Life Science Today 039 – Kintor, AVEO, Takeda + Maverick, AgomAb

Originally Published as The Niche Podcast

92% reduction in COVID mortality, AVEO gets FDA approval, Takeda acquires Maverick and targets emerging markets, and AgomAb raises $74M Series B for regenerative medicine.

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Music by Luke Goodson
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Life Science Today is your source for stories, insights, and trends across the life science industry. Expect weekly highlights about new technologies, pharmaceutical mergers and acquisitions, news about the moves of venture capital and private equity, and how the stock market responds to biotech IPOs. Life Science Today also explores trends around clinical research, including the evolving patterns that determine how drugs and therapies are developed and approved. It’s news, with a dash of perspective, focused on the life science industry.

Transcript

Introduction

Welcome to The Niche Podcast – Your weekly rundown of the biotech, clinical research, and life science industries. I’m your host, Dr. Noah Goodson. This week, 92% reduction in COVID mortality, AVEO gets FDA approval, Takeda acquires Maverick and targets emerging markets, and AgomAb raises $74M Series B for regenerative medicine.


Kintor’s Therapeutics COVID Treatment Reduces Death 92%

Promising topline results have emerged from a COVID19 therapy, developed by the Chinese company Kintor Therapeutics. A Phase II trial tested the impact of proxalutamide on COVID19. Proxalutamide is an androgen receptor antagonist currently in Phase III trials for prostate cancer and phase II for breast cancer.

The randomized, double-blind placebo-controlled trial enrolled 588 COVID19 patients in Brazil admitted to hospital in a multi-center study that compared standard of care with standard of care + proxalutamide. The therapy group had a 92% reduction in deaths and a median reduction in hospital stay of 9 days. Using the COVID19 Ordinal Scale, the study group saw a reduction from 5.6 to 1.6 after 14 days. The placebo group was reduced from 5.6 to just 5.4. Additionally, in the study arm, only 4.4% of treatment group required ventilation, compared to 52.7% in the standard of care group.

How good are these results? Crazy good. But how could a prostate cancer therapeutic treat COVID19? That’s not totally known, but preclinical data suggests it may limit the expression of ACE-2 and TMPRSS2, key genes in the COVID19 disease pathway. The data are definitely promising. So promising that Kintor is the first Chinese based small-molecule company to earn an IND for a COVID therapy from the FDA. As of March 5th they are moving forward with a phase III trial in the United States for the use of proxalutamide in male patients with COVID19.

Now, it should be noted that they are probably not looking at a wanning pandemic as a cash cow, though it definitely could be. More likely a EAU approval for COVID19 will give them a better shot at speeding approval of proxalutamide for oncological therapies, it’s original targets. History shows that whatever regulatory agencies may say, approved therapies get new indications easier than unapproved therapies. Keep in mind, that backing this process is the $240M raised in an IPO last May. While they probably still have a sizeable cash reserve, if the COVID platform moves forward, I would not be surprised to see some senior notes or added stock options come out to raise another $100M. Mostly to counteract COVID spending and speed forward the rest of their pipeline. Provided they continue on the current path without major adverse events news, this is definitely a company to watch.


AVEO’s Fotivda cleared by FDA, 3 years after Europe

The FDA has granted AVEO Oncology approval to use Fotivda to treat relapsed or refractory renal cell carcinoma (RCC). Fotivda is an oral VEFG tyrosine kinase inhibitor (TKI) which inhibits VEGF receptors 1, 2, and 3 with a long half-life of 5.1 days. The therapy has been approved in the EU since mid-2017. However, the FDA wanted a bit more evidence. A Phase III trial compared Fotivda to Bayer’s Nexavar in a 1:1 trial. Patients on Fotivda has a higher response rate and longer progression free survival. This was enough to get the nod from the FDA.

The RCC space has progressed significantly over the last decade through a variety of treatment options. While Fotivda is not an industry changing addition, it should add meaningfully to the available options for relapsed RCC. This should give providers the chance to try multiple therapeutic pathways and specialize treatments to individuals.

AVEO’s stocks doubled on the news, but settled down to a more moderate 55% increase at closing on Friday. Looking down the pipeline, AVEO appears to have shifted their developments to monoclonal antibodies for a variety of conditions. Following the FDA approval, they drew down $20M of an announced loan, bringing to total to $35M out of an allowed $45M. Does this mean they’re just running on debt fumes? Not exactly. They reported $68.8M in cash + equivalents and securities, but they are hoping sales of Fotivda in the US will give them access to the next $10M, from that loan, to run through 2022. At that point, the hope is that something in the pipeline will be ready for partnership or a biobucks deal.


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Takeda Acquires Maverick Therapeutics in $0.5B Deal

Takeda has exercised their option to acquire Maverick Therapeutics in a $525M deal. Maverick has a proprietary COBRA line which conditionally activates T cell engaging molecules but that technology is all preclinical at the moment. Their lead candidate targets EGRF-expressing solid tumors while their second candidate targets B7H3-expressing solid tumors. What’s the alphabet soup mean? They have a wide range of solid tumor therapeutics ranging from preclinical to early clinical stages. Takeda has been invested in Maverick since 2017, when they put in $125M. This type of holistic acquisition suggests broad interest in their technological pipeline, not just a lead candidate. Remember the Prodrugs we mentioned last week? Well the COBRA platform is built on a prodrug design. Which is pretty sensible if you want targeted site-specific activation. Basically, it utilizes the unique environment present in most solid tumors to drive T cell activation. Takeda thinks it’ll work.

But that’s not all Takeda is working on. They want their growth and emerging markets division to run double-digit revenue increases for the next decade. They’re investing to surpass the market and reach $9B in revenues by 2030, with 20% compound growth for five years. Their plan basically pairs market specific growth of their numerous brands and actualization of a series of assets in the pipeline. These numbers are not without caveats, this area of the market can drive up significant revenue, but also include major costs and logistical needs. I imagine Takeda is looking out at these markets and saying, hey there is room for brand awareness in these emerging markets and we can outcompete generics and drive significant revenue. Takeda was at $30B in revenue last year, so this will not be stock defining growth, but just one of the areas the company hopes to expand in the coming decade. I can also imagine them building this wing and then spinning it off into a subsidiary corporation. Time will tell.


AgomAb $74M Series B in Regenerative Medicine

Regenerative Medicine is a complex space in biopharma. See the interview with Dr. Mitrani for just a few of the challenges. AgomAb Therapeutics has raised a $74M series B to advance their pipeline of monoclonal antibodies to treat degenerative and inflammatory diseases through modulating regenerative pathways. Their lead candidate AGMB-101 is currently seeking INDs. Based on this round of funding, I suspect they are close, though this has not been announced yet.

Their therapy works through the MET pathway and they see it as quite promising. Without seeing their data I am a bit skeptical. MET signaling pathways are nearly ubiquitous. They function properly in stem cells and progenitors, but aberrant expression is involved in numerous diseases and cancers. AGMB-101 is an agonist that specifically mimics HGF MET signaling. In theory, this could drive “regenerative” processes in a ton of diseases. But this broad application is also why I’m skeptical. Not specifically of function, but of complex side effects as they move into clinical studies. They are obviously aware of these potential challenges. They’ve at least got a specific candidate that meets some of the clinical needs by being targeted and having an appropriate half-life. I’m excited to see some of the clinical data as well as their therapeutic targets. With $74M in the bank, it shouldn’t be too long before we can get a glance at their pipeline and the specific therapeutic targets they envision. That might help us understand how they will mitigate pathway specific risks moving forward. 


Closing Credits

Thanks for joining me on The Niche Podcast; your weekly summary of top news in the biotech, clinical trials, and life science industries. You can learn more at thenichepod.com or find us on your favorite podcast app. Like, comment, subscribe, and most of all share with your friends. If you like what you hear, please rate and review, it really helps us. Once again, I’m Dr. Noah Goodson, I’ll see you next week.