On May 11, 2023 Affimed N.V. (Nasdaq: AFMD) ("Affimed", or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that two abstracts have been accepted to EHA (Free EHA Whitepaper)2023, the annual meeting of the European Hematology Association (EHA) (Free EHA Whitepaper) taking place in Frankfurt, Germany on June 8-11, 2023 (Press release, Affimed, MAY 11, 2023, View Source [SID1234631576]).

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In the REDIRECT study, the AFM13 innate cell engager (ICE) exhibited clinical efficacy in a heavily pre-treated CD30-positive r/r PTCL population. Overall, the objective response rate (ORR) based on FDG-PET assessed by an independent review committee was 32.4%, thus comparable to therapies approved for this indication. The median duration of response, progression-free survival, and overall survival were 2.3, 3.5, and 13.8 months, respectively. The highest objective response rate was observed in patients with angioimmunoblastic T-cell lymphoma (53.3%). AFM13 showed a well-managed safety profile. The most common adverse event (AE) was infusion-related reactions (IRRs) reported in 34 patients, with 6 patients and 5 patients reported to have Grade 3 and serious events, respectively. The data to be presented at EHA (Free EHA Whitepaper) are based on additional post-hoc efficacy analysis of AFM13 to identify potential patient characteristics which may predict a more favorable response to AFM13.

Details of the AFM13 poster presentation are as follows:

Title: AFM13 in Patients with R/R Peripheral T Cell Lymphoma: A Post-Hoc Subgroup Analysis from the Redirect Study

Presenting Author: Jake Shortt

Date and Time: Friday, June 9; 18:00 – 19:00 CET

Final Abstract Code: P1142

The AFM28 abstract describes the first-in-human study that aims to investigate the safety and tolerability of AFM28 monotherapy, establish the maximum tolerated dose (MTD), determine the recommended Phase 2 dose (RP2D), and establish the potential for this novel treatment modality to redirect NK cells to eliminate leukemic blasts and leukemic stem cells (LSCs), thereby potentially achieving durable remissions in patients with r/r AML.

AFM28 ICE is a bispecific monoclonal antibody with specificity for CD123 and the human Fc gamma receptor III-A (CD16A). AFM28 is intended to be developed as an antineoplastic agent for hematological malignancies known to express CD123, including AML. Its primary pharmacological mechanism of action is the induction of antibody-dependent cellular cytotoxicity (ADCC) by targeting CD16A-expressing immune effector cells, primarily natural killer (NK) cells, towards CD123-expressing cells.

Details of the AFM28 online publication are as follows:

Title: Engaging Innate Immunity: A Phase 1 Dose Escalation Study to Assess Safety and Tolerability of AFM28 Monotherapy in Patients with Relapsed/Refractory CD123-Positive Acute Myeloid Leukemia (AML)

Final Abstract Code: PB1884

More details about the EHA (Free EHA Whitepaper) 2023 meeting are available online at EHA (Free EHA Whitepaper)2023 Hybrid Congress (ehaweb.org).

About AFM13

AFM13 is a first-in-class innate cell engager (ICE) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. AFM13 induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. AFM13 is Affimed’s most advanced ICE clinical program and was evaluated as monotherapy in a phase 2B trial in patients with relapsed/refractory peripheral T cell lymphoma (REDIRECT). Additional details can be found at www.clinicaltrials.gov (NCT04101331). The study achieved an ORR of 32.4% demonstrating anti-tumor activity with a DOR of 2.3 months and a well-managed safety profile. AFM13 is a tetravalent bispecific innate cell engager designed to act as a bridge between the innate immune cells and the tumor creating the necessary proximity for the innate immune cells to specifically destroy the tumor cells.

About AFM28

AFM28, a tetravalent bispecific CD123- and CD16A-binding Innate Cell Engager (ICE) developed on Affimed’s Redirected Optimized Cell Killing (ROCK) platform, is designed to bring a new immunotherapeutic approach to patients with CD123-positive myeloid malignancies, including acute myeloid leukemia (AML) by engaging natural killer (NK) cells to initiate tumor cell killing via antibody-dependent cellular cytotoxicity (ADCC), even at low CD123 expression levels. A first-in-human clinical study with AFM28 monotherapy is ongoing in patients with relapsed/refractory CD123-positive AML (NCT05817058). In addition, development of AFM28 in combination with allogeneic NK cells is planned.

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]).

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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]).

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"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]).

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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

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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]).

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"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.