Af­ter falling off a cliff, Edge Ther­a­peu­tics pro­vides can­cer-fo­cused PDS Biotech a re­verse merg­er on­to Nas­daq

Bat­tered by a late-stage set­back in March, tiny Edge Ther­a­peu­tics $EDGE has pro­vid­ed can­cer im­munother­a­py com­pa­ny PDS Biotech­nol­o­gy Corp. a ve­hi­cle for a quick re­verse merg­er on­to Nas­daq. The com­pa­ny’s shares — which end­ed last week deep in pen­ny stock ter­ri­to­ry — sky­rock­et­ed near­ly 43% pre­mar­ket on the an­nounce­ment.

Frank Bedu-Ad­do

In late March, Edge re­port­ed that a pre-spec­i­fied in­ter­im analy­sis of its lead drug, EG-1962, which was be­ing in­ves­ti­gat­ed in a late-stage study in­volv­ing pa­tients with aneurys­mal sub­arach­noid he­m­or­rhage (aSAH) — a fre­quent­ly fa­tal brain bleed caused by the rup­ture of an aneurism — would like­ly fail. Based on that rec­om­men­da­tion, the Berke­ley Heights, New Jer­sey-based com­pa­ny de­cid­ed to aban­don the ex­per­i­men­tal drug. A month lat­er Edge said it was ex­plor­ing strate­gic al­ter­na­tives.

Bri­an Leuth­n­er

On Mon­day, Edge and PDS an­nounced that the com­bined com­pa­ny — with PDS share­hold­ers keep­ing a ma­jor­i­ty 70% and ex­ist­ing Edge in­vestors re­tain­ing the re­main­ing 30% share — would have suf­fi­cient cash to fund op­er­a­tions till 2020. The merged en­ti­ty, which will re­tain the PDS name and trade un­der a so far un­spec­i­fied tick­er on the Nas­daq, will fo­cus on de­vel­op­ing next-gen­er­a­tion can­cer im­munother­a­pies based on PDS’ Ver­samune tech­nol­o­gy.

The plat­form is based on man-made cation­ic lipids that are de­signed to pro­mote in­tra­cel­lu­lar de­liv­ery of tu­mor-re­lat­ed anti­gens and ac­ti­vate im­muno­log­ic sig­nalling path­ways that in­duce the pro­lif­er­a­tion of killer T-cells that at­tack and kill can­cer­ous cells. PDS Biotech­nol­o­gy is gear­ing up to ini­ti­ate mul­ti­ple Phase II/III clin­i­cal tri­als for its lead ex­per­i­men­tal prod­uct, PDS0101, in HPV-as­so­ci­at­ed can­cers.

Co-founder and chief of PDS Frank Bedu-Ad­do will con­tin­ue at the helm, while Edge CEO Bri­an Leuth­n­er will take on the role of pres­i­dent of the com­bined com­pa­ny.  The deal is ex­pect­ed to close in the first quar­ter of next year.

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.

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.

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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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a rather narrow market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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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.

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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Ex-My­lan em­ploy­ee pleads guilty to in­sid­er trad­ing, il­le­gal­ly deal­ing on FDA ap­provals, earn­ings and Up­john merg­er

A former Mylan IT executive pleaded guilty Friday to an insider trading scheme where he bought and sold stock options on another executive’s advice.

Prosecutors secured the plea from Dayakar Mallu, Mylan’s former VP of global operations information technology, after uncovering the plan. Mallu collaborated with an unnamed “senior manager,” the SEC said, to trade options ahead of Mylan public announcements regarding FDA approvals, revenue reports and its merger with the Pfizer generics subsidiary Upjohn. The two subsequently shared profits.

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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.