNT327/PM8002 plus chemotherapy in advanced TNBC (NCT06449222) and first line SCLC (NCT06449209) in 2025.
Autogene cevumeran (BNT122/RO7198457), an investigational mRNA cancer immunotherapy based on an individualized neoantigen-specific immunotherapy ("iNeST") approach being developed in collaboration with Genentech Inc. ("Genentech"), a member of the Roche Group:

In December 2024, the first patient was treated in a global randomized Phase 2 clinical trial (IMCODE004) (NCT06534983) evaluating autogene cevumeran in combination with nivolumab compared to nivolumab alone in high-risk muscle-invasive urothelial carcinoma ("MIUC").
Interim data from an ongoing global randomized Phase 2 clinical trial (NCT04486378) evaluating autogene cevumeran compared to watchful waiting in adjuvant ctDNA+ stage II (high risk) / stage III colorectal cancer ("CRC") are anticipated in late 2025 or 2026.
BNT323/DB-1303 (trastuzumab pamirtecan), an investigational HER2-targeted ADC being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. ("DualityBio"):

Plan to present clinical data from an ongoing Phase 1/2a trial (NCT05150691) evaluating BNT323/DB-1303 in HER2-expressing advanced endometrial cancer in 2025.
Preparation of a potential Biologics License Application ("BLA") submission for BNT323/DB-1303 as a second line or subsequent therapy in HER2-expressing advanced endometrial cancer​ in 2025.
Plan to initiate a global Phase 3 confirmatory clinical trial (NCT06340568) evaluating BNT323/DB-1303 in advanced endometrial cancer in 2025.
COVID-19 vaccine and other candidates

For 2025, BioNTech and Pfizer Inc. ("Pfizer") expect largely stable vaccination rates and market share in the U.S. and revenue phasing similar to 2024, primarily concentrated in the back half of the year, with the distribution between Q3 and Q4 dependent on the timing of strain recommendation and approvals by regulatory agencies. Advanced purchase agreements remain in place outside of the U.S., including in the European Union.
BioNTech and Pfizer continue to invest in the research and development of next-generation and combination COVID-19 vaccine candidates.
Upcoming Investor and Analyst Events

Full Year and Fourth Quarter 2024 Financial Results: March 10, 2025
Annual General Meeting: May 16, 2025

On January 14, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported that it will present its 2025 strategic priorities and progress on the Company’s pipeline of mRNA therapeutics, immunomodulators, and targeted therapies at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, California (Press release, BioNTech, JAN 14, 2025, View Source [SID1234649700]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We aim to develop BioNTech into a global immunotherapy powerhouse with the potential to improve the standard of care with innovative oncology products and prophylactic vaccines against infectious diseases​. In oncology, we are focused on addressing the full spectrum of solid tumors with investigational combination therapies in two pan-tumor technology pillars: our mRNA-based cancer immunotherapies for the early, adjuvant setting, and our differentiated anti-PD-L1/-VEGF-A bispecific antibody candidate BNT327/PM8002 for the treatment of advanced cancers. With our capabilities, we believe BioNTech is uniquely positioned to develop personalized, yet scalable cancer treatments based on mRNA," said Prof. Ugur Sahin, M.D., Co-Founder and Chief Executive Officer of BioNTech. "2025 is an important year, with data updates expected across both pillars and additional global clinical trial starts planned to generate evidence on our combination treatment concepts."

Prof. Ugur Sahin, M.D., will present strategic priorities and a pipeline update at the conference on Tuesday, January 14, 2025, at 6:00 p.m. CET/ 12:00 p.m. EST. A live webcast of the presentation will be available on the "Events & Presentations" page in the investor relations section on the Company’s website. A replay of the webcast will be archived on the Company’s website for 30 days following the conference.

Summary of selected pipeline updates

BNT327/ PM8002, an investigational bispecific antibody combining PD-L1 checkpoint inhibition with VEGF-A neutralization being developed in collaboration with Biotheus:

In December 2024, BioNTech initiated a global randomized Phase 3 clinical trial (NCT06712355) evaluating BNT327/PM8002 plus chemotherapy compared to atezolizumab plus chemotherapy in first line extensive-stage small cell lung cancer ("ES-SCLC").
In December 2024, BioNTech initiated a global randomized Phase 2/3 clinical trial (NCT06712316) evaluating BNT327/PM8002 plus chemotherapy compared to pembrolizumab and chemotherapy in first line NSCLC.
A global randomized Phase 3 clinical trial evaluating BNT327/PM8002 in first line triple-negative breast cancer ("TNBC") is on track to start in 2025.
Plan to initiate additional clinical trials exploring novel combinations of BNT327/PM8002 with ADCs BNT323/DB-1303 (trastuzumab pamirtecan), BNT324/DB-1311 and BNT326/YL202 in 2025.
Plan to present first clinical data from the ongoing global Phase 1/2 expansion cohorts (NCT05438329) evaluating BNT327/PM8002 plus BNT325/DB-1305 in multiple solid tumors in 2025.
Plan to present clinical data from the ongoing global Phase 2 dose optimization trials evaluating BNT327/PM8002 plus chemotherapy in advanced TNBC (NCT06449222) and first line SCLC (NCT06449209) in 2025.
Autogene cevumeran (BNT122/RO7198457), an investigational mRNA cancer immunotherapy based on an individualized neoantigen-specific immunotherapy ("iNeST") approach being developed in collaboration with Genentech Inc. ("Genentech"), a member of the Roche Group:

In December 2024, the first patient was treated in a global randomized Phase 2 clinical trial (IMCODE004) (NCT06534983) evaluating autogene cevumeran in combination with nivolumab compared to nivolumab alone in high-risk muscle-invasive urothelial carcinoma ("MIUC").
Interim data from an ongoing global randomized Phase 2 clinical trial (NCT04486378) evaluating autogene cevumeran compared to watchful waiting in adjuvant ctDNA+ stage II (high risk) / stage III colorectal cancer ("CRC") are anticipated in late 2025 or 2026.
BNT323/DB-1303 (trastuzumab pamirtecan), an investigational HER2-targeted ADC being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. ("DualityBio"):

Plan to present clinical data from an ongoing Phase 1/2a trial (NCT05150691) evaluating BNT323/DB-1303 in HER2-expressing advanced endometrial cancer in 2025.
Preparation of a potential Biologics License Application ("BLA") submission for BNT323/DB-1303 as a second line or subsequent therapy in HER2-expressing advanced endometrial cancer​ in 2025.
Plan to initiate a global Phase 3 confirmatory clinical trial (NCT06340568) evaluating BNT323/DB-1303 in advanced endometrial cancer in 2025.
COVID-19 vaccine and other candidates

For 2025, BioNTech and Pfizer Inc. ("Pfizer") expect largely stable vaccination rates and market share in the U.S. and revenue phasing similar to 2024, primarily concentrated in the back half of the year, with the distribution between Q3 and Q4 dependent on the timing of strain recommendation and approvals by regulatory agencies. Advanced purchase agreements remain in place outside of the U.S., including in the European Union.
BioNTech and Pfizer continue to invest in the research and development of next-generation and combination COVID-19 vaccine candidates.
Upcoming Investor and Analyst Events

Full Year and Fourth Quarter 2024 Financial Results: March 10, 2025
Annual General Meeting: May 16, 2025

On January 14, 2025 Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported that it has commenced a public offering of shares of its common stock (or pre-funded warrants in lieu thereof) (Press release, Azitra, JAN 14, 2025, View Source [SID1234649699]). All of the shares of common stock (or pre-funded warrants in lieu thereof) to be sold in the proposed offering will be sold by Azitra. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Maxim Group LLC is acting as the sole placement agent for the proposed offering.

Azitra intends to use the net proceeds of this offering for working capital and general corporate purposes.

The public offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-280648), previously filed with the U.S. Securities and Exchange Commission (the "SEC") on July 1, 2024, as amended, and declared effective on July 8, 2024. The shares may be offered only by means of a prospectus. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the public offering will be filed with the SEC and are available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement and accompanying prospectus relating to the public offering may also be obtained by contacting Maxim Group LLC, at 300 Park Avenue, 16th Floor, New York, NY 10022, Attention: Prospectus Department, or by telephone at (212) 895-3745 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On January 14, 2025 Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, reported that the US Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to commence a Phase I/II clinical trial (‘SANTANA-225’) of its proprietary radiolabelled peptide, 225Ac-SSO110, in patients with small cell lung cancer (SCLC) or Merkel Cell Carcinoma (MCC) (Press release, Ariceum Therapeutics, JAN 14, 2025, View Source [SID1234649698]).

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The SANTANA-225 trial is a global, open-label Phase I/II study, that will assess the safety, tolerability, preliminary efficacy and recommended Phase II dose of 225Ac-SSO110 in patients with extensive-stage SCLC or MCC who are on first-line maintenance therapy with checkpoint inhibitors. Ariceum is working with its partners and clinical sites in the US and other countries to commence recruitment of patients in Q1 2025.

Germo Gericke, Chief Medical Officer at Ariceum Therapeutics, said: "This is an important milestone, not only for Ariceum but for the whole field of targeted radionuclide cancer treatments. 225Ac-SSO110 is the first somatostatin receptor 2 (SSTR2) antagonist labelled with Actinium-225 to undergo human trials, providing the optimum combination of a long half-life α particle emitter with a long tumour retention tracer. Based on encouraging clinical data with 177Lu-SSO110 and very promising pre-clinical data of 225Ac-SSO110, we are very optimistic about the potential for patients with difficult to treat cancers."

225Ac-SSO110 is being developed together with its companion patient selection tracer 68Ga-SSO120 as a ‘theranostic pair’ targeted radionuclide treatment of multiple indications expressing SSTR2, such as SCLC, MCC, and other aggressive cancers. Ariceum has recently expanded its global supply agreements for the medical radionuclides Actinium-225 (225Ac) and Lutetium-177 (177Lu), which will be used to radiolabel SSO110.

On January 13, 2025 ImmuneOnco Biopharma reported that the Phase Ib/II clinical trial of its PD-L1xVEGF bispecific antibody IMM2510 combined with chemotherapy for the treatment of first-line non-small cell lung cancer (NSCLC) has completed the enrollment of its first patient (Press release, ImmuneOnco Biopharma, JAN 13, 2025, View Source [SID1234655707]). This marks another significant milestone in the rapid clinical advancement of IMM2510. Following a safety run-in, the Company plans to enroll first-line patients in the aforesaid clinical trial and anticipates releasing initial clinical data, including data from the first-line patients with NSCLC, as early as the second half of 2025.

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Results from the dose-escalation stage of the Phase I study of IMM2510 have demonstrated promising therapeutic signals: partial tumor response (PR) was observed in several patients with advanced solid tumors who had failed multiple lines of treatment. As of December 31, 2024, over 100 patients have been enrolled in the Phase I/II monotherapy clinical trials of IMM2510, showing good tolerability and encouraging initial tumor remission signals in multiple solid tumor indications (including NSCLC, triple-negative breast cancer, and soft tissue sarcoma) after repeated treatment failures. Currently, Phase Ib/II clinical trials are being actively developed in various solid tumor indications, exploring both monotherapy and combination treatment modalities.

Immune Onco is accelerating the development of IMM2510 for first-line NSCLC treatment in China, while also advancing the launch of the Phase Ib/Il project of IMM2510 combined with chemotherapy for first-line triple-negative breast cancer (TNBC). Based on the results of the Phase II clinical trial, ImmuneOnco and Instil Bio, Inc. are expected to initiate global clinical registration studies for IMM2510 combined with chemotherapy targeting first-line non- squamous and squamous NSCLC and/or first-line TNBC.

Dr. Tian Wenzhi, Founder and Chairman of ImmuneOnco, stated:
"We are delighted to announce that the Phase Ib/Il clinical trial of IMM2510 combined with chemotherapy for first-line NSCLC has successfully enrolled its first patient. This progress is not only a testament to our team’s hard work and commitment but also brings us one step closer to providing more effective treatment options for patients. IMM2510, as a bispecific antibody-receptor recombinant protein targeting PD-L1 and VEGF, has the potential to modulate the tumor microenvironment and significantly improve therapeutic outcomes. We will continue to advance research on the IMM2510 project to bring hope to cancer patients as soon as possible."

Dr. Lu Qiying, Chief Medical Officer and Senior Vice President of ImmuneOnco, commented:
"Today, we have reached a significant milestone with the successful enrollment of the first patient in the Phase Ib/II clinical trial of IMM2510 combined with chemotherapy for first-line NSCLC. In the Phase I clinical trial, tumor remission was observed in both squamous cell carcinoma and adenocarcinoma patients after repeated treatments with IMM2510 monotherapy, demonstrating a favorable response regardless of cancer subtype. This provided the rationale for advancing the development of IMM2510 combined with chemotherapy for newly diagnosed NSCLC. We are confident in IMM2510’s potential and look forward to its significant role in treating newly diagnosed NSCLC patients."

About IMM2510
IMM2510 is a bispecific antibody developed by ImmuneOnco’s proprietary "mAb- Trap" platform. It blocks the binding of PD-L1 to PD-1, relieving tumor immune evasion, and enhances immune response through Fc-mediated ADCC/ADCP, activating NK cells and macrophages for robust anti-tumor effects. Additionally, it inhibits VEGF/VEGFR signaling pathways, suppressing tumor angiogenesis, growth, and metastasis. Preclinical studies have demonstrated that IMM2510 achieves superior therapeutic outcomes compared to single-target or dual-target combination therapies, with a significant safety advantage. Its main indications include various advanced solid tumors.