On October 15, 2023 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that it will share new research results during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 from October 20-24, showcasing the company’s focus on making a meaningful difference for people living with hard-to-treat cancers (Press release, Astellas, OCT 15, 2023, View Source [SID1234635967]). A total of 13 abstracts will be presented, highlighting data from two established medicines and one investigational therapy, across prostate, urothelial, and gastric/gastroesophageal junction (GEJ) cancers.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

"At Astellas, we’re working to change the course of cancer care, including through scientific advancements to address pressing unmet needs. We look forward to sharing our latest investigational data at ESMO (Free ESMO Whitepaper), including data from the Phase 3 EV-302 study of enfortumab vedotin, which is developed in partnership with Seagen, in combination with Merck’s pembrolizumab in patients with previously untreated locally advanced or metastatic urothelial cancer in a late-breaking presentation. We will also present expanded data from a Phase 3 study investigating enzalutamide plus leuprolide in patients with nonmetastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence."

Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Senior Vice President and Head of Immuno-Oncology Development, Astellas

"Over the last several months, Astellas has demonstrated considerable progress in our efforts to make a purposeful impact in the care of patients with advanced gastric cancer through regulatory submissions for our investigational therapy, zolbetuximab, across the U.S., Asia, and Europe. During ESMO (Free ESMO Whitepaper), we will share updated data from two Phase 3 clinical studies, highlighting important clinical data of zolbetuximab in gastric and GEJ cancer patients whose tumors are CLDN18.2-positive."

Other highlights at the ESMO (Free ESMO Whitepaper) Congress 2023 include:

Data from Cohort L of the EV-103 study evaluating enfortumab vedotin monotherapy in cisplatin-ineligible patients with muscle invasive bladder cancer (MIBC)
Health-related quality of life (HRQoL) data from the Phase 3 SPOTLIGHT and GLOW trials, evaluating zolbetuximab as a first-line treatment in patients with human epidermal growth factor receptor 2 (HER2)-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma whose tumors are Claudin 18.2 (CLDN18.2)-positive
HRQoL data in nonmetastatic hormone-sensitive prostate cancer (nmHSPC) patients with high-risk biochemical recurrence (BCR) from the EMBARK study evaluating enzalutamide plus leuprolide, leuprolide plus placebo, and enzalutamide monotherapy
Astellas Presentations at ESMO (Free ESMO Whitepaper) Congress 2023

Enfortumab Vedotin

View News Release Full Screen
Presentation Title

Speaker

Presentation Details

EV-302/KEYNOTE-A39: Open-label, randomized Phase
3 study of enfortumab vedotin in combination with
pembrolizumab (EV+P) vs chemotherapy (chemo) in
previously untreated locally advanced metastatic
urothelial carcinoma (la/mUC)

T. B. Powles

Type: Presidential 2

Abstract Number: LBA6

Date: Sunday, October 22

Study EV-103 Cohort L: Perioperative treatment w/
enfortumab vedotin (EV) monotherapy in cisplatin (cis)-
ineligible patients (pts) w/ muscle invasive bladder
cancer (MIBC)

S. Sridhar

Type: Mini Oral

Abstract Number: 2365MO

Date: Sunday, October 22

Enzalutamide

Presentation Title

Speaker

Presentation Details

Health-related quality of life in nonmetastatic hormone-
sensitive prostate cancer patients with high-risk
biochemical recurrence from the EMBARK study

S. Freedland

Type: Mini Oral

Abstract Number: 1766MO

Date: Sunday, October 22

Treatment of high-risk biochemically recurrent prostate
cancer with enzalutamide in combination with leuprolide
acetate: Secondary endpoints from EMBARK

N. Shore

Type: Poster

Abstract Number: 1778P

Date: Sunday, October 22

Enzalutamide monotherapy for the treatment of prostate
cancer with high-risk biochemical recurrence: EMBARK
secondary endpoints

U. F. De Giorgi

Type: Poster

Abstract Number: 1777P

Date: Sunday, October 22

Real-world overall survival with enzalutamide and
abiraterone acetate in patients with chemotherapy-naïve
metastatic castration-resistant prostate cancer

S. Freedland

Type: Poster

Abstract Number: 1827P

Date: Sunday, October 22

China ARCHES: a multicenter, Phase 3, randomized,
double-blind, placebo-controlled efficacy and safety trial
of enzalutamide + androgen deprivation therapy (ADT)
vs placebo + ADT in Chinese patients with metastatic
hormone-sensitive prostate cancer

G. Zeng

Type: Poster

Abstract Number: 1795P

Date: Sunday, October 22

Blood based biomarkers identify metastatic castration-
resistant prostate cancer with the greatest benefit from
continuing enzalutamide beyond progression in
combination with docetaxel: a pre-specified biomarker
study of the phase 3b PRESIDE trial

M. Ruiz Vico

Type: Poster

Abstract Number: 1836P

Date: Sunday, October 22

Zolbetuximab

Presentation Title

Speaker

Presentation Details

Updated efficacy and safety results from phase 3 GLOW
study evaluating zolbetuximab + CAPOX as first-line (1L)
treatment for patients with claudin-18 isoform 2-positive
(CLDN18.2)+, HER2−, locally advanced (LA)
unresectable or metastatic gastric or gastroesophageal
junction (mG/GEJ) adenocarcinoma

F. Lordick

Type: Mini Oral

Abstract Number: LBA81

Date: Saturday, October 21

Updated efficacy and safety results from phase 3
SPOTLIGHT study evaluating zolbetuximab +
mFOLFOX6 as first-line (1L) treatment for patients with
claudin-18 isoform 2-positive (CLDN18.2+), HER2−,
locally advanced (LA) unresectable or metastatic gastric
or gastroesophageal junction (mG/GEJ) adenocarcinoma

J. A. Ajani

Type: Mini Oral

Abstract Number: LBA82

Date: Saturday, October 21

Health-related quality of life (HRQoL) in patients with
claudin-18 isoform 2-positive (CLDN18.2+) locally
advanced (LA) unresectable or metastatic gastric or
gastroesophageal junction (mG/GEJ) adenocarcinoma:
results from SPOTLIGHT and GLOW

F. Lordick

Type: Poster

Abstract Number: 1530P

Date: Monday, October 23

Effects of antiemetics on zolbetuximab-induced gastric
injury and emesis frequency in ferrets

J. Wang

Type: Poster

Abstract Number: 38P

Date: Sunday, October 22

Real-world practices and physician perspectives on
biomarker testing and treatment patterns in patients with
locally advanced unresectable or metastatic (la/m)
gastric/gastroesophageal junction (G/GEJ)
adenocarcinoma in the US

K. Lewis

Type: Poster

Abstract Number: 160P

Date: Saturday, October 21

On October 15, 2023 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that it will present updated Phase 1/2 trial data for bavdegalutamide (ARV-110) at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress (Press release, Arvinas, OCT 15, 2023, View Source [SID1234635966]). Bavdegalutamide is an investigational orally bioavailable PROTAC androgen receptor (AR) degrader and is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer (mCRPC). This update will be presented during a poster session at the annual congress being held from October 20-24, 2023, in Madrid, Spain.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Poster session details are as follows:

Date: Sunday, October 22, 2023
Time: 12:00 – 1:00 p.m. CEST / 6:00 – 7:00 a.m. EDT
Presentation Number: 1803P
Speaker: Daniel Petrylak, M.D.

Phase 1/2 study of bavdegalutamide, a PROTAC androgen receptor (AR) degrader, in metastatic castration-resistant prostate cancer (mCRPC): radiographic progression-free survival (rPFS) in patients (pts) with AR ligand-binding domain (LBD) mutations.
For more information, visit the official ESMO (Free ESMO Whitepaper) Congress website here.

Investor Call & Webcast Details
Arvinas will host a conference and webcast call on Sunday, October 22 at 3 p.m. CEST/9 a.m. ET to discuss the poster presentation. A live audio webcast of the presentation and supporting material will be available on the Events & Presentations section in the Investors & Media section of the Company’s website. A replay of the webcast will be archived on the Arvinas website following the presentation.

About bavdegalutamide (ARV-110)
Bavdegalutamide (ARV-110) is an investigational orally bioavailable PROTAC protein degrader designed to selectively target and degrade the androgen receptor (AR). Bavdegalutamide is being developed as a potential treatment for men with mCRPC.

Bavdegalutamide has demonstrated activity in preclinical models of AR mutation or overexpression, both potential mechanisms of resistance to currently available AR-targeted therapies.

On October 15, 2023 Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) reported that they will present updated Phase 1/2 data for vepdegestrant (ARV-471) at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress (Press release, Arvinas, OCT 15, 2023, View Source [SID1234635965]). Vepdegestrant is a novel oral PROTAC estrogen receptor (ER) degrader that is being jointly developed by Arvinas and Pfizer for the treatment of patients with locally advanced or metastatic ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. This update will be presented during a poster session at the annual congress being held from October 20-24, 2023, in Madrid, Spain.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Poster session details are as follows:

Date: Saturday, October 21, 2023
Time: 12:00 – 1:00 p.m. CEST / 6:00 – 7:00 a.m. EDT
Presentation Number: 390P
Speaker: Erika P. Hamilton, M.D.

Vepdegestrant, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, in ER+/human epidermal growth factor receptor 2 (HER2)- advanced breast cancer: update of dose escalation results from a phase 1/2 trial
For more information, visit the official ESMO (Free ESMO Whitepaper) Congress website here.

About vepdegestrant (ARV-471)
Vepdegestrant is an investigational, orally bioavailable PROTAC protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with early and locally advanced or metastatic ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. Use of vepdegestrant in the ongoing and planned clinical trials will continue to monitor and evaluate patient safety and anti-tumor activity.

In preclinical studies, vepdegestrant demonstrated up to 97% ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed increased anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will equally share worldwide development costs, commercialization expenses, and profits.

On October 14, 2023 IIT Bombay and Laurus Labs backed ImmunoACT reported the approval of India’s first CAR-T cell therapy, NexCAR19 (Actalycabtagene autoleucel), for the treatment of r/r B-cell lymphomas and leukemia from the Central Drugs Standard Control Organization (CDSCO) (Press release, ImmunoACT, OCT 14, 2023, View Source [SID1234639859]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Immunoadoptive Cell Therapy Private Limited ("ImmunoACT") received the marketing authorization approval for the first humanized CD19-targeted Chimeric Antigen Receptor T cell (CAR-T cell) therapy product for relapsed/refractory (r/r) B-cell lymphomas and leukemia in India.

NexCAR19 is an indigenously developed CD19-targeted CAR-T cell therapy. It is the first-of-its-kind, made-in-India product and is a major stride in advanced cell-and-gene therapies.

NexCAR19 is the culmination of a collaborative effort across a decade, between the IIT- Bombay, and Tata Memorial Centre (TMC). Dr Atharva Karulkar, Dr Alka Dwivedi and the team led by Dr Rahul Purwar, Associate Professor at IIT Bombay designed and developed the NexCAR19, which subsequently underwent integrative process development & manufacturing under cGMP at ImmunoACT. Clinical investigations and translational studies were led by Dr Hasmukh Jain and Dr Gaurav Narula and their teams at TMH.

The clinical trial, led by Dr Hasmukh Jain, was conducted with 60 patients of r/r B-cell lymphomas and leukemia. The clinical data indicates approximately 70 percent overall response rate (ORR). The safety profile in terms of cytokine release syndrome (CRS) and absence of neurotoxicity indicates a significant improvement over the other commercially approved CD19-directed CAR-T cell therapies. "NexCAR19 has shown an excellent balance of efficacy and low toxicity, which is a significant advantage in clinical management (post-infusion) of the patients in our resource-constrained settings," Dr Hasmukh Jain noted.

"Now our patients in India and countries with limited resources will have access to this life-saving drug at an affordable cost. In terms of technical achievement, this is comparable to the moon shot and it puts India on the elite list of select countries that have access to CAR-T therapy," said Dr Rahul Purwar, Founder & CEO of ImmunoACT.

ImmunoACT is an IIT Bombay incubated company under the aegis of SINE (Society for Innovation and Entrepreneurship) and was founded in 2018 with the intention to be able to translate this academic research into a commercially viable product.

Laurus funding will help make CAR-T therapy affordable in India: Rahul Purwar, ImmunoACT

Pharma major Laurus Labs Limited was the early backer of ImmunoACT and has invested over $18 million to support ImmunoACT to scale its R&D and commercialization efforts.

ImmunoACT intends to make the NexCAR19 (Actaly cabtagene autoleucel) therapy available to its partner hospitals as soon as possible.

On October 14, 2023 Avistone Biotechnology Co., Ltd ("Avistone" or "the Company"), a clinical-stage biotechnology company focused on precision oncology therapeutics, reported results from its China and US IND enabling nonclinical studies for ANS014004 ("ANS01"), a novel small-molecule type II c-Met tyrosine kinase inhibitor (TKI) (Press release, Avistone Pharmaceuticals, OCT 14, 2023, View Source [SID1234635984]). The data were presented today (Poster# C145) at the AACR (Free AACR Whitepaper)-NCI-EORTC meeting hosted by the American Association for Cancer Research (AACR) (Free AACR Whitepaper), the National Cancer Institute (NCI), and the European Organisation for Research and Treatment of Cancer (EORTC) in Boston, Massachusetts USA.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Mesenchymal epithelial transition (MET) proto-oncogene receptor tyrosine kinase (RTK) is a cell surface receptor selective for hepatocyte growth factor (HGF), and is involved in embryogenesis regulation, wound healing, organ regeneration, angiogenesis, and immunomodulation. Aberrant MET oncogenic alterations include: MET exon 14 skipping (MET∆ex14) mutations; activating mutations in the kinase domain; MET gene amplification; MET fusions; and MET protein overexpression. These oncogenic alterations occur in a wide range of human solid cancers.

Presently, type I c-Met inhibitors such as Capmatinib are used as monotherapies in patients with locally advanced or metastatic NSCLC with MET∆ex14 mutations. However, development of post-treatment resistance to type I c-Met inhibitors occurs clinically, including through acquired mutations in codons D1228 and Y1230. No drugs have been approved globally for MET alteration indications other than MET∆ex14 mutations. Next generation MET inhibitors are thus needed to treat patients harboring various MET oncogenic alterations beyond MET∆ex14, including post-treatment acquired mutations.

Overall, the non-clinical studies of ANS014004 demonstrated it is a potent, orally-bioavailable type II c-Met inhibitor with activity against various pathogenetic MET alterations and with favorable absorption, distribution, pharmacokinetic, efficacy, and tolerability profiles in vivo. The molecule will enter Phase 1 clinical studies in both China and the US soon.

"Avistone is a science-driven, innovative biotechnology company committed to the discovery and clinical development of first-in-class and best-in-class drugs," said Dr. Hepeng Shi, Chairman, CEO, and Founder of Avistone. "We are proud to share these preclinical data for ANS014004 at this year’s AACR (Free AACR Whitepaper)-NCI-EORTC meeting for which has promise for patients with c-MET aberrations in NSCLC."

Electronic copies of the poster presented at the AACR (Free AACR Whitepaper)-NCI-EORTC annual meeting are available upon request.