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Gene&Cell Therapy >> Century Therapeutics buys Clade; Eliem announces $120M PIPE and a deal: Plus, news about Leap Therapeutics, Allay Therapeutics, Harmony Biosciences, Rallybio and CSL Behring: Century Therapeutics acquires Clade: Century is purchasing the off-the-shelf cell therapy startup for $35 million upfront in cash and stock in a deal that comes after Clade laid off employees and closed its Dutch subsidiary, as Endpoints News reported in February. Clade launched with $87 million in 2021 and was founded by CRISPR Therapeutics co-founder Chad Cowan. Century also announced that it’s expanding its lead iNK cell therapy into autoimmune disease, beginning with a form of lupus called SLE, and it raised $60 million from a private placement in light of the autoimmune expansion. — Lei Lei Wu Eliem acquires Tenet, plans to advance its lead drug: The company will now focus on TNT119, an anti-CD19 antibody designed to treat autoimmune diseases, including systemic lupus erythematosus. In conjunction with the buyout, Eliem raised $120 million in a PIPE financing, which likely gives the company runway into 2027. Most of Eliem’s board will remain, and Tenet CEO Stephen Thomas has been named interim CEO of the newly combined company. — Max Gelman Leap Therapeutics also announces a PIPE: The oncology biotech sold approximately $40 million in shares to institutional investors including Gilead, Samsara BioCapital, 683 Capital Partners, Laurion Capital Management and Rock Springs Capital. It plans to use the proceeds to fund its lead program, an anti-DKK1 antibody that it’s studying in second-line colorectal cancer. — Lei Lei Wu Allay Therapeutics’ pain drug sails through Ph2b: The biotech said ATX101 achieved sustained post-surgical pain relief for up to four weeks in patients following knee replacement. The non-opioid drug candidate also outperformed the standard of care — bupivacaine — in durability. Allay is planning to start a separate, registrational Phase 2b test later this year. — Ayisha Sharma Harmony Biosciences nabs license for OX2R agonist: Harmony will pay $25.5 million upfront to French pharma company Bioprojet to “develop, manufacture and commercialize” TPM-1116, per a press release. If everything works out, Harmony is also on the hook for up to $357.5 million in development and sales milestones. — Max Gelman MIT-founded DeepCure raises $24M: The company, which has put together about $72 million so far, is calling the raise a “Series A-1″ round. DeepCure researchers are working to develop new small-molecule drugs and identify new targets with the help of artificial intelligence. — Max Gelman Rallybio’s non-traditional deal with J&J: Johnson & Johnson is teaming up with Rallybio, which is developing a “complementary” treatment for a rare disease affecting fetuses and newborns. In addition to a $6.6 million equity… #lucidquest #genetherapy #celltherapy

Gene&Cell Therapy >> Kyverna Therapeutics is considering a February IPO, according to people familiar with its plans: Kyverna Therapeutics, one of the clinical-stage biotechs at the forefront of CAR-T cell therapy’s expansion into autoimmune diseases, is considering an IPO as early as next month, people familiar with the company’s thinking told Endpoints News. The California biotech could seek a listing shortly before Valentine’s Day, according to the people, who asked not to be identified to discuss confidential matters. The company could reveal its IPO filing as early as next week, though it’s also possible that plans could change. A spokesperson for Kyverna declined to comment. If it follows through, Kyverna would join four other biotechs that have filed for IPOs so far this year. That includes late-stage cancer drugmakers CG Oncology and ArriVent; Phase IIb CNS biotech Alto Neuroscience and the preclinical gene editing company Metagenomi, which Endpoints reported last year had hired bankers for its IPO. Kyverna has raised more than $170 million from investors since its founding, including a $60 million Series B extension last August. CAR-T cell therapies for autoimmune diseases have been a hot topic in biotech R&D in recent months, including at December’s American Society of Hematology, where research usually focuses on blood disorders and oncology. The first wave of biotech IPO contenders for 2024 comes as insiders shared a feeling of renewed optimism at this year’s JP Morgan Healthcare Conference in San Francisco earlier this week. They see the current IPO market as a place for clinical-stage biotechs that have some data already in hand or are on the cusp of gathering early data. Au­toim­mune pa­tients in CAR-T study see strik­ing im­prove­ments across lu­pus and oth­er dis­eases Kyverna fits squarely into that bucket with its lead program. The startup’s autologous CD19 CAR-T is being studied in B cell-driven autoimmune diseases. The candidate, named KYV-101, is already in the clinic for lupus nephritis and recently received FDA clearance to be tested in patients with multiple sclerosis and myasthenia Gravis. It also has an allogeneic cell therapy, dubbed KYV-201, that it plans to bring into the clinic for autoimmune diseases. Kyverna’s investors include Bain Capital Life Sciences, GordonMD Global Investments, Gilead Sciences, Westlake Village BioPartners, Vida Ventures, Northpond Ventures, RTW Investments, Insight Partners, CAM Capital, LYFE Capital, jVen Capital and others. The biotech has partnerships with ElevateBio on manufacturing, a lentiviral license with Oxford Biomedica and a biomarker discovery and trial design partnership with Alphabet’s Verily. About 15 biotechs made the transition onto Wall Street last year, a far cry from the approximately 100 that joined Nasdaq in 2021, when… #lucidquest #genetherapy #celltherapy

🔹IL-18 is a potent inflammatory cytokine that induces innate and adaptive immune responses and is a powerful IFNγ amplifier. Because IL-18BP can neutralize IL-18's activity by binding with high affinity, Bright Peak Therapeutics created a variant of IL-18 resistant to IL-18BP. Additionally, PEGylation was performed to extend its half-life. 🔹Using Ajinomoto's technology, IL-18 was site-specifically conjugated to the Fc domain of Lipustobart (a clinical-stage anti-PD-1 Ab). 🔹BPT567 can 'cis-target' PD-1-positive cells. However, whether it also has a PD-1/PD-L1 blockade effect remains to be seen in future clinical data. https://lnkd.in/guM_J-Qi

LucidQuest Strategic Insights (lqventures.com) >>> Gene&Cell Therapy >> Idorsia’s Jean-Paul Clozel retires as CEO, plots next steps; CRISPR Therapeutics nabs CMO from Sanofi: Jean-Paul Clozel → Jean-Paul Clozel is ready to pass the torch at his Actelion follow-up Idorsia, but he doesn’t want to walk away from the company altogether. Clozel will retire as CEO on June 13, and Idorsia has tapped his longtime lieutenant André Muller to replace him. The 69-year-old Clozel will now stand for election as chairman, while Mathieu Simon moves into the vice chairman post. The changes on the board don’t stop there. Jörn Aldag, Felix Ehrat and Peter Kellogg are stepping down, and Idorsia has nominated ex-Galapagos president Bart Filius. “It has been an absolute privilege to serve as CEO of Actelion and Idorsia for the past 24 years. I can think of no greater endeavor than discovering new medicines that help patients lead better lives,” Clozel said in a statement. “Having devoted so much energy to Idorsia, I want to stay engaged and support the company to realize its potential.” Muller was CFO at Actelion and followed Clozel to Idorsia as finance chief after J&J bought Actelion for $30 billion in 2017. Muller had a 17-year career at Pierre Fabre, where he was CFO from 2002-11. Idorsia has notched two FDA approvals in its seven-year history: insomnia med Quviviq and high blood pressure drug Tryvio. Naimish Patel → CRISPR Therapeutics has found a new medical chief and promoted one of its execs. Naimish Patel takes over as CMO from PK Morrow, who resigned on Jan. 26 and joined Takeda as head of the oncology therapeutic area unit. Patel quickly moved up to global program head for the megablockbuster Dupixent early in his tenure at Sanofi, where he was recently the head of global development in immunology and inflammation. Vertex’s Casgevy partner has also elevated Julianne Bruno to COO. She left McKinsey for CRISPR in 2019 and had been SVP and head of programs & portfolio management since March 2023. → Bavarian Nordic will be looking for a CMO after Laurence de Moerlooze’s departure at the end of the month. The GSK and Takeda vaccines alum succeeded Chris Heery as medical chief in the spring of 2020. “We have an operational setup that is robust enough for people to continue doing their jobs until a replacement is in place,” Bavarian Nordic CEO Paul Chaplin told MedWatch about the search. “They can manage that for six months or more, so I have no concerns at all.” Hanneke Schuitemaker → Meanwhile, at another vaccine developer, Valneva has welcomed Hanneke Schuitemaker as CSO. As J&J’s global head of viral vaccine discovery and translational medicine, Schuitemaker was involved in the development of vaccine candidates for Covid-19, HIV, RSV, Ebola and more. Valneva overcame a nearly two-and-a-half-month delay and received an… #lucidquest #genetherapy #celltherapy

Eder Therapeutics and xcube.bio have announced a strategic cooperation to facilitate the market entry and commercialization of biotech assets in Canada and Europe. The two companies will coordinate their offerings to biopharma innovators in their respective regions and leverage the numerous synergies that exist between the healthcare systems of Europe and Canada. The collaboration will specifically focus on product profiling, regulatory processes, Health Technology Assessment (HTA), and medical communication, and commercialization - ultimately benefiting patients and biopharma partners.   "Eder Therapeutics is thrilled to combine its unique depth in the Canadian market with the breadth of a European platform like xcube.bio. This partnership will enhance access to innovative treatments for Canadian patients, which is our ultimate goal," said Jared Rhines, CEO of Eder Therapeutics.   Pierre-Henri Belin, CEO of xcube.bio, stated, "xcube.bio, a European market-entry specialist, has found a valued like-minded partner in Eder Therapeutics. We look forward to expanding this cooperation to accelerate patient access and provide added value to our biopharma partners."   An initial phase of expert cooperation will begin with Eder Therapeutics' investigational gene therapy for Lipoprotein Lipase Deficiency. #biopharma #partnering #commercialization

Get familiarized with the new designations being ascribed to the drugs now and then only at PharmaShots!  PharmaShots brings every month a Designation report, highlighting the designations allotted to drugs in various geographies.  This month, we have covered designations from the US, China, Canada and EU regions.  For a curated report on the designation of your need, reach out to us at connect@pharmashots.com  Stay Tuned for more updates!  Ascendis Pharma Longboard Pharmaceuticals Lisata Therapeutics, Inc. Aisa Pharma, Inc. Actuate Therapeutics, Inc. Agios Pharmaceuticals Atsena Therapeutics uniQure Amarex Clinical Research, LLC, an NSF company Gibson Oncology, LLC Astria Therapeutics, Inc. Abdera Therapeutics CAMP4 Therapeutics YolTech Therapeutics Somite Therapeutics EydisBio, Inc. Skyline Therapeutics SeaBeLife Biotech SUN PHARMA Moebius Medical Ltd. Priovant Therapeutics Innovent Biologics Glycomine Inc. ImCheck Therapeutics Amplia Therapeutics Limited PTC Therapeutics, Inc. Caribou Biosciences Synthekine Elevation Oncology Simcere MSD (Shanghai) Pharmaceuticals Co Ltd Arrowhead Pharmaceuticals BridgeBio Neuraptive Therapeutics, Inc. GSK BioCity Biopharma Biogen Cartesian Therapeutics NS Pharma, Inc.   #healthcanada #nmpa #usfda #ema #us #eu #orphandrugdesignation #fasttrackdesignation #breakthroughtherapydesignation #breakthroughdevicedesignation #regenerativemedicineadvancedtherapydesignation #rarepediatricdiseasedesignation #priorityreview #designations #regulatory 

LucidQuest Strategic Insights (lqventures.com) >>> Gene&Cell Therapy >> Kyverna Therapeutics is considering a February IPO, according to people familiar with its plans: Kyverna Therapeutics, one of the clinical-stage biotechs at the forefront of CAR-T cell therapy’s expansion into autoimmune diseases, is considering an IPO as early as next month, people familiar with the company’s thinking told Endpoints News. The California biotech could seek a listing shortly before Valentine’s Day, according to the people, who asked not to be identified to discuss confidential matters. The company could reveal its IPO filing as early as next week, though it’s also possible that plans could change. A spokesperson for Kyverna declined to comment. If it follows through, Kyverna would join four other biotechs that have filed for IPOs so far this year. That includes late-stage cancer drugmakers CG Oncology and ArriVent; Phase IIb CNS biotech Alto Neuroscience and the preclinical gene editing company Metagenomi, which Endpoints reported last year had hired bankers for its IPO. Kyverna has raised more than $170 million from investors since its founding, including a $60 million Series B extension last August. CAR-T cell therapies for autoimmune diseases have been a hot topic in biotech R&D in recent months, including at December’s American Society of Hematology, where research usually focuses on blood disorders and oncology. The first wave of biotech IPO contenders for 2024 comes as insiders shared a feeling of renewed optimism at this year’s JP Morgan Healthcare Conference in San Francisco earlier this week. They see the current IPO market as a place for clinical-stage biotechs that have some data already in hand or are on the cusp of gathering early data. Au­toim­mune pa­tients in CAR-T study see strik­ing im­prove­ments across lu­pus and oth­er dis­eases Kyverna fits squarely into that bucket with its lead program. The startup’s autologous CD19 CAR-T is being studied in B cell-driven autoimmune diseases. The candidate, named KYV-101, is already in the clinic for lupus nephritis and recently received FDA clearance to be tested in patients with multiple sclerosis and myasthenia Gravis. It also has an allogeneic cell therapy, dubbed KYV-201, that it plans to bring into the clinic for autoimmune diseases. Kyverna’s investors include Bain Capital Life Sciences, GordonMD Global Investments, Gilead Sciences, Westlake Village BioPartners, Vida Ventures, Northpond Ventures, RTW Investments, Insight Partners, CAM Capital, LYFE Capital, jVen Capital and others. The biotech has partnerships with ElevateBio on manufacturing, a lentiviral license with Oxford Biomedica and a biomarker discovery and trial design partnership with Alphabet’s Verily. About 15 biotechs made the transition onto Wall Street last year, a far cry from the… #lucidquest #genetherapy #celltherapy

Quarterly reviews often miss the mark for future insights. But that's not our style. 👽 Yes, we’ve got your standard funding totals and FDA approvals. But Zymewire's Q2 Biopharma Recap goes further, offering twice the insights compared to Q1. We dive into trends shaping Q3 and beyond: upcoming trials, new biotech players, what's on the horizon for Cell & Gene Therapies, and more. Check it out and let me know what you'd like to see in our next recap. #ClinicalTrialNews #FundingUpdates #SalesIntelligence https://lnkd.in/e3giy8qJ

It can be very tricky to understand the nuts and bolts of some of our most complex, innovative advances in biotechnology. This makes it difficult to visualize the impact they can have on patients. Fortunately, #Avalere was commissioned to help articulate how RNA therapeutics, which represent a strong pipeline of early-and late-stage innovative biotechnologies, are poised to augment the treatment landscape across a host of disease areas with both large and small patient populations. We discuss ways in which product development incentives impact the outlook for continued investment in RNA therapeutics, and how patients may be impacted in the future. A particularly cool report to have been a part of! See the full report at the bottom of our insight, linked below. #RNA #DNA #NDA #BLA #GeneTherapy #GTx #IRA Megan West (Olsen) Mariia Salova, MD, MS Nicole Meyerson, MPH Maggie Kruger

ExoXpert, a CDMO launched by EXO Biologics to service increasing worldwide demand for exosomes - https://lnkd.in/gbGt4WNy EXO Biologics  SA, a Belgian biotech company committed to developing biopharmaceuticals using exosomes to treat rare diseases with high unmet medical needs, today announces the worldwide launch of ExoXpertTM, a contract development and manufacturing organization (CDMO) specializing in exosomes. ExoXpert offers a MSC-based exosome manufacturing platform used in European clinical trials. ExoXpert is a wholly owned subsidiary of EXO BiologicsTM. “The potential of exosomes continues to be demonstrated across the cell and gene therapy sector. As a result, exosome-based clinical trials have the potential to significantly increase in number, if industrial supply of exosomes can be met. Currently there is a lack of exosome production, manufacturing specialists and facilities to supply exosomes for both R&D and clinical trials,” said Romain du Hecquet de Rauville, Chief Business Officer, EXO Biologics. Read more at: https://lnkd.in/gbGt4WNy #exosomes #researchanddevelopment #stemcells