Merck & Co., Inc.

NEW YORK, April 05, 2024 (GLOBE NEWSWIRE) -- HiberCell, Inc., a clinical-stage biotechnology company developing therapeutics to address cancer relapse, metastasis, and resistance, today announced the publication of “Discovery of HC-7366: An Orally Bioavailable and Efficacious GCN2 Kinase Activator” in the Journal of Medicinal Chemistry along with two poster presentations on this same molecule which will be highlighted at the American Association for Cancer Research (AACR) Annual Meeting 2024, taking place in San Diego, California. This publication and abstracts are now available online and on the AACR website, respectively. “The acceptance of these publications and presentations in top journals and at prestigious conferences are recognition of the strong scientific foundation that is the backbone of our clinical studies,” said Jonathan Lanfear, President & CEO of HiberCell. “In particular, our publication in the Journal of Medicinal Chemistry illustrates that that HC-7366 is a refined GCN2 activator with a superior PK/PD profile, enhanced selectivity, and robust preclinical efficacy.” Mr. Lanfear continued “We also look forward to presenting two posters highlighting key preclinical data for HC-7366 in two distinct combinations with important SOC agents at the upcoming AACR meeting. Our first poster features the remarkable preclinical activity of HC-7366 as monotherapy and in combination with belzutifan in clear cell renal cell carcinoma models (ccRCC). This work was foundational to our ongoing Phase 1b study in ccRCC in combination with belzutifan, which was announced earlier this year. Our second presentation details preclinical data demonstrating the ability of HC-7366 to augment osimertinib therapy to counteract resistance mechanisms in models of EGFR mutant NSCLC.” HiberCell is seeking partners to further develop the combination of HC-7366 and EGFR-TKIs, and other EGFR pathway inhibitors. Poster Presentations: Abstract Title: HC-7366, a potent GCN2 activator, complements belzutifan, a HIF-2⍺ antagonist, by providing combination benefit in belzutifan-sensitive models and monotherapy activity in belzutifan-resistant models Poster/Abstract Number: 4615 Session Date and Time: Tuesday Apr 9, 2024 9:00 AM - 12:30 PM Abstract Title: HC-7366, a potent GCN2 kinase activator, augments osimertinib therapy to delay resistance in EGFR mutant NSCLC models. Poster/Abstract Number: 4666 Session Date and Time: Tuesday Apr 9, 2024 9:00 AM - 12:30 PM About HC-7366 HC-7366 is a first-in-class, first-in-human, selective, potent, small molecule activator of the general control nonderepressible 2 (GCN2) kinase. GCN2 is one of the kinases of the integrated stress response (ISR) family, which responds to amino acid deprivation and is a key metabolic stress sensor in cells. While cancer cells utilize the ISR for survival, prolonged or hyperactivation of GCN2 with HC-7366 has been shown to have antitumor and immunomodulatory activity as a monotherapy and in combination with SOC agents in models of both solid and liquid tumors. HC-7366 is currently under clinical development in a Phase 1b study in clear cell renal cell renal cell carcinoma in combination with Merck’s oral hypoxia-inducible factor-2α (HIF-2α) inhibitor WELIREG® (belzutifan) (NCT06234605). WELIREG® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About HiberCell HiberCell is a clinical stage oncology company, dedicated to the advancement of first-in-class agents with the novel MOA of modulation of adaptive stress pathways and antitumor immunity. We believe that therapeutic modulation of these mechanisms allows us to address tumor metastasis, treatment resistance, and cancer relapse; all significant drivers of cancer-related deaths. Our product candidates HC-5404 and HC-7366, both having completed Phase 1a clinical trials, target the stress response kinases PERK and GCN2, respectively, while our product candidate odetiglucan, currently advancing towards Phase 2 clinical development, modulates the antitumor innate immune response. For more information about HiberCell, please visit hibercell.com. For Media/Investor Inquiries: IR@hibercell.com

Total spending for March was $188 million, up from $168.4 million in February. This is still some way off the $200 million-plus we saw tallied up for most months toward the end of 2023. It’s as you were at the top of the pharma drug ad spending list in March as AbbVie’s immunology blockbusters Rinvoq and Skyrizi stay first and second, respectively. This is the same order as we saw in February, according to data from real-time ad trackers at iSpot.TV, with spending also barely moving across both drugs and their spots. However, the third position saw a significant shift. This spot is usually reserved for Sanofi and Regeneron’s rival immunology giant Dupixent, but, in March, Otsuka and Lundbeck's Rexulti took its place. After spending just under $11 million in February and not being listed, Rexulti ads jumped right into the final podium position in March as the pair spent $24.8 million on three spots. Bristol Myers Squibb’s moderate to severe plaque psoriasis drug Sotyktu also jumped into the top 10 after not being in the listing at all the month before, more than doubling spending from $8.6 million in February to $19 million in March. Dupixent has dropped down to fifth place from its usual ranking, while Merck's Gardasil HPV vaccine has made an unexpected appearance at No. 6 on the list of ad spending. Gardasil's ad spending saw a major boost from $7,600 to $14.7 million month over month. In seventh place is Astellas’ hot flash treatment Veozah, down three places, while BMS makes its second entry into the top 10 with its skin, lung and many other cancers immunotherapy Opdivo. Opdivo has over time been in these top 10 lists—but never consistently—and it remains unusual to see any cancer med in these listings, given that it’s not a general drug for common conditions like psoriasis or asthma. BMS was, however, clearly feeling flush as it also splashed out $14 million on ads for a third drug, namely its obstructive hypertrophic cardiomyopathy treatment Camzyos. Rounding off the top 10 is UCB’s moderate to severe plaque psoriasis therapy Bimzelx, which saw exactly $0 spent in February and rose to $13.6 million in March, as it launched its first DTC campaign in time for the Oscars. Total spending for March was $188 million, up from $168.4 million in February. This is still some way off the $200 million-plus we saw tallied up for most months toward the end of 2023, but still a strong showing so early in the year, when overall spending numbers tend to be lower.   Check out the top 10 pharmaceutical drug ad spenders as compiled for Fierce Pharma Marketing by iSpot.TV below.     1. Rinvoq Movement: No change What is it? AbbVie’s JAK inhibitor immunology drug Est. national TV ad spend: $31 million (up from $30.1 million in February) Number of spots: Six (one eczema, two arthritis, three UC/Crohn’s) Biggest-ticket ad: “Mountains” (est. $8.6 million)   2. Skyrizi Movement: No change What is it? AbbVie’s immunology drug Est. national TV ad spend: $24.8 million (down from $24.9 million in February) Number of spots: Eight (four psoriasis, one Crohn’s, three psoriatic arthritis) Biggest-ticket ad: “Sailing” (est. $12.5 million)   3. Rexulti Movement: Not listed last month What is it? Otsuka and Lundbeck’s atypical antipsychotic Est. national TV ad spend: $23.4 million (up from $10.8 million in February) Number of spots: Three (two Alzheimer’s, one depression) Biggest-ticket ad: “Still Masking” (est. $18.8 million)   4. Sotyktu Movement: Not listed last month What is it? Bristol Myers Squibb’s moderate to severe plaque psoriasis drug Est. national TV ad spend: $19 million (up from $8.6 million in February) Number of spots: Three Biggest-ticket ad: “Live Unfiltered” (est. $16 million)   5. Dupixent Movement: Down two spots What is it? Sanofi and Regeneron’s immunology drug. Est. national TV ad spend: $18.7 million (down from $20.3 million in February) Number of spots: Seven (three eczema, three asthma, one gastrointestinal) Biggest-ticket ad: “DU More: Diving Board, Soccer and Playground” (est. $7.7 million)   6. Gardasil Movement: Not listed last month What is it? Merck's HPV vaccine Est. national TV ad spend: $14.7 million (up from $7.6K in February) Number of spots: One Biggest-ticket ad: “Numbers Move You” (est. $14.7 million)   7. Veozah Movement: Down three spots What is it? Astellas’ hot flash treatment Est. national TV ad spend: $14.4 million (down from $16.2 million in February) Number of spots: One Biggest-ticket ad: “Not Flash” (est. $14.4 million)   8. Opdivo Movement: Up one spot What is it? Bristol Myers Squibb’s cancer medicine Est. national TV ad spend: $14.4 million (up from $11.3 million in February) Number of spots: One Biggest-ticket ad: “Advanced Lung Cancer” (est. $14.4 million)   9. Camzyos Movement: Down four spots What is it? Bristol Myers Squibb’s symptomatic obstructive hypertrophic cardiomyopathy treatment Est. national TV ad spend: $14 million (down from $16 million in February) Number of spots: Two Biggest-ticket ad: “Mike” (est. $7.9 million)   10. Bimzelx Movement: Not listed last month What is it? UCB’s moderate to severe plaque psoriasis therapy Est. national TV ad spend: $13.6 million (up from $0 in February) Number of spots: Three Biggest-ticket ad: “Born With Wings” (est. $12 million)

None  Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please send the good word—or the bad—from your shop to Max Bayer or Gabrielle Masson, and we will feature it here at the end of each week.  Lonza nabs new CEO after snapping up Roche site Lonza From one Swiss CDMO to another. That’s the course Wolfgang Wienand is taking, with summer plans to jump from his role at Siegfried’s helm over to lead Lonza.  Lonza’s interim CEO Albert Baehny, who stepped up from his chair position in October after Pierre-Alain Ruffieux abruptly left, is set to retire from the CDMO giant after a transition period. The interim leader is expected to cede his chair title to Heineken Chair Jean-Marc Huët at Lonza’s annual shareholder meeting this May. Newly tapped Wienand will join Lonza after serving as Siegfried’s CEO for five years. He joined the CDMO in 2010 and held a variety of leadership roles before taking up the top spot, including chief scientific officer, head of global R&D and chief strategy officer.  The CEO announcement follows years of leadership turnover at Lonza and comes a few weeks after the CDMO unveiled a $1.2 billion acquisition of a large biologics manufacturing facility in California from Roche’s Genentech. Fierce Pharma  Amgen R&D leader jumps to Acadia Acadia Pharmaceuticals After leading R&D at Horizon Therapeutics, and then Amgen after Horizon’s $27.8 billion acquisition, Elizabeth H. Z. Thompson, Ph.D., is heading over to neuroscience-focused Acadia Pharmaceuticals.  Thompson is taking on the role of EVP and head of R&D at Acadia, which touts the only FDA-approved drug to treat hallucinations and delusions tied to Parkinson’s disease psychosis as well as the only FDA-approved drug for treating Rett syndrome. Thompson will focus on Acardia’s clinical-stage programs, which include a candidate for a genetic disorder called Prader-Willi syndrome and an Alzheimer’s disease psychosis program. Thompson joins from Amgen, where she was EVP of rare disease R&D after the October acquisition of Horizon, where Thompson led R&D activities. Years ago, from 2003 to 2014, Thompson had started her biopharma career at Amgen before going on to hold roles across AbbVie, Raptor and InterMune. Release  3 C-suite leaders depart I-Mab I-Mab I-Mab’s chief business officer Weimin Tang, chief communications officer Gigi Qi Feng and chief legal officer Richard Cheng Li have all chosen to exit the oncology biotech. The departures aren’t due to any disagreement with the company, according to a Securities and Exchange Commission filing, with all three leaders leaving to pursue other opportunities.  Lan Kang, a director of I-Mab’s board, has also resigned, citing personal reasons. Of late, the company has taken steps toward becoming a U.S.-focused biotech, beginning the process of divesting its China operations in February. I-Mab did not return Fierce Biotech’s request for comment as of the time of publication. Release  > Julie Clauss is joining Odyssey Therapeutics’ adventure as chief operating officer, the company announced this week. Joining her is Christopher Butler, who was named SVP and head of chemistry. Release  > Mosaic is painting an updated R&D future with two new hires. The biotech has named Malavi Madireddi, Ph.D., as SVP of drug discovery and Scott Glaser, Ph.D., as SVP of biologics discovery. Release  > Margaret Garin, M.D., has been named VP of clinical development at Trevi Therapeutics after working on the clinical development team at now-GSK-owned Bellus Health. Former Bellus CEO Roberto Bellini took to LinkedIn last month to advocate for his former employees following layoffs at the bought biotech. Release  > NewAmsterdam Pharma has appointed Juliette Audet to serve as the company’s chief business officer. Audet was most recently a partner at life sciences VC Forbion, where she helped build NewAmsterdam Pharma. “She was very instrumental in our founding—she and I worked together on the first financing, the series A, and has been very involved in the strategy for the company formation,” NewAmsterdam CEO Michael Davidson, M.D., told Fierce Biotech this week. “So it's exciting to see her with her talent and experience actually join the leadership team now.” Release > Zura Bio has tapped Robert Lisicki to replace founding CEO Someit Sidhu, M.D., who will stay on as a non-independent board director. Lisicki most recently worked a brief six-month stint as CEO of InCarda Therapeutics. Release  > After overseeing regulatory development at Samsung Bioepis, Luke Oh, Ph.D., is set to join NeoImmuneTech as CEO. Oh worked at the FDA prior to his executive position at Samsung. Release  > Ratio Therapeutics has called on Bill Cupelo to be chief business officer after he led the sales team at Invicro. The company also announced that D. Scott Holbrook would join its board of directors. Release  > Dutch biotech Prilenia Therapeutics has hired Jina Swartz, M.D., Ph.D., as its chief medical officer. She previously held the same role at fellow neurodegenerative-focused company, Exciva. Release  > CDMO KBI Biopharma is bringing aboard Peter Carbone as chief quality officer. He joins from the Center for Breakthrough Medicines, another CDMO where he was chief operating officer. Fierce Pharma > Former CEO of Seeker Biologics, Rand Sutherland, M.D., has been named the new CEO of Upstream Bio. The company also brought on Mike Gray as CFO and COO in addition to Lisa Fiering as SVP of people and culture. Release > Addex CEO Tim Dyer will lead a new spinout company, Neurosterix, according to an announcement this week. He has been at Addex for more than 20 years. Release > Ex-Heron Therapeutics CMO Chris Storgard, M.D., has been named chief medical officer of ADARx. Before that, he was the CMO of Fate Therapeutics. Release > Merck & Co. has a new head of human resources, naming Betty Larson for the job, according to an emailed press release. She most recently was chief people officer at GE HealthCare.  > It’s difficult to fully understand the human impact of biopharma layoffs, but Fierce Biotech calculated at least 2,398 people laid off from the 25 companies reporting numbers of employees affected for 2024’s first quarter. In total, 58 layoff rounds were recorded for the industry from January through March. Fierce Biotech