On November 13, 2021 Seven and Eight Biopharmaceuticals Inc., a clinical stage biotechnology company developing proprietary novel immuno-oncology therapies to activate the immune system against cancer, reported the presentation of interim Phase 1 data for BDB001 in combination with atezolizumab in advanced solid tumors at the 2021 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (Press release, Seven and Eight Biopharmaceuticals, NOV 13, 2021, View Source [SID1234595520]).

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BDB001 is an immune modulator capable of activating dendritic cells to initiate both innate and adaptive immunity against cancer. BDB001 is a first-in-class TLR7/8 agonist delivered intravenously, allowing for broader treatment of solid tumors. Previously, Seven and Eight Biopharma reported that intravenous administration of BDB001 both as monotherapy and in combination with an anti-PD-1 mAb exhibit favorable tolerability and robust systemic immune activation leading to durable clinical responses in multiple advanced solid tumor types (SITC, 20201; ASCO (Free ASCO Whitepaper), 20212).

The presentation at SITC (Free SITC Whitepaper) 2021 provides interim safety and efficacy results for a Phase 1 dose escalation / expansion trial of BDB001 in combination with atezolizumab in advanced solid tumors (NCT04196530). The results show that BDB001 in combination with atezolizumab is well tolerated with evidence of robust immune activation leading to clinical responses in multiple tumor types.

"It is encouraging to see that BDB001 in combination with atezolizumab can be safely delivered intravenously and produces clinical responses in heavily pre-treated tumors" said lead author and study investigator Dr. Manish R. Patel, of Florida Cancer Specialists/Sarah Cannon Research Institute.

"These promising interim results show that BDB001 in combination with atezolizumab represents a novel and viable treatment for advanced solid tumors. It is especially encouraging to see responses in both PD-1 naïve and refractory tumors." said Dr. Robert H.I. Andtbacka, Chief Medical Officer, Seven and Eight Biopharma. "The Phase 1 trial helped establish the BDB001 phase 2 dose which is being evaluated in an ongoing Phase 2 trial (NCT03915678) of BDB001 in combination with atezolizumab and radiotherapy in selected tumor types."

"We are very excited about the clinical data for BDB001 in combination with atezolizumab, as we continue to advance our robust immuno-oncology pipeline in treatments beyond anti-PD-(L)1, including preclinical platform programs in TLR Ligand Antibody Conjugation" said Dr. Walter Lau, Chief Executive Officer, Seven and Eight Biopharma.

Presentation Details:

Abstract Title: BDB001, a Toll-Like Receptor 7 and 8 (TLR7/8) agonist, can be safely administered intravenously in combination with atezolizumab and shows clinical responses in advanced solid tumors.

Abstract Authors: Manish R. Patel, Drew W. Rasco, Melissa L Johnson, Anthony W. Tolcher, Angela Tatiana Alistar, David Sommerhalder, Omid Hamid, Lixin Li, Alexander H. Chung, Robert H.I. Andtbacka

Session: Poster Presentation

On-Demand Session Release Date and Time: November 13th, 2021 @ 7:00 AM

Abstract Number: 472

The poster presentation will be available at the SITC (Free SITC Whitepaper) 2021 Annual Meeting website.

Abstract Summary:

Seven and Eight Biopharma’s systemic delivery of the TLR 7 and 8 dual agonist BDB001 is first in class.
BDB001 was delivered safely intravenously in combination with atezolizumab.
BDB001 in combination with atezolizumab showed robust dose dependent immune activation without increased risk of cytokine release syndrome.
Overall, BDB001 was well tolerated and 31.7% of subjects did not have any treatment related adverse events. No DLTs occurred and there were no Grade 4 or 5 Adverse Events.
Clinical responses were seen in subjects with urothelial carcinoma and non-small cell lung cancer and showed evidence of robust anti-tumor immune activation.
Clinical responses were seen in tumors that had progressed on anti-PD-1 therapy and with low probability of responding to anti-PD-(L)1 therapy based on their PD-L1 negative, MSI-stable, and Tumor Mutational Burden-low status.
A Phase 2 trial has been initiated and is actively enrolling subjects to further investigate BDB001 in combination with atezolizumab and radiotherapy in patients with advanced solid tumors
BDB001 in combination with atezolizumab represents a novel and viable therapeutic option for patients with advanced solid tumors.

On November 13, 2021 Triumvira Immunologics ("Triumvira"), a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that do not require gene editing and co-opt the natural biology of T cells to treat patients with solid tumors, reported the presentation of preclinical data from its proof-of-concept study in gastric cancer (Press release, Triumvira Immunologics, NOV 13, 2021, View Source [SID1234595519]). These new data demonstrate that Triumvira’s novel T cell antigen coupler (TAC)-T cell candidate targeting Claudin 18.2 (CLDN18.2) effectively eradicates CLDN18.2-expressing gastric tumor cells in vitro and in vivo. The results will be presented in a poster presentation today at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting, taking place November 10-14, 2021, virtually and in-person at the Walter E. Washington Convention Center in Washington, D.C.

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CLDN18.2 is a promising, clinically validated target for cancer drug development as gastrointestinal malignancies, more prominently gastric tumor cells, have been found to selectively express CLDN18.2 on their surface, making it a preferred antigen for specific targeting of tumor cells using TAC-T cells. A key feature of TAC-T cells is the proprietary TAC receptor, a multi-domain chimeric molecule that works directly with the natural T cell receptor to help a T cell recognize and attack cancer cells. Unlike CAR-T cells, TAC-T cells do not exhibit tonic signaling, do not show premature exhaustion, show long term persistence, and demonstrate deep penetration into and activation in solid tumors in various preclinical models.

"We’re excited about the level of activity we are seeing with our Claudin 18.2-directed TAC-T cells in our preclinical models of gastric cancer," said Andreas Bader, Ph.D., Chief Scientific Officer of Triumvira. "These results confirm the versatility of our TAC platform for difficult-to-treat solid tumors and pave the way for initiating IND-enabling studies in an effort to bring CLDN18.2-TAC T cells to patients as quickly as possible in an area of significantly unmet medical need."

In addition to eradicating CLDN18.2-expressing gastric tumor cells in vitro and in vivo, the study demonstrated that the activation of CLDN18.2-TAC T cells was specific to target cells that expressed CLDN18.2. CLDN18.2-TAC T cells did not show signs of auto-activation or elevated exhaustion markers post-manufacturing, which is a key feature of the TAC technology designed to enhance the durability of TAC-T products.

Details of the poster presentation are as follows:

Poster Title: Development of Claudin 18.2 TAC T cells for the treatment of gastric cancer
Poster Number: 118
Category: Cellular Therapies
Date and Time: Saturday, November 13, 2021; 7:00 a.m. – 8:30 p.m. EST
Location: Walter E. Washington Convention Center, Hall E
Presenter: Christopher Helsen, Ph.D. – Executive Director, Research and Development, Triumvira

On November 13, 2021 Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage biopharmaceutical company developing proprietary antibody-based therapeutics to treat cancer, reported financial results for the third quarter ended September 30, 2021 and highlighted recent corporate accomplishments (Press release, Compass Therapeutics, NOV 13, 2021, View Source [SID1234595476]).

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"We have made major progress on reaching our corporate goals, highlighted by achieving significant advancements for both of our clinical stage programs and raising capital to support our objectives," said Thomas J. Schuetz, MD, PhD, Co-founder and Chief Executive Officer. "We released promising interim Phase 2a data on our lead program, CTX-009, which support our conviction that CTX-009 is a promising novel bispecific antibody therapy with activity across a broad range of solid tumors. Additionally, CTX-471 continues to advance well in development, and has demonstrated encouraging activity as a monotherapy in the post anti-PD-1/PD-L1 patient population, an area of a particularly high unmet medical need."

"On the financing side, we completed a $125 million public offering and concurrently uplisted to Nasdaq," added Vered Bisker-Leib, PhD, MBA, President and Chief Operating Officer. "We expect this offering will extend our cash runway into the fourth quarter of 2024, which will support the advancement of our pipeline. These are significant achievements for Compass and position us well to grow and fund key milestones throughout the next several years."

Third Quarter Development Highlights:

CTX-009 (DLL4 and VEGF-A bispecific antibody):

A Phase 2a study was initiated in Q1 2021 testing CTX-009 in combination with paclitaxel in patients with Biliary Tract Cancers (cholangiocarcinoma). Enrollment in the first part of the study has been completed and the criteria to advance to the second part of the study have been met. Notably, five partial responses (PRs) have already been observed among the first 17 patients evaluated leading to a preliminary overall response rate (ORR) of 29%, and all patients evaluated have had stable disease or better with a decline in tumor burden observed in 16 of the 17 patients leading to a Clinical Benefit Rate (CBR) of 100%. The study is being conducted in South Korea by Handok Pharmaceuticals and the clinicaltrials.gov identifier for the study is NCT04492033. Compass plans to submit an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) in the fourth quarter of 2021 and subject to the IND clearance with the FDA, to initiate a Phase 2 study in 2022 in the United States.
CTX-471 (monoclonal antibody agonist of CD137, a key co-stimulatory receptor on immune cells):

We initiated a Phase 1b dose expansion study for CTX-471 in 2019 and treated 36 patients with 13 different tumor types in the study as of October 21, 2021. Of the 25 evaluable patients in the dose expansion part of the study, two patients had a PR, one of which has been confirmed by RECIST 1.1 and the other PR has been seen at the first tumor evaluation at Week 9. 11 patients have reached stable disease, leading to a preliminary ORR of 8% and a CBR of 52%. The first PR observed in the study was in a patient with advanced small cell lung cancer who had a PR at Week 17 and this response was confirmed at Week 25. This patient has now been treated with CTX-471 for more than one year with a durable PR. In October 2021, a second PR was observed in a patient with metastatic melanoma who was previously treated with and progressed on nivolumab. We expect to complete the Phase 1b stage of this study during the first half of 2022.
CTX-8371 (bispecific antibody that simultaneously targets both PD-1 and PD-L1):

We initiated IND-enabling studies and the GMP manufacturing campaign for CTX-8371. Due in part to delays at our contract development manufacturing organization, we are currently targeting an IND submission in the second half of 2022.
Third Quarter Corporate Highlights:

In November 2021, Compass closed an underwritten public offering to sell 35,715,000 shares of common stock at a public offering price of $3.50 per share. The gross proceeds to Compass from the offering, before deducting the underwriting discounts and commission, were approximately $125 million. In addition, the Company has granted the underwriters a 30-day option to purchase up to an additional 5,357,250 shares of common stock.
In connection with the public offering, Compass also uplisted its common stock to Nasdaq and its shares began trading on the Nasdaq Capital Market under the symbol "CMPX" on November 2, 2021.
Third Quarter 2021 Financial Results

Cash Position: As of September 30, 2021, cash and cash equivalents were $25.5 million as compared to $47.1 million as of December 31, 2020. The Company believes that our existing cash and cash equivalents, together with the proceeds of our November 2021 public offering, will allow us to fund our operating expenses and capital expenditures into the fourth quarter of 2024.
Research and development (R&D) Expenses: R&D expenses were $3.2 million for the third quarter of 2021, as compared to $3.7 million for the same period in 2020, a decrease of $0.5 million or 14%. The lower costs were principally driven by less depreciation expense of $0.3 million and program related expenses of $0.2 million.
General and Administrative (G&A) Expenses: G&A expenses were $2.7 million during the third quarter of 2021, as compared to $5.3 million for the same period in 2020, a decrease of $2.6 million or 49%. The lower costs were driven primarily by lower stock compensation expense of $1.4 million due to an accelerated vesting of shares and $0.5 million of professional fees related to the reverse merger in the third quarter of 2020. In addition, facilities expense decreased by $0.3 million.
Net Loss: Net loss for the third quarter was $6.0 million or $0.10 per diluted common share, compared to $9.2 million or $0.18 per diluted common share for the third quarter of 2020.

On November 12, 2021 iOnctura SA, a clinical stage oncology company targeting core resistance and relapse mechanisms at the tumor-stroma-immune interface, reported its compelling preclinical evidence on its next-generation autotaxin inhibitor, IOA-289, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (#SITC) Annual Meeting on November 10–14, 2021 (Press release, iOnctura, NOV 12, 2021, View Source [SID1234640239]).

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Autotaxin is a secreted glycoprotein that hydrolyzes LPC to LPA. LPA has a direct effect on tumor cell growth and survival. It also modulates the tumor microenvironment at the level of immune and stromal cells, enabling tumors to evade host immunity and impairing the response to therapy. The expression of both autotaxin and LPA is elevated in most solid tumors, with corresponding increases measurable in patients’ plasma. iOnctura is developing IOA-289 as a novel therapy for oncology indications where the response to chemotherapy and / or immunotherapy is sub-optimal due to the presence of an immunosuppressive stromal microenvironment.

The data presented at SITC (Free SITC Whitepaper) showed that IOA-289 is able to dose-dependently reduce LPA levels, potently modulate fibrotic processes and restore T cell migration in preclinical models. Furthermore, the data also demonstrated IOA-289 exhibited monotherapy activity to inhibit primary tumor growth and metastasis in orthotopic, immunocompetent tumor models. Finally, autotaxin expression was found to be elevated in the plasma of pancreatic cancer patients and its presence was correlated with the tumor biomarker CA19-9, a blood marker used to follow progression in patients with pancreatic cancer.

iOnctura has recently completed recruitment into the healthy volunteer study of IOA-289, investigating the safety and pharmacokinetic profile of IOA-289 in humans. Detailed results will be presented at an upcoming medical oncology conference. iOnctura plans to advance IOA-289 into a Phase 1 clinical study in pancreatic cancer, AION-01, in the first half of 2022.

The poster presentation at SITC (Free SITC Whitepaper) entitled "A novel autotaxin inhibitor, IOA-289, modulates tumor, immune and stromal cell function and has monotherapy activity in fibrotic cancer models," is available at the SITC (Free SITC Whitepaper) platform and iOnctura’s website.

Contacts

iOnctura
Catherine Pickering
Chief Executive Officer
T : +41 79 952 72 52
E: [email protected]

Press Relations
Jeremy Nieckowski
LifeSci Advisors
T: +41 79 699 97 27
E: [email protected]
iOnctura SA is clinical stage oncology company targeting core resistance and relapse mechanisms at the tumor-stroma-immune interface. iOnctura’s best-in-class drug development programs combine immune-mediated and direct anti-tumor activity to deliver molecules with superior clinical efficacy and safety in oncology. Its lead program, IOA-244 is the only semi-allosteric PI3Kδ specific, orally dosed, small molecule inhibitor that is being developed in solid and hematologic malignancies to address tumor and stroma induced immune suppression. IOA-244 is currently in a Phase 1 study which will support transition to subsequent registration studies. iOnctura’s second program, IOA-289, is an oral small molecule that inhibits the cross-talk between the tumor and its stroma and is in a Phase 1 study. iOnctura is backed by blue chip investors including M Ventures, Inkef Capital, VI Partners, Schroders Capital, and 3B Future Health Fund. For more information, please visit www.ionctura.com

IOA-289, originally licensed from Cancer Research UK, is iOnctura’s second clinical compound, a next generation oral small molecule autotaxin inhibitor. iOnctura have completed recruitment in a single ascending dose study of IOA-289 in healthy volunteers and plans to advance IOA-289 into a phase 1 clinical study in pancreatic cancer, AION-01, in the first half of 2022. iOnctura has undertaken extensive validation of the autotaxin inhibition mechanism in multiple preclinical solid tumor models.

On November 12. 2021 Thyas reported that it has raised JPY 300 million in Series A3 financing with participation from Kyoto University Innovation Capital Co., Ltd., and D3 LLC (Press release, Thyas , NOV 12, 2021, View Source [SID1234629207]).

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The funds will be used for accelerating the research and development including preclinical studies of iPS cell-derived immune cell therapy and discovery research of new pipelines for the treatment of solid cancers and infectious diseases. In addition to R&D, Thyas further strives for business development and aims to deliver the early clinical applications to patients as soon as possible.