Atara Biotherapeutics’ Post

A massive congratulations to Atara Biotherapeutics, where I worked for almost 3 years, a pioneering allogeneic (aka off-the-shelf) Cell Therapy company. Why is this an important development? The first cell therapies were autologous, meaning each therapy was derived from the patient and used for the same patient. In contrast, allogeneic cell therapies are off-the-shelf. This distinction is crucial for three reasons: 1) Cost 🤑 : having a medicine that is off-the-shelf is substantially cheaper than having to make it personalized. 2) Speed 👟 : whereas in autologous therapy the patient had to donate cells, and having to wait to get them back, off-the-shelf means that the medicine is ready for the patient. 3) Access ♿ : sometimes those patients are so sick that the cells are not usable anymore, by having off-the-shelf EVERYONE has access to it. Amazing congrats to all the hard work! I still remembering going to conferences representing Atara where I was the odd-man out because I was the only person in the room asking questions from the allogeneic perspective. #CellTherapy #Biotech #Cancer #Tcells #Atara

Projecting ourselves, hopefully, to an approval: an interesting nuance on cell therapy (allogeneic but not universal, thus requiring the maintenance of an HLA-typed inventory). And thus, another one with a, hem, *interesting* business model. But given the almost-complete lack of *business* in CGT these days (outside of CAR-Ts), we'll watch anything! #cellandgenetherapy

Today Atara announced that it submitted a Biologics License Application (BLA) to the U.S. FDA for tabelecleucel (tab-cel®) indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus (#EBV) positive post-transplant lymphoproliferative disease (#PTLD) who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate. This represents the first-ever #allogeneic #Tcell therapy BLA submission to the FDA, and if approved, tab-cel would be the first approved therapy in the U.S. for EBV+ PTLD. Read more about this significant milestone for Atara: https://bit.ly/4dL7elE

In May, US HCPs discussed trial results presented at the American Thoracic Society's International Conference. Here are some key points: • HCPs shared research showing that beta blocker bisoprolol is a safe treatment option for cardiac disease in #COPD patients. • They celebrated the positive NOTUS trial results involving Sanofi-Regeneron’s monoclonal antibody Dupixent (dupilumab) and its subsequent priority FDA review. They celebrated it as a “big win for patient care” and considered it among the new biologics for COPD treatment and research. • Following the FDA approval of Verona Pharma's Ohtuvayre (ensifentrine) on 26th June as maintenance treatment for COPD, US HCPs reposted about the “exciting news”, considering it as “potent” and celebrating it as the first in its class to be approved by the FDA for COPD in many years. 👉 Read the full COPD tracker here to find out more! https://lnkd.in/eU9T2QnH To stay up-to-date with our monthly trackers, sign up to CREATION Knowledge https://lnkd.in/e7NbQFQA

FDA approves selpercatinib for RET fusion-positive thyroid cancer On June 12, 2024, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients 2 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). Selpercatinib received accelerated approval for this indication for patients 12 years of age and older in 2020. The interesting features of this approval are Expedited Programs This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. This application was granted breakthrough designation and orphan drug designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics. https://lnkd.in/gXvGZ3dS

Please consider participating in an important Phase 2a clinical trial for patients with non-tuberculous mycobacterial pulmonary disease (NTM-PD) sponsored by Spero Therapeutics. Eligible participants are either treatment-naïve or have received treatment for NTM-PD in the past and responded well. The study will compare two doses of oral SPR720 monotherapy, 500 mg and 1000 mg, with placebo (no active drug). The goal of Study SPR720-202 is to lay the groundwork for a later-stage and longer-term trial evaluating SPR720, in combination with current standard-of-care agents. For more information on eligibility, click here. https://bit.ly/3UlhsQw

Please consider participating in an important Phase 2a clinical trial for patients with non-tuberculous mycobacterial pulmonary disease (NTM-PD) sponsored by Spero Therapeutics. Eligible participants are either treatment-naïve or have received treatment for NTM-PD in the past and responded well. The study will compare two doses of oral SPR720 monotherapy, 500 mg and 1000 mg, with placebo (no active drug). The goal of Study SPR720-202 is to lay the groundwork for a later-stage and longer-term trial evaluating SPR720, in combination with current standard-of-care agents. For more information on eligibility, click here. https://bit.ly/49DZBdx

A good day for Crohns disease patients: Anti-IL23 offers another treatment option. Phase 3 clinical trial shows mirikizumab passed both primary and secondary endpoints. 39% achieved composite response in biologics treatment naive patients compared to 36% biologics-failed patients. Note that mirikinumab did not show superiority over Stelara IL12/23. A major advance in the field as success rate of treatment of patients with Crohns, a recalcitrant disease that hovers around 60% failure for any one treatment method. To have another treatment option that offers an alternative to patients that have failed previously is a huge win for the patient community. Anti-IL23 joins the rank of other Crohns disease biologics - anti-TNF, anti-IL12/23 and anti-alpha4/beta7-integrin. Eli Lilly stock up 3% increase of ~$20 Bn in a single day. Disclaimer- Views expressed here are of the Author only https://lnkd.in/eqFuqGcB

C4K's Dr. Joshi explorex the history of pediatric and adult rheumatology, from the use of gold as therapy to the discovery of glucocorticoids and methotrexate. Discover the biggest breakthrough in treating rheumatic diseases: biologics. #RheumatologyBreakthroughs #Cure4TheKidsFoundation #Glucocorticoids #Methotrexate #BiologicsInnovation #RheumaticDiseases #MedicalAdvancements #HealthcareProgress

📒 INFEX Therapeutics announced that it has successfully completed dosing in its Phase I study for RESP-X, the Company's new anti-virulence therapy to treat Pseudomonas aeruginosa (Pa) infections in non-cystic fibrosis bronchiectasis (NCFB) patients. ✔ No serious or adverse events ("SAEs") or infusion reactions were reported, and pharmacokinetics (PK) was dose linear across all four dose escalations. RESP-X shows a long 30-day half-life, and the potential for a three-monthly dosing interval in patients. 🔗 https://lnkd.in/eCTXb6Sh