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Gene&Cell Therapy >> Lexeo brings in $95M; FDA lifts hold on Nurix cancer trial: Plus, news about Ventyx Biosciences, CEPI, Evolus, Recursion and Sensorion: Lexeo Therapeutics raises $95M: The financing is nearly the same size as the gene therapy maker’s $100 million IPO four months ago. The new money from Novo Holdings and other investors is expected to give the clinical-stage biotech runway into 2027. — Kyle LaHucik Nurix Therapeutics gets FDA go-ahead to continue trial: The regulator lifted its partial hold on Nurix’s Phase Ia/Ib clinical trial investigating NX-2127 to treat B-cell malignancies. The FDA halted the trial in November after the company said it wanted to change the manufacturing process for the drug. NX-2127 works by degrading BTK and IMiD neosubstrates. — Anna Brown Ventyx Biosciences’ stock sinks on pipeline reorganization: The San Diego startup announced plans to shift focus to two NLRP3 inhibitor programs and partner out a third program, VTX002. Last October, VTX002 succeeded in a Phase II study in ulcerative colitis but analysts wondered whether it could compete with other programs. The reorganization follows a $100 million PIPE announced on Thursday. Ventyx shares $VTYX fell about 20% on Monday. — Max Gelman CEPI raises $57 million for Covid-19 challenge trials: The studies will examine the effectiveness of nasal and inhaled vaccines in preventing Covid-19. Researchers from Imperial College London will lead the five-year international project. — Max Gelman Evolus prices $50M offering: The California medical aesthetics company expects to raise the money to grow its neurotoxin Jeuveau business and its line of dermal fillers. — Kyle LaHucik Recursion opens a London office: The Salt Lake City biotech and its subsidiary Valence Lab are launching in London, with plans to open a new office in King’s Cross in June. The company also appointed Michael Bronstein, an artificial intelligence professor at the University of Oxford, as a scientific advisor. — Anna Brown Sensorion’s hearing preservation drug reaches proof of concept: The biotech’s SENS-401 met the primary endpoint in a Phase IIa test of 28 patients who underwent a cochlear implant. The study has now finished, and complete data are set to be published in the third quarter. SENS-401 is also in a Phase II trial for the prevention of cisplatin-induced ototoxicity. — Ayisha Sharma #lucidquest #genetherapy #celltherapy

Gene&Cell Therapy >> Roche's Spark loses CEO to RNA upstart; Ex-Elevation Oncology chief takes over at Affimed: Ron Philip → Ron Philip has stepped down as CEO at Roche’s Spark to run the show at Orbital Therapeutics, an RNA biotech tied to Beam Therapeutics that launched in April 2023 with a hefty $270 million Series A. Founding CEO and Beam president Giuseppe Ciaramella will still be connected to ARCH-backed Orbital as a scientific and strategic advisor. Meanwhile, Sylke Poehling has replaced Philip at Spark and will continue in her role at Roche as SVP and global head of therapeutic modalities. Philip worked at Pfizer/Wyeth for 10 years before coming to Spark in 2017 as head of global commercial. He then moved up to chief commercial officer nine months after the gene therapy Luxturna was approved and would be elevated to CEO in April 2022. “Over the course of my career, I’ve pursued opportunities that have pushed the boundaries of science to bring new therapies to patients,” Philip said in a statement. “I firmly believe that Orbital’s state-of-the-art platform has the potential to expand the possibilities of RNA-based treatments, with RNA programs that precisely align with the distinct attributes needed to treat a specific disease.” Later in the week, Orbital also said that it named Anna Dixon as SVP of human resources. She just led the HR team at Pyxis Oncology and had a five-year stint at Solid Biosciences. Shawn Leland → Shawn Leland is back in the saddle, this time as CEO of German cancer biotech Affimed. Andreas Harstrick will return to his CMO post after an eight-month period in which he replaced longtime leader Adi Hoess as acting CEO. Leland founded Elevation Oncology and held the top spot until January 2023. He reemerged the following August at Fore Biotherapeutics, steering the company as interim CEO until it hired former Axcella chief Bill Hinshaw in February. Affimed began this year by laying off nearly half of its workforce and shuttering research and preclinical development operations in an attempt to extend its cash runway into the second half of 2025. Ashley Cordova → Novocure CEO Asaf Danziger is retiring at the end of the year and will be replaced by CFO Ashley Cordova. Danziger, the CEO since 2002, will keep his seat on the board of directors and will serve in an advisory capacity “into early 2026,” Novocure said in a release. Cordova has handled various responsibilities at the Swiss biotech for the past decade and was elevated to the CFO post in September 2020. In other personnel news, Mukund Paravasthu — the current SVP of product development — will take over as COO at Novocure when Wilco Groenhuysen leaves on Oct. 1. Job cuts impacted about 200 employees last November; three months earlier, Novocure reported a Phase 3 miss with its electric fields cancer therapy in ovarian cancer. Antony Mattessich… #lucidquest #genetherapy #celltherapy

LucidQuest Strategic Insights (lqventures.com) >>> Gene&Cell Therapy >> Roche's Spark loses CEO to RNA upstart; Ex-Elevation Oncology chief takes over at Affimed: Ron Philip → Ron Philip has stepped down as CEO at Roche’s Spark to run the show at Orbital Therapeutics, an RNA biotech tied to Beam Therapeutics that launched in April 2023 with a hefty $270 million Series A. Founding CEO and Beam president Giuseppe Ciaramella will still be connected to ARCH-backed Orbital as a scientific and strategic advisor. Meanwhile, Sylke Poehling has replaced Philip at Spark and will continue in her role at Roche as SVP and global head of therapeutic modalities. Philip worked at Pfizer/Wyeth for 10 years before coming to Spark in 2017 as head of global commercial. He then moved up to chief commercial officer nine months after the gene therapy Luxturna was approved and would be elevated to CEO in April 2022. “Over the course of my career, I’ve pursued opportunities that have pushed the boundaries of science to bring new therapies to patients,” Philip said in a statement. “I firmly believe that Orbital’s state-of-the-art platform has the potential to expand the possibilities of RNA-based treatments, with RNA programs that precisely align with the distinct attributes needed to treat a specific disease.” Later in the week, Orbital also said that it named Anna Dixon as SVP of human resources. She just led the HR team at Pyxis Oncology and had a five-year stint at Solid Biosciences. Shawn Leland → Shawn Leland is back in the saddle, this time as CEO of German cancer biotech Affimed. Andreas Harstrick will return to his CMO post after an eight-month period in which he replaced longtime leader Adi Hoess as acting CEO. Leland founded Elevation Oncology and held the top spot until January 2023. He reemerged the following August at Fore Biotherapeutics, steering the company as interim CEO until it hired former Axcella chief Bill Hinshaw in February. Affimed began this year by laying off nearly half of its workforce and shuttering research and preclinical development operations in an attempt to extend its cash runway into the second half of 2025. Ashley Cordova → Novocure CEO Asaf Danziger is retiring at the end of the year and will be replaced by CFO Ashley Cordova. Danziger, the CEO since 2002, will keep his seat on the board of directors and will serve in an advisory capacity “into early 2026,” Novocure said in a release. Cordova has handled various responsibilities at the Swiss biotech for the past decade and was elevated to the CFO post in September 2020. In other personnel news, Mukund Paravasthu — the current SVP of product development — will take over as COO at Novocure when Wilco Groenhuysen leaves on Oct. 1. Job cuts impacted about 200 employees last November; three months earlier, Novocure reported a Phase 3 miss with its electric fields cancer… #lucidquest #genetherapy #celltherapy

Denmark’s SNIPR Biome secures $5.48M funding from CARB-X for clinical trial of CRISPR therapy in cancer patients SNIPR Biome - A CRISPR Company, a Copanhagen-based clinical-stage biotech company pioneering precision medicines using CRISPR technology for microbial gene therapy, has secured $5.48 million in funding from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) to co-fund a Phase 1b/2a clinical trial in hematological cancer patients. The trial will evaluate SNIPR001, a CRISPR-armed phage therapeutic targeting E. coli in the gut, for the prevention of E. coli bloodstream infections in patients undergoing hematopoietic stem-cell transplantation (HSCT) and colonized with Fluoroquinolone Resistant (FQR) E. coli. SNIPR Biome intends to use this funding to advance SNIPR001 into clinical trials, focusing on safety, tolerability, pharmacokinetics, and pharmacodynamics in 24 patients across Europe and the United States. https://lnkd.in/gzvHiNPz #funding #nordicmade #denmark #startups #biotech #healthttech #deeptech #trending

Biologics and gene therapy are expensive. And not only in the production context: the development is expensive too. And when the money is tight - in this economy - they get axed (chainsawed) off the first. Takeda is cutting off some of the candidates in the pipeline. What other overengineered solutions are going to be cut off this year? #drugdevelopment #biologics #genetherapy https://lnkd.in/dYqkcz38

Thoughts on this? >> Georgia Tech Researchers Identify Novel Gene Networks Associated with Aggressive Type of Breast Cancer | News ... - Georgia Tech News Center >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #healthcare #biotech #pharmaceutical #competitivemarketing #pharma

Thoughts on this? >> Georgia Tech Researchers Identify Novel Gene Networks Associated with Aggressive Type of Breast Cancer | News ... - Georgia Tech News Center >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #healthcare #biotech #pharma #competitivemarketing

Gene&Cell Therapy >> WuXi AppTec subsidiary to manufacture Iovance’s solid tumor TIL therapy in US: WuXi Advanced Therapies (ATU) will manufacture Iovance’s recently approved Amtagvi for advanced melanoma, which was heralded as the first modern cell therapy to secure an approval in solid tumors and also the first approval for a tumor-infiltrating lymphocyte-based therapy. WuXi ATU — a cell and gene subsidiary of WuXi AppTec — will be the first third-party manufacturer to produce the individualized T cell therapy for solid tumors for commercial use, the manufacturer noted. The product’s analytical testing and manufacturing will be at WuXi ATU’s site located near Iovance’s Cell Therapy Center at the Philadelphia Navy Yard. WuXi AppTec and its associated company WuXi Biologics hit headlines in the past several weeks when US lawmakers accused the Chinese conglomerate of having ties with the People’s Liberation Army and posing as a “national security threat to the United States.” Law­mak­ers’ ex­plo­sive charges turn a glob­al spot­light on Chi­na’s WuXi, and it’s feel­ing the heat Autologous T cell therapy Amtagvi received accelerated approval on Feb. 16 as a second or third-line option for adults with advanced melanoma that persists after treatment with an anti-PD-1. To receive Amtagvi, patients must also have a mutation in the BRAF V600 gene. About 50% of patients with melanoma have this mutation. “WuXi ATU has partnered with Iovance since 2015, and we are thrilled to help them through each step of the drug development pipeline — from research to clinical manufacturing to FDA approval,” said WuXi ATU Edward Hu in the release. #lucidquest #genetherapy #celltherapy

$800m partnership signed, For off-the-shelf in vivo CAR T, Here's this week's news in CGT 👇 Astellas Pharma US and Kelonia Therapeutics partner for $800M in vivo CAR T cell therapies This alliance aims to develop innovative universal, off-the-shelf in vivo CAR T cell therapies. How does it work? Kelonia's expertise in in vivo gene delivery placement system combined with Xyphos Biosciences universal CAR technology ACCEL presents a potent synergy to revolutionize cancer treatment. 1. Xyphos’ ACCEL technology utilizes engineered ligands and receptors for precise targeting, enabling the creation of universal CAR T cells adaptable to different tumor antigens. 2. Kelonia's iGPS facilitates efficient in vivo gene delivery, eliminating the need for preparative chemotherapy and streamlining treatment processes. By combining technologies for generating flexible and adaptable CAR T cells and gene delivery, the companies will develop universal, off-the-shelf in vivo CAR T cell therapies. https://lnkd.in/e4YND-2Y #CART #CellTherapy #Biotech #CGT

First 𝐢𝐧-𝐡𝐮𝐦𝐚𝐧, 𝐢𝐧 𝐯𝐢𝐯𝐨 𝐂𝐀𝐑-𝐓, 𝐂𝐀𝐑-𝐍𝐊 clinical trial ok'd to begin down under. 🇦🇺 Interius BioTherapeutics received approval yesterday from the Australian Therapeutic Goods Administration to begin a Phase 1 for their in vivo CAR-T cell therapy, INT2104, targeting B-cell malignancies. https://bit.ly/3W05ehr According to the press release, INT2104 is an investigational gene therapy that directly delivers a CAR transgene to CD7-positive T and NK cells, thus generating autologous CAR-T and CAR-NK cells in vivo. It's only a Phase 1 (so lots can go wrong from here), but in vivo generating CAR therapies could potentially upend both autologous and allogeneic cell therapies; the CAR delivery vehicles are off-the-shelf, and you skip the entire cell-focused manufacturing process. Considering that for certain cancers, CAR-T's "waitlist mortality" (patients that die while on the wait list) is as high as 80%, having a mass-produced, off-the-shelf in vivo option would be a game changer. https://bit.ly/3S0pGgQ (Also of note, and as is in-vogue these days with CAR-T specifically, Interius is also working on a second autoimmune program with this same in vivo CAR approach.) With their move, Interius has beaten out two other in vivo competitors to the clinic: 1) Umoja Biopharma is still pre-clinical, though they've reported non-human primate in vivo CAR-T generation data just last month. https://bit.ly/45WM28y 2) Astellas signed an $800M R&D and licensing partnership with Kelonia Therapeutics earlier this year, focused on developing in vivo CAR-T therapeutics - no clinical updates here as of late. https://bit.ly/3S3b7sR Image ref: https://bit.ly/4eXWgKg —————————— Comprehensive, daily coverage of the biotech and pharma industry, straight to your inbox (and all in one email) - that's TLDR Biotech. 🧬🔔 #biotech #pharma #pharmanews #biotechnews #tldrbiotech