Alpine Immune Sciences Announces R&D Day to Provide Clinical Updates on Wholly-Owned Programs ALPN-303 and Davoceticept

On August 30, 2022 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune and inflammatory diseases, reported that it will host an R&D Day featuring clinical data presentations on ALPN-303, a potentially best-in-class dual B cell cytokine antagonist being developed for the treatment of B cell mediated inflammatory and autoimmune diseases, and davoceticept (ALPN-202), a conditional CD28 costimulator and dual checkpoint inhibitor in development for the treatment of cancer (Press release, Alpine Immune Sciences, AUG 30, 2022, View Source [SID1234618765]).

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The event will also feature presentations by two leading experts, Vibeke Strand, MD, Biopharmaceutical Consultant and Adjunct Clinical Professor, Division of Immunology/Rheumatology, Stanford University School of Medicine, and Katy E. Beckermann, MD, PhD, Assistant Professor of Medicine, Division of Hematology/Oncology, Vanderbilt University Medical Center, who will review the current treatment landscape as well as the potential role for new treatment options in lupus and renal cell carcinoma, respectively.

R&D Day Event Information:

Date and Time: Monday, September 12, 5:00 pm to 6:30 pm ET

Event registration will be available through the Alpine Immune Sciences website at View Source An archive of the presentation will be accessible after the event through the Alpine Immune Sciences website.

Novartis presents new data in breast and prostate cancer at ESMO

On August 30, 2022 Novartis reported that it will showcase new data from across its oncology portfolio at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 with over 35 accepted abstracts from Novartis-sponsored and investigator-initiated trials including new data in advanced breast cancer and metastatic castration-resistant prostate cancer (Press release, Novartis, AUG 30, 2022, View Source [SID1234618782]).

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"We are excited to share the data being presented across our portfolio of cancer therapies, which reinforce our commitment to pursuing every possible approach to address the urgent and significant unmet medical needs of people living with cancer," said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development, Novartis. "Our presentations at ESMO (Free ESMO Whitepaper) will highlight our continued dedication to advancing innovative treatment options for these critical diseases."

Key highlights of data accepted by ESMO (Free ESMO Whitepaper):

Medicine Abstract Title Abstract Number/ Presentation Details
Kisqali (ribociclib)*

Pooled exploratory analysis of survival in patients (pts) with HR+/HER2− advanced breast cancer (ABC) and visceral metastases (mets) treated with ribociclib (RIB) + endocrine therapy (ET) in the MONALEESA (ML) trials
​ Abstract #205P
Poster Session
Saturday, September 10

Kisqali (ribociclib)*

HARMONIA SOLTI-2101 / AFT-58: A head-to-head phase III study comparing ribociclib (RIB) and palbociclib (PAL) in patients with hormone receptor-positive/HER2-negative/HER2-Enriched (HR+/HER2-/HER2-E) advanced breast cancer (ABC)†

Abstract # 272TiP
Poster Session
Saturday, September 10
Piqray (alpelisib) BYLieve trial (alpelisib [ALP] + endocrine therapy [ET]) versus real-world (RW) standard of care (SOC) in patients (pts) with PIK3CA-mutated (mut), hormone receptor-2 positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced 3 breast cancer (ABC) who progressed on cyclin-dependent kinase 4/6 inhibitor (CDKi) 4 therapy (tx)

Abstract #222P
Poster Session
Saturday, September 10

Tislelizumab​

Final Analysis of RATIONALE-301: Randomized, Phase 3 study of tislelizumab versus sorafenib as first-line treatment for unresectable hepatocellular carcinoma

Abstract #LBA36
Proffered Paper Session
Saturday, September 10
09:15 – 09:25 AM CEST

Tislelizumab​ Tislelizumab (TIS) versus docetaxel (TAX) as second- or third-line therapy in previously treated patients (pts) with locally advanced non-small cell lung cancer (NSCLC): Asian versus non-Asian subgroup analysis of the RATIONALE-303 study

Abstract #1031P
Poster Session
Monday, September 12

Pluvicto (lutetium 177Lu vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617) Association between prostate-specific antigen decline and clinical outcomes in patients with metastatic castration-resistant prostate cancer in the VISION trial Abstract #1372P
Poster Session
Sunday, September 11

Pluvicto (lutetium 177Lu vipivotide tetraxetan) Radiographic progression-free survival correlation with patient-relevant outcomes: a post hoc analysis of time-to-event endpoints of the VISION trial

Abstract #1374P
Poster Session
Sunday, September 11,

Prostate Cancer Quality of life across three countries using a large-scale, fully digital survey of patients with prostate cancer

Abstract #1401P
Poster Session
Sunday, September 11

Canakinumab
(ACZ885) CANOPY-A: phase III study of canakinumab (CAN) as adjuvant therapy in patients (pts) with completely resected non-small cell lung cancer (NSCLC)

Abstract #LBA49
Proffered Paper Session
Sunday, September 11
09:20 – 09:30 AM CEST

Vijoice (alpelisib) Clinical benefit of alpelisib in pediatric patients with PIK3CA-related overgrowth spectrum (PROS): an EPIK-P1 analysis

Abstract #468P
Poster Session
Monday, September 12

Product Information
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aTen Therapeutics awarded £282k to develop new breast cancer treatment

On August 30, 2022 Scottish biotech company, aTen Therapeutics, reported a £282,733 Innovate UK grant to advance a promising new therapy for breast cancer (Press release, aTen Therapeutics, AUG 30, 2022, View Source [SID1234625372]). The award will allow the company, in collaboration with scientists at ARU (Cambridge), to accelerate the development of its novel human monoclonal antibody ATN-E11.

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ATN-E11 has already been shown to prolong survival in experimental models of cancer. It targets the angiotensin-II type I receptor (AT1R), which is overexpressed in a range of different cancers. This overexpression stimulates tumour growth and increases the ability of malignant cancer cells to invade and migrate. By blocking the receptor, ATN-E11 could become a powerful new cancer treatment.

Breast cancer is the most commonly diagnosed cancer globally. With an estimated 2.3 million new cases in 2020, it accounts for 1 in 4 female cancer diagnoses and 685,000 deaths annually. There are several subtypes of breast cancer with different molecular and clinical features (including drug resistance) that dictate and limit treatment options, so demand for novel therapies remains very high.

Dr Karen Spink, Head of Medicines at Innovate UK, said: ‘This exciting project, funded through our Biomedical Catalyst Programme, addresses a critical unmet need for better targeted and more effective cancer treatments. Access to a diverse armoury of precision therapies is at the heart of our mission on cancer, that promises to radically improve patient outcomes.’

aTen Therapeutics’ CEO, Ian Abercrombie, said: ‘We’re excited by the potential of our technology to extend and improve lives. The Innovate UK grant is a great endorsement of this potential and the hard work of our team in Edinburgh. We look forward to progressing ATN-E11 towards clinical trials, and ultimately providing a new treatment option for people living with breast cancer.’

Prof Chris Parris, Head of School of Life Sciences at ARU, said: ‘We’re delighted to be working with the aTen Therapeutics team to explore this exciting new approach to cancer treatment and we look forward to generating key data in the coming months. Our first target is breast cancer but the therapy could also be effective in many other cancer types.’

PAT-DX1 Engineering Run Update

On August 30, 2022 Patrys’ appointed Contract Development Manufacturing Organisation (CDMO) reported that has successfully completed specification testing of PAT-DX1 drug substance produced in the recently-completed engineering run, laying strong foundations for the Company’s planned phase 1 clinical trial next year (Press release, Patrys, AUG 30, 2022, View Source [SID1234618730]).

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Specification, or batch release, testing is a necessary requirement to ensure high quality pharmaceuticals are used in GMP and clinical studies.

Avid Bioservices to Report Financial Results for First Quarter of Fiscal Year 2023 After Market Close on September 6, 2022

On August 30, 2022 Avid Bioservices, Inc. (NASDAQ:CDMO), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality services to biotechnology and pharmaceutical companies, reported that it will report financial results for the first quarter of fiscal year 2023 on September 6, 2022 after market close and will host a webcast at 1:30 PM Pacific Time (4:30 PM Eastern Time) (Press release, Avid Bioservices, AUG 30, 2022, View Source [SID1234618766]). Members of Avid’s senior management will discuss financial results for the first quarter and review recent corporate developments.

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To listen to the live webcast, or access the archived webcast, please visit: View Source