On May 11, 2023 Onconova Therapeutics, Inc. (NASDAQ: ONTX), ("Onconova"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported that the first patient has been dosed in the Company’s Phase 1/2a trial evaluating narazaciclib combined with letrozole in recurrent metastatic low-grade endometrioid endometrial cancer (LGEEC) (Press release, Onconova, MAY 11, 2023, View Source [SID1234631578]). Narazaciclib is a multi-kinase inhibitor targeting CDK 4, CDK 6, and other kinases important for cell proliferation and motility. Preliminary data from the trial’s Phase 1 portion are expected in 4Q 2023.

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Endometrial cancer arises in the uterine lining and is the most common cancer of the female reproductive organs. Endometrioid endometrial cancer is the most common subtype of endometrial cancer, accounting for approximately 75% of cases. Data from prior randomized and single-arm trials have demonstrated the anti-cancer activity of letrozole combined with CDK 4/6 inhibition in recurrent endometrial cancer1-3. Currently, there is no health authority-approved CDK 4/6 inhibitor for the treatment of endometrial cancer.

"Improved treatment options for recurrent LGEEC are urgently needed, as the CDK 4/6 inhibitors currently used off-label for this indication are marked by limitations related to safety, tolerability, and treatment resistance," said Bhavana Pothuri, M.D., Professor, Department of Obstetrics and Gynecology at NYU Grossman School of Medicine and Director, Gynecologic Oncology Research; Perlmutter Cancer Center and Principal Investigator of the trial. "Narazaciclib’s kinase inhibitory profile suggests it can overcome each of these limitations thanks to reduced activity against kinases whose inhibition is associated with bone marrow toxicity and diarrhea, and increased activity against those implicated in pro-tumor immune suppression and cancer cell survival. This hypothesis is supported by data from in vitro and murine cancer models, and I look forward to its continued evaluation in the ongoing Phase 1/2a trial."

Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova, commented, "Our recurrent LGEEC program provides an opportunity to establish narazaciclib as a best-in-class therapy in an indication where clinical proof-of-concept for its mechanism of action has been demonstrated. We, therefore, view the program as a key avenue for value creation and look forward to our Phase 1/2a trial’s preliminary data readout expected later this year."

About the Phase 1/2a Trial

The Phase 1/2a trial is an open-label, multicenter study evaluating narazaciclib in combination with letrozole as a second or third-line treatment for patients with recurrent metastatic LGEEC. Both narazaciclib and letrozole are administered orally with a continuous daily dosing schedule. The trial begins with a Phase 1 dose escalation phase before moving to a Phase 2 expansion cohort designed to enroll approximately 30 patients. The primary objective of the Phase 1 portion of the trial is to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in order to determine a recommended Phase 2 dose (RP2D) of the combination. The primary objective of the Phase 2 portion will be to evaluate the efficacy of the combination at the RP2D, as measured by progression-free survival at 24 weeks. The estrogen/progesterone receptor status of participants will be recorded as part of an exploratory objective. The trial will be conducted at sites including NYU Langone Health, the site of the Principal Investigator of the study, sites affiliated with MD Anderson Cancer Center, and U.S. Oncology Research sites.

References

1. Mirza MR. ESMO (Free ESMO Whitepaper) Virtual Congress 2020. Abstr. LBA28.

2. Konstantinopoulos PA, et al.; 2022 SGO Annual Meeting on Women’s Cancer; March 18-21, 2022. Phoenix, AZ

3. Colon-Otero G, Zanfagnin V, Hou X, et al. ESMO (Free ESMO Whitepaper) Open. 2020 Oct;5(5):e000926. doi: 10.1136/esmoopen-2020-000926.

On May 11, 2023 Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported its financial results for the quarter ended March 31, 2023 and provided a business update (Press release, Aptevo Therapeutics, MAY 11, 2023, View Source [SID1234631577]).

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First Quarter Highlights

Raised $9.7 million in non-dilutive funding, extending cash runway beyond 12 months
A portion of the proceeds was used to fully repay the existing debt facility on the Company’s balance sheet
The Company achieved this by closing a transaction for the complete sale of all future IXINITY deferred payments and a portion of IXINITY milestones to XOMA Corporation
Announced plans to initiate its Phase 2 program in the second half of 2023 to further evaluate APVO436, a bispecific CD3xCD123 ADAPTIR molecule, in combination with venetoclax and azacytidine in frontline and relapsed/refractory venetoclax treatment naïve patients with acute myeloid leukemia (AML). The trial design will be informed by the positive Phase 1 results announced at ASH (Free ASH Whitepaper) in December 2022
Dosed the first patient in the Company’s Phase 1 trial evaluating ALG.APV-527 intended for the treatment of solid tumors, potentially including, but not limited to, breast, colon, lung and pancreatic, which are likely to express the 5T4 antigen
ALG.APV-527 is a bispecific antibody designed to target cancer cells by activating both T-cells and natural killer cells and is intended to bind to tumor-specific antigens while sparing healthy cells and maximizing immune response
Introduced pipeline candidate, APVO711, a PD-L1 x CD40 compound with a dual mechanism of action that includes a checkpoint inhibitor that blocks the T cell inhibitory pathway while also stimulating antigen presenting cells
APVO711 has the potential to fight a range of solid malignancies such as head and neck squamous cell carcinoma, melanoma, and carcinomas of the lung, gastrointestinal tract and colon
The Company filed a provisional patent for APVO711 in January 2023
"As promised, momentum on all fronts continued into the first quarter of this year. Clinical plans continue to progress for our APVO436 Phase 2 program in the treatment of AML, and we continue to advance our ALG.APV-527 Phase 1 trial for the treatment of multiple solid tumor types after dosing the first patient in early February. This trial is ongoing, and we expect preliminary results in the second half of this year, said Marvin White, President and Chief Executive Officer at Aptevo. "We are particularly excited about our new molecule, APVO711. It’s dual mechanism of action has the potential to both stimulate cells that fight cancer and as a checkpoint inhibitor, block the pathways that cause it to spread. APVO711 was also built with safety in mind and is specifically designed to overcome the clinical toxicity commonly associated with CD40."

He added, "On the business front, we were very pleased to raise $9.7 million in non-dilutive capital by completing the sale of all future IXINITY deferred payments and a portion of IXINITY milestones to XOMA Corporation. We used part of the proceeds to fully repay our debt and are very pleased to say that Aptevo is a debt-free company," Mr. White concluded.

First Quarter 2023 Financial Results

Cash Position: Aptevo had cash and cash equivalents as of March 31, 2023 totaling $25.3 million.

Royalty Revenue: Royalty revenue for the period covered by this report reflects revenue recorded only in the first quarter of 2022 due to our Amendment to Royalty Purchase Agreement with HCR. As a result of the amendment, we ceased reporting as royalty revenue, royalties paid by Pfizer to HCR related to Pfizer’s sales of RUXIENCE (rituximab-pvvr). The last quarter for which we reported this royalty revenue was Q1 2022. The Amendment was effected to address a Nasdaq compliance matter and had the additional effect of eliminating the requirement to report all future Pfizer non-cash royalty revenue and extinguishing the liability that we recorded upon the initial sale of the royalties to HCR. RUXIENCE is a registered trademark of Pfizer.

Research and Development Expenses: For the three months ended March 31, 2023, research and development expenses decreased by $0.7 million, to $4.2 million from $4.9 million for the three months ended March 31, 2022. The decrease was primarily due to lower spending on APVO436 as we concluded enrollment in our dose expansion phase of the clinical trial and working toward the launch of Phase 2, following promising clinical data reported in the fourth quarter of 2022. Additionally, we had lower consulting and employee related costs compared to the same period in prior year. The decrease was partially offset by higher spending on the ALG.APV-527 Phase 1 clinical trial.

General and Administrative Expenses: For the three months ended March 31, 2023, general and administrative expenses decreased by $0.3 million, to $3.6 million from $3.9 million for the three months ended March 31, 2022. The decrease is primarily due to lower employee and consulting costs.

Other Income (Expense): Other income (expense) consists primarily of a gain related to sale of nonfinancial asset, costs related to debt extinguishment, accrued exit fees on debt, non-cash interest on financing agreements, and interest on debt.

Other Expense, Net

Other expense, net was $0.1 million and $2.3 million for the three months ended March 31, 2023 and 2022, respectively. Beginning in Q2 2022, we no longer record non-cash interest expense due to our Amendment to the Royalty Purchase Agreement in the second quarter of 2022, which eliminated the liability related to the sale of royalties. This contributed $1.7 million of the decrease during the period. The rest of the decrease is primarily due to lower interest expense recorded in Q1 2023 on our MidCap term loan due to principal paydown.

Gain Related to Sale of Non-Financial Asset

We recorded $9.7 million in other income for the three months ended March 31, 2023, due to the sale of the deferred payments and milestones to XOMA during the quarter. We did not have any such gain for the comparative period in the prior year.

Discontinued Operations: Income from discontinued operations was $1.0 million and $0.2 million for the for the three months ended March 31, 2023 and 2022, respectively. For the three months ended March 31, 2023, we collected $0.5 million in deferred payments from Medexus related to IXINITY sales and $0.2 million related to funds released from escrow from the sale of Aptevo BioTherapeutics in 2020. Additionally, we received $0.3 million related to the sale of hyperimmune business Saol as a result of the collection of certain accounts receivable. For the three months ended March 31, 2022, we collected $0.2 million in deferred payments from Medexus related IXINITY sales.

Net Income (Loss): Aptevo had a net income of $2.8 million or $0.39 per share for the period ended March 31, 2023, compared to a net loss of $7.7 million or $1.55 per share for the corresponding period in 2022.

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.