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alphavestcapital.com

alphavestcapital.com

@alphavestcap

Jun 9

$nwbo @alphavestcap x.com/alphavestcap/status/20… x.com/andrewcaravello/status… x.com/d_stock07734/status/20… x.com/alphavestcap/status/20… @d_stock07734·May 14Show more$NWBO youtu.be/Bi-1iTknxL4?t=1364 I'm Mike Strand and I'm the CEO of ImmunoRestoration which is the company who has the exclusive global license for Dr. Czerniecki's cell therapy. We have been in the process of developing a pivotal trial as we speak which will be a 2B3 uh pivotalyoutube.comLive Q&A With Dr. Czerniecki, MD, PhDA live Q&A on breast cancer treatment with Dr. Brian Czerniecki, MD...Tommy Bax 🇬🇧 📷 📷@TomBaxers·May 14so this given does it transpire that NWBOs licence with Roswell does not in fact cover Dr. Czerniecki body of work after all?@d_stock07734@andrewcaravelloAndrew Caravello, DO@andrewcaravello·May 14Yes, it does cover.Tommy Bax 📷 📷 📷@TomBaxers·May 14How can ImmunoRestoration claim to have the exclusive global licence to his therapy then?Andrew Caravello, DO@andrewcaravello·May 14That was 2018, the Roswell patents are more recent and supercede.Andrew Caravello, DO@andrewcaravelloThe patent records resolve this cleanly. The Penn-era protocol that ImmunoRestoration licensed in November 2018 and the αDC1 chemistry that defines $NWBO platform are two distinct systems with separate IP estates. They are not parallel protocols. The αDC1 system was filed specifically to advance beyond the LPS method. ImmunoRestoration’s November 2018 license from the University of Pennsylvania covers Brian Czerniecki’s Penn-era DC1 work, which uses LPS plus IFN-gamma as the maturation stimulus, together with the IND BB-IND-11043. That is the chemistry. That is the protocol. That is the entire scope of the license. “Exclusive global” describes geographic reach, not property scope. A license can be exclusive worldwide and still only convey what the licensor owns. Czerniecki left the University of Pennsylvania in April 2016, joining Moffitt Cancer Center as Chair of Breast Oncology. The ImmunoRestoration license was executed in November 2018, two years after he had already left Penn. UPenn was licensing the work of a scientist who no longer worked there. Everything Czerniecki has invented since April 2016 belongs to Moffitt and his collaborating institutions, not to Penn. ImmunoRestoration licensed his Penn-era past, not his ongoing scientific output. The modern clinically active product is the αDC1 family. Its maturation cocktail is IFN-alpha, IFN-gamma, poly-I:C, IL-1-beta, and TNF-alpha. It does not use LPS. This chemistry was developed by Pawel Kalinski and traces back to a 2003 provisional, with foundational issued patents US 7,972,847 (granted 2011) and US 8,691,570 (granted 2014), both assigned to the University of Pittsburgh and exclusively licensed to NWBO. The αDC1 estate predates the November 2018 ImmunoRestoration license by 15 years. The αDC1 is a human cDC1. It is a type-1 polarized dendritic cell with enhanced IL-12p70 production and strong cross-presentation, which is the defining functional profile of human cDC1s. The Kalinski patents claim that product space directly. US 7,972,847 is titled “Mature type-1 polarized dendritic cells with enhanced IL-12 production and methods of serum-free production and use.” The patents cover the cells themselves and the methods of producing and using them, across the serum-free maturation space. The Kalinski patent explicitly identifies the LPS plus IFN-gamma protocol as prior art. US 7,972,847 lists “DC1-inducing protocols previously known in the art” with “maturation by LPS and IFNγ” as the comparator the αDC1 system was designed to surpass. The grant of the αDC1 patent over that prior art is the patent office’s confirmation that the αDC1 system is a patentable advancement on the LPS method. ImmunoRestoration’s exclusive license is therefore a license to acknowledged prior art. The ST-αDC1 refinement is US 12,059,434 B2, granted August 13, 2024, assigned to the University of Pittsburgh, and exclusively licensed to NWBO. The continuation US 2024/0342211 A1 establishes the operative claim scope. Independent claim 1 reads: “A method of treating a cancer in a subject comprising administering to the subject a therapeutically effective amount of one or more short-term activated alpha type 1-polarized dendritic (ST-αDC1) cells, wherein one or more immature DC cells are exposed to one or more of a type 1 interferon and one or more of a type 2 interferon for less than 16 hours, thereby resulting in the one or more ST-αDC1 cells.” This is a method-of-treatment claim. It reaches clinical administration of the cell product, not merely its manufacture. Both Kalinski and Czerniecki are named as co-inventors. Kalinski subsequently moved to Roswell Park Comprehensive Cancer Center. In June 2024, NWBO secured exclusive licenses to five additional patent families from Roswell Park, with filings spanning 2021 through 2024 and terms extending into the 2040s. Three are publicly confirmed in full patent text. WO2025096694A1, “Endogenous TGF-Beta Inhibited Dendritic Cells,” granted May 8, 2025, claims methods of treating cancer using TGF-beta inhibited DCs matured with the αDC1 cocktail (IL-1β, TNFα, IFNα, IFNγ, poly-I:C). US 2024/0299544 A1 covers αDC1 cells loaded with HER2/HER3 peptides combined with a chemokine-modulating regimen that induces CXCR3 and CCR5 expression on effector T cells. Czerniecki is a named co-inventor on US 2024/0299544 A1 alongside Kalinski. US 2024/0342211 A1 is the ST-αDC1 continuation discussed above. The institutional ownership structure across time is the resolving point. UPenn owns Czerniecki’s Penn-era LPS work, exclusively licensed to ImmunoRestoration in November 2018. Pittsburgh owns the Kalinski/Czerniecki ST-αDC1 patent, exclusively licensed to NWBO. Health Research Inc. (Roswell Park) and Moffitt jointly own the CKM/CXCR3 chemokine axis patent on which Czerniecki is also a named co-inventor, with the Roswell portion exclusively licensed to NWBO. Vaccinex and Moffitt jointly own US 12,201,719 B2, granted January 21, 2025, the combination patent requiring both a pulsed DC and a SEMA4D inhibitor. ImmunoRestoration’s “exclusive global license to Dr. Czerniecki’s therapy” is exclusive only to UPenn’s Penn-era slice. It does not include anything Czerniecki did after leaving UPenn. Czerniecki’s later inventive contributions sit at three other institutions, and the largest share of that later output is exclusively licensed to NWBO. $NWBO also controls the manufacturing layer. Flaskworks, a wholly owned NWBO subsidiary, holds four issued US patents on the EDEN closed perfusion manufacturing system, including US 12,297,412 B2, granted May 13, 2025. The Moffitt trial NCT05378464 that produced the 63.6 percent pathological complete response in trastuzumab-refractory metastatic HER2-positive breast cancer uses the αDC1 chemistry, not the Penn-era LPS protocol. The maturation culture is the five-component serum-free cocktail confirmed in WO2025096694A1. This is NWBO-licensed chemistry. The clinical data ImmunoRestoration would want to leverage was generated using technology it does not have rights to use. ImmunoRestoration retains the right to manufacture the obsolete LPS-based Penn-era protocol under its UPenn license, with whatever non-EDEN manufacturing platform it chooses. It has no rights to the αDC1 chemistry, the ST-αDC1 cell product (where the operative claim is method-of-treatment), the Roswell Park families covering the chemokine axis and TGF-beta resistance, the EDEN manufacturing system, or the Moffitt/Vaccinex combination framework with SEMA4D blockade. Different chemistries. Different patent lineages. Different licensees. Different institutions over time. The αDC1 family is not UPenn IP and never was, so UPenn could not have licensed it to anyone in 2018 or at any other time. NWBO controls the modern human cDC1 platform. ImmunoRestoration’s claim to hold an “exclusive global license to Dr. Czerniecki’s therapy” is a marketing description, not a legal boundary. Under US patent law, patent ownership belongs to the institution where an invention is conceived, not to the inventor personally. Czerniecki the scientist is not a licensable asset. UPenn licensed its own patents, the ones generated during his Penn employment, and nothing beyond them. His post-2016 inventive output at Moffitt, Pittsburgh, and Roswell Park is owned by those institutions and, through the exclusive licenses NWBO holds, sits within NWBO’s platform. The exclusive global license covers a former employer’s patents. It does not follow the man. The 2018 ImmunoRestoration license has no bearing on it. x.com/alphavestcap/status/20…

alphavestcapital.com

@alphavestcap

Jun 8

$nwbo @alphavestcap @ATLnsider x.com/alphavestcap/status/20… "Brief Summary This trial proposes to evaluate the immunologic and potential clinical effectiveness of intensive locoregional sequential intraperitoneal (IP) cisplatin (IPC) with intravenous (iv) paclitaxel followed by peritoneal infusion of a chemokine modulatory (CKM) regimen composed of a cocktail of IP rintatolimod and interferon-alpha (IFNα) for patients with advanced stage ovarian cancer (III-IV) in the primary neoadjuvant setting. It was previously determined the tolerable dose of IPC-CKM. This study will add intradermal (ID) autologous αDC1 vaccines (known to be nontoxic) to the tolerable IPC-CKM regimen and systemic Keytruda (pembrolizumab). To optimize the pattern of immunity, all patients will also receive oral celecoxib (COX2 inhibitor)." x.com/alphavestcap/status/20… x.com/d_stock07734/status/20…

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