On September 6, 2022 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), reported it has signed a Material Transfer Agreement ("Agreement") with the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw, Poland to enable an investigator-initiated open label Phase II clinical trial (Press release, Immutep, SEP 6, 2022, View Source [SID1234619129]). The trial will evaluate Immutep’s lead product candidate efti in combination with pembrolizumab and radiotherapy in the neoadjuvant setting (prior to surgery) in up to 40 patients with select soft tissue sarcoma (STS).

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!

Subject to the necessary approvals from the Polish State Institute for Drug Control and ethics committee, the dosing of the first patient is anticipated in the first half of calendar year 2023, with initial interim data expected in the fourth quarter of CY 2024.

Under the Agreement, the Maria Skłodowska-Curie National Research Institute of Oncology will primarily fund the study with an approved grant from the Polish government of €1.5M (~A$2.2M) awarded by the Polish Medical Research Agency program. Immutep will provide efti at no cost to the Maria Skłodowska-Curie National Research Institute of Oncology and will technically support the trial. The trial will be led by Principal Investigators, Dr. Katarzyna Kozak, M.D. PhD., and Paweł Sobczuk, M.D., medical oncologists at the Department of Soft Tissue/Bone Sarcoma and Melanoma at the Maria Skłodowska-Curie National Research Institute of Oncology.

Immutep CEO, Marc Voigt, said: "We were delighted to be approached by Dr Paweł Sobczuk and Dr. Katarzyna Kozak to form this collaboration with the Maria Skłodowska-Curie National Research Institute of Oncology to explore the potential of efti in combination with pembrolizumab and radiotherapy in soft tissue sarcoma. We thank the Polish government for granting €1.5M in non-dilutive cash funding for this trial. Recurrence and lack of deep and durable responses are challenges with the limited standards of care available for this rare and difficult-to-treat disease. Efti’s novel mechanism of action offers potential to enhance anti-tumour responses for these patients. This latest expansion of the efti pipeline is further evidence of the increased interest from a variety of interested parties to investigate the broad potential of efti to improve patient outcomes in yet another cancer indication and treatment regimen."

Immutep CSO and CMO, Dr Frederic Triebel said: "Efti stimulates the immune system through a differentiated mechanism that targets LAG-3-driven activation of antigen-presenting cells. By working upstream of T cells, efti has potential to generate a broad and robust anti-tumour immune response even in the immunosuppressed tumour microenvironment of soft tissue sarcomas. Therefore, we are very pleased to be collaborating with our colleagues at the Maria Skłodowska-Curie National Research Institute of Oncology."

Maria Skłodowska-Curie National Research Institute of Oncology, Medical Oncology Fellow and Co-Principal Investigator, Dr. Paweł Sobczuk said: "The need for new approaches in this rare and aggressive disease is evident by the still dismal responses with current standards of care including surgery, radiotherapy and chemotherapy. Clinical data in other solid tumours suggest that efti can synergize with radiotherapy and pembrolizumab for robust responses across PD-L1 status, supporting the potential of this combination to mount effective immunity against aggressive malignancies like soft tissue sarcoma and replace the need for chemotherapy."

Efti’s Mechanism of Action

Efti is a first-in-class antigen presenting cell (APC) activator currently being developed by Immutep for the treatment of cancer. Efti binds to antigen presenting cells such as dendritic cells, monocytes and macrophages via MHC II molecules. This activates the APCs causing them to become professional antigen presenting cells, thereby presenting antigen to the adaptive immune system. This leads to activation and proliferation of CD4+ (helper) and CD8+ (cytotoxic) T cells. Thus, the aim of efti is to "push the gas" on the body’s innate and adaptive immune systems making it a suitable candidate to evaluate not only for the treatment of cancer, but also for the treatment of infectious diseases.

On September 6, 2022 Illumina, Inc. (NASDAQ:ILMN), reported a decision from the European Commission prohibiting the company’s acquisition of GRAIL (Press release, Illumina, SEP 6, 2022, View Source [SID1234619123]). The company is reviewing the Commission’s order and intends to appeal the decision. The EC decision follows last week’s ruling by US Federal Trade Commission judge in favor of Illumina’s acquisition of GRAIL.

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!

"We are disappointed with the European Commission’s decision prohibiting us from acquiring GRAIL back to Illumina," said Charles Dadswell, General Counsel of Illumina. "Illumina can make GRAIL’s life-saving multi-cancer early detection test more available, more affordable, and more accessible – saving lives and lowering healthcare costs. As we continue to believe, this merger is pro-competitive and will accelerate innovation. Last week the Chief Judge of the US Federal Trade Commission issued a decision supporting Illumina acquiring GRAIL."

In addition, to prepare for the anticipated divestment order from the European Commission in the coming months, the company will begin reviewing strategic alternatives for GRAIL in the event the divestiture is not stayed pending Illumina’s appeal.

The merger of Illumina and GRAIL would usher in a transformational phase in the detection and treatment of cancer by facilitating equal and affordable access to the life-saving early cancer detection Galleri test.

With a single blood test, Galleri can screen asymptomatic patients for more than 50 types of cancer, many of which have no other form of screening and are often caught too late to treat effectively. In addition, Galleri can identify the tissue in which a cancer has developed. Galleri is unique as a multicancer early detection test suitable for general population screening. There is no other test available for this purpose. Galleri is available today in the US and the UK, but not in the European Union.

Illumina would accelerate GRAIL’s commercial entry into the EU at scale by at least five years, saving tens of thousands of lives in the EU and billions of euros in healthcare costs.

A combined Illumina and GRAIL is key to helping the European Union achieve the goals outlined in Europe’s Beating Cancer Plan, which states: "Early detection through screening offers the best chance of beating cancer and saving lives." Today, 71% of cancer-related deaths are in cancers with no recommended screening. With limited screening, cancer is more likely to be detected in late stages but when we diagnose cancer too late, less than 20% of patients will survive more than 5 years. In contrast, if we diagnose cancer early, approximately 90% of patients are expected to survive beyond five years.1 The GRAIL merger would not only accelerate multicancer early detection in the EU but would also reduce inequity in cancer care by making early diagnosis affordable and widespread, another key priority of Europe’s Beating Cancer Plan.

1 Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov)

Illumina is separately appealing a July 2022 decision by the General Court of the European Union regarding the European Commission’s jurisdiction to challenge the GRAIL deal.

On September 6, 2022 Celularity Inc. (Nasdaq: CELU) ("Celularity"), a clinical-stage biotechnology company developing placental-derived allogeneic cell therapies, reported that Robert Hariri, M.D., Ph.D., Founder, Chairman and Chief Executive Officer of Celularity, will participate in fireside chats at the following investor conferences (Press release, Celularity, SEP 6, 2022, View Source;utm_medium=rss&utm_campaign=celularity-announces-participation-in-upcoming-investor-conferences [SID1234619119]):

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!

C. Wainwright 24th Annual Global Investment Conference on Monday, September 12, 2022, at 1:30 p.m. ET
Morgan Stanley 20th Annual Global Healthcare Conference on Wednesday, September 14, 2022, at 12:20 p.m. ET
A live webcast of the fireside chats can be accessed on the Investors section of Celularity’s website at View Source A replay of the webcasts will be archived and available following the event for approximately 30 days.

On September 6, 2022 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision oncology biopharmaceutical company, reported that Susan Molineaux, Ph.D., the company’s founder, president and chief executive officer, will present at the H.C. Wainwright 24th Annual Global Investment Conference, being held September 12-14 both virtually and in New York, NY (Press release, Calithera Biosciences, SEP 6, 2022, View Source [SID1234619118]).

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 presentation will be available for on-demand viewing starting Monday, September 12, 2022, at 7:00 a.m. Eastern Time, and can be accessed through the Investors section of the Company’s website at www.calithera.com. The replay of the webcast will be available on the Company’s website for 30 days.

On September 6, 2022 Dong-A ST Co., Ltd. (170900: Korea SE), a Korean pharmaceutical company, and Beactica Therapeutics AB, a Swedish precision oncology company, reported that they have mutually agreed to terminate their collaboration and licensing agreement (Press release, Dong-A ST, SEP 6, 2022, View Source [SID1234619115]). The collaboration focused on developing novel candidate compounds against multiple cancer targets of mutual interest. The partnership has been productive, and multiple compound classes are now in various stages of lead generation and optimization.

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!

As part of the termination, both Dong-A ST and Beactica Therapeutics will gain exclusive global rights for further development and commercialization for different compounds series developed during the collaboration. No obligations to pay milestone payments or royalties will remain for the assets divided between Dong-A and Beactica. For a limited time, each company is entitled to a revenue share from any related future outlicensing activities by the other party. Full financial details remain undisclosed.

"We appreciate the opportunity we have had to collaborate with Beactica Therapeutics over the past five years. Our combined efforts have led to important breakthroughs," said Dr Jae-Hong Park, President and CSO of Dong-A ST. "We will continue to share with Beactica the ambition to make a clinical impact where it is urgently needed."

"We have valued the partnership with Dong-A and are pleased by what we have achieved together. Gaining exclusive global rights to certain compounds is perfectly aligned with Beactica’s ambition to itself become a clinical-stage precision oncology company," said Dr Per Källblad, CEO of Beactica Therapeutics. "We are excited to now add these assets to our pipeline as wholly-owned programmes."

The collaboration between Dong-A ST and Beactica Therapeutics was initiated in October 2016 and expanded in December 2018. In December 2019, a key milestone was achieved.