Phase I clinical study of Huihe Biotech’s triple antibody CC312 completed the administration of the first patient

On August 7, 2023, Huihe Biotechnology (CytoCares) reported that the company conducted CC312 at the Hematology Hospital of the Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences) for the treatment of relapsed/refractory patients The Phase I first-in-human trial in adult patients with CD19-positive B-cell malignant hematological tumors has completed the enrollment and administration of the first patient (Press release, CytoCares, AUG 7, 2023, View Source [SID1234635269]). Judging from the current clinical safety testing data of the first patient, the first patient tolerated it well and did not take the drug. Related adverse events occurred. The hospital and the sponsor will strictly follow the plan to conduct DLT observation and safety assessment. The main purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of CC312, and to determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of CC312. As a globally innovative clinical project, its safety research is crucial to the drugability of the CC312 project.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

CC312 is the first drug for clinical use developed on the first T cell activation platform independently developed by Huihe Biotech. It is a triple drug that targets B cell surface antigen CD19, T cell antigen CD3 and T cell costimulatory molecule CD28. Specific T cell adapter (TriTE ). CC312 can form a bridge between tumor cells (B cells) and T cells, and coordinately regulates T cells by activating the CD3 signaling pathway of T cells and the costimulatory signal CD28 pathway, inducing long-lasting and sustained T cell activation, making T cells Kill tumor cells more effectively.

Preclinical studies have shown that CC312 exhibits significant anti-tumor activity in tumor cell lines expressing CD19 antigen, and is expected to provide better treatment options for patients with CD19+ refractory/relapsed B-cell malignancies. In addition, preclinical safety data indicate that CC312 is well tolerated in Hu-HSC mice and cynomolgus monkeys, and no administration-related toxicological abnormalities were observed in histopathological studies.

Mr. Huang Yingfeng, CEO of Huihe Biotech , said: "The current treatment of B-cell malignant hematological tumors cannot fully meet clinical needs, and there is an urgent need to research new treatment methods. We are very pleased to have completed the enrollment of the first patient with CC312, which is consistent with expectations. The patient’s medication process went smoothly and post-administration observation is ongoing. We will continue to rapidly advance the clinical research of CC312 and look forward to bringing safer and more effective treatment options to patients as soon as possible."

Capital raised

On August 7, 2023 Hubro Therapeutics reported that NOK 41,1 mill has been raised in a private placement (Press release, Hubro Therapeutics, AUG 7, 2023, View Source [SID1234635192]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The funds will be used to continue the company’s development of lead candidate vaccine FMPV-1, adjuvant GM-CSF and companion diagnostics, as well as preparing for initiation of the phase 2 study with FMPV-1/GM-CSF in MSI-colorectal cancer.

Consolidated Financial Results for the First Three Months of the Fiscal Year Ending March 31, 2024

On August 7, 2023 JSR reported its Consolidated Financial Results for the First Three Months of the Fiscal Year Ending March 31, 2024 (Presentation, JSR, AUG 7, 2023, View Source [SID1234634972]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


Compugen Reports Second Quarter 2023 Results

On August 7, 2023 Compugen Ltd., a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported its financial results for the second quarter ended June 30, 2023 and provided a corporate update on key events since the start of 2023 (Press release, Compugen, AUG 7, 2023, View Source [SID1234634869]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In the first half of the year, we continued to execute on our goals," said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. "Patient enrollment is advancing in our two proof-of-concept studies with our unique triple immunotherapy combination approach and initial findings are expected by the end of the year. We presented new clinical data in metastatic endometrial cancer at ASCO (Free ASCO Whitepaper) in June showing durable responses, including in a patient failing immunotherapy which is consistent with data we previously presented in other hard to treat tumors. The totality of our data to date, suggest that our COM701 based combinations have the potential to offer a treatment option with a favorable safety profile for hard-to-treat patients, across the spectrum of PD-L1 expression levels, including in patients who are anti-PD-1 refractory, pointing to a potential COM701 mediated mechanism of action."

Dr. Cohen-Dayag added, "Our immediate focus is on expanding our data in two indications, platinum resistant ovarian cancer and microsatellite stable colorectal cancer, while continuing to invest in biomarker discovery, which is important to efficiently set our development path forward. We believe that the therapeutic potential of COM701 and COM902 as part of the DNAM-1 axis may be much broader than these two indications."

Dr. Cohen-Dayag concluded, "In the second half of the year we are planning to present new and follow up data with our COM701 combinations including in ovarian and breast cancer as well as additional data on our COM503 lead pre-clinical program. Additionally, we are delighted to see the continued advancement in the development of rilvegostomig derived from COM902 by our partner AstraZeneca."

Corporate Update:


March 2023: First patient dosed in microsatellite stable colorectal cancer study; enrollment is on track to complete by year end.

CIMT May 2023: Presentation of data on lead pre-clinical asset COM503, an anti- IL-18BP antibody, designed to induce a potent anti-tumor response and pronounced localized tumor microenvironment immune modulation by unleashing natural IL-18 activity in the tumor and potentially overcoming the challenges of administering a cytokine therapeutic.

June 2023: First patient dosed in platinum resistant ovarian cancer study. Enrollment to date is slower than anticipated, however we believe that we can catch up on enrollment with the planned activation of additional sites.

June 2023: Win at the European Patent Office (EPO), which ruled to uphold the Company’s broad PVRIG patent for the treatment of cancer reflecting the strength of Compugen’s patent strategy in novel target discovery. The EPO ruling is subject to appeal.

ASCO June 2023: Presentation of data from triple immunotherapy combination (COM701+ nivolumab + BMS anti-TIGIT) in microsatellite stable endometrial cancer study showing durable partial responses in patients who failed standard of care, including pembrolizumab and lenvatinib.

ASCO June 2023: Presentation of clinical data by partner AstraZeneca on rilvegostomig, a PD-1/TIGIT bispecific derived from COM902, establishing its safety and pharmacokinetic profile and showing anti-tumor activity in checkpoint inhibitor experienced NSCLC patients who typically do not respond to immunotherapy.

Next Planned Milestones in H2 2023:

Report initial findings from ongoing triple combination (COM701+COM902+ pembrolizumab) proof-of-concept studies in microsatellite stable colorectal and platinum resistant ovarian cancer by end of the year.

Presentation of new translational data and initial biomarker data from platinum resistant ovarian cancer studies evaluating COM701 + nivolumab ± BMS anti-TIGIT.

Presentation of longer-term patient follow up from platinum resistant ovarian cancer study evaluating COM701 + nivolumab + BMS anti-TIGIT.

Presentation of new data from the metastatic breast cancer cohort expansion study of patients treated with COM701 and nivolumab.

Presentation of data from COM503 lead pre-clinical program.

Rilvegostomig (PD-1/TIGIT bispecific derived from COM902): AstraZeneca continues to advance the development of rilvegostomig in multiple trials, including a Phase 2 trial in checkpoint inhibitor naïve NSCLC and a Phase 2 trial in hepatobiliary cancer. AstraZeneca disclosed plans to initiate a Phase 3 trial with rilvegostomig this year.

Financial Results
As of June 30, 2023, cash, cash equivalents and cash investments were approximately $66.5 million, compared with approximately $83.7 million as of December 31, 2022. The Company expects its existing cash and cash related balances to be sufficient to fund its operating plan into at least the end of 2024, based on current plans. During the three months ended June 30, 2023, the Company sold approximately 1.6 million ordinary shares under its "at-the-market offering" (ATM) facility pursuant to a sales agreement entered with Leerink Partners on January 31, 2023, for aggregate gross proceeds of approximately $1.6 million.

Compugen has no debt.

R&D expenses for the second quarter ended June 30, 2023, were approximately $7.8 million, up from $6.8 million for the comparable period in 2022. The increase is mainly due to end of the amortization of the deferred participation in R&D expenses following the termination of the agreement with Bristol Myers Squibb in the third quarter of 2022, and an increase in preclinical and CMC activities associated with COM503, offset by a decrease in clinical trial expenses, headcount and currency exchange effect.

General and administrative expenses for the second quarter ended June 30, 2023, were approximately $2.4 million down from approximately $2.6 million for the comparable period in 2022.

Net loss for the second quarter ended June 30, 2023, was approximately $9.3 million, or $0.11 per basic and diluted share, compared with a net loss of approximately $9.1 million, or $0.11 per basic and diluted share, for the comparable period in 2022.

Biodesix Announces Second Quarter 2023 Results and Highlights

On August 7, 2023 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported its financial and operating results for the second quarter ended June 30, 2023 and provided a corporate update (Press release, Biodesix, AUG 7, 2023, View Source [SID1234634051]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"I am very pleased to announce another record-setting quarter from our core lung diagnostics," said Scott Hutton, President and Chief Executive Officer. "In addition to continued sales growth, we had a number of important publications this past quarter that highlighted the benefits to patient care of our lung diagnostic tests in a real-world, clinical setting. We are also happy to announce the successful completion of a private placement that included some of our largest shareholders and management. All board members, all Section 16 officers, and additional members of the Biodesix leadership team participated in the round raising $27.5 million in equity funding to further support our growth. We also maintained strong cost discipline, with sustainable and improving gross margins to 73% from 65%, and reducing our Operating Expense excluding direct costs and expenses by $2.7 million, all versus first quarter 2023. We continue to focus on projects and initiatives that drive near term-revenue growth, while reducing expenses and cash burn. Overall, the progress and positive trends in our core lung diagnostics tests in the first half of the year solidifies our confidence in reaffirming our 2023 revenue guidance and making progress on our path to profitability."

Business Highlights
Biodesix continues to publish new data supporting the value and utility of their lung diagnostics portfolio. The Company was pleased to announce the following accomplishments:

Published the achievement of the primary endpoint of the prospective ORACLE clinical utility study, demonstrating that use of the Nodify XL2 test resulted in a 74% decrease in unnecessary invasive procedures on patients with benign lung nodules compared to the control group;
Researchers from Beth Israel Deaconess, Tulane University, and Einstein Medical Center published an independent, multi-center study demonstrating that use of the Nodify XL2 test resulted in a 73% reduction in the number of invasive procedures compared to the control arm;
Presented new health economics data on the Nodify XL2, Nodify CDT, and VeriStrat tests at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the International Society for Pharmaceutical and Outcomes Research (ISPOR). These data indicate savings to the US healthcare system with use of the tests;
Completed enrollment of 5,000 patients with non-small cell lung cancer (NSCLC) in the large multi-center observational registry study INSIGHT. The study was designed to further validate the utility of the VeriStrat test;
Announced that CMS has designated the Nodify CDT Test as an Advanced Diagnostic Laboratory Test (ADLT) effective June 30, 2023. ADLT status is reserved for innovative tests with Medicare coverage that provide new clinical diagnostic information that cannot be obtained from any other test or combination of tests.
Second Quarter 2023 Financial Results
For the three-month period ended June 30, 2023, as compared to the same period of 2022 (where applicable):

Total revenue of $11.9 million, an increase of 8% including COVID testing revenue in second quarter 2022, driven primarily by strong year-over-year growth in core lung diagnostics, and a 48% year-over-year increase excluding COVID testing revenues from the prior year comparison.
Core lung diagnostic revenue of $11.4 million reflected a year-over-year increase of 58% driven primarily by the continued adoption of Nodify Lung nodule management tests;
BioPharma Services revenue of $0.4 million decreased 43% year-over-year. Timelines for existing and new agreements continue to be impacted by delayed enrollment in clinical trials; entered the third quarter of 2023 with continued strong dollars under contract;
COVID-19 testing revenue decreased by 100% year-over-year, the Company no longer provides COVID-19 diagnostic testing services commercially;
Second quarter 2023 gross profit of $8.6 million, or 73% gross margin as compared to 64% gross margin in the comparable prior year period primarily driven by growth in Lung Diagnostic Testing and optimization of testing workflows that resulted in improvements in costs per test, and the commercial discontinuation of our lower-margin COVID-19 diagnostic testing;
Operating expenses (excluding direct costs and expenses) of $19.6 million, an increase of approximately $1.0 million, or 5% as compared to the second quarter 2022 (includes non-cash stock compensation expense of $1.1 million as compared to $1.4 million). This increase is primarily attributable to increased sales and marketing costs to support core lung diagnostic sales growth including increased travel-related costs and marketing programs to enhance product awareness as we actively participate in an increasing number of peer-to-peer physician educational events;
Net loss of $13.4 million, a decrease of approximately $2.5 million, or 16%;
Cash and cash equivalents of $17.4 million as of June 30, 2023, a decrease of $7.9 million from March 31, 2023. This represented an improvement of approximately 56% in cash utilization versus the cash utilized in the first quarter 2023;
Scheduled milestone payment of $2.3 million paid in April 2023 to Integrated Diagnostics;
Subsequent to quarter end, raised $27.5 million in gross equity proceeds from a private placement to be used for commercial expansion of sales, research and development, and for general corporate purposes.
2023 Financial Outlook

The Company reaffirms our 2023 financial outlook and expects to generate between $52 million and $55 million in total revenue in 2023.

Conference call and webcast information

Listeners can register for the webcast via this link. Analysts wishing to participate in the question-and-answer session should use this link. A replay of the webcast will be available via the Company’s investor website approximately two hours after the call’s conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time.

For a full list of Biodesix’s press releases and webinars, please visit biodesix.com.