On May 17, 2023 Indapta Therapeutics, Inc., a privately held biotechnology company developing a natural killer (NK) cell therapy platform for the treatment of blood and solid tumor cancers, reported that the company has reached agreement with the U.S. Food and Drug Administration (FDA) on an Investigational New Drug (IND) application to commence its first-in-human phase 1 trial in patients with multiple myeloma and lymphoma anticipated to begin in the second half of 2023 (Press release, Indapta Therapeutics, MAY 17, 2023, View Source [SID1234631830]). The University of Texas MD Anderson Cancer Center will serve as the initial clinical site, where Dr. Krina Patel will lead the study.

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This milestone triggers the second $30 million tranche of its $60M Series A financing raised in January 2022 from its lead investors, Leaps by Bayer, Vertex Ventures, RA Capital, and Pontifax.

"This is a major milestone achievement for our team who successfully demonstrated the reproducibility of our manufacturing process and designed a robust clinical trial," said Dr. Mark Frohlich, CEO of Indapta. "G-NK cells have demonstrated highly potent antibody dependent cytotoxicity in combination with monoclonal antibodies in preclinical models and we are excited to evaluate the safety and clinical activity of G-NK cells in this Phase 1 trial."

The study will explore three different dose levels of Indapta’s G-NK cells alone and in combination with interleukin-2 and the monoclonal antibodies, rituximab and daratumumab.

Indapta’s Differentiated G-NK Cell Therapy

Indapta’s universal, allogeneic G-NK cell therapy platform is designed to substantially improve the cancer killing power of monoclonal antibody (mAb) therapy in multiple types of cancers. G-NK cells are a specific and potent subset of NK cells with specialized antitumor activity resulting from epigenetic changes. Indapta’s off-the-shelf G-NK cell therapy is further differentiated from other NK cell therapies in that it is a cell-banked product with low variability.

Indapta produces a G-NK cell therapy with its proprietary manufacturing process that has demonstrated more potent and persistent antitumor activity in preclinical studies compared to conventional NK cells, without the need for genetic engineering. Indapta’s G-NK cells recognize cancer cells coated with monoclonal antibodies and are capable of releasing dramatically more cancer-killing compounds than conventional NK cells, leading to potentially increased efficacy.

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.