Wuxi Biologics (Cayman), Inc.

Planegg/Martinsried, November 26, 2024. Medigene AG (Medigene, FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided therapies for the treatment of cancer, announced today an update of its corporate strategy to refocus its capital allocation on R&D programs with highest potential for return on invested capital resulting in an organizational realignment. This strategic refocus supports the Company’s short-, mid-, and long-term vision of generating optimal 3S (sensitive, specific and safe) TCRs for the development of multiple off-the-shelf TCR-guided therapies while creating value for patients, investors and partners. The organizational realignment will include a workforce reduction of approximately 40% effective in 2025 as well as other cost-reducing measures in line with the refocused R&D activities. Medigene intends to retain employees essential for supporting these activities as well as the Company’s ability to continue to deliver on its obligations for its existing partners, which will remain unaffected. “Medigene has continuously prioritized projects and optimized the allocation of our resources to the R&D work and programs that we believe create the most value for patients and shareholders. While we have successfully advanced our lead TCR-T therapy MDG1015 to IND approval, we have decided to delay the MDG1015 clinical trial and pause all further development of our other autologous cell therapy programs, whilst we continue to seek future financing and partnerships to re-initiate their further development. This enables us to keep our strategic options open while focusing near term on our ability to generate 3S TCRs for TCR-guided therapies, and in advancing our TCR-guided T cell engager (TCR-TCE) MDG3010 program in collaboration with WuXi Biologics,” said Selwyn Ho, CEO at Medigene. “The decision to reduce personnel to match our new focus has been a difficult decision to make, but this is a necessary step to ensure the long-term success of Medigene. As we implement these changes, we are grateful to all our employees for their dedication, passion and commitment in advancing TCR-guided therapies to patients and we will support all our employees through this difficult process.” Medigene remains confident in the potential of MDG1015, a first-in-class, third-generation T cell receptor-engineered T cell (TCR-T) therapy targeting NY-ESO-1/LAGE-1a. This innovative therapy, co-expressing the costimulatory switch protein PD1-41BB, is designed to address a significant unmet medical need in the treatment of solid tumors. As such, the Company will temporarily delay the start of its IND approved, clinic-ready MDG1015 Phase 1 clinical trial while actively seeking partnerships and additional financing options to advance this program into the clinic. Strategic refocus Portfolio Prioritization in 2025 Medigene will continue to focus on generating 3S TCRs for use in off-the-shelf TCR-guided modalities. Medigene will focus its R&D on generating new TCRs for TCR-guided therapies, and also in advancing its TCR-guided T cell engager (TCR-TCE) MDG3010 program in collaboration with WuXi Biologics. The Company expects to expand its TCR-TCE pipeline through additional partnerships in the near future.The Company will temporarily delay the start of its IND approved, clinic-ready MDG1015 Phase 1 clinical trial while actively seeking partnerships and additional financing options to advance this program into the clinic. In line with the Company’s previous communication, the CTA submission is planned for Q4 2024 to enhance the opportunity for patient recruitment.Medigene will deprioritize further work on all other autologous cell therapy programs including MDG2021 (targeting KRAS G12D with HLA-A*11), MDG2011 (targeting KRAS G12V with HLA-A*11) and MDG2012. As such, the Company will pause all pre-clinical development work and will actively seek partnerships to advance those programs through pre-clinical stage to IND. Corporate Update The Company’s ability to continue to deliver on its obligations for its existing partners will remain unaffected. Medigene will also continue to explore establishing new partnerships as it has successfully done in the past.The organizational realignment and optimization will include a workforce reduction of approximately 40%, effective in 2025 as well as other cost-reducing measures in line with the reduced R&D activities. Medigene intends to retain employees essential for supporting activities as part of its strategic refocus.The Company maintains its 2024 guidance including its cash runway guidance into July 2025 due to lower income expected in 2025 off-setting the aforementioned cost reductions. The Company continues to evaluate all appropriate financing and strategic options to advance its cash runway into 2026 and beyond. Medigene will host a conference call in English and German on Wednesday, 27 November 2024 at 2:30 pm CET/8:30 am EDT. Please register at least 10 minutes in advance using the following link: https://us06web.zoom.us/webinar/register/WN_GAqv8kFeQGWuQG1QjVS9dQ You will receive an e-mail with your registration confirmation, which contains the link to participate in the audio webcast as well as dial-in numbers for participation by phone. Please note that the Q&A function will only be available for webcast participants. --- end of press release --- About Medigene AG Medigene AG (FSE: MDG1) is an immuno-oncology platform company dedicated to developing T cell receptor (TCR)-guided therapies to effectively eliminate cancer. Its End-to-End Platform generates optimal 3S (sensitive, specific and safe) T cell receptors with unique and distinctive attributes that are utilized in multiple therapeutic modalities, such as off-the-shelf TCR-guided T cell engager (TCR-TCE) therapies (MDG3010), TCR-natural killer cell (TCR-NK) therapies and T cell receptor engineered T cell (TCR-T) therapies (MDG1015). For more information, please visit https://medigene.com/ This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene® is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only. Medigene AG Pamela Keck Phone: +49 89 2000 3333 01 E-mail: investor@medigene.com In case you no longer wish to receive any information about Medigene, please inform us by e-mail (investor@medigene.com). We will then delete your address from our distribution list.

San Diego biotech Avenzo Therapeutics has in-licensed another asset, this time securing the global ex-China rights to a bispecific in the bustling antibody-drug conjugate space. Avenzo will pay up to $800 million to Shanghai-based VelaVigo for access to a Nectin-4/TROP2 bispecific ADC, the startup told Endpoints News , and it plans to submit the experimental drug for clinical trial clearance in the US in the middle of 2025. Former WuXi Biologics SVP Jing Li formed VelaVigo. The startup disclosed a $47 million angel funding round in November 2021. The deal follows Avenzo’s in-licensing of a Phase 1 CDK2 inhibitor from Allorion Therapeutics in January. Avenzo CEO Athena Countouriotis said her company is “looking to hopefully” exercise its option on another Allorion target “early next year,” which would give it another clinical-stage asset. And it’s looking for additional ADC assets, she added. Countouriotis has been searching for an ADC for some time. Earlier this year, she told Endpoints that Avenzo had been outbid on other deals in the red-hot field as large pharmas were willing to “bid quite high.” “We do think that the monospecific ADC targets are probably oversaturated,” Countouriotis told Endpoints this month. VelaVigo’s asset, dubbed VBC103, selectively targets both TROP2 and Nectin-4, which are co-expressed in urothelial cancer, triple-negative breast cancer and other solid tumors, the company’s researchers wrote in an abstract in April. Gilead’s Trodelvy is TROP2-directed, and Pfizer (by way of Seagen) and Astellas’ Padcev targets Nectin-4. “These are two targets that have not been put together before so this could be first,” she said. Avenzo plans to eventually do a manufacturing tech transfer with each of its deals. “I can appreciate there’s a lot because of the Biosecure Act as well as a lot of the other things that are currently ongoing and in flux,” Countouriotis said, and “the intent is always to try to transfer manufacturing to the US partner if you can and have a US subsidiary.” After leading Turning Point Therapeutics to a $4.1 billion exit from Bristol Myers Squibb in 2022, Countouriotis has been busy securing funds for her new startup. In addition to the VelaVigo deal, Avenzo also announced Monday that it reeled in another $39 million in a third tranche of its Series A, bringing the total funding to $386 million. Avenzo now has 16 investors, and the CEO said she has personally invested in all of the tranches. The money will help the company grow from 35 employees now to 80 next year. One of those employees, Scott Lipman, was promoted to chief business officer. Like a couple dozen other former Turning Point employees, he moved with Countouriotis to Avenzo. As for Avenzo’s next financing step, it has time to decide, especially as the capital markets are in flux. “I think there’s a tremendous amount of uncertainty as to where 2025 will go now, but I think this size of a Series A gives us enough flexibility to decide IPO timing and whether that’s going to be latter part of next year or into 2026,” Countouriotis said. She’s previously told Endpoints that she’s picked out the ticker “ AVZO ” to honor the names of her children: “We’re very fortunate.”

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Lonza said it is expanding a facility in Visp, Switzerland, to house two extra manufacturing suites for bioconjugates, including ADCs, according to a Tuesday release. The expansion will open in 2028 and will create around 200 new jobs. WuXi Biologics is expanding its factory in Leverkusen, Germany, by adding a new sterile filling line for prefilled syringes, according to a Wednesday announcement. The new line will use isolator tech so that multiple syringe sizes can be filled at the same time at a rate of 400 syringes per minute. The expansion is expected to finish by 2026. Baxter Healthcare anticipates losing about $200 million in sales in the fourth quarter of 2024 due to the damage caused by Hurricane Helene. The company estimates it will lose around $40 to $50 million in its kidney care business, and also $150 to $160 million in sales from its medical products and therapies, the company said Friday. Repligen reported a revenue of $155 million in Q3 , up 10% compared to the same period last year, the company said Tuesday. The CDMO is actively looking for new M&A deals, CEO Tony Hunt said during its earnings call. Repligen is seeking “bigger targets” to diversify its offerings, he added. Forge Biologics will manufacture clinical trial assets for gene therapy company Affinia Therapeutics, the manufacturer said Wednesday. Forge will make Affinia’s cardiomyopathy drug, named AFTX-201, among other projects. Adragos has opened a new manufacturing line in Livron, France, to increase its capacity to 160 million ampoules per year. Cell and gene therapy manufacturer BioLife Solutions is divesting its pharma storage subsidiary SciSafe Holdings for $73 million in cash, according to a Tuesday release. Cellares has appointed former Legend Biotech exec Ossama Eissa as its new chief operating officer. Eissa most recently served as a general manager for cell and gene technologies at Legend and has held positions at Novartis and Lonza. GenScript Biotech is opening a new site in Sydney, Australia, to make mRNA, growth factors and proteins, the company said Sunday. Clinical-stage biotech Aravax has spun off a commercial manufacturing subsidiary, which will make peptides in the UK. Aravax will invest $10 million into the subsidiary over the next two years, the company said Thursday. Clinical-stage biotech Orano Med broke ground to a new facility in Haute-Vienne, France, the company said Thursday. The site will make the radioisotope thorium-228, which can be made into lead-212, for radiotherapies.