On May 11, 2023 Mustang Bio, Inc. ("Mustang") (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that Phase 1/2 data on MB-106, a CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphomas ("NHL") and chronic lymphocytic leukemia ("CLL"), will be presented at the European Hematology Association (EHA) (Free EHA Whitepaper) ("EHA2023") Hybrid Congress taking place June 8-11, 2023, in Frankfurt, Germany and at the International Conference on Malignant Lymphoma ("ICML") taking place June 13-17, 2023, in Lugano, Switzerland (Press release, Mustang Bio, MAY 11, 2023, View Source [SID1234631575]).

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!

Both presentations will be given by Mazyar Shadman, M.D., M.P.H., Associate Professor and physician at Fred Hutchinson Cancer Center ("Fred Hutch") and University of Washington. MB-106 is being developed in a collaboration between Mustang and Fred Hutch.

"As we continue to progress our CD20-targeted CAR T cell therapy program, we look forward to the upcoming presentations highlighting data from the Phase 1/2 study of MB-106 taking place at Fred Hutch. MB-106 has been demonstrating compelling clinical activity and a favorable safety profile in the ongoing Phase 1/2 trial at Fred Hutch for patients with follicular lymphoma and Waldenstrom macroglobulinemia, a rare type of indolent B-NHL," said Manuel Litchman, M.D., President and Chief Executive Officer of Mustang. "Looking ahead, Mustang plans to provide a data update in the near future from our Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106 in a multicenter setting."

Details of the presentations are as follows:

EHA2023 poster presentation
Title: CD20 CAR-T Therapy with MB-106 for BTK Inhibitor-Refractory Waldenström Macroglobulinemia (WM) / Lymphoplasmacytic Lymphoma (LPL) – Single Institution Study
Abstract Number: P1097
Dates and Time: Friday, June 9, 18:00 CEST (available on demand)
For more information, please visit the EHA (Free EHA Whitepaper)2023 website: View Source

ICML oral presentation
Title: High Efficacy and Favorable Safety of 3rd Generation CD20 CAR-T (MB-106) for Outpatient Treatment of Follicular Lymphoma (FL) – Results of a Single-Institution Trial
Session 7: New CAR-T Cell Approaches
Program and Abstract Book Number: 49
Date and Time: Thursday, June 15, 15:30 to 16:45 CEST
For more information, please visit the ICML website: View Source

Scientists at Fred Hutch played a role in developing these discoveries, and Fred Hutch and certain of its scientists may benefit financially from this work in the future.

On May 11, 2023 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat cancers, reported its financial results for the first quarter of 2023 and provided a business update (Press release, Xenetic Biosciences, MAY 11, 2023, View Source [SID1234631546]).

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 made solid progress with our DNase platform by the establishment of a research and development collaboration with The Scripps Research Institute. Importantly, with the recent addition of business development, R&D and regulatory expertise and experience to our team, we expect to establish additional strategic collaborations that we believe will enable us to expedite our pathway toward a first in human study and expand our opportunities," commented, Jeffrey Eisenberg, Chief Executive Officer of Xenetic.

Recent Highlights:

Appointed leading business development and translational research and development experts, Scott N. Cullison and Reid P. Bissonnette, Ph.D., to support the advancement of the DNase oncology platform.
Entered into a research and development collaboration agreement with The Scripps Research Institute to advance the development of the Company’s systemic DNase program as well as its DNase-armored CAR T program.
Received Notice of Allowance for Canadian patent covering use of DNase enzyme for preventing or ameliorating toxicity associated with chemotherapy.
Summary of Financial Results for First Quarter 2023

Net loss for the quarter ended March 31, 2023 was approximately $0.9 million. Research & development expenses for the three months ended March 31, 2023 decreased by approximately $0.5 million, or 46.0%, to approximately $0.6 million from approximately $1.1 million in the comparable quarter in 2022. The decrease was primarily due to the Company’s decrease in spending related to XCART U.S. pre-clinical development efforts which was partially offset by costs related to the Company’s initial development efforts associated with the DNase platform. Royalty payments of approximately $0.6 million were received from our sublicense with Takeda Pharmaceuticals Co. Ltd in the three months ended March 31, 2023, representing an approximate 55.7% increase over the same period in 2022. General and administrative expenses for the three months ended March 31, 2023 increased by approximately $0.02 million, or 2.0%, to approximately $0.93 million from approximately $0.91 million in the comparable quarter in 2022.

The Company ended the quarter with approximately $12.0 million of cash.

On May 11, 2023 Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, reported an oral presentation and an onsite poster presentation highlighting data from Wugen’s WU-NK-101 and WU-CART-007 programs at the European Hematology Association (EHA) (Free EHA Whitepaper) 2023 Congress, taking place from June 8 – 11, 2023 in Frankfurt, Germany (Press release, Wugen, MAY 11, 2023, View Source [SID1234631545]).

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 oral presentation includes clinical data demonstrating the unique ability of memory-like natural killer cells to engage the adaptive immune system, and the potential for durable effectiveness in the relapsed or refractory (R/R) acute myeloid leukemia (AML) setting. The poster presentation includes new clinical data highlighting the promising safety profile of WU-CART-007 and preliminary evidence of anti-leukemic activity in patients with R/R T-cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL). This will be the first clinical data presented from Wugen’s WU-CART-007 program.

The details of Wugen’s presentations at EHA (Free EHA Whitepaper) are as follows:

Title: Adoptively Infused Memory-Like (ML) Natural Killer (NK) Cells Elicit Adaptive Immune Responses in Patients with Acute Myeloid Leukemia (AML)

Session: S433 – AML Biology, Microenvironment and Drug Resistance

Session Date and Time: Saturday, June 10, 2023 from 4:30 – 5:45 p.m. CEST

Location: Hall 3.2

Presenter: Sergio Rutella, M.D., Ph.D., FRCPath, FRSB, Professor of Cancer Immunotherapy at Nottingham Trent University

Abstract Code: S129

———-

Title: Phase 1/2 Dose-Escalation/Dose-Expansion Study of Anti-CD7 Allogeneic CAR-T Cell in Relapsed or Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma (T-ALL/LBL)

Session Date and Time: Friday, June 9, 2023 from 6:00 – 7:00 p.m. CEST

Presenter: Kenneth Jacobs, M.D., Vice President of Pharmacovigilance and Clinical Development, Wugen

Abstract Code: P356

Additional meeting information can be found at View Source

About WU-CART-007

WU-CART-007 is an allogeneic, off-the-shelf, fratricide-resistant CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat CD7+ hematological malignancies. Wugen is deploying CRISPR/Cas9 gene editing technology to delete CD7 and the T-cell receptor alpha constant (TRAC), preventing CAR-T cell fratricide and mitigating the risk of graft-versus-host-disease (GvHD). WU-CART-007 is manufactured using healthy donor-derived T-cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. WU-CART-007 is currently being evaluated in a global Phase 1/2 clinical trial for the treatment of relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL). Additional information is available on clinicaltrials.gov, identifier NCT# 04984356.

About WU-NK-101

WU-NK-101 is a novel immunotherapy harnessing the power of memory natural killer (NK) cells to treat liquid and solid tumors. Memory NK cells are hyper-functional, long-lasting immune cells that exhibit enhanced anti-tumor activity and a cytokine-induced memory-like (CIML) phenotype. This rare cell population has a superior phenotype, proliferation capacity, and metabolic fitness that makes it better suited for cancer therapy than other NK cell therapies. Wugen is applying its proprietary MonetaTM platform to advance WU-NK-101 as a commercially scalable, off-the-shelf cell therapy for cancer. WU-NK-101 is currently in development for acute myelogenous leukemia (AML) and solid tumors.

On May 11, 2023 vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of an adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D"), reported financial results for the first quarter ended March 31, 2023, and provided an update on recent corporate developments (Press release, vTv Therapeutics, MAY 11, 2023, View Source [SID1234631544]).

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!

"During the first several months of 2023, we continued making progress to align with the FDA on an efficient development pathway to support registration of TTP399 as an adjunctive therapy to insulin for the treatment of type 1 diabetes and we remain on-track to commence study activities in the second half of the year," said Paul Sekhri, Chief Executive Officer of vTv. "In addition to our ongoing efforts to advance studies of TTP399 in type 1 diabetes, we continue to work with an affiliate of G42 Investments in preparation for a phase 2 study comparing TTP399 with placebo in patients with type 2 diabetes on insulin therapy."

Recent Company Highlights

•Strengthened the Company’s balance sheet following receipt of approximately $12.0 million from G42 Investments on February 28, 2023, in satisfaction of the promissory note issued in connection with the common stock purchase agreement entered into between vTv and G42 Investments in 2022. As of March 31, 2023, the Company’s cash and cash equivalents totaled approximately $18.8 million.

•On February 24, 2023, the Company received written confirmation that the FDA is in agreement with its pediatric study plan for the study of TTP399 in T1D patients between 2 and 16 years of age.
First Quarter 2023 Financial Results

•Cash Position: The Company’s cash position as of March 31, 2023, was $18.8 million compared to $12.1 million as of December 31, 2022. The increase is attributed to receipt of the promissory note from G42 Investments on February 28, 2023.

•Research & Development (R&D) Expenses: R&D expenses were $3.9 million and $3.1 million in each of the three months ended March 31, 2023 and 2022, respectively. The increase of $0.8 million is primarily attributable to higher spending on TTP399, due to increases in drug product related costs, an increase in indirect costs and other projects related to the development of TTP399.
•General & Administrative (G&A) Expenses: G&A expenses were $3.5 million and $5.3 million for each of the three months ended March 31, 2023 and 2022, respectively. The decrease of $1.9 million was primarily due to decreases in legal expense and severance expense, partially offset by higher other G&A costs.
•Other Income (Expense): Other income for the three months ended March 31, 2023, was $1.6 million and was driven by an unrealized gain related to our investment in Reneo, offset by losses related to the change in the fair value of the outstanding warrants to purchase shares of our stock issued to related parties and the loss from the early redemption of the G42 promissory note. Other expense for the three months ended March 31, 2022, was

$2.7 million and was related to the unrealized loss recognized related to our investment in Reneo as well as gains related to the change in the fair value of the outstanding warrants held by a related party.
•Net Loss: Net loss attributable to vTv shareholders for the three months ended March 31, 2023, was $4.5 million or $0.06 per basic share. Net loss attributable to vTv shareholders for the comparable period a year ago was $7.0 million or $0.10 per basic share.

On May 11, 2023 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported its financial results for the first quarter ended March 31, 2023 and provided a corporate update (Press release, Vincerx Pharma, MAY 11, 2023, View Source [SID1234631543]).

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 ADC space is going through an exciting period of innovation," said Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx. "The therapeutic potential of new conjugates is being widely recognized, as reflected in the recent industry announcements of collaborations, acquisitions, and positive clinical results. So, for Vincerx, this is an exciting time to be a bioconjugation company with a next-generation platform and multiple programs in, or soon to be in, the clinic."

Dr. Hamdy continued, "2023 has already been a productive year for us, with the initiation of our Phase 1 dose escalation study for VIP236, our first-in-class αvβ3 SMDC. Most recently, preclinical data presented at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting highlighted compelling monotherapy efficacy data for VIP236 in patient-derived xenograft models (PDX) across a number of aggressive indications. The data also showed significant tumor growth inhibition for VIP236 when compared with ENHERTU, an approved ADC, independent of HER2 status. We are encouraged to see our SMDC show improved in vivo efficacy across a range of HER2 expression levels, including HER2 low and HER2 negative gastric models, suggesting a potential new treatment option for patients across various aggressive solid tumors.

"On the ADC front, we expect to file the first IND from our ADC program, VIP943, for CD123+ hematologic malignancies in mid-2023. In preclinical data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in 2022, our next-generation kinesin spindle protein inhibitor (KSPi) payload, unique linker, and CellTrapper technology showed significant improvement in safety over Mylotarg, an approved ADC for the treatment of acute myeloid leukemia (AML). The data also showed improved efficacy and survival for VIP943 in combination with venetoclax and azacitidine. This triple combination resulted in significant tumor regression, as demonstrated by an increased number of complete responses and overall survival, compared with venetoclax and azacitidine. These data support the opportunity to move to earlier lines of therapy once the dose and safety profile for VIP943 have been established.

"We believe our next-generation ADC technology represents a significant step forward in the treatment of cancer by solving problems associated with current ADCs. We look forward to sharing advances for our programs as we continue to position Vincerx as a leader in the ADC space," concluded Dr. Hamdy.

First Quarter 2023 Corporate Highlights

Bioconjugation Platform
VIP236, an αvβ3 integrin binder linked to an optCPT payload SMDC:

At AACR (Free AACR Whitepaper) 2023, Vincerx presented compelling preclinical data demonstrating that VIP236 had potent and durable antitumor activity in multiple mouse models implanted with tumor cells from cancer patients:
VIP236 treatment is efficacious in a PDX non-small cell lung cancer model, including durable complete responses (CRs).
Significant tumor growth inhibition in a PDX colorectal carcinoma (CRC) liver metastasis model and significantly reduced lung and brain metastasis in a PDX orthotopic triple-negative breast cancer (TNBC) model.
Significant tumor growth inhibition, independent of HER2 status, in gastric PDX and cell line-derived cancer models when compared with ENHERTU.
Dosed the first cohort of the ongoing Phase 1 first-in-human dose-escalation study with VIP236 monotherapy in the first quarter 2023 (ClinicalTrials.gov NCT05712889).
VIP943, CD123-KSPi ADC:

At ASH (Free ASH Whitepaper) 2022, Vincerx presented preclinical data on VIP943 in AML models demonstrating:
Superiority with significantly improved safety in monkeys when compared with Mylotarg (gemtuzumab ozogamicin).
AML ex vivo and in vivo monotherapy activity.
No signs of cytokine release in human blood cells.
Significant tumor regression in combination with venetoclax and azacitidine in a PDX AML model.
IND-enabling studies continue to advance with an IND filing on track for mid-2023.
VIP924, CXCR5-KSPi ADC:

IND-enabling studies continue to advance, with an IND filing planned for mid-2024.
Additional Platform Updates

At AACR (Free AACR Whitepaper) 2023, Vincerx presented preclinical data on the synthesis and characterization of novel SMDCs with different payloads. Data showed high elastase-dependent potency and cytotoxicity across several cancer cell lines:
The large scope of potential payloads and conjugation chemistries support the strategy for selective delivery of payloads to the tumor microenvironment, without requiring the tumor target to internalize.
Evaluation of linker variations with in vivo studies across different payload classes is ongoing.
Enitociclib, Positive Transcription Elongation Factor b (P-TEFb)/CDK9 inhibitor

First patient dosed in National Institutes of Health collaborative Phase 1 combination study with venetoclax and prednisone (VVIP) in diffuse large B-cell lymphoma (ClinicalTrials.gov NTC05371054).
Anticipate dosing first patient in Phase 1b study of enitociclib in combination with an approved BTK inhibitor in patients with a high-risk chronic lymphocytic leukemia (CLL) in second quarter 2023.
First Quarter 2023 Financial Results

Vincerx had approximately $39.8 million in cash, cash equivalents and marketable securities as of March 31, 2023, as compared to approximately $52.5 million as of December 31, 2022. Based on its current business plans and assumptions, Vincerx believes its available capital will be sufficient to meet its operating requirements into late 2024.

Research and development (R&D) expenses for the first quarter ended March 31, 2023 were approximately $10.6 million, as compared to approximately $16.0 million for the same period in 2022. This decrease is primarily the result of declines in stock-based compensation expense of approximately $3.1 million, payroll related costs of approximately $1.4 million as a result of our headcount reduction in June 2022, manufacturing services associated with our ADC program of approximately $1.2 million, and clinical services of approximately $0.6 million, partially offset by an increase in third party research and preclinical work of approximately $1.3 million.
General and administrative (G&A) expenses for the first quarter ended March 31, 2023 were approximately $4.5 million, as compared to approximately $5.7 million for the same period in 2022. This decrease is primarily driven by a decrease in stock-based compensation expense of approximately $1.1 million.

For the first quarter ended March 31, 2023, Vincerx reported a net loss of approximately $14.3 million, or $0.68 per share. For the first quarter ended March 31, 2022, Vincerx reported a net loss of approximately $16.4 million, or $0.79 per share.