On June 18, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX), reported data from two presentations evaluating TG-1701, the Company’s investigational once-daily, oral BTK inhibitor, presented today during the 16th International Congress on Malignant Lymphoma (ICML)(Press release, TG Therapeutics, JUN 18, 2021, View Source [SID1234584125]). One presentation evaluated TG-1701 preclinically and the other included Phase 1 data evaluating TG-1701 as a monotherapy and as a triple therapy in combination with ublituximab, the Company’s novel glycoengineered anti-CD20 monoclonal antibody, and UKONIQ (umbralisib), the Company’s once-daily, inhibitor of PI3K-delta and CK1-epsilon in patients with front line or relapsed/refractory non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). The Phase 1 data presented today were previously presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting and the 2021 European Hematology Association (EHA) (Free EHA Whitepaper) annual meeting.

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PRESENTATION HIGHLIGHTS:

Poster Presentation Title: Antitumoral activity of the novel BTK inhibitor TG-1701 is associated with disruption of Ikaros signaling and improvement of anti-CD20 therapy in B-cell non-Hodgkin lymphoma

TG-1701 is a novel irreversible BTK inhibitor currently in Phase 1 clinical development, as monotherapy or in combination with ublituximab and UKONIQ (umbralisib).
In patient samples from a Phase 1 clinical trial of TG-1701, phosphoproteomic analysis differentiated early and late CLL responders to TG-1701 therapy.
Disruption of an active Ikaros pathway is a signature of early responders, while absence of Ikaros modulation upon TG-1701 therapy is a signature of non-/late responders.
TG-1701 did not impair FcγR-driven ADCC and ADCP and cooperated with U2 in in vitro and in vivo models of BTKi-sensitive and BTKi-resistant B-NHL.
Poster Presentation Title: TG-1701, A Selective Bruton Tyrosine Kinase (BTK) Inhibitor, as Monotherapy and in Combination with Ublituximab and Umbralisib (U2) in Patients with B-cell Malignancies

A total of 125 patients with R/R CLL or B-cell lymphoma have been treated with TG-1701, with patients receiving monotherapy in the dose-escalation cohort (n=25), 200 mg in a dose-expansion cohort (n=61), 300 mg in a CLL dose-expansion cohort (n=20), or TG-1701 in combination with U2 in the dose escalation cohort (n=19).
TG-1701 monotherapy was well tolerated and the maximum tolerated dose was not reached up to 400 mg QD.
Adverse Events (AEs) of special interest in patients treated with 200 mg and 300 mg QD of TG-1701 (n=81), included Grade 3 hypertension (4.9%), atrial fibrillation (1.2%), and no instances of major bleeding observed. Grade 3 AEs occurring in ≥10% of patients treated with U2+1701 included diarrhea (11%), neutropenia (11%), ALT increase (16%), and AST increase (16%), and Grade 4 AEs occurring in ≥10% of patients treated with U2+1701 included neutropenia (11%).
At a median follow up of 12.2 months in the 200 mg QD monotherapy expansion cohorts, overall response rates (ORR) were: 95% (19/20) in CLL, 65% (13/20) in mantle cell lymphoma (MCL), and 95% (19/20) in Waldenstrom macroglobulinemia (WM).
100% ORR observed at a median follow up of 8.6 months in the 300 mg CLL monotherapy cohort (n=19).
At a median follow up of 15.6 months, the 1701+U2 dose escalation (using doses of 100mg to 300 mg QD of TG-1701) resulted in 79% ORR, with 21% CR rate across patients with WM, CLL, marginal zone lymphoma (MZL), diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) (n=19).
Data presented at ICML 2021 is available on the Publications page of the Company’s website at View Source

On June 17, 2021 Cleveland BioLabs, Inc. (NASDAQ: CBLI), an innovative biopharmaceutical company developing novel approaches to activate the immune system, announced that its registration statement on SEC Form S-4 (the "Registration Statement") filed with U.S. Securities and Exchange Commission (the "SEC") in connection with its previously reported merger with Cytocom Inc. ("Cytocom") was declared effective by the SEC on June 10, 2021(Press release, Cytocom, JUN 18, 2021, https://www.cytocom.com/2021/06/18/cleveland-biolabs-inc-and-cytocom-announce-registration-statement-and-proxy-statement-for-previously-announced-merger-declared-effective-by-sec/ [SID1234584123]). Cytocom is a leading biopharmaceutical company creating next-generation immune therapies that deliver immune homeostasis.

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A special meeting of the Cleveland BioLabs stockholders to approve the proposals related to the merger (the "Special Meeting") will be held virtually. Details of the meeting are as follows:

Date:

Tuesday, July 6, 2021

Time:

10:00 a.m. ET

Registration:

www.virtualshareholdermeeting.com/CBLI2021SM

The Registration Statement includes a definitive proxy statement and a prospectus. Notice of the Special Meeting and the definitive proxy statement/prospectus was mailed to stockholders of the Company as of June 9, 2021.

ubsequent to the closing of the merger, the new combined company will be named "Cytocom Inc.", and its common stock is expected to trade on the Nasdaq Capital Market under the symbol "CYTO". The closing of the merger, which is expected to occur during the third quarter of 2021, is subject to approval by Cleveland BioLabs’ stockholders, the approval of the application for listing of the combined company’s stock on the Nasdaq Capital Market and the satisfaction of other customary closing conditions.

On June 17, 2021 BioNTech SE (NASDAQ: BNTX, "BioNTech" or "the Company"), reported that the first patient has been treated in its BNT111 Phase 2 cancer vaccine trial (2020-002195-12; NCT04526899)(Press release, BioNTech, JUN 18, 2021, View Source [SID1234584122]). The study is evaluating the Company’s therapeutic cancer vaccine candidate BNT111 in combination with Libtayo (cemiplimab) in patients with anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma. BNT111 is the lead product candidate from BioNTech’s FixVac platform that targets a fixed combination of mRNA-encoded, tumor-associated antigens with the objective of triggering a strong and precise immune response against cancer and is fully owned by BioNTech.

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The BNT111-01 trial which is being conducted in collaboration with Regeneron, was reviewed and approved by the regulatory authorities in Spain, Germany, Italy and Poland as well as in the United Kingdom, the United States and Australia. The open-label randomized trial evaluates the efficacy, tolerability, and safety of BNT111 in combination with Libtayo, an anti-PD-1 monoclonal antibody, being co-developed by Regeneron and Sanofi. The trial is enrolling a total of 120 patients and will evaluate the effects of the combination as well as single agents alone. The primary endpoint is the overall response rate of BNT111 in combination with Libtayo. Secondary endpoints include overall response rate in the single agent arms, duration of response, and safety. The first patient has been dosed in the EU. BioNTech retains global commercial rights to BNT111.

"Our vision is to harness the power of the immune system against cancer and infectious diseases. We were able to demonstrate the potential of mRNA vaccines in addressing COVID-19. We must not forget, that cancer is also a global health threat, even worse than the current pandemic," said Özlem Türeci, M.D., Co-founder and Chief Medical Officer of BioNTech. "BNT111 has already shown a favorable safety profile and encouraging preliminary results in early clinical evaluation. With the start of patient treatment in our Phase 2 trial, we are encouraged to continue on our initial path to realize the potential of mRNA vaccines for cancer patients."

BNT111 is an intravenous therapeutic cancer vaccine candidate encoding for a fixed set of four cancer-specific antigens optimized for immunogenicity and delivered as RNA-lipoplex formulation. More than 90% of melanomas in patients express at least one of the four tumor-associated antigens encoded in BNT111 (NY-ESO-1, MAGE-A3, tyrosinase, and TPTE). BNT111 is one of the most advanced of five clinical-stage FixVac product candidates within BioNTech’s development pipeline.

This Phase 2 clinical trial is based on previous results from the Phase 1 Lipo-MERIT dose escalation trial (NCT02410733) that demonstrated a favorable safety profile in 89 patients with advanced melanoma. In addition, efficacy analysis of the Lipo-MERIT study in a subset of 42 metastatic melanoma patients previously treated with a checkpoint-inhibitor (CPI) showed that BNT111 mediated durable responses both as a single agent and in combination with anti-PD-1 antibodies and that durable objective responses by BNT111 were associated with activation and strong expansion of tumor-antigen-specific CD4+ and CD8+ T cells. These results were published in Nature in July 2020.

The Company also plans to start randomized Phase 2 trials with mRNA vaccine product candidates in two additional programs in 2021 (FixVac: BNT113 and iNeST: BNT122). As part of its development strategy, BioNTech aims to rapidly advance its broad oncology pipeline and expects to bring additional candidates into late-stage clinical development and towards market entry within the next five years.

About FixVac
BioNTech’s FixVac platform candidates consist of a fixed combination of mRNA-encoded non-mutated antigens shared within specific cancer types. They feature the Company’s proprietary RNA-lipoplex delivery formulation which is designed to enhance stability and translation of the mRNA cargo as well as specifically target dendritic cells. Thus, the vaccine candidate aims to trigger a strong and precise innate and adaptive immune response against cancer cells overexpressing the respective antigen.

On June 17, 2021 Cothera Bioscience reported that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a global multi-center phase 2 clinical trial for the treatment of high-grade B-cell lymphoma that is resistant or refractory to first-line and second-line treatments with PC-002, an inhibitor that targets MYC mutations (Press release, Cothera Bioscience, JUN 17, 2021, View Source [SID1234618852]).

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PC-002 is a first-in-class small molecule drug targeting MYC- mutated tumors. With more than 50% of human cancers showing increased expression, MYC is regarded as one of the most important yet "undruggable" cancer targets. With a unique mechanism of action, PC-002 selectively induces MYC protein degradation and cell apoptosis in MYC-dependent tumors. PC-002 may potentially target multiple indications in cancer involving MYC dysregulation.

Dr. Alex Wu, Co-founder and CEO of Cothera Bioscience, said: "The FDA’s approval of PC-002 to initiate human phase 2 clinical trials is an important milestone for Cothera. I believe this is a good start, and the company will continue its effort to launch late-stage clinical trials for other cancer indications, bringing breakthroughs and better treatment options to more cancer patients."

On June 17, 2021 CytoReason, an AI company developing a computational disease model of the human body for clinical drug development, reported the initiation of a project with French global biopharmaceutical company Sanofi, which will utilize its cell-centered models and deconvolution techniques to suggest mechanistic insights for each asthma endotype (Press release, CytoReason, JUN 17, 2021, View Source [SID1234597888]).

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The focus of this project is to gain clarity on the heterogeneity of asthma patients, with the goal of identifying stable and reproducible asthma endotypes, as well as associated diagnostic features, using minimal invasive procedures. For this project, CytoReason’s AI platform will use one of the most comprehensive datasets in moderate to severe asthma, covering samples from both adults and children.

Asthma is a complex disease with genetic and environmental factors that lead to airway inflammation, resulting in excess mucus in a patient’s airway, which causes coughing, wheezing and shortness of breath. It can appear in several degrees of severity, ranging from mild to severe, and can be classified as either Type 2 asthma, which includes allergic and eosinophilic asthma, or non-Type 2 asthma, which is associated with low eosinophil counts often presented with altered innate immune response and activation of Th17 cells. Though symptoms of the disease can often be controlled, asthma, which is a key area of research for Sanofi, cannot be completely cured. One of the main challenges in the disease is classification of patients to find the most suitable treatment.

"We are very excited to be launching our collaboration with Sanofi," said David Harel, CEO and Co-founder of CytoReason. "It represents a chance to make a real difference in driving better understanding of the heterogeneous and complex nature of asthma and its diversified manifestation in patients. Additionally, the work we do with Sanofi could enhance future research in this field and could inform precision medicine strategies for improved patient benefit."