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Actinium Highlights Actimab-A Combined with CD47 Immunotherapy Results in Upregulation of Calreticulin Leading to Enhanced Phagocytosis in AML at the Society for Immunotherapy for Cancer (SITC) Conference

On November 12, 2021 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company"), a leader in the development of targeted radiotherapies for patients with unmet needs, reported that data highlighting Actimab-A in combination with a CD47 blocking antibody immunotherapy are being presented at the 36th Annual Meeting of the Society for Immunotherapy for Cancer (SITC 2021) November 12th – 14th (Press release, Actinium Pharmaceuticals, NOV 12, 2021, View Source [SID1234595453]). The poster presentation highlights that in multiple AML cell lines, Actimab-A induced an increase in cell surface calreticulin as much as 3-times higher than control. When combined with a CD47 blocking antibody, enhanced pro-phagocytic immune response was seen in vitro across 3 AML cell lines. In vivo studies in disseminated AML tumor models showed a significant increase in survival with the Actimab-A plus CD47 immunotherapy combination compared to single agent therapy.

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Actimab-A is an antibody radiation conjugate (ARC) comprised of a CD33 targeting antibody armed with the alpha-emitting radioisotope Actinium-225, which has shown single agent anti-leukemic activity in a Phase 2 trial as well as synergy in combination with chemotherapy and targeted agents in Phase 1 trials. It has been shown that upregulation of CD47, which acts as a "don’t eat me" signal, is one mechanism in which AML cells can evade targeting and destruction by an innate immune response. The data presented at SITC (Free SITC Whitepaper) shows for the first time the potential to upregulate calreticulin, a pro-phagocytic "eat me" signal, with a CD33 ARC armed with the Actinium-225 radioisotope payload resulting in a potential synergistic effect with CD47 immunotherapy.

Dr. Avinash Desai, Actinium’s Chief Medical Officer, said, "As CD47 emerged as a highly attractive novel immunotherapy target, we rapidly identified the potential to combine Actimab-A with a CD47 blocking antibody. Based on the data to date with CD47 in patients with AML and MDS, we believe the potential exists to improve patient outcomes by combining with Actimab-A. Actimab-A is a highly differentiated agent for the treatment of AML as it uses radiation as the cytotoxic payload. AML, and many other blood cancers, are highly sensitive to radiation but cannot be properly targeted with standard external radiation sources due to their diffuse nature. With the increasing recognition of radiation’s potential to activate immune responses, we believe we are best poised to lead the field with our ARCs that can deliver and target the radiation with cellular precision and minimize systemic exposure and toxicities. By targeting CD33, we are targeting a validated marker that is expressed in a majority of AML patients with a radioisotope payload that is agnostic to cytogenetic or molecular markers. With initial mechanistic synergy demonstrated with CD47 immunotherapy, we look forward to exploring collaborations to advance this novel and differentiated combination from preclinical studies into patients in the clinic to further bolster Actimab-A’s potential as a backbone therapy for the treatment of AML."

SITC Poster Details

Poster Title: Anti-CD33 actinium-225 targeted radioimmunotherapy enhances the biologic activity of anti-CD47 antibody immunotherapy in preclinical models of acute myeloid leukemia

Poster Number: 590

Location: Poster Hall, Walter E. Washington Convention Center in Washington, D.C.

Dates and Times: 11/12/2021 – 11/14/2021, 7:00 am – 5:00 pm

The poster will be accessible on Actinium’s website on the Presentations & Webinars page: View Source

aTyr Pharma to Present at Upcoming Investor Conferences in November

On November 12, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, reported that Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer, will present at two upcoming virtual investor conferences in November (Press release, aTyr Pharma, NOV 12, 2021, View Source [SID1234595452]).

Details of the events are as follows:

Conference: Stifel 2021 Virtual Healthcare Conference
Date: Wednesday, November 17, 2021
Time: Live Corporate Presentation at 4:40pm EST / 1:40pm PST

Conference: Piper Sandler 33rd Annual Virtual Healthcare Conference
Date: Monday, November 22, 2021
Time: Pre-recorded Fireside Chat available on demand starting at 10:00am EST / 7:00am PST

In addition to the presentations, company management will be available to participate in virtual one-on-one meetings with investors who are registered attendees of the conferences. Following the events, a replay of each presentation will be available on the Investor’s section of the company’s website at www.atyrpharma.com.

Xenetic Biosciences, Inc. Reports Third Quarter 2021 Financial Results and Provides Business Update

On November 12, 2021 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, reported its financial results for the third quarter of 2021 and provided a corporate update (Press release, Xenetic Biosciences, NOV 12, 2021, View Source [SID1234595451]).

"Our team continues to advance the XCART program and validate key workflow and manufacturing components which move us closer to conducting IND-enabling studies. Building on the proven success of CAR T therapy, we believe that Xenetic’s approach is innovative and is well-positioned to have a meaningful impact by addressing the significant unmet needs in certain hematological malignancies. As we continue to advance this important program and witness the potential of the XCART platform, our confidence holds strong in its ability to target cancers with a patient- and tumor-specific approach," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic.

XCART Platform Technology Overview: Significantly differentiated, proprietary approach to personalized CAR T lymphoma therapy targeting tumor-specific neoantigens that target independently of CD19 or other surface antigens that are common to both normal and malignant B-cells. Lead program for Non-Hodgkin lymphoma, an area of significant unmet need, with the potential to address an initial global market opportunity of over $7 billion annually.1

Program Highlights:

Advancing preclinical efforts through ongoing research and development collaborations including with Scripps Research and other institutions covering design and implementation of the pre-clinical development program, as well as activities supporting process development for clinical manufacturing.
The exploratory biopsy study in Eastern Europe achieved its initial objective of supporting further XCART platform development, including that of downstream XCART processes, and has provided materials and methods needed to proceed with IND-enabling studies.
Bolstered intellectual property portfolio with issuance of a U.S. patent covering the co-administration of XCART-derived CAR T cells, together with a personalized vaccine designed to enhance the effectiveness of the CAR T therapy.
PolyXen Platform Technology: Patent-protected platform technology designed for protein or peptide therapeutics, enabling next-generation biological drugs by prolonging a drug’s circulating half-life and potentially improving other pharmacological properties.

Program Highlights:

Royalty payments of approximately $0.3 million were received in the quarter ended September 30, 2021, from the Company’s sublicense with Takeda. Takeda’s sublicensee has now launched the relevant product in multiple global markets.
Company’s partner, Pharmsynthez, has filed a registration dossier in Russia to obtain approval of Epolong, a polysialylated form of human erythropoietin as a treatment for anemia in patients with chronic kidney disease.
Summary of Financial Results for Third Quarter 2021
Net loss for the quarter ended September 30, 2021, was approximately $1.4 million. Research and development expenses for the three months ended September 30, 2021, increased by approximately $0.2 million, or 36.1%, to $0.8 million from $0.6 million in the comparable quarter in 2020. The increase was due to the Company’s increased spending on the XCART platform technology. General and administrative expenses for the three months ended September 30, 2021, was $0.9 million, increasing $0.1 million, or 17.5%, compared to the same period in the prior year. The increase was primarily due to increases in employee related, legal and consulting costs during the three months ended September 30, 2021, compared to the same period in 2020. In July 2021, the Company completed a $12.5 million private placement of common stock and warrants to purchase common stock resulting in approximately $11.5 million of net proceeds to the Company. At September 30, 2021, the Company reported working capital was approximately $19.5 million. The Company ended the quarter with approximately $19.7 million of cash.

Candel Therapeutics Presents Novel Biomarker Data Demonstrating Immune Activation After Administration of CAN-3110 in Patients with Recurrent High-Grade Glioma

On November 12, 2021 Candel Therapeutics, Inc. (Nasdaq: CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported presentation of novel biomarker data from their ongoing phase 1 open-label, dose-escalation clinical trial of CAN-3110 in patients with recurrent high-grade glioma (HGG) (Press release, Candel Therapeutics, NOV 12, 2021, View Source [SID1234595450]). CAN-3110 is an HSV replication-competent oncolytic virus engineered to provide selective killing of cancer cells while sparing neighboring healthy cells. The presentation entitled "Detection of viral antigen and immune activation after intra-tumor injection of CAN-3110 (ICP-34.5 expressing HSV-1 oncolytic virus) in patients with recurrent high-grade glioma" was presented at the SITC (Free SITC Whitepaper) 36th Annual Meeting by Candel’s Vice President and Head of Research, Francesca Barone, MD, PhD.

During the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2021, Candel reported preliminary clinical data demonstrating an overall survival of 11.7 months in this difficult-to-treat patient population. The current presentation, focused on the biological findings of this study, showed the ability of CAN-3110 to induce immune activation both locally in the tumor microenvironment and systemically in peripheral blood.

Histologic analysis and molecular profiling of post-treatment brain samples demonstrated persistence of viral antigen associated with significant T-cell infiltration in the tumor parenchyma as well as a molecular signature consistent with local activation of innate and adaptive immunity. Analysis of post-treatment serum samples showed upregulation of pro-inflammatory cytokines and chemokines. These findings collectively indicate that CAN-3110 treatment can induce both local and systemic immune activation associated with an encouraging clinical response.

"There is a critical need for treatment options for patients with recurrent high-grade glioma. The data from this trial support the mechanistic approach of tumor cell-specific replication that was the intent of the CAN-3110 design," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel Therapeutics. "The biomarker data presented at SITC (Free SITC Whitepaper), in conjunction with the overall survival data previously reported at ASCO (Free ASCO Whitepaper), are encouraging signals as we endeavor to bring novel oncolytic viral immunotherapies to patients with cancer."

Details from the presentations will be available on Candel’s company website at View Source

About CAN-3110

CAN-3110 is an HSV replication-competent oncolytic virus engineered to enhance selective killing of cancer cells while sparing neighboring healthy cells. CAN-3110 selectively expresses ICP34.5, a key gene in HSV replication, in tumor cells that overexpress nestin, a cytoskeletal protein. Nestin is highly expressed in high-grade glioma cells and other tumor tissues, but it is absent in healthy adult brain tissue.

Candel is evaluating the effects of treatment with CAN-3110 in recurrent high-grade glioma.

For more information on this clinical study, please visit View Source

Monopar Therapeutics Reports Third Quarter 2021 Financial Results and Recent Clinical Developments

On November 12, 2021 Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported third quarter 2021 financial results and summarized recent clinical developments (Press release, Monopar Therapeutics, NOV 12, 2021, View Source [SID1234595449]).

Recent Clinical Developments

Validive

Monopar received clearance in multiple European countries to conduct its Phase 2b/3 VOICE clinical trial of Validive (clonidine HCl mucobuccal tablet) for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy (CRT) for oropharyngeal cancer.
Monopar continues to actively initiate additional clinical sites in both the U.S. and the EU for the Phase 2b clinical trial, which is on track to reach the interim in the first half of 2022.
There remains no FDA-approved prevention or treatment for CRT-induced SOM.
Camsirubicin

Camsirubicin, a propriety doxorubicin analog, has been engineered specifically to retain the anticancer activity of doxorubicin while minimizing the toxic effects on the heart.
In August 2021, Monopar received clearance from the U.S. Food and Drug Administration to proceed under an Investigational New Drug (IND) application with an open-label Phase 1b dose-escalation clinical trial evaluating camsirubicin plus growth factor support (pegfilgrastim/G-CSF) in patients with advanced soft tissue sarcoma.
In September 2021, Monopar initiated the Phase 1b clinical trial, and in October 2021, dosed the first patients.
Monopar continues to work on activating additional clinical sites in the U.S. for the Phase 1b clinical trial.
Results for the Third Quarter Ended September 30, 2021, Compared to the Third Quarter Ended September 30, 2020

Cash and Net Loss

Cash and cash equivalents as of September 30, 2021, were $22.3 million. Monopar anticipates that its current cash and cash equivalents will fund: the Phase 2b portion of the VOICE clinical trial; the commencement of the Phase 3 portion of the VOICE clinical trial; and the Phase 1b camsirubicin clinical trial through December 2022. The Company plans to raise additional funds and/or engage a partner within the next 12 months to complete the VOICE clinical program and continue camsirubicin clinical development beyond the Phase 1b clinical trial.

Net loss for the third quarter of 2021 was $2.5 million or $0.20 per share compared to net loss of $1.6 million or $0.15 per share for the third quarter of 2020.

Research and Development (R&D) Expenses

R&D expenses for the third quarter of 2021 were $1.8 million compared to $1.2 million for the third quarter of 2020. This increase of $0.6 million was primarily due to increases of $0.5 million for VOICE clinical trial expenses and $0.2 million for R&D personnel expenses offset by a decrease of $0.1 million for Phase 1b camsirubicin clinical trial expenses.

General and Administrative (G&A) Expenses

G&A expenses for the third quarter of 2021 were $0.6 million, compared to $0.4 million for the third quarter of 2020. This increase of $0.2 million was primarily due to an increase in G&A personnel expenses.