An up­start in the poly­clon­al an­ti­body biz just lined up $50M for its plan to dis­rupt a multi­bil­lion-dol­lar busi­ness

The multi­bil­lion-dol­lar busi­ness for im­muno­glo­bin prod­ucts is dom­i­nat­ed by three key play­ers: CSL, Shire and Gri­fols.  And one of them re­cent­ly in­vest­ed $50 mil­lion in a South San Fran­cis­co-based biotech that thinks it has a key to dis­rupt­ing the en­tire glob­al mar­ket.

The com­pa­ny is a lit­tle known pri­vate play­er called Gi­ga­Gen. It has all of 10 staffers who are now so close­ly packed in­to their work space that the com­pa­ny will have to find new digs to ex­pand in­to. But it has glob­al am­bi­tions to do some­thing com­plete­ly new in poly­clon­al an­ti­bod­ies.

The big im­muno­glo­bin busi­ness cen­ters on prod­ucts like IVIG, the in­tra­venous in­fec­tion fight­er that ex­tracts a swarm of poly­clon­al an­ti­bod­ies from donor-de­rived plas­ma — dis­tinct from the mon­o­clon­al an­ti­body busi­ness that has in­spired a whole gen­er­a­tion of new ther­a­pies. Gi­ga­Gen has been spend­ing the last few years work­ing with about a mil­lion dol­lars in grant mon­ey, and a once-off project from No­var­tis, on its re­com­bi­nant poly­clon­al work.

The goal is as sim­ple as it is big: in­dus­tri­al­ize poly­clon­al an­ti­bod­ies, tak­ing sam­ples from the best donors and then mak­ing them more po­tent from low­er dos­es, and cre­at­ing a new sup­ply by mak­ing them over and over and over again.

“I in­vent­ed the tech­nol­o­gy in 2011,” says Gi­ga­Gen CEO David John­son, cred­it­ing his al­liance with Stan­ford As­so­ci­ate Pro­fes­sor Everett Mey­er — an ex­pert in T cell im­munol­o­gy — on the work.

Gri­fols is in­trigued. The Span­ish com­pa­ny paid $35 mil­lion in ear­ly Ju­ly to gain a 44% stake in the com­pa­ny, adding $15 mil­lion for a li­cens­ing fee on the tech. That gains them rights on all the work that Gi­ga­Gen is do­ing on poly­clon­al an­ti­bod­ies.

Orig­i­nal­ly, John­son — a for­mer COO at Nat­era — says he went to a line­up of VCs to see about or­ga­niz­ing a syn­di­cate for the com­pa­ny, but they re­al­ly didn’t get it. Most are com­plete­ly fo­cused on mon­o­clon­als. Start talk­ing to most peo­ple about poly­clon­als, says John­son, and they as­sume it’s a small, mar­gin­al busi­ness.

“It’s not small,” John­son pa­tient­ly ex­plained to me (a com­plete novice on poly­clon­als). “It’s a huge op­por­tu­ni­ty. $10 bil­lion. Big mar­kets.”

It was the VCs that sug­gest­ed he take the sto­ry to the three big play­ers in the in­dus­try — and that is what worked the charm.

The game plan now is to con­tin­ue the pre­clin­i­cal work un­til it’s ready for hu­man test­ing, not an easy propo­si­tion. In the mean­time, John­son’s team has been busi­ly work­ing on PD-1 and a slate of check­point in­hibitors, fig­ur­ing that he can line up some new can­di­dates as the play­ers in that hec­tic mon­o­clon­al an­ti­body busi­ness com­pete in field­ing new prod­ucts. And they’re spin­ning out some T cell work in­to a new com­pa­ny as well.

That’s a lot for a small com­pa­ny with 10 staffers. A year from now, says John­son, he ex­pects the team to grow to 15 to 20, with a new fa­cil­i­ty to work out of. With Gri­fols part­ner­ing on the re­search, he has some sub­stan­tial funds to work with. And in the mean­time he can con­sid­er his chances on an IPO or some oth­er way to raise cash, along with po­ten­tial part­ner­ships.

Gi­ga­Gen is a small com­pa­ny that just took a big step. And it’s aim­ing at a big tar­get.

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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Róbert Wessman, Alvotech chairman and founder

Ice­landic bil­lionare's biosim­i­lar com­pa­ny rais­es $450M, preps for Nas­daq launch with SPAC merg­er

As Icelandic billionaire Róbert Wessman tries to take down AbbVie’s megablockbuster Humira in court, he’s also taking his biosimilar upstart to the big time with a $2.25 billion SPAC merger, Nasdaq launch and $450 million raise announced early Tuesday.

While Wessman’s Alvotech has not won FDA approval for any of its biosimilar candidates yet, the company was the first to file with the FDA for approval of its high-concentration Humira biosimilar and to have successfully conducted a switching study in support of a highly-coveted interchangeability designation. But other companies like Amgen, Boehringer Ingelheim and Pfizer have since caught up ahead of the launches of their own Humira biosimilar competitors in 2023.

Klick Health agency employees appear in its annual holiday greeting video with this year's theme to #SpreadJoy (via Klick Health)

Klick Health hands out $100 bills in an­nu­al hol­i­day greet­ing that’s turned in­to de­fault re­cruit­ing tool

Editor’s Note: For more news, analysis and exclusive coverage from the marketing beat, subscribe to the Endpoints MarketingRx weekly report in your reader profile.

What would you do with $100 and the simple instruction to “spread joy?” That’s what pharma and healthcare agency Klick Health asked its employees as part of its annual holiday greeting for clients, friends and future recruits.

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Warren Huff, Reata CEO

FDA slams Reata's kid­ney drug as in­ef­fec­tive ahead of ad­comm meet­ing

The FDA on Monday offered an overwhelmingly negative opinion on Reata Pharmaceuticals’ potential drug to slow the loss of kidney function in those with the rare disease Alport syndrome, according to briefing documents released ahead of an advisory committee meeting Wednesday.

The agency’s review team said it “does not believe the submitted data demonstrate that bardoxolone is effective in slowing the loss of kidney function in patients with AS and reducing the risk of progression to kidney failure.” Originally developed as a cancer drug, bardoxolone was later scuttled by Reata almost a decade ago as a chronic kidney disease drug due to deaths in a Phase III trial.

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