Photo: Amber Tong, Endpoints News

In a bid to get to Chi­nese pa­tients faster, Shang­hai's I-Mab plans $100M Nas­daq IPO

Aim­ing to be the next Chi­nese com­pa­ny to list on Nas­daq af­ter Zai Lab’s de­but two years ago, the Shang­hai drug de­vel­op­er I-Mab is gun­ning for a $100 mil­lion IPO.

The com­pa­ny — which has raised more than $400 mil­lion in the last three years — has a shrewd strat­e­gy for bi­o­log­ic de­vel­op­ment: it first con­ducts its proof-of-con­cept tri­als in the Unit­ed States and works to­wards get­ting FDA clear­ance for in-hu­man stud­ies.  The da­ta gen­er­at­ed are then used to ad­vance clin­i­cal de­vel­op­ment in Chi­na. Even­tu­al­ly, af­ter the ex­per­i­men­tal drug has been clin­i­cal­ly val­i­dat­ed in the Unit­ed States, the com­pa­ny re­tains Chi­nese rights for fur­ther de­vel­op­ment and com­mer­cial­iza­tion — while re­tain­ing the op­tion to out-li­cense glob­al­ly.

I-Mab’s ap­proach could al­low Chi­nese pa­tients to ac­cess treat­ments con­cur­rent­ly or soon af­ter their mar­ket ap­provals else­where, par­tic­u­lar­ly since Chi­nese of­fi­cials have carved out a path­way for the fast-track ap­proval of drugs sup­port­ed by sol­id over­seas clin­i­cal da­ta and grant­ed pri­or­i­ty re­views. Zai Lab, which has ac­quired a slate of late-stage and com­mer­cial prod­ucts to quick­ly build its port­fo­lio, has ben­e­fit­ed from these Chi­nese re­forms.

I-Mab, mean­while, has a slate of ten clin­i­cal and pre­clin­i­cal bi­o­log­ics for au­toim­mune dis­ease and can­cer, which is on the rise in Chi­na due to pol­lu­tion and lofty rates of smok­ing. Growth in Chi­na’s bi­o­log­ics mar­ket has sur­passed the glob­al bi­o­log­ics mar­ket and is ex­pect­ed to reach $189.4 bil­lion in sales by 2030, I-Mab said, cit­ing a Frost & Sul­li­van re­port.

The com­pa­ny’s glob­al port­fo­lio hous­es mon­o­clon­al an­ti­bod­ies and bi-spe­cif­ic an­ti­bod­ies. Three drugs: TJM2, TJC4 and TJD5 are in phase 1 tri­als in the Unit­ed States — and ap­pli­ca­tions to test TJC4 and TJD5 in hu­mans was grant­ed by Chi­na’s Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion (NM­PA) ear­li­er this year.

In its Chi­na port­fo­lio, the com­pa­ny has five home-grown in­ves­ti­ga­tion­al drugs that are in or ready for phase II or phase III tri­als in Chi­na, hav­ing met the re­lat­ed pre-set safe­ty and pre­lim­i­nary ef­fi­ca­cy end­points in ear­ly or mid-stage stud­ies in Eu­rope or the Unit­ed States. TJ202 is in two piv­otal tri­als test­ing its use in mul­ti­ple myelo­ma in Tai­wan, while the NM­PA has en­dorsed test­ing the drug for the same in­di­ca­tions in hu­mans in Chi­na. Da­ta on TJ101 is be­ing com­piled for an ap­pli­ca­tion to test in a reg­is­tra­tional tri­al in Chi­na. For enobli­tuzum­ab, an IND is be­ing prepped for 2020 for a mid-stage tri­al or a piv­otal tri­al. Al­to­geth­er, the com­pa­ny is vy­ing to sub­mit a slate of mar­ket­ing ap­pli­ca­tions come 2021.

The com­pa­ny was es­tab­lished in June 2016 and has inked a num­ber of col­lab­o­ra­tions, in­clud­ing Mor­phoSys, Genex­ine, Macro­Gen­ics, and Fer­ring. It in­tends to list on the Nas­daq with the sym­bol $IMAB.

Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

Sanjiv Patel, Relay CEO

Re­lay reaps $400M IPO wind­fall af­ter draw­ing the cur­tain on mo­tion-based drug de­sign pipeline

A red-hot venture market back in 2018 propelled Relay Therapeutics to a whopping $400 million crossover round. And now, the biotech is riding on a red-hot IPO market to a public debut that brought in the same exact amount.

The $400 million raise breaks down to 20 million shares sold at $20 each — above even the amended proposed range of $16 to $18.

It’s also double what Relay had penciled in with the initial S-1 filing, in yet another illustration that those figures are often nothing more than a placeholder these days.

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Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

John Furey, Imvax CEO

A neu­ro­sur­geon spent the past 30 years de­vel­op­ing a neoanti­gen tu­mor vac­cine. Now he has $112M to put it to piv­otal test

As a neurosurgeon, David Andrews knew there wasn’t much he could do for his glioma patients after resecting — rarely fully — their tumor. Even with the best treatment and care available, median overall survival is just somewhere between 14 and 16 months.

Then in the 1990s, his mentor at Thomas Jefferson University introduced him to Renato Baserga, a pathologist who had been studying the effect of using antisense oligonucleotide to knock out the insulin-like growth factor type 1 receptor in cancers. As IGF-R1 drives tumor growth and metastasis, the preclinical reasoning went, implanting a molecule targeting the receptor together with the tumor material near lymph nodes can slow down the spread of the cancer.

BioAt­la rakes in $72.5M Se­ries D, ad­vanc­ing re­search for pH-de­tect­ing can­cer treat­ments

A little over a year after agreeing to a worldwide collaboration with hefty Chinese biotech BeiGene worth up to $270 million, BioAtla is ready for another haul.

The San Diego-based biotech pulled in a $72.5 million haul for their Series D financing, which the company announced Wednesday. Funds will go toward their four main clinical programs developing cancer treatments, two of which are currently in Phase II, BioAtla president and former Celgene COO Scott Smith said.

Mene Pangalos, AstraZeneca R&D chief (AstraZeneca via YouTube)

A day af­ter Mod­er­na vac­cine re­sults, ru­mors swirl of pend­ing As­traZeneca da­ta

A day after Moderna and the NIH published much-anticipated data from their Phase I Covid-19 vaccine trial, attention is turning to AstraZeneca which, according to a UK report, is expected to publish its own early data tomorrow.

ITV’s Robert Peston reported that AstraZeneca will publish the Phase I data in The Lancet. 

AstraZeneca and Moderna represent the two most ambitious Covid-19 vaccine efforts, having set the quickest timelines for approval (though they were recently joined in that regard by the Pfizer-BioNTech partnership) and some of the loftiest goals in total doses. Yet there is even less known about AstraZeneca’s vaccine’s effect on humans than there was about Moderna’s before yesterday. Although, in a controversial move, Moderna released some statistics from its Phase I in May, AstraZeneca has yet to say anything about what it saw in its Phase I trial — a move consistent with the scientific convention to withhold data until it can be published in a peer-reviewed journal.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

‘Plan­ning to vac­ci­nate every­one in the US,’ Mod­er­na out­lines ef­forts to sup­ply their Covid-19 vac­cine as man­u­fac­tur­ing ramps up ahead of PhI­II

Twelve days from the planned start of their Phase III pivotal trial, the executive crew at Moderna has set up the manufacturing base needed to begin production of the first 500,000 doses of their Covid-19 vaccine with plans to feed it into a global supply chain. But the initial batches will likely be ready in the US first, where company CEO Stéphane Bancel plans to be able to vaccinate everyone.

“We have started making commercial product at-risk, and will continue to do so every day and every week of the month,” Bancel told analysts during their morning call on the Phase I data just published in the New England Journal of Medicine.

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Jeff Albers, Blueprint CEO

Di­ag­nos­tic champ Roche buys its way in­to the RET ti­tle fight with Eli Lil­ly, pay­ing $775M in cash to Blue­print

When Roche spelled out its original $1 billion deal — $45 million of that upfront — with Blueprint to discover targeted therapies against immunokinases, the biotech partner’s RET program was still preclinical. Four years later, pralsetinib is on the cusp of potential approval and the Swiss pharma giant is putting in much more to get in on the commercial game.

Roche gains rights to co-develop and co-commercialize the drug, with sole marketing responsibility for places outside the US and China (where CStone has staked its claim).

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