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M T Wed Th F 3 April, 2024

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spotlight
Additional drugmakers flag risks of working with WuXi amid heightened US
scrutiny

top stories

1. LENZ plans NDA submission for presbyopia eye drops this year, looks to launch
in 2025 2. Exclusive: Backed with $350M, secretive startup Metsera jumps into
the obesity race 3. Obsidian Therapeutics rakes in $160M for solid tumor cell
therapy program 4. Apogee, Spyre founder launches its third biotech and heads
straight to Nasdaq 5.

news briefing

Ascletis Pharma scraps liver disease program; Another reverse merger 6. Genmab
fuels ADCs' hot streak with $1.8B buyout of ProfoundBio 7. Antibody biotech
Diagonal Therapeutics lands $128M to pursue rare diseases 8. Neurosterix emerges
with $63M to follow Karuna, Cerevel 9. Alterome raises $132M to take next-gen
cancer drugs aimed at the 'undruggable' into clinic 10. FibroGen eyes rebound
path with Ph1 ADC data for prostate cancer drug

more stories

• 
Roivant announces study win in eye disease for Pfizer asset, plans $1.5B share
buyback

.

Andrew Dunn’s latest story looks into a secretive startup that’s raised $350
million, hired a pharma CEO and in-licensed six obesity candidates. That’s some
major funding in one of the decade’s hottest categories. Be sure to check it
out!

.

Jaimy Lee Deputy Editor, Endpoints News


Eef Schimmelpennink, LENZ Therapeutics CEO

1

LENZ plans NDA sub­mis­sion for pres­by­opia eye drops this year, looks to
launch in 2025
by Katherine Lewin

LENZ Ther­a­peu­tics plans to seek FDA ap­proval for its in­ves­ti­ga­tion­al
eye drops for pres­by­opia, set­ting up the drug to com­pete against Ab­b­Vie’s
Vuity and Ora­sis Phar­ma­ceu­ti­cals’ Qlosi.

The bio­phar­ma on Wednes­day shared pos­i­tive Phase 3 da­ta for two
for­mu­la­tions of the treat­ment, say­ing both met the study's pri­ma­ry
end­point, though it plans to pur­sue an NDA for the ver­sion that does­n't
in­clude bri­moni­dine.

In topline da­ta from the CLAR­I­TY 1 and 2 tri­als, LENZ in­ves­ti­gat­ed two
for­mu­la­tions of ace­cli­dine: LNZ100 and LNZ101, which con­tains
bri­moni­dine. In the CLAR­I­TY 2 tri­al, LNZ100 won out, with 71% of pa­tients
achiev­ing three lines or greater im­prove­ment in eye­sight af­ter 30 min­utes
based on the Best Cor­rect­ed Dis­tance Vi­su­al Acu­ity test, which is used to
mea­sure eye­sight with an eye chart that dis­plays let­ters of dif­fer­ent
sizes.

Click here to continue reading

2

Ex­clu­sive: Backed with $350M, se­cre­tive start­up Met­sera jumps in­to the
obe­si­ty race
by Andrew Dunn

Fund­ed with $350 mil­lion from top-tier VCs and led by a vet­er­an phar­ma CEO,
a new obe­si­ty start­up called Met­sera has been qui­et­ly build­ing plans to
get mul­ti­ple drugs in­to the clin­ic over the next two years, End­points News
has ex­clu­sive­ly learned.

Met­ser­a's CEO is Clive Mean­well, the for­mer chief ex­ec­u­tive of The
Med­i­cines Com­pa­ny. The com­pa­ny was in­cor­po­rat­ed in 2022 by
Pop­u­la­tion Health Part­ners, an in­vest­ment firm start­ed in 2020 by
Mean­well and for­mer Pfiz­er CEO Ian Read.

Op­er­at­ing in stealth mode, Met­sera has in-li­censed six obe­si­ty drug
can­di­dates from a Ko­re­an biotech, ac­quired a Lon­don-based biotech, and is
tar­get­ing up to sev­en IND fil­ings over the next 12 to 24 months.
End­points pieced to­geth­er Met­ser­a's op­er­a­tions in the red-hot weight
loss space through US and glob­al le­gal fil­ings, Ko­re­an press re­leas­es
that out­line the li­cens­ing deals, re­cent job post­ings, and an
in-de­vel­op­ment-but-pub­lic-fac­ing ver­sion of the star­tup's web­site.
(Af­ter End­points reached out to Met­sera, a pass­word-pro­tect­ed lo­gin was
added to ac­cess the site.)

Click here to continue reading

3

Ob­sid­i­an Ther­a­peu­tics rakes in $160M for sol­id tu­mor cell ther­a­py
pro­gram
by Lei Lei Wu

Ob­sid­i­an Ther­a­peu­tics an­nounced Wednes­day that it raised $160.5 mil­lion
to push its tu­mor-in­fil­trat­ing lym­pho­cyte (TIL) pro­gram fur­ther in
clin­i­cal tri­als.

The Se­ries C raise comes af­ter Ob­sid­i­an re­port­ed ini­tial da­ta from six
pa­tients with ad­vanced melanoma who re­ceived its tu­mor-in­fil­trat­ing
lym­pho­cyte cell ther­a­py. With the new $160.5 mil­lion, Ob­sid­i­an plans to
push its TIL ther­a­py, OBX-115, for­ward in mul­ti­cen­ter stud­ies in both
melanoma and non-small cell lung can­cer.

“On the back of that press-re­leased da­ta, we launched in­to the jour­ney of
the Se­ries C fi­nanc­ing,” Ob­sid­i­an CEO Madan Ja­ga­sia told End­points News
in an in­ter­view. In De­cem­ber, Ob­sid­i­an shared that three of six melanoma
pa­tients re­spond­ed to its TIL ther­a­py at a me­di­an fol­low-up of about
four months, with two of those pa­tients go­ing in­to com­plete re­mis­sion.

Click here to continue reading

Vice President - Science & Technology Alexandria Real Estate Equities Cambridge,
MA, USA

Life Sciences Senior Associate General Catalyst Redwood City, CA, USA

Vice President/SVP Discovery Business Development 3D CRO Group Fair Lawn, NJ,
USA

Assistant Controller Precision BioSciences Durham, NC

Recruit talent with Endpoints Careers Contact Meg Estacio:
mestacio@endpointsnews.com

Lawrence Klein, Oruka Therapeutics CEO

4

Apogee, Spyre founder launch­es its third biotech and heads straight to Nas­daq
by Kyle LaHucik

Af­ter cre­at­ing an­ti­body mak­ers Apogee and Spyre, Paragon Ther­a­peu­tics
is back with an­oth­er in­flam­ma­to­ry and im­mune dis­ease biotech, and the
start­up is im­me­di­ate­ly go­ing to the pub­lic mar­kets.

Waltham, MA-based bi­o­log­ics mak­er Oru­ka Ther­a­peu­tics, fo­cused on
chron­ic skin dis­eases like plaque pso­ri­a­sis, has inked a re­verse merg­er
agree­ment with a lit­tle-known Col­orado biotech that had at­tempt­ed to break
in­to the dif­fi­cult car­dio­vas­cu­lar field of atri­al fib­ril­la­tion, or
ir­reg­u­lar and rapid heart rate.

Oru­ka will take the place of AR­CA bio­phar­ma, which for 23 months had been
search­ing for a merg­er or sale, on the Nas­daq. Its stock had plum­met­ed
af­ter a Phase 2b fail in AF in ear­ly 2018. ABIO will be­come OR­KA when the
deal clos­es, which is ex­pect­ed in the third quar­ter.

Click here to continue reading

5

As­cle­tis Phar­ma scraps liv­er dis­ease pro­gram; An­oth­er re­verse merg­er
by ENDPOINTS

Plus, news about Benev­o­len­tAI, Adap­tive Biotech­nolo­gies, Ei­sai, CNX
Ther­a­peu­tics, Van­da Phar­ma­ceu­ti­cals and Nu­cle­ai:

As­cle­tis Phar­ma ends liv­er dis­ease pro­gram: The Chi­nese biotech will not
pur­sue fur­ther de­vel­op­ment of ASC42 for pri­ma­ry bil­iary cholan­gi­tis
af­ter Phase 2 da­ta sug­gest­ed a lack of com­pet­i­tive­ness ver­sus
com­pet­ing can­di­dates. As­cle­tis al­so dropped clin­i­cal work on the FXR
ag­o­nist in he­pati­tis B. — Ay­isha Shar­ma

Kin­tara inks re­verse merg­er with TuHU­RA: The com­bined com­pa­ny will go by
TuHU­RA Bio­sciences and change its tick­er from KTRA to HU­RA. TuHU­RA’s
per­son­al­ized can­cer vac­cine is in Phase 3. It has bi­func­tion­al AD­Cs, as
well. The deal marks the third biotech re­verse merg­er this week, fol­low­ing
the cre­ation of Traws Phar­ma and Oru­ka Ther­a­peu­tics. — Kyle LaHu­cik

Click here to continue reading

6

Gen­mab fu­els AD­C­s' hot streak with $1.8B buy­out of Pro­found­Bio
by Amber Tong

Dan­ish an­ti­body spe­cial­ist Gen­mab is pay­ing $1.8 bil­lion in cash to
scoop up Pro­found­Bio and throw its hat in­to the packed an­ti­body-drug
con­ju­gate ring.

Pro­found­Bio brings to the ta­ble three clin­i­cal can­di­dates gen­er­at­ed on
its tech­nol­o­gy plat­form, in­clud­ing a Phase 2 ADC be­ing test­ed to treat
ovar­i­an can­cer and oth­er sol­id tu­mors ex­press­ing fo­late re­cep­tor
al­pha (FRα). The ac­qui­si­tion comes just two months af­ter the Seat­tle-based
biotech raised $112 mil­lion to take the lead com­pound in­to a piv­otal study.

The deal, an­nounced Wednes­day morn­ing, will mark Gen­mab’s first
ac­qui­si­tion af­ter years of ink­ing col­lab­o­ra­tions around its an­ti­body
plat­form. But it’s not the biotech’s first go at ap­ply­ing its tech­nol­o­gy
on AD­Cs: It pre­vi­ous­ly part­nered with Seagen — whose $43 bil­lion sale to
Pfiz­er stoked ex­cite­ment in the space — to de­vel­op what be­came Tiv­dak, a
cer­vi­cal can­cer treat­ment that the com­pa­nies con­tin­ue to joint­ly
mar­ket.

Click here to continue reading

7

An­ti­body biotech Di­ag­o­nal Ther­a­peu­tics lands $128M to pur­sue rare
dis­eases
by Kyle LaHucik

Di­ag­o­nal Ther­a­peu­tics has launched with $128 mil­lion to go af­ter an
or­phan dis­ease that leads to chron­ic ane­mia, and an­oth­er an­ti­body for
the same rare dis­ease that is al­so tar­get­ed by Mer­ck­'s new­ly ap­proved
drug, Win­re­vair. Just last week, the biotech was con­grat­u­lat­ing its chief
sci­en­tif­ic of­fi­cer on his con­tri­bu­tions to the same Mer­ck drug.

The Cam­bridge, MA-based biotech came out of stealth on Wednes­day morn­ing with
the seed and Se­ries A funds from blue-chip back­ers like BVF Part­ners and
At­las Ven­ture. Ad­di­tion­al in­vestors in­clude Light­speed Ven­ture
Part­ners, RA Cap­i­tal Man­age­ment, Fra­zier Life Sci­ences, Viking Glob­al
In­vestors, Velos­i­ty Cap­i­tal and Check­point Cap­i­tal.

CEO Alex Lu­gov­skoy co-found­ed the biotech af­ter serv­ing in ex­ec­u­tive
posts at Drag­on­fly Ther­a­peu­tics and Mor­phic Ther­a­peu­tic.

Click here to continue reading

Apr 09 11:00am ET

Navigating Policy, Funding, CMC and Regulatory Dynamics for Successful Orphan
Drug Development sponsored by Catalent

8

Neu­roster­ix emerges with $63M to fol­low Karuna, Cerev­el
by Kyle LaHucik

Small Swiss biotech Ad­dex Ther­a­peu­tics is trans­fer­ring its neu­ro­science
as­sets and its al­losteric mod­u­la­tor plat­form to a new biotech that has
picked up $63 mil­lion in a Se­ries A raise.

The 22-year-old pub­licly trad­ed Ad­dex will own about 20% of the new com­pa­ny
called Neu­roster­ix, CEO Tim Dy­er said in an in­ter­view with End­points News
ahead of the Wednes­day an­nounce­ment.

Dy­er will lead both com­pa­nies, and Neu­roster­ix will take Ad­dex's
fa­cil­i­ty and team of 19 em­ploy­ees with it, he said.

The new biotech's lead as­set is a mus­carinic acetyl­choline re­cep­tor
sub­type 4 pos­i­tive al­losteric mod­u­la­tor, or M4 PAM, for schiz­o­phre­nia
that will en­ter IND-en­abling stud­ies lat­er this year, Dy­er said. In
al­losteric mod­u­la­tors, the treat­ment binds to the tar­get re­cep­tor
be­yond the bor­ders of the ac­tive site. The com­pa­ny says it could lead to
bet­ter se­lec­tiv­i­ty and hence stronger ef­fi­ca­cy and im­proved safe­ty
over oth­er med­ica­tions.

Click here to continue reading

Eric Murphy, Alterome CEO

9

Al­terome rais­es $132M to take next-gen can­cer drugs aimed at the
'un­drug­gable' in­to clin­ic
by Lei Lei Wu

With a new $132 mil­lion in hand, Al­terome Ther­a­peu­tics is fi­nal­ly
di­vulging what it’s work­ing on.

The on­col­o­gy com­pa­ny will be us­ing its Se­ries B raise to bring two
pro­grams — each de­signed to go af­ter spe­cif­ic can­cer-dri­ving mu­ta­tions
— to the clin­ic with­in the next year. The San Diego start­up emerged from
stealth in 2022, but had not dis­closed its pipeline un­til Wednes­day’s
an­nounce­ment.

Al­terome’s first pro­gram is an AKT1 in­hibitor and the sec­ond is a KRAS
in­hibitor. In re­cent years, the first drugs that specif­i­cal­ly tar­get AKT
and KRAS have been ap­proved by the FDA. Al­terome's goal is to de­vel­op
po­ten­tial­ly more ef­fec­tive and safer drugs that tar­get well-known
mu­ta­tions that cause can­cer.

Click here to continue reading

10

Fi­bro­Gen eyes re­bound path with Ph1 ADC da­ta for prostate can­cer drug
by Ayisha Sharma

Af­ter a se­ries of clin­i­cal dis­ap­point­ments, Fi­bro­Gen could be on the
come­back trail with promis­ing ear­ly da­ta from a CD46-tar­get­ing
an­ti­body-drug con­ju­gate de­vel­oped by part­ner For­tis Ther­a­peu­tics.

The ADC can­di­date, FG-3246, is the sub­ject of a four-year agree­ment made in
May 2023 in which Fi­bro­Gen has the op­tion to buy For­tis for $80 mil­lion
up­front with the biotech al­so el­i­gi­ble for up to $200 mil­lion in
ap­proval-linked mile­stones.

Late Tues­day, Fi­bro­Gen un­veiled re­sults from the Phase 1 test of the
as­set, al­so known as FOR46, in 56 pa­tients with metasta­t­ic
cas­tra­tion-re­sis­tant prostate can­cer (mCR­PC) who pro­gressed af­ter at
least one an­dro­gen re­cep­tor-sig­nal­ing in­hibitor.

In pa­tients evalu­able for prostate-spe­cif­ic anti­gen (PSA), 36% had PSA
re­duc­tions of at least 50%, ac­cord­ing to a re­lease. Of those evalu­able for
a tu­mor re­sponse, 20% met the cri­te­ria for a par­tial re­sponse with a
me­di­an 7.5-month du­ra­tion of re­sponse.

Click here to continue reading

John Carroll Editor & Founder

Arsalan Arif Publisher & Founder

Igor Yavych Chief Technical Officer

Valentin Manov Creative Director

Ryan McRae Chief Revenue Officer

Amanda Florez Chief of Staff

Drew Armstrong Executive Editor

Jaimy Lee Deputy Editor

Lydia R. Pflanzer Deputy Editor

Amber Tong Senior Editor

Zachary Brennan Senior Editor

Beth Snyder Bulik Senior Editor

Max Gelman Senior Editor

James Cherrick Controller

Melissa Nazzaro Executive Director, Brand Partnerships

Julie Notario Executive Director, Brand Partnerships

Carrie Cliggett VP, Events



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