On March 15, 2023 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) (Paris:OSE) reported it will be presenting five posters at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, OSE Immunotherapeutics, MAR 15, 2023, View Source [SID1234628856]). AACR (Free AACR Whitepaper) will be held in person in Orlando (Florida) on April 14-19.

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Four communications will feature the latest research on pre-IND programs for the pioneering Myeloid and BiCKI platforms, namely presentations on CLEC-1 (new myeloid immune checkpoint) and BiCKI-IL7 (new bifunctional therapy targeting PD-1 and IL-7), and OSE-127 (anti-IL-7 receptor antagonist) hematology program. A fifth communication will feature biomarker analyses on BI 765063 (anti-SIRPα monoclonal antibody on CD47/SIRPα pathway) from the ongoing Phase 1 clinical trial in advanced solid tumors.

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: "We are very pleased to have several poster presentations at the prestigious AACR (Free AACR Whitepaper) annual meeting. This selection by the international scientific community underlines the recognition and the interest in the quality of our R&D engines with preclinical and clinical innovative research programs. It further highlights our long-term commitment to fight against debilitating cancer and chronic diseases through the development of first-in-class innovative immunotherapies."

Poster presentation details:

Poster CLEC#1*

Title: ""CLEC-1 inhibitory myeloid checkpoint blockade enhances antitumor responses and tumor phagocytosis by macrophages""
Session Category: Immunology
Session Title: Immune Checkpoints
Session Date and Time: April 19, 2023 – 9:00 AM – 12:30 PM
Location: Section 23
Poster Board Number: 2

Poster CLEC#2*

Title: "TRIM21 is a novel endogenous partner of the inhibitory myeloid checkpoint CLEC-1 involved in tumor antigen cross-presentation"
Session Category: Immunology
Session Title: Immune Checkpoints
Session Date and Time: April 19, 2023 – 9:00 AM – 12:30 PM
Location: Poster Section 23
Poster Board Number: 9

Poster BiCKI-IL-7

Title: "Anti-PD-1/IL-7v bispecific antibody promotes TCF1+ stem like CD8 T cells expansion and long-lasting in vivo efficacy"
Session Category: Immunology
Session Title: Therapeutic Antibodies 3
Session Date and Time: April 17, 2023 – 1:30 PM – 5:00 PM
Location: Poster Section 24
Poster Board Number: 2

Poster OSE-127

Title: "CD127 is expressed by acute lymphoblastic leukemias and is efficiently targeted by the IL7R-antagonist OSE-127 through macrophage-mediated antibody dependent phagocytosis"
Session Category: Immunology
Session Title: Therapeutic Antibodies 3
Session Date and Time: April 17, 2023 – 1:30 PM – 5:00 PM
Location: Poster Section 24
Poster Board Number: 4

In parallel, OSE-127 is currently being developed in clinical stage in partnership with Servier. Two clinical studies are ongoing in inflammatory diseases: a phase 2a study conducted in primary Sjögren’s syndrome by Servier, for which completion of patient enrollment has been announced in November 2022, and a Phase 2 study conducted in ulcerative colitis by OSE Immunotherapeutics.

Poster BI 765063

Title: "Predictive response biomarkers from Phase I clinical trial of a SIRPalpha inhibitor BI765063, stand-alone and in combination with ezabenlimab, a PD1 inhibitor, in patients with advanced solid tumors"
Session Category: Clinical Research Excluding Trials
Session Title: Biomarkers of Therapeutic Benefit 2
Date & Time: April 17, 2023 – 9:00 AM – 12:30 PM
Location: Poster Section 39, Poster Board 3
Poster Number: 2129

BI 765063 is being evaluated in combination with Ezabenlimab in a Phase 1 expansion clinical trial in patients with microsatellite stable (MSS) advanced colorectal cancer and MSS advanced endometrium cancer whose disease relapsed after standard of care and who received no prior anti-PD-L1 inhibitors.

This Phase 1 clinical trial with BI 765063 is conducted by OSE Immunotherapeutics as part of a collaboration and license agreement under which Boehringer Ingelheim obtained exclusive rights to BI 765063.

* Collaborative academic program between OSE Immunotherapeutics and Dr Elise Chiffoleau’s research teams (Center for Research in Transplantation and Translational Immunology (CR2TI), UMR1064, INSERM, Nantes University at Nantes University Hospital, View Source).

On March 15, 2023 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, reported financial results and operational highlights for the fourth quarter and year ended December 31, 2022 (Press release, Adicet Bio, MAR 15, 2023, View Source [SID1234628855]).

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"In 2022, Adicet demonstrated strong execution in advancing our gamma delta T cell therapy pipeline and clinical proof of concept for our therapeutic approach that may provide significant benefit for people living with cancer. Following the Phase 1 clinical update in December evaluating ADI-001 for relapsed or refractory non-Hodgkin’s lymphoma, we are continuing to track and enroll patients in the study and expect to report additional efficacy, durability, and safety data in the second quarter of 2023. We plan to discuss the design of our first potential pivotal study with the FDA in the second quarter of this year and initiate the pivotal portion of the study in the second half of the year, potentially in the third quarter," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "In addition, we plan to build on the preclinical data presented at ISCT, SITC (Free SITC Whitepaper) and our R&D event, to expand our pipeline of first-in-class allogeneic, off-the-shelf gamma delta CAR T-cell product candidates, and in the second half of 2023, expect to submit an IND for ADI-925, our novel CAd gamma delta T cell product candidate."

Fourth Quarter 2022 and Recent Operational Highlights:

Announced Safety & Efficacy Data from Ongoing Phase 1 Study of ADI-001. In December 2022, Adicet reported interim safety and efficacy data from its ongoing Phase 1 study of ADI-001, Adicet’s investigational therapy targeting CD20 for the potential treatment of relapsed or refractory B-cell NHL. As of a December 5, 2022 data-cut date, treatment with ADI-001 demonstrated a 75% overall response rate (ORR) and a 69% complete response (CR) across all dose levels with a favorable safety and tolerability profile. Additionally, in 5/5 large B-cell lymphoma (LBCL) patients that previously relapsed after prior autologous anti CD-19 CAR T-cell therapy, treatment with ADI-001 demonstrated a 100% ORR and CR rate. Enrollment in the trial is currently ongoing to provide additional durability data and further support the recommended Phase 2 dose. In the second quarter of 2023, Adicet plans to discuss the design of its first potential pivotal clinical study evaluating ADI-001 in post CAR T LBCL patients with the U.S. Food and Drug Administration (FDA), and initiate the study in the second half of the year, potentially in the third quarter.
Presented Preclinical Data for Four New Pipeline Programs at SITC (Free SITC Whitepaper) Annual Meeting. In November 2022 at SITC (Free SITC Whitepaper), Adicet presented four posters highlighting preclinical data for four differentiated CAR and CAd gamma delta T cell programs targeting several hematologic and solid malignancies.
Hosted R&D Pipeline Event Highlighting Preclinical Candidates. In November 2022, Adicet hosted an R&D event to provide additional detail regarding its emerging pipeline of allogeneic CAR and CAd gamma delta T cell therapy product candidates for a variety of cancer indications, including solid tumors. Adicet expects to submit an Investigational New Drug Application (IND) to the FDA for its lead preclinical candidate, ADI-925, in the second half of 2023.
Appointed Nancy Boman, M.D., Ph.D., as Senior Vice President and Chief Regulatory Officer of Adicet. In November 2022, Adicet announced the appointment of Dr. Nancy Boman, M.D., Ph.D., as Senior Vice President and Chief Regulatory Officer. Dr. Boman brings nearly 30 years of industry experience in the biotech and pharmaceutical industry with expertise in regulatory, clinical development, chemistry, manufacturing and quality, leading more than 15 drug marketing applications.
In-House Manufacturing Capacity Established in Redwood City Facility. In the fourth quarter of 2022, Adicet’s new in-house manufacturing capabilities in its Redwood City facility became operational. The facility is designed to enable drug product and vector manufacturing operations for early clinical development of Adicet’s pipeline candidates.
Financial Results for Fourth Quarter and Full Year 2022:

Three months Ended December 31, 2022

Research and Development (R&D) Expenses: R&D expenses were $25.0 million for the three months ended December 31, 2022, compared to $14.7 million during the same period in 2021. The $10.3 million increase is primarily driven by a $3.4 million increase in payroll and personnel expenses, a net increase of $2.8 million for expenses related to contract manufacturing drug organizations (CDMO), contract research organizations (CRO) and consultant costs related to our lead product candidate ADI-001, and a $2.7 million increase in facility allocation. There was also a $1.0 million increase in lab expenses. Payroll and personnel expenses for the three months ended December 31, 2022, includes $1.9 million of non-cash stock-based compensation expense compared to $1.6 million during the same period in 2021.
General and Administrative (G&A) Expenses: G&A expenses were $6.6 million for the three months ended December 31, 2022, compared to $6.4 million during the same period in 2021. The $0.2 million increase is primarily driven by an increase of $0.5 million of professional fees as well as a $0.2 million increase of payroll and personnel expenses. This increase was partially offset by a decrease of $0.1 million in recruiting fees. Payroll and personnel expenses for the three months ended December 31, 2022, includes $2.4 million of non-cash stock-based compensation expense compared to $2.7 million during the same period in 2021.
Net Loss: Net loss for the three months ended December 31, 2022 was $29.9 million, or a net loss of $0.72 per basic and diluted share, including non-cash stock-based compensation expense of $4.3 million, as compared to a net loss of $15.8 million during the same period in 2021, or a net loss of $0.47 per basic and diluted share, including non-cash stock-based compensation expense of $4.3 million.
Twelve Months Ended December 31, 2022

Research and Development (R&D) Expenses: R&D expenses were $71.2 million for the year ended December 31, 2022, as compared to $48.9 million for year ended December 31, 2021. The increase of $22.3 million in R&D expenses year-over-year was primarily due to a $9.9 million increase in payroll and personnel expenses resulting from an increase in overall headcount, a net $4.4 million increase in expenses related to CDMOs, CROs and consultant costs related to our lead product candidate ADI-001, a $4.2 million increase in facility and other expenses and a $2.3 million increase in lab expenses. The increases in facilities and lab expense are primarily due to the move to new facilities in Redwood City and setup activities.
General and Administrative (G&A) Expenses: G&A expenses were $26.3 million for the year ended December 31, 2022, compared to $22.2 million for the year ended December 31, 2021. The increase of $4.1 million was primarily due to a $4.8 million increase in payroll and personnel expenses, which includes an increase in stock-based compensation of $2.1 million, salaries and benefits of $2.0 million and contractor fees of $0.5 million and an increase in professional fees of $0.4 million. These increases were primarily due to increased headcount for the period. These increases were partially offset by a net $1.2 million decrease in facilities and other related expense.
Net Loss: Net loss for the year ended December 31, 2022 was $69.8 million, or a net loss of $1.70 per basic and diluted share, including non-cash stock-based compensation expense of $17.1 million, as compared to a net loss of $62.0 million during the same period in 2021, or a net loss of $2.00 per basic and diluted share, including non-cash stock-based compensation expense of $12.5 million.
Cash Position: Cash and cash equivalents were $257.7 million as of December 31, 2022 as compared to $277.5 million as of December 31, 2021. During fiscal year 2022, the Company received $43.4 million of net proceeds from the sale of common stock through an "at-the-market" offering and $20 million from the exercise of an option by Regeneron related to ADI-002. The Company expects that current cash and cash equivalents securities as of December 31, 2022 will be sufficient to fund its operating expenses into the first half of 2025.

On March 15, 2023 Scholar Rock (NASDAQ: SRRK; "The Company"), a Phase 3, clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported that the company granted inducement equity awards covering an aggregate of 26,250 shares of its common stock to 1 newly hired employee, consisting of inducement stock options to purchase an aggregate of 15,000 shares of common stock and inducement restricted stock units, ("RSUs"), covering an aggregate of 11,250 shares of its common stock (Press release, Scholar Rock, MAR 15, 2023, View Source [SID1234628854]).

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The awards are subject to all terms and conditions and other provisions set forth in the Company’s 2022 Inducement Equity Plan ("The Plan") and form of stock option agreement thereunder.

The Plan, which was adopted by the Company’s board of directors on June 16, 2022, is used exclusively for the grant of equity awards to individuals who were not previously employees of Scholar Rock, or following a bona fide period of non-employment, as an inducement material to such individuals entering into employment with Scholar Rock, pursuant to Nasdaq Listing Rule 5635(c)(4).

The options have an exercise price of $9.52, which is equal to the closing price of Scholar Rock’s common stock on March 13, 2023. The stock option award will vest with respect to 25% of the shares of common stock underlying the award on the first anniversary of the employee’s start date, and the remaining 75% of the shares of common stock underlying the Stock Option Award will vest in 12 equal quarterly installments thereafter. Vesting for RSUs will be in four equal annual installments. All vesting related to inducement awards is subject to the employee’s continuing service at the Company through the applicable vesting date.

On March 15, 2023 OncoNano Medicine, Inc. reported three poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, taking place April 14-19, 2023 at the Orange County Convention Center, Orlando, Florida (Press release, OncoNano Medicine, MAR 15, 2023, View Source [SID1234628853]).

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Presentation Overview:

TITLE:

Improved tolerability and tumor specific delivery of a therapeutic bispecific T cell engager using a pH-sensitive nanoparticle platform

PRESENTER:

Qingtai Su, Ph.D.

DATE:

April 16, 2023

TIME:

1:30 – 5:00 PM ET

SECTION and PRESENTATION NUMBER:

Poster Section 30, No. 815

TITLE:

Encapsulation of IL-12 with an ultra pH-sensitive nanoparticle platform improves tolerability and promotes antitumor response in mice

PRESENTER:

Tian Zhao, Ph.D.

DATE:

April 16, 2023

TIME:

1:30 – 5:00 PM ET

SECTION and PRESENTATION NUMBER:

Poster Section 34, No. LB001

TITLE:

ONM-501, a dual-activating polyvalent STING agonist, enhances tumor retention and demonstrates favorable preclinical safety profile

PRESENTER:

Zirong Chen, Ph.D.

DATE:

April 18, 2023

TIME:

1:30 – 5:00 PM ET

SECTION and PRESENTATION NUMBER:

Poster Section 34, No. LB245

On March 15, 2023 Boundless Bio, a next-generation precision oncology company developing innovative therapeutics directed against extrachromosomal DNA (ecDNA) in oncogene amplified cancers, reported plans to present at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, held in Orlando and virtually from April 14-19, 2023 (Press release, Boundless Bio, MAR 15, 2023, View Source [SID1234628852]). The in-person poster presentation reveals a synthetic lethal relationship between ecDNA bearing tumors and checkpoint kinase 1 (CHK1) inhibition, providing a potential therapeutic strategy for addressing ecDNA-enabled oncogene amplified cancers.

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Presentation details:

Poster Title: Tumors driven by oncogene amplified extrachromosomal DNA (ecDNA) demonstrate enhanced sensitivity to cell cycle checkpoint kinase 1 (CHK1) inhibition
Session Category: Experimental and Molecular Therapeutics
Session Title: Novel Antitumor Agents 3
Abstract Presentation Number: 1626
Date and Time: April 17, 2023, 9:00 a.m. – 12:30 p.m. ET
Location: Section 17

About ecDNA

Extrachromosomal DNA ("ecDNA") are circular units of nuclear DNA that are physically distinct from chromosomes and are found within cancer cells. ecDNA encode full length genes, including oncogenes and regulatory regions, are highly transcriptionally active, and lack centromeres. ecDNA replicate and express within cancer cells and, due to their lack of centromeres, can be asymmetrically passed to daughter cells during cell division, leading to focal gene amplification and copy number heterogeneity in cancer. By leveraging the plasticity afforded by ecDNA, cancer cells have the ability to increase or decrease copy number of select oncogenes located on ecDNA to enable survival under selective pressures, including targeted therapy, immunotherapy, chemotherapy, or radiation, thereby making ecDNA one of cancer cells’ primary mechanisms of growth, recurrence, and treatment resistance. ecDNA are not found in healthy cells but are present in many solid tumor cancers. They are a key driver of the most aggressive and difficult-to-treat cancers, specifically those characterized by high copy number amplification of oncogenes.