Humanigen Inc (HGENQ)

[cowtown jay]

Taking a look at Humanigen's latest discussion regarding the nature of our business, we see the following.

"1. Nature of Operations...

The Company’s lead product candidate, lenzilumab, or LENZ®, and its other product candidate, ifabotuzumab (“iFab”), are Humaneered monoclonal antibodies. The Company’s Humaneered antibodies are closer to human antibodies than chimeric or conventionally humanized antibodies and have a high affinity for their target. In addition, the Company believes its Humaneered antibodies offer further important advantages, such as high potency, a slow off-rate and a lower likelihood to induce an inappropriate immune response or infusion related reactions.

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 April 2023, the Company announced that as of December 31, 2022, eleven subjects had been dosed with lenzilumab and with current standard of care, azacytidine, in the PREACH-M study. Six subjects were evaluable based on at least three months of follow-up, including those with high risk CMML, and all demonstrated clinical benefit. In addition, LENZ appeared to be well-tolerated. The Company anticipates the first patient dosing in the RATinG study to occur in the second quarter of 2023. A leading network of centers, The Mayo Clinics, is currently progressing with an investigator-initiated trial (“IIT”) of lenzilumab in combination with CAR-T therapies."

see pg.8
https://www.sec.gov/ix?doc=/Archives/edgar/data/1293310/000121465923007002/hgen-20230331.htm

Approval to treat CMML was a target objective that, "I don't see how we could: Miss getting an expedited approval to treat CMML from the Australian government, complete with a possible $100M+ Priority Review Voucher..."

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172877542

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173383975

Results of that effort were presented at the latest ASH conference.

"All patients (5/5) in INNATE-1 showed 100% response (CR or optimal marrow response resulting in <5% blasts) to AZA/LENZ. Two subjects (2/6) in INNATE-2 demonstrated partial responses or haematological improvement thus far.

Conclusion: CMML is a disorder of profound innate immune activation, driven by GM-CSF and other pro-inflammatory cytokines. Early treatment with LENZ/AZA, a precision immunotherapeutic approach, leads to a) efficacy in INNATE-1 that exceeds historical CR rates for hypomethylating agents1,2; and b) evolving efficacy in INNATE-2, in which pro-inflammatory activity is more robust."

https://ash.confex.com/ash/2023/webprogram/Paper179706.html

This tendency for lenz to perform so well in the early stage of disease progression, when cytokine levels are lower, was also exhibited in the ACTIV-5 trial compared to the LIVE-AIR trial, in my opinion. I also believe that it is accurate to say that lenz, for this indication, could prove to be a preventative, versus just a therapeutic, since CMML is myeloid-driven, and lenz modulates the production of those myeloid cells.

Acute Graft versus Host Disease (aGvHD) was also detailed in Humanigen's10-K as a developmental treatment target, and was included in my list of catalysts and was a target that I did not think we could miss. The first patient patient was dosed in the on-going RATinG study (Risk Adapted Therapy in Acute GvHD) as the company announced in August.

https://ir.humanigen.com/English/news/news-details/2023/Humanigen-Announces-First-Participant-Dosed-in-RATinG-Trial-of-Lenzilumab-for-Early-Treatment-of-Acute-Graft-Versus-Host-Disease-Following-Allogeneic-Stem-Cell-Transplantation/default.aspx#:~:text=The%20RATinG%20trial%2C%20a%20Phase,stem%20cell%20transplant%20(HSCT).

In addition to the PREACH-M and RATinG studies Humanigen disclosed were in development, and which I included as target objectives in our list of catalysts, the company also noted Mayo Clinic was conducting an Investigator Initiated Trial (IIT) of the use of lenz in CAR-T therapy. In addition, we see Gracell also conducting an IIT in the US for their CAR-T platform. And we see label updates for Gilead/Kite's yescarta and tecartus. Together, these CAR-T developments before and following the ASH conference could suggest a critical role for lenz in CAR-T.

https://www.sec.gov/Archives/edgar/data/1826492/000110465923126860/tm2332578d1_ex99-1.htm

I could go on and talk about lenz for covid, or about lenz and ifab as ADC's, but the point of the post was to look at what Humanigen stated were the projects they were working on, and how that progress seems to have progressed.

What I would most like to see for Christmas, or in the week following, is Humanigen's announcement of the recall of their loaned shares, coupled with some news in regards to either regulatory approval, or a business combination or partnerships.