Keytru­da gets ac­cel­er­at­ed OK in HER2-pos­i­tive gas­tric can­cer; Twin­Strand gets $50M to hunt for 'nee­dles in a haystack'

King Keytru­da keeps rack­ing up ap­provals, earn­ing a new ac­cel­er­at­ed OK from the FDA on Wednes­day.

Reg­u­la­tors hand­ed down the ap­proval for HER2-pos­i­tive gas­tric can­cer in the first-line set­ting, in com­bi­na­tion with trastuzum­ab, flu­o­ropy­rim­i­dine- and plat­inum-based chemo. It’s yet an­oth­er thumbs-up for one of the best-sell­ing drugs in the world.

Wednes­day’s OK came on the ba­sis of a 264-pa­tient study with in­di­vid­u­als who had not pre­vi­ous­ly re­ceived treat­ment for their dis­ease. Pa­tients were ran­dom­ized 1-to-1 to re­ceive Keytru­da or place­bo every three weeks in ad­di­tion to the chemother­a­py reg­i­men.

The drug arm reg­is­tered an over­all re­sponse rate of 74% com­pared to 52% tak­ing the con­trol, good for a p-val­ue of p<0.0001. Re­searchers al­so saw a me­di­an du­ra­tion of re­sponse of 10.6 months with Keytru­da ver­sus 9.5 months in the con­trol arm.

With the ap­proval, reg­u­la­tors gave pa­tients the op­tion of tak­ing 200 mg of Keytru­da every three weeks or 400 mg every six weeks. Both are rec­om­mend­ed for use by the FDA in oth­er in­di­ca­tions. The full in­di­ca­tion is for lo­cal­ly ad­vanced un­re­sectable or metasta­t­ic HER2-pos­i­tive gas­tric or gas­troe­sophageal junc­tion ade­no­car­ci­no­ma. — Max Gel­man

Twin­Strand gets $50M to hunt for ge­net­ic ‘nee­dles in a haystack’

A cou­ple months af­ter wran­gling a $16 mil­lion Se­ries A round, Twin­Strand Bio­sciences has re­turned to the ven­ture well, this time near­ly dou­bling its last raise to fund the de­vel­op­ment of tech­nol­o­gy used to find ge­net­ic “nee­dles in a haystack.”

Twin­Strand un­veiled a $50 mil­lion Se­ries B round on Thurs­day, led by Sec­tion 32, with par­tic­i­pa­tion from Soleus Cap­i­tal, Janus Hen­der­son In­vestors, Madrona Ven­ture Group, Ridge­back Cap­i­tal, Alexan­dria Ven­ture In­vest­ments and oth­ers.

Jesse Salk

The com­pa­ny’s DNA se­quenc­ing tech de­liv­ers “a new lev­el of sen­si­tiv­i­ty, clar­i­ty, and ac­cu­ra­cy to the ex­plo­ration of ge­nom­ic vari­a­tion,” Sec­tion 32’s Michael Pelli­ni said in a state­ment. Twin­Strand says it can iden­ti­fy ul­tra-low fre­quen­cy DNA mu­ta­tions with a res­o­lu­tion 10,000-fold greater than oth­er tools on the mar­ket.

“In ad­di­tion to the com­mer­cial launch of our first prod­ucts, and the build out of our clin­i­cal lab, 2020 marked an im­por­tant mile­stone in the val­i­da­tion of our ex­pand­ing in­tel­lec­tu­al prop­er­ty port­fo­lio as we closed a ma­jor deal in liq­uid biop­sy to kick off our out-li­cens­ing pro­gram,” CEO and CSO Jesse Salk said in a state­ment. — Nicole De­Feud­is 

Val­ne­va makes Nas­daq de­but two weeks af­ter launch­ing PhI­II Covid-19 vac­cine tri­al

The lat­est over­seas biotech de­vel­op­ing Covid-19 vac­cines has hit the Nas­daq in France-based Val­ne­va. The com­pa­ny raised $94 mil­lion and priced Thurs­day at $26.41, the mid­point of its pro­posed range.

Val­ne­va made news re­cent­ly when it an­nounced in late April that it would be giv­ing up vac­cine sup­ply dis­cus­sions with the EU and in­stead deal­ing with mem­ber states di­rect­ly. It had been wary of the trade ten­sions be­tween the UK and rest of the con­ti­nent since Brex­it, not­ing in its S-1 that ex­port re­stric­tions may af­fect its abil­i­ty to de­liv­er those shots promised to the UK.

Val­ne­va has com­mit­ments to de­liv­er 100 mil­lion vac­cines to Britain by 2022, with the UK own­ing ad­di­tion­al op­tions for an­oth­er 90 mil­lion in sup­ply be­tween 2023 and 2025.

In a Phase I/II tri­al, more than 90% of all study par­tic­i­pants de­vel­oped sig­nif­i­cant lev­els of an­ti­bod­ies to the SARS-CoV-2 virus spike pro­tein across all dose groups test­ed. They launched their Phase III tri­al on April 21, look­ing to en­roll 4,000 in a study pit­ting its own vac­cine head-to-head against the As­traZeneca/Ox­ford Uni­ver­si­ty shot. — Max Gel­man

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Den­mark's Gubra to col­lab­o­rate with Bay­er on pep­tides; Sam­sung and Bio­gen re­ceive FDA ap­proval for Lu­cen­tis biosim­i­lar

Danish biotech Gubra announced a research collaboration and license agreement with Bayer to develop peptide therapeutics to treat cardiorenal diseases. The collaboration will utilize Gubra’s peptide drug discovery platform to identify potential candidates.

This is not the first time Gubra has partnered with a company on peptide therapeutics — they partnered with Boehringer Ingelheim back in 2017 to create peptide therapeutics to treat obesity.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.