On October 20, 2020 Cytocom, Inc. (Cytocom), a leading biopharmaceutical company in the area of immune-modulation, and Cleveland BioLabs, Inc., (NASDAQ: CBLI), an innovative biopharmaceutical company developing novel approaches to activate the immune system, reported that they have entered into a definitive merger agreement to combine their businesses in an all-stock transaction (Press release, Cytocom, OCT 20, 2020, https://www.cytocom.com/2020/10/20/cytocom-and-cleveland-biolabs-announce-definitive-merger-agreement/?utm_source=rss&utm_medium=rss&utm_campaign=cytocom-and-cleveland-biolabs-announce-definitive-merger-agreement [SID1234568915]). Cytocom shareholders will have a majority position in the newly combined entity, which the parties anticipate will continue to be listed on the Nasdaq, and the initial Board of Directors for the combined company will consist of four members selected by Cytocom and three members selected by Cleveland BioLabs. The Boards of Directors of both companies have approved the combination.

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!

Each party to the proposed merger believes that the combined company will create near-term commercial opportunities in numerous areas of significant unmet medical needs including acute radiation injury, oncology, infectious disease, inflammation and autoimmune-mediated conditions, with multiple commercial, regulatory and clinical milestones expected over the next 12 to 18 months. Operating as "Cytocom, Inc." and under the leadership of Cytocom’s experienced management team, the combined company will be positioned for consistent growth.

Overview

Michael K. Handley, President and Chief Executive Officer of Cytocom, stated, "Our merger with Cleveland BioLabs and its subsequent immune-focused platform will be a transformative growth opportunity for Cytocom and Cleveland BioLabs shareholders. We believe that the combination of these highly complementary late-stage pipelines will strengthen our position and advance our efforts to unlock the potential of immune-modulating agents in the treatment of serious medical conditions. Further, this merger will enhance our ability to become a recognized leader in immune-modulating treatments and builds on the momentum created by our recent acquisition of ImQuest Life Sciences. We plan to utilize the combined platform to further drive value with additional clinical and commercial products and continue to seek strategic partnerships and acquisitions."

Dr. Andrei Gudkov, Chief Scientific Officer of Cleveland BioLabs, said: "This is an exciting day for Cleveland BioLabs and a great opportunity for our stockholders. The merger with Cytocom will allow us to add the strength of our science and bright perspectives associated with Entolimod development in cancer treatment and radiation defense arenas with a string of immunomodulators developed by Cytocom to form a powerful blend of conceptually and scientifically aligned products. We believe that the merger with Cytocom is the ideal way to unlock the value of our technology platform and our lead drug candidate, Entolimod, and I look forward to seeing this exciting new therapy advance through the clinic."

Conditions

The proposed transaction is subject to customary closing conditions, including approval by the stockholders of Cleveland Biolabs, the shares of the combined company being approved for listing on Nasdaq and a registration statement under the Securities Act becoming effective. Cytocom and Cleveland Biolabs expect the transaction to close during the first quarter of 2021.

Conference Call

Cytocom will host a conference call and live audio webcast at 8:00 a.m. EDT on October 28th to discuss the merger and provide a strategic vision for the combined company. To access the conference call supported with slides, please dial 646-558-8656 with the meeting ID: 841 7826 2704 and passcode: 281020. The conference call can also be accessed at https://cleartrustonline.com/cytocom. Approximately two hours following the live event, a webcast replay of the conference call will be available on Cytocom’s website https://www.cytocom.com/investors/ for approximately 30 days.

On October 20, 2020 WindMIL Therapeutics, a clinical-stage company developing marrow-infiltrating lymphocyte (MILs) products for cancer immunotherapy, reported that data regarding MILs as a potential cancer immunotherapy for hematological and solid tumors has been selected for a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting which will take place virtually November 9 – 14, 2020 (Press release, WindMIL Therapeutics, OCT 20, 2020, View Source [SID1234568826]).

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!

Details of the presentation are as follows:

Title: Marrow-infiltrating Lymphocytes (MILs): A Novel Adoptive Immunotherapy for Hematological and Solid Tumors
Abstract ID: 14151
Presenter: Eric Lutz, PhD, Director of Research, WindMIL Therapeutics

A copy of the abstract can be viewed online through the SITC (Free SITC Whitepaper) website. The presentation will be available in the Virtual Poster Hall from November 9 – 14, 2020.

On October 20, 2020 Researchers from the Moffitt Cancer Center reported a new study in the journal Nature Communications on Oct. 14 detailing their latest pan-cancer analysis (Press release, Moffitt Cancer Ctr, OCT 20, 2020, View Source [SID1234568788]). Through their work, they were able to determine that the protein, TAp63, appears to impact the level of RNA molecules within the body. This subsequently connects the activities of p53 and AKT, the altered genes in cancer.

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!

Mutations in p53, in particular, can impact the TAp63 protein and block its anti-cancer properties, thus encouraging tumor development. Similarly, AKT is a mediator of cancer progression that affects proliferation, migration, invasion and survival.

The researchers from Moffitt had previously been able to show that TAp63 acts as a tumor suppressor gene, and that a loss of its activity can result in tumor growth. They made it their goal to determine in follow-up studies whether a loss of TAp63 activity could lead to cancer in a therapeutic setting.

In the end, they were able to connect the protein to a type of RNA molecule called long noncoding RNA (lncRNA). Altered expression or activity of lncRNA in the body can lead to the develop and progression of disease. Along with researchers from the MD Anderson Cancer Center, Baylor College of Medicine, University of Houston and University of Nottingham, the Moffitt researchers were able to demonstrate their findings in laboratory and mouse studies.

The study appeared to suggest that lncRNAs stimulate cell migration and invasion, and high expression of two of the lncRNAs (TROLL-2 and TROLL-3) were associated with breast cancer progression. TROLL-2 and TROLL-3 also seemed to be highly expressed in a variety of metastatic human cancers.

"Our findings identify a crucial mechanism for the activation of the AKT pathway through TAp63-regulated lncRNAs (TROLLs) and pave the way for more effective diagnostic tools for cancer progression and therapies against metastatic cancers with alterations in TP53 and hyperactivation of the PI3K/AKT pathway," said Elsa Flores, Ph.D., chair of the Department of Molecular Oncology and leader of the Cancer Biology and Evolution Program at Moffitt.

This is just one of many breakthroughs that the researchers at Moffitt have brought to the table thus far in 2020. Back in July, the group discovered a key protein that oscillates its expression through mRNA regulation to spread cancer throughout the body. ΔNp63, as the protein is known, is a part of the p53 family, and many primary and metastatic tumors express high levels of it.

Flores and her colleagues developed mouse models to modulate ΔNp63 expression during breast cancer metastasis. They also discovered a network of four microRNAs that can target and silence the expression of ΔNp63.

"This finding is important because it gives us better insight into the regulation of ΔNp63 and TGFβ, key players in the metastatic process," Flores said. "P53 is commonly mutated in human cancers, and we have found that ∆Np63 and p53 interact extensively in cancer. We can use this information to design personalized therapies for cancer patients with alterations in the p53/p63 pathways."

The Flores lab continues to work on developing microRNA-based therapies to keep certain proteins expressed at the appropriate level. In general, doing so in the future may be able to help block the metastatic spread of cancer throughout the body.

The Moffitt Cancer Center is based in Tampa, Fla. It is one of only 51 National Cancer Institute-designated Comprehensive Cancer Centers in the country.

On October 20, 2020 Beijing Immunochina Pharma reported that it raised $15 million in C+ round of financing to support its portfolio of 12 CAR-T candidates (Press release, Immunochina, OCT 20, 2020, View Source [SID1234568787]). Established in 2015, Beijing Immunochina has developed a serum-free production process and large-scale gene vector production platforms to improve the safety and efficacy of CAR-T products. It has started clinical trials for one CAR-T candidate, IM19, that it is co-developing with China’s Simcere Pharma for leukemia and non-Hodgkin’s lymphoma.

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!

On October 20, 2020 ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, reported that FDA has completed its administrative review and accepted ANGLE’s FDA submission for substantive review (Press release, ANGLE, OCT 20, 2020, View Source [SID1234568786]).

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 announced on 28 September 2020, ANGLE has submitted a full Class II De Novo FDA Submission for its Parsortix PC1 system seeking FDA clearance for use with metastatic breast cancer (MBC) patients ("the Submission"). ANGLE has now received an Acceptance Review Notification from FDA that the Submission has been accepted. The administrative acceptance review is a formal process undertaken by FDA to determine that the Submission contains all of the necessary elements and information needed by FDA to proceed with substantive review.

The Submission is the output of five years’ work including extensive dialogue with FDA, and the development of over 400 technical reports and documents, which have been submitted to FDA.

FDA’s goal is to make a decision about a De Novo request in 150 review days. Review days are calculated as the number of calendar days between the date the De Novo request was received by FDA and the date of FDA’s decision. The review clock stops, however, when FDA requests further information or clarification from the Company. ANGLE believes that the earliest prospect of FDA clearance is Q2 CY21.*

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"We are pleased that our FDA submission has successfully completed FDA administrative review and is now in substantive review. We believe there is a tremendous opportunity for ANGLE to secure the first ever FDA clearance for a platform that captures and harvests intact circulating tumour cells from patient blood for subsequent analysis, in the first instance for metastatic breast cancer."