On March 28, 2023 Treatment of the first participant in a clinical trial of FLASH proton therapy for cancers in the bones of the chest has been completed at the Cincinnati Children’s/University of Cincinnati Medical Center Proton Therapy Center (Press release, Cincinnati Children’s Hospital Medical Center, MAR 28, 2023, View Source [SID1234629464]).

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FLASH is an investigational mode of radiation therapy delivery that can be administered to a patient in less than 1 second. Research in the laboratory suggests that FLASH may result in fewer side effects than standard forms of radiation delivery, and the clinical trial is testing the feasibility of FLASH to treat people with cancer.

The new study, called FAST-02, marks a significant achievement for the Proton Therapy Center in Cincinnati, which continues to lead the way in global research in the field of FLASH proton therapy.

FAST-02 follows a breakthrough last year in the world’s first clinical trial of FLASH proton therapy in people, the FAST-01 study (FeAsibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases). That study focused on people with bone metastases in the extremities.

Now, Cincinnati Children’s researchers are collaborating with University of Cincinnati researchers to establish the efficacy of ultra-high dose rate proton therapy in treating painful bone metastases in the chest. The FAST-02 study is sponsored by Varian, a Siemens Healthineers company.

Ten adults whose metastatic cancer has spread to their chest bones will participate in the research clinical trial of FLASH proton therapy.

In pre-clinical testing, FLASH proton therapy has been shown to potentially reduce side effects of radiation treatment compared to conventional radiation. However, until recently, the technology to deliver FLASH radiation for cancer patients was not available.

"Our dedicated team of researchers, clinicians, and staff are committed to advancing the field of cancer treatment and finding new ways to improve patient outcomes," said John Breneman, MD, medical director of the Cincinnati Children’s/UC Medical Center Proton Therapy Center, who is principal site investigator for the FAST-02 clinical trial.

The Proton Therapy Center in Cincinnati is a state-of-the-art facility that features cutting-edge technology and equipment, allowing researchers to develop and test new treatments for a wide range of malignancies.

"This trial of an ultra-high dose rate of proton therapy is just one of our efforts to develop new and innovative cancer treatments," said John Perentesis, MD, who is research director of the Proton Therapy Center and director of oncology and cancer programs at Cincinnati Children’s. "Our goal is to establish a foundation for future potential trials in brain tumors, sarcomas, lymphomas, lung cancer, and other malignancies, and we are excited about the impact this research might have on cancer care."

Anthony Mascia, PhD, who is chief physicist at the Proton Therapy Center in Cincinnati, said: "The promise of FLASH is to be able to deliver treatment at ultra-high dose rates with potentially fewer side effects. We currently are doing research studies into its efficacy, which, if confirmed, could transform radiation oncology."

The $126 million Cincinnati Children’s/UC Medical Center Proton Therapy Center incorporates a $24 million, one-of-a-kind research facility, which includes integrated laboratories and a fully operational proton treatment room dedicated exclusively for research. In addition, children and adults from around the world receive treatment for more than 30 types of cancer in the two clinical proton therapy rooms.

The Proton Therapy Center on the Liberty Campus of Cincinnati Children’s is one of only a few facilities in the world that can deliver FLASH proton therapy in a clinical setting. With this latest clinical trial, the medical center continues to push the boundaries of cancer treatment – and to offer hope to patients and families affected by this devastating disease.

On March 28, 2023 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), reported its full-year 2022 financial results and provided updates on key events and achievements since the start of 2022 (Press release, Antengene, MAR 28, 2023, View Source [SID1234629463]).

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1. Sales Revenue Reached 5.6 Times Year-Over-Year while the Adjusted Loss Narrowed by 10.3%

– XPOVIO (selinexor), Antengene’s first commercialized product and the world’s first oral XPO1 inhibitor leveraging a novel mechanism of action, generated a total of RMB160 million in revenue in 2022, a sum amounted to 5.6 times of 2021 (the product was commercially launched in Mainland of China on May 13, 2022).

– As a result of the strong revenue growth, the adjusted loss for 2022 was narrowed by 10.3%.

2. First/Best-in-Class Potential Clinical Programs as Value Drivers for Future Growth of Antengene

– Antengene has built a pipeline of 9 oncology programs at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. Some of these assets, such as ATG-031 (anti-CD24 antibody), have first-in-class potentials; while others, such as ATG-008 (mTORC1/2 inhibitor), ATG-037 (CD73 inhibitor), ATG-101 (PD-L1/4-1BB bispecific antibody), ATG-008 (ATR inhibitor), ATG-022 (Claudin 18.2 antibody-drug conjugate), and ATG-017 (ERK1/2 inhibitor), have best-in-class potentials. These assets are currently being evaluated in a total of 16 clinical trials around the world.

– Clinical achievements in 2022 and early 2023 include obtaining 7 IND approvals and an Orphan Drug Designation, as well as the dosing of the first patient in 5 studies.

– Released results from 16 preclinical and clinical studies at 7 renowned international congresses and medical journals including the AACR (Free AACR Whitepaper), ASCO (Free ASCO Whitepaper), SITC (Free SITC Whitepaper), CSCO, EHA (Free EHA Whitepaper), ASH (Free ASH Whitepaper) and BMC Medicine.

3. Fast-Growing Pan-APAC Commercialization of XPOVIO

– The commercialization network for XPOVIO in China now covers 600 hospitals and over 120 direct-to-patient (DTP) pharmacies in over 30 provinces and autonomous regions, and municipalities. XPOVIO attained 34 urban-customized commercial health insurance listings (Huiminbao).

– 6 XPOVIO regimens received a total of 27 inclusions or upgraded recommendations by 7 major clinical guidelines and evidence-based studies. In addition, XPOVIO was also included into 2 Guiding Principles for Clinical Applications and expert consensuses.

– In 2022, XPOVIO obtained NDA approvals in 3 markets including Australia, Singapore, and Taiwan, China. In addition, Antengene secured the first APAC reimbursement listing for XPOVIO by the Pharmaceutical Benefits Scheme (PBS) in Australia. NDAs for XPOVIO were submitted in 3 other countries and regions including Macau, China, Thailand, and Malaysia.

– In 2023, Antengene expects XPOVIO to be approved in Hong Kong, China and Macau, China and plans to submit an NDA for XPOVIO in Indonesia. Moreover, the company also plans to submit a supplementary New Drug Application (sNDA) for XPOVIO for the treatment of patients with diffuse large B-cell lymphoma (DLBCL) in Mainland of China.

4. High Profile Clinical Trial Collaborations in 2022

– Entered into a clinical collaboration with BeiGene on a Phase I/II study evaluating XPOVIO in combination with tislelizumab in patients with T and NK-cell lymphoma.

– Entered into a clinical collaboration with MSD on the Phase I STAMINA-001 trial designed to evaluate ATG-037 in combination with pembrolizumab in patients with locally advanced or metastatic solid tumors.

5. A Strong Cash and Bank Balance to Provide Runway Beyond 2025

– As of December 31st, 2022, the company has a cash and bank balance of about RMB1.8 billion. This strong cash and bank balance, together with the strong near-term revenue growth potential of XPOVIO and careful spending, enables the continuous growth, development, and operation of Antengene beyond 2025.

"In 2022, we made notable strides on multiple fronts of our business. The revenue from our lead product, XPOVIO, reached RMB160 million in 2022, a sum amounted to 5.6 times year-over-year. Meanwhile, we delivered crucial milestones in drug discovery and development, with a number of our potential BIC/FIC programs already entered clinical studies in Australia, Mainland of China, and the U.S. We expect these clinical programs to begin yielding results sometime during 2023 and 2024," said Dr. Jay Mei, Antengene’s Founder, Chairman and CEO. "This impressive performance is a testament to the highly effective global collaboration by our commercial teams and the company’s strong capabilities in drug discovery and development. Moreover, we expect our cash and bank balances totalling about RMB1.8 billion to support Antengene’s planned operations and revenue growth beyond 2025. Moving forward, we will continuously strive to become a leading multinational biopharmaceutical company with a portfolio of commercialized products, committed to improving the quality of life for cancer patients and creating value for our shareholders and partners."

On March 28, 2023 Mount Sinai Medical Center (MSMC) reported the results of a clinical trial led by Brian Slomovitz, MD, Professor of Obstetrics/Gynecology and Division Director at Mount Sinai Medical Center in Miami Beach, Florida (Press release, Mount Sinai Hospital, MAR 28, 2023, View Source [SID1234629462]). The investigator-initiated phase II trial, sponsored by the GOG Foundation, investigated the combination of ribociclib and letrozole in patients with recurrent low-grade serous ovarian cancer (LGSOC) (GOG-3026) presenting positive results that will change the standard of care for this cancer moving forward. As the Principal Investigator for this trial, Dr. Slomovitz presented the results at The Society of Gynecologic Oncology’s 2023 Annual Meeting on Women’s Cancer in Tampa, Florida.

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Ribociclib and letrozole combination is active in patients with advanced or recurrent LGSOC: Phase II trial results:

ORR, PFS, DOR compare favorably to most active agents previously investigated.
In this trial, the reported response rate was 23%, the progression-free survival 19.1 months, and the duration of response of 19.1 months. Sixty-four percent of evaluable patients experienced a reduction in target tumor size.

"These results are promising. Women with this disease have limited treatment options. The progression-free survival and duration of response are both 6 months greater than what we have observed with the current standard treatments," stated Dr. Slomovitz. LGSOC is a rare subtype of ovarian cancer, which typically occurs in younger women and may arise from a non-invasive precursor disease (serous borderline tumor). Approximately 80% of women with LGSOC suffer disease recurrence following primary therapy. Traditional treatment options, including chemotherapy, hormonal therapy, and biologic targeted therapies, have limited clinical efficacy and short durations of response. In particular, response rates to chemotherapy range from 0-15%. Treatment options for women with recurrent disease remains an unmet need.

Dr. Slomovitz added, "Our next steps are to compare this regimen of ribociclib and letrozole vs the best current therapies in a head-to-head study. Hopefully this work can lead to an FDA approval for this combination."

Mount Sinai Medical Center is excited about this promising advancement for gynecologic cancer patients dealing with rare tumors. This is yet another opportunity to help transform the standard of care in gynecologic oncology.

On March 28, 2023 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune, ophthalmology and other major diseases, reported its 2022 annual results and major company business updates (Press release, Innovent Biologics, MAR 28, 2023, View Source [SID1234629461]).

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Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "2022 was the first year for Innovent’s second decade in business. Despite challenges amid COVID and macro environments in the year, we are taking initiative to make profound improvements and strengthen our foundation for more sustainable growth, as we believe efficiency improvement, sustainable growth and technology innovation will be more emphasized in the biopharmaceutical industry. During the year, we built a more diversified commercial portfolio and further improved our commercial operational efficiency. Our strategical position in several key non-oncology areas brings us another important pillar of our future business growth. We further strengthened innovation with extended Innovent Academy technology and multiple international collaborations. Looking ahead, Innovent will strive to achieve our strategic goals of sustainable growth and global innovation, through further expansion of commercial portfolio, improvement of operational efficiency, and innovation through advanced R&D platform for the global market. We will uphold the vision of ‘to become a global premier biopharmaceutical company’ and create sustainable value for patients, employees, shareholders and the society."

Commercial – Continuous portfolio expansion and efficiency improvement achieved

Expansion of commercial portfolio into eight approved products, including: TYVYT, BYVASDA, SULINNO, HALPRYZA, PEMAZYRE, Olverembatinib, CYRAMZA (new product) and Retsevmo (new product).
Product revenue RMB4,139 million in year 2022: an increase of 3.4% compared with the prior year with fast ramp-up of product volume and contribution of new products despite impact of COVID and price reduction of TYVYT (sintilimab injection) during 2022.
NRDL coverage further expanded, benefiting broader patient groups: In January 2023, two additional indications of TYVYT (sintilimab injection), olverembatinib for the first listing, and multiple additional indications of BYVASDA (bevacizumab injection), HALPRYZA (rituximab injection), and SULINNO (adalimumab injection) were included in the updated NRDL.
Broad coverage in commercial channels and networks with an experienced and professional sales and marketing team: expansive coverage of over 5,000 hospitals and a well-structured commercial team of nearly 3,000 talents. The Company is also strategically establishing commercial presence in certain non-oncology therapeutic areas for more diversified and long-term growth.
Improved efficiency in commercial operation with preliminary results observed:
The Company continuously develops a more sustainable and healthier commercial management model, which could further improve operational efficiency and expand the scale of business for long-term sustainable business growth.
In the past year, preliminary positive results were observed: the ratio of sales and marketing expenses to total product revenue (under IFRS measurement) decreased from 65.5% in 2021 to 62.6% in 2022, and from 68.5% in the first half of 2022 to 56.9% in the second half of 2022, in particular.
Pipeline – Expand the boundary of novel oncology therapies, and roll out non-oncology high-potential products

We have built a strong pipeline with over 30 innovative drug candidates, among which 8 products are approved, 3 assets are currently under NDA review by the NMPA, 5 assets are in Phase 3 or pivotal clinical trials, and approximately 20 assets in early Phase 1/2 clinical studies.

Oncology：Introduce novel modalities and therapies to expand the oncology pipeline

Submitted NDAs of two product candidates for the treatment of hematological malignancies, and have pioneered the development of three drug candidates for treatment of lung cancer:
IBI326 (BCMA CAR-T): the NDA was accepted for the treatment of r/r MM
IBI376 (PI3Kδ): the NDA was accepted for the treatment of r/r FL
IBI344 (ROS1/TRK): Ongoing pivotal Phase 2 for ROS1 positive NSCLC
IBI351 (KRASG12C): Ongoing pivotal Phase 2 for KRASG12C mutated NSCLC
IBI126 (CEACAM5 ADC): Ongoing Phase 3 for CEACAM5 highly expressed NSCLC
Received preliminary positive data for multiple global innovative molecules：
IBI110 (LAG3) : 1L sqNSCLC, 1L GC
IBI939(TIGIT): 1L NSCLC (PD-L1 TPS≥50%)
IBI188 (CD47): 1L MDS
Established a fully-integrated and differentiated ADC proprietary technology platform:
IBI343 (CLDN18.2 ADC) : Phase 1 multi-regional clinical trial ongoing in Australia and China. IBI343 has potential best-in-class profiles with differentiated design for potential wide therapeutic window and high potency.
More than 10 differentiated ADC projects in IND-enabling stage.
Non-Oncology：Strategically positioned in three major chronic diseases to accelerate the development of high-potential assets

Cardiovascular and metabolism ("CVM") field — high-potential innovative assets for multiple high-prevalence chronic diseases:
IBI306 (PCSK9): the NDA was accepted for the treatment of hypercholesteremia
IBI362 (GLP-1R/GCGR): Phase 2 study results in obesity and type 2 diabetes shows its best-in-class potential in weight loss, blood glucose lowering with favorable safety and multiple metabolic benefits. Phase 3 registrational studies for both indications have been initiated during late 2022 to early 2023.
IBI128 (XOI) : Phase 2 study (by LG Chem) data readout demonstrated its potential as best-in-class XOI for the treatment of hyperuricemia in gout patients, with overall superior efficacy and good safety profile. The Company plans to start a Phase 3 clinical study in 2023 in China.
IBI311 (IGF-1R) : Phase 2 study for the treatment of thyroid associated ophthalmopathy ("TAO") is ongoing and a Phase 3 registrational study will start in 2023.
Autoimmune field — capture differentiated clinical value and fulfill substantial unmet medical needs:
IBI112 (IL-23p19) : the Phase 2 data for IBI-112 (IL-23p19) demonstrated its potential long-lasting efficacy advantage and convenient extended dosing intervals for psoriasis. The Phase 3 registrational clinical study started in early 2023.
IBI353(PDE4): the multi-regional Phase 2b clinical study (led by UNION) of IBI353 in psoriasis reached positive topline results. Phase 2 clinical study in China will start in 2023.
Additional innovative autoimmune molecules such as IBI355 (CD40L) and IBI356 (OX40L) will enter first-in-human clinical studies in 2023 to explore other unmet medical needs in various types of autoimmune diseases.
Ophthalmology field — multiple differentiated bispecific antibodies:
IBI302(VEGF/C): Phase 2 studies of IBI302 for the treatment of nAMD are ongoing to explore potential effect in anti-macular atrophy.
IBI324 (VEGF-A/ANG-2) and IBI333 (VEGF-C/VEGF-A) are in the Phase 1 stage. The potential differentiation versus existing therapy brought by their innovative mechanisms and molecule designs as bispecific antibodies will be explored.
R&D: Global innovation continues as core long-term strategy

We continue to build Innovent Academy as an engine of innovation power:
In 2022, Innovent Academy has successfully delivered six high quality novel molecules into IND enabling stage.
Further enhance the R&D platform by leveraging the Company’s profound know-how in immunology, cancer biology and antibody engineering, with a focus on global innovation and cutting-edge technology extension.
Innovent Academy has built a fully integrated and differentiated ADC proprietary technology platform, which will gradually deliver next-generation ADC candidates into the clinical development stage to further enrich our long-term pipeline.
Deploy scientific and efficient approaches to early stage innovative pipeline development
Exploring the early-to-mid stage pipeline with global potential in ongoing PoC studies, with several molecules in the IO and ophthalmology fields.
Further explore the early clinical development of novel molecules with global potential, such as PD-1/IL-2, ADC clusters, etc, in multi-regional clinical trials.
BD: Strategic collaborations deepen overall strength of innovation

Entered into strategic collaboration with Sanofi to benefit more patients in China and Sanofi’s initial equity investment of EUR300 million in Innovent. Both companies are committed to accelerating the development and commercialization of clinical Phase 3 stage SAR408701 (tusamitamab ravtansine; anti-CEACAM5 ADC) and clinical Phase 2 stage SAR444245 (non-alpha IL-2) in China.
Expanded oncology strategic partnership with Lilly: Innovent obtained the sole commercialization right of Cyramza (ramucirumab) and Retsevmo (selpercatinib) in mainland China, and the right of first negotiation for potential future commercialization of pirtobrutinib (BTK inhibitor) in mainland China.
Launched antibody drug benefiting emerging markets: BYVASDA (Indonesian trademark: Bevagen) was approved by the Indonesian Food and Drug Administration (BPOM) and is the first Chinese antibody drug commercialized and expected to be locally manufactured in Southeast Asia markets.
CMC：High-quality and scalable manufacturing capabilities

60,000L GMP certified production capacity which is currently the largest stainless steel bioreactor production capacity in China with more capacity construction in plan.
Quality compliance to GMP and cost advantage further strengthen market competitiveness.
Financial Highlights for the Year 2022

Total revenue was RMB4,556.4 million, an increase of 6.7% compared to the prior year.
R&D expenses were RMB2,871.2 million, an increase of RMB548.7 million from the prior year.
The ratio of selling and marketing expenses to produce revenue was 62.6%, a decrease of 2.9% compared to the prior year.
Loss for the year was RMB2,179.3 million, mainly due to continuous investment in R&D to support our long-term strategic goal of global innovation.
Cash and short-term financial assets was RMB9,166.0million, or approximately USD1.3 billion, which enables us to focus on the long-term sustainable development.

On March 28, 2023 Medigene AG (Medigene, FSE: MDG1, Prime Standard), an early stage immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, reported financial results for the year ended December 31, 2022 and provided a corporate update (Press release, MediGene, MAR 28, 2023, View Source [SID1234629460]).

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Full Year 2022 Financial Results

Revenues amounted to EUR 31.3 million, up 200% compared to EUR 10.5 million in 2021.The increase in revenues compared to the previous year is mainly a result of the comprehensive TCR-T and technology partnership with BioNTech as well as a milestone payment received from 2seventy bio.

General and administrative (G&A) expenses were EUR 7.7 million in 2022 compared to EUR 6.2 million in the year prior. This 25% increase was mainly due to higher personnel expenses and consulting costs. In addition, some of the expenses for Executive Board compensation were reported under G&A expenses, whereas in previous years they were reported under R&D expenses.

Research and development (R&D) expenses increased from EUR 12.8 million in 2021, to EUR 28.5 million in fiscal 2022. The significant increase is mainly due to depreciation related to the full impairment of the drug candidate RhuDex, which was out-licensed to Dr. Falk Pharma GmbH, for the amount of EUR 20.4 million. This is attributable to the results of a clinical trial for primary biliary cirrhosis, where the efficacy of the drug candidate RhuDex could not be demonstrated. In the previous year, the impairment loss on RhuDex amounted to EUR 1.5 million.

Cash and cash equivalents amounted to EUR 22.2 million at the end of 2022, compared to EUR 22.4 million at the end of 2021. Based on current planning, Medigene is financed into the fourth quarter 2024.

"2022 was a transformational year for Medigene. We announced a strategic update, that involved the shift of our pipeline focus from liquid to solid tumors, expanding our in-house pipeline and accelerating the development of our lead candidates. We were thrilled to welcome BioNTech as our global strategic partner and received a milestone payment from one of our existing partners, 2seventy bio. In addition, we continued to expand our patent portfolio, which now consists of 57 issued and 94 pending patents across both our assets and technologies in our End-to-End Platform," said Selwyn Ho, Chief Executive Officer of Medigene.

"In 2023, we continue to progress our own MDG1015 program towards a first-in-human clinical trial and look forward to selecting our first lead candidate from the MDG10xx program in the second half of this year. We expect to extend our collaborative approach to R&D, maximizing our existing partnerships and evaluating new partnerships. We will continue to innovate and expand our End-to-End Platform to generate additional value from new development optimization and product enhancement technologies. Finally, despite our current strong cash position, we will explore opportunities to extend our cash runway into 2025 and beyond."

Recent Program Development Highlights and Anticipated 2023 Milestones

MDG1015: 3rd Generation TCR-T therapy for NY-ESO-1 combined with PD1-41BB Switch Receptor technology: MDG1015 is our lead internal solid tumor program. MDG1015 is being advanced towards a phase 1 clinical trial and is currently undergoing Investigational New Drug (IND) and Clinical Trial Application (CTA) enabling experiments, with the aim of having the IND / CTA approved in the 2nd half of 2024.

The first presentation of pre-clinical data for MDG1015 has been accepted for poster presentation at the upcoming American Academy of Clinical Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2023.

MDG10xx: Multiple TCR-T therapies for yet undisclosed targets combined with PD1-41BB Switch Receptor technology: MDG10xx is being developed against several, as yet undisclosed targets and involving multiple human leukocyte antigens (HLAs), again in combination with the PD1-41BB Switch Receptor technology. The Company expects to announce the first lead for this program in the second half of this year.

MDG1011: TCR-T therapy in blood cancers: The successful completion of the phase 1 MDG1011 trial provides clear clinical validation of our ability to generate and manufacture TCR-T therapies. Despite the positive data generated for MDG1011, the Company made the strategic decision to focus future research and development efforts towards solid tumors indications.

Recent Corporate Development Highlights

Milestone payment from 2seventy bio: In December 2022, a strategic partnership between 2seventy bio (Nasdaq: TSVT) and JW Therapeutics (HKEX: 2126) was announced that included plans for the advancement of the MAGE-A4 TCR licensed from Medigene into a phase 1 clinical trial in China. This triggered a USD 3 million milestone payment from 2seventy bio, which the Company received in January 2023. As a reminder, our partnership with 2seventy bio concluded in June 2022 in accordance with the contract. Upon achievement of contractually defined targets, Medigene remains eligible for milestone payments and royalties from 2seventy bio as per the existing agreement.

Strengthened leadership team with new appointments of James Cornicelli, Pamela Keck and Kirsty Crame: Mr. Cornicelli is the Head of Corporate Development and Strategy. As a highly seasoned executive with over 20 years in senior corporate development and strategic advisory roles, Mr. Cornicelli brings multiple areas of expertise that will help guide the company on critical decisions about partnering and accelerate the growth strategy.

Pamela Keck is the Head of Investor Relations and Corporate Communications. Ms. Keck brings more than 15 years of experience as investor relations and corporate communications professional, and will lead Medigene’s investor relations and corporate communication actvities.

Kirsty Crame, MD, was recently appointed as Medigene’s Head of Clinical Research & Development. Kirsty brings more than 10 years of experience in drug development and clinical operations, focusing primarily in immuno-oncology and in cell therapy development. Dr. Crame will lead the Company’s clinical operations and guide the development of the MDG1015 program towards IND/CTA submissions and approval