On November 22, 2023 Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported an update about the final preparations for the Marketing Authorization Application (MAA) that will be submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA)(the equivalent of the U.S. FDA) in the U.K. for commercial approval of the Company’s DCVax-L treatment for glioblastoma (Press release, Northwest Biotherapeutics, NOV 22, 2023, View Source [SID1234637934]).

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!

The Company previously reported that one key section of the MAA package remained to be completed and to then be delivered to an independent publisher for quality control checking of citations, numbers, cross-references, formatting and the like, in preparation for the submission.

The Company provided an update that most of the work has been completed on the key section of the MAA that remained to be done at the time of the prior update, as well as on required supporting documents, the majority of which have been delivered to the publisher/QC team. That team is now under way on this final stage of their work.

As described in the Company’s prior update, it is anticipated that the publisher/QC team will need several weeks to complete their work on both the last portion of the MAA package and the integrated whole. Their work is independent of the Company.

On November 22, 2023 Be Biopharma, Inc. ("Be Bio"), a company pioneering the discovery and development of Engineered B Cell Medicines (BeCMs), reported that Chief Executive Officer Joanne Smith-Farrell, Ph.D., will present at the 35th Annual Piper Sandler Healthcare Conference being held at the Lotte New York Palace in New York, NY on Thursday, November 30, 2023 (Press release, Be Biopharma, NOV 22, 2023, View Source [SID1234637932]).

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!

35th Annual Piper Sandler Healthcare Conference

Presentation Date: Thursday, November 30, 2023

Presentation Time: 10:10 am ET

On November 22, 2023 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported that Pascal Touchon, President and Chief Executive Officer, will participate in a fireside chat at the 6th Annual Evercore ISI HealthCONx Conference on Tuesday, November 28, 2023, at 10:50 a.m. EST (Press release, Atara Biotherapeutics, NOV 22, 2023, View Source [SID1234637931]).

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!

A live webcast of the presentation will be available by visiting the Investors and Media section of atarabio.com. An archived replay of the webcast will be available on the Company’s website for 30 days following the live presentation.

On November 22, 2023 Amgen (NASDAQ:AMGN) reported that it will present at the Evercore ISI HealthCONx Conference at 9:10 a.m. EST on Wednesday, Nov. 29, 2023 (Press release, Amgen, NOV 22, 2023, https://investors.amgen.com/news-releases/news-release-details/amgen-present-evercore-isi-healthconx-conference [SID1234637930]). Peter H. Griffith, executive vice president and chief financial officer at Amgen, and Paul Burton, senior vice president and chief medical officer at Amgen will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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!

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On November 22, 2023 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapiesfor cancer and autoimmune disease, reported that the INSIGHT-003 trial has been expanded to four sites across Germany including the University Clinic of Ruhr Universität Bochum and the Lung Clinic Cologne-Merheim (Press release, Immutep, NOV 22, 2023, View Source [SID1234637914]). This site expansion will support faster enrolment in this cost-efficient, investigator-initiated study evaluating eftilagimod alpha (efti) in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) and doublet chemotherapy for first line treatment of non-squamous non-small cell lung cancer (NSCLC).

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!

The strength of the early clinical data in this first-in-man triple combination study led to its increase to 50 patients. The extension opened in mid-2023 and 29 patients have been enrolled to date. With the addition of the new sites, the trial is expected to complete recruitment in 1H CY2024.

As presented at ESMO (Free ESMO Whitepaper) Congress 2023, the triple combination in INSIGHT-003 achieved a 70.6% overall response rate and 10.9-month median progression-free survival1 in patients with PD-L1 Tumor Proportion Score (TPS) of <50%, who are typically less responsive to anti-PD-1 therapy. This compares favourably to data in the same patient population, including a response rate of 40.8%, from a registrational trial of anti-PD-1 and doublet chemotherapy.2

Furthermore, the triple combination is well tolerated, and the addition of efti does not appear to increase the toxicity of KEYTRUDA and carboplatin/pemetrexed, building upon the favourable safety profile of efti that has been established across multiple clinical trials to date.

About INSIGHT-003

INSIGHT-003 is an investigator-initiated study conducted by the Frankfurt Institute of Clinical Cancer Research IKF. It is being run as the third arm (Stratum C) of the ongoing Phase I INSIGHT trial with Prof. Dr. Salah-Eddin Al-Batran as lead investigator. The study is evaluating a triple combination therapy in front line non-small cell lung cancer patients consisting of efti administered subcutaneously in conjunction with an existing approved standard-of-care combination of anti-PD-1 therapy (pembrolizumab) and doublet chemotherapy (carboplatin and pemetrexed) delivered intravenously. The trial will assess the safety, tolerability, and initial efficacy of the combination.