On May 25, 2023 AstraZeneca reported its advances in ambition to revolutionise cancer care with new data across its industry-leading portfolio of cancer medicines at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, 2 to 6 June 2023 (Press release, AstraZeneca, MAY 25, 2023, View Source [SID1234632017]).

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More than 130 abstracts will feature 22 approved and potential new medicines across the Company’s diverse oncology portfolio and pipeline, including 11 oral presentations and a late-breaking plenary presentation of overall survival (OS) results from the ADAURA Phase III trial of Tagrisso (osimertinib) in the adjuvant treatment of patients with early-stage epidermal growth factor receptor-mutated (EGFRm) lung cancer.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "Our unwavering commitment to continually raising the standard of cancer care for patients with high unmet needs is evident in our data at ASCO (Free ASCO Whitepaper) this year. With our leading portfolio of medicines in lung cancer, our ambition is to have the right AstraZeneca medicine for more than half of all patients with this disease by 2030. We will showcase significant steps toward that goal with overall survival data from ADAURA that reinforce Tagrisso as the backbone therapy in EGFR-mutated lung cancer."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "We are extending the benefits of our practice-changing cancer medicines, including Tagrisso, Imfinzi and Lynparza, while also investing in new scientific platforms such as T-cell engagers and cell therapy to attack cancer from multiple angles and advance the next wave of options for patients. At ASCO (Free ASCO Whitepaper), the extraordinary momentum for our antibody drug conjugate collaboration portfolio continues with data for Enhertu underscoring its potential across many HER2-expressing tumour types beyond breast, lung and gastric, and updated results for datopotamab deruxtecan that reinforce our confidence in this TROP2-directed treatment."

Improving outcomes across lung cancer settings
A late-breaking plenary presentation will showcase OS results from the ADAURA Phase III trial evaluating Tagrisso in early-stage (IB, II and IIIA) EGFR-mutated non-small cell lung cancer (NSCLC).

Several posters will describe trials-in-progress of Imfinzi (durvalumab) that further reinforce the Company’s progress toward moving lung cancer treatment to earlier stages of disease. These include NeoCOAST-2 evaluating Imfinzi in multiple novel immunotherapy combinations in resectable, early-stage NSCLC; PACIFIC-4 in combination with standard of care stereotactic body radiation therapy in medically unresectable Stage I/II NSCLC; PACIFIC-8 in combination with anti-TIGIT monoclonal antibody domvanalimab in unresectable Stage III NSCLC; and PACIFIC-9 in combination with novel immunotherapies oleclumab or monalizumab in patients with unresectable Stage III NSCLC.

Additionally, several presentations and posters will highlight the Company’s commitment to improving outcomes in advanced lung cancer with next-wave treatments and novel combinations. These include:

An oral presentation of updated results from the TROPION-Lung02 Phase Ib dose escalation and expansion trial of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemotherapy in patients with previously untreated or pretreated, advanced or metastatic NSCLC without actionable genomic alterations. TROPION-Lung02 is the first trial to show results for an antibody drug conjugate (ADC) plus an immune checkpoint inhibitor combination with or without chemotherapy in this setting.
Interim results from the ARTEMIDE-01 Phase I trial assessing rilvegostomig (AZD2936), a PD-1/TIGIT bispecific antibody, in patients with advanced or metastatic NSCLC. The Company is advancing rilvegostomig into Phase III development this year.
A trial-in-progress poster describing the EGRET Phase I trial, a first-in-human study evaluating AZD9592, an EGFR/cMET bispecific ADC, in patients with advanced solid tumours including in combination with Tagrisso in metastatic EGFRm NSCLC. This is the Company’s first bispecific ADC to enter the clinic and has shown a promising efficacy and safety profile in preclinical models.
A trial-in-progress poster describing the LATIFY Phase III trial of ceralasertib, an ataxia telangiectasia and rad3-related (ATR) kinase inhibitor, plus Imfinzi in patients with locally advanced or metastatic NSCLC who progressed on or after anti-PD-(L)1 and platinum-based therapy. This combination has previously demonstrated promising efficacy in this setting in the ongoing HUDSON Phase II trial.
A trial-in-progress poster detailing the TROPION-Lung04 Phase Ib dose escalation and expansion study of Dato-DXd in various immunotherapy combinations with or without carboplatin in patients with previously untreated advanced or metastatic NSCLC, including recently initiated cohorts with bispecific immunotherapies rilvegostomig and volrustomig.
Showcasing the potential of Enhertu across multiple HER2-expressing tumours
Several presentations will reinforce the potential of Enhertu (trastuzumab deruxtecan) in a broad range of HER2-expressing tumours with significant unmet need, including gynaecological, genitourinary, gastrointestinal and breast cancers.

A late-breaking oral presentation of interim results from the DESTINY-PanTumor02 Phase II trial will highlight the efficacy and safety of Enhertu in heavily pretreated patients across multiple HER2-expressing advanced solid tumours including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic, and rare cancers. In March, Enhertu met the prespecified target for objective response rate and demonstrated durable responses across multiple HER2-expressing tumour types in this trial.

Additionally, an oral presentation of primary results from the DESTINY-CRC02 Phase II trial will be presented, demonstrating the safety and efficacy of Enhertu in patients with HER2-positive advanced colorectal cancer with progression following standard-of-care treatment. This trial was initiated based on positive data for Enhertu in the DESTINY-CRC01 Phase II trial.

Another oral presentation will feature a pooled benefit-risk analysis from the DESTINY-Breast01, 02 and 03 trials of Enhertu in patients with breast cancer aged 65 and older compared to those younger than 65.

Potential to transform outcomes across tumours by attacking cancer from multiple angles
A late-breaking oral presentation will feature interim progression-free survival (PFS) results from the DUO-O Phase III trial evaluating a combination of Lynparza, Imfinzi, chemotherapy and bevacizumab in newly diagnosed patients with advanced high-grade epithelial ovarian cancer without tumour BRCA mutations. In April, it was announced that DUO-O demonstrated a statistically significant and clinically meaningful improvement in PFS for this Lynparza and Imfinzi combination versus chemotherapy plus bevacizumab alone.

Data will be also shared from a post-hoc exploratory analysis of the SERENA-2 Phase II trial in patients with advanced ER-positive breast cancer who have disease recurrence or progression after endocrine therapy. The analysis will show PFS data for patients treated with next-generation selective estrogen receptor degrader (ngSERD) camizestrant versus Faslodex (fulvestrant) based on the type of ESR1 mutation at baseline, detected via circulating tumour DNA. Previously presented primary results from SERENA-2 demonstrated PFS benefit with camizestrant irrespective of ESR1 mutation status or prior treatment with CDK4/6 inhibitors.

Data will also be shared from a matching-adjusted indirect comparison (MAIC) of the efficacy and safety of Calquence (acalabrutinib) versus zanubrutinib in relapsed or refractory chronic lymphocytic leukemia, based on data from the ASCEND and ALPINE Phase III trials.

In addition, interim Phase I results evaluating AZD0486 (TNB-486), a CD19/CD3 next-generation T-cell engager, will show the potential of targeting CD19 in heavily pretreated patients with follicular lymphoma.

Results from a Phase Ib/II dose escalation and expansion trial of the novel immunotherapy oleclumab in combination with Imfinzi and chemotherapy will also be presented in patients with metastatic pancreatic cancer, including those with high levels of CD73 expression.

A poster discussion will feature health-related quality-of-life results from the PROpel Phase III trial of Lynparza plus abiraterone in patients with metastatic castration-resistant prostate cancer.

Two presentations will focus on immune-mediated adverse events (imAEs) in the HIMALAYA Phase III trial of Imfinzi plus Imjudo (tremelimumab) in 1st-line unresectable liver cancer, including an oral presentation on outcomes by imAE occurrence and a poster on temporal patterns of imAE occurrence.

Collaboration in the scientific community is critical to improving outcomes for patients. AstraZeneca is collaborating with Daiichi Sankyo Company Limited to develop and commercialise Enhertu and datopotamab deruxtecan; with MSD (Merck & Co., Inc. in the US and Canada) to develop and commercialise Lynparza. AstraZeneca obtained full oncology rights to monalizumab from Innate Pharma in October 2018 through a co-development and commercialisation agreement initiated in 2015.

Key AstraZeneca presentations during ASCO (Free ASCO Whitepaper) 2023

Lead Author

Abstract Title

Presentation details (CDT)

Tumour drivers and resistance

Herbst, R

Overall survival analysis from the ADAURA trial of adjuvant osimertinib in patients with resected EGFR mutated‑ (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC).

Abstract #LBA3

Plenary Session

4 June 2023

2:17pm

Oliveira, M

Clinical activity of camizestrant, a next-generation SERD, versus fulvestrant in patients with a detectable ESR1 mutation: Exploratory analysis of the SERENA-2 Phase 2 trial.

Abstract #1066

Poster Session

Breast Cancer—Metastatic

4 June 2023

8:00am

Antibody drug conjugates

Meric-Bernstam, F

Efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-expressing solid tumors: DESTINY-PanTumor02 (DP-02) interim results.

Abstract #LBA3000

Oral Abstract Session Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

5 June 2023

8:00am

Raghav, K

Trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-overexpressing/amplified (HER2+) metastatic colorectal cancer (mCRC): Primary results from the multicenter, randomized, Phase 2 DESTINY-CRC02 study.

Abstract #3501

Oral Abstract Session Gastrointestinal Cancer—Colorectal and Anal

4 June 2023

8:12am

Krop, I

An age-specific pooled analysis of trastuzumab deruxtecan (T‑DXd) in patients (pts) with HER2-positive (HER2+) metastatic breast cancer (mBC) from DESTINY-Breast01, -02, and -03.

Abstract #1006

Oral Abstract Session Breast Cancer—Metastatic

5 June 2023

1:30pm

Goto, Y

TROPION-Lung02: Datopotamab deruxtecan (Dato-DXd) plus pembrolizumab (pembro) with or without platinum chemotherapy (Pt-CT) in advanced non-small cell lung cancer (aNSCLC).

Abstract #9004

Oral Abstract Session Lung Cancer—Non-Small Cell Metastatic

6 June 2023

10:57am

Aggarwal, C

EGRET: A first-in-human study of the novel antibody-drug conjugate (ADC) AZD9592 as monotherapy or combined with other anticancer agents in patients (pts) with advanced solid tumors.

Abstract #TPS3156

Poster Session Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

3 June 2023

8:00am

Borghaei, H

TROPION-Lung04: Phase 1b, multicenter study of datopotamab deruxtecan (Dato-DXd) in combination with immunotherapy ± carboplatin in advanced/metastatic non-small cell lung cancer (mNSCLC).

Abstract#TPS3158

Poster Session Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

3 June 2023

8:00am

DNA damage response

Harter, P

Durvalumab with paclitaxel/carboplatin (PC) and bevacizumab (bev), followed by maintenance durvalumab, bev, and olaparib in patients (pts) with newly diagnosed advanced ovarian cancer (AOC) without a tumor BRCA1/2 mutation (non-tBRCAm): Results from the randomized, placebo (pbo)-controlled Phase III DUO-O trial.

Abstract #LBA5506

Oral Abstract Session Gynecologic Cancer

3 June 2023

5:12pm

Armstrong, A

Health-related quality of life (HRQoL) and pain outcomes for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) who received abiraterone (abi) and olaparib (ola) versus (vs) abi and placebo (pbo) in the Phase III PROpel trial.

Abstract #5012

Poster Discussion Genitourinary Cancer—Prostate, Testicular, and Penile Session

3 June 2023

1:27pm

Immuno-Oncology

Hübner, H

RNA expression levels from peripheral immune cells, a minimally invasive liquid biopsy source to predict response to therapy, survival and immune-related adverse events in patients with triple negative breast cancer enrolled in the GeparNuevo trial.

Abstract #1011

Oral Abstract Session

Clinical Science Symposium: Harnessing the Breast Cancer Immune Response

3 June 2023

1:51pm

Lau, G

Outcomes by occurrence of immune-mediated adverse events (imAEs) with tremelimumab (T) plus durvalumab (D) in the Phase 3 HIMALAYA study in unresectable hepatocellular carcinoma (uHCC).

Abstract #4004

Oral Abstract Session Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

2 June 2023

3:57pm

Besse, B

LATIFY: Phase 3 study of ceralasertib + durvalumab vs docetaxel in patients with locally advanced or metastatic non-small-cell lung cancer that progressed on or after anti-PD-(L)1 and platinum-based therapy.

Abstract #TPS9161

Poster Session Lung Cancer—Non-Small Cell Metastatic

4 June 2023

8:00am (CDT)

Rohrberg, K

Safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of AZD2936, a bispecific antibody targeting PD-1 and TIGIT, in checkpoint inhibitor (CPI)-experienced advanced/metastatic non-small-cell lung cancer (NSCLC): First report of ARTEMIDE-01.

Abstract #9050

Poster Session Lung Cancer—Non-Small Cell Metastatic

4 June 2023

8:00am

Guisier, F

NeoCOAST-2: A Phase 2 study of neoadjuvant durvalumab plus novel immunotherapies (IO) and chemotherapy (CT) or MEDI5752 (volrustomig) plus CT, followed by surgery and adjuvant durvalumab plus novel IO or volrustomig alone in patients with resectable non-small-cell lung cancer (NSCLC).

Abstract #TPS8604

Poster Session Lung Cancer—Non-Small Cell Local Regional/Small Cell/Other Thoracic Cancers

4 June 2023

8:00am

Robinson, C

Phase 3 study of durvalumab with SBRT for unresected stage I/II, lymph-node negative NSCLC (PACIFIC-4/RTOG3515).

Abstract #TPS8607

Poster Session Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

4 June 2023

8:00am

Özgüroğlu, M

Phase 3 trial of durvalumab combined with domvanalimab following concurrent chemoradiotherapy (cCRT) in patients with unresectable stage III NSCLC (PACIFIC-8).

Abstract #TPS8609

Poster Session Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

4 June 2023

8:00am

Barlesi, F

Phase 3 study of durvalumab combined with oleclumab or monalizumab in patients with unresectable stage III NSCLC (PACIFIC-9).

Abstract #TPS8610

Poster Session Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

4 June 2023

8:00am

Ganti, A

The prognostic value of patient reported outcomes (PROs) and clinical/demographic variables in the CASPIAN study.

Abstract #8516

Poster Discussion Session Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

4 June 2023

11:45am

Lau, G

Temporal patterns of immune-mediated adverse events (imAEs) with tremelimumab (T) plus durvalumab (D) in the Phase 3 HIMALAYA study in unresectable hepatocellular carcinoma (uHCC).

Abstract #4073

Poster Session Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

5 June 2023

8:00am

Coveler, A

Safety and clinical activity of oleclumab (O) ± durvalumab (D) + chemotherapy (CT) in patients (pts) with metastatic pancreatic ductal adenocarcinoma (mPDAC): A Phase 1b/2 randomized study.

Abstract #4136

Poster Session Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

5 June 2023

8:00am

Haematology

Kittai, A

A matching-adjusted indirect comparison (MAIC) of the efficacy and safety of acalabrutinib (acala) versus zanubrutinib (zanu) in relapsed or refractory chronic lymphocytic leukemia (RR CLL).

Abstract #7540

Poster Session Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

5 June 2023

8:00am

Nair, R

High complete response rate with TNB-486 in relapsed/refractory follicular lymphoma: Interim results an ongoing Phase 1 study.

Abstract #7524

Poster Session Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

5 June 2023

8:00am

On May 25, 2023 Sandoz, a global leader in off-patent (generic and biosimilar) medicines, reported that the European Medicines Agency (EMA) has accepted the marketing authorization applications (MAA) for proposed biosimilar denosumab for regulatory review (Press release, Sandoz, MAY 25, 2023, View Source [SID1234632016]).

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The two applications include all indications covered by the reference medicines Prolia (denosumab)* and Xgeva (denosumab)*, respectively, for treating a variety of conditions, including osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal related complications in cancer that have spread to the bone, and giant cell tumor of the bone.1,2

"Sandoz is one of the first to have its applications for a proposed biosimilar denosumab accepted by the EMA. If approved, this has the potential to provide people living with osteoporosis and cancer of the bone or bone metastasis access to a cost-effective and high-quality treatment option." said Florian Bieber, Development Platform Head Biopharmaceuticals and Chief Medical Officer, Sandoz. "This news follows the recent application acceptance by the US Food and Drug Administration and supports our continued commitment to providing expanded access to life-changing treatments, while also helping over-burdened healthcare systems generate savings."

Approximately 500 million men and women worldwide may be affected by osteoporosis, which causes 8.9 million fractures annually – or one fracture every three seconds.3 By 2050, hip fractures are projected to increase by 240% in women and 310% in men compared to 1990.3 Prevalence of skeletal related complications in cancer is estimated to be as high as 63% for breast cancer, 59% for lung cancer and 52% for prostate cancer. Skeletal related complications in cancer are associated with loss of mobility and social functioning, reduced quality of life, increased health care expenditure and worse survival.4,5,6

The EMA applications are based on a comprehensive analytical and clinical data package, comprised of data from a Phase I PK/PD similarity study in healthy volunteers and the integrated Phase I/III ROSALIA study. The data package confirmed the denosumab biosimilar matches the reference medicine in terms of pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity in the respective study populations; and contributes to the demonstration of similarity, which is the basis for use in all indications for which Xgeva and Prolia are approved.

Sandoz is committed to helping millions of patients sustainably and affordably access critical and potentially life-changing biologic medicines across a range of areas including immunology, oncology, supportive care and endocrinology. It has a leading global portfolio with eight marketed biosimilars and a further 24 assets in various stages of development. Since launching the first biosimilar in Europe in 2006, Sandoz has proven biosimilars create early and expanded patient access to life-altering medicines while increasing healthcare savings and creating competition that fuels innovation and development of new and enhanced treatments in areas of unmet need.

About denosumab
Denosumab is a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts (cells involved in breaking down bone tissue).1 By binding to and inhibiting RANKL, denosumab decreases the production and activity of osteoclasts, resulting in a reduction of bone loss, and subsequently the likelihood of fractures and other serious bone conditions.7

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

References

European Medicines Agency (EMA). Prolia (Denosumab): Prescribing Information. Available from: View Source [Last accessed: May 2023].
European Medicines Agency (EMA). Xgeva (Denosumab): Prescribing Information. Available from: View Source [Last accessed: May 2023].
International Osteoporosis Foundation. Facts and Statistics. Available from: View Source [Last accessed: May 2023].
Bhowmik D. et al. Current Medical Research and Opinion, 35:3, 513-523.
Cadieux B. et al. Journal of Bone Oncology, 2022, 33: 1-13.
Coleman R. et al. Bone health in cancer: ESMO (Free ESMO Whitepaper) Clinical Practice Guidelines, 2020.
Amgen Europe B.V. Xgeva (Denosumab): Summary of Product Characteristics. Available from: View Source [Last accessed: May 2023].

On May 24, 2023 Excyte Biopharma reported its YK012 (CD3), a bispecific antibody drug, was used for the treatment of recurrent/refractory B-cell non Hodgkin’s lymphoma × CD19) Phase I clinical study completed the first drug administration in Phase I ward of Chinese Academy of Medical Sciences Cancer Hospital (Press release, Excyte Biopharma, MAY 24, 2023, View Source;lang=en [SID1234646276]).

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At 9:40 am on the same day, YK012 injection slowly flowed into the subject’s body through a micro injection pump and infusion pipeline. After 24 hours of administration, the subject had no adverse reactions and was in stable condition. In order to ensure the safety of the subjects and collect safety data of this product, the research team is closely monitoring the treatment response of the subjects and will promptly share information with all parties involved in the project.

Under the full promotion of the project team of the company, contract research organization Beijing New Leading Medicine and the Cancer Hospital of the Chinese Academy of Medical Sciences worked together to complete the first drug administration 17 days after the project kick-off meeting, highlighting the "speed of Yikesite". Yike Si Te is making every effort to rapidly advance the clinical progress of YK012, complete the product launch as soon as possible, and enable more patients to use the new drug as soon as possible, solve their pain, and improve their quality of life.

YK012 developed by Yikesite has a similar mechanism of action to Amgen’s Beretol, but it is significantly superior to Beretol in terms of molecular structure, half-life, production level and toxicity. Preclinical studies have shown that YK012 may have better clinical efficacy and safety, and is expected to provide better treatment options for refractory and recurrent ALL and NHL. In addition, through clinical trial exploration, it is possible to expand YK012 to more indications.

Yikesite (Beijing) Pharmaceutical Technology Development Co., Ltd. was jointly founded by Dr. Yuan Qing’an and Mr. Meng Qingwu, who came back from a famous American pharmaceutical company. The company makes full use of the founder’s years of experience, technical advantages and team strength to develop innovative bispecific antibody drugs for blood cancer, multiple myeloma, triple negative breast cancer and liver cancer. These projects have the characteristics of long-term, low toxicity, and high-yield technological innovation, and are positioned as the best or first of their kind. I believe that with the progress of the product pipeline, the company will have more dual antibody varieties entering the clinical stage, providing better treatment methods for patients.

On May 24, 2023 Cyteph, a spin-out biotechnology company from QIMR Berghofer Medical Research Institute, reported a $1.5m grant via the CUREator incubator (Press release, Cyteph, MAY 24, 2023, View Source [SID1234638281]).

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This grant signals an official launch milestone for the Company, supporting its imminent plan to conduct a phase 1 clinical trial for its lead candidate CYT-101 in recurrent glioblastoma multiforme (GBM) patients. Under the guidance of QIMR Berghofer’s Professor Rajiv Khanna, the goal is to develop allogeneic or ‘off-the-shelf’ T cell therapies and a dual-targeting CAR T platform to rapidly advance the treatment of solid tumours.

CYT-101 is an allogeneic cytomegalovirus (CMV)-specific T cell therapy developed by Professor Khanna’s team. The novel immunotherapy uses the immune system and the power of virus-specific T cells to recognise and attack cancer cells. CMV-specific T cells are particularly effective at targeting and destroying virus-infected and malignant cells because they are primed in the body as killer T cells which rapidly migrate and penetrate deep into diseased tissues.

The program has been de-risked through two previous clinical trials using autologous CMVspecific T cell therapy in GBM patients, where it was found to be safe with preliminary efficacy signals. Autologous treatments use the patient’s own immune cells which are harvested, manipulated, then injected back into the patient; a process which is costly, can take many weeks, and the immune cells can be dysfunctional. Allogeneic treatments, often termed ‘offthe-shelf’, use donor cells from healthy volunteers. Pivoting to allogeneic treatment offers many potential benefits over autologous, including a more robust and consistent product with longer duration and treatment without delay, which is crucial for treating fast-growing tumours such as GBM.

QIMR Berghofer Distinguished Scientist, Co-Director of Queensland Immunology Research Centre and Cyteph Founder, Professor Rajiv Khanna, commented: "Securing this grant is an important commercial milestone for Cyteph and a vital step in progressing the development of its lead technology, which has been nurtured at QIMR Berghofer for 15 years. For our medical research team, one of the most rewarding parts of the job is guiding work from the lab, closer to the patient, and I am optimistic about how CYT-101 may improve the lives of people suffering from GBM."

Cyteph Chief Executive Officer, Dr Melissa Knight, shared her enthusiasm: "We are thrilled to receive the CUREator funding and are right now welcoming further engagement with the investor community to progress our broader pipeline into the clinic. We are resolutely focused on our near-term goal to test and prove the merits of this Australian technology and to address pressing, unmet needs in the treatment of cancer."

In addition to CYT-101, Cyteph plans to utilise the unique properties of allogenic CMV-specific T cells as a dual targeting, CAR T delivery platform ‘Cyt-ATTAC’ (Cytomegalovirus – Allogeneic Tumor TArgeting Car t) to treat solid tumours. The first CAR T asset in pre-clinical development using the platform, CYT-AT1, targets EphA3 positive solid tumours such as GBM, colorectal, prostate and lung cancer. Capital raise efforts are underway to support this promising pipeline of medical research.

On May 24, 2023 Philogen S.p.A. (BIT:PHIL), a clinical-stage biotech company focused on the development of innovative medicines based on tumor-targeting antibody and small molecule ligands, reported the publication of the latest results of Fibromun (L19TNF, Onfekafusp alfa) in combination with lomustine (an alkylating agent) for the treatment of glioblastoma in Science Translational Medicine describing how the combination treatment cured orthotopic glioma-bearing mice and mediated durable objective responses and major tumor shrinkage in patients with recurrent glioblastoma (Press release, Philogen, MAY 24, 2023, https://www.philogen.com/2023/05/26/philogen-publishes-new-data-on-a-fibromun-based-treatment-combination-in-science-translational-medicine-in-collaboration-with-the-university-hospital-zurich/ [SID1234632147]). The paper can be accessed at the following link.

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The study demonstrated that the combination Fibromun and lomustine was highly synergistic and relied on an intact immune system. A thorough investigation of the treatment’s mechanism of action showed that it could transform tumors from being "invisible" to the immune system ("cold") into being easily recognized and attacked ("hot"). This transformation was proven by several indicators: the activation of the tumor endothelium, enhanced tumor DNA damage signaling pathways, treatment-associated tumor necrosis, increased immunogenicity of cancer cells and elevation of immune cell infiltration within the neoplastic mass.

Prof. Michael Weller and Dr. Tobias Weiss of University Hospital Zürich, commented: "We are excited to release this follow-up work based on the Science Translational Medicine paper published together with Philogen back in 2020. The preclinical anti-tumor activity of the combination of Fibromun with lomustine chemotherapy is very promising and the emerging clinical results of the ongoing Phase I/II trial NCT04573192 provide hope for better therapeutic opportunities for patients affected by this serious disease. We now look forward to exploring this promising approach in the Phase II randomized part which is currently starting."

Prof. Dario Neri, co-founder, CEO and CSO of Philogen, commented: "These latest findings show the promising potential of Fibromun for the treatment of glioblastoma, one of the biggest unmet medical needs. While the Phase II randomized part of the GLIOSTAR clinical trial is about to start, the preliminary evidence collected in the Phase I part demonstrates encouraging, durable objective responses in an indication where responses are very rare. We are committed to advancing our research and development efforts, with the ultimate goal of delivering this innovative treatment to patients in need." * * *

About L19TNF (also known as Fibromun)

L19TNF is a fully-human immunomodulatory product consisting of the L19 antibody and tumor necrosis factor (TNF), a strong proinflammatory cytokine. The L19 antibody is specific to the EDB domain of fibronectin and mediates selective localization of TNF to the site of disease while sparing healthy organs. The product is currently investigated in multiple clinical trials for the treatment of soft tissue sarcoma and glioblastoma, both in Europe and in the United States.

About glioblastoma

Glioblastoma is the most common and most aggressive primary brain tumor. It affects approximately 5 out of 100’000 people every year (Source: Orphanet). Newly diagnosed patients are typically treated with surgery, radiation and temozolomide (chemotherapy), which result in a median Overall Survival (mOS) in the range of 15 months. Virtually all patients progress and may subsequently receive another systemic or local second-line therapy. The mOS of patients at first progression ranges between 4.7 and 9.8 months in previous clinical trials.

About clinical trial NCT04573192

The Phase I/II clinical trial NCT04573192, which investigates the combination of L19TNF and lomustine for the treatment of patients suffering from glioblastoma at first progression after standard of care radiotherapy and chemotherapy. The Phase I part of the trial with escalating dose levels of L19TNF and lomustine is followed by a randomized Phase II part to investigate the efficacy of the combination treatment compared to standard of care lomustine as monotherapy with overall survival as primary endpoint. The first cohort of the phase I part of the study, comprising 6 patients, is presented in this publication.