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After seven months of searching, Landos hires a CEO; Marty Duvall re-emerges from ill-fated Oncopeptides tenure

Landos Biopharma has landed a new CEO after seven months of being led by an interim chief executive.
Gregory Oakes took the helm of the autoimmune biotech…

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Landos Biopharma has landed a new CEO after seven months of being led by an interim chief executive.

Gregory Oakes took the helm of the autoimmune biotech this month, bringing with him nearly 30 years of industry chops, most recently as president of Vifor Pharma’s North America division and, before that, VP at Celgene. Oakes also spent a better part of the 2010s at Novartis, making his way up to head of biopharmaceuticals for generics division Sandoz.

He assumes the top post as Landos figures out its future path, about 18 months after landing on the Nasdaq. A “complete review of clinical development plans” will occur by year’s end, the biotech said this week.

“We are excited to leverage Greg’s strong background in inflammation and immunology as we refine and finalize developments plans for our three clinical-stage product candidates – omilancor, NX-13 and LABP-104,” chair Chris Garabedian said in a statement.

Landos has evaluated omilancor and NX-13 in the clinic for ulcerative colitis and Crohn’s disease. LABP-104 has also been tested in the clinic for lupus and rheumatoid arthritis.

Oakes will also be tasked with turning around a company with little stock $LABP value remaining — going from a peak of $15 last September to under $1 today — and relatively few funds in the bank. Landos had $73.8 million at the end of March, just enough to keep the lights on into the second half of 2023, as of a May update.

Kyle LaHucik


Marty Duvall

→ We see it all the time in sports: Just because a head coach hits a snag with one team doesn’t mean that coach isn’t being courted elsewhere. So it is with Marty Duvall, the ex-Tocagen CEO who has signed on to be chief executive at little-known ADC biotech Angiex. Duvall presided over Oncopeptides when the Swedish biotech decided to yank its multiple myeloma drug Pepaxto from the US market in October 2021, sending the company into a tailspin. Duvall left Oncopeptides more than a year into the job in November, leading to the return of Jakob Lindberg as CEO — and the possible stateside return of Pepaxto itself after an unexplained change of heart about the withdrawal in January. On Thursday, CHMP delivered a unanimously positive opinion on Pepaxti in the EU, setting the stage for the EMA’s final decision. Chaired by Iain Dukes, Angiex focuses on nuclear-delivered antibody-drug conjugates, or ND-ADCs.

Arati Prabhakar

→ The White House has nominated Arati Prabhakar as the next director of the Office of Science and Technology Policy (OSTP), the first woman and woman of color to be so nominated. The position, which requires Senate confirmation, was previously filled by Eric Lander, the founding director of the Broad Institute who resigned his post in February shortly after numerous accounts piled up regarding his pattern of bullying and disparaging staff. The White House bridged the gap by coaxing Francis Collins out of retirement before nominating Prabhakar, the head of DARPA from 2012-17 and the National Institute of Standards and Technology from 1993-97.

Stephen Gould

→ It didn’t escape the litany of biotechs scaling back their workforces, but antibody-focused Atreca has shored up its senior leadership with Stephen Gould as CSO. Gould capped a 16-year career with Genentech by spending the last year as executive director, translational oncology before venturing off to California-based Atreca, which decided to chop 25% of its staff earlier this month in a restructuring that is expected to keep the train on the tracks through 2023. Phase Ib data are expected for its lead monoclonal antibody candidate ATRC-101 — both as a monotherapy and in combination with Merck’s Keytruda — by year’s end.

John Stubenrauch

→ Already doing a trepak dance over its $167 million Series C round from March, Bob Nelsen-backed mRNA player Nutcracker Therapeutics has welcomed a trio of leaders to the stage. John Stubenrauch, who had a long career in Merck’s manufacturing division from 1996-2015, climbs aboard as COO after spending a year at Gilead as VP of biologics commercial operations (he had been SVP of manufacturing for Immunomedics before the buyout).

Geoff Nosrati, now Nutcracker’s CBO, had filled the same position at ImmunoScape and was SVP of strategy and corporate development with Aduro Biotech. Finally, Ian Wiener has been named general counsel, ending a nearly 30-year association with Los Angeles-based Irell & Manella.

Tanya Hayden

→ Hampered by a CRL this week for  its urea cycle disorder drug ACER-001 “because the facility was not ready for inspection,” Acer Therapeutics has nonetheless promoted Tanya Hayden to COO. Before leaping to Acer in June 2021 as VP of program and strategic alliance management, Hayden was head of operational excellence at Lonza’s Bend, OR campus, which the CDMO giant purchased through its acquisition of Bend Research in 2017. Hayden’s predecessor, Harry Palmin, will focus solely on his CFO duties.

Michael Kauffman is making his way over to Israel-based SIRTLab Corporation. The co-founder and former CEO of Karyopharm is taking up the mantle of CMO and will also co-chair the company’s board of directors. Prior to his stint at Karyopharm, Kauffman was CMO of Onyx Pharmaceuticals, CEO of EPIC Pharmaceuticals and held a variety of roles at Millennium Pharmaceuticals and Biogen.

Liquidia, which has been in an ongoing tussle with United Therapeutics over its competing pulmonary arterial hypertension drugs, has lined up Rajeev Saggar as CMO, taking over for Tushar Shah on July 18. Saggar, the former interim chief of the pulmonary critical care division of The University of Arizona College of Medicine — Phoenix, was recently VP of clinical development for Theravance Biopharma. In November 2021, Liquidia received a “tentative approval” with its inhalation powder for PAH, named Yutrepia, and then its stock tumbled when United nabbed an actual approval for Tyvaso DPI in May, all while getting entangled in a patent dispute that United lost in March.

Ben Yerxa

Ben Yerxa has been named permanent CEO of Opus Genetics, a gene therapy play from Luxturna architect Jean Bennett that kicked things off with $19 million in seed funding last September. Yerxa, the acting CEO at the retinal disease biotech since its debut, has also been CEO of the Foundation Fighting Blindness and the Retinal Degeneration Fund. He also co-founded Envisia Therapeutics and has board seats at such companies as SparingVision and Nacuity Pharmaceuticals.

EMD Serono tells Peer Review that Dan Zolnierz has been named global brand lead for Merck KGaA’s multiple sclerosis drug evobrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor. In 2016, Zolnierz started out as a member of the Mavenclad launch team, and two years ago, EMD Serono promoted him to neurology & immunology (N&I) business unit director for the UK and Ireland.

Euan Menzies

Jim Datin has retired after nine years as chief executive of Durham, NC-based CRO BioAgilytix and has been succeeded by Euan Menzies, who will also be chairman. Menzies has also been chairman and CEO of Bioclinica (which merged with ERT to form Clario) and the CEO of Vertafore. His appointment comes after BioAgilytix appointed two scientific officers — ex-Genentech scientist Lynn Kamen and Michelle Miller —  cvvvvvand added former Labcorp CEO David King to the board of directors.

Nina DeLorenzo

→ Traveling down a new road after running into trouble with the Department of Justice over its opioid addiction drug — leading to jail time for ex-CEO Shaun ThaxterIndivior has selected Big Pharma vet Nina DeLorenzo as chief global impact officer. DeLorenzo comes from a place that’s had its own share of trials and tribulations, Emergent BioSolutions, where she was SVP of global communications and public affairs. Earlier, she held public affairs roles at Merck and Pfizer; was VP, international government affairs for AbbVie; and was chief of staff, external affairs for Sanofi.

Igor Matushansky

→ There are changes aplenty at arenaviral immunotherapy player Hookipa Pharma, a month removed from Christine Baker’s promotion to COO. Igor Matushansky, Hookipa’s CMO and global head of R&D since 2017, will step away from these positions on June 30, but he’ll maintain a presence at the biotech as chairman of the scientific advisory board.

Additionally, head of immuno-oncology Katia Schlienger has earned a promotion to EVP, clinical development. In her most recent stop at Merck, Schlienger was senior director, clinical research, late development oncology (GI tumors). And Roman Necina, who took on the role of chief technology officer at Hookipa in 2019 after a short stay at Takeda, has now shifted to chief development officer.

Mark Strobeck

→ Iron deficiency outfit Rockwell Medical is cycling through another CEO as Russell Ellison exits stage left on June 30. He’ll be replaced on July 1 by Aquilo Partners managing director Mark Strobeck, the ex-COO of Zyla Life Sciences and then Assertio Therapeutics after the two companies merged in 2020. Ellison became chief executive in April 2020 after the departure of Stuart Paul, and the Paul era followed the acrimonious firing of Rockwell Medical founder Robert Chioini, who refused to step down and then sued the company. Chioini would become CEO of SQI Diagnostics in the summer of 2020, but he was gone within nine months.

→ Swedish kidney cancer biotech Oncorena has tapped one of its founders, Börje Haraldsson, as CEO. A longtime professor with the Sahlgrenska Academy at the University of Gothenburg, Haraldsson led global program teams at Novartis for iscalimab — a compound that CEO Vas Narasimhan played up, only to see it land with a thud in the kidney transplant indication — and ianalumab.

Carrie Melvin

Carrie Melvin has been named the first COO at Viridian Therapeutics, which rebranded from miRagen last year and is tackling thyroid eye disease with its lead program VRDN-001. Melvin had been SVP of clinical development operations at X4 Pharmaceuticals since August 2020. She was also VP of global clinical sciences and delivery, oncology at GSK after its acquisition of Tesaro, where she was VP of clinical operations.

Aleksandra Rizo

→ With Faye Feller taking over as CMO of Geron Corporation on July 9, current CMO Aleksandra Rizo will take on a consultant role as senior medical and regulatory advisor. Feller has been with Geron since 2019, serving as the imetelstat maker’s VP of clinical development. Prior to joining Geron, Feller was a medical leader in the hematology program at Janssen.

→ Facing regulatory barricades in the PI3K class with its Kyowa Kirin-partnered drug zandelisib, MEI Pharma has selected Anne Frese as chief people officer. The ex-VP of human resources at Bellicum and Artiva Therapeutics, Frese just completed a brief stay as chief human resources officer with Vyripharm Enterprises.

Shawna Wolverton

→ San Francisco-based Benchling, which last year pulled in a $200 million Series E in April and a $100 million Series F in November for its R&D cloud platform, has appointed Shawna Wolverton as chief product officer and Stuart Kerst as head of revenue operations. Wolverton brings experience from Zendesk and Salesforce, while Kerst most recently served as VP of global field operations at Workday.

Aditya Khosla

→ Developing AI-based therapies for GI diseases, specifically inflammatory bowel disease, Iterative Scopes has appointed Aditya Khosla as chief technology officer. Khosla co-founded and was CTO of PathAI, which just teamed up with GSK in April on a NASH/oncology drug discovery alliance.

Robert Denison

→ Digital health company Congenica is locking in Robert Denison as CEO. Denison joined the company in September 2019 as chief information officer. Prior to joining the Cambridge, UK-based company, Denison was VP of technology at Abcam and chief technology officer at Summit Media.

Herve Berdou

→ Indian drug manufacturer Piramal Pharma Solutions — which has been busy opening and updating its facilities across the globe — has tapped Herve Berdou as COO. Berdou makes his way to the Mumbai-based company from Lonza, where he served as global head of operations, cell and gene technologies. Prior to that, Berdou was with AstraZeneca, MedImmune and Novartis.

Maryam Abdul-Kareem

→ Unspooling data at this month’s ASCO for a BCMA CAR-T that’s pitting itself against J&J/Legend’s Carvykti in multiple myeloma, Arcellx has brought on Maryam Abdul-Kareem as general counsel. Abdul-Kareem had been deputy general counsel at Kinnate Biopharma after seven years of legal roles with AstraZeneca, including assistant general counsel, corporate.

Frank Scholz is upping his role at radiopharmaceuticals-focused NorthStar Medical Technologies, being promoted to the position of president and COO. When Scholz hopped into the company last June, he started as SVP and COO. Scholz came to the company from AlixPartners, where he served as managing director. Before that, Scholz had a six-year gig with Mallinckrodt.

Chris Horvath

→ To the Crossroads of America we go, and with the radiopharma frenzy showing no signs of abating, Indianapolis-based Point Biopharma has enlisted Chris Horvath as EVP, commercial. Horvath brings experience in the space from Novartis’ Advanced Accelerator Applications, where he was VP, head of US sales and marketing, prostate cancer franchise, radioligand therapy. He’s also held marketing positions at Janssen, Merck (with Keytruda), Dendreon (with Provenge) and Bayer (with darolutamide and the radiopharma drug Xofigo).

Kevin Litwiler

→ Led by Array Biopharma co-founder Tony Piscopio, Boulder, CO cancer player OnKure Therapeutics has recruited a former Array colleague, Kevin Litwiler, as SVP of DMPK and clinical pharmacology. Litwiler spent 19 years at Array before Pfizer’s $11.4 billion acquisition in 2019, and after the buyout, he was the pharma giant’s executive director, clinical pharmacology global product development.

American Gene Technologies has named Jeff Boyle as CSO. Boyle joins the company from Ellume USA, where he helped organize the construction of the company’s automated manufacturing facility for Covid-19 home tests in partnership with the Department of Defense. Prior to that, Boyle was with Qiagen.

→ San Diego-based Tryp Therapeutics has added on Sid Taubenfeld as COO. Taubenfeld most recently served as CEO of Tikun Olam Pharma and has served as a healthcare analyst at companies like Scopia Capital, RH Capital and Paw Partners.

Samantha Truex

→ DNA damage specialist and Novartis partner Artios has added Samantha Truex to the board of directors. The former chief executive at Quench Bio, Truex is now CEO of Upstream Bio, which set sail with $200 million in financing earlier this month. Upstream’s lead monoclonal antibody is an Astellas castoff named UPB-101.

→ Former GSK and Sanofi exec Anne Whitaker has been named chair of the board at ALS biotech QurAlis. Whitaker, who led the US cardiovascular, metabolic and urology business to conclude her 19 years at GSK, still chairs the board of Aerami Therapeutics, the company she helmed from 2018-20.

Vik Bajaj

Verily co-founder and ex-CSO Vik Bajaj, is sliding into the board of directors at Quantum-Si. Bajaj currently serves as managing director at Foresite Capital and previously served as CSO of Grail.

Doug Fambrough has clinched his spot on the board of directors at Oncorus, led by Moderna oncology vet Ted Ashburn. Fambrough was CEO of Dicerna from 2010 until Novo Nordisk purchased the RNAi biotech for $3.3 billion in late 2021.

Donna Ambrosino

Donna Ambrosino and Big Pharma alum Ralf Clemens are walking over to Clover Biopharmaceuticals, joining the company’s board of directors. Ambrosino is on Clover’s vaccine scientific advisory board and she had previously served as CEO of Nosocomial Vaccine Corporation. Clemens, the chair of Valneva’s SAB and a member of the SAB at CureVac, joins the board as a veteran executive from GSK, Novartis Vaccines, and Takeda.

William Kaelin has joined the board of directors at IconOVir Bio, which just brought in John Huynh as chief technology officer a couple weeks ago. The 2019 Nobel Prize recipient is a professor in the Department of Medicine at Dana-Farber and at Brigham and Women’s Hospital.

Jill Quigley has been elected to the board of directors at Chemomab Therapeutics, the Peter Thiel-backed Israeli biotech studying CM-101 in multiple indications, including primary sclerosing cholangitis. Quigley left Passage Bio in January after three years as COO and is a board member at Terns Pharmaceuticals.

Derek Graf contributed to this edition.

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International

Apple Reportedly Shifting Watch And MacBook Production To Vietnam

Apple Reportedly Shifting Watch And MacBook Production To Vietnam

Wary of soaring tensions surrounding out-of-favor countries like China,…

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Apple Reportedly Shifting Watch And MacBook Production To Vietnam

Wary of soaring tensions surrounding out-of-favor countries like China, multinational corporations such as Apple are diversifying production to places with less geopolitical risk.

Nikkei Asia spoke to three sources with direct knowledge of Apple's plans to shift Watch and MacBook production out of China to Vietnam for the first time. 

Apple suppliers Luxshare Precision Industry and Foxconn have already piloted a production run of the Watch in northern Vietnam. 

The move by Apple is a further win for the Southeast Asian country as it already produces iPads and AirPods. 

Two sources told Nikkei Asia that Apple had requested suppliers to set up a MacBook test production line in Vietnam. They said progress in constructing laptop production in the country has been "slow, partly due to pandemic-related disruptions but also because notebook computer production involves a larger supply chain."  

"AirPods, Apple Watch, HomePod and more ... Apple has big plans in Vietnam, apart from iPhone manufacturing," one of the people with direct knowledge of Apple's plans said. "The components for MacBooks have become more modularized than in the past, which makes it easier to produce the laptops outside of China. But how to make it cost-competitive is another challenge."

This trend is called "friendshoring." While it's a play on "offshoring," this isn't about companies moving operations back to the US and Europe, but rather seeking foreign alternatives that retain the benefit of low labor costs but with less international controversy. 

Apple's production diversification comes as the US and China already had an increasingly adversarial relationship before House Speaker Nancy Pelosi's visit to Taiwan sparked anger with Beijing. The fact is, geopolitical and trade war tensions aren't going away anytime soon and will only push Apple further away from China. Though reshoring production to the US is unfeasible because of labor costs, maybe robotics can offset some of those costs or perhaps set up shop in Mexico, where there's abundant cheap labor and healthy demographics. 

A recent Rabobank analysis of friendshoring showed that chief beneficiaries would include countries like Vietnam, India, Brazil, Bangladesh, Indonesia, Mexico, Turkey, Egypt, and South Africa.

Apple's Tim Cook appears to have learned a valuable lesson this year that high exposure of supply chains to China during Beijing's zero-Covid policies and worsening geopolitical tensions with the West is a dangerous cocktail, and the need to diversify production in a trend dubbed friendshoring is essential for survival in a multi-polar world. 

Tyler Durden Wed, 08/17/2022 - 18:30

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International

Apple Reportedly Shifting Apple Watch And MacBook Production To Vietnam

Apple Reportedly Shifting Apple Watch And MacBook Production To Vietnam

Wary of soaring tensions surrounding out-of-favor countries like China,…

Published

on

Apple Reportedly Shifting Apple Watch And MacBook Production To Vietnam

Wary of soaring tensions surrounding out-of-favor countries like China, multinational corporations such as Apple are diversifying production to places with less geopolitical risk.

Nikkei Asia spoke to three sources with direct knowledge of Apple's plans to shift Watch and MacBook production out of China to Vietnam for the first time. 

Apple suppliers Luxshare Precision Industry and Foxconn have already piloted a production run of the Watch in northern Vietnam. 

The move by Apple is a further win for the Southeast Asian country as it already produces iPads and AirPods. 

Two sources told Nikkei Asia that Apple had requested suppliers to set up a MacBook test production line in Vietnam. They said progress in constructing laptop production in the country has been "slow, partly due to pandemic-related disruptions but also because notebook computer production involves a larger supply chain."  

"AirPods, Apple Watch, HomePod and more ... Apple has big plans in Vietnam, apart from iPhone manufacturing," one of the people with direct knowledge of Apple's plans said. "The components for MacBooks have become more modularized than in the past, which makes it easier to produce the laptops outside of China. But how to make it cost-competitive is another challenge."

This trend is called "friendshoring." While it's a play on "offshoring," this isn't about companies moving operations back to the US and Europe, but rather seeking foreign alternatives that retain the benefit of low labor costs but with less international controversy. 

Apple's production diversification comes as the US and China already had an increasingly adversarial relationship before House Speaker Nancy Pelosi's visit to Taiwan sparked anger with Beijing. The fact is, geopolitical and trade war tensions aren't going away anytime soon and will only push Apple further away from China. Though reshoring production to the US is unfeasible because of labor costs, maybe robotics can offset some of those costs or perhaps set up shop in Mexico, where there's abundant cheap labor and healthy demographics. 

A recent Rabobank analysis of friendshoring showed that chief beneficiaries would include countries like Vietnam, India, Brazil, Bangladesh, Indonesia, Mexico, Turkey, Egypt, and South Africa.

Apple's Tim Cook appears to have learned a valuable lesson this year that high exposure of supply chains to China during Beijing's zero-Covid policies and worsening geopolitical tensions with the West is a dangerous cocktail, and the need to diversify production in a trend dubbed friendshoring is essential for survival in a multi-polar world. 

Tyler Durden Wed, 08/17/2022 - 18:30

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Economics

Reduced myocardial blood flow is new clue in how COVID-19 is impacting the heart

Patients with prior COVID may be twice as likely to have unhealthy endothelial cells that line the inside of the heart and blood vessels, according to…

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Patients with prior COVID may be twice as likely to have unhealthy endothelial cells that line the inside of the heart and blood vessels, according to newly published research from Houston Methodist. This finding offers a new clue in understanding covid-19’s impact on cardiovascular health.

Credit: Houston Methodist

Patients with prior COVID may be twice as likely to have unhealthy endothelial cells that line the inside of the heart and blood vessels, according to newly published research from Houston Methodist. This finding offers a new clue in understanding covid-19’s impact on cardiovascular health.

In a new study published today in JACC: Cardiovascular Imaging, Houston Methodist researchers examined the coronary microvasculature health of 393 patients with prior covid-19 infection who had lingering symptoms. This is the first published study linking reduced blood flow in the body and COVID-19.

Using a widely available imaging tool, called positron emission tomography (PET), researchers found a 20% decrease in the ability of coronary arteries to dilate, a condition known as microvascular dysfunction. They also found that patients with prior COVID-19 infection were more likely to have reduced myocardial flow reserve – and changes in the resting and stress blood flow – which is a marker for poor prognosis and is associated with a higher risk of adverse cardiovascular events.

“We were surprised with the consistency of reduced blood flow in post covid patients within the study,” said corresponding author Mouaz Al-Mallah, M.D., director of cardiovascular PET at Houston Methodist DeBakey Heart and Vascular Center, and president elect of the American Society of Nuclear Cardiology. “The findings bring new questions, but also help guide us toward further studying blood flow in COVID-19 patients with persistent symptoms.”

Dysfunction and inflammation of endothelial cells is a well-known sign of acute Covid-19 infection, but little is known about the long-term effects on the heart and vascular system. Earlier in the pandemic, research indicated that COVID-19 could commonly cause myocarditis but that now appears to be a rare effect of this viral infection.

A recent study from the Netherlands found that 1 in 8 people had lingering symptoms post-covid. As clinicians continue to see patients with symptoms like shortness of breath, palpations and fatigue after their recovery, the cause of long covid is mostly unknown.

Further studies are needed to document the magnitude of microvascular dysfunction and to identify strategies for appropriate early diagnosis and management. For instance, reduced myocardial flow reserve can be used to determine a patient’s risk when presenting with symptoms of coronary artery disease over and above the established risk factors, which can become quite relevant in dealing with long Covid.

Next steps will require clinical studies to discover what is likely to happen in the future to patients whose microvascular health has been affected by COVID-19, particularly those patients who continue to have lingering symptoms, or long COVID.

This work was supported, in part, by grants from the National Institutes of Health under contract numbers R01 HL133254, R01 HL148338 and R01 HL157790.

———————–

For more information: Coronary microvascular health in patients with prior COVID-19 infection. JACC: Cardiovascular Imaging. (online Aug. 16, 2022) Ahmed Ibrahim Ahmed, Jean Michel Saad, Yushui Han, Fares Alahdab, Maan Malahfji, Faisal Nabi, John J Mahmarian, John P. Cook, William A Zoghbi and Mouaz H Al-Mallah. DOI: www.doi.org/10.1016/j.jcmg.2022.07.006

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