On May 17, 2023 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, reported seven accepted abstracts at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held June 2-6, 2023 (Press release, Arcus Biosciences, MAY 17, 2023, View Source [SID1234631829]). The selected abstracts presented in partnership with Gilead Sciences highlight the company’s expanding portfolio of investigational medicines and late-stage studies across multiple types of cancer, including lung, upper GI and kidney cancer.

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"The Arcus and Gilead abstracts that will be presented in June highlight the size and breadth of our portfolio and development program and include four of our investigational medicines being studied across multiple types of cancer," said Terry Rosen, Ph.D., Chief Executive Officer of Arcus. "The update from the ARC-7 study will include an analysis of all 150 efficacy-evaluable participants. The TIPs highlight our broad, late-stage domvanalimab program in lung and upper GI cancer, and our newest molecule, AB521, being studied in kidney cancer and other solid tumors."

Seven Accepted Abstracts Will Be Presented

Study

Title

Abstract Number

Session Type & Title

Session Date & Time

domvanalimab (Fc-silent anti-TIGIT monoclonal antibody)

ARC-7

ARC-7: Randomized phase 2 study of domvanalimab + zimberelimab ± etrumadenant versus zimberelimab in first-line, metastatic, PD-L1-high non-small cell lung cancer (NSCLC)

397600

Primary Track: Special Sessions

June 3, 2023, session start time: 12:30 PM CT

VELOCITY-Lung Sub Study-01 TIP

VELOCITY-Lung: A Phase (Ph) 2 study evaluating safety and efficacy of domvanalimab (dom) + zimberelimab (zim) + sacituzumab govitecan (SG), or etrumadenant (etruma) + dom + zim, or etruma + zim in patients (pts) with treatment-naïve metastatic non-small cell lung cancer (mNSCLC).

TPS9155

Poster Session – Lung Cancer—Non-Small Cell Metastatic

6/4/2023, 8:00 AM-11:00 AM CT

ARC-10 TIP

ARC-10: A Phase 3 study to evaluate zimberelimab + domvanalimab versus pembrolizumab in front-line, PD-L1-high, locally advanced or metastatic non–small-cell lung cancer.

TPS9148

Poster Session – Lung Cancer—Non-Small Cell Metastatic

6/4/2023, 8:00 AM-11:00 AM CT

PACIFIC-8 TIP

Phase 3 trial of durvalumab combined with domvanalimab following concurrent chemoradiotherapy (cCRT) in patients with unresectable stage III NSCLC (PACIFIC-8).

TPS8609

Poster Session – Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

6/4/2023, 8:00 AM-11:00 AM CT

STAR-121 TIP

STAR-121: a Phase 3, randomized study of domvanalimab (DOM) and zimberelimab (ZIM) in combination with chemotherapy vs pembrolizumab (pembro) and chemotherapy in patients with untreated metastatic non-small cell lung cancer (mNSCLC) with no actionable gene alterations

TPS9141

Poster Session – Lung Cancer—Non-Small Cell Metastatic

6/4/2023, 8:00 AM-11:00 AM CT

STAR-221 TIP

STAR-221: A randomized, open-label, multicenter, Phase 3 trial of domvanalimab, zimberelimab, and chemotherapy versus nivolumab and chemotherapy in previously untreated, locally advanced, unresectable or metastatic gastric, gastroesophageal junction, and esophageal adenocarcinoma.

TPS4206

Poster Session – Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

6/5/2023, 8:00 AM-11:00 AM CT

AB521 (HIF-2a small molecule inhibitor)

ARC-20 TIP

ARC-20: A phase 1 dose-escalation and dose-expansion study to investigate the safety, tolerability, and pharmacology of HIF-2α inhibitor AB521 monotherapy in patients with clear cell renal cell carcinoma and other solid tumors.

TPS4602

Poster Session – Genitourinary Cancer—Kidney and Bladder

6/3/2023, 8:00 AM-11:00 AM CT

On May 17, 2023 Kelonia Therapeutics, a biotech company revolutionizing in vivo gene delivery, reported the results of preclinical research demonstrating that its in vivo Gene Placement System (iGPS) technology efficiently delivered CAR molecules specifically to T cells at therapeutic dose levels in both mice and non-human primates (NHPs) (Press release, Kelonia Therapeutics, MAY 17, 2023, View Source [SID1234631828]). Kelonia’s iGPS platform enables CAR T cell therapy without the need for lymphodepleting chemotherapy or time-consuming ex vivo manufacturing. These data demonstrate the potential for iGPS particles to be a highly effective, safe, "off-the-shelf" therapy for patients with multiple myeloma, which Kelonia is pursuing as its lead indication. Kelonia shared the data for the first time during an oral presentation at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 26th Annual Meeting in Los Angeles.

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"In just over a year since launching, the extraordinary Kelonia team has shown the potential of our iGPS technology to provide precise, efficient, and safe CAR gene delivery directly to multiple myeloma patients intravenously and as an off-the-shelf therapy that doesn’t require preparative chemotherapy for potent CAR T cell activity," said Kevin Friedman, Ph.D., Founder, President, and Chief Scientific Officer, Kelonia Therapeutics. "Cancer patients are waiting for an incredibly effective medicine without the severe toxicities or complicated manufacturing that have limited the accessibility and impact of existing CAR T cell therapies. Today, we’ve shown compelling preclinical evidence that achieving this transformative treatment for multiple myeloma is possible with Kelonia’s iGPS technology, and we look forward to sharing additional information as we progress towards the clinic."

Highlights from the oral presentation (Abstract 90):

Intravenous infusion of NHPs with surrogate iGPS particles expressing an anti-CD20 CAR in the absence of preparative chemotherapy resulted in potent CAR T cell activity across a 10x dose range. No clinical or biomarker evidence of toxicities, including cytokine release syndrome or neurotoxicities, was observed even at the highest dose level.
Potent anti-tumor activity was observed with iGPS particles that expressed an anti-BCMA CAR in mouse models of multiple myeloma. CAR T cells generated in vivo with iGPS particles exhibited prolonged functional persistence and tumor control compared to standard, ex vivo CAR T cells.
In both mice and NHPs, therapeutic dose levels of iGPS particles specifically transduced T cells and showed no evidence of unexpected "off-target" transduction, including progenitor cells or in vital and reproductive organs.

On May 17, 2023 Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT) (the "Company," or "Shuttle Pharmaceuticals"), reported that its Chief Executive Officer, Anatoly Dritschilo, M.D., will be participating in a Webcast and Panel Presentation at the Lytham Partners Spring 2023 Investor Conference (the "Conference") on Thursday, May 18, 2023 (Press release, Shuttle Pharmaceuticals, MAY 17, 2023, View Source [SID1234631827]). Management will also be conducting one-on-one meetings with investors.

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Company Webcast

The Company’s webcast presentation will be available for viewing at 9:00 am ET on Thursday, May 18, 2023, on the Company’s website at View Source or View Source The webcast will also be archived and available for replay.

Panel Presentation

Additionally, Dr. Dritschilo will be participating in a panel titled, "Advancements in the Fight Against Cancer." This panel, also to be conducted virtually, will be held on Thursday, May 18, 2023, at 11:00 am ET. To access the panel, please visit: View Source

1×1 Meetings

Management will be participating in virtual one-on-one meetings throughout the Conference. To arrange a meeting with management, please contact Lytham Partners at 1×[email protected] or register at View Source

On May 17, 2023 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a Cayman Islands incorporated biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported its financial results for the three months ended March 31, 2023 (Press release, CASI Pharmaceuticals, MAY 17, 2023, View Source [SID1234631826]).

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Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "Revenue for EVOMELA was $8.3 million in the first quarter of 2023, down 8% from the same period in 2022. This decline is primarily due to the enhanced impact of the COVID-19 restrictions in major cities in China since fourth quarter 2022. We are also facing competition from a generic melphalan for injection product with lower cost and undifferentiated formulation in China market. CASI’s commercial and medical marketing team has implemented a strategy to defend our market leadership position. CASI has a strong foundation for our commercial franchise in the oncology malignant hematology therapeutic area. We will continue to grow our commercial franchise throughout 2023 and beyond."

Dr. He continued, "Advancement, development, and commercialization of the portfolio remains our strategic focus. We have achieved a major milestone with our partner Juventas Biotechnology (Tianjin) ("Juventas") on the CNCT-19 CART cell therapy. CNCT-19’s New Drug Application (NDA) was accepted by National Medical Products Administration (NMPA) in December 2022. We are now diligently preparing for the anticipated CNCT-19 launch in China. We are advancing the clinical development of BI-1206 in combination with rituximab and presently undertaking the enrollment of patients for the second cohort of the phase I trial in China. CB-5339 also received Clinical Trial Application approval from the NMPA in January 2023. We are transitioning the development of CID-103 into China for the malignant hematology indications and have submitted the multiple myeloma IND to the Chinese Health Authority. We plan to build on the momentum to drive our portfolio forward by executing on several milestones as well as bringing in new potential opportunities for synergy in the quarters ahead."

First Quarter 2023 Financial Highlights

Revenues consist primarily of product sales of EVOMELA. Revenue was $8.3 million for the three months ended March 31, 2023, compared to $9.0 million for the three months ended March 31, 2022.

Costs of revenues were $3.4 million for the three months ended March 31, 2023, compared to $3.8 million for the three months ended March 31, 2022.

Research and development expenses for the three months ended March 31, 2023 were $2.5 million, compared with $4.0 million for the three months ended March 31, 2022. The decrease was mainly due to reduced R&D expenses on CID-103.

General and administrative expenses for the three months ended March 31, 2023 were $5.7 million, compared with $5.3 million for the three months ended March 31, 2022.

Selling and marketing expenses for the three months ended March 31, 2023 were $4.0 million, compared with $3.3 million for the three months ended March 31, 2022. The increase was mainly due to increased marketing activities.

Other income for the three months ended March 31, 2023 was $1.3 million, compared with $0.04 million for the three months ended March 31, 2022. The increase was mainly attributed to the $1.3 million refund from Pharmathen Global BV with respect to the termination of the exclusive distribution license agreement of product Octreotide LAI.

Net loss for the three months ended March 31, 2023 was $5.8 million, compared with $8.4 million for the three months ended March 31, 2022.

As of March 31, 2023, CASI had cash, cash equivalents, short term investments and long-term deposit of $44.8 million compared to $51.6 million as of December 31, 2022. Cash and cash equivalents are expected to fund current operations beyond the first quarter of 2024.

Further information regarding the Company, including its Quarterly Report for the quarter ended March 31, 2023, can be found at www.casipharmaceuticals.com.

On May 17, 2023 Kyverna Therapeutics ("Kyverna"), a cell therapy company with the mission of engineering a new class of therapies for serious autoimmune diseases, reported that it will present for the first time preclinical findings on the development of KYV-101, a novel CD19 CAR T-cell therapy, at the 26th Annual meeting of the American Society for Gene and Cell Therapy (Press release, Kyverna Therapeutics, MAY 17, 2023, View Source;cell-therapy-26th-annual-meeting-301826412.html [SID1234631825]).

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The study demonstrates the successful manufacture and functional activity of KYV-101 from the blood of patients with systemic lupus erythematosus (SLE). KYV-101 is a novel therapy for lupus nephritis (LN), a serious complication of SLE, more commonly known as lupus.

"These results are encouraging and demonstrate the promise of KYV-101 as a transformative therapy for patients with LN and other B cell-driven autoimmune diseases," said James Chung, M.D., Ph.D., chief medical officer of Kyverna.

Poster details:

Development of KYV-101, a Novel CD19 CAR-T Cell Therapy for the Treatment of B Cell-Driven Autoimmune Diseases
Abstract Number: 636
Session: Wednesday Poster Session
Presenter: Charles Kaplan, Ph.D., Kyverna Therapeutics
Date/Time: Wednesday, May 17, 2023; 12:00 p.m. – 2:00 p.m. PT

About Lupus Nephritis (LN)
Lupus nephritis (LN) is a serious complication of systemic lupus erythematosus (SLE), more commonly known as lupus. Approximately 40 percent of adults diagnosed with lupus eventually develop LN and 60 percent of LN patients will fail standard of care and approved treatments1. Aside from modest efficacy, current treatments expose these young adults to the well-demonstrated detrimental consequences of chronic treatment with corticosteroids and other powerful immunosuppressants. Up to 10 percent of patients with LN and 40 percent with diffuse LN (class IV) will ultimately develop kidney failure, requiring dialysis or a kidney transplant to stay alive2.

About KYV-101
KYV-101 is an autologous version of a novel, fully human clinical-stage anti-CD19 chimeric antigen receptor T-cell (CAR T) construct with properties well suited for use in B cell-driven autoimmune diseases such as lupus nephritis and other B-cell driven autoimmune diseases. In a 20-patient Phase 1/2 study in oncology, expected anti-lymphoma activity was associated with a significant reduction of cytokines released that translated into a strong reduction of cytokine-driven side effects such as the rate of immune effector cells-associated neurotoxicity syndrome (ICANS)3. The fully human anti-CD19 CAR also translated into reduced immunogenicity that favorably impacted cell persistence at one month. Kyverna recognized that these properties singled out KYV-101 as a product ideally poised for use in autoimmune disease patients, and the company obtained exclusive, worldwide licenses from the National Institutes of Health (NIH) to use this CD19 construct in both autologous and allogeneic CAR T-cell therapies.