On January 17, 2023 Glycotope GmbH, a biotechnology company with a proprietary platform technology for developing antibodies against proteins carrying tumor-specific carbohydrate structures, repoerted that it will present its glyco-engineered cell lines at GlycoBioTec 2023 – 3rd International GlycoBioTec Symposium, being held in Berlin, Germany, on 17 and 18 January 2023 (Press release, Glycotope, JAN 17, 2023, View Source [SID1234626294]).

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!

Patrik Kehler, Chief Scientific Officer of Glycotope GmbH commented: "Our glyco-engineered cell lines provide the basis for the generation of therapeutic antibodies with increased tumor specificity and safety for highly potent therapeutic approaches like ADCs, CARs and radiotherapeutics. It represents a versatile tool for target validation and screening of glycosylation-dependent protein binding antibodies. It is great, that our scientists have the opportunity to present their work at GlycoBioTec 2023 and to discuss with other glycobiotechnology experts."

Poster details are as follows:

Abstract: Download here

Title: Using glyco-engineered cells with flexible expression of tumor-associated carbohydrates for the generation of highly tumor-specific antibodies

Poster Presentation: 17 January 2023, 6:00am – 7:00pm CET

Contact Information:

Glycotope GmbH

Dr. Patrik Kehler (CSO)

Phone: +49 30 9489 2600

Email: [email protected]

On January 17, 2023 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported the presentation of research across various types of gastrointestinal cancers during the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (#GI23), which is taking place in-person in San Francisco, California and virtually from January 19-21 (Press release, Eisai, JAN 17, 2023, View Source [SID1234626293]).

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!

Notable data include an update from the dose-escalation part of a Phase 1 Study evaluating E7386*1, a CREB-binding protein (CBP) / β-catenin interaction inhibitor, in patients with advanced solid tumors including colorectal cancer (NCT03833700(New Window); Abstract: #106). Based on these additional analyses, further investigation of safety, preliminary efficacy, pharmacokinetics and biomarker analyses of E7386 is ongoing using two dose levels in the expansion part.

Research from the LEAP (LEnvatinib And Pembrolizumab) clinical program includes a poster presentation featuring a health-related quality of life analysis from the Phase 3 LEAP-002 trial investigating the lenvatinib (LENVIMA) plus pembrolizumab (KEYTRUDA*2) combination versus lenvatinib plus placebo as a first-line treatment for patients with unresectable hepatocellular carcinoma (NCT03713593(New Window); Abstract: #506). Additional presentations on Eisai’s oncology pipeline showcase Eisai’s investigational compound, E7389-LF, a new liposomal formulation of eribulin, in combination with nivolumab in patients with solid tumors. Efficacy and safety were evaluated in expansion cohorts, including an esophageal cancer cohort (NCT04078295(New Window); Abstract: #337) and a gastric cancer cohort (NCT04078295(New Window); Abstract: #339).

"We are eager to share new data at the annual symposium where specialists in gastrointestinal cancers gather from all over the world, including findings from a Phase 1 study evaluating the novel investigational anticancer agent, E7386, in advanced solid tumors including colorectal cancer," said Dr. Takashi Owa, Chief Scientific Officer, Senior Vice President, Eisai Co., Ltd. "Our findings across colorectal, esophageal, gastric and liver cancer illustrate Eisai’s commitment to further oncology research for people living with gastrointestinal cancers, who account for over one quarter of the global cancer incidence1."

In March 2018, Eisai and Merck (known as MSD outside the United States and Canada), through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with Merck’s anti-PD-1 therapy pembrolizumab. To date, more than 10 trials have been initiated under the LEAP clinical program, which is evaluating the combination across multiple tumor types.

This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

The full list of Eisai presentations is included below. The majority of abstracts are currently available on the ASCO (Free ASCO Whitepaper) website. The late-breaking abstracts will be released at the time of presentation during the symposium.

Cancer Type Study/ Compound Abstract Title Abstract Type & Details (Pacific Standard Time)
Pipeline
Solid Tumors

E7386

A phase 1 study of E7386, a CREB-binding protein (CBP)/β-catenin interaction inhibitor, in patients (pts) with advanced solid tumors including colorectal cancer: updated dose-escalation part
Poster Presentation
Abstract #106
January 21, 2023

6:30-7:55 AM
E7389-LF

Gastric cancer (GC) cohort of a phase 2 trial of E7389-LF (liposomal formulation of eribulin) in combination with nivolumab
Poster Presentation
Abstract #339
January 19, 2023

12:00-1:30 PM
E7389-LF

The esophageal cancer cohort of a phase 2 trial of E7389‐LF (liposomal formulation of eribulin) + nivolumab
Poster Presentation
Abstract #337
January 19, 2023

12:00-1:30 PM
LEAP clinical program
Gastrointestinal Cancers LEAP-015 First-line lenvatinib plus pembrolizumab plus chemotherapy versus chemotherapy in advanced/metastatic gastroesophageal adenocarcinoma: (LEAP-015): Safety run-in results (Encore presentation)
Poster Presentation
Abstract #411
January 19, 2023

12:00-1:30 PM
LEAP-002 Health-related quality of life (HRQoL) impact of lenvatinib (len) plus pembrolizumab (pembro) versus len plus placebo (pbo) as first-line (1L) therapy for advanced hepatocellular carcinoma (aHCC): Phase 3 LEAP-002 study
Poster Presentation
Abstract #506
January 20, 2023

12:00-1:30 PM
Real World Evidence
Gastrointestinal Cancer Real-world data Prevalence of historical medical conditions or comorbidities with potential role in clinical decision making related to suitability of immuno-oncologic plus IV antiangiogenic therapy in newly diagnosed first-line unresectable hepatocellular carcinoma in the United States
Poster Presentation
Presentation #511
January 20, 2023

12:00-1:30 PM

On January 17, 2023 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that it will participate in two upcoming investor conferences (Press release, Allogene, JAN 17, 2023, View Source [SID1234626292]).

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!

B. Riley Securities’ 3rd Annual Oncology Conference
Wednesday, January 18, 2023
7:00AM PT/10:00AM ET

5th Annual Guggenheim Oncology Days
Thursday, February 9, 2023
6:35AM PT/9:35AM ET

Any available webcasts will be posted to the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following a live webcast, a replay will be available on the Company’s website for approximately 30 days.

On January 17, 2023 THREAD, the leading technology and consulting service provider enabling electronic clinical outcome assessments (eCOA) and decentralized clinical trials (DCTs), reported its five-year collaboration with innovative global health care company, Sanofi (Press release, Sanofi, JAN 17, 2023, View Source [SID1234626290]). THREAD will serve as the sole provider of unified decentralized clinical trials (DCTs) and electronic clinical outcome assessments (eCOA) technology for Sanofi’s Integrated Patient Platform (IPP), part of its global Act4Patients program.

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!

Sanofi selected THREAD to support its enterprise-wide commitment to reshape its clinical research programs around technology with the power to improve diversity, inclusion, and accessibility for patients. THREAD’s technology and services enable flexible, patient-centric, and inclusive clinical trials by providing an interconnected and uniform digital experience for patients, investigators, and sites across their clinical trials journey. By leveraging THREAD’s configurable platform and global reach, Sanofi can conduct studies globally and improve access by customizing trial design to align with research participant and site needs.

Sanofi commissioned its ACT4Patients program to fundamentally reimagine clinical research across the development continuum to enable broader patient access to clinical research through technology and innovative research approaches. Sanofi chose THREAD as its sole collaborator under its Integrated Patient Platform to help drive this digital transformation, support the company’s commitment to diversity and inclusion, and accelerate the clinical development timeline.

"At Sanofi, patients are at the heart of everything we do – and that includes helping them to participate in clinical trials. We are excited to partner with THREAD as we pursue our vision of transforming clinical research through the lens of the patient," said Sanofi’s Senior Vice President, Global Head of Clinical Sciences & Operations Lionel Bascles. "This collaboration will enhance our efforts to connect and engage patients and investigators as we continue on our mission to decentralize clinical trials and extend these life-changing opportunities to more patients across the world."

"THREAD’s technology platform is transforming clinical research through its ability to increase efficiencies, improve patient engagement, and most importantly, enable patients who previously did not have access to studies to participate in them," said John Reites, CEO, THREAD. "We are honored that Sanofi selected THREAD to support its bold and industry-leading commitment to put patients at the center of all their studies through its ACT4Patients Program."

On January 17, 2023 Elicio Therapeutics, a privately-held, clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, reported that it has entered into a definitive merger agreement with Angion Biomedica Corp (NASDAQ:ANGN) under which Elicio will merge with a wholly-owned subsidiary of Angion in an all-stock transaction (Press release, Elicio Therapeutics, JAN 17, 2023, View Source [SID1234626288]). The combined company will continue under the Elicio Therapeutics name and will focus on advancing Elicio’s proprietary lymph node-targeting Amphiphile (AMP) technology to develop immunotherapies, with a focus on ELI-002, a therapeutic cancer vaccine targeting mKRAS-driven tumors.

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 merger with Angion comes at an ideal time with ELI-002 now completing the dose escalation portion of Phase 1 clinical studies in patients. We believe Elicio is at the forefront of changing the tide regarding how cancers with these mutations, which account for 25% of human solid tumors, are treated," said Robert Connelly, Chief Executive Officer of Elicio. "We believe this merger reflects the strength of the ELI-002 program, our pipeline, and the value-creating potential of our lymph node-targeting approach to treating cancer and other diseases by engaging lymph nodes, the ‘schoolhouse’ of the immune system."

"We are delighted to announce the proposed merger with Elicio Therapeutics," said Jay Venkatesan, MD, MBA, President and Chief Executive Officer of Angion. "The Angion team reviewed in detail numerous strategic alternatives for creating shareholder value, and this transaction with Elicio was the clear choice. We see tremendous potential in the AMP platform and ELI-002, right at a time when the oncology community is rediscovering the value of cancer vaccines. We believe this merger will provide Angion shareholders the opportunity to meaningfully participate in a company treating cancer patients in an innovative way."

The combined company will work to advance ELI-002, a therapeutic cancer vaccine designed with Elicio’s proprietary lymph node-targeting AMP technology. ELI-002 is being evaluated in the AMPLIFY-201 Phase 1 trial (NCT04853017) in patients who have mKRAS-driven tumors including pancreatic ductal adenocarcinoma and colorectal cancer. AMPLIFY-201 has recently completed enrollment of initial subjects at the final level in the dose escalation, with an additional Phase 1b/2 trial planned for the second half of 2023.

About the Transaction

Under the terms of the merger agreement, pending stockholder approval of the transaction, Elicio will merge with a wholly-owned subsidiary of Angion, and stockholders of Elicio will receive newly issued shares of Angion common stock.

Current Angion stockholders are expected to own approximately 34.5% of the newly combined company while Elicio stockholders will own 65.5% of the newly combined company, in each case on a fully diluted basis. The final percentage of the combined company owned by Elicio stockholders and Angion stockholders upon completion of the merger may be subject to certain adjustments, including potential adjustments based on Angion’s net cash balance upon deal completion.

The proposed transaction has been unanimously approved by the boards of directors of both companies and is expected to close in the second quarter of 2023, subject to customary closing conditions.

Concurrent with the execution of the merger agreement, Angion committed up to $10 million in a bridge loan to Elicio, to be made in two installments, subject to certain conditions.

Following the merger, the executive team of Elicio will serve as the executive team of the combined company, led by Robert Connelly as Chief Executive Officer. The board of directors will be comprised of nine directors including Mr. Connelly and Angion’s current President and Chief Executive Officer, Jay Venkatesan, MD, MBA. Upon completion of the transaction, the combined company will operate under the Elicio Therapeutics name, and the combined company’s common stock is expected to trade on the Nasdaq Global Market under the ticker symbol "ELTX". The corporate headquarters will be in Boston, Massachusetts.

Oppenheimer & Co., Inc is serving as a financial advisor and Cooley LLP is providing legal counsel to Angion. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. and Goulston & Storrs PC are legal counsel to Elicio.

Conference Call

The Elicio and Angion management teams will host a conference call on Wednesday, January 18, 2023, at 8:00 am Eastern Time to discuss the merger. A live webcast of the conference call can be accessed at the "Events & Presentations" page on the Angion website at View Source A replay will be available on the Angion website at the same link shortly after conclusion of the event.