On May 8, 2024 Coeptis Therapeutics Holdings, Inc. (Nasdaq: COEP) (the "Company" or "Coeptis"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, autoimmune, and infectious diseases, reported that the Company has been selected for an oral presentation of the abstract titled Developing A First-In-Class Universal Allogeneic Snap-Car NK Cell Therapy at the International Society for Cell & Gene Therapy 2024, being held May 28th to June 1st in Vancouver, Canada (Press release, Coeptis Therapeutics, MAY 8, 2024, View Source [SID1234642910]).

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 Company’s SNAP-CAR platform technology has demonstrated its potential as a "universal" CAR therapy with the potential to target multiple antigens through combinatorial use of different adaptors, thus potentially avoiding toxicities and relapse due to antigen loss. In Q3 of 2023, Coeptis expanded its exclusive license agreement with the University of Pittsburgh for SNAP-CAR to include natural killer (NK) cells.

The background and aim of the abstract revolve around chimeric antigen receptor (CAR) expression by engineered NK cells and the ability to improve their innate anti-tumor functions by specifically activating NK cells in the presence of tumor antigen. Backed by research performed in conjunction with the University of Pittsburgh and Deverra Therapeutics, allogeneic CAR NK cells may be a safer, more clinically accessible, and cost-effective cellular therapy than autologous CAR T-cells. Based on the demonstrated successful use of a novel SNAP-CAR technology in T-cells, the Company is developing a first-in-class universal allogeneic SNAP-CAR NK cell. This product replaces the antigen binding domain of a CAR with a SNAP tag enzyme that carries out a self-labeling reaction to covalently attach any antibody conjugated to a benzylguanine (BG) tag to create a functional antigen-specific CAR.

"ISCT 2024 is a prestigious gathering renowned for fostering groundbreaking ideas and innovation," said Dave Mehalick, President and CEO of Coeptis Therapeutics. "Our presentation represents a significant and meaningful path forward in advancing our mission to develop a proprietary, allogeneic cell generation platform aimed at universalizing the treatment of many debilitating diseases."

Details of the presentations are outlined below:

TITLE: DEVELOPING A FIRST-IN-CLASS UNIVERSAL ALLOGENEIC SNAP-CAR NK CELL

PRESENTATION TYPE: Oral, Thursday, May 30, 2024 at 8am

AUTHORS: Carrie Stoltzman, Erika von Euw, Braxton Jamison (presenting author), Emily Hsieh, Kevin Green, Lara Ionescu Silverman, Dan Yerace, Dave Mehalick, Colleen Delaney

INSTITUTIONS: Deverra Therapeutics, Seattle, WA, United States

Coeptis Therapeutics, Wexford, PA, United States

The International Symposium on Cell and Gene Therapy (ISCT) brings together leading researchers, clinicians and industry experts in cell and gene therapy from around the world. Serving as a nexus for collaboration, the conference promotes the exchange of new scientific advances, technological advances and clinical insights in the rapidly developing field of cell and gene therapy. For more information: www.isctglobal.org/isct2024.

On May 8, 2024 Minghui Pharmaceutical, Inc., a late-stage clinical biopharmaceutical company focused on autoimmune diseases and oncology, reported that it will feature Dr. Lin Shen from Beijing Cancer Hospital at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago (Press release, Minghui Pharmaceutical, MAY 8, 2024, View Source [SID1234642909]). Dr. Shen will present the results from the Phase I/II clinical study of MHB088C, a well-differentiated B7-H3-targeting antibody-drug conjugate (ADC) for recurrent or metastatic solid tumors, in an oral presentation.

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!

Oral Presentation
Abstract Title: Results of a Phase 1/2 Study of MHB088C: a Novel B7-H3 Antibody-Drug Conjugate (ADC) Incorporating a Potent DNA Topoisomerase I Inhibitor in Recurrent or Metastatic Solid Tumors
Session Title: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Session Date and Time: 6/3/2024; 8:00 AM-9:30 AM CDT
Presentation Time/Duration: 8:00 AM – 8:06 AM CDT
Presenter: Dr. Lin Shen
Abstract ID: 3012

About MHB088C

MHB088C is a novel B7-H3 ADC generated through Minghui’s SuperTopoiTM ADC platform. Minghui’s proprietary payload is 5 to 10 times more potent than Dxd, retaining key advantages such as bystander effect while eliminating the risk of interstitial lung disease. Conjugated with Minghui’s proprietary B7-H3 antibody, which has superior binding and internalization compared to the competitor’s antibodies, MHB088C has demonstrated remarkable anti-tumor efficacy across various cancer types. It was 3 to 10 times more potent in killing tumor cells than the competitor’s compound in xenograft models.

Preclinical GLP tox studies revealed an excellent safety profile, with no unique toxicities, particularly no pulmonary toxicities. The highest non-severely toxic dose (HNSTD) was identified at 30 mg/kg, administered once every two weeks (Q2W) for a total of seven doses. The first patient in the Phase I/II study was enrolled on June 20, 2023. Since then, over 150 patients with different tumor types have been enrolled and received at least one dose of MHB088C, showing promising efficacy and a favorable safety profile. Registrational trials for selected tumor types are expected to start by the end of the year.

On May 8, 2024 Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported new data demonstrating preclinical proof of concept using engineered anti-fibrotic macrophages for the treatment of liver fibrosis (Press release, Carisma Therapeutics, MAY 8, 2024, View Source [SID1234642907]). The data was presented in a poster session at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2024 Annual Meeting on May 8, 2024, in Baltimore, MD.

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!

"We are pleased to unveil preclinical proof of concept data for our liver fibrosis program, which highlight the potential of engineered macrophages to combat a prevalent disease that is associated with late-stage metabolic dysfunction-associated steatohepatitis (MASH) and represents a significant unmet need," said Michael Klichinsky, PharmD, PhD, Co-founder and Chief Scientific Officer of Carisma. "The data, from two independent models, demonstrate that engineered macrophages trafficked to fibrotic tissues, expressed genetically encoded disease-modifying payloads, and significantly reduced fibrosis in the liver. Given these encouraging data, we look forward to further progressing the liver fibrosis program, which is our first expansion outside of oncology."

In the presentation titled "Genetically Engineered Macrophage Cell Therapy Reverses Liver and Lung Fibrosis in Preclinical Models," Carisma presented preclinical proof-of-concept data for engineered macrophage cell therapy in liver fibrosis. In liver models, the data showed that a single dose of macrophages co-expressing the anti-fibrotic factor relaxin and the anti-inflammatory cytokine IL10 significantly improved established fibrosis in a CCl4-induced liver fibrosis model, with a 116% reduction in fibrosis relative to untreated control. Also, systemic administration of engineered macrophages co-expressing relaxin and IL10 significantly reduced liver fibrosis in a high fat diet MASH model, with a 45% reduction in fibrosis relative to untreated control. In both models, the relaxin-IL10 macrophage treatment also resulted in a greater reduction in liver fibrosis compared to non-engineered macrophages.

The presentation also included initial data for the use of engineered macrophages in pulmonary fibrosis. The data showed that a single dose of macrophages expressing a dominant negative TGFβ receptor, which nullified pro-fibrotic TGFβ signaling in the lung, prevented fibrosis in a bleomycin mouse model of pulmonary fibrosis, with a 90% reduction in fibrosis relative to untreated control.

Carisma expects to nominate a development candidate for its liver fibrosis program in the first quarter of 2025.

The poster presented at ASGCT (Free ASGCT Whitepaper) 2024 is now available online in the "Publications" section of Carisma’s website at View Source

On May 8, 2024 Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage, precision oncology company focused on developing and commercializing therapies for cancers with alterations in the mTOR pathway, reported financial results for the first quarter ended March 31, 2024, and highlighted recent corporate progress (Press release, Aadi Bioscience, MAY 8, 2024, View Source [SID1234642906]).

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’m pleased to announce that PRECISION1 is now fully enrolled across a broad array of tumor types and our promising development plan continues to gain momentum. We look forward to providing the two-thirds interim analysis in the third quarter, and full results in early 2025. Additionally, the recently initiated Phase 2 trials in EEC and NETs are enrolling well, and we anticipate initial data from these later this year," said Dave Lennon, President and CEO of Aadi Bioscience. "On the commercial side, FYARRO continues to perform well and has cemented its position as the preferred treatment for malignant PEComa after just two years on the market. The impacts to sales in the first quarter are well-understood events and we expect to return to sales growth in Q2."

Recent Operational Highlights

FYARRO net product sales were $5.4 million in the first quarter of 2024. This decrease of 8.8% from the prior year period reflects impacts from distributor ordering patterns and fewer new patient initiations than the historical average, which we anticipate will correct in subsequent quarters.

Registration-intended PRECISION1 trial is now fully enrolled. PRECISION1 is exploring nab-sirolimus in solid tumors with TSC1 or TSC2 inactivating alterations. The two-thirds interim analysis is expected in Q3 2024, and study completion is expected by year-end.

Enrollment into two Phase 2 trials ongoing. These tumor specific trials are investigating the potential of nab-sirolimus for difficult-to-treat mTOR-driven cancers: advanced or recurrent endometrioid-type endometrial cancer (EEC) in combination with letrozole, and neuroendocrine tumors (NETs).

At Aadi’s request, Mirati/Bristol Myers Squibb and Aadi mutually agreed to terminate their collaboration and clinical supply agreement. Aadi is prioritizing investment in its Phase 2 trials in EEC and NETs. The Phase 1/2 trial with Mirati/Bristol Myers Squibb evaluated the combination of nab-sirolimus + adagrasib in non-small cell lung cancer with a KRASG12C mutation.
First Quarter 2024 Financial Results

Cash, cash equivalents and short-term investments as of March 31, 2024, were $88.3 million as compared to $108.8 million as of December 31, 2023, which is expected to fund operations into Q4 2025 based on current plans.

Total revenue for the quarter ended March 31, 2024, was $5.4 million, resulting from sales of FYARRO.

Net loss for the three months ended March 31, 2024, was $18.3 million as compared to $15.2 million for the three months ended March 31, 2023.
Conference Call Information

The Aadi management team is hosting a conference call and webcast today at 8:30 am EDT (5:30 am PDT) to provide a corporate update and discuss results for the first quarter 2024.

Participants may access a live webcast of the call on the "Investors & News" page of the Aadi Bioscience website at aadibio.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

On May 8, 2024 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported that it has entered into a clinical supply agreement with Roche to study PT217, its first-in-class bispecific antibody targeting DLL3 and CD47, in combination with Roche’s anti-PD-L1 therapy, atezolizumab, in patients with small cell lung cancer (SCLC), large cell neuroendocrine carcinoma of the lung (LCNEC) and extrapulmonary neuroendocrine carcinomas (EP-NECs) (Press release, Phanes Therapeutics, MAY 8, 2024, View Source [SID1234642905]). PT217 was granted orphan drug designation (ODD) for the treatment of SCLC by the FDA in 2022, and recently granted Fast Track designation by the agency for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression following platinum chemotherapy with or without a checkpoint inhibitor.

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!

Phanes is currently enrolling patients in a multi-center Phase I clinical trial of PT217. The Phase I clinical trial (NCT05652686), known as the SKYBRIDGE study, is currently evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of PT217 in patients with advanced or refractory cancers expressing DLL3. The next phase of Phanes’ study is investigating the therapeutic potential of PT217 as a combination therapy in SCLC, LCNEC and EP-NECs. The clinical collaboration with Roche will evaluate PT217 in combination with atezolizumab in these patients.

"Phanes is very excited about partnering with Roche on this novel approach to treat patients with SCLC, LCNEC and EP-NECs," said Rita Laeufle, MD, PhD, Chief Medical Officer (CMO) of Phanes. "DLL3 is highly expressed in SCLC, LCNEC and EP-NECs and an important target for treating these cancers. We believe the mechanisms of PT217 and atezolizumab are complementary and the combination has the potential to improve outcomes for patients. This collaboration marks another milestone for Phanes in fulfilling our vision of developing innovative approaches to treat cancer."

TECENTRIQ is a registered trademark of Roche.