BioNTech SE’s Post

Thanks FirstWord Pharma for covering our upcoming #ASCO24 data: AffyImmune Therapeutics said Thursday its autologous CAR-T cell therapy AIC100 is the first to achieve a complete response in a patient with a solid tumour. The Phase I trial data, shared ahead of a presentation at the American Society of Clinical Oncology (ASCO) annual meeting, suggest the therapy could be a tolerable and efficacious option to treat thyroid cancer. The study is enrolling patients with either anaplastic thyroid cancer (ATC) or poorly differentiated thyroid cancer (PDTC) to receive one of three dose levels of AIC100 – either 1x 107, 1 x 108, or 5 x 108 cells – which is an ICAM-1 targeting and affinity-tuned LFA-1 binder CAR-T. Read the article by Elizabeth Eaton: https://lnkd.in/eEn5crhA

We are happy to announce our return to the "Invest in Oncology Forum" for the second time, where we will be among Nordic companies pioneering advanced therapies in the field of cancer. At the forum, we are excited to showcase the latest developments of iadademstat, the most potent LSD1 inhibitor currently in clinical development for cancer treatment. Specifically, we will highlight the progress of our ongoing FRIDA trial in AML R/R-Flt3+ patients. Furthermore, we are thrilled to introduce the first outcome of our CRADA collaborative efforts with the NCI-NIH. This collaboration has resulted in the initiation of the first clinical trial where we combine iadademstat with atezolizumab or durvalumab in 1L-ED SCLC patients. This marks a significant milestone in our commitment to advancing innovative treatment approaches in oncology. #LSD1 #epigenetics #personalizedmedicine #iadademstat #AML #SCLC #ICIs #gilteritinib #durvalumab #atezolizumab #oryzon 

FDA Approval: New treatment for non-small cell lung cancer (NSCLC) that is advanced/metastatic, is positive for the EGFR (epidermal growth factor receptor) mutations Exon 19 or Exon 21 L858R, and has progressed after prior use of an EGFR targeted therapy. On September 19, 2024, the FDA issued a new approval for the targeted therapy drug Rybrevant (amivantamab-vmjw) in combination with the existing combination chemotherapy treatment, Paraplatin (carboplatin) + Alimta (pemetrexed). This approval marks a critical advancement for EGFR-positive lung cancer patients, opening doors to more effective treatment strategies. Learn more ➡️ https://lnkd.in/eMVnesdR #FDAApproval #LungCancerTreatment #EGFRPositive #OncologyInnovation #PrecisionMedicine

We are pleased to receive clearance from the FDA of our investigational new drug application for our novel folate receptor-⍺ (FR⍺) targeted topoisomerase I inhibitor antibody-drug conjugate (ADC). FR⍺ is a clinically validated target that is expressed in approximately 75% of ovarian carcinomas and 70% of non-small cell lung cancer. This is an exciting milestone for our team, showcasing the strength of our approach in developing best-in-class ADCs. For more information, see our press release: https://lnkd.in/eyXTC9VJ #OvarianCancer #LungCancer #NonSmallCellLungCancer #ADCs #AntibodyDrugConjugates #CancerResearch #Oncology #ClinicalTrials #DrugDevelopment

Lantern Pharma Receives Regulatory Approval to Expand Harmonic™ Clinical Trial for Non-Small Cell Lung Cancer in Never-Smokers into Japan and Taiwan This approval to proceed with the Phase 2 clinical trials in Japan and Taiwan are expected to accelerate the collection of patient and response data needed for the next-stage of evaluation and development of LP-300, a therapeutic for the treatment of relapsed and inoperable primary adenocarcinoma of the lung given in combination with chemotherapy  Additionally, it  may also bring a needed therapeutic option for LCINS diagnosed patients in Japan and Taiwan, where one-third of all lung cancer diagnoses are made among those who have never smoked.

Join the FDA Oncology Center of Excellence for a Conversation on Cancer on Feb. 1 in recognition of World Cancer Day. The conversation will focus on the introduction of certain innovative therapeutic classes in the past two decades that have revolutionized the care for patients with chronic myeloid leukemia, multiple myeloma, and melanoma. The discussion will provide an overview of regulatory programs that expedite access to patients, including FDA’s Breakthrough Therapy designation and Accelerated Approval; and the European Medicines Agency’s Prime and Conditional Approval. The panel of patients, investigators and regulators aims to highlight successes from development to approval. This is the second collaboration between OCE and the EMA in this public panel discussion series. Register here: https://lnkd.in/eNM-Gjns #OCEProjectCommunity #cancer #drugdevelopment #FDA #EMA

AZD0901 (formerly known as CMG901) has recently initiated dosing in its first patient for a Phase 3 clinical trial (NCT06346392), marking it as the second claudin 18.2-targeting drug to progress to this phase following Transcenta's osemitamab. Unlike osemitamab, which is targeted for 1st line Gastric/Gastroesophageal Junction cancer treatment in combination with nivolumab and chemotherapy, AZD0901 is uniquely positioned in the 2nd line setting and is administered as a monotherapy. Interestingly, South Korea is missing among the known clinical sites, even though it's a gastric cancer trial.

📣‼️ The Union for International Cancer Control (UICC) was founded in 1933 as a call to action on cancer. 👉🏼 World Cancer Day 2024 is the third and final of their "Close the care gap" campaign, created as a call to action for governments to reduce inequities related to patient access to quality cancer care and services. 👉🏼 Please join US FDA Oncology Center of Excellence, the European Medicines Agency, and #patients for a panel discussion on regulatory programs that quicken therapeutic access to patients. #cancer #cancertreatment #patientcare #patientcentricity 👇🏼

At #AmplityHealth, our contract sales, medical, and communications experts have a front-row seat in advancing #immunotherapy and #precisionmedicine to combat cancer more effectively with our biopharma clients. Here are some key highlights from #ASCO24 Day 1: - Discussion of newly FDA-approved oncology agents - Presentation of 5 years of data from the CROWN study comparing lorlatinib and crizotinib in new patients with advanced ALK-positive non-small cell lung cancer - Analysis of research into whether circulating tumor DNA can help predict the effectiveness of neoadjuvant chemotherapy and evaluate the prognosis for those with early breast cancer View our full Day 1 summary and join our mailing list for updates: https://lnkd.in/gA3s6Gh7

Results from our Phase 3 clinical trial evaluating treatments for patients with advanced ALK-positive NSCLC shared at American Society of Clinical Oncology (ASCO) 2024 Albert Bourla Pfizer #ASCO24 #Cancer #LCSM #NSCLC #ClinicalTrials #OncoDaily #Oncology