April 2nd Week, 2025 Regulatory Events 🎯AstraZeneca and Daiichi Sankyo’s trastuzumab deruxtecan (HER2 ADC) mono has been approved in the EU for the Tx of unresectable/metastatic HR+ve, HER2-low/ultralow breast cancer patients who have received at least one endocrine Tx in the metastatic setting and who are not suitable for endocrine Tx as the next line of Tx. (Ref 1) ❓What is the status of trastuzumab deruxtecan for these patients in other key markets? 🎯AstraZeneca and D

April 1st Week, 2025 Regulatory Events 🎯 AstraZeneca's neoadjuvant durvalumab (anti-PD-L1) + chemo followed by adjuvant durvalumab mono has been approved for adults with resectable NSCLC at a high risk of recurrence and no EGFR mutations or ALK rearrangements in the EU. (Ref 1) ❓ What are the other approved regimens in the early-stage NSCLC, and how do the outcomes of the AEGEAN regimen compare against those regimens? 🎯 The US FDA approved AstraZeneca’s neoadjuvant durval

March 4th Week, 2025 Regulatory Events 🎯 CStone Pharmaceuticals submitted a Type II variation application to the EMA for sugemalimab (Cejelmy; anti-PD-L1) to treat stage III NSCLC patients who have not progressed following concurrent or sequential platinum-based CRT. (Ref 1) ❓ How do sugemalimab’s outcomes compare with those of previously approved AstraZeneca’s durvalumab? Special Designations ⭐ Shandong Boan Biotechnology's BA1302 (a first-in-class CD228-directed ADC) has

May 5th & June 1st Week ⭐ Regulatory Updates 🎯 China’s NMPA granted Priority Review to CARsgen Therapeutics’ satri-cel (CT041; an autologous, anti-CLDN18.2 CAR-T) for ≥3L aGC/GEJA pts (Ref 1) ❓ What is the current landscape of cell therapies in GC? 🎯 Autolus Therapeutics’ obe-cel (an autologous, anti-CD-19 CAR-T) received a positive CHMP opinion in the EU for the treatment of R/R B-ALL in adults, based upon Ph1/2 FELIX/NCT04404660 study results (Ref 2) ❓ What are the ap

May 3rd Week, 2025 ⭐ Regulatory Update 🎯 The US FDA granted the RMAT designation to BrainChild Bio’s BCB-276 (an autologous, B7-H3 CAR-T) for the treatment of Diffuse Intrinsic Pontine Glioma (DIPG) based on the positive survival data from the Ph1 BrainChild-03/NCT04185038 trial (Ref 1) ❓ Which other CAR-Ts are currently being investigated in clinical trials for DIPG? ⭐ Clinical DataReadouts 🔬 Updated data from the pivotal Ph2, iMMagine-1/NCT05396885 trial of Gilead Sci

May 1st & 2nd Week, 2025 ⭐ Deals & Collaborations 🤝 NKure Therapeutics and CRISPR Therapeutics partnered to co-develop CRISPR’s CTX112 (an allogeneic, anti-CD19 CAR-T) for the treatment of R/R B-cell malignancies in India. NKure plans to seek the CDSCO approval by Jun’25 to begin Ph2 trials in India (Ref 1) ❓ What is the competitive landscape of CAR-Ts in India? 🤝 Chong Kun Dang Pharm. acquired a 7.3% stake in AbClon, and received priority rights to commercialize nespecab

April 2nd April, 2025 ⭐ Regulatory Events 🎯 The US FDA cleared an IND application of CERo Therapeutics, Inc.’s CER-1236 (anti-Tim-4L chimeric engulfment receptor T-cell (CER-T)) for a Phase 1 trial in advanced solid tumors specifically NSCLC and ovarian cancer (Ref 1) ❓ What is the difference between CER-T and CAR-Ts and what benefits do CER-Ts offer? ⭐ Setbacks 🛑 Carisma Therapeutics paused R&D activities and is exploring strategic alternatives to maximize value, incl

March 3rd Week, 2025 Regulatory Events 🎯 The European commission granted approval to Bristol Myers Squibb’ Breyanzi (lisocabtagene maraleucel; an autologous, anti-CD19 CAR-T) for the treatment of adult patients with ≥3L FL (Ref 1) ❓ How many CAR-Ts are currently approved for FL, and what makes Breyanzi unique? 🎯 The US FDA granted Fast Track Designation (FTD) to Imugene Limited’s azercabtagene zapreleucel (azer-cel; an allogeneic, anti-CD19 CAR-T) for the treatment of R/R

March 1st Week, 2025 ⭐ Regulatory Events 🎯 China’s NMPA granted Breakthrough Therapy Designation (BTD) to CARsgen Therapeutics’ satricabtagene autoleucel (satri-cel; CT041; an autologous, anti-CLDN18.2 CAR-T) for the treatment of Claudin18.2-positive ≥third-line G/GEJ cancer (Ref 1) ❓ What are CARsgen’s next steps in advancing satri-cel? Has CARsgen obtained similar designations in other markets? 🎯 The US FDA accepted Bioheng Therapeutics’ IND application for CTD402 (anti-

February 4th Week, 2025 📝 The US FDA granted RMAT designation for ImmunityBio’s Anktiva (n ogapendekin alfa inbakicept; IL-15 superagonist) and its PD-L1 t-haNK (an allogeneic, a-PD-L1 CAR-NK) for the reversal of lymphopenia in patients receiving SOC chemo/radiotherapy and in Multiply Relapsed Locally Advanced or Metastatic Pancreatic Cancer (Ref 1) ❓ What are the next steps in the development process for Anktiva and PD-L1 t-haNK following the RMAT designation? 📝 UCARsgen

📢 The U.S. FDA launched a new program - the Commissioner’s National Priority Voucher (CNPV) - to shorten review timelines from 10-12 months to 1-2 months following a sponsor’s final drug application submission. ⭐ The vouchers will be given only to the companies that are aligned with U.S. national priorities. ⭐ Attached is the slide deck with additional details. 📧 For further details, please write to us at support@oncofocus.com. 🌐 References: 1) https://www.fda.gov/news-eve

“The right target, at the right time, for the right price” …is and always has been a guiding principle for Merck KGaA, as stated by its CEO, Belen Garijo. It appears that Merck KGaA has now identified the ‘right’ acquisition target - SpringWorks Therapeutics. As reported by Reuters, Merck KGaA is in advanced talks to acquire the US-based cancer and rare disease biotech SpringWorks. The potential deal, which could be finalized in the coming weeks, is expected to expand Merck’