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Ex-Moderna commercial leader lands at Celsion as CEO; Schwan song: Changing of the guard at Roche to take effect next year

Corinne Le Goff
Less than 12 months into her job leading the commercial rollout of one of the world’s biggest-selling biotech products, Moderna’s Covid-19…

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Corinne Le Goff

Less than 12 months into her job leading the commercial rollout of one of the world’s biggest-selling biotech products, Moderna’s Covid-19 vaccine, Corinne Le Goff departed the household name in December 2021, but her future in the industry is just now coming into clear view.

The more than 30-year industry veteran — whose posts have run the gamut across Pfizer, Sanofi, Merck, Roche and Amgenis now CEO and president of Celsion, which itself is potentially looking to get into the SARS-CoV-2 vaccine landscape, albeit way later than her previous employer.

Le Goff kicked off her stint at the New Jersey biotech on July 18, replacing Michael Tardugno, who held the top post for the past 15 years. He remains in his role as executive chair.

“She adds tremendous depth of knowledge and joins us at a key inflection point in our evolution, as we work to rapidly advance our GEN-1 program for the treatment of advanced-stage ovarian cancer and build a proprietary vaccine platform based on our PLACCINE technology,” the outgoing CEO said in a statement.

The 37-year-old company has for decades been working on cancer drugs and has been working through a Phase III trial of its lead asset, dubbed ThermoDox, since the second half of 2014.

Celsion also has clinical-stage work in ovarian cancer, and is in the preclinical stages with glioblastoma and bladder cancer assets. Another potential avenue going forward is developing a vaccine candidate for the pandemic.

The new chief executive steps into a biotech with relatively small cash reserves of $47.3 million, which is about 3x its market cap. Celsion said that amount, as of March 31, is good enough to fund operations into the second quarter of 2025.

Kyle LaHucik


Severin Schwan

Severin Schwan is the latest Big Pharma CEO to plan his exit, handing the keys to Roche Diagnostics chief Thomas Schinecker on March 15, 2023. Roche will nominate Schwan, who has guided the Swiss multinational since 2008, as chairman to replace Christoph Franz. A board member for 11 years, Franz has been chairman since 2014 and won’t seek re-election.

Under Schwan’s watch, a number of drugs achieved blockbuster status at Roche, including Ocrevus, Kadcyla, Actemra and Tecentriq. Analysts project that its spinal muscular atrophy drug Evrysdiapproved in August 2020 — is headed down the same blockbuster path, giving Zolgensma and Spinraza a run for their money.

Schwan follows the recent transitions of Merck’s Ken Frazier and J&J’s Alex Gorsky in the land of pharma giants, and Biogen is on the hunt for Michel Vounatsos’ successor. Both Frazier and Gorsky have served as executive chairman of their respective companies after their CEO days ended.

Kabir Nath

Compass Pathways is pointing in the direction of a new CEO, as Kabir Nath takes over for George Goldsmith at the London psychedelics biotech on Aug. 1. From there, Goldsmith will be executive chairman until Dec. 31, when he’ll settle into his role as chairman. Nath is currently senior managing director of Otsuka’s global pharmaceutical business, and earlier he was president and CEO of the Otsuka North America pharmaceutical business. Nath also held several posts at Bristol Myers Squibb, including president of BMS China and SVP, virology, transplant & optimized brands.

Feng Ren vaulted to co-CEO with Alex Zhavoronkov at Insilico Medicine last month just after a $60 million cash infusion, and the AI outfit’s team has grown with Sujata Rao overseeing global clinical development. At Eli Lilly, Rao was associate VP of global clinical development for such drugs as sintilimab, which has famously been struck down by the FDA for its reliance on China-only data. Rao has further Big Pharma ties as immuno-oncology medical lead and oncology scientific advisor at Bristol Myers for nivolumab (Opdivo).

Baisong Mei

→ Not only has Editas Medicine seen volatility at the top with multiple CEOs in short order, the CMO position had been vacant since Lisa Michaels’ sudden and unexplained ouster in February. Baisong Mei was named as her successor early this week, leaving Sanofi behind after his tenure as senior global project head, rare diseases and rare blood disorders. Following 10 years at Bayer, he then moved on to Biogen in 2010, first as director, discovery research and then as therapeutic area head for hematology clinical development.

Editas is on its fourth chief executive in three years after Katrine Bosley’s departure in early 2019. In April, ex-Sarepta CMO Gilmore O’Neill replaced Jim Mullen, who took control when Cynthia Collins left in February 2021.

Kunwar Shailubhai

Kunwar Shailubhai has turned in his resignation as CEO, CSO and member of the board at Tiziana Life Sciences, and on Aug. 1, executive chairman Gabriele Cerrone will take charge as interim CEO. Shailubhai’s decision “is not related to any disagreement with the Company on any matter relating to the Company’s operations, policies or practices,” the statement reads. Tiziana has two candidates in early-stage trials: foralumab, an anti-CD3 monoclonal antibody; and milciclib, a pan-CDK inhibitor.

Elizabeth Forminard

→ J&J general counsel Michael Ullmann is calling it a career after 33 years at the pharma giant, retiring “at the end of this year” and assisting with the transition as Elizabeth Forminard takes the wheel on Oct. 17. Ullmann started out as an M&A attorney for J&J in 1989 and has spent the last 11 years as general counsel, while Forminard joined from Pfizer in 2006 and was elevated to worldwide VP, general counsel for the pharmaceutical sector three years ago.

Mark Pruzanski

→ Life after Intercept is coming into clearer focus for Mark Pruzanski, taking another CEO gig at Versanis Bio, Joe Jimenez and Mark Fishman’s obesity play from the Aditum Bio family of companies. “There were a number of other opportunities that I was looking at, but Versanis just became utterly compelling to me,” Pruzanski told Endpoints News this week. “And the reason for that starts with the fact that we’re looking at addressing what I consider to be the chronic disease epidemic of our age.”

And at this point, where isn’t John Maraganore grabbing a board seat or an advisory post? The Maraganore Meter is up and running again, and ex-Intercept CFO Barbara Duncan joins him on Versanis’ board.

Stephen Dilly

Stephen Dilly is making a quick comeback to the biotech scene as the new CEO of enzyme engineer Codexis. Dilly makes the jump not long after selling Sierra Oncology to GSK in February. Dilly is taking over the reins from John Nicols, who is retiring after a decade of service to focus on family and to devote his time to Solve ME/CFS — the nonprofit he chairs that is dedicated to myalgic encephalomyelitis/chronic fatigue syndrome. Dilly has worn the CEO hat not only at Sierra, but at Aimmune Therapeutics as well, which was sold to Nestlé Health Science after securing the first FDA nod for a peanut allergy treatment.

Volker Knappertz

Max Colao is out as chief commercial officer of Aurinia “to tend to personal matters” as CEO Peter Greenleaf lines up Scott Habig as his replacement. The revolving door is getting a workout at the Lupkynis maker, which has also welcomed Volker Knappertz as EVP of R&D and DeDe Sheel as VP of investor relations.

Habig just ended a 10-year run at UCB as head of global SLE (systemic lupus erythematosus) and he’s also held sales and marketing posts at Centocor. Knappertz spent nearly five years as CMO and EVP of R&D at GW Pharmaceuticals, now in the hands of Jazz Pharmaceuticals after a $7.2 billion buyout in 2021. Sheel owned the same title at Sierra Oncology and Aimmune, and she also had investor relations roles at Exelixis and Myovant.

Cathryn Clary

→ Fab Five: Notching a $115 million Series B in January for its gene therapy 3.0 ambitions, SalioGen is brimming with new hires under CEO Ray Tabibiazar. First up is Cathryn Clary (SVP of clinical Development and CMO), an ex-Pfizer and Ipsen exec who was CSO and head of US medical affairs and clinical development in the general medicines division at Novartis.

Also, Pat Sacco (SVP of manufacturing, quality, and operations) was SVP of technical operations at Translate Bio from 2019-20 after a 16-year run at Shire; Joe Senn (SVP of nonclinical development) comes to SalioGen from Moderna, where he finished up eight years at the Covid-19 vaccine titan as VP, nonclinical sciences; Feng Yao (VP of research — molecular switch and gene regulation) invented the T-REx technology used by Thermo Fisher and also taught at Brigham and Women’s Hospital and Harvard Medical School; and Oleg Iartchouk (VP of genomics and biomarkers) was global head of genomics during his eight years at NIBR.

Michele Anderson

→ The HBV drug vebicorvir will ride the pine at Assembly Biosciences, and as a result of the discontinued studies, 30% of John McHutchison’s workforce will be shown the door, prompting a game of musical chairs in the C-suite. CMO Luisa Stamm and CFO Michael Samar are out in the coming weeks, but a couple of colleagues have been promoted: Michele Anderson, Assembly Bio’s SVP of development operations, will move up to chief development officer, and COO Jason Okazaki will add the role of president to his business card on Aug. 1. In dueling statements, McHutchison didn’t see a way forward with vebicorvir combos, while its HBV partner Arbutus Biopharma begged to differ.

Peter McNamara

Tim Springer and Andrew Kruse’s GPCR play Tectonic Therapeutic, one of the Endpoints 11 winners last year and under the leadership of ex-Merck R&D vet Alise Reicin, has promoted Peter McNamara to CSO after bringing him on board from the Genomics Institute of the Novartis Research Foundation as head of research in May 2021. Tectonic has also introduced Barry Rubenstein as SVP, people and culture and Washington Alves as VP, biologics manufacturing. Rubenstein makes a change here after three years as VP, human resources at Kala Pharmaceuticals, and he also took on a series of HR positions at AMAG Pharmaceuticals from 2010-19. A Pfizer and Merrimack vet, Alves had previously been senior director, CMC operations for Gemini Therapeutics.

Chris Morabito

→ You may have read last week that Chris Morabito left Fulcrum Therapeutics, and it hasn’t taken him long to turn up at another biotech. Astria Therapeutics, the company once named Catabasis Pharmaceuticals until September 2021, has put down the welcome mat for Morabito as CMO after a year in the same position at Fulcrum. The ex-Cardurion CMO has also held a number of R&D posts at Takeda, Sanofi and Merck. Astria’s lead program STAR-0215 is in a Phase Ia trial for hereditary angioedema.

Marella Thorell

→ While Evelo Biosciences’ $79.2 million direct offering in May has done little for its fading stock price, Marella Thorell will seek to put the Flagship inflammatory disease biotech on solid footing as CFO on Sept. 1. After her dual role as CFO and COO of Realm Therapeutics, Thorell became finance chief of Palladio Biosciences, now a Centessa subsidiary. She was then named head of finance at Centessa and had served as chief accounting officer since April 2021.

Samuel Zhang

→ Chinese CAR-T player Gracell has selected Samuel Zhang as CBO. His Big Pharma experience runs the gamut, to wit: global launch lead for blockbuster drug Alimta at Eli Lilly; medical director/global medical head, immuno-oncology with Pfizer; head of prostate tumor strategy for Bristol Myers; and head of immuno-oncology product and portfolio strategy at Novartis. Most recently, Zhang was the business chief at NeoImmuneTech.

Peter Høngaard Andersen

→ European venture capital firm Forbion, which made an initial close of $504 million for its second growth fund last month, has tapped Peter Høngaard Andersen as operating partner and Matt Cooper as venture partner. Andersen hails from Lundbeck and Novo Nordisk and comes aboard with quite a few other stints under his belt, including co-founding Acadia Pharmaceuticals, Zealand Pharmaceuticals, Glycom and Epitherapeutics.

Meanwhile, Cooper has founded or co-founded companies such as Sitala and Inflazome and was the founder of the Center for superbug solutions, community for open access antibiotic discovery & center for drug discovery and design at the University of Queensland.

Kerry Wentworth

→ Trying to scrape itself off the canvas after getting knocked down by a partial clinical hold with its CDK inhibitor NUV-422, David Hung’s Nuvation Bio has installed David Liu as CMO and Kerry Wentworth as chief regulatory officer. Liu worked on Opdivo and Yervoy for Bristol Myers in China as group director, oncology global clinical research and was recently the medical chief for Shanghai-based 3D Medicines. Wentworth was chief regulatory officer for Flexion before Pacira Biosciences bought it for a song last year, and she also spent a decade with Agenus, where she was VP, clinical, regulatory, and quality.

Erin O’Neil

→ More execs are pouring into Opus Genetics, the new gene therapy biotech for eye diseases based in the Research Triangle founded by Jean Bennett. Vikram Arora (VP of non-clinical development) spent 11 years at Grifols and was director of pharmacology & toxicology at Talecris Biotherapeutics; Erin O’Neil (VP of clinical development) is a Google marketing specialist-turned-ophthalmologist at the Children’s Hospital of Philadelphia; and Sarah Tuller (VP of regulatory and medical writing) is an Astellas regulatory alum who comes to Opus after a year as VP of regulatory affairs at Disc Medicine.

Karla MacDonald

→ With its Endosomal Escape Vehicles (EEVs) going after Duchenne muscular dystrophy and myotonic dystrophy type 1 (DM1) first, Boston’s Entrada Therapeutics has promoted Karla MacDonald to chief corporate affairs officer. MacDonald, formerly VP of corporate communications and investor relations, was Ipsen’s VP, communications and patient advocacy following an 11-year run at Merck, where she rose to head of international communications.

Robert Foerster

→ Back in May 2020, Robert Foerster and Bill Erhardt joined New York neuro biotech Oligomerix as CFO and CMO, respectively. Foerster has now tacked on the role of COO, while Erhardt has been named president, head of development & operations to accommodate Oligomerix’s shift to two business units. CEO James Moe will be head of research & strategy and handle Discovery Group duties, while Erhardt leads the Development Group. Foerster and Erhardt both worked for Pfizer at the same time and have more than 35 years of combined experience at the pharma giant.

Zelanna Goldberg

→ San Diego-based Replicate Bioscience has welcomed Zelanna Goldberg as CMO and Mohit Trikha as a member of its board of directors. Goldberg joins the company after a stint as CMO at Alpine Immune Sciences. Prior to that, Goldberg was SVP of clinical development at Iovance and a 9-year gig at Pfizer. Meanwhile, Trikha is a venture partner at Apple Tree Partners and is the former VP and head of oncology early development at AbbVie.

Kate Surdez

Kate Surdez has signed on to be chief human resources officer of regenerative medicine biotech MiMedx. She was global HR director during her eight-year run at AstraZeneca, then led HR at the pharma giant’s spinoff Viela Bio until it was sold to Horizon for $3 billion last year. Since then, Surdez had been head of HR for Vaxxinity.

RenovoRx has named James Ahlers as CFO, succeeding Christopher Lehman, who is heading for greener pastures. Ahlers most recently served as CFO of Intarcia Therapeutics and served in finance roles at Titan Pharmaceuticals and Ansan Pharmaceuticals.

In addition, the company has recruited Ronald Kocak as VP and controller. Kocak hops aboard from Sensei Biotherapeutics, where he was controller and senior director of finance.

→ Backed in part by Oxford Science Enterprises, which started its week off with a bang by raising $300 million (£250 million), OMass Therapeutics has plugged in Jon Roffery as VP, head of medicinal chemistry. Roffery had led drug discovery at Nanna Therapeutics since February 2021, and he’s also been director of chemistry at Azeria Therapeutics. Oxford Science Enterprises contributed to OMass’ $100 million Series B in April alongside such investors as Syncona and GV.

Debra Hussain

→ Now that Eagle Pharmaceuticals plunked down $103 million for Acacia Pharma and its approved meds Barhemsys and Byfavo in late March, Debra Hussain will help with the relaunch of both products as SVP, head of commercial. Hussain was Acacia’s chief commercial officer until the deal was made, and she held a string of roles during a 22-year tenure at Eli Lilly that concluded in 2021 as senior director of marketing.

→ Based in the small Canadian border town of Baudette, MN — touted as the walleye capital of the world — ANI Pharmaceuticals has reeled in Meredith Cook as SVP, general counsel and corporate secretary. Cook spent the last two years as VP and associate general counsel for Amneal Pharmaceuticals after joining the company in 2019 as VP, transactions.

Serene Forte

→ Swiss-based Relief Therapeutics is bringing on Serene Forte as SVP, head of genetic medicine. Forte hails from RCP Bio, where she served as CSO. Prior to that, she was VP, medical affairs — gene therapy at Krystal Biotech. Earlier in her career, Forte had gigs at PTC Therapeutics, Sarepta and Medimmune.

Relmada Therapeutics is reeling in John Hixon as head of commercial. Hixon had a 31-year stint at Eli Lilly, most recently serving as senior director for global new product planning — biomedicines.

Jeff Hatfield

Vividion CEO Jeff Hatfield has been named chairman of the board of directors at repeatome-focused ROME Therapeutics, which features ARCH’s Kristina Burow, Nimbus CEO Jeb Keiper and ROME CEO Rosana Kapeller. Hatfield, a Bristol Myers vet and board member at George ScangosVir Biotechnology, replaced Diego Miralles as Vividion chief in November 2020.

→ Cambridge, MA-based GV20 Therapeutics is picking up a trio of advisors with the appointments of Alessandra Cesano (CMO of ESSA Pharmaceuticals), Julie Cherrington (former CEO and president of ARCH Oncology) and Mike Varney (former head of Genentech Research and Early Development and life sciences senior advisor at Frazier Healthcare Partners).

Dannielle Appelhans

→ Picking up the pieces after disastrous animal studies for its hemophilia A gene therapy program, Generation Bio has elected Novartis vet Dannielle Appelhans to the board of directors. Appelhans surfaced on Peer Review a year ago around this time when she took the COO job at Rubius.

→ We’re not done with Rubius execs getting board gigs, as Jose Carmona joins the board at allosteric drug developer HotSpot Therapeutics. Carmona, the CFO at Rubius for nearly two years, is also on the board of directors at Senda Biosciences.

→ Belgian biotech Apaxen, whose lead program is an NLRP3 inflammasome inhibitor for pulmonary arterial hypertension, has pegged Graham Dixon as chairman of the board. The AstraZeneca alum has also been CSO of Galapagos, where CAR-T is now a part of ex-J&J star Paul Stoffels’ turnaround project.

Bill Symonds

→ After picking up GSK vet Amol Ketkar as chief development officer at the start of the month, London-based Resolution Therapeutics has now brought Bill Symonds onto its board of directors. Symonds currently serves as the CEO of Sumitovant subsidiaries Altavant Sciences and Enzyvant Sciences. Symonds is also the former chief development officer of Roivant Sciences.

Mitch Gold has reserved space at Alpine Immune Sciences for Viela Bio co-founder Jörn Drappa on the board of directors. Drappa, an Amgen and Genentech vet, recently left Ventyx Biosciences just eight months after taking the CMO job.

Carlos Albán

Carlos Albán is headed to the board of directors at Pfizer spinoff SpringWorks Therapeutics. After 26 years at Abbott, Albán became AbbVie’s EVP, commercial operations in 2018 and retired as chief commercial officer in March 2021.

Eiger BioPharmaceuticals — the company that received an FDA OK back in 2020 in Progeria for a drug Merck licensed to them at no cost — has made the addition of Lisa Kelly-Croswell to its board of directors. Kelly-Croswell currently serves as SVP and chief human resources officer at Boston Medical Center Health System and is the former human resources lead at Vertex.

→ Back in 2021, iOmx Therapeutics bagged $75.3 million in a Series B to search for immune checkpoint targets on tumor cells, now the German company is adding three new members to its advisory board: Matthias Kromayer (managing partner at MIG Capital), Michael Burgess (head of R&D at SpringWorks Therapeutics) and Rainer Kramer (CBO at Immatics). The trio are joining Gerald Moeller (former CEO of Boehringer Mannheim Group), Henrijette Richter (managing parter at Sofinnova Partners) and Rainer Strohmenger (managing partner at Wellington Partners).

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#AAO22: Iveric Bio, undeterred by looming PDUFA for competitor, touts subgroup data on GA drug

CHICAGO — While its competitor is on the cusp of likely securing the first FDA nod, Iveric Bio is trudging ahead with its potential treatment for geographic…

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CHICAGO — While its competitor is on the cusp of likely securing the first FDA nod, Iveric Bio is trudging ahead with its potential treatment for geographic atrophy, an advanced form of AMD, and has new data to support its upcoming NDA filing.

The biotech said its drug was more favorable than sham across all subgroups in the second Phase III study of the investigational complement C5 protein inhibitor, performing similarly to a previous, smaller late-stage trial.

Dubbed avacincaptad pegol, or Zimura (more on that later), the drug beat out sham across patient groups with differing GA disc areas, patients with varying levels of vision clarity based on how many letters they can correctly read, age groups and gender.

Earlier this month, Iveric said the drug met the primary endpoint in the GATHER2 study, reducing the mean rate of GA lesion growth by 14.3%, a p-value of 0.0064. Avacincaptad pegol also cleared the bar in the GATHER1 study last year at a p-value of 0.007. With those two successes, Iveric claims it was the first to do so in GA.

Competitor Apellis, with a Nov. 26 PDUFA date, only succeeded on that prespecified primary goal in one of its two Phase III studies. But 18- and 24-month follow-ups turned the tide in Apellis’ favor, with the reduction rates improving. Both biotechs, within minutes of each other, presented the new data on their GA drugs at the American Academy of Ophthalmology’s annual conference in the Windy City.

Iveric is also collecting data out to 24 months, with half of the patients receiving the drug every month for the first 12 months and then rerandomized to receive it either monthly or every other month to see if benefit can be maintained.

Dhaval Desai

“We don’t really look at the guys ahead of us to say whether it influences one way or another. It just means there either will be someone there or there won’t be someone there,” Dhaval Desai, Iveric development chief and SVP, told Endpoints News Friday morning.

Desai said Iveric thinks it has a unique asset on its hands with a pegylated RNA aptamer “as opposed to a pure biologic play like some of these other compounds out there for geographic atrophy.”

“When aptamers were first in vogue, a big thing around it is they’re small molecules and they have affinity to the target. But the small molecule piece of this, we didn’t really appreciate the potential benefit until recently,” he continued, referring to the GATHER2 topline data from earlier this month.

Iveric believes the safety side is strong, too, with an “extremely clean safety profile,” Desai said. The serious treatment emergent adverse events were higher in the sham group, at 16.7%, than in the Zimura-treated patients, at 13.3%. For both groups, less than 1% of the serious events were ocular-related in the study eye.

GATHER2 was initially supposed to kick off in the early days of 2020, but the Covid-19 pandemic led Iveric to readjust and hold off on enrolling patients until after the first wave of the virus slowed down with the thought that it would lead to fewer patient no-shows. To track how well they did at retaining patients, Iveric observed “injection fidelity” rates, or the number of injections actually delivered over the number of injections expected to be given in the study. The results: 91% for Iveric’s drug and 94% for the sham group.

To help with patient retention, Desai said Iveric gave extra stipends to sites to help arrange car services for patients to get vaccinated.

With the Phase III data from both studies now out in the world, Iveric’s NDA paperwork will be at the FDA’s doorsteps before the end of the first quarter of 2023. Iveric will try to speed up that six-month timeframe, Desai said. The thought is that patients could be on treatment for five, six or more years, Desai said. The mean age of patients on the drug was 76.3 years and 76.7 years for the sham group.

In the meantime, Iveric is focused on bringing everybody up to speed on the need for treatment, how quickly GA lesions can grow and how big of an impact they have on vision, and what the health economic impact is — diminished eyesight, falling, or losing the ability to get behind the wheel.

“I think the community as a whole nor, very frankly, industry really appreciates that very well right now, so those are all the things that not only do we have to educate the community on, but we have to educate ourselves on,” Desai said.

Internally, Iveric also has to decide whether to stick with the name Zimura, which Desai said came to them via Eyetech Pharmaceuticals, well before he or other leaders arrived.

“We’ll see,” he said.

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Industry groups call to block WTO IP waiver expansion to Covid-19 therapeutics

The WTO’s TRIPS Council in mid-October is expected to debate whether to extend the IP waiver for Covid-19 vaccines to therapeutics and diagnostics too.
While…

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The WTO’s TRIPS Council in mid-October is expected to debate whether to extend the IP waiver for Covid-19 vaccines to therapeutics and diagnostics too.

While the Biden administration backed the original vaccine waiver, which critics note has not done much to expand access to vaccines as demand has dried up, US trade officials haven’t offered any perspective yet on whether to expand the waiver to Covid treatments.

The US Chamber of Commerce, as well as industry groups BIO and EFPIA, this week expressed “strong opposition” to any expansion of the WTO TRIPS waiver to therapeutics or diagnostics, arguing that waived IP protections damage the nation’s ability to innovate and compete.

Kevin O’Connor

Illinois-based IP attorney Kevin O’Connor at Neal, Gerber & Eisenberg told Endpoints News in a phone interview that he doesn’t think the vaccine waiver has done much so far.

“I don’t think it was the right solution for a demand problem,” O’Connor said. And an extension to therapeutics “would double down” on the same concept, except small molecule manufacturing is more straightforward than vaccine manufacturing. There’s also the question of whether there is a need for an extension given the voluntary licensing already in place.

BIO also noted that the expansion of a TRIPS waiver to therapeutics can create problems for therapeutics used for other indications too as these other indications “may be their only path to financial viability and sustained investment to fund future R&D initiatives.”

The industry group also noted the lack of a “supply and demand challenge globally that justifies the extension of an IP waiver” considering the fact that manufacturers are supplying therapeutics at a rate that outpaces demand.

The US Chamber of Commerce also noted that in the case of Covid-19 vaccine IP, “the waiver’s realization came long after its ostensible purpose was mooted by a large and growing surplus of COVID-19 vaccine supplies.”

Peter Maybarduk

But Public Citizen’s Peter Maybarduk told Endpoints these are “specious arguments and scare tactics,” adding, “Pharma is worried and that is a good thing for people.”

WTO members and developing countries pledged support for the waiver extension last summer, according to a read out of a meeting. Some even called for this extension to be discussed “with a sense of urgency given the fact that many least developed countries (LDCs) lack access to life-saving drugs and testing therapeutics.”

But other member countries “cautioned that more time was needed to conduct domestic consultations on a possible extension of the waiver to therapeutics and diagnostics” while:

Some members also flagged the importance of an evidence-based negotiation as there was no evidence that intellectual property did indeed constitute a barrier to accessing COVID-19 vaccines. Some also reiterated the need for members to fully make use of all the flexibilities that already exist in the TRIPS Agreement (including compulsory licensing) before requesting new flexibilities.

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Covid-19 roundup: Swiss biotech halts in-patient PhII study; Houston-based vaccine and Chinese mRNA shot nab EUAs in Indonesia

Another Covid-19 study is hitting the breaks as a Swiss biotech is pausing its Phase II trial in patients hospitalized with Covid-19.
Kinarus Therapeutics…

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Another Covid-19 study is hitting the breaks as a Swiss biotech is pausing its Phase II trial in patients hospitalized with Covid-19.

Kinarus Therapeutics announced on Friday that the Data and Safety Monitoring Board (DSMB) has reviewed the company’s Phase II study for its candidate KIN001 and has recommended that the study be stopped.

According to Kinarus, the DSMB stated that there was a low probability to show statistically significant results as the number of Covid-19 patients that are in the hospital is lower than at other points in the pandemic.

Thierry Fumeaux

“As many of our peers have learned since the beginning of the pandemic, it has become challenging to show the impact of therapeutic intervention at the current pandemic stage, given the disease characteristics in Covid-19 patients with severe disease. Moreover, there are also now relatively smaller numbers of patients that meet enrollment criteria, since fewer patients require hospitalization, in contrast to the situation earlier in the pandemic,” said Thierry Fumeaux, Kinarus CMO, in a statement.

Fumeaux continued to state that the drug will still be investigated in ambulatory Covid-19 patients who are not hospitalized, with the goal of reducing recovery time and the severity of the virus.

The KIN001 candidate is a combination of the small molecule inhibitor pamapimod and pioglitazone, which is currently used to treat type 2 diabetes.

The news has put a dampener on the company’s stock price $KNRS.SW, which is down 22% since opening on Friday.

Houston-developed vaccine and Chinese mRNA shot win EUAs in Indonesia

While Moderna and Pfizer/BioNTech’s mRNA shots to counter Covid-19 have dominated supplies worldwide, a Chinese-based mRNA developer and IndoVac, a recombinant protein-based vaccine, was created and engineered in Houston, Texas by the Texas Children’s Hospital Center for Vaccine Development  vaccine is finally ready to head to another nation.

Walvax and Suzhou Abogen’s mRNA vaccine, dubbed AWcorna, has been approved for emergency use for adults 18 and over by the Indonesian Food and Drug Authority.

Li Yunchun

“This is the first step, and we are hoping to see more families across the country and the rest of the globe protected, which is a shared goal for us all,” said Walvax Chairman Li Yunchun, in a statement.

According to Walvax, the vaccine is 83% effective against the “wild-type” of SARS-CoV-2 infection with the strength against the Omicron variants standing at around 71%. The shots are also not required to be stored in deep freeze conditions and can be put in storage at 2 to 8 degrees Celsius.

Walvax and Abogen have been making progress on their mRNA vaccine for a while. Last year, Abogen received a massive amount of funding as it was moving the candidate forward.

However, while the candidate is moving forward overseas, it’s still finding itself stuck in regulatory approval in China. According to a report from BNN Bloomberg, China has not approved any mRNA vaccines for domestic usage.

Meanwhile, PT Bio Farma, the holding company for state-owned pharma companies in Indonesia, is prepping to make 20 million doses of the IndoVac COVID-19 vaccine this year and 100 million doses by 2024.

IndoVac’s primary series vaccines include nearly 80% of locally sourced content. Indonesia is seeking Halal Certification for the vaccine since no animal cells or products were used in the production of the vaccine. IndoVac successfully completed an audit from the Indonesian Ulema Council Food and Drug Analysis Agency, and the Halal Certification Agency of the Religious Affairs Ministry is expected to grant their approval soon.

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