On May 8, 2024 Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, reported its financial results for the first quarter ended March 31, 2024, and provided business highlights (Press release, Tango Therapeutics, MAY 8, 2024, View Source [SID1234642913]).

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 progressing both TNG908 and TNG462 into dose expansion in order to accelerate our clinical development. We look forward to sharing a comprehensive clinical data update on our PRMT5 program in the second half of this year," said Barbara Weber, M.D., President and Chief Executive Officer of Tango Therapeutics. "We continue to make substantial progress across our other programs as enrollment and dose escalation are continuing in the phase 1/2 clinical trials of TNG260 and TNG348. Finally, we welcomed the newest member of our leadership team, Julie Carretero, as Chief Human Resources Officer. She will play an instrumental role in growing the company while maintaining our culture at a pivotal time for the company."

Recent Business Highlights

Pipeline Update

TNG908, a blood-brain barrier penetrant, MTA-cooperative PRMT5 inhibitor

Expansion cohorts have been opened in MTAP-deleted solid tumors in glioblastoma (GBM), non-small cell lung and pancreatic cancers at 600 mg BID in the TNG908 phase 1/2 clinical trial.
MTAP deletions occur in approximately 10%-15% of all human cancers, including 40% of GBM.
TNG462, a potentially best-in-class MTA-cooperative PRMT5 inhibitor

Dose expansion is expected to initiate in the TNG462 phase 1/2 clinical trial in 2Q 2024.
The safety, tolerability and pharmacokinetic profiles of TNG462 remain favorable with increasing doses.
TNG260, a first-in-class, highly selective CoREST complex inhibitor

Dose escalation is ongoing in the TNG260 phase 1/2 clinical trial evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of TNG260 in combination with pembrolizumab in patients with locally advanced or metastatic solid tumors with an STK11 loss-of-function mutation. To date, safety, tolerability and pharmacokinetic profiles remain favorable.
STK11 mutations occur in approximately 15% of NSCLC, 15% of cervical, 10% of carcinoma of unknown primary, 5% of breast and 3% of pancreatic cancers.
TNG348, a novel USP1 inhibitor

Single agent dose escalation is ongoing in the TNG348 phase 1/2 clinical trial evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of TNG348 as a single agent and in combination with olaparib, a PARP inhibitor, in patients with BRCA1/2-mutant and other HRD+ (homologous recombination deficient) cancers.
Early clinical data support switch to once-a-day dosing.
Single agent dose escalation pharmacokinetic, pharmacodynamic, safety and tolerability data are favorable and support the opening of the combination cohort with olaparib in 2Q 2024.
HRD+ cancers, including BRCA1/2 mutations, represent up to 50% of ovarian cancers, 25% of breast cancers, 10% of prostate cancers and 5% of pancreatic cancers.
Upcoming Milestones

Dose expansion in the TNG462 phase 1/2 clinical trial is expected to initiate in 2Q 2024.
A comprehensive update of the PRMT5 program, including clinical data from the ongoing phase 1/2 clinical trials of TNG908 and TNG462, is expected in 2H 2024.
Scientific Publications

"Discovery of TNG908: A Selective, Brain Penetrant, MTA-Cooperative PRMT5 Inhibitor That Is Synthetically Lethal with MTAP-Deleted Cancers," was published in March in the Journal of Medicinal Chemistry.
Leadership Update

Julie Carretero joined as Chief Human Resources Officer in March. Ms. Carretero brings over 25 years of biopharmaceutical and human resources experience to this newly created role. Most recently, Ms. Carretero served as Chief People Officer at Evelo Biosciences where she oversaw growth from a clinical to a commercial-stage company. Previously she held senior human resources roles at multiple companies, including FXI, Matter Communications and Novartis.
Financial Results

As of March 31, 2024, the Company held $343.6 million in cash, cash equivalents and marketable securities, which the Company expects to be sufficient to fund operations into late 2026.

Collaboration revenue was $6.5 million for the three months ended March 31, 2024, compared to $5.8 million for the same period in 2023. Research costs incurred under the collaboration were similar during each of the three-month periods presented which resulted in similar collaboration revenue amounts recognized.

Research and development expenses were $38.1 million for the three months ended March 31, 2024, compared to $28.0 million for the same period in 2023. The change is due to increased spend relating to the advancement of our clinical programs and personnel-related costs to support our research and development activities.

General and administrative expenses were $10.7 million for the three months ended March 31, 2024, compared to $8.0 million for the same period in 2023. The change was primarily due to increases in personnel-related costs.

Net loss for the three months ended March 31, 2024 was $37.9 million, or $0.35 per share, compared to a net loss of $28.0 million, or $0.32 per share, in the same period in 2023.

On May 8, 2024 CEL-SCI Corporation (NYSE American: CVM) reported a significantly positive outcome from its recent meeting with the U.S. Food and Drug Administration (FDA) regarding the path to approval for its first-line investigational cancer immunotherapy Multikine* (Leukocyte Interleukin, Injection) (Press release, Cel-Sci, MAY 8, 2024, View Source [SID1234642912]). Based on strong safety and efficacy data from CEL-SCI’s completed Phase 3 head and neck cancer study, the FDA indicated CEL-SCI may move forward with a confirmatory Registration Study of Multikine in newly diagnosed advanced primary head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy).

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!

"Through this discussion and agreement with the FDA, we have achieved a tremendous milestone for people who are newly diagnosed with head and neck cancer. The survival benefit was so strong and clear in the target patient population that our confirmatory study needs to enroll only 212 people to confirm what was already achieved in the Phase 3 study. This gives us a clear path forward," stated CEL-SCI CEO, Geert Kersten. "We are eager to begin the study as soon as possible."

CEL-SCI published a report on the FDA’s agreement and Multikine’s path forward. Please click on this link View Source to read the full report. Highlights include:

The FDA agreed to a 212-person confirmatory Registration Study based on the strength of the safety and survival benefit data in the selected target population from the prior 928-person Phase 3 study. The confirmatory study will be a randomized controlled trial with two arms: Multikine treatment plus standard of care versus standard of care alone. As presented at the ESMO (Free ESMO Whitepaper) cancer conference in October 2023, Multikine-treated patients in the selected group had a 73% 5-year survival vs a 45% 5-year survival in the control group who did not receive Multikine.
Generally, patient selection for different treatments in newly diagnosed head and neck cancer is done only after surgery. That presented CEL-SCI with a challenge, because Multikine has to be given before surgery. By analyzing Multikine’s biological mechanism of action, as supported by the completed Phase 3 study, CEL-SCI developed criteria for selecting, before surgery, those patients who would have the best survival from Multikine. The FDA accepted the selection criteria and the proposed study design, which now permits CEL-SCI to enroll patients in the confirmatory study.

CEL-SCI met a very high bar set by the FDA, which requires more stringent analysis for newly-diagnosed patients than for terminal cancer patients. One regulator called these newly-diagnosed cancer patients "much more delicate" and explained that the standard for permitting a new study with these patients has to be more stringent, since they are not all expected to die.

CEL-SCI has been advised by statisticians and physicians that the confirmatory study has a high likelihood of success because a large survival benefit has already been demonstrated in the target population in the completed Phase 3 study. The much smaller confirmatory study—less than a quarter the size of the prior study—will focus on the patients who saw the greatest survival benefit when treated with Multikine.
If approved as a pre-surgical treatment, Multikine should be added to the standard of care for the target population.
The FDA also acknowledged in the meeting that there is a great unmet need in the target population for improved therapies. This is an important factor that weighs in favor of approval for Multikine.
CEL-SCI believes that its de-risked value proposition for investors presents a unique opportunity to invest in a Phase 3 oncology company with a large body of data demonstrating not only tumor responses, but also long-term survival, in the target patient population. The goal of our smaller confirmatory study is to confirm these positive results in a prospectively defined target population.

On May 8, 2024 Acepodia (6976:TT), a clinical stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) and allogeneic gamma delta 2 (γδ2) T cell platforms to address gaps in cancer care, reported preliminary data from its Phase 1 dose escalation clinical trial of ACE1831, an anti-CD20 antibody conjugated allogeneic gamma delta T cell therapy being evaluated in patients with non-Hodgkin’s lymphoma (NHL) (Press release, Acepodia, MAY 8, 2024, View Source [SID1234642911]).

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!

Key Results From Preliminary Clinical Data

One out of five patients demonstrated complete response (CR) and three out of five patients experienced disease stabilization (SD) with single dose of ACE1831 at the lowest dose level. Among those patients, one CR and two SD patients were previously treated with CD19 CAR-T.
Durability of clinical response was observed for three months after a single dose of ACE1831.
The lowest dose of ACE1831 was well tolerated with no ACE1831-related serious adverse events or dose limiting toxicities. Dose escalation is ongoing.
ACE1831 is Acepodia’s first cell therapy to enter clinical development from its proprietary ACC platform, which uses bioorthogonal chemistry to conjugate gamma delta 2 (γδ2) T cells with antibodies targeting CD20. The platform, based on the pioneering work of 2022 Nobel Prize laureate Dr. Carolyn Bertozzi that applied click chemistry to living systems, creates an off-the-shelf, non genetically engineered version of CAR-T cell therapy that is more easily scaled and avoids cytokine release storms, neurotoxity and other side effects associated with CAR-T cell therapies. The preliminary data demonstrates that ACE1831 activates both an innate and adaptive immune response by direct killing of tumor cells, tumor opsonization, and recruitment of T cells through cytokine secretion, and may therefore generate a more comprehensive immune response than standard CAR-T cell therapies.

"This ongoing trial is the first to demonstrate potential clinical benefit to patients using bioorthogonal chemistry and opens the door to a powerful, new approach for cell therapy that overcomes limitations of current CAR-T cell therapies and is more accessible to patients," said Sonny Hsiao, Ph.D., chief executive officer of Acepodia. "We are encouraged to see a robust and durable effect after a single treatment at the lowest dose, and remain focused on the continued development of this first-of-its kind treatment option."

The first-in-human, phase 1 trial is an open-label, dose escalation study that aims to evaluate the safety and tolerability, pharmacokinetics, and efficacy of ACE1831 in patients with relapsed/refractory non-Hodgkin’s lymphoma. The multi-center trial is expected to enroll up to 42 patients in the United States and Taiwan.

About ACE1831

ACE1831 is an off-the-shelf gamma delta T cell therapy candidate developed from Acepodia’s proprietary ACC platform. ACE1831 targets CD20-expressing hematological cancers using anti-CD20 antibody conjugated gamma delta T cells. Taking advantage of the high expression of NK cell activating receptors of the gamma delta T cells to scavenge the malignant blood cells, ACE1831 has demonstrated in models enhanced cytotoxicity against cancer cells both in vitro and in vivo. ACE1831 is currently being evaluated in a Phase 1, first-in-human clinical trial for patients with non-Hodgkin’s lymphoma.

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.