Aventis Pharmaceuticals, Inc.

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. TORL taps new CEO  TORL BioTherapeutics  Mark Alles, who’s spent the better part of the last four decades in biopharma leadership roles, has been named chairman and CEO of TORL BioTherapeutics. He’s replacing Dave Licata, who co-founded TORL and helped design its drug development framework. Licata will stick around TORL as a board member and the company’s president, while also taking on a new role as its CFO.  Alles has been a member of TORL’s board for two years and was named its executive chair in late 2022. Before that, he spent more than a decade at Aventis Pharmaceuticals and then another 15 years at Celgene, culminating in a stint as its CEO from 2016 until its acquisition by Bristol Myers Squibb in 2019.  He’s taking the helm as TORL plans to begin a phase 2 trial of its lead antibody-drug conjugate candidate, TORL-1-23, targeting multiple cancers. Meanwhile, the company is actively enrolling patients in phase 1 studies of a handful of other ADCs and monoclonal antibody therapies.  “TORL has rapidly realized significant success in identifying novel cancer targets, developing first-in-class antibody-based therapies directed at these targets, and with the support of our world-class investors, has recently advanced multiple products into Phase 1 studies,” said Dennis Slamon, M.D., Ph.D., TORL’s scientific founder. “We have reached a major inflection point where our opportunity to generate value for patients, our investors and our team made it both possible and important for us to build on the great work Dave has done by adding and appointing Mark Alles as Chairman and CEO.” Release  Insitro installs first CMO  Insitro  As Insitro inches closer to bringing its first artificial intelligence-discovered drug candidates into clinical trials, it has appointed its first-ever chief medical officer.   In the new role, S. Michael Rothenberg, M.D., Ph.D., will take charge of the company’s clinical development work, heading up translational biology and overseeing trial design and medical and regulatory affairs.  Rothenberg hails from Pfizer, where he spent the last four years carrying out similar responsibilities, including, most recently, as VP of early oncology development and clinical research. At the Big Pharma, he led early-phase trials of oncology and hematology therapies, including overseeing the initial first-in-human and proof-of-concept studies of the multiple myeloma drug now approved as Elrexfio. Release  Sanofi’s interim specialty care chief lands permanent role Sanofi Brian Foard has temporarily filled the role of chief of Sanofi’s specialty care global business unit since September, when former head Bill Sibold hit the exit to lead Madrigal Pharmaceuticals as CEO. Now, Foard has claimed the title on a permanent basis and will also join Sanofi’s executive committee. The exec has been with Sanofi since 2017 and was bumped up from his former slot as head of the specialty care business in North America and U.S. country lead. Before that, he bounced from head roles in dermatology and respiratory to immunology, among other positions. Foard is credited with overseeing launches of Sanofi and Regeneron’s Dupixent across multiple indications and more than 50 countries worldwide, work that will “help to set our roadmap for the first- and best-in-class molecules we are preparing to launch in the coming years,” according to Sanofi CEO Paul Hudson. Release > FDA commissioner Robert Califf has selected his next chief of staff in Elizabeth “EJ” Jungman, who will leave her current role as the Center for Drug Evaluation and Research’s associate director for policy and director of the Office of Regulatory Policy. Jungman is taking over from Julie Tierney, who recently moved to a deputy director role at the FDA’s Center for Biologics Evaluation and Research. Release  > Rare disease specialist BioMarin has a new CEO in Alexander Hardy and he appears to be shaking up his commercial team as the company announced its lead Jeffrey Ajer will leave the company by July. The disclosure, made via a short SEC filing, said Ajer would "step down" as the company's executive vice president and chief commercial officer in July and that the termination was “without cause." Fierce Pharma > Longtime Affimed CEO Adi Hoess, M.D., Ph.D., is hanging up the gloves after 13 years at the helm. The company tapped CMO Andreas Harstrick, M.D., to serve as interim CEO while it searches for a successor. Release  > Ginkgo Bioworks selected six executives from across the industry to make up its new Biopharma Advisory Board. The board now includes Kronos Bio CEO Norbert Bischofberger, Ph.D., global head of oncology and hematology at Novartis Jeff Legos, Ph.D., founding Alnylam chief John Maraganore, Ph.D, International Therapeutic Research Centers’ chief scientific officer Paolo Martini, Ph.D., IconOVir Bio head Mark McCamish, M.D., Ph.D., and former Kite Pharma CEO Christi Shaw. Release > PMV Pharmaceuticals is shaking up its clinical team with the appointment of two new leaders of the clinical program for its lead candidate, PC14586, which is set to begin a phase 2 study this quarter. Deepika Jalota, Pharm.D., and Marc Fellous, M.D.—PMV’s chief development officer and senior VP of clinical development and medical affairs, respectively—are taking the reins from Leila Alland, M.D., who is stepping down to pursue other opportunities but will remain an advisor to PMV. Release > Athira Pharma is now on the hunt for a new chief medical officer after Hans Moebius, M.D., Ph.D., stepped down to retire, effective Jan. 5. Moebius, who is staying on as a senior scientific advisor to Athira, was appointed CMO in 2019, following a nearly 30-year career in biopharma that included postings at Rodin Therapeutics, Allergan, Merz Pharmaceuticals, Novartis and more. Release  > CRISPR-focused cell therapy developer Caribou Biosciences has named its first chief technology officer: Tim Kelly, who previously served as CEO of Oxford Biomedica Solutions and COO of Homology Medicines and led technical operations at Sarepta, Shire, UCB and Biogen. Release  > Prolific startup starter Flagship Pioneering has promoted from within to name four new origination partners: Kyle Chiang, Ph.D., Molly Gibson, Ph.D., Armen Mkrtchyan, Ph.D., and Jacob Rubens, Ph.D. In their new roles, each will oversee a team tasked with creating and growing new biotech companies. Release  > Capstan Therapeutics tapped Ramin Farzaneh-Far, M.D., to be chief medical officer, following stints at Ra Pharmaceuticals, Akebia Therapeutics, Gilead Sciences and, most recently, RA Capital, where he’s been a venture partner since 2020. Capstan also promoted Miguel Arcinas, the biotech’s VP of corporate development since 2021, to the senior VP level. Release  > Celia Lin, M.D., stepped down from her post as chief medical officer of Vera Therapeutics. Taking over the role is Robert Brenner, M.D., who hails from Orionis Biosciences, while William Turner, formerly of Sierra Oncology, was named Vera’s chief development officer, with both appointments effective immediately. Release  > Maria Törnsén, most recently the chief commercial officer at Passage Bio, has been appointed president of the North America division at Calliditas Therapeutics. Her career also includes stops at Sarepta Therapeutics, Sanofi Genzyme and Shire. Release  > Zura Bio has found a new president and chief operating officer in Robert Lisicki, whose three-decade career in biopharma spans leadership roles at the now-Pfizer-owned Arena Pharmaceuticals, Regeneron, InCarda Therapeutics, Daiichi Sankyo and Amgen. Meanwhile, Kiran Nistala, M.B.B.S., Ph.D., has been tapped as the biotech’s chief medical officer and executive VP of development. Release  > AbbVie’s retired CMO Rob Scott has a new gig as CMO and head of R&D at Abionyx Pharma, where he will lead the team through pivotal trials for its lead sepsis candidate. Back at AbbVie, the medical chief held his role through major approvals including Skyrizi and Rinvoq. Release  > XOMA has selected Owen Hughes as its next CEO. Hughes—who held the top job at the biotech royalty aggregator on an interim basis for all of 2023—was previously CEO of Sail Bio and Cullinan Oncology, and chief business officer at Intarcia Therapeutics. Release  > Probiotics maker Pendulum Therapeutics tapped former Mayo Clinic medical director Adam Perlman, M.D., as chief medical officer. Now-retired CMO Orville Kolterman, M.D., led the selection of Perlman as his successor. Release > Nutcracker Therapeutics bumped up its executive VP of early R&D, Sam Deutsch, M.D., Ph.D., to the CSO role. Deutsch has been with Nutcracker since its beginnings in 2018 and will now lead the team through trialing its lead mRNA candidate, dubbed NTX-250. Release  > Central nervous system CRO Cognitive Research Corporation appointed Tom Zoda, M.D. Ph.D., as CEO. Zoda came from Apex Innovative Sciences and CenExel clinical research, where he served as chief operating officer. Release  

Mark Alles, Executive Chairman of TORL BioTherapeutics, LLC (TORL) and former Chairman and CEO of Celgene Corporation has been appointed TORL's Chairman and CEO. Mark brings more than 35 years of global biopharmaceutical experience, and will lead TORL as it advances its expanding clinical-stage antibody programs in oncology and builds additional programs through the high-value discovery pipeline established and led by TORL Scientific Founder Dennis Slamon, M.D., Ph.D. Dave Licata, Co-Founder, previous CEO of TORL, and the architect of its innovative approach to drug development, continues as a Board Member and President and is appointed TORL's first fully-dedicated Chief Financial Officer. As President and CFO, Dave will lead and manage future financing, business development and partnering, fiscal operations, and continue to provide strategic and operational support for the Company's novel approach to drug development Based upon the emerging and promising clinical response data and favorable safety profile demonstrated during dose finding and early expansion for TORL-1-23, the Company's first-in-class ADC targeting Claudin 6, TORL expects to begin a pivotal Phase 2 trial during the second half of 2024. This trial will be designed to facilitate review and potential approval by the FDA In addition to TORL-1-23 and TORL-2-307, the Company's second clinical-stage ADC designed to target Claudin 18.2 in pancreatic and gastric cancers, TORL has begun patient enrollment in Phase 1 trials for two additional new ADCs developed to address internally discovered targets overexpressed in approximately 80% of patients with colorectal cancer and in patients with small-cell-lung and liver cancers, respectively LOS ANGELES, Jan. 9, 2024 /PRNewswire/ -- TORL Biotherapeutics, LLC (TORL), established in 2019, is a clinical stage biotechnology company discovering and developing new antibody-based immunotherapies to improve and extend the lives of patients with cancer worldwide. Today, the company announced the appointment of Mark J. Alles, TORL's Executive Chairman, as the company's new Chairman and CEO. Mr. Alles is the former Chairman and Chief Executive Officer of Celgene Corporation with over 35 years of biopharmaceutical experience and an outstanding record of driving innovation and growth at multiple companies focused on hematology and oncology. Mark succeeds Dave Licata, TORL Co-Founder and previous CEO, who successfully led the Company through the initiation of five (5) phase I clinical trials testing ADCs against four (4) cancer targets and led the closing of a $158 million Series B financing in April 2023, and who will continue as a Board Member, President, and has been appointed CFO. "TORL has rapidly realized significant success in identifying novel cancer targets, developing first-in-class antibody-based therapies directed at these targets, and with the support of our world-class investors, has recently advanced multiple products into Phase 1 studies," said Board Member and TORL's scientific founder Dennis Slamon, M.D., Ph.D., of UCLA. "We have reached a major inflection point where our opportunity to generate value for patients, our investors and our team made it both possible and important for us to build on the great work Dave has done by adding and appointing Mark Alles as Chairman and CEO. He is a highly regarded industry veteran with proven operational, financial, business development, clinical development, and commercial experience building and scaling oncology-focused companies. I am extremely excited about what his proven level of experience and expertise will bring to TORL during its next critical phase." "Since joining the TORL Board two years ago and becoming Executive Chairman in late 2022, I have had the privilege to work with Dave Licata and Dennis Slamon as they built the foundation for what has become an oncology-focused biotechnology company full of promise and potential," said Mr. Alles. "We are driven by a shared passion to discover, develop and commercialize breakthrough therapies for patients challenged with cancer worldwide. I am excited and honored to lead the Board and the company at such a pivotal time." "I am proud of the prolific scientific discoveries and the remarkable progress we have made in advancing high potential biologics into the clinic since launching the company only four years ago," said Dave Licata, TORL Co-Founder, Board Member, President, and CFO. "After co-founding TORL with Dennis with a common vision for a new approach to drug development, and leading the company as CEO, I feel immense pride in what we have achieved. I am excited and eager to work even more closely with Mark as we continue to build TORL into what we believe will be a highly successful biopharmaceutical company." During his 15-year tenure at Celgene, Mr. Alles executed several multi-billion-dollar company and asset acquisitions, helped to build a broad portfolio of globally marketed medicines and high-potential cancer therapeutics, and led the expansion of Celgene from a US-based organization of approximately 500 employees to a global company with more than 8,800 employees serving patients globally. As Chairman and CEO of Celgene, he led the company's acquisition by Bristol Myers Squibb for $74B in late 2019. He has served on the Boards of several biopharmaceutical companies and industry groups, including Board Chair of Turning Point Therapeutics (acquired by Bristol Myers Squibb for $4.1B in 2022), the Pharmaceutical Research and Manufacturers of America (PhRMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the Biotechnology Innovation Organization (BIO). He previously served on the Boards of Antengene Corporation and Syros Pharmaceuticals, and currently serves on the Boards of BioMarin Pharmaceutical and Wugen, Inc. Prior to joining Celgene in 2004, Mr. Alles was Vice President of the U.S. Oncology business unit at Aventis Pharmaceuticals. He began his industry career at Bayer and Centocor after serving as a Captain in the United States Marine Corps. About the TORL123-001 (TRIO-049) Clinical Study TORL Bio is currently enrolling patients in the expansion portion of their phase 1 study, TORL123-001 (TRIO-049), assessing the safety, pharmacokinetics, biomarkers, and antitumor activity of TORL-1-23. Further details including current study sites can be found at Key study findings to date for this Claudin 6 targeting ADC include: TORL-1-23 is generally well tolerated from 0.2 to 2.4 mg/kg IV every 21 days With consistent use of prophylactic granulocyte colony-stimulating factor (G-CSF), current dosing regimen of 3 mg/kg every 21 days is well tolerated Pharmacokinetic data indicate sustained exposure of TORL-1-23 over the 21-day dosing period with low levels of the free monomethyl auristatin E (MMAE) payload Encouraging antitumor activity has been observed in heavily pretreated population during dose finding Confirmed responses in 12/36 (33%) patients across all enrolled disease types and all nine dose levels without G-CSF (0.2 mg/kg to 3 mg/kg every 21 days) At the two highest dose levels without G-CSF (2.4 mg/kg and 3 mg/kg every 21 days) there were confirmed responses in 7/12 (58%) patients with CDLN6+ platinum resistant/refractory ovarian cancer In preparation for a planned phase 2 study that could allow for regulatory approval, expansion cohorts of patients with pretreated ovarian, lung, and other CLDN6+ cancers have been initiated to further guide dose selection About TORL2307MAB-001 (TRIO-051) Clinical Study TORL Bio is currently enrolling patients in the expansion portion of their phase 1 study, TORL2307MAB-001 (TRIO-051), assessing the safety, pharmacokinetics, biomarkers, and antitumor activity of TORL-2-307MAB. Further details including current study sites can be found at About TORL2307ADC-001 (TRIO-052) Clinical Study TORL Bio is currently enrolling patients in the expansion portion of their phase 1 study, TORL2307ADC-001 (TRIO-052), assessing the safety, pharmacokinetics, biomarkers, and antitumor activity of TORL-2-307ADC. Further details including current study sites can be found at About TORL3600-001 (TRIO-055) Clinical Study TORL Bio is currently enrolling patients in the expansion portion of their phase 1 study, TORL3600-001 (TRIO-055), assessing the safety, pharmacokinetics, biomarkers, and antitumor activity of TORL-3-600. Further details including current study sites can be found at About TORL 4-500-001 (TRIO-056) Clinical Study TORL Bio is currently enrolling patients in the expansion portion of their phase 1 study, TORL4500-001 (TRIO-056), assessing the safety, pharmacokinetics, biomarkers, and antitumor activity of TORL-4-500. Further details including current study sites can be found at About TORL BioTherapeutics, LLC TORL Biotherapeutics, LLC (TORL or Company) is a clinical-stage biopharmaceutical company developing new antibodies, both monoclonal (mABs) and drug conjugates (ADCs) with the goal of transforming the lives of patients challenged with a variety of human malignancies. Through a strategic partnership with the Slamon Research Lab at UCLA, TORL has exclusive development and commercial rights to a large program of biologics-based drugs for new, promising and novel cancer targets. The lead program, TORL-1-23, is a CLDN6-directed ADC for patients across multiple cancers. The Company has four (4) additional clinical-stage antibody programs. Additionally, TORL is building a broad pipeline of novel ADCs and mABs in cancers of high unmet medical need. TORL Bio is headquartered in Los Angeles, California. SOURCE TORL Biotherapeutics LLC

Dive Brief:Sanofi will stop developing one of its top cancer drug prospects after the experimental treatment fell short in a late-stage study in advanced lung cancer, the company said Thursday.Trial monitors found the drug, dubbed tusamitamab ravtansine, missed both of its main study goals, failing to significantly delay tumor progression or extend patients lives compared to standard chemotherapy. Though a trend in survival was reported, Sanofi said it is ending development nonetheless.Sanofi has been testing the drug, a type of targeted cancer medicine known as an antibody-drug conjugate, in multiple lung cancer settings and against other tumor types. Despite the setback, it will continue exploring the potential of ADCs that involve a component of tusamitamab ravtansine and its target, a tumor protein called CEACAM5, according to the statement.Dive Insight:After years of ups and downs, ADC drug development has become one of the most competitive areas in oncology, spurred on by key technical advances, acquisitions and an uptick in approvals.Like many of its pharmaceutical peers, Sanofi has built a presence through deals. Its interest dates back 20 years, when Aventis Pharmaceuticals, prior to its merger with Sanofi, formed an alliance with early ADC innovator ImmunoGen. That deal yielded the blood cancer drug Sarclisa and, in 2017, was amended to include an experimental ADC now known as tusamitamab ravtansine.Since then, the drug has become a top prospect for Sanofi, which in recent years has struck several deals for cancer and immune disease medicines. Among the experimental cancer medicines in its pipeline, tusamitamab ravtansine is the only one in late-stage testing. Its target, CEACAM5, is overexpressed in a variety of epithelial tumors, including gastric, lung and colorectal cancers.Early data in solid tumors showed enough promise for Sanofi to bet on a broad development program. But Sanofi is changing up its strategy after seeing the results of its first definitive test, a Phase 3 trial that compared it to the chemotherapy docetaxel in second-line lung cancer. Its decision to end development affects multiple mid-stage studies in other tumor types.The company isnt giving up on the approach, though. In its statement, Sanofi said it still intends to go after CEACAM5 with different ADCs that involve tusamitamab, the targeting component of the drug. Last year, for instance, it struck a deal with Seagen now owned by Pfizer to develop another ADC aimed at CEACAM5. Preclinical results were disclosed at a scientific meeting in March.Although the results are not what we hoped for, our research and work to advance potentially transformative therapies in areas of high unmet need for people living with cancer will not stop, said Dietmar Berger, Sanofis chief medical officer, in a statement. We will continue to explore the potential of CEACAM5 as a biomarker in cancer types where it is highly expressed. '