On August 21, 2024 Incyte (Nasdaq: INCY) reported that the Company will present key data from its oncology portfolio at the upcoming European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024, to be held September 13-17 in Barcelona and virtually (Press release, Incyte, AUG 21, 2024, View Source [SID1234646045]).

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"The data at ESMO (Free ESMO Whitepaper) underscore the progress across our oncology portfolio and the potential to impact patients where additional treatment options are needed. Notably, a Presidential Symposium will feature new, pivotal results from the Phase 3 POD1UM-303/InterAACT2 study of retifanlimab (Zynyz) for the treatment of squamous cell anal carcinoma (SCAC). The POD1UM-303 data will support the supplemental Biologics License Application (sBLA) filing for retifanlimab in SCAC planned by year end 2024," said Pablo Cagnoni M.D., President, Head of Research and Development, Incyte. "We will also present new data on INCB123667, a potential first-in-class CDK2 inhibitor, which we believe has the potential to enhance outcomes and serve as a foundational treatment for platinum-resistant ovarian and other cancers."

Details on the abstracts accepted for presentation at ESMO (Free ESMO Whitepaper) include:

Presidential Symposium

Retifanlimab (PD-1)
POD1UM-303/InterAACT2: Phase 3 Study of Retifanlimab With Carboplatin-Paclitaxel (C-P) in Patients (Pts) With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal (SCAC) Not Previously Treated With Systemic Chemotherapy
Presidential Symposium I: Practice-changing trials. Presentation Number: LBA2. Presentation Time: 10:50-11:02 a.m. ET (4:50-5:02 p.m. CET), September 14, 2024

Mini Oral Session

INCB123667
Safety and Tolerability of INCB123667, a Selective CDK2 Inhibitor, in Patients (Pts) With Advanced Solid Tumors: A Phase 1 Study
Mini oral session: Developmental therapeutics. Presentation Number: 617MO. Presentation Time: 9:35 – 9:40 a.m. ET (3:35-3:40 p.m. CET), September 14, 2024

Conference Call and Webcast
Incyte will host an in-person analyst and investor event on Saturday, September 14, 2024, from 1:00-2:30 p.m. ET (7:00-8:30 p.m. CEST) to discuss key data presentations at ESMO (Free ESMO Whitepaper) including data from the POD1UM-303 Presidential Symposia and its CDK2 inhibitor program. The CDK2 data presentation will include new results from a later data cut-off, as well as the data included in the ESMO (Free ESMO Whitepaper) accepted abstract and mini-oral presentation. The event will be webcasted and can be accessed via the Events and Presentations tab of the Investor section of Incyte.com and it will be available for replay for 90 days.

Conference call details will be provided on the Investor section of Incyte.com.

Abstracts will be available to registered attendees on the ESMO (Free ESMO Whitepaper) Virtual Congress platform beginning on September 9, 2024. All accepted abstracts will be published in the ESMO (Free ESMO Whitepaper) Congress 2024 Abstract Book, a supplement to the official ESMO (Free ESMO Whitepaper) journal, Annals of Oncology.

More information regarding the 2024 ESMO (Free ESMO Whitepaper) Congress can be found at View Source

About Retifanlimab (Zynyz)
Retifanlimab (Zynyz), is an intravenous PD-1 inhibitor indicated in the U.S. for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Zynyz is marketed by Incyte in the U.S. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab.

Zynyz is a trademark of Incyte.

On August 21, 2024 Arcus Biosciences (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, reported that its management team will participate in the following upcoming investor conferences in September (Press release, Arcus Biosciences, AUG 21, 2024, View Source [SID1234646046]):

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Morgan Stanley 22nd Annual Global Healthcare Conference
Date: Wednesday, September 4th, 2024 at 4:55 p.m. ET
Location: New York, NY
Format: Fireside Chat

Cantor Fitzgerald Global Healthcare Conference 2024
Date: Thursday, September 19th, 2024 at 10:55 a.m. ET
Location: New York, NY
Format: Fireside Chat

Live webcasts of the fireside chats and panel will be available by visiting the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. Replays will be available following the live event.

On August 20, 2024 Crown Bioscience, a global contract research organization (CRO) and a JSR Life Sciences company, reported a strategic partnership with Clinical Trial & Consulting Services (CTI), a renowned global full-spectrum research service provider, to bolster oncology-focused consulting services (Press release, Crown Bioscience, AUG 21, 2024, https://www.crownbio.com/about-us/news-and-events/crown-bioscience-partners-with-cti-to-support-consulting-services-in-oncology-drug-development [SID1234646030]). This collaboration unites decades of expertise from both organizations in oncology drug discovery and development, leveraging Crown Bioscience’s preclinical and translational models and CTI’s well-established track record in the clinical and regulatory space.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Customers will benefit from combined expert guidance, supporting the transition of oncology compounds from discovery through early-phase clinical trials more rapidly and effectively. This alliance aims to determine the optimal and most expeditious path to the clinic, ensure long-term drug development success and growth, and accelerate the delivery of superior oncology therapeutics to patients.

From today, customers can access consulting services to ensure an integrated drug development approach, including:

Strategic preclinical development planning
Study data analysis, interpretation and advice
Regulatory guidance
De novo assay development
Grant review
Alex Slater, Senior Vice President of Commercial, commented: "Crown Bioscience has an established reputation for exceeding the typical services offered by a regular CRO. This initiative unites deep-seated expertise spanning all phases of drug development, marking a pivotal step towards delivering a true translational offer to our clients."

Ryan Gifford, Vice President of Global Laboratory Services, Business Development, shares: "We are delighted to collaborate with Crown Bioscience and view this as a valuable synergy. Crown Bioscience’s leadership in early-phase oncology research and suite of preclinical services complement CTI’s broad spectrum of capabilities. Together, we can offer enhanced support to our oncology clients and deepen our commitment to advancing cancer research."

On August 21, 2024 Propanc Biopharma, Inc. (OTC Pink: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that two scientific, peer reviewed journal articles published by the Company and its research partners reached 10 citations and 4,500 reads, respectively, in August, 2024 (Press release, Propanc, AUG 21, 2024, View Source [SID1234646032]). "This shows unprecedented interest in our field from researchers and among the broader scientific community," said Dr Kenyon, MD, MB, ChB, Propanc’s Chief Scientific Officer.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The first article, which reached 10 citations, published in Scientific Reports, is entitled, "Pancreatic proenzymes treatment suppresses BXPC-3 pancreatic Cancer Stem Cell subpopulation and impairs tumour engrafting." From the publishers of Nature, it is an online, open access journal, which publishes from all areas of the natural and clinical sciences. According to an insider, Scientific Reports is published on the most prestigious site of the National Institute of Health (NIH) and considered top line coverage: View Source

Published data from the Company’s joint research and development program were generated in conjunction with the Universities of Jaén and Granada, Biosanitary Research Institute of Granada, and University Hospital, Spain. Cancer stem cells (CSCs) subpopulation within the tumour is responsible for metastasis and cancer relapse. Exposure of human pancreatic CSCs to proenzymes resulted in significant decrease of specific pancreatic CSC markers. Also, in vivo (in a living organism) anti-tumor, xenograft (tissue graft) studies demonstrated high anti-tumour efficacy against tumors induced by human pancreatic CSCs. They concluded that "proenzymes treatment is a valuable strategy to suppress the CSC population in solid pancreatic tumours."

The second article, achieved 4,500 reads, also published in Scientific Reports, entitled "A formulation of pancreatic proenzymes provides potent anti-tumor efficacy: A pilot study focused on pancreatic and ovarian cancer." Published data from the Company’s R&D program were conducted with vivoPharm Pty Ltd, Australia, and the Dove Clinic for Integrated Medicine, UK, along with the Company’s joint researchers. Highlights include anti-angiogenic (anti-tumor blood vessel formation) effects of proenzymes, along with analysis of epithelial to mesenchymal transition (EMT) markers performed on human cancer cells treated with proenzymes. The EMT is a mechanism by which cancerous cells become motile and invasive, as well as immortal, thus seeding new tumors. For online access: View Source

Additionally, clinical efficacy of a suppository formulation of pancreatic proenzymes in the context of a UK Pharmaceutical Specials Scheme, led by Dr Kenyon, where 19 from 46 patients (41.3%) with late-stage cancers, had a survival time significantly longer than expected. Mean survival of 9.0 months was significantly higher than mean life expectancy, 5.6 months, in a one-way ANOVA (analysis of variance) test (alpha = 0.05, P less than 0.05).

For diagnosed pancreatic and ovarian cancer patients, there is a 20% survival rate and a 5-year relative survival rate of 29%, respectively, according to the National Cancer Institute. The global market projection for pancreatic cancer drugs is $6.93 billion by 2030, according to Brainy Insights and for ovarian cancer drugs is $13.9 billion by 2029, according to iHealthcareAnalyst.

"Survival rates, especially for pancreatic and ovarian cancers, continue to remain low. As a result, there is a pressing market need for new therapies, but without severe, or serious side effects associated with standard treatments," said Dr Kenyon. "We look forward to advancing our lead asset, PRP, into early-stage clinical development to further improve the significant life extension I first observed using proenzymes treatment in the UK Pharmaceuticals Scheme."

About PRP:

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas, administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include pancreatic, ovarian, kidney, breast, brain, prostate, colorectal, lung, liver, uterine, and skin cancers. Orphan Drug Designation status of PRP has been granted from the US Food and Drug Administration (FDA) for treatment of pancreatic cancer.

To view the Company’s "Mechanism of Action" video on the Company’s lead asset, PRP, please click on the following link: View Source

On August 21, 2024 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for rare and ultrarare diseases, reported the grant of 37,975 restricted stock units of the company’s common stock to 12 newly hired non-executive officers of the company (Press release, Ultragenyx Pharmaceutical, AUG 21, 2024, View Source [SID1234646034]). The awards were approved by the compensation committee of the company’s board of directors and granted under the Ultragenyx Employment Inducement Plan, with a grant date of August 16, 2024, as an inducement material to the new employees entering into employment with Ultragenyx in accordance with Nasdaq Listing Rule 5635(c)(4).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The restricted stock units vest over four years, with 25% of the underlying shares vesting on each anniversary of the grant date, subject to the employee being continuously employed by the company as of such vesting dates.