Roche Korea Co., Ltd.

FN Media Group Presents USA News Group News Commentary VANCOUVER, British Colombia , Dec. 1, 2022 /PRNewswire/ -- USA News Group - A series of new Fast Track designations have been handed out by the United States Food and Drug Administration (FDA) this week, causing a flurry of activity in the markets for the worthy recipients. The most recent to gain such a designation is pelareorep from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) in combination with atezolizumab, an anti-PD-L1 checkpoint inhibitor from Roche Holding AG (OTCQX: RHHBY) for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). Among the small handful of other companies that recently received this distinction for their platforms have been Aravive, Inc. (NASDAQ: ARAV), Caribou Biosciences, Inc. (NASDAQ: CRBU), and Kintara Therapeutics, Inc. (NASDAQ: KTRA). The Fast Track process is designed to facilitate the development and expedite the review of investigational drugs to treat serious conditions and fill an unmet medical need. Drugs that receive Fast Track designation may be eligible for more frequent communications and meetings with the FDA to discuss the drug's development plan. Drugs with Fast Track designation may also qualify for accelerated and priority review of new drug applications if relevant criteria are met. "Receiving this Fast Track designation is an important accomplishment that speaks to the impressive response rate and the durability of the response in our PDAC study, and it also reflects the pressing need to improve upon the standard of care in this indication," stated Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "We expect the opportunity for more frequent communication about our data with FDA provided by this designation will be invaluable as we work to align with the Agency on the best design for a registrational PDAC study. With our core programs in breast and pancreatic cancer both nearing pivotal trials, and eligible for the Fast Track program's numerous benefits, we believe we are at a crucial point in Oncolytics' evolution and are excited for what's ahead." The approval for pelareorep came swiftly on the heels of the release of interim clinical data in a cohort of first-line advanced/metastatic PDAC patients treated with the combination of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel in Oncolytics' phase 1/2 GOBLET study. Within that study's cohort was a 69% objective response rate (ORR), including a complete response, which the National Cancer Institute defines as "the disappearance of all signs of cancer in response to treatment" (aka "remission"). For reference, this ORR is nearly triple the average ORR of ~25% reported in historical control trials evaluating gemcitabine in combination with nab-paclitaxel in pancreatic cancer. "The robust efficacy signal in GOBLET markedly exceeded expectations based on historical results and is especially encouraging as most responding patients had their tumor regressions confirmed by subsequent evaluations," said Thomas C. Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics Biotech. "We were particularly excited to see a partial response deepen into a confirmed complete response as of the latest data cut, since this further indicates potentially durable anti-cancer effects from the combination therapy." This represents the second FDA Fast Track designation in Oncolytics' history, with the first being for pelareorep in Metastatic Breast Cancer back in May 2017. Though not in the United States, the day prior saw Roche Holding AG (OTC: RHHBY) subsidiary Roche Korea's lymphoma treatment Lunsumio gain the distinction of the first drug designated as the subject of the South Korean government's Global Innovative products on Fast Track (GIFT). South Korea's Ministry of Food and Drug Safety said that it picked Lunsumio Inj. as the first product of the government's new program, as it was designated as a drug with no existing competitors as a treatment for recurrent and refractory follicular lymphoma. The news of both the pelareorep combination and Lunsumio win in Korea comes as an optimistic spot for Roche, having just rescinded its indication for Tecentriq® (the trade name for atezolizumab) for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC, bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. "While we are disappointed with this withdrawal, we understand the need to uphold the principles of the FDA's Accelerated Approval Program, which brings innovative medicines to patients sooner," said Levi Garraway, M.D., Ph.D., Chief Medical Officer and head of Global Product Development. "We remain confident in the benefit Tecentriq offers to people diagnosed with some of the most difficult-to-treat forms of cancer." Late clinical-stage oncology company Aravive, Inc. (NASDAQ: ARAV) also announced that Fast Track Designation was granted by the FDA, for its lead program, batiraxcept, for treatment of patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have progressed after 1 or 2 prior lines of systemic therapy that include both immune-oncology (IO)-based and vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI)-based therapies (either in combination or sequentially). The designation comes after Aravive demonstrated new data that delivered a 57% ORR and median Progression-Free Survival (PFS) of 11.4 months. "Response rates to single agent targeted kinase inhibitors are approximately 30% with a PFS of approximately 7 months," said lead investigator for the trial, Kathryn Beckermann, M.D., Ph.D., Assistant Professor, Division of Hematology and Oncology, Vanderbilt University Medical Center. "The early data seen with batiraxcept including biomarker development, response rate, and progression-free survival are promising." Leading clinical-stage CRISPR genome-editing biopharmaceutical company Caribou Biosciences, Inc. (NASDAQ: CRBU) also announced the FDA granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track Designations to CB-010, an allogeneic anti-CD19 CAR-T cell therapy for relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). "RMAT and Fast Track designations for CB-010 are important recognitions of the significant unmet patient need for an off-the-shelf cell therapy in the treatment of aggressive B-NHL," said Caribou President and CEO, Rachel Haurwitz, Ph.D. "Through genome editing with our precision CRISPR chRDNA genome-editing technology, CB-010 has been designed with a PD-1 knockout strategy to improve the persistence of antitumor activity by limiting premature CAR-T cell exhaustion. In our ANTLER Phase 1 trial, 3 of 6 patients treated with CB-010 at dose level 1 maintained a durable complete response at 6 months. We are encouraged that CB-010 has demonstrated early potential as an off-the-shelf cell therapy that may meaningfully rival autologous cell therapies." The FDA also granted Fast Track Designation to REM-001 Therapy from Kintara Therapeutics, Inc. (NASDAQ: KTRA), for the treatment of patients with cutaneous metastatic breast cancer (CMBC), after being studied in four Phase 2/3 clinical trials in patients with CMBC who had previously received chemotherapy and/or failed radiation therapy. With clinical efficacy to-date of 80% complete responses of CMBC evaluable lesions, and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is focused on securing the funding necessary to restart a 15-patient study in CMBC patients in advance of a Phase 3 study. "This designation from the FDA emphasizes the important unmet medical need for safe and effective therapeutic options to address CMBC," said Dennis Brown, Ph.D., Chief Scientific Officer of Kintara. "We have extensive data in hand to support the advancement of this clinical program and look forward to the continued investigation of our drug candidate in the next study as planned." For more information please visit: Article Source: USA News Group info@usanewsgroup.com DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. USA News Group is Source of all content listed above. FN Media Group, LLC (FNM), is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNM is NOT affiliated in any manner with USA News Group or any company mentioned herein. The commentary, views and opinions expressed in this release by USA News Group are solely those of USA News Group and are not shared by and do not reflect in any manner the views or opinions of FNM. FNM is not liable for any investment decisions by its readers or subscribers. FNM and its affiliated companies are a news dissemination and financial marketing solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. FNM was not compensated by any public company mentioned herein to disseminate this press release. This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and FNM undertakes no obligation to update such statements. Media Contact Information: FN Media Group, LLC Media Contact e-mail: editor@financialnewsmedia.com U.S. Phone: +1(954)345-0611

Hong Chow → Beginning Oct. 1, Roche China CEO Hong Chow will be head of China & international for Merck KGaA’s healthcare business, a position that also encompasses Japan, Europe, Latin America, Asia-Pacific, the Middle East, Africa and Russia. The multi-pronged position also has Chow leading the cardiovascular metabolism & endocrinology franchise and the Global Business Innovation (GBI) unit. A Bayer alum, Chow has helmed Roche China since 2015. “My years with Roche have been just incredible and I am forever grateful for the opportunity to work with so many amazing people in China and around the world to deliver so many more innovative drugs to Chinese patients in an unimaginable speed,” Chow said on LinkedIn. “At the same time, I am very excited to start the new chapter in October with Merck to make a broader impact to patients and society in China and internationally.” Cristal Downing → As for the other Merck, Cristal Downing will become chief communications & public affairs officer for new CEO Rob Davis’ team, effective Aug. 16. Downing jumps from another Big Pharma, J&J, where she spent six years in multiple communications capacities, ending her run there as VP, communication & public affairs, medical devices. Merck’s leadership revamp has extended beyond the CEO slot, with Caroline Litchfield succeeding Davis as CFO, former chief marketing officer Mike Nally leaving for Flagship’s Generate Biomedicines, and Dean Li taking over R&D for Roger Perlmutter, who’s getting a fresh start as CEO of Eikon Therapeutics. Karen Linehan → Longtime execs Karen Linehan (EVP, general counsel and head of legal, ethics & business integrity) and Philippe Luscan (EVP, global head of industrial affairs) are retiring from Sanofi, with Roy Papatheodorou and Brendan O’Callaghan slated to replace them. Papatheodorou has been general counsel at Novartis since 2017 and joined the Swiss pharma in 2014. O’Callaghan scores a promotion from his current position as global head of Sanofi’s biologics platform that will take effect after Luscan’s retirement sometime in 2022. Their predecessors share an impressive run: Luscan’s Sanofi career began in 1990, while Linehan, who retires on Dec. 31, joined soon after in 1991. → Luciana Borio has quite the decorated résumé and she’s adding a new gig as a venture partner at Bob Nelsen’s ARCH to the list. Borio, who was once vetted by President Biden’s team to lead the FDA as commissioner, formerly served as the administration’s acting chief scientist. In addition, she’s held roles as VP at nonprofit investment firm In-Q-Tel, serves as a senior fellow for global health at the Council on Foreign Relations, and is a member of CEPI’s scientific advisory committee. Bruce Eaton → Jim Mullen is filling another C-suite vacancy at Editas Medicine by promoting Bruce Eaton to CBO after choosing Mark Shearman to replace Charles Albright as CSO. Eaton’s association with Editas dates back to 2015 when he started consulting for the genome editing player, then became a research collaborator before ultimately gaining the title of SVP, chemistry, and site head in Boulder, CO. Eaton also co-founded and was CEO of i2 Pharmaceuticals and fleetingly served as COO of SomaLogic. On a related Editas note, former CEO Cynthia Collins has been elected to the board of directors at Poseida Therapeutics. → Orchard Therapeutics’ former chief technical officer, Ran Zheng, is taking over the wheel at Landmark Bio — a new center for advanced cell manufacturing once known as the Center for Advanced Biological Innovation and Manufacturing (CABIM). During her time at Orchard, Zheng was advancing the company’s product pipeline with the approval of Libmeldy for metachromatic leukodystrophy. Besides her stint at Orchard, Zheng held leadership positions at Genzyme and Amgen. → Medicxi-backed SynOx Therapeutics launched in November 2020 with a $44 million Series A round, aiming to develop an antibody to treat tenosynovial giant cell tumors (TGCT) named emactuzumab that John Reed once had on his radar while he was with Roche. This week Ray Barlow takes over as CEO of SynOx, while Ton Logtenberg has been named chairman. Barlow was CBO of Kiadis Pharma, the Dutch biotech which was sold to Sanofi — where Reed now leads R&D — for $357 million. He took on a number of business development roles at AstraZeneca and was Amgen’s executive director of corporate development from 2012-17. In addition to starting Crucell (acquired by J&J), Logtenberg founded Merus and stepped down as the company’s president, CEO and principal financial officer at the end of 2019. Kristen Albright → London-based microbial immunotherapy outfit Prokarium has promoted Kristen Albright to CEO. Albright, who set her career in motion as a postdoctoral fellow at J&J, first turned up at Prokarium in 2018 as VP, business development & translational research, then got the bump to COO last summer. Albright has also been a business development and licensing manager with Emergent BioSolutions. That isn’t the only C-suite news here: Prokarium has enlisted Uz Stammberger as CMO, formerly the translational clinical oncology program leader at the Novartis Institutes for BioMedical Research and the clinical lead for tepotinib at Merck KGaA. Jude Samulski → It’s go big or go home with the reinforcements at Selecta Biosciences, appointing AAV trailblazer Jude Samulski as a gene therapy special advisor. What’s the connection here? Playing a quick Six Degrees of Jude Samulski game, he co-founded and is CSO at AskBio, which made a splash by bringing in president of therapeutics Kathy High, who co-founded Spark, which has collaborated on gene therapies with … Selecta Biosciences. James Cassidy → Pfizer spinout SpringWorks Therapeutics adds to its long line of new execs with CMO James Cassidy. While he was with Len Schleifer’s squad at Regeneron, Cassidy was VP of oncology/strategic program direction, and he’s also been VP of oncology at Bristol Myers Squibb. In December 2020, SpringWorks promoted Badreddin Edris to COO and Mary Smith to chief development officer, then plucked chief commercial officer Bhavesh Ashar from Bayer in March. SpringWorks subsequently brought in R&D chief Mike Burgess from Turnstone Biologics in May. Peter Buhler → French vaccine biotech Valneva has finally found a replacement for CFO David Lawrence, but they’re stretching out the transition by indicating that Peter Buhler’s first day will be sometime “within the six months.” This odyssey toward a new CFO began when Lawrence initially retired from Valneva in September 2020, only to be named acting CFO several months later. Now he’ll “continue supporting Valneva until late 2021” in a change to the original plan upon retirement to stick around as an advisor until early 2021. Buhler, the current CFO of Quotient, has a number of financial roles on his résumé, including head of finance, Europe at Merck Serono. → The next wave of new leadership at Peter Thiel-backed Peptilogics features a quintet of execs, with CBO Nik Bhide leading off. A Novartis and Allergan vet in finance and corporate development, Bhide joins the peptide drug developer after a stint as the executive director, business development & licensing for Merck Research Laboratories. Marc Lesnick (SVP, regulatory and quality) co-founded and was chief development officer at Park Therapeutics, and his regulatory knowhow has taken him to such companies as Shionogi, Cascadian Therapeutics and Spruce Therapeutics. Jodie Gillon (SVP, corporate affairs and patient advocacy) is a Big Pharma alum who was recently Abeona’s chief patient officer and head of corporate and medical affairs. Also new to Pittsburgh-based Peptilogics is Albert Fonticiella (VP of people), who has worked in the Steel City as VP of corporate services for Edwards Marc Brands, the chocolatier which also has The Milk Shake Factory and Snappers pretzel snacks within its umbrella. And Shire vet Steve Kulp (VP of operations) moves on from his corporate operations gig at Idera Pharmaceuticals. Thiel contributed to the $35.4 million Series B that Peptilogics announced this past December before Christmas. Lisa Danzig → The pieces to the leadership puzzle at CRISPR player Excision BioTherapeutics — built around the work of Kamel Khalili — continue to fit into place with Lisa Danzig taking the CMO reins. Danzig’s leadership on Chiron’s clinical meningococcal franchise team laid the groundwork for her career; she has held the CMO position at PaxVax and was global head of medical & scientific affairs at Novartis. Since its Series A, Excision has also appointed an SVP of clinical development, a CFO and a head of translational medicine. → Anti-aging player Alkahest, now a Grifols subsidiary after a $146 million deal in September 2020, has pegged Amgen vet César Cerezo as CMO. Cerezo pivots to Alkahest after four years with the pharma giant, which just channeled Monty Hall again this week and made a deal to acquire Teneobio for $2.5 billion. For the last year, Cerezo was Amgen’s VP, therapeutic area head of global affairs, general medicine in the following therapeutic areas: cardiovascular/metabolic, bone, nephrology, neuroscience, inflammation and biosimilars. Dannielle Appelhans → Dannielle Appelhans has been named COO at Pablo Cagnoni’s Rubius Therapeutics, which saw its stock soar due to the mid-March release of human data for its red blood cell-derived cancer drug. Appelhans, an ex-team leader in pharmaceutical manufacturing at Eli Lilly, was previously SVP of technical operations and chief technical officer for Novartis Gene Therapies. Rubius’ shares have since leveled off and the biotech is pinning its hopes on RTX-240 after “deprioritizing” its lead drug RTX-134 in March 2020. → RARE-X has tapped Charlene Son Rigby to helm its company as CEO of the rare disease technology nonprofit. Son Rigby previously served in positions at Oracle and Doubletwist before hopping over to the CBO role at Fabric Genomics. Additionally, Nicole Boice, RARE-X’s founder and current executive director, will shift over to the role of chief engagement officer. → Fresh off its $40 million Series A, Stephen Squinto-led Gennao Bio has brought on Claudine Prowse as CFO after the biotech announced the addition of COO Chris Duke a couple weeks ago. Prowse wraps up her time at Rocket Pharmaceuticals (which predates the Inotek merger) as SVP, strategy and corporate development, and she’s been an investor relations exec with Biogen and Human Genome Sciences. Sung You → Our Max Gelman profiled SalioGen when it announced its Series A financing in March, looking to play an integral part in gene therapy 3.0 by using mammalian-derived enzymes as its delivery system. This week SalioGen is assembling more members of the team with Sung You, chief business and strategy officer; Nancy Craig, SVP of genetic engineering and mobile elements; and Sandeep Nema, SVP of technical operations. Before becoming a managing partner with PBM Capital, You was a healthcare investment banking exec with Morgan Stanley; Craig’s work in mobile genetic elements is the driving force behind SalioGen’s gene coding platform called EDIT; and Nema ends a 24-year association with Pfizer, making his exit as executive director of biotherapeutics pharmaceutical science. → When miRagen bought out Viridian last fall — taking the Viridian name with it — Jonathan Violin was chosen to conduct the Boulder, CO biotech orchestra and Barrett Katz landed the CMO slot. This week Viridian has another principal musician to add with CFO and CBO Kristian Humer coming on board. Humer had been with Citigroup for 11 years, and since 2016 he was managing director of banking, capital markets & advisory for Citi’s global healthcare team. Tracey Lodie → Treg-focused Quell Therapeutics has pulled in Tracey Lodie as CSO, following a stint at Gamida Cell where she served in the same role. Prior to that, she was SVP, transitional immunology at BlueRock Therapeutics and VP of immunology at Syros Pharmaceuticals. Lodie jump-started her career at Sanofi Genzyme. → With first-year CEO Andrin Oswald at the controls, Centogene has tapped Patrice Denèfle as CSO starting Aug. 16. Denèfle picks up the mantle from Phil Lambert, who’s leaving the German rare disease biotech for undisclosed reasons after less than two years on the job. Once the general manager of the Roche Institute for Research and Translational Medicine, Denèfle has been a chief scientist before with 4P-Pharma and Genethon. Simon Harnest → Simon Harnest has answered the call to be chief investment officer at Emeryville, CA-based Metagenomi, the gene editing biotech that debuted with a Series A that Leaps by Bayer co-led in November. When he first clocked in at Cellectis at 2015, Harnest was VP, finance and investor relations, and he leaves André Choulika’s team after being promoted to chief investment officer this January. Bruce Kerwin → The cash spigot is flowing at Peer Review mainstay Umoja Biopharma after its $210 million Series B in June, and the Seattle-based company continues its torrid hiring pace with three new execs. Bruce Kerwin (SVP of process and product development) was VP of drug product design at Just Biotherapeutics — also out of Seattle — and served as a scientific director in protein formulation development at Amgen, where he spent 16 years. Ryan Larson (VP and head of translational science) co-founded the cell therapy product sciences department at Bristol Myers and was senior director of the cell therapy product and analytical team. Finally, Mike Fitzpatrick (VP of business development and operations) is also a Bristol Myers vet — spending 15 years at ZymoGenetics before the 2010 buyout — with responsibilities ranging from protein biochemistry and process development to corporate operations. → Metrion Biosciences has recruited Nick Foster as CCO and head of global business development. Foster joins with experience from his times at BioFocus (now Charles River Laboratories) as associate director, business development Europe; Optibrium as head of commercial operations; and WuXi AppTec as director, business devlopment. Anand Shah → Making its plans to go public last week, Tillman Gerngross and Adagio Therapeutics are building a blue-ribbon group for its board of directors, with Tom Heyman, Anand Shah and Michael Wyzga reserving their seats alongside Adagio chair Rene Russo. Heyman, the ex-president of Johnson & Johnson Development Corporation, retired in 2019 after 37 years with J&J. Shah was deputy commissioner for medical and scientific affairs at the FDA for a year until he stepped aside in January. And Wyzga, who was with Genzyme from 1993-2011 and was president and CEO of Radius Health, is president of MSW Consulting, Inc. Amy Garabedian → Not shying away from the IPO volcano that has erupted the past couple years, Lava Therapeutics exceeded $100 million with its raise in March and has welcomed Amy Garabedian this week as general counsel and corporate secretary. Garabedian had previously been associate general counsel at Spark, where she had been lending her legal expertise since 2015. → SPT Labtech has some changes in its leadership team. David Newble, who has been serving as managing director has been tapped as the company’s CEO — taking over for Patrick Bennett who will assume the role of chairman of the board. Additionally, Paul Ventura has been named VP of sales and Joby Jenkins joins as VP of business development. → Attralus has brought on Jake Bauer as an independent director on its board of directors. Bauer was most recently CBO of MyoKardia and VP, business operations and head of corporate development at Ablexis. Adrian Woolfson → After Sangamo’s R&D split last summer, Adrian Woolfson has resurfaced as a board member at ImmunoScape, which zeroes in on technology “that allows for immune profiling and characterization of the human immune response at extremely high resolution.” Jason Fontenot, the acting head of research after Woolfson’s departure, has since been promoted to CSO, while Rob Schott came in to lead development at Sangamo earlier this year. → Sizing things up for an IPO according to Bloomberg, Singapore’s Hummingbird Bioscience has beefed up its board of directors with Fred Hutch president Tom Lynch. In May, Hummingbird raised $125 million for its precision oncology pipeline in a Series C led by Novo Holdings. Helen Collins → Troy Wilson-led Kura Oncology has made Helen Collins a member of its board of directors. The CMO at Five Prime until the Amgen purchase, Collins has also been Gilead’s global lead of oncology biosimilars. → Cambridge, MA immuno-oncology biotech Oncorus has opened up a seat for Barbara Yanni on a board of directors that has expanded in the last year after the appointments of Scott Canute and fellow Merck vet Eric Rubin. Yanni retired from Merck in 2014 as VP and chief licensing officer Karimah Es Sabar → Linda Marbán and the folks at Capricor Therapeutics are bringing in Karimah Es Sabar as a member of their board of directors. Es Sabar is CEO and partner at Vancouver-based Quark Venture and she chairs the Health & Biosciences Economic Strategy Table for the government of Canada. → Cell and gene therapy biotech Inceptor Bio has named Mark Gilbert as chair of its scientific advisory board. Gilbert was the former CMO of Juno Therapeutics and was a faculty member at Fred Hutch and the University of Washington in Seattle. → Janssen vet Mark Bach has gained a seat on the clinical scientific advisory board at Lumos Pharma. Bach is currently CMO for ShouTi, having joined the company from Ascendis Pharma.

Benny Sorensen Don’t let the short week deceive you. Peer Review has a lot to get to: → When our Nicole DeFeudis profiled new Codiak CMO Jennifer Wheler, she also wrote that Benny Sorensen would be taking on the role of SVP of strategic projects after heading up clinical development. That didn’t last long. We’ve learned that Sorensen has resigned to lead Danish biotech Hemab Therapeutics as CEO. Backed by Novo Holdings, Hemab is a three-year-old company that develops bispecific antibodies for rare bleeding disorders that had been helmed by co-founder Johan Faber. Sorensen, an Alnylam vet, will still be connected to Codiak as a member of the scientific advisory board and a clinical consultant. → We’re staying in Denmark as Michael Pehl has been named CEO at Adcendo, focused on ADCs and equipped with the largest Series A round for a biotech in the land of Borgen. As CEO of German CAR-T player GEMoaB, Pehl helped join forces with Blackstone and CRISPR bigwig Intellia to launch a new CAR-T biotech in late June. Blackstone plunked down $250 million on the investment. Pehl, the ex-president and CEO of Immunomedics, was president of oncology (among other positions) during his tenure with Celgene from 2006-17. Axel Hoos → GlaxoSmithKline is losing its oncology head as Axel Hoos hits the exit to man the ship at stealthy biotech Scorpion Therapeutics as CEO. During his nine-year gig with the UK pharma giant, Hoos oversaw a long-awaited turnaround at GSK oncology after the company opted to offload its entire late oncology pipeline to Swiss drugmaker Novartis in March 2015. Most recently, Hoos served as GSK’s SVP, R&D governance chair and therapeutic area head oncology. Christopher Giordano → We have a succession plan in place at Tenax Therapeutics in the Research Triangle, as Christopher Giordano grabs the top spot and Anthony DiTonno retires as CEO. Giordano officially takes over at Tenax on July 14 after more than a dozen years with IQVIA, three of those as president of IQVIA Biotech. DiTonno had led the company since June 1, 2018 and had been on the board of directors since 2011. Tenax has hit its share of turbulence in the past — after lead candidate levosimendan tumbled badly in Phase III in early 2017, giving its stock a thrashing, then-CEO John Kelley resigned a couple months later. Concurrent with the Giordano news, Tenax is unloading $10 million in stocks to an investor not identified in the release. → Hoping to get back in the good graces of investors in the Duchenne sweepstakes, Ilan Ganot has lined up three new execs at Solid Biosciences a month after adding chief regulatory officer Iman Barilero to the staff. Up first, Roxana Donisa Dreghici leaves Roche to take on the role of SVP, clinical development for Solid Bio. Donisa Greghici was the Swiss pharma’s global development lead/associate group medical director, neuroscience. Also at Solid Bio, American Express vet Caitlin Lowie (VP, communications & IR) hits the scene after her time at Stallargenes Greer as senior director, communications and strategic growth initiatives. And Alison Kessler (VP, legal corporate & IP), formerly global head of patents for Novartis’ over-the-counter business, was briefly chief legal officer with Cosette Pharmaceuticals. Lou Arcudi → Lou Arcudi took over for Millendo co-founder Julia Owens as CEO after a Phase I implosion of NK3R antagonist MLE-301 left an empty cupboard and the option of a sale on the table. A merger with Tempest Therapeutics has since closed, and Arcudi is moving on to Amolyt Pharma — a maker of peptides for endocrine and metabolic diseases — as CFO. Arcudi, a Genzyme finance alum, was CFO and SVP of operations during his 11 years at Idera Pharmaceuticals. Prior to Idera, he served as Peptimmune’s VP of finance and administration. That’s not all: Amolyt has added Janssen alum and Ixaltis chief development officer Elisabeth Svanberg to the board of directors along with longtime Amgen exec James Hindman. → CRISPR upstart Locanabio, helmed by Jim Burns and awash with cash from a $100 million Series B, has recruited John Leonard as CSO and Edward Conner as CMO. Leonard (not to be confused with the Intellia CEO) makes the switch from CRISPR Therapeutics, where he led hematology and in vivo research and translation, and he also was head of metabolic and neuromuscular research in Sanofi Genzyme’s rare disease unit. Meanwhile, Conner exits Audentes (now Astellas Gene Therapies) after his tenure as CMO and has held that same title before with Sangamo. He was previously VP of global clinical development at Ultragenyx before his run of C-suite appointments. Sarah Lu → BioShin, the Biohaven subsidiary in Shanghai that hit pay dirt back in September with a $60 million round led by OrbiMed, has bolstered its leadership with CMO Sarah Lu and chief commercial officer Mary Ma. Lu is a 13-year UCB vet and former clinical development exec at Simcere who was recently SVP, president of global development for Shanghai Green Valley. Ma tackles the CCO role after a string of Big Pharma stops in China including Eli Lilly, AbbVie and — just before this move to BioShin — Merck, where she was a VP and led the hospital specialty care business unit. Caren Deardorf → Several weeks after losing CMO and head of R&D John Davis for “family reasons,” Magenta Therapeutics is reloading in another position as Caren Deardorf takes the chief commercial officer job. Deardorf, who was previously CCO at Ohana Biosciences, closed out her eight years at Biogen in 2019 as VP, global product development & commercialization lead for Spinraza and the SMA portfolio. In a related development, ex-Magenta chief operating and financial officer Jason Ryan is now on the board of directors at Sema4, which merged with the Casdin Capital SPAC named CM Life Sciences in February. → Partnering with Coherus on the anti-PD-1 toripalimab, Junshi Biosciences has selected Wei Qian as chief commercial officer. Qian spent the last five years as a VP at Roche China and the previous 10 playing a bevy of positions at AstraZeneca in China, including VP of the GAA business unit (gastrointestinal system, anesthesia and anti-infection). Junshi and Coherus unveiled data at last month’s ASCO for nasopharyngeal cancer that nudges toripalimab into the conversation in a crowded PD-1/L-1 space. Nikhil Goel → Sean McClain’s Absci filed for an IPO last week, shooting for the $100 million figure that’s become a popular placeholder. A slight stylistic change to the company name isn’t the only other move Absci has made, with Nikhil Goel stepping in as CBO and Sarah Korman as general counsel. Goel jumps over to the protein printing biotech based in Washington state after five years at Credit Suisse and was a director in the M&A business. After a stint as head of intellectual property for final drug products at Amgen, Korman then became Neuvogen’s general counsel and corporate secretary in 2019. → Outlook Therapeutics has nabbed Russell Trenary as the company’s president and CEO, succeeding Lawrence Kenyon who will continue to serve as CFO. Trenary joins the company from InnFocus, where he served as president and CEO in a seven-year stint before its acquisition by Santen Pharmaceutical. Before that, Trenary was president and CEO of global medical device company G&H Orthodontics and served in a variety of roles at Sunrise Technologies, VidaMed and Allergan. Sabine Daugelat → With the radiopharmaceuticals field sizzling, Germany-based ITM is bringing in Sabine Daugelat as COO after nabbing $109 million in loan financing back in April. Daugelat, once the senior global program team director at Sandoz, ends her two-year association with Pieris Pharmaceuticals as executive director, head of project leadership. RayzeBio and Aktis are among the other players who have joined the radiopharma bandwagon just in the past year. Rob Brainin → As Marc Stapley takes up the CEO mantle from Bonnie Anderson, Veracyte has locked in two other execs with EVP and CBO Rob Brainin and SVP and chief information officer Bill Zondler. Brainin, the erstwhile CEO of Genuity Science, was once VP and general manager of Illumina’s life sciences and applied genomics business. Fleetingly the consulting CIO at Axovant, Zondler comes to Veracyte from another CIO post at Biotheranostics. → David Hewitt has signed on as CMO of Bay Area non-opioid pain management biotech Allay Therapeutics, which made its debut in May with sterling Phase I pain relief data that showed they “were on to something that precipitated the coming-out party,” as CEO Adam Gridley told Endpoints News. Hewitt, the ex-Syneos Health CMO who broke into biopharma at J&J and then migrated to the neurology group at Merck, is the former SVP of clinical development for both Nura Bio and Karuna Therapeutics. Adam Cutler → Q32 Bio — the Cambridge, MA biotech where CMO Jason Campagna landed after his time at Intercept — has locked in Adam Cutler as CFO. Cutler makes the switch after almost four years in the same post at Austin-based Molecular Templates, which struck an I/O deal in February with Bristol Myers Squibb worth $70 million upfront. Before jumping to that CFO spot, he was SVP of corporate affairs at Arbutus. Making the most progress thus far at Q32 Bio is an anti-IL-7Ra antibody in Phase I dubbed ADX-914. → Biophytis isn’t one of the flashier companies to go public in 2021; nevertheless, the French biotech did price its IPO at $16.75 million after withdrawing its first try, and its lead drug for sarcopenia is also in Phase II/III for Covid-19 patients with pneumonia. This week Biophytis has fleshed out its C-suite with Jean Mariani as CMO and Benoit Canolle as CBO. Mariani, the director of L’Institut de la Longévité, is also professor emeritus at Sorbonne University. When his 11-year run at Sanofi drew to a close in 2015, Canolle was project manager for the immuno-inflammation development franchise. For the last year, he’s been Pierre Fabre’s head of corporate medical portfolio & project direction. Just one more thing, as Columbo liked to say: Claude Allary is in line to replace Jean Franchi on Biophytis’ board of directors. Tina Beamon → San Diego cancer biotech MEI Pharma — collaborating with Kyowa Kirin on PI3Kδ inhibitor zandelisib —has appointed Tina Beamon chief compliance officer. Beamon, who just filled the same role at Karyopharm, has also been Alexion’s executive director of compliance and ethics. Before Alexion, she brought her legal experience to Boehringer Ingelheim as the German pharma’s senior counsel in the US oncology business unit. → Copenhagen-based IO Biotech has enlisted Keith Vendola as CFO. Vendola brings to the table experience from his times at Rezolute, Coherus, Eiger BioPharmaceuticals and Threshold Pharmaceuticals (now Molecular Templates). Jisoo Park → Melinta Therapeutics makes Peer Review for the second week in a row as the antibiotics maker brings in Jisoo Park as head of business development, M&A and strategy. A veteran of JP Morgan’s global healthcare team, Park was previously VP of business development and M&A at Covis Pharma. This marks the second hire in as many weeks for Melinta as the company removed the interim tag from CFO Susan Blum. → Elevar Therapeutics is adding some fresh faces to its leadership team with the appointments of Maureen Conlan as CMO, Julie Boisvert as VP, regulatory affairs and Dominick DiPaolo as VP, quality assurance. Conlan comes to the Salt Lake City-based company from Radius Health; Boisvert hops aboard from BeiGene USA, where she served as senior director in regulatory affairs; while DiPaolo joins from quality and compliance consultancy firm Quality by Design. Preethi Sundaram → Having battled it out in court over the approval of rival Jacobus’ LEMS drug — a battle that was ultimately lost — Catalyst Pharmaceuticals has tapped Preethi Sundaram as chief product development officer. Sundaram comes to Catalyst after an assortment of R&D and medical affairs roles in 16 years at Sanofi, ranging from global project head in multiple therapeutic areas to her latest responsibilities as global head of medical operations, general medicines business unit. → Austin, TX-based Aeglea BioTherapeutics has named Jonathan Alspaugh as CFO. Alspaugh makes the jump from Evercore, where he most recently served as a managing director in the firm’s corporate advisory business. Prior to that, Alspaugh was with Barclays Capital. Robert Millham → CATO SMS, a global provider of clinical research solutions, has bagged Robert Millham as president of clinical trial operations. Millham had a 17-year stint at Pfizer, where he led and contributed to the development of compounds against multiple indications of cancer, including lung, breast, colorectal and ovarian. He was also the COO of Odonate Therapeutics, SVP at Syneos Health and VP of strategic alliances for Caris Life Sciences. → Peer Review regular jCyte’s leadership keeps on growing with chief development officer and longtime GlaxoSmithKline exec Adrian Morris. From 1997-2012, Morris served in a number of capacities at the pharma giant ranging from VP, global commercial strategy in the respiratory pipeline to VP, diagnostics business unit and Pandemic Centre of Excellence. Since he left GSK, Morris had been managing director at Pharmaco Consulting. For those scoring at home, jCyte has added a CFO, chief commercial officer, general counsel and other execs in clinical development and medical affairs along with Morris since Shannon Blalock was promoted to CEO in February. Mark Altmeyer → Mark Altmeyer has been named chairman of Dutch-based AM-Pharma’s supervisory board. The Bristol Myers, Otsuka and Axovant vet was president and CEO of Arvelle before Angelini purchased it to ring in 2021 with a nearly $1 billion price tag. → Morningside Group co-founder Gerald Chan has added another chairmanship, this time at Cognito Therapeutics, which showed positive Phase II data with its lead digital product for Alzheimer’s. Chan is also chairman at Apellis and Stealth Biotherapeutics. Linda Bain → Codiak CFO Linda Bain is hopping onto the board of directors at VBI Vaccines. Prior to her role at Codiak, Bain was CFO at Adverum Biotechnologies; VP, finance, business operations, and treasurer at bluebird bio; and held roles at Genzyme. In addition to her new seat, Bain sits on the boards of Autolus Therapeutics and Arvinas. → OncoResponse has recruited CytomX president, CEO and chairman Sean McCarthy as an independent director of its board. McCarthy joined CytomX in 2010 as CBO and has served as CEO since 2011. Prior to that role, McCarthy was with Pappas Ventures, SGX Pharmaceuticals and Millennium Pharmaceuticals. Jan Hillson → Autoimmune and neurodegenerative disease biotech Eledon Pharmaceuticals has elected Jan Hillson to the board of directors. Hillson, the SVP of clinical development at Alpine Immune Sciences, was once SVP of drug development for ChemoCentryx. → Chaired by Brent Saunders and with new CMO David Tanzer joining the fray, the folks at eye disease biotech OcuTerra have enlisted Richard Lindstrom and Sheri Rowen for their scientific advisory board. The founder of Minnesota Eye Consultants, Lindstrom is an adjunct professor emeritus at the University of Minnesota’s ophthalmology department. Rowen, a LASIK surgeon in Newport Beach, CA, founded Mercy Medical Center’s ophthalmology department in Baltimore 25 years ago. → Chimeric Therapeutics has plucked up George Matcham as a non-executive director of its board. Matcham is a Celgene vet and was part of the company from its early days in 1988 to his retirement in 2018 — serving as COO of Celgene Cellular Therapeutics and SVP of CAR-T CMC development. Matcham previously sat on the board of Instil Bio as an advisor.