A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant Compared With Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)

The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer.

Start Date01 Aug 2024

Sponsor / Collaborator

AstraZeneca PLC

CTRI/2024/06/068435 / Not yet recruitingPhase 3

A Randomized, 2 cohort, Double blind, Placebo controlled, Phase III Study of AZD5305 in Combination with Physicians Choice New Hormonal Agents in Patients with HRRm and non HRRm Metastatic Castration Sensitive Prostate Cancer EvoPAR Prostate01 - EvoPAR Prostate01

Start Date17 Jun 2024

Sponsor / Collaborator

AstraZeneca AB

[+1]

CTR20241066 / RecruitingPhase 3

一项Saruparib（AZD5305）联合研究者所选新型内分泌治疗药物治疗HRRm和非HRRm转移性去势敏感性前列腺癌患者的随机、2队列、双盲、安慰剂对照、III期研究（EvoPAR-Prostate01）

[Translation] A randomized, 2-cohort, double-blind, placebo-controlled, phase III study of saruparib (AZD5305) in combination with a novel endocrine therapy selected by the investigator in patients with HRRm and non-HRRm metastatic castration-sensitive prostate cancer (EvoPAR-Prostate01)

评估AZD5305联合NHA对照安慰剂联合NHA的有效性和安全性。包括对以下终点的评价：即无影像学进展生存期、第二次无进展生存期、无症状性骨骼事件生存期、至首次发生去势抵抗性事件的时间、疼痛进展时间、泌尿系统症状恶化时间、疲劳恶化时间、身体机能恶化时间、至首次后续治疗或死亡时间、总生存期、以及有效性和安全性的评估。

[Translation]

To evaluate the efficacy and safety of AZD5305 combined with NHA versus placebo combined with NHA. This includes evaluation of the following endpoints: radiographic progression-free survival, second progression-free survival, skeletal event-free survival, time to first castration-resistant event, time to pain progression, time to urinary symptom deterioration, time to fatigue deterioration, time to physical function deterioration, time to first subsequent treatment or death, overall survival, and evaluation of efficacy and safety.

Start Date26 Apr 2024

Sponsor / Collaborator

AstraZeneca AB

[+1]

100 Clinical Results associated with Saruparib

100 Translational Medicine associated with Saruparib

100 Patents (Medical) associated with Saruparib

Literatures (Medical) associated with Saruparib

27 Mar 2023·Cancer Research Communications

The PARP1 Inhibitor AZD5305 Impairs Ovarian Adenocarcinoma Progression and Visceral Metastases in Patient-derived Xenografts Alone and in Combination with Carboplatin

Article

Author: Formenti, Laura ; Dellavedova, Giulia ; Staniszewska, Anna D. ; Albertella, Mark R. ; Leo, Elisabetta ; Bani, Maria Rosa ; Ghilardi, Carmen ; Decio, Alessandra ; Wilson, Joanne ; Giavazzi, Raffaella

PARP inhibitors (PARPi) have changed the management of patients with ovarian cancer and their effectiveness has been demonstrated especially in homologous recombination repair–deficient tumors. These first-generation drugs target PARP1, but also PARP2 and other family members potentially responsible for adverse effects that limit their therapeutic potential and restrict their use in combination with chemotherapeutic agents.We investigated ovarian cancer patient-derived xenografts (OC-PDXs) to assess whether malignant progression could be impaired by a novel inhibitor selective for PARP1 (AZD5305) and to assess the potential of its combination with carboplatin (CPT), the standard-of-care for patients with ovarian cancer.In BRCA-mutated OC-PDXs, AZD5305 achieved greater tumor regressions and longer duration of response as well as a superior impairment of visceral metastasis and improved survival benefit compared with the first-generation dual PARP1/2 inhibitors.The combination of AZD5305 plus CPT was more efficacious than single agents. Subcutaneously growing tumors experienced regression that persisted after therapy stopped. Combination efficacy was greater against tumors that did not respond well to platinum, even at a dose at which AZD5305 monotherapy was ineffective. The combination therapy impaired metastatic dissemination and significantly prolonged the lifespan of mice bearing OC-PDXs in their abdomen. This combination benefit was evident even when CPT was used at suboptimal doses, and was superior to full-dose platinum treatment.These preclinical studies demonstrate that the PARP1-selective inhibitor AZD5305 retains and improves the therapeutic benefit of the first-generation PARPi, providing an opportunity to maximize benefits for this class of anticancer agents.Significance:Selective PARP1i AZD5305 can exceed the efficacy of first-generation PARPi, which target both PARP1 and PARP2, and potentiates the efficacy of CPT when given in combination. AZD5305 alone or in combination with platinum delayed visceral metastasis, ultimately extending the lifespan of OC-PDX–bearing mice. These preclinical models mimic the progression of the disease occurring in patients after debulking surgery, and are translationally relevant.

24 Mar 2023·Science Advances

Clinical PARP inhibitors allosterically induce PARP2 retention on DNA

Article

Author: Pascal, John M. ; Lin, Xiaohui ; Langelier, Marie-France ; Zha, Shan

PARP1 and PARP2 detect DNA breaks, which activates their catalytic production of poly(ADP-ribose) that recruits repair factors and contributes to PARP1/2 release from DNA. PARP inhibitors (PARPi) are used in cancer treatment and target PARP1/2 catalytic activity, interfering with repair and increasing PARP1/2 persistence on DNA damage. In addition, certain PARPi exert allosteric effects that increase PARP1 retention on DNA. However, no clinical PARPi exhibit this allosteric behavior toward PARP1. In contrast, we show that certain clinical PARPi exhibit an allosteric effect that retains PARP2 on DNA breaks in a manner that depends on communication between the catalytic and DNA binding regions. Using a PARP2 mutant that mimics an allosteric inhibitor effect, we observed increased PARP2 retention at cellular damage sites. The PARPi AZD5305 also exhibited a clear reverse allosteric effect on PARP2. Our results can help explain the toxicity of clinical PARPi and suggest ways to improve PARPi moving forward.

01 Dec 2022·Bioorganic & Medicinal Chemistry Letters

Synthesis and in vitro biological evaluation of 3-ethyl-1,5-naphthyridin-2(1H)-one derivatives as potent PARP-1 selective inhibitors and PARP-1 DNA trappers

Article

Author: Li, Jiani ; Liu, Ying ; Quan, Xu ; Li, Zhiyu ; Ren, Junkang ; Zhang, Xiaomeng ; Zhang, Xiaoyu

Inhibition of poly (ADP-ribose) polymerase (PARP) has been applied with great success in the clinical treatment of homologous recombination-deficient malignancy. Recent study demonstrated that not only PARP-1 inhibition but also DNA trapping contributes to the efficacy in BRCA mutant tumors and the toxicities results from the poor selectivity of PARP-1 over PARP-2 as well as their DNA trapping. Herein, a series of 3-ethyl-1,5-naphthyridin-2(1H)-one derivatives (7a-7l, 8a-8n) were synthesized and identified as PARP-1 selective inhibitors and PARP-1 DNA trappers. Among them, compound 8m was found to be highly potent and selective. It inhibited PARP-1 activity and BRCA mutant DLD-1 cell activity with IC₅₀ values of 0.49 nM and 4.82 nM, and the in vitro DNA trapping efficacy of compound 8m was 1.85 nM. Compared with AZD5305, compound 8m significantly improved the selectivity of PARP-1 over PARP-2 as well. Compound 8m was>1000-fold selective for PARP-1 DNA trapping over PARP-2.

News (Medical) associated with Saruparib

15 Oct 2024

·www.prnewswire.com

Metastatic Castration-Sensitive Prostate Cancer Clinical Trial Pipeline Insights Featuring 35+ Companies | DelveInsight

Metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC), refers to prostate cancer that has spread beyond the prostate but still responds to therapies that lower testosterone (castration) with an aging population, the incidence of prostate cancer is rising, leading to an increased demand for advanced therapies to treat metastatic forms of the disease. LAS VEGAS, Oct. 15, 2024 /PRNewswire/ -- DelveInsight's ' Metastatic Castration-Sensitive Prostate Cancer Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline mCSPC therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the mCSPC pipeline domain. Key Takeaways from the Metastatic Castration-Sensitive Prostate Cancer Pipeline Report DelveInsight's mCSPC pipeline report depicts a robust space with 35+ active players working to develop 40+ pipeline therapies for mCSPC treatment. Key mCSPC companies such as Tavanta Therapeutics, AstraZeneca, Regeneron Pharmaceuticals, Astellas Pharma, Propella Therapeutics, POINT Biopharma, Amgen, Janssen Research & Development, LLC, Bayer, Beigene, Amgen, Merck Sharp & Dohme LLC, Jiangsu HengRui Medicine Co., Ltd., Suzhou Kintor Pharmaceutical Inc, Astellas Pharma, and others are evaluating new mCSPC drugs to improve the treatment landscape. Promising mCSPC pipeline therapies such as TAVT-45 (abiraterone acetate), Saruparib (AZD5305), Capivasertib, REGN2810, Abiraterone decanote + dexamethasone or prednisone (PRL-02/ASP5541), [Ac-225]-PSMA-62, Xaluritamig, Apalutamide, Darolutamide, Luteinizing Hormone Releasing Hormone, Pembrolizumab, Dalpiciclib isethionate, GT0918, PRL-02, and others are under different phases of mCSPC clinical trials. In October 2024, Apalutamide (Erleada) was found to provide a significant improvement in overall survival (OS) at 24 months compared with enzalutamide (Xtandi) in the treatment of androgen receptor pathway inhibitor (ARPI)-naïve patients with metastatic castration-sensitive prostate cancer (mCSPC). In April 2024, Saruparib (AZD5305) demonstrated encouraging efficacy, favorable safety, a wide therapeutic index, and improved pharmacokinetic properties compared with currently approved PARP inhibitors in patients with advanced solid tumors harboring BRCA1/2, PALB2, or RAD51C/D mutations, according to findings from the Phase I/IIa PETRA study. In February 2024, Capivasertib combined with docetaxel to enhance anti-tumour activity through inhibition of AKT-mediated survival mechanisms in prostate cancer. Capivasertib can enhance anti-tumour effects of docetaxel by targeting residual docetaxel-persister cells, independent of PTEN status, to induce apoptosis and DNA damage in part through GSK3β. In January 2023, Tavanta Therapeutics announced positive top-line results from its pivotal, global Phase III clinical trial, evaluating the safety and efficacy of TAVT-45 (abiraterone acetate). The trial met its primary objective of establishing therapeutic equivalence of TAVT-45 to Zytiga® in patients with metastatic castrate-resistant prostate cancer (mCRPC) and metastatic high-risk castrate-sensitive prostate cancer (mCSPC), in addition to demonstrating a comparable safety profile. Request a sample and discover the recent advances in mCSPC treatment drugs @ Metastatic Castration-Sensitive Prostate Cancer Pipeline Report The mCSPC pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage mCSPC drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the mCSPC clinical trial landscape. Metastatic Castration-Sensitive Prostate Cancer Overview Metastatic castration-sensitive prostate cancer (mCSPC) is an advanced form of prostate cancer in which the cancer cells have spread beyond the prostate to other parts of the body, such as bones or lymph nodes, but remain responsive to hormone therapy. This means that reducing testosterone levels can still effectively slow the growth of cancer cells. mCSPC often arises when prostate cancer is initially diagnosed or when early-stage prostate cancer recurs after treatment. It is distinct from castration-resistant prostate cancer (CRPC), where the cancer continues to progress despite low testosterone levels. The causes of mCSPC primarily involve the spread of prostate cancer cells beyond the local prostate region, a process called metastasis. Although the exact mechanisms are complex, certain risk factors increase the likelihood of developing prostate cancer and its progression to metastatic disease. These risk factors include advanced age, a family history of prostate cancer, genetic mutations such as BRCA1/BRCA2, and race. Symptoms of mCSPC can include bone pain, urinary issues, fatigue, weight loss, and general malaise, especially if the cancer has spread to bones or lymph nodes. However, in many cases, early stages of metastasis may be asymptomatic, making regular screening essential for those at risk. Diagnosis of mCSPC typically involves a combination of blood tests, such as measuring prostate-specific antigen (PSA) levels, imaging studies, and biopsy to confirm the presence of cancer cells. Treatment for mCSPC revolves around androgen deprivation therapy to lower testosterone levels, often combined with other agents like chemotherapy (e.g., docetaxel) or second-generation androgen receptor inhibitors (e.g., abiraterone or enzalutamide). In recent years, clinical trials have shown the benefit of combining ADT with novel therapies to improve survival rates and manage symptoms, with personalized treatment approaches based on genetic testing becoming more common. Find out more about mCSPC treatment drugs @ Drugs for Metastatic Castration-Sensitive Prostate Cancer Treatment A snapshot of the mCSPC Pipeline Drugs mentioned in the report: Learn more about the emerging mCSPC pipeline therapies @ Metastatic Castration-Sensitive Prostate Cancer Clinical Trials Metastatic Castration-Sensitive Prostate Cancer Therapeutics Assessment The mCSPC pipeline report proffers an integral view of the mCSPC emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Metastatic Castration-Sensitive Prostate Cancer Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous Therapeutics Assessment By Molecule Type: Small molecule, Cell therapy, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Steroidal inhibitor of CYP17A1, PARP1 inhibitor, Proto-oncogene protein c-akt inhibitors, CYP17 lyase inhibitor, Antibody-dependent cell cytotoxicity, Immunostimulants, T lymphocyte stimulants, Ionizing radiation emitters. Key Metastatic Castration-Sensitive Prostate Cancer Companies: Tavanta Therapeutics, AstraZeneca, Regeneron Pharmaceuticals, Astellas Pharma, Propella Therapeutics, POINT Biopharma, Amgen, Janssen Research & Development, LLC, Bayer, Beigene, Amgen, Merck Sharp & Dohme LLC, Jiangsu HengRui Medicine Co., Ltd., Suzhou Kintor Pharmaceutical Inc, Astellas Pharma, and others. Key Metastatic Castration-Sensitive Prostate Cancer Pipeline Therapies: TAVT-45 (abiraterone acetate), Saruparib (AZD5305), Capivasertib, REGN2810, Abiraterone decanote + dexamethasone or prednisone (PRL-02/ASP5541), [Ac-225]-PSMA-62, Xaluritamig, Apalutamide, Darolutamide, Luteinizing Hormone Releasing Hormone, Pembrolizumab, Dalpiciclib isethionate, GT0918, PRL-02, and others. Dive deep into rich insights for new drugs for mCSPC treatment, visit @ Metastatic Castration-Sensitive Prostate Cancer Drugs Table of Contents For further information on the mCSPC Cancer pipeline therapeutics, reach out @ Metastatic Castration-Sensitive Prostate Cancer Treatment Drugs Related Reports Metastatic Castration-Sensitive Prostate Cancer Market Metastatic Castration-Sensitive Prostate Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key mCSPC companies including Myovant Sciences, Pfizer, Bayer, Orion, Novartis, AstraZeneca, Pfizer, Janssen, Merck, Eli Lilly, among others. Metastatic Prostate Cancer Market Metastatic Prostate Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key metastatic prostate cancer companies including AstraZeneca, Arvinas, Madison Vaccines, Phosplatin Therapeutics, Hinova Pharmaceuticals, Bristol Myers Squibb, Merck, MacroGenics, Daiichi Sankyo, Seagen, Taiho Pharmaceutical, Modra Pharmaceuticals, Xencor, Point Biopharma, Lantheus Holdings, Zenith Epigenetics, Essa Pharma, Telix Pharmaceuticals, Kintor Pharmaceutical, AB Science, Eli Lilly and Company, Exelixis among others. Metastatic Castration-Resistant Prostate Cancer Market Metastatic Castration-Resistant Prostate Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key mCRPC companies including AstraZeneca, Merck Sharp & Dohme, Hinova Pharmaceuticals, Pfizer, Astellas Pharma, Modra Pharmaceuticals, AB Science, Eli Lilly and Company, Zr Pharma & GmbH, Bristol-Myers Squibb, Ipsen, Exelixis, Takeda, Janssen Research & Development, Tesaro, Lantheus Holdings, Kintor Pharmaceutical, MacroGenics, Daiichi Sankyo, Madison Vaccines, Novartis, Point Biopharma, Xencor, Essa Pharma, Telix International, Bayer, Arvinas, among others. Metastatic Castration-Resistant Prostate Cancer Pipeline Metastatic Castration-Resistant Prostate Cancer Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key mCRPC companies, including AstraZeneca, Merck Sharp & Dohme, Hinova Pharmaceuticals, Pfizer, Astellas Pharma, Modra Pharmaceuticals, AB Science, Eli Lilly and Company, Zr Pharma & GmbH, Bristol-Myers Squibb, Ipsen, Exelixis, Takeda, Janssen Research & Development, Tesaro, Lantheus Holdings, Kintor Pharmaceutical, MacroGenics, Daiichi Sankyo, Madison Vaccines, Novartis, Point Biopharma, Xencor, Essa Pharma , Telix International, Bayer, Arvinas, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical Result

29 May 2024

·www.biospace.com

How Realistic is AstraZeneca’s $80B Revenue Target by 2030?

Pictured: Exterior of AstraZeneca’s building in South San Francisco, California/iStock, Michael Vi AstraZeneca announced an ambitious goal last week: to reach $80 billion in total revenue and launch 20 new medicines by 2030. The U.K.-based pharma giant said it plans to focus on improving productivity in its operations and initiating other efforts designed to usher in a “new era” of growth. But how feasible is it for AstraZeneca to hit this lofty target? While AstraZeneca currently has several mid- to late-stage pipeline programs with strong potential, Etzer Darout, a senior biotech analyst at BMO Capital Markets, in an email to BioSpace said the company’s $30 billion goal is “above our and consensus projections.” Other analysts have also provided cautious estimates. AstraZeneca’s “revenue ambition” is “broadly expected” but Jefferies analysts project the company will only reach $70 billion by 2030, while the consensus is around $66.8 billion, according to the firm’s note to investors last week. Still, AstraZeneca has delivered strong and consistent growth from 2018 to 2023 with the help of its product launches. A report last week from Zacks Equity Research noted that the company has been “quite successful with its new products, and almost every new product it has launched in recent years has done well,” as AstraZeneca touts 12 blockbuster drugs. Though the company has a track record of recent success, including delivering last year on its ambitious $45 billion revenue goal set a decade ago, Darout cautioned that past performance is not always an indicator of future results. At the same time, he contends that AstraZeneca’s target for a mid-30% core operating margin by 2026 is achievable, as part of a strategy to focus on improving productivity throughout its operations. Jefferies reiterated its hold rating on AstraZeneca, noting that assets outside of oncology are “largely being ignored” while offering “significant longer-term upside optionality.” AstraZeneca “is primarily a top-line growth and pipeline story,” Jefferies analysts concluded. “However, clear aims from management may be needed for stock upside, and 2024 has fewer major pipeline catalysts.” A major challenge looming on the horizon is patent expirations for AstraZeneca’s key marketed products. Medicines that will lose their exclusivity include the cancer drug Lynparza, which is set to lose its patent this year, as well as the asthma medication Fasenra. The type 2 diabetes therapy Farxiga, which is also used to treat patients with heart failure and chronic kidney disease, will lose its patent in 2025. “Pharma companies face loss of exclusivity, competition and IRA [drug price negotiations] headwinds, so new product launches [are] critical to sustained growth for these companies,” Darout said. “The $80 billion figure the company disclosed takes these headwinds into account.” The Path to $80 Billion CEO Pascal Soriot told investors last week that AstraZeneca will see significant growth from its existing portfolio and that “many” of the 20 new medicines planned for launch by 2030 have the potential to generate more than $5 billion in peak year revenues. But what new products will get across the finish line for AstraZeneca to start reaching its $80 billion goal? Darout estimates that the company has several programs in the mid-to-late stage of development, with at least seven new drugs from its cohort of over 30 in its pipeline that can deliver on AstraZeneca’s $5 billion-plus peak revenue target. These products include the Daiichi Sankyo-partnered antibody-drug conjugate (ADC) datopotamab deruxtecan (Dato-DXd), which has a target action date for the second line for non-small cell lung cancer (NSCLC) set for Dec. 20, 2024. The ADC is also being investigated in several types of breast cancer. Other oncology assets that have the potential to get over $5 billion in peak revenue include: camizestrant, which is being investigated on its own and in combination for breast cancer which is primarily in the later stages of development; rilvegostomig, in clinical trials for solid tumors and in the late stage for biliary tract cancer; volrustomig, in late stage trials for several types of cancer including NSCLC and cervical cancer; and saruparib, which is in a late-stage trial for metastatic castration-sensitive prostate cancer. Darout also identified baxdrostat, which has two Phase III trials in chronic kidney disease and hypertension, as a potential blockbuster. AstraZenceca’s recent acquisitions of radiopharma biotech Fusion Pharmaceuticals and cancer biotech Gracell and its partnership with GLP-1 developer Eccogene could all yield lucrative results. “Like other global pharmaceutical companies, AstraZeneca faces competitive, pricing and regulatory risks as well as loss of exclusivities of key programs,” Darout said. “Loss of exclusivities are more predictable but competition, pricing and regulatory risks are dynamic, and so the impact of these factors is less certain and harder to predict.” Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

Phase 3AcquisitionADC

23 May 2024

·www.fiercebiotech.com

AstraZeneca pays $19M to Harbour BioMed's Nona for preclinical cancer antibodies

The antibodies will be generated by Nona’s so-called “Harbour Mice” technology. Days after AstraZeneca set out how new oncology drugs would help fuel its “bold” ambition to almost double its revenue by the end of the decade, the Big Pharma has further swelled this pipeline via a deal with Harbour BioMed subsidiary Nona Biosciences. In exchange for preclinical monoclonal antibodies, the Massachusetts-based biotech will receive $19 million upfront, with a $10 million near-term payment down the line and potentially another $575 million in biobucks, as well as tiered royalties on any net sales. The antibodies, which will be generated by Nona’s so-called “Harbour Mice” technology, will be used to create targeted oncology therapies, according to the post-market May 22 release. Nona’s approach uses mice and can produce heavy chain only antibodies, a class of molecules that are found naturally in some species and have novel properties that have attracted researchers. Nona’s chairman Jingsong Wang, M.D., Ph.D., said yesterday’s deal “further validates our leading antibody discovery platform, and we look forward to seeing our antibodies developed into potential new medicines for cancer patients.” "We are delighted to announce this agreement with AstraZeneca, global leaders in developing tumor targeted therapies, to maximize the potential of our novel antibodies," he added in the release. The release was light on details and didn’t offer many clues as to the exact cancer targets the newly licensed antibodies would be focused on nor how many would be included in the deal. However, it did allude to AstraZeneca’s ability to pay Nona more money if the Big Pharma chooses to option further programs. "The global license agreement with Nona Biosciences is an exciting opportunity to further develop these antibodies derived from Nona's innovative biologics discovery engine into novel tumor targeted therapies using AstraZeneca's industry-leading capabilities," Puja Sapra, Ph.D., senior vice president, tumor targeted delivery, oncology R&D at AstraZeneca, said in the release. AstraZeneca has built itself into an oncology powerhouse, increasing its sales of cancer drugs by 20% in 2023 alone. The growth is expected to continue, with the company using an investors' day Tuesday to point to several cancer programs in phase 3 during its presentation, including candidates for prostate (saruparib), breast (camizestrant, Dato-DXd) and lung (rilvegostomig, volrustomig) cancers. Nona, which is owned by Chinese antibody specialist Harbour BioMed, has attracted attention from other Big Pharmas in the past. Moderna has struck a couple of deals over the years, while in December 2023 Pfizer handed over $53 million for a mesothelin-targeted antibody-drug conjugate.

License out/inPhase 3

100 Deals associated with Saruparib

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Castration-sensitive prostate cancer	Phase 3	CH	AstraZeneca AB	21 Nov 2023
Castration-sensitive prostate cancer	Phase 3	PR	AstraZeneca PLC	21 Nov 2023
Castration-sensitive prostate cancer	Phase 3	NL	AstraZeneca PLC	21 Nov 2023
Castration-sensitive prostate cancer	Phase 3	CL	AstraZeneca PLC	21 Nov 2023
Castration-sensitive prostate cancer	Phase 3	BE	AstraZeneca PLC	21 Nov 2023
Castration-sensitive prostate cancer	Phase 3	AU	AstraZeneca PLC	21 Nov 2023
Castration-sensitive prostate cancer	Phase 3	IT	AstraZeneca PLC	21 Nov 2023
Castration-sensitive prostate cancer	Phase 3	PE	AstraZeneca PLC	21 Nov 2023
Castration-sensitive prostate cancer	Phase 3	JP	AstraZeneca PLC	21 Nov 2023
Castration-sensitive prostate cancer	Phase 3	TW	AstraZeneca PLC	21 Nov 2023

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05367440 (PETRANHA, ASCO_GU2024) Manual	Phase 1/2	Metastatic Prostate Carcinoma	48	enzalutamide or abiraterone acetate or darolutamide+AZD5305	(fwewpdwgsz) = fovqbeygse fokzhnbusk (vjqrgpciyd ) View more	Positive	25 Jan 2024
NCT04644068 (PETRA, AACR2022) Manual	Phase 1	Ovarian Cancer \| Breast Cancer \| Prostatic Cancer \| Pancreatic Cancer BRCA1 Mutation \| BRCA2 Mutation \| PALB2 Mutation ... View more	46	AZD5305	(ixnwjfmkgj) = bnmlwqrkow teqojfkvng (cxqwbbdxey ) View more	Positive	15 Jun 2022

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