On November 10, 2021 CytoImmune Therapeutics, a privately-held cell therapy company focused on developing natural killer (NK) immune cells to fight cancer, reported the appointment of Christina Coughlin M.D., Ph.D., as their Chief Executive Officer (Press release, CytoImmune Therapeutics, NOV 10, 2021, View Source [SID1234595112]). Dr. Coughlin will provide strategic leadership for the recently launched biotech and its clinical-stage pipeline of engineered NK cell therapies designed to improve outcomes for patients with cancer. Dr. Coughlin will join the company’s Board of Directors.

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Dr. Coughlin joins CytoImmune from Rubius Therapeutics, Inc. where she served as the Chief Medical Officer and led the clinical development, translational medicine, and regulatory efforts in the allogeneic red cell therapy platform. Prior to Rubius, Dr. Coughlin was with Tmunity Therapeutics, Inc., where she served as Chief Medical Officer and was responsible for the preclinical and clinical development of autologous CAR-T and TCR-T cellular therapies. Dr. Coughlin has held other leadership roles in the pharmaceutical and biotechnology fields in her career including Chief Medical Officer at Immunocore, heading the development of the soluble TCR platform, and Oncology Asset Team Leader at Pfizer.

"We’re pleased to welcome Dr. Coughlin as our Chief Executive Officer," said Michael Caligiuri M.D., scientific co-founder, and Chief Medical Officer at CytoImmune. "We have made exciting progress in advancing our Cytokine-Induced Engineered CAR-NK cell technologies to the clinic, and Christina’s expertise across multiple cell therapy platforms and her understanding of the immuno-oncology space will help propel CytoImmune to the next level."

"Christina’s deep industry experience and knowledge of cell therapy positions her to lead CytoImmune as we continue to advance our pipeline to make an impact for patients," said Richard Santulli, the Chairman of CytoImmune. "With Christina at the helm as CEO, we are firmly poised to rapidly expand our clinical trial programs for NK cell therapies."

Dr. Coughlin received her M.D. and Ph.D. from the University of Pennsylvania and completed fellowships in Hematology and Oncology at the Children’s Hospital of Philadelphia and in the Translational Research Group under the direction of Carl June, M.D. at the University of Pennsylvania.

"I am honored to join CytoImmune and excited to advance its disruptive scientific approach to the off-the-shelf fully allogeneic engineered NK cell therapies targeting solid tumors and hematologic malignancies," said Dr. Coughlin. "I look forward to partnering with the team to positively impact patients."

On November 10, 2021 Genenta Science, a clinical-stage biotechnology company pioneering the development of hematopoietic stem progenitor cell immuno-gene therapy for cancer (Temferon), reported that it has filed a registration statement on Form F-1 (the "Registration Statement") with the U.S. Securities and Exchange Commission ("SEC") relating to a proposed initial public offering of the Company’s ordinary shares, to be delivered in the form of American Depositary Shares ("ADSs") (Press release, Genenta Science, NOV 10, 2021, View Source [SID1234595111]). The number and price of the securities to be sold in the offering has not yet been determined.

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The Company has applied to list the ADSs on the Nasdaq Capital Market in the United States under the symbol "GNTA" (file number 333-260923). ADSs are U.S. dollar-denominated negotiable instruments issued by a depositary bank that facilitate U.S. trading and investment in shares of non-U.S. companies. Each ADS represents the right to receive one ordinary share.
Roth Capital Partners is acting as sole book-running manager of the offering. Maxim Group LLC is acting as lead manager of the offering.
The Registration Statement on Form F-1 relating to the proposed sale of these securities has been filed with the SEC but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the Registration Statement becomes effective.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of any 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. Any potential offering is subject to market and other conditions.

The proposed offering of ADSs will only be made by means of a prospectus. When a copy of the preliminary prospectus relating to the offering is available, copies may be obtained from Roth Capital Partners, 888 San Clemente Drive, Newport Beach, CA 92660, Attention: Equity Capital Markets at (800) 678-9147 or by email at [email protected]; or from Maxim Group LLC at 300 Park Avenue, 16th Floor, New York, NY 10022,

On November 10, 2021 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported its financial results for the quarter ended September 30, 2021 and provided a business update (Press release, Phio Pharmaceuticals, NOV 10, 2021, View Source [SID1234595110]).

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"Our development programs continue to generate positive in vivo data showing how INTASYL technology can be utilized in various applications to treat cancer. These data have generated broad interest in our programs as we prepare to enter the clinic with the initiation of two trials expected in the next couple of quarters," said Dr. Gerrit Dispersyn, President and CEO of Phio. "We expect to initiate our first-in-human clinical study of our lead program, PH-762, in the first quarter of 2022, which will be followed by the first study with PH-762-empowered tumor infiltrating lymphocyte therapy to start in Q2. In addition, we’ve generated a lot of exciting in vivo data in support of the development of our PH-894 compound, showing it provides enhanced immunotherapeutic activity by reprograming T cells and other cells in the TME, and supporting our plans to file for a clinical trial application with the FDA in the second half of 2022."

Quarter in Review and Recent Corporate Updates

Presented positive data from several in vivo preclinical studies demonstrating the flexibility and application of INTASYL in the field of immuno-oncology at leading scientific conferences held during the third quarter of 2021:
Announced new data showing that local treatment in vivo with INTASYL has the potential to cure locally treated and distal untreated tumors and generate systemic tumor immunity that is both durable and tumor specific, further highlighting the technology’s potential in direct therapeutic applications. Data from this study, presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021, showed a complete response in up to 83% of the animals treated with a low dose formulation of dual-targeting INTASYL PH-3861 (targeting PD-1 and BRD4).
Introduced new in vitro and in vivo data that showed silencing BRD4 with INTASYL compound PH-894 had a significant impact on T cell function and phenotype promoting T cell activation and immunosuppression in the tumor microenvironment as presented at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). These new data build upon a growing body of evidence that BRD4 plays a role in tumor cells and can also regulate T cell function, and that PH-894 can reprogram T cells to provide enhanced immunotherapeutic activity.
Completed additional in vivo and in vitro preclinical studies with PH-894, an INTASYL product candidate for direct drug therapy, which showed the potential of INTASYL compounds to modulate the expression of intracellular and/or commonly considered "undruggable" targets, such as epigenetic targets. These data will support our regulatory filings and the Company expects to file a clinical trial application for PH-894 in the second half of 2022.
Upcoming Pipeline Milestones

Expect to initiate a first-in-human clinical study on the direct therapeutic use of PH-762 in patients with advanced melanoma in the first quarter of 2022.
Expect to initiate a first-in-human clinical study on the use of PH-762 and tumor infiltrating lymphocytes (TILs) in adoptive cell therapy (ACT) in patients with advanced melanoma in the second quarter of 2022.
Expect to file a clinical trial application for PH-894 in the second half of 2022.
Additional data publications on the Company’s pipeline programs.
Financial Results

Cash Position

At September 30, 2021, the Company had cash of $26.5 million as compared with $14.2 million at December 31, 2020. The Company expects its current cash will be sufficient to fund currently planned operations to the second quarter of 2023.

Research and Development Expenses

Research and development expenses were approximately $2.8 million for the quarter ended September 30, 2021, compared to approximately $1.3 million for the quarter ended September 30, 2020. The increase in research and development expenses was primarily due to manufacturing costs for the Company’s PH-762 and PH-894 INTASYL compounds and fees for the required preclinical studies in support of the Company’s clinical trials for PH-762 as compared to the same period in the prior year.

General and Administrative Expenses

General and administrative expenses were approximately $0.9 million for the quarter ended September 30, 2021, compared to approximately $1.1 million for the quarter ended September 30, 2020. The decrease is primarily due to a decrease in legal fees partially offset by increased stock-based compensation expense as the Company did not grant equity awards in the same period in the prior year.

Net Loss

Net loss was $3.7 million, or $0.28 per share, for the quarter ended September 30, 2021, compared with $2.3 million, or $0.40 per share, for the quarter ended September 30, 2020. The increase in net loss was primarily attributable to the increase in research and development expenses related to the Company’s preclinical activities in preparation for the start of its clinical trials with PH-762, as described above. The change in net loss per share was primarily due to an increase in the number of shares outstanding as a result of the Company’s capital raise activities as compared to the prior year period.

On November 10, 2021 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative gamma-delta T cell therapies utilizing its DeltEx platform, reported financial results and operational highlights for the third quarter ended September 30, 2021 (Press release, In8bio, NOV 10, 2021, View Source [SID1234595109]). In addition, the Company provided an overview of recent corporate developments.

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"Our IPO has provided the capital to enable us to advance our clinical programs for INB-100 in leukemia and INB-200 in newly diagnosed glioblastoma (GBM) and other solid tumors as well as progress our preclinical-stage assets," said William Ho, Chief Executive Officer and co-founder of IN8bio. "Both of our clinical programs continue to progress and we took the opportunity during the required safety observation period for the allogeneic INB-100 trial to improve our manufacturing processes and overall gamma-delta T cell yield. We look forward to the continued advancement of our clinical and preclinical programs and to providing updates on them in the future."

Third Quarter Business Highlights & Corporate Updates

In July 2021, IN8bio appointed Emily Fairbairn and Luba Greenwood as two independent members of the Company’s Board of Directors. Ms. Fairbairn is currently a principal of Transcend Partners and was co-founder and CEO of Ascend Capital. Ms. Greenwood serves as Managing Partner of Binney Street Capital LLC, a venture capital fund established by the Dana Farber Cancer Institute, and as CEO of LUCA Biologics.

In August 2021, IN8bio closed its initial public offering, in which it issued and sold 4,000,000 shares of common stock at a public offering price of $10.00 per share. The net proceeds to the Company were approximately $32.3 million, after deducting underwriting discounts, commissions and offering expenses.

In August 2021, IN8bio completed dosing of the first cohort of INB-100, a Phase 1 clinical trial of donor-derived allogeneic gamma-delta T cells in leukemia patients undergoing haploidentical hematopoietic stem cell transplant (HSCT). No severe adverse infusion reactions, cytokine release syndrome, neurotoxicity (or ICANS) or dose-limiting toxicities were observed. Episodes of mild-to-moderate acute skin graft-versus-host-disease (GvHD) responsive to standard therapy have been observed. Additional patients will be enrolled at the first dose-level to further assess these events and any potential relationship to the ongoing positive clinical responses observed in the INB-100 treated patients. Skin biopsies were consistent with the expected pathology in post-HSCT GvHD and the vast majority of immune cell infiltration were alpha-beta T cells. All three patients treated with INB-100 continue in remission with the first two patients beyond 18- and 16-months post-transplant, respectively. The Company continues to expect to report initial results from the first cohort in this Phase 1 trial in 2022, with topline results for all cohorts in 2023.

In September 2021, IN8bio announced the peer-reviewed publication of preclinical results that it believes provides foundational support for the use of its DeltEx Drug Resistant Immunotherapy (DRI) in newly diagnosed GBM. This work, published in Scientific Reports, a Nature Portfolio journal, focused on the use of gamma-delta T cells genetically engineered to be chemotherapy resistant through the addition of an O6-Methylguanine-DNA Methyltransferase (MGMT). Concurrent dosing of DRI cells with temozolomide (TMZ) resulted in a significant improvement in survival outcomes in mice over either monotherapy alone in both classical and mesenchymal primary high-grade gliomas.

In October and November 2021, the Company presented updates on its programs at the 2021 Advanced Therapies Congress and at the 13th Annual Protein and Antibody Engineering Summit (PEGS) Europe.
Upcoming Scientific Presentations

36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), November 10 – 14, 2021.

26th Annual Meeting of the Society of Neuro-Oncology (SNO), November 18 – 21, 2021.
Third Quarter 2021 Financial Highlights

Cash position: As of September 30, 2021, the Company had cash of $40.7 million, compared to $18.0 million as of December 31, 2020. The increase in cash was primarily due to the IPO proceeds, net of cash used by the Company in operations to advance its programs and research and development.

Research & Development (R&D) expense: R&D expense was $1.4 million for the three months ended September 30, 2021, compared to $1.1 million for the comparable prior year period. The increase in R&D expense was primarily due to increased third-party clinical trial related activities and contract manufacturing costs for the ongoing clinical trials and increased personnel-related costs, including salaries, benefits and stock-based compensation.

General and administrative expense: General and administrative expense was $2.0 million for the three months ended September 30, 2021, compared to $0.6 million for the comparable prior year period. The increase was primarily due to increased personnel costs, including salaries, benefits and stock-based compensation and increased legal expenses in anticipation of operating as a public company.

Net loss: The Company reported a net loss of $3.4 million, or $0.25 per basic and diluted common share, for the three months ended September 30, 2021, compared to a net loss of $1.7 million and a net loss attributable to common stockholders of $2.2 million, or $0.60 per basic and diluted common share, for the comparable prior year period.

On November 10, 2021 Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported financial results for the third quarter ended September 30, 2021 (Press release, TapImmune, NOV 10, 2021, View Source [SID1234595108]).

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"This quarter, we continued our momentum in advancing Marker’s Phase 2 trial of MT-401, Marker’s lead MultiTAA-specific T cell therapy, for the treatment of post-transplant acute myeloid leukemia, or AML," said Peter L. Hoang, President & CEO of Marker Therapeutics. "We are pleased to announce that the first patients in Marker’s Phase 2 AML trial have been dosed with study drug. Further, we are on track to enroll the first 20 patients of the trial in the fourth quarter, with the first data readout expected in the first quarter of 2022. We look forward to providing year-end updates in a conference call and webcast early next year."

PROGRAM UPDATES

The Company continues to enroll patients and activate clinical sites across the U.S. in Marker’s Phase 2 trial of MT-401, its lead MultiTAA-specific T cell product candidate, for the treatment of post-transplant AML. The trial is expected to enroll approximately 120 patients in the adjuvant setting and 40 patients with active disease at approximately 20 clinical sites.
BUSINESS UPDATES

The Company’s new cGMP manufacturing facility in Houston, Texas is fully operational and is supporting ongoing operations. The facility will also manufacture Marker’s MultiTAA-specific T cell products for future hematological and solid tumor trials, in addition to producing the potential commercial supply of any products, if approved.
In August, the Company announced that it received notice of a Product Development Research award totaling approximately $13.1 million from the Cancer Prevention and Research Institute of Texas (CPRIT) to support the Company’s Phase 2 AML trial.
ANTICIPATED PROGRAM MILESTONES

AML Trial Milestones

Enrollment of first 20 patients of the Phase 2 AML trial expected in Q4 2021
Topline readout of Group 2 active disease anticipated in Q1 2022
THIRD QUARTER 2021 FINANCIAL RESULTS

Cash Position and Guidance: At September 30, 2021, Marker had cash and cash equivalents of $48.7 million. The Company believes that its existing cash and cash equivalents will fund its operating expenses and capital expenditure requirements into the first quarter of 2023.
R&D Expenses: Research and development expenses were $6.8 million for the quarter ended September 30, 2021 compared to $4.8 million for the quarter ended September 30, 2020. The increase was primarily attributable to increases in clinical trial and sponsored research expenses and headcount-related expenses due to growth of research and development operations.
G&A Expenses: General and administrative expenses were $3.2 million for the quarter ended September 30, 2021 compared to $2.6 million for the quarter ended September 30, 2020.
Net Loss: Marker reported a net loss of $12.4 million for the quarter ended September 30, 2021, compared to a net loss of $7.4 million for the quarter ended September 30, 2020.