A Phase I, Open-label Study to Assess the Absolute Bioavailability of Saruparib (AZD5305) and Absorption, Distribution, Metabolism, and Excretion (ADME) of [14C]-Saruparib ([14C]-AZD5305) in Patients With Advanced Solid Malignancies

This Phase I, open-label study aims to study to absolute bioavailability of Saruparib (AZD5305) and the absorption, distribution, metabolism and excretion (ADME) of [14C]-Saruparib in patients with advanced solid malignancies.
This will be done on an inpatient basis in 2 parts (single-dose oral administration with radiolabeled microtracer in Part A, single-dose IV radiolabeled administration in Part B) during which samples will be obtained of plasma, urine, feces and vomitus (where applicable).

Start Date18 Dec 2024

Sponsor / Collaborator

AstraZeneca PLC

[+1]

NL-OMON56674 / RecruitingPhase 3

IVD1: Clinical Performance Study Plan For The Use of Myriad MyChoice® For Patient Enrolment Into the AZD5305 (Saruparib) vs Placebo in Participants with Metastatic Castration-Sensitive Prostate Cancer Receiving Physician*s Choice New Hormonal Agents;IVD2: Clinical Performance Study Plan for F1LCDx Used in Clinical Trial EvoPAR-Prostate01 ;Main: A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of AZD5305 in Combination with Physician*s Choice New Hormonal Agents in Patien - EvoPAR-Prostate01

Start Date07 Aug 2024

Sponsor / Collaborator-

NCT06380751 / RecruitingPhase 3

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

100 Clinical Results associated with Saruparib

100 Translational Medicine associated with Saruparib

100 Patents (Medical) associated with Saruparib

Literatures (Medical) associated with Saruparib

12 Dec 2024·JOURNAL OF MEDICINAL CHEMISTRY

Discovery of Pyrazolo[1,5,4-de]quinoxalin-2(3H)-one Derivatives as Highly Potent and Selective PARP1 Inhibitors

Article

Author: Jiang, Shujuan ; Zhang, Chaobo ; Yu, Bing ; Liu, Lei ; Xu, Yanxiao ; Li, Leping ; Li, Jingjing ; Gao, Shanyun ; Zhang, Yixiang ; Tu, Wangyang ; Hou, Yingjie ; Yu, Songda

Poly-ADP-ribose-polymerase 1/2 (PARP1/2) inhibitors have been approved for cancers with homologous recombination deficiency (HRD). However, their narrow therapeutic indexes largely due to hematologic toxicities have limited their clinical usefulness. Developing selective PARP1 inhibitors has emerged as an attractive strategy to achieve equivalent antitumor activity while alleviating the hematological toxicity caused by PARP2 inhibition. Herein, we report the discovery of pyrazolo[1,5,4-de]quinoxalin-2(3H)-one 30 as a novel selective PARP1 inhibitor. 30 formed tighter PARP1-DNA trapping than AZD9574, leading to better potency in inhibiting cancer cell proliferation. 30 achieved tumor regression in the BRCA1-mutated MDA-MB-436 xenograft model and showed synergistic efficacy in combination with carboplatin in the SUM149PT xenograft model. In the rat hematological toxicity study, 30 exhibited minimal impact on hematological parameters at 25 mg/kg, while AZD5305 at 1 mg/kg caused 56.5% reduction of reticulocyte. Taken together, we discovered compound 30 with a therapeutic index superior to that of PARP1 inhibitors AZD5305 and AZD9574 in the preclinical setting.

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

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.

14 Mar 2023·CLINICAL CANCER RESEARCH

Design and Preclinical Evaluation of a Novel B7-H4-Directed Antibody-Drug Conjugate, AZD8205, Alone and in Combination with the PARP1-Selective Inhibitor AZD5305.

Communications

Author: Christie, R James ; Yuan, Jiaqi ; Vijayakrishnan, Balakumar ; Davies, Michael ; Wortmann, Philipp ; Anderton, Judith ; Tosto, Frances Anne ; Chesebrough, Jon ; Novick, Steven ; Wallez, Yann ; Dimasi, Nazzareno ; Luheshi, Nadia ; McFarlane, Mary ; Howard, Philip W ; Sabol, Darrin ; Tice, David A ; Masterson, Luke ; Leo, Elisabetta ; Dickinson, Niall J ; Cailleau, Thais ; Cooper, Zachary A ; Kinneer, Krista ; Huang, Yue ; Ball, Kathryn ; Wang, Jixin ; Monks, Noel ; Albertella, Mark R ; Staniszewska, Anna D ; Lewis, Arthur ; Sapra, Puja ; Hutchinson, Ian ; Rosenbaum, Anton I

PURPOSE:

We evaluated the activity of AZD8205, a B7-H4-directed antibody-drug conjugate (ADC) bearing a novel topoisomerase I inhibitor (TOP1i) payload, alone and in combination with the PARP1-selective inhibitor AZD5305, in preclinical models.

EXPERIMENTAL DESIGN:

IHC and deep-learning-based image analysis algorithms were used to assess prevalence and intratumoral heterogeneity of B7-H4 expression in human tumors. Several TOP1i-ADCs, prepared with Val-Ala or Gly-Gly-Phe-Gly peptide linkers, with or without a PEG8 spacer, were compared in biophysical, in vivo efficacy, and rat toxicology studies. AZD8205 mechanism of action and efficacy studies were conducted in human cancer cell line and patient-derived xenograft (PDX) models.

RESULTS:

Evaluation of IHC-staining density on a per-cell basis revealed a range of heterogeneous B7-H4 expression across patient tumors. This informed selection of bystander-capable Val-Ala-PEG8-TOP1i payload AZ14170133 and development of AZD8205, which demonstrated improved stability, efficacy, and safety compared with other linker-payload ADCs. In a study of 26 PDX tumors, single administration of 3.5 mg/kg AZD8205 provided a 69% overall response rate, according to modified RECIST criteria, which correlated with homologous recombination repair (HRR) deficiency (HRD) and elevated levels of B7-H4 in HRR-proficient models. Addition of AZD5305 sensitized very low B7-H4-expressing tumors to AZD8205 treatment, independent of HRD status and in models representing clinically relevant mechanisms of PARPi resistance.

CONCLUSIONS:

These data provide evidence for the potential utility of AZD8205 for treatment of B7-H4-expressing tumors and support the rationale for an ongoing phase 1 clinical study (NCT05123482). See related commentary by Pommier and Thomas, p. 991.

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
Advanced breast cancer	Phase 3	US	AstraZeneca PLC	01 Aug 2024
Advanced breast cancer	Phase 3	CN	AstraZeneca PLC	01 Aug 2024
Advanced breast cancer	Phase 3	JP	AstraZeneca PLC	01 Aug 2024
Advanced breast cancer	Phase 3	AR	AstraZeneca PLC	01 Aug 2024
Advanced breast cancer	Phase 3	AU	AstraZeneca PLC	01 Aug 2024
Advanced breast cancer	Phase 3	AT	AstraZeneca PLC	01 Aug 2024
Advanced breast cancer	Phase 3	BR	AstraZeneca PLC	01 Aug 2024
Advanced breast cancer	Phase 3	BG	AstraZeneca PLC	01 Aug 2024
Advanced breast cancer	Phase 3	CA	AstraZeneca PLC	01 Aug 2024
Advanced breast cancer	Phase 3	CL	AstraZeneca PLC	01 Aug 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04644068 (PETRA, AACR2022) Manual	Phase 1	Ovarian Cancer \| Breast Cancer \| Prostatic Cancer ... BRCA1 Mutation \| BRCA2 Mutation \| PALB2 Mutation ... View more	46	AZD5305	frlwtnkgww(vlcbactujq) = kjoqlfotxu pekayrwash (tiljvfmgpr ) View more	Positive	15 Jun 2022

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