BioNTech SE (BNTX) Options

Autogene cevumeran with or without atezolizumab in advanced solid tumors: a phase 1 trial https://www.nature.com/articles/s41591-024-03334-7

A new paper. From it: ''BNT221 was well tolerated across both DLs, with no dose-limiting toxicities of grade 3 or higher attributed to the T cell product observed. Specifically, no cytokine release, immune effector cell-associated neurotoxicity or macrophage activation syndromes were reported. A dose of 5.0?×?108–1.0?×?1010 cells was identified for further study conduct. Six patients showed stable disease as best overall response, and tumor reductions (=20%) were reported for four of these patients.'' https://www.nature.com/articles/s41591-024-03418-4

This is what you’re up against largest sector


https://www.barchart.com/stocks/quotes/ADMA/competitors?quoteSectors=-MEBI&viewName=main&orderBy=weightedAlpha&orderDir=desc&page=5

We will know in the fullness of time

Ouch 1.2bn in settlements over covid19 vaccine royalties - will MRNA be affected too?

How it started: https://www.reuters.com/legal/litigation/biontech-sued-by-upenn-over-covid-19-vaccine-patent-royalties-2024-08-06/
https://www.fiercepharma.com/pharma/biontech-hit-notice-default-nih-tied-covid-19-vaccine-royalty-dispute

How it ended:
https://www.reuters.com/business/healthcare-pharmaceuticals/biontech-enters-settlement-with-us-agency-upenn-over-covid-vaccine-royalties-2024-12-27

Duality Biologics and BioNTech Presented Positive Interim Data for Investigational B7-H3 Antibody-Drug Conjugate BNT324/DB-1311 in Advanced Solid Tumors at the ESMO Asia Congress 2024

https://quantisnow.com/insight/duality-biologics-and-biontech-presented-positive-interim-data-for-investigational-b7h3-antibodydrug-conjugate-bnt324db1311-5802791

BNTX 10Q 11/4

BNTX under $200;

First-ever mRNA vaccine halts pancreatic cancer in its tracks

https://www.thebrighterside.news/post/first-ever-mrna-vaccine-halts-pancreatic-cancer-in-its-tracks/

BNTX new 52;week high

BNTX +11% on no company-specific news I’m aware of. The 11% gain in the BNTX’s share price and market cap equates to a roughly 40%(!) increase in BNTX’s enterprise value because the BNTX has a whopping $17B in net cash.

p.s. The impetus for today’s bounce is definitely not related to COVID.

BNTX reports 2Q24 results—opts_out_of acasunlimab phase-3 development:

https://www.globenewswire.com/news-release/2024/08/05/2924129/0/en/BioNTech-Announces-Second-Quarter-2024-Financial-Results-and-Corporate-Update.html

https://www.globenewswire.com/news-release/2024/08/05/2924128/0/en/Genmab-Takes-Full-Control-of-Acasunlimab-Development-Program.html

BNTX 10Q due AUGUST5

BNTX under $100

FDA places partial hold on ADC trial after multiple deaths https://www.biospace.com/article/fda-slaps-biontech-medilink-adc-with-partial-clinical-hold-due-to-significant-risk-of-illness-/

Medigene & BioNTech Extend T Cell Receptor Immunotherapy Collaboration https://www.contractpharma.com/contents/view_breaking-news/2024-05-21/medigene-biontech-extend-t-cell-receptor-immunotherapy-collaboration/

MRNA wins patent dispute over PFE and BNTX https://www.fiercepharma.com/pharma/eu-patent-office-backing-key-patent-moderna-wins-one-battle-covid-patent-war-against-pfizer

For_some_reason, COVID-related stocks_are_up_today:

MRNA +11%
BNTX +9%
NVAX +8%
AVIR +5%
PFE +3%

BNTX ASCO lineup:

https://www.globenewswire.com/news-release/2024/05/21/2885408/0/en/BioNTech-to-Present-Clinical-Data-Updates-for-Next-Generation-Immunotherapy-Candidates-at-the-ASCO-Annual-Meeting-2024.html

BNTX reports 1Q24 results—reiterates 2024 sales guidance:

https://finance.yahoo.com/news/biontech-announces-first-quarter-2024-104500069.html

2024 sales guidance remains $2.7-3.7B (€2.5-3.5B). Echoing partner PFE, BNTX says ~90% of 2024 COVID-vaccine revenue will come in 4Q24.

Cash at 3/31/24 was $18.2B, down $1.0B relative to 12/31/23.

Might be a buy again someday

This biotechnology company has nearly 90% of its market value in cash and investments.

BNTX—Updated 2024 revenue guidance=€2.5-3.1B—($2.7-3.3B):

https://finance.yahoo.com/news/biontech-announces-fourth-quarter-full-101500625.html

The prior 2024 guidance had been €3B.

Cash at 12/31/23 was €17.7B ($19.2B)

BNTX slide set from JPM webcast:

https://investors.biontech.de/system/files-encrypted/nasdaq_kms/assets/2024/01/10/13-16-03/JPM%202024%20Presentation_Ugur_FINAL.pdf

BNTX’s 2024 clinical and financial goals:

https://finance.yahoo.com/news/biontech-outlines-2024-strategic-priorities-114500463.html

Wow

The prior treatment can decide the outcome of single agent efficacy. In the case of ICE, high PD-L1 due to chemo(24) or battered innate cells by ADC aggregates(13). 2 agents combo doesn't guarantee higher afficacy as shown by PDL1 + chemos

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8837541/

I view ICE+PD-L1 as jockey and horse. You need Pd-L1 to upregulate cancer cell necrosis genes, block the IC on M, NK, T. ICE is the jockey that direct and activates the NK, M to the weakened cancer cells to make the kill. Turning the trojan horse into CARNK, CARM without CRISPR, IPSC etc..

Drugs or therapies with no single-agent activity rarely, if ever improve outcomes in (randomised and controlled) trials when used in combination.

These cell therapies need ATEZO to block the PD-L1 exosomes. Drones are used by cancer to promote mets and suppress lymphocytes.

I found some slides on Twitter. Although there was some evidence of tumour shrinkage, (like the abstract said) there were no responses. On top of that, manufacturing time is around four months. So far, it looks like its purchase of Neon turned out to be a waste of money. It's ''lucky'' only $67 million was paid. They should go back to the drawing board.

Data worse than GNCA cell therapy results.

The ESMO abstract

1017O - NTC-001: A phase I study to test safety and efficacy of BNT221, a non-engineered neoantigen-specific T cell product, in patients with advanced or metastatic melanoma

Background
Neoantigens are tumor-specific antigens derived from somatic mutations and have been shown to elicit antitumor immune responses. The interim results of a phase I study (NCT04625205) testing a personalized, non-engineered, neoantigen-specific T cell product (BNT221) targeting multiple neoantigens are presented.

Methods
Nine patients with checkpoint- and, if applicable, BRAFi-resistant metastatic melanoma were treated with BNT221. Up to sixty immunogenic MHCI- and MHCII-restricted neoantigens were selected using our RECON® bioinformatics platform and used in an ex vivo induction process (NEO-STIM™) to prime, activate and expand memory and de novo T-cell responses from both the CD4+ and the CD8+ T cell compartment, using PBMCs collected via leukapheresis. Two BNT221 doses (≥ 1 × 108 cells to ≤ 1 × 109 cells and >2 × 109 cells to ≤ 1 × 1010 cells) were evaluated in a 3+3 escalation design, with primary (safety and determination of highest tolerable dose), secondary (efficacy, per RESIST 1.1) and exploratory endpoints. Patients were treated with lymphodepleting chemotherapy prior to infusion. Peripheral blood and biopsies were collected for immune monitoring.

Results
BNT221 was well-tolerated. No dose-limiting toxicities were observed, with grade 3-4 toxicities post infusion limited to hematologic toxicities from lymphodepletion. Seven patients showed stable disease as best overall response (12-36+ weeks). Of those, two patients showed tumor reductions at cutaneous and visceral disease sites and reported quality of life improvements. For all patients, drug products were generated with multiple neoantigen specific CD8+ and CD4+ T cell responses, also detected up to 6 weeks post infusion. Evidence of tumor infiltration was observed through TCR sequencing analysis in one patient tested.

Conclusions
In this first in human study, BNT221 as a single infusion therapy demonstrated a tolerable safety profile, product persistence, prolonged stable disease, and tumor regressions in patients with checkpoint inhibitor-resistant metastatic melanoma. Additional study is warranted and BNT221 combination with anti-PD-1 is currently underway.

https://insiderfinancial.com/the-next-axcella-axla-squeeze-bioxytran-bixt/184558/

has anyone here heard enzolytics pharm announced yesterday that they now have a CURE for hiv/aids called clone3.?

Tomorrow is a great Day !

A Old Star —> Rallye!

Q2 results https://finance.yahoo.com/news/biontech-announces-second-quarter-2023-100000124.html

Presentation https://investors.biontech.de/static-files/f8876fe3-b151-4f6e-83e6-b8e93130a863

Call https://seekingalpha.com/article/4624988-biontech-se-bntx-q2-2023-earnings-call-transcript

The PhII is now open https://classic.clinicaltrials.gov/ct2/show/NCT05968326

Not a huge surprise https://www.fiercebiotech.com/biotech/sanofi-biontech-cull-mrna-clinical-cytokine-cancer-candidate-based-early-data

CVAC ups_the_ante_in COVID-vaccine patent suits_against PFE/BNTX:

https://www.accesswire.com/viewarticle.aspx?id=767607&lang=en

The market appears to be skeptical of CVAC’s litigation prospects in either Germany or the US. Background info from the above PR: CureVac filed a patent infringement lawsuit in Germany against BioNTech in early June 2022. A first public hearing on this lawsuit will take place on August 15, 2023, before the Regional Court Düsseldorf. A nullity action covering one of the patents at issue (EP1857122B1) was filed by Pfizer/BioNTech in September 2022. A preliminary opinion issued in April 2023 by the German Federal Patent Court supports the validity of the CureVac patent.

In the U.S., Pfizer/BioNTech filed its case in late July 2022, asking for confirmation that Comirnaty does not infringe three CureVac patents. These patents are included in the ten U.S. patents of CureVac's counter¬claim: 11,135,312; 11,149,278; 11,286,492; 11,345,920; 10,760,070; 11,241,493; 11,471,525; 11,576,966; 11,596,686 and 11,667,910.

BioNTech SE $BNTX Total Debt (mrq) $209.8M

PFE/BNTX, EU come_to_terms_on COVID-vaccine orders:

https://finance.yahoo.com/news/2-eu-pfizer-biontech-announce-084015609.html The European Union and drugmakers Pfizer and BioNTech said on Friday they had reached a deal to amend a COVID-19 vaccine contract, cutting the number the EU must buy and pushing the delivery deadline to 2026.

…a source with knowledge of the negotiations told Reuters that the contract change cuts by about a third the number of those remaining doses the EU is on the hook to buy [i.e. a reduction of ~300M doses].

…The EU member states will have to pay a fee for each cancelled dose, the source said, while declining to say what the fee would be. The companies and the Commission also declined to comment on this.

The amended contract specifies that the EU will continue to have access to vaccines adapted to new variants as soon as they are authorised by regulators.

A follow-up global randomised trial is imminent. Also, the estimated primary (disease-free survival) completion date of a PhII testing RO7198457 (versus watchful waiting in patients with ctDNA+, resected Stage II (high-risk) and Stage III CRC) is Sept this year.

New paper https://www.nature.com/articles/s41586-023-06063-y

https://www.nytimes.com/2023/05/10/health/pancreatic-cancer-vaccine-mrna.html

BNTX authorizes $500M share buyback for_remainder_of_2023:

https://www.globenewswire.com/news-release/2023/03/28/2635491/0/en/BioNTech-Announces-New-ADS-Repurchase-Program.html

BNTX still has an EV of ~$18B, but the share price is down about 75% from its pandemic peak in mid 2021.

Good article (eom).

https://www.fiercebiotech.com/biotech/bristol-myers-cmo-still-skeptical-about-cancer-vaccine-biontech-moderna-march-ahead-i-o

Data from the ongoing PhI/II in patients with advanced solid tumours were presented at SITC in 2022 [1] and 2021, where it showed clinical activity, either as a single agent or in combination with Keytruda, particularly in those who progressed on prior checkpoint blockade.

ONC-392 received Fast Track designation from the FDA as a monotherapy for immunotherapy-resistant NSCLC. The data as a monotherapy for anti-PD-1 resistant NSCLC supports the initiation of a randomised PhIII trial which will evaluate ONC-392 as monotherapy against the current SOC (docetaxel) in that that could open in the next few months. Also, it is currently also being evaluated in an additional PhII trial as a combination therapy with Keytruda in platinum-resistant ovarian.

Refs:
1 https://www.globenewswire.com/news-release/2022/11/07/2549654/0/en/OncoC4-to-Present-Positive-Data-from-Ongoing-Phase-1-2-PRESERVE-001-Trial-of-ONC-392-in-Combination-with-pembrolizumab-at-SITC-2022.html
2 https://www.globenewswire.com/en/news-release/2021/11/09/2330344/0/en/OncoC4-Inc-Reports-Phase-Ia-Data-on-Safety-and-Clinical-Activities-of-ONC-392-Nextgen-Anti-CTLA-4-Monotherapy-for-Stage-IV-Solid-Tumors.html

The company announces an exclusive license and collaboration agreement with OncoC4 on Monday to jointly develop and commercialise the latter's, ONC-392. ONC-392 is an anti-CTLA-4 mAb candidate. Under the partnership, BNTX and OncoC4 will equally share the costs to develop it as monotherapy and in combination with anti-PD-(L)-1 mAbs for multiple solid tumours.

Per the terms, OncoC4 will receive $200M upfront in addition to future payments linked to development, regulatory and commercial milestones, and double-digit tiered royalties.