On November 12, 2021 MiNA Therapeutics Limited ("MiNA" or the "Company"), the pioneer in small activating RNA (saRNA) therapeutics, reported that its Chief Executive Officer, Robert Habib, will present and host one-on-one meetings at the Jefferies 2021 London Healthcare Conference, taking place from 16-19 November 2021 in-person and virtually (Press release, MiNA Therapeutics, NOV 12, 2021, View Source [SID1234595463]).

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MiNA’s presentation will take place at 3:40pm GMT on Tuesday, 16 November 2021, with a live webcast available via the following link: View Source

Mr Habib will introduce MiNA and its saRNA technology platform, as well as provide an update on the Company’s clinical progress and strategy.

On November 12, 2021 Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics designed to elicit a potent and durable immune response in the tumor microenvironment, reported that a poster highlighting promising new preclinical data for BCA101, a bifunctional antibody designed to localize the TGF-β trap to EGFR+ tumors currently in an ongoing Phase 1/2 study, will be presented on Saturday, November 13, 2021 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2021 Annual Meeting in Washington, D.C (Press release, Bicara Therapeutics, NOV 12, 2021, View Source [SID1234595462]).

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"These data show that BCA101, our first-in-class bifunctional antibody, has strong potential to improve anti-tumor response versus historical EGFR inhibitors by leveraging the interplay between the EGFR and TGF-β signaling pathways. It also suggests synergy in combination with PD-1 inhibitors with the potential to delay and overcome PD-1 resistance," said Liviu Niculescu, M.D., Chief Medical Officer of Bicara Therapeutics. "These preclinical data are very encouraging for our ongoing clinical trial aimed at giving cancer patients a treatment option with better efficacy and safety than currently available options. We look forward to reporting data from the Phase 1/2 clinical trial in the second half of 2022."

Details of the poster are as follows:

Title: Development of BCA101, a Bifunctional Antibody Capable of Simultaneously Disabling EGFR and TGF-β Signaling, as a Novel Single-agent Immunotherapy
Poster Number: 874
Category: Novel Single-Agent Immunotherapies
Presentation Date and Time: Friday, November 12, 2021, at 7:00 a.m.
Authors: Srinivas R. Boreddy, Ph.D.; Reshmi Nair; Arindam Banerjee; Anshu Kuriakose; Prashant Kumar Pandey; Chaitali Dey; Meena Shri; Shruthi Rao; Bhadravathi Marigowda Shivakumar; Moni Abraham Kuriakose; Ram Bhupal Reddy; Amrita Suresh; Praveen Reddy Moole; Usha Bughani; Seng-Lai Tan, Ph.D.; Pradip Nair

Key findings:

Improved retention of BCA101 in tumor microenvironment compared to TGF-bRII-Fc alone
BCA101 inhibits TGF-β-induced epithelial to mesenchymal transition and rescues from TGF-β-mediated immune inhibition
BCA101 demonstrates superior anti-tumor efficacy compared to cetuximab + TGF-bRII-Fc in vivo
BCA101 demonstrates sustained tumor regression compared to cetuximab in HNSCC-PDX models
BCA101 exhibited improved efficacy in combination with anti-PD-1 inhibitor in checkpoint-resistant HuNOG-EXL humanized model
BCA101 is currently being evaluated in a Phase 1/2 study as both a monotherapy in patients with EGFR-driven tumors and in combination with pembrolizumab (anti-PD-1) in squamous cell carcinoma of the head and neck (SCCHN) and squamous cell carcinoma of the anal canal (SCCAC). The study is currently enrolling patients in dose escalation and will open dose expansions in 2022.

About BCA101

BCA101 is a first-in-class EGFR / TGF-β-trap bifunctional antibody designed to enhance both innate and adaptive immune responses directly at the site of the tumor by binding to the well-validated EGFR antigen and disabling TGF-β, a signaling molecule that plays a key role in suppressing the immune response in the tumor microenvironment. Promising preclinical data suggest that BCA101 is superior to the anti-EGFR antibody cetuximab in preventing tumor recurrence, as well as in restoring immune activation. An ongoing Phase 1/2 clinical trial of BCA101, initiated in July 2020, has dosed the first six cohorts of patients in a dose-escalation study with BCA101 as a single agent. A second arm of the study began enrolling patients for combination treatment with BCA101 and pembrolizumab, a PD-1 inhibitor, in January 2021. For more information, please visit www.clinicaltrials.gov.

On November 12, 2021 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported that new SQZ AAC and eAPC preclinical research describing the robust potential of these platforms to treat cancer, including data demonstrating synergistic activity when combined with chemotherapy (Press release, SQZ Biotech, NOV 12, 2021, View Source [SID1234595461]). The company also presented new research on the development of enhanced tumor infiltrating lymphocytes (TILs) that show increased potency in the absence of exogenous cytokine (IL-2) support. The data was presented at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) being held November 10-14, 2021, in Washington, D.C. and virtually.

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"Our presentations at SITC (Free SITC Whitepaper) provide compelling new preclinical data on the multiple biologically diverse, directed immunity approaches that we are pursuing for cancer therapies," said Howard Bernstein, M.D., Ph.D., Chief Scientific Officer at SQZ Biotechnologies. "Our AAC and eAPC platform work provides translational insights that are relevant to clinical development, including combination chemotherapy and potential expansion to broader patient populations and tumor types."

"We are also excited to present initial preclinical results on enhanced tumor infiltrating lymphocytes, highlighting a potential future therapeutic avenue," said Jonathan Gilbert, Ph.D., Vice President and Head of Exploratory Research, SQZ Biotechnologies. "Working with tumor reactive TILs provided by AgonOx, Inc., we developed mRNA engineered TILs that can proliferate and kill matched patient tumor cells in the absence of exogenous IL-2 cytokine support. Engineered TILs may enable the removal of toxic preconditioning and systemic IL-2 use with TIL therapies, making them more broadly applicable to patients."

Major Findings from Preclinical Research

Poster #156: RBC-Derived, Activating Antigen Carriers (SQZ AACs) Prime Potent T Cell Responses and Drive Tumor Regression In Vivo

SQZ Activating Antigen Carriers (AAC) were derived from red blood cells (RBCs) and engineered to direct tumor-specific antigens and adjuvant to endogenous professional APCs, which subsequently activated T cell responses in vivo
In TC-1 tumor bearing mice, a model of HPV16+ cancers, AACs demonstrated a synergistic therapeutic effect in combination with cisplatin, a common chemotherapy used in many clinical settings
Median survival of mice increased in all combination treatment cohorts compared to single agent cisplatin or ACC treatment
Poster #211: SQZ eAPCs Generated from PBMCs by Delivery of Multiple mRNAs Encoding for Antigens, Costimulatory Proteins, and Engineered Cytokines

SQZ Enhanced Antigen Presenting Cells (eAPC) derived from peripheral blood mononuclear cells (PBMCs) and engineered with various mRNA encoding for multiple target antigens and immuno-stimulation signals, including CD86 and membrane bound IL-2 and IL-12, generated robust T cell responses in human in-vitro models
HPV16-encoding mRNA delivery to PBMCs stimulated CD8+ T cells across a range of HLA haplotypes, supporting future eAPC clinical development in broad HPV16+ patient populations
eAPC data highlights the potential to expand the therapeutic impact across tumor types by changing the antigen-encoding mRNA
Poster #165: Generating Enhanced Tumor Infiltrating Lymphocytes through Microfluidic Cell Squeezing

Cell Squeeze delivery of mRNA encoding membrane bound IL-2 (mbIL2) and IL-12 (mbIL12) into expanded tumor reactive CD8 human tumor infiltrating lymphocytes (TILs) from AgonOx* (AGX-148) demonstrated high levels of membrane-bound cytokine expression in vitro
Enhanced TILs proliferated independent of exogenous IL-2 and demonstrated improved granzyme B levels, illustrating the potential to eliminate systemic IL-2 administration in the clinical setting.
In an in vitro co-culture model with matched human melanoma cells, enhanced TILs demonstrated increased tumor killing as compared to un-modified TILs
* AgonOx, Inc. is a biotechnology company with a close alignment with the Earle A. Chiles Research Institute at the Providence Cancer Institute in Portland, OR.

On November 12, 2021 Asher Biotherapeutics, a biotechnology company developing precisely-directed immunotherapies for cancer, autoimmune, and infectious diseases, reported new preclinical data demonstrating proof of concept for its cis-targeting platform and lead program AB248 (Press release, Asher Biotherapeutics, NOV 12, 2021, View Source [SID1234595460]). AB248 is an engineered intereukin-2 (IL-2) immunotherapy, designed to selectively target CD8+ effector T cells. The data will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting (SITC 2021), being held in Washington D.C. and virtually, November 10-14, 2021.

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"We are pleased to share two presentations at SITC (Free SITC Whitepaper), providing further evidence that our cis-targeting approach enables us to craft exquisitely selective molecules, which activate only the desired immune cell types. This approach allows us to deliver immune activators to the cell types that drive efficacy, while avoiding other cell types that can lead to increased toxicities or other undesired consequences. These data provide further validation for our platform, which has now generated multiple lead molecules against high value targets and support our efforts to advance a pipeline of immunotherapies to provide better outcomes to patients," said Andy Yeung, Ph.D., Chief Technology Officer and Founder of Asher Bio.

Ivana Djuretic, Ph.D., Chief Scientific Officer and Founder of Asher Bio, added: "Historically IL-2 has proven to be a very potent immunotherapy capable of inducing durable complete responses in some cancer patients, but IL-2’s potential has been severely limited by toxicities, which arise due to non-selective activation of many different cell types. Our approach is to focus IL-2 to selectively activate CD8+ T cells, the primary immune cell subset that drives anti-tumor efficacy in response to IL-2 pathway activation. We are encouraged by the preclinical results presented at SITC (Free SITC Whitepaper), which demonstrate the potential for AB248 to deliver both enhanced anti-tumor efficacy and improved safety and reinforce our confidence in AB248’s potential as a best-in-class IL-2 immunotherapy. We look forward to advancing AB248 into clinical studies across multiple solid tumor types next year."

In an oral presentation titled, "CD8-targeted IL-2 drives potent anti-tumor efficacy and promotes action of tumor specific vaccines," Bob Schreiber, Ph.D., Professor of Pathology & Immunology; Director, Bursky Center for Human Immunology & Immunotherapy Programs; Washington University School of Medicine and a scientific founder of Asher Bio, reviewed new preclinical data from studies of CD8-IL2, a murine surrogate of AB248, which was evaluated in a T3 sarcoma model. The data showed that:

In an anti-PD-1 resistant tumor model, a single dose of CD8-IL2 resulted in complete tumor rejection in 90% of treated mice. In contrast, high dose IL-2 produced minimal efficacy.
Treatment with CD8-IL2 led to the expansion of antigen specific T cells with increased expression of activation-associated markers and reduced expression of exhaustion-associated markers.
CD8-IL2 monotherapy was well-tolerated, demonstrating therapeutic activity without inducing body weight loss.
In a poster titled, "Selective activation of CD8+ T cells by a CD8-targeted IL-2 results in enhanced anti-tumor efficacy and safety," lead author Kelly Moynihan, Ph.D., Associate Director and AB248 Program Lead at Asher Bio, described the design of ­cis-targeted CD8-IL2 molecules and reviewed preclinical in vitro and in vivo data, which showed that:

Treatment with a single dose of CD8-IL2 resulted in a majority of complete responses in established MC-38 tumors, and superior efficacy as compared to a "not α" IL-2. CD8-IL2 also showed marked synergy in combination with an anti-PD1 against established B16F10 melanomas, inducing complete responses in 100% of treated mice.
Efficacy with a "not α" IL-2 in mice cannot be achieved unless "not α" IL-2 is dosed to levels that drive a high degree of toxicity-induced body weight loss (>10%). In contrast, treatment with CD8-IL2 drives strong anti-tumor efficacy without inducing body weight loss.
Treatment with CD8-IL2 led to selective expansion of CD8+ T cells in both the peripheral blood and tumor compartments in mice, and in cynomolgus monkeys, showed strong and selective expansion of CD8+ T cells.
Both presentations will be available in the "Presentations and Posters" section of Asher Bio’s website: View Source

On November 12, 2021 Avenue Therapeutics, Inc. (or the "Company") (NASDAQ: ATXI), a company focused on the development of intravenous ("IV") tramadol for the U.S. market, reported the closing of its public offering of 1,946,787 shares of common stock at a public offering price of $1.34 (Press release, Avenue Therapeutics, NOV 12, 2021, View Source [SID1234595459]). The gross proceeds of the offering were approximately $2.6 million before deducting underwriting discounts, commissions and offering expenses. In addition, the Company has granted Aegis Capital Corp. a 45-day option to purchase up to an additional 292,018 shares of common stock to cover over-allotments, if any, at the public offering price, less the underwriting discount.

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The common stock is trading on The Nasdaq Capital Market under the symbol "ATXI".

Aegis Capital Corp. acted as the sole book-running manager for the offering.

A registration statement on Form S-3 relating to common stock being sold in this offering was declared effective by the Securities and Exchange Commission (the "SEC") on October 1, 2021. The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained on the SEC’s website, www.sec.gov, or by contacting Aegis Capital Corp., Attention: Syndicate Department, 810 7th Avenue, 18th Floor, New York, NY 10019, by email at [email protected], or by telephone at (212) 813-1010.

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.