Dr. Durrant Was On Tucker Carlson’s Odious Fox Show, Tonight — Sandwiched Between Lunatic Segments…

But I watched it all, and felt he handled the short interview quite well.

Afterall, he was dumbing it down — for the relatively “science impaired” Tucker, and his audience — whom, reliable research indicates, tend to be less educated than the average American, by over four years. [Proportionately more of Carlson’s audience never went to college, than any other nightly information program’s average audience, per 2017 Nielsen demographics.]

So, Cameron spoke in very easy (if overly simple) metaphors. But he clearly conveyed the sense that lenz- is showing remarkable (if preliminary) results, in up to 80 per cent of hospitalized cases — at ending the cytokine storm.

That in turn reduces lung inflammation, and that in turn improves… breathing.

Which — in many cases, allows the COVID-19 patient to leave the hospital altogether.

So — given that his slot was between pre-booked Carlson “village idiot” guests… he did quite well.

Quite well, indeed.

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More Positives, For Humanigen’s Lenz-Program: Now In Study With Gilead’s Leading Remdesivir, On Covid-19 Therapies…

Again, the study is just getting underway, but this is a very important validation — that Gilead, and its admittedly leading Remdesivir program for COVID-19 therapies… is being jointly trialed with Humanigen’s Lenz-… it must be very gratifying for Dr. Durrant and his team.

One bad result, and the whole circus will have to fold its tents, and hop a train out of town — but for now, they are playing… Madison Square Garden. And the shows are… sold out.

In truth, quite a nice karmic turnaround, from Martin Shkreli’s long-ago debauchery (of its former entity’s life science programs, on unrelated agents). Here’s the bit, tonight:

“…Humanigen… trading for 46 cents per share as recently as mid-March, announced Monday afternoon that its lenzilumab will be tested in combination with remdesivir in NIAID’s Big Effect Trial, effectively categorizing it as a high-priority Covid-19 therapeutic candidate….”

Some times, the good guys do indeed win out — eventually. And this may be one of those stories.

Do stay tuned.


June 2020: Humanigen Brings In $72 Million In A Private Placement — And Has More (Smallish) Nice Lenz- Results… At ~$5.30/Share…

And that’s up from $0.34/share as recently as December of 2019…

So — still early, and only 12 very ill patients seen, but they all made remarkable improvements.

Here’s the early June 2020 JP Morgan capital raise — giving them quite a bit of new runway.

Perhaps childishly, I am smiling, because… it will really bug old Martin Shkreli that this company actually now has a real drug — to be sensibly priced, of course — and a real on-ramp to big returns — all while saving human lives (doing well, by doing… good), in otherwise desperate situations.

And… the shares are now well above the level at which the bankruptcy court forced Martin to sell his stake.

That’s what hurts him… the most.

Congrats, to Dr. Durrant and his fine team!

Onward, grinning….

Friday — Smiling — UPDATE: FDA “Compassionate Use” Authorization Now Granted…

Do See this press release, as of April 2, 2020.

Well… that was quick.

Gratifying, too… see this:

…Ultra-thinly traded micro cap Humanigen (OTCQB:HGEN +156%) rockets up on a 16x surge in volume, a scant 67K shares, in response to its proposed plan to conduct a Phase 3 clinical trial evaluating lead drug lenzilumab for the prevention and treatment of cytokine storm (potentially life-threatening out-of-control immune response) that could lead to acute respiratory distress syndrome associated with SARS-CoV-2 infection, the coronavirus responsible for the COVID-19 outbreak….

Lenzilumab is a monoclonal antibody that neutralizes (binds to) a pro-inflammatory protein called granulocyte-macrophage colony stimulating factor (GM-CSF) that is over-expressed in COVID-19 patients. The company is developing it for the potential treatment of CART-T toxicity, graft versus host disease, certain blood cancers and eosinophilic asthma….

Yep — it may all not ultimately pan out, but I am grinning, this afternoon. Onward.


From Our Other Properties…

Here it is — yet another post scriptum:

In 2016, Dr. Cameron Durrant [As The Polar Opposite Of Martin] Took Over At KaloBios — Now Called Humanigen…

…And Dr. Durrant may well (if rather suddenly) have on his deft hands… a viable COVID-19 “radical intervention” treatment candidate — for the wracking lung destruction the most severe form of the viral infection occassionally inflicts.

[What a sweet irony it would work, should all of this play out in the favor of those investors burned by Martin, since long ago he was required to divest all his holdings in what became Humanigen. But back to the story, proper, then:]

One of the programs Dr. Durrant has pursued since the company was freed of Martin via a bankruptcy reorganization, involved… Lenzilumab.

Here is a bit from the top of page 78 of the just filed Humanigen SEC Form 10-K, related to the at least animal model studies of Lenzilumab:

“…Recent data from China and the subject of a pre-publication titled “Aberrant pathogenic GM-CSF+ T cells and inflammatory CD14+CD16+ monocytes in severe pulmonary syndrome patients of a new coronavirus”, supports the hypothesis that cytokine storm-induced immune mechanisms have contributed to patient mortality with the current pandemic strain of coronavirus.

The severe clinical features associated with some COVID-19 infections result from an inflammation-induced lung injury requiring Intensive Care Unit (ICU) care and mechanical ventilation. This lung injury is a result of a cytokine storm resulting from a hyper-reactive immune response. The lung injury that leads to death is not directly related to the virus, but appears to be a result of a hyper-reactive immune response to the virus triggering a cytokine storm that can continue even after viral titers begin to fall.

The authors of the study assessed samples from patients with severe pneumonia resulting from COVID-19 infection to identify whether inflammatory factors such as GM-CSF, G-CSF, IL-6, MCP-1, MIP 1 alpha, IFN-gamma and TNF-alpha were implicated.

The authors noted that steroid treatment in such cases has been disappointing in terms of outcome, but suggested that a monoclonal antibody that targets GM-CSF may prevent or curb the hyper-active immune response caused by COVID-19 in this setting. Humanigen believes that the authors’ findings are worthy of further investigation, suggesting that to reduce or eradicate ICU care and prevent deaths from COVID-19 infection, an intervention may be needed to prevent cytokine storm.

Separate publications confirm that cytokine storm is characterized by surge of high levels of circulating inflammatory cytokines, and is an overreaction of the immune system under the conditions, such as CAR-T therapy and patients infected with SARS-CoV-2. These recent studies revealed that high levels of GM-CSF, along with a few other cytokines, are critically associated with severe clinical complications in COVID-19 patients. High concentration of GM-CSF was found in the plasma of severe and critically ill patients, which account for approximately 20% of all patients, especially in those requiring intensive care.

Lenzilumab has been shown to prevent cytokine storm in animal models and this work has been published in peer reviewed journals. Patients are expected to be enrolled soon in a clinical study to determine lenzilumab’s effect on cytokine storm associated with the hyper-active immune response associated with CAR-T therapy, in collaboration with Kite Pharma….”

Clearly, these are only early green shoots — but promising, just the same.

And no matter how the Lenz- program turns out, I am abidingly convinced Martin didn’t really spend his talent very wisely, or well — in the first half of his life.

Even so, I’ll remain hopeful that was “the life he learned with“… and, now [starting in 2024] — perhaps he may yet do something wonderful with the “life after” — his now hard-learned BoP lessons…. just maybe.

Onward — smiling. Ever… smiling.

Post Scriptum: Huzzah! Ronald Informs Us… Daraprim Is Now FDA Approved As A Generic; Cerovene To Begin Sales IMMEDIATELY…

Well, this is great news for toxoplasmosis sufferers.

And it likely is the end of Phoenixus’ minimally remainining business model, in the US.

As commenter “Ron” so helpfully alerts us, over on the Shkreli site — the US FDA just approved the first generic version of… Daraprim. It will be sold by a company out of India, called Cerovene. I post here, since Martin had from time to time, with different investors, suggested Daroprim might become a pre-reorganization KaloBios asset. What a tangled web he wove….

Now about four years later — time to buckle up, Martin — whatever Turing / Vyera / Phoenixus private company shares you are still holding…

They just became… so much birdcage / wastebin lining material.

Grin. Not entirely, in truth — but it is nice… karma, for Martin, to be certain.


Humanigen Exploring A Reg. A+ Rights Offering — Just Testing The Waters. No Indicated Terms Yet.

On the heels of extending the maturity date of the company’s bridge loans to year end 2019, the company is now testing the waters for a Reg. A+ short form registered offering of shares, via a rights package to existing holders, at a price as yet undetermined. Specifically, the company says it is “contemplating conducting a broadly syndicated rights offering…[precise terms TBD].”

The presser is here; and that prior link above is the maturity extender, filed with the SEC on October 8.

“…Humanigen plans to “test the waters” to gauge market demand for its proposed Regulation A+ rights offering prior to filing the Offering Statement with the SEC. No money or other consideration is being solicited at this time, and if sent in response, will not be accepted. No offer to buy the Shares or other securities can be accepted and no part of the purchase price can be received until the Offering Statement is filed with the SEC and qualified, and any such offer may be withdrawn or revoked, without obligation or commitment of any kind, at any time before notice of its acceptance given after the qualification date of the Offering Statement. Any person’s indication of interest regarding the Shares or this press release involves no obligation or commitment of any kind….”

Now you know. I foresee at least one more maturity extender, on the bridge, before this all gets placed.

Possibly out to February 2020. We shall see. [I had a spike in traffic this morning, here — and noticed that it is likely due to the above events being announced, but not yet SEC filed. That should come by an SEC Form 8-K — in two days. Onward.]

A Strong Science-Based Validation, Of The “New” Humanigen Team…

A very kind anonymous commenter pointed us to this Gilead / Kite / Stifel Nicolaus item.

I must say, this is precisely the sort of company one would hope to see people as fine as Dr. Durrant… keeping. [Long gone is the sordid past usurper.]

Here is the latest — in a continuing rebirth of a fine research based life science company:

Kite, a Gilead Company (Nasdaq: GILD) and Humanigen, Inc., (HGEN) announced today the formation of a clinical collaboration to conduct a Phase 1/2 study of lenzilumab, an investigational anti-GM-CSF monoclonal antibody, with Yescarta® (axicabtagene ciloleucel) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The objective of this study is to determine the effect of lenzilumab on the safety of Yescarta. Kite will act as the sponsor of this study and will be responsible for its conduct.

GM-CSF has been identified, through clinical correlative analysis and preclinical modeling, as a potential key signal in the inflammatory cascade triggering toxicities associated with chimeric antigen receptor T (CAR T) cell therapy.1 Toxicities associated with CAR T therapy include neurologic toxicity and cytokine release syndrome (CRS). Emerging pre-clinical evidence suggests that lenzilumab inhibition of GM-CSF may have the potential to disrupt CAR T cell mediated inflammation without disrupting CAR T cell anti-tumor efficacy.

“CAR T therapy represents a significant advance in the way relapsed or refractory large B-cell lymphoma is treated,” said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research and Development, Gilead. “As leaders in cell therapy, we are committed to pursuing a number of clinical and preclinical strategies aimed at further improving the efficacy and safety of CAR T therapy. We look forward to this clinical collaboration with Humanigen and to evaluating the combination of lenzilumab and Yescarta in our clinical trial….”

“Humanigen has pioneered the approach to neutralizing GM-CSF to improve CAR T,” said Cameron Durrant, MD, Chief Executive Officer, Humanigen. “This collaboration with Kite will help validate the work Humanigen has done in understanding the pathophysiology of the inflammatory cascade as well as the potential role GM-CSF plays in influencing CAR T cell treatment outcomes….”

Stifel, Nicolaus & Company, Incorporated acted as exclusive financial advisor to Humanigen in this transaction….

[Long gone is the felon who shall not be named — thank the goddesses. It is so gratifying to see him flailing — mostly helplessly, from jail (filing loony-bin suits against the people… he stole from)… while this fine reborn company makes scientific strides, and perhaps… history.]

Mountain biking, by the lake — after hot coffee (cream and sugar, please!), OJ, a banana, and a bunch of bright Michigan cherries, now. Grin.


Out Of The Mists — For A Moment Only — To Mention A New Convert Financing: $1.3 Million….

Been a bit, but I appear, just to complete the record (and remember the first image, in August, seven years ago).

Here is a link to the full SEC Form 8-K, filed overnight — and a bit of it:

“…$1.3 million of loans made to the Company by an investor group led by Soundview Capital Partners LP.

The Notes bear interest at a rate of 7.5% per annum and will mature on the earliest of (i) twenty-four months from the date the Notes are signed (the “Stated Maturity Date”), (ii) the occurrence of any customary event of default, or (iii) the certain liquidation events including any dissolution or winding up of the Company or merger or sale by the Company of all or substantially all of its assets (in any case, a “Liquidation Event”). The Company plans to use the proceeds from the Notes for working capital.

The Notes are convertible into equity securities in the Company in four different scenarios….”

See the full SEC Form 8-K, for those scenarios. Onward, and best of luck to Dr. Durant, and his entire team!

Early 2019: Good News Post Scriptum | Brain Cancer Pipeline Possibilities…

Yes… it is only in a mouse model study, but it is encouraging, as this fine new management team truly leaves Shkreli more and more as… some ancient (largely irrelevant) history.

Here’s the full release — I am a week late on it, but here you go:

“…The research, led by Professors Bryan Day and Andrew Boyd from the Department of Cell and Molecular Biology, QIMR Berghofer Medical Research Institute in Brisbane, Australia, used an anti-EphA3 antibody (IIIA4) which is the murine predecessor of the company’s Humaneered® ifabotuzumab. The research assessed the efficacy of the antibody drug conjugate (ADC) and a radioimmunotherapy (RIT) conjugate using orthotopic human GBM xenograft tumors in NOD/SCID mice. Positron emission tomography/computed tomography (PET/CT) imaging, showed that the anti-EphA3 antibody is effectively delivered across the blood-tumor barrier and accumulates specifically at the tumor site with no observed normal brain tissue uptake. Anti-tumor activity was observed in this immunocompromized mouse model, using an ADC comprising the cytotoxic drug maytansine or an RIT comprising the radioisotope Lutetium-177. Significant increases in overall survival (p=0.0007, n=6 for the ADC, p=0.0329, n=6 for the RIT) were observed for both types of conjugates.

Critically, the researchers showed previously that EphA3 is expressed most highly on glioma stem cells (GSCs), where EphA3 has a functional role in survival and self-renewal. In GBM, EphA3 expression has been shown to be significantly elevated in recurrent versus treatment-naïve disease. EphA3 has also been shown to be over-expressed in a number of human solid tumors. EphA3 antibody targeting has been shown to inhibit tumor growth by disrupting newly formed tumor microvasculature (neovasculature).

Brain cancer sufferers have not seen meaningful increases in overall survival for decades,” stated Dr. Cameron Durrant, Chief Executive Officer of Humanigen. “By targeting the tumor stem cells, stromal cells and neovasculature, we believe ifabotuzumab has the potential to emerge as a next-generation oncology therapy.” A phase 1 clinical trial is currently underway using ifabotuzumab, the Humaneered® version of the anti-EphA3 targeting monoclonal antibody that was used in this study, in patients with recurrent GBM. This study is in part motivated by reports of the positive results of other ADC therapies in the treatment of GBM. An ADC which is in Phase 3 for GBM is in development by Abbvie and utilizes the cytotoxic agent monomethyl auristatin F (MMAF) combined with depatuxizumab. Efficacy has been demonstrated as both a single agent and in combination with temozolomide (TMZ). “Ifabotuzumab is being developed by the leading experts in the space, who played a critical role in the discovery and development of depatuxizumab,” continued Dr. Durrant….”

Onward. Now you know.