BioNTech CEO Ugur Sahin (File photo)

Hong Kong strife holds up al­most $100M of BioN­Tech's Se­ries B haul

Late on Mon­day, it was re­vealed that Ger­man can­cer drug de­vel­op­er BioN­Tech is eye­ing a $100 mil­lion pub­lic list­ing in the Unit­ed States, two months af­ter the can­cer-fo­cused com­pa­ny un­veiled a her­culean $325 mil­lion in an up­sized round of fi­nanc­ing.

In the IPO fil­ing, how­ev­er, the Mainz-based drug de­vel­op­er re­vealed that shares worth about $97 mil­lion that were ex­pect­ed to be bought by an undis­closed Hong Kong-based in­vestor have been de­layed, in part due to the po­lit­i­cal un­rest in Hong Kong and the on­go­ing trade dis­pute be­tween the Unit­ed States and Chi­na.

“(T)he pay­ment may be in­def­i­nite­ly de­layed, or po­ten­tial­ly not re­ceived at all. In the event that this in­vestor is not able to fund the pur­chase of the shares and we do not make al­ter­na­tive arrange­ments for the pur­chase of the shares, we may de­mand that the shares be trans­ferred back to us for no con­sid­er­a­tion. We in­tend to make use of this right in case the funds have not been paid by the an­tic­i­pat­ed pub­lic of­fer­ing,” the fil­ing said.

The trade ten­sion be­tween Chi­na and the Unit­ed States has re­ver­ber­at­ed in the bio­phar­ma in­dus­try.

Last year the Com­mit­tee on For­eign In­vest­ment in the Unit­ed States (CFIUS) — a fed­er­al in­ter­a­gency com­mit­tee chaired by the US Trea­sury De­part­ment — ex­pand­ed its re­view of for­eign in­vest­ment in the biotech­nol­o­gy sec­tor, cit­ing na­tion­al se­cu­ri­ty rea­sons, trig­ger­ing con­cern that US biotechs may have trou­ble ac­cess­ing Chi­nese mon­ey.

And in re­cent months, MD An­der­son Can­cer Cen­ter sanc­tioned five of its own re­searchers — three of whom were eth­ni­cal­ly Chi­nese — for pur­port­ed­ly vi­o­lat­ing con­flict of in­ter­est poli­cies, al­leg­ing ‘for­eign in­flu­ence’, af­ter the NIH re­quest­ed the in­sti­tu­tion in­ves­ti­gate their con­duct.

BioN­Tech’s Ju­ly round of Se­ries B fundrais­ing — mark­ing one of the largest sin­gle pri­vate fund­ing rounds for a Eu­ro­pean biotech — was up­sized and led by Fi­deli­ty Man­age­ment & Re­search. New and ex­ist­ing in­vestors par­tic­i­pat­ed, in­clud­ing Red­mile Group, In­vus, Mi­rae­As­set Fi­nan­cial Group, Plat­inum As­set Man­age­ment, Jeb­sen Cap­i­tal, Steam Athena Cap­i­tal, BVCF Man­age­ment and the Stru­eng­mann Fam­i­ly Of­fice. Two-thirds of the fund­ing came from new in­vestors, BioN­Tech said.

Jeb­sen Group, the par­ent com­pa­ny of Jeb­sen Cap­i­tal, is based in Hong Kong. BVCF Man­age­ment says it was found­ed as Chi­na’s first US dol­lar fund.

Found­ed in 2008, BioN­Tech counts the Strüng­mann group, a fam­i­ly firm led by Ger­man bil­lion­aires and iden­ti­cal twins Thomas and An­dreas Strüng­mann, as its largest share­hold­ers and the source of BioN­Tech’s ini­tial seed cap­i­tal.

Most of BioN­Tech’s clin­i­cal as­sets are mes­sen­ger RNA ther­a­pies (mR­NA), a fam­i­ly of treat­ments in which a nat­ur­al sys­tem is har­nessed to send the body a sig­nal to pro­duce its own drug — in this case, to fight can­cer. The com­pa­ny al­so has cell ther­a­pies and an­ti­bod­ies in its ar­se­nal. Al­to­geth­er, the com­pa­ny has 20 prod­uct can­di­dates, of which eight have en­tered in­to nine on­go­ing clin­i­cal tri­als. BioN­Tech’s com­peti­tors, such as Cure­Vac and the uni­corn Mod­er­na $MR­NA — which re­cent­ly pulled off a his­toric $604 mil­lion US IPO — are square­ly fo­cused on mR­NA.

Hel­mut Jeg­gle, who is re­spon­si­ble for the life sci­ence ini­tia­tives of the Strüng­mann broth­ers, holds about 50.35% of BioN­Tech’s shares, while the com­pa­ny’s CEO Ugur Sahin has a 18.80% stake.

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,000+ biopharma pros reading Endpoints daily — and it's free.

Anthony Fauci (AP Images)

UP­DAT­ED: NIH-part­nered Mod­er­na ships off its PhI-ready coro­n­avirus vac­cine can­di­date to a sea of un­cer­tain­ty

Off it goes.

Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study.

It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates.

The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,000+ biopharma pros reading Endpoints daily — and it's free.

In fi­nal re­port, ICER ap­pears to have a change of heart on new acute mi­graine ther­a­pies

ICER appears to have reversed course on the fresh crop of acute migraine therapies.

The cost-effectiveness watchdog in November issued a draft report suggesting that existing generic medicines are more effective and cheaper than Allergan’s December-approved CGRP ubrogepant, Biohaven rival molecule, rimegepant (which is under FDA review), and Lilly’s October-sanctioned lasmiditan, which binds to 5-HT1F receptors.

Bi­cy­cle Ther­a­peu­tics takes Roche's Genen­tech on an up to $2B im­muno-on­col­o­gy ride

Bicycle Therapeutics — which is developing a new class of chemically synthesized drugs designed to be pharmacologically as active as biologics, yet manufactured as small molecules —  has scored another big partner: Roche’s Genentech.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,000+ biopharma pros reading Endpoints daily — and it's free.

When drug val­ue as­sess­ment meets re­al-world ev­i­dence: ICER en­lists Ae­tion in pric­ing eval­u­a­tion

In a union of two of the hottest trends in the US biopharma world, ICER is teaming up with a high-profile company to integrate real-world evidence in their assessment of treatment value.

The drug pricing watchdog — formally the Institute for Clinical and Economic Review — said it will utilize Aetion’s evidence platform in “select upcoming assessments” and their new 24-month re-evaluations of drugs granted accelerated approval by the FDA.

Anthony Fauci, AP Images

First US Covid-19 tri­als set to get un­der­way in Ne­bras­ka and Wash­ing­ton, backed by NIH

The first US clinical trials on the novel coronavirus are scheduled to get underway next month at the University of Nebraska Medical Center, where American passengers were taken after being evacuated from the Diamond Princess cruise ship, and at the Kaiser Permanente Washington Health Research Institute. Both trials are sponsored by the NIH’s National Institute for Allergy and Infectious Diseases, which has led the US’s medical response to the outbreak.

UP­DAT­ED: NGM Bio takes leap for­ward in crowd­ed NASH field

South San Francisco-based NGM Bio may have underwhelmed with its interim analysis of a key cohort from a mid-stage NASH study last fall — but stellar topline data unveiled on Monday showed the compound induced significant signs of antifibrotic activity, NASH resolution and liver fat reduction, sending the company’s stock soaring.

There are an estimated 50+ companies focused on developing drugs for non-alcoholic steatohepatitis, or NASH, a common liver disease that has long flummoxed researchers. The first wave of NASH drug developers struggled with efficacy as well as safety — and companies big and small have crashed and burned.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,000+ biopharma pros reading Endpoints daily — and it's free.