Humanigen Inc (HGENQ)

[cowtown jay]

At last report, Humanigen had several sponsored clinical trials of lenzilumab in progress.

"The Company is developing lenzilumab in chronic myelomonocytic leukemia (“CMML”), a rare blood cancer, for which the Precision Approach to Chronic Myelomonocytic Leukemia (“PREACH-M”) study is underway, and is continuing its plans for the Risk Adapted Therapy in Acute GvHD (“RATinG”) study in acute graft versus host disease (“aGvHD”) that occurs in patients undergoing bone marrow transplant, as these studies are majority funded by its partners."

In addition, we have the following. Mayo Clinic, whose trial investigators led Humanigen's successful LIVE-AIR trial for the treatment of hospitalized and hypoxic covid patients, is also conducting an Investigator Initiated Trial..."of lenzilumab in combination with CAR-T therapies. We are also developing iFab, an EpAh-3 targeted monoclonal antibody, currently in Phase 1 development, as part of an antibody drug conjugate (“ADC”), for certain solid tumors."

see pg 14
https://www.sec.gov/ix?doc=/Archives/edgar/data/1293310/000121465923007002/hgen-20230331.htm

More on Mayo Clinic's CAR-T program can be found here, which includes a 7 minute video.

https://www.mayoclinic.org/departments-centers/car-t-cell-therapy-program/home/orc-20404317

None of the above is speculative. In addition, we know that the interim analysis of the PREACH-M trial showed outstanding results for CMML.

"The additional data demonstrate that in all 10 participants with at least three months of treatment with both lenzilumab and azacitidine, blood monocyte count decreased fivefold (P=0.03), the percentage of blast cells and pro-monocytes decreased more than twofold (P=0.04), and C-reactive protein decreased more than threefold (P=NS) with improvements noted after both 3 months and 6 months of this combination treatment. These results suggest lenzilumab may normalize hematologic and inflammatory aberrations in CMML and improve the condition of participants. All ten evaluable participants had a rapid clinical response."

https://ir.humanigen.com/English/news/news-details/2023/Humanigen-Presents-Promising-New-Hematologic-Data-from-PREACH-M-Trial-for-Chronic-Myelomonocytic-Leukemia-Treatment-at-the-2023-European-Hematology-Association-Congress/default.aspx

Also, Mayo Clinic's Dr. Zelalem Temesgen also led Humanigen's effort to establish CRP as a biomarker, to identify which covid patients would benefit the most by being treated with lenz. The Thorax peer review of those results confirmed the following. "Exploratory analysis for the effect of lenzilumab on SWOV was conducted by the CRP baseline quartile. Response to lenzilumab was observed in the first through third quartiles of baseline CRP with the greatest lenzilumab treatment effect observed in the first quartile (CRP <41 mg/L; HR: 8.20; 95% CI 1.74 to 38.69; p=0.0079)..."

https://thorax.bmj.com/content/78/6/606

Those are facts which should have forced regulatory authorization or approval. Instead, the FDA conducted a study of late-stage patients, beyond the treatment scope management intended, and failed to meet the primary endpoint in that trial, which the class action lawyers negligently used as the basis for their suit against the company.

Regardless, I am looking forward to seeing if lenz is being used by Novavax to enhance their covid vaccine. On October 15th of last year, the EU delayed approval of the vaccine. "The Financial Times, which first reported the news, said the EMA had questions on the potency of the vaccine's latest version, and that it is seeking to ensure its characteristics will be the same across different production sites."

https://www.reuters.com/business/healthcare-pharmaceuticals/eu-delays-approval-novavaxs-revised-covid-vaccine-ft-2023-10-15/

By the end of the month, the EU approved the vaccine.

"Novavax's Updated COVID-19 Vaccine Now Approved in the EU
October 31, 2023...

Approval was based on non-clinical data showing that Novavax's updated COVID-19 vaccine induced functional immune responses against XBB.1.5, XBB.1.16 and XBB.2.3 variants. Additional non-clinical data demonstrated that Novavax's vaccine induced neutralizing antibody responses to newly emerging subvariants BA.2.86, EG.5.1 FL.1.5.1 and XBB.1.16.6 as well as CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. These data indicate Novavax's vaccine can stimulate both arms of the immune system and may induce a broad response against circulating variants."

https://ir.novavax.com/press-releases/2023-10-31-Novavaxs-Updated-COVID-19-Vaccine-Now-Approved-in-the-EU

What better vaccine enhancement than lenz could have so quickly caused the 180 by the EU, for multiple variants, and imbued a T cell response with a high level of potency and dependable replication?

For that matter, will Mayo discover similar increases in lenziulmab's safety and efficacy in their ITT for CAR-T, as Gracell may have? And will Mayo, as well as Sanofi, find success in using Ifab as an antibody drug conjugate (ADC) in their cancer tumor treatment programs?

Humanigen has never been stronger than we are now, and we have never been closer to success. Incredible performance and execution by management.