On August 10, 2023 Researchers with City of Hope, one of the largest cancer research and treatment organizations in the nation, reported preclinical research in Nature Communications demonstrating that a chimeric antigen receptor (CAR)-engineered T cell therapy worked against ovarian cancer in the laboratory and in preclinical models (Press release, City of Hope, AUG 10, 2023, View Source [SID1234634236]).

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City of Hope’s Saul Priceman, Ph.D., is conducting research on chimeric antigen receptor (CAR)-engineered T cell therapy and has demonstrated in the laboratory and in preclinical models that the investigational cell therapy can work against ovarian cancer. The preclinical study was published in Nature Communications.
City of Hope’s Saul Priceman, Ph.D., is conducting research on chimeric antigen receptor (CAR)-engineered T cell therapy and has demonstrated in the laboratory and in preclinical models that the investigational cell therapy can work against ovarian cancer. The preclinical study was published in Nature Communications.
"City of Hope’s research helped develop CAR T cell therapies for blood cancers, and these patients are now seeing long-term benefits from the therapy, but we can’t stop there," said Saul Priceman, Ph.D., associate professor in the Department of Hematology & Hematopoietic Cell Transplantation and associate director of Translational Sciences & Technologies in the T Cell Therapeutics Research Laboratories at City of Hope. "The next frontier is solid tumors, and City of Hope is taking on that challenge."

The therapy is currently in a first-in-human Phase 1 trial at City of Hope for patients with advanced epithelial ovarian cancer who have already received platinum-based chemotherapy. The trial, led by Lorna Rodriguez-Rodriguez, M.D., Ph.D., City of Hope professor in its Division of Gynecologic Oncology, Department of Surgery, is testing the therapy’s safety, side effects and activity of the therapy in patients. The trial is currently enrolling patients for treatment.

Developing a CAR T cell therapy for solid tumors is particularly challenging because the therapy needs to first reach the solid tumor and then survive in a harsh microenvironment that is filled with cancer cells and other cells that prevent attack by the CAR T cells. But Priceman and his team have made significant progress in overcoming these challenges.

The team’s most recent research found that a CAR T cell therapy targeting TAG72, a target found on the surface of ovarian cancer cells, eradicates cancer cells in mouse models.

"What’s exciting about this is that TAG72 is also found on other cancer cells, including pancreatic, colorectal, breast and brain tumors, so if the clinical trial in ovarian does well, we can investigate expanding this to other patients," he added.

CAR T cell therapy involves taking a patient’s T cells, a white blood cell that helps fight disease, from the bloodstream. T cells are then reprogrammed with a CAR in a City of Hope laboratory to recognize and attack a specific cancer-causing protein, such as TAG72, and reintroduced into the patient’s bloodstream. CAR T cells should then eradicate cancer cells. Patients are closely monitored for any side effects.

Priceman and his team also found that by adding the cytokine Interleukin-12 (IL-12), a protein that sends signals to the immune system, to the CAR T cell therapy, the treatment worked more effectively against cancer cells in the lab. The co-first authors Eric Hee Jun Lee and John P. Murad, Ph.D., along with the rest of the team, showed that IL-12 also enabled the T cells to both fight the cancer and leave the tumor area, enter the bloodstream and target other cancer cells around the body. Priceman noted that IL-12 is not currently part of the current Phase 1 clinical trial.

The preclinical research also found that delivering the CAR T cell therapy via an injection where the cancer is located, regionally, is also effective in enabling CAR T cells to target cancer elsewhere. This technology allows for both safety and improved anti-tumor activity in several cancer types tested to date.

"This therapy has been years in the making at City of Hope, so we are excited to finally see it in patients whose cancer is advanced and are in need of more treatments," Priceman added.

On August 10, 2023 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, and Hansoh Pharmaceutical Group Company Limited ("Hansoh Pharma" SEHK: 3692.HK), a leading innovation-driven pharmaceutical company with a focus on the treatment of major diseases including oncology, infectious diseases, CNS disorders, metabolic diseases, and autoimmune diseases, reported the entrance into a collaboration agreement between Antengene and Hansoh Pharma for the commercialization of XPOVIO in the mainland of China (Press release, Antengene, AUG 10, 2023, View Source [SID1234634235]).

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"Our collaboration with Hansoh Pharma further strengthens our confidence in the market potential of the First and Only-in-class XPO1 inhibitor XPOVIO in the mainland of China," said Dr. Jay Mei, Founder, Chairman, and Chief Executive Officer of Antengene. "Through collaborating with Hansoh Pharma, we will leverage their well-established commercialization infrastructure to make XPOVIO more accessible to patients in the mainland of China. Given Antengene’s plans to apply for inclusion into the National Reimbursement Drug List (NRDL) for XPOVIO in the near future, and the broad indication expansion potential of XPOVIO, it is crucial to ensure that XPOVIO could reach as many cities, hospitals and prescribers, and benefit as many patients as possible. We believe this collaboration with Hansoh Pharma will not only enhance assess of XPOVIO but also lead to commercial success in the mainland of China."

"Hansoh Pharma is excited to enter into this partnership with Antengene and is committed to bringing XPOVIO to more patients in China," said Ms. Yuan Sun, Executive Director of Hansoh Pharma. "We believe that XPOVIO is a drug with great commercial potential, addressing huge unmet medical needs for those hematologic patients in China. In addition to obtaining approvals in multiple countries and regions globally for multiple myeloma and diffuse large B-cell lymphoma, XPOVIO has indication expansion potential in myelofibrosis, endometrial cancer, as well as T/NK-cell lymphoma. We look forward to collaborating with Antengene and make XPOVIO available to the widest possible number of Chinese patients with hematological malignancies."

Under the terms of the agreement, Antengene will continue to be responsible for research and development, regulatory approvals and affairs, product supply, and distribution of XPOVIO, while Hansoh Pharma will be exclusively responsible for commercialization of XPOVIO in the mainland of China. Antengene will receive up to RMB200 million of upfront payments, RMB100 million of which shall be received upon signing, and pursuant to the Agreement and subject to the terms and conditions thereof, Antengene shall be eligible to receive up to RMB100 million of the remaining upfront payments, and up to RMB535 million in milestone payments from Hansoh Pharma. Antengene will continue to record revenues from sales of XPOVIO in the mainland of China and Hansoh Pharma will charge a service fee to Antengene.

About Multiple Myeloma

Multiple myeloma (MM) is caused by the dysregulated proliferation of plasma cells. It is the second most common hematologic malignancy in many countries. Despite availability of a number of treatments for relapsed patients, MM is prone to relapse and most patients still succumb to their disease. MM is the second most common hematologic malignancy in China, with an estimated about 15,000 to 20,000 new MM patients and 10,300 deaths per year.1

About XPOVIO (selinexor)

XPOVIO is the world’s first approved orally-available, selective inhibitor of the nuclear export protein XPO1. It offers a novel mechanism of action, synergistic effects in combination regimens, fast onset of action, and durable responses.

By blocking the nuclear export protein XPO1, XPOVIO can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins. XPOVIO delivers its antitumor effects through three mechanistic pathways: 1) exerting antitumor effects by inducing the intranuclear accumulation of tumor suppressor proteins; 2) reducing the level of oncogenic proteins in the cytoplasm by inducing the intranuclear accumulation of oncogenic mRNAs; 3) restoring hormone sensitivity by activating the glucocorticoid receptors (GR) pathway. To utilize its unique mechanism of actions, XPOVIO is being evaluated for use in multiple combination regimens in a range of indications. At present, Antengene is conducting 8 clinical studies of XPOVIO in mainland of China for the treatment of relapsed/refractory hematologic malignancies and solid tumors (3 of these studies are being jointly conducted by Antengene and Karyopharm Therapeutics Inc. [Nasdaq:KPTI]).

XPOVIO is approved in South Korea for the following two indications:

In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
As a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy.
XPOVIO is approved in mainland of China for the following indication:

In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received prior therapies and whose disease is refractory to at least one proteasome inhibitor, at least one immunomodulatory agent, and an anti-CD38 monoclonal antibody.
XPOVIO is approved in Taiwan China for the following three indications:

In combination with dexamethasone (Xd) for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors (PIs), at least two immunomodulatory agents (IMiDs), and an anti-CD38 monoclonal antibody.
In combination with bortezomib and dexamethasone (XVd) for the treatment of adult patients with MM who have received at least one prior therapy.
As a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy.
XPOVIO is approved in Hong Kong China, for the following indication:

In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors (PIs), two immunomodulatory agents (IMiDs), an anti-CD38 monoclonal antibody (mAb), and who have demonstrated disease progression on the last therapy.
XPOVIO is approved in Australia for the following two indications:

In combination with bortezomib and dexamethasone (XVd) for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy.
In combination with dexamethasone (Xd) for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor (PI), at least one immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody (mAb).
XPOVIO is approved in Singapore for the following three indications:

In combination with bortezomib and dexamethasone for treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy.
In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
As a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy who are not eligible for haematopoietic cell transplant.

On August 10, 2023 WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), and Boostimmune, a biotech company dedicated to developing next-generation anti-cancer therapies modulating the tumor immune microenvironment and ADCs to novel targets, reported a Memorandum of Understanding (MOU) had been signed for research and discovery services for Boostimmune’s pipeline (Press release, WuXi Biologics, AUG 10, 2023, View Source [SID1234634234]).

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Under the collaboration, Boostimmune will have access to WuXi Biologics’ integrated discovery services and extensive expertise in antibody discovery, lead optimization, in vitro screening and characterization, as well as in vivo tests. WuXi Biologics will be the exclusive service partner to support Boostimmune in generating different modality candidates, including monoclonal antibodies, bispecific antibodies and recombinant proteins.

Dr. Gwanghee Lee, Co-founder and CEO of Boostimmune, commented, "Collaborating with WuXi Biologics – and accessing their comprehensive antibody generation technology platform – offers an opportunity to discover novel biological candidates and explore the science of complex proteins. We look forward to working with WuXi Biologics to build a compelling pipeline with the potential to meaningfully improve the lives of patients."

Dr. Chris Chen, CEO of WuXi Biologics, commented, "We are very pleased to partner with Boostimmune to advance their innovative pipeline. The biotech industry in South Korea is flourishing, and there is increasing demand for end-to-end discovery and development services. WuXi Biologics is proud to support our global and Asia partners in bringing innovative biologics solutions to market for patients around the world."

On August 10, 2023 Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-­stage biopharmaceutical company focused on developing innovative treatments for cancer patients, reported second quarter 2023 financial results and summarized recent developments (Press release, Monopar Therapeutics, AUG 10, 2023, View Source [SID1234634233]).

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Recent Developments

Camsirubicin – Phase 1b Dose­-Escalation Trial, Treating Fifth Dose­-Level Cohort (650 mg/m2)

As recently reported, both of the advanced soft tissue sarcoma (ASTS) patients so far in the fifth dose-level cohort (650 mg/m2) have experienced tumor size reductions – of 18% and 20%, respectively – after the first two cycles of camsirubicin treatment. These patients are set to receive additional cycles of camsirubicin treatment, which may result in further tumor size reduction.
Phase 1b clinical trial data continue to support Monopar’s dose-response hypothesis with camsirubicin. The best response seen prior to the current 650 mg/m2 dose level was a 21% reduction in tumor size in a patient after receiving six cycles of camsirubicin treatment at the immediately prior dose level (520 mg/m2). This patient’s cancer was unresectable at study entry, but after the tumor size reduction, the patient was able to undergo a successful surgical removal of the cancer with clear margins. All three patients at this prior dose level (520 mg/m2) achieved stable disease with either a net reduction or no overall change in tumor size per RECIST 1.1 while on study drug.
No drug-­related cardiotoxicity has been observed in the trial to date as evaluated by the industry standard left ventricular ejection fraction (LVEF). This compares favorably to the well­-documented cumulative dose-­restricting cardiotoxicity experienced with doxorubicin, the current first-­line treatment for ASTS.
MNPR­101 for Radiopharmaceutical Use – Promising Preclinical Studies Support First in Human Study

MNPR­-101 is a uPAR-targeting antibody being developed in collaboration with NorthStar Medical Radioisotopes LLC as a precision radiopharmaceutical for both imaging and treatment of cancer. Both the imaging and therapeutic agents are showing promise in preclinical studies and are advancing toward first-in-human (FIH) studies potentially as early as the end of this year.
MNPR-101-Zr is a cancer imaging agent radiolabeled with 89Zirconium, a positron emission tomography (PET) imaging isotope. Recent preclinical imaging studies have shown selective, high, and enduring tumor uptake across multiple aggressive cancers including pancreatic, colorectal, and triple negative breast cancers.
MNPR-101-RIT is a cancer therapeutic agent radiolabeled with 225Actinium, a powerful alpha-emitting isotope. Preclinical studies show a favorable biodistribution and a strong, dose-dependent anti-tumor effect in triple-negative breast cancer models.
Monopar and the Cancer Science Institute at the National University of Singapore (NUS) recently announced a collaborative effort to investigate uPAR expression levels in subtypes of ASTS as a means to identify the most promising subtypes to pursue in subsequent human clinical trials using MNPR-101-Zr and MNPR-101-RIT.
MNPR­202­ Promising Preclinical Data Ignite Further Research

MNPR­202 is a camsirubicin analog designed to retain the same potentially non-­cardiotoxic backbone as camsirubicin but is modified at other positions which may enable it to work in cancers that are resistant to doxorubicin, one of the most commonly-used cancer drugs worldwide.
In collaboration with Dr. Anand Jeyasekharan at NUS, preclinical studies are showing that MNPR-202 has a similar cytotoxic potency to doxorubicin but that it works in a distinct way and against doxorubicin-sensitive cancers as well as doxorubicin-resistant ones.
Preclinical work comparing the cardiotoxic effects of doxorubicin to MNPR-202 is currently underway using well-established models of doxorubicin cardiotoxicity.
Results for the Second Quarter Ended June 30, 2023 Compared to the Second Quarter Ended June 30, 2022
Cash and Net Loss

Cash, cash equivalents and short­-term investments as of June 30, 2023 were $10.2 million. Monopar expects that its current funds will be sufficient for Monopar to obtain topline results from its ongoing open­-label Phase 1b camsirubicin clinical trial by mid-2024 (but this may not be the case if camsirubicin reaches even higher dose levels than anticipated and topline results are deferred as dosing continues beyond mid-2024), advance the Company’s MNPR-101 radiopharmaceutical program into its first-in-human clinical trial, and close out Monopar’s terminated Validive Phase 2b/3 (VOICE) clinical program. The Company estimates its cash, cash equivalents and short-term investments will fund the Company’s planned operations at least through September 2024. Monopar will require additional funding to advance its clinical and preclinical programs beyond that and anticipates seeking to raise additional capital within the next 12 months to fund its future operations.

Net loss for the second quarter of 2023 was $2.2 million or $0.16 per share compared to net loss of $2.8 million or $0.22 per share for the second quarter of 2022.

Research and Development (R&D) Expenses

R&D expenses for the three months ended June 30, 2023 were $1,595,000, compared to $2,078,000 for the three months ended June 30, 2022. This represents a decrease of $483,000 primarily attributed to (1) a decrease of $606,000 in camsirubicin clinical trial expenses and manufacturing-related expenses, and (2) a decrease of $68,000 in Validive clinical trial and manufacturing-related expenses. These decreases were partially offset by (1) a $99,000 increase in non-clinical studies related to MNPR-101-Zr and MNPR-101-RIT activity, and (2) an increase of $112,000 in R&D personnel and consulting expenses.

General and Administrative (G&A) Expenses

G&A expenses for the three months ended June 30, 2023 were $733,000, compared to $685,000 for the three months ended June 30, 2022. This represents an increase of $48,000 primarily attributed to an increase in G&A salaries and benefits.

On August 10, 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 financial results and provided an update on clinical and corporate progress for the second quarter of 2023 (Press release, Affimed, AUG 10, 2023, View Source [SID1234634232]).

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"Affimed continues to make important progress across all three of our clinical assets, setting the stage for a catalyst-rich next 12 months," said Dr. Adi Hoess, CEO of Affimed. "This includes data in the first half of 2024 from the LuminICE-203 trial of AFM13 which builds upon our unprecedented proof of concept data. For AFM24, we plan to present data later this year from the combination with atezolizumab. Finally, we are rapidly advancing our phase 1 study for AFM28 towards what we believe could be therapeutic dose levels."

PROGRAM UPDATES
AFM13 (CD30/CD16A)

Investigational new drug (IND) application cleared by FDA for LuminICE-203, a phase 2 clinical study to investigate AFM13 in combination with Artiva’s AB-101 natural killer (NK) cells. LuminICE-203 will investigate the combination therapy of AFM13 and AB-101 in patients with r/r classical Hodgkin lymphoma (HL). The study will also include a cohort of 20 r/r PTCL patients. Affimed is in the final stages of site activation and expects to have the first sites open in September/October. The Company is on track to report initial data in the first half of 2024.

Type C meeting request submitted to FDA to further discuss the requirements for an accelerated approval based on the LuminICE-203 study. Affimed expects to gain further insight from the agency on the requirements for a registration application in the U.S. Based on FDA guidelines, Affimed expects the meeting to be held in the fourth quarter of 2023.

Preclinical data presented at the International Conference on Malignant Lymphoma showed that AFM13 binds homogeneously to thawed AB-101, guiding NK cells to CD30-positive tumor cells, and boosting AB-101’s cytotoxic activity against these cells. This effect was accompanied by increased functional activation of AB-101, evidenced by degranulation and IFN-γ production. Furthermore, tumor growth control was achieved by combining AFM13 with AB-101 in a mouse xenograft model.

AFM13-203 (LuminICE-203) will build on data generated from the Company’s AFM13-104 study which demonstrated the promise of AFM13 in combination with cord blood-derived NK (cbNK) cells for the treatment of r/r HL and non-Hodgkin lymphoma (NHL) patients. Data from the study, presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2022 annual meeting, demonstrated a 94% objective response rate (ORR) and a complete response rate (CR) rate of 71% in 35 heavily pre-treated CD30-positive HL and Non-Hodgkin lymphoma (NHL) patients treated at the recommended phase 2 dose (RP2D). 63% of patients (n=24) treated at the RP2D with at least 6 months of follow-up after the initial infusion remained in CR for at least 6 months. In addition, the treatment was well tolerated with no cases of cytokine release syndrome, immune effector cell-associated neurotoxicity or graft versus host disease observed. A data update from the AFM13-104 study is expected at ASH (Free ASH Whitepaper) in December, including a longer follow-up of patients.
AFM24 (EGFR/CD16A)

Presented clinical data from the ongoing AFM24 trials at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). Update from AFM24-101 phase 1/2 monotherapy study included 15 patients from the EGFR mutant NSCLC cohort showed AFM24 clinical activity in 7 out of 15 heavily pre-treated patients with tumor reductions, including 2 confirmed partial responses and 5 patients exhibiting stable disease. Based on the data, the Company decided to focus near-term development efforts on advancing AFM24 in combination with checkpoint inhibitors as part of its ongoing AFM24-102 study to further investigate the synergies between AFM24 and atezolizumab. As a result, enrollment in the monotherapy study and the combination of AFM24 with autologous NK cells will be terminated.

Enrollment ongoing for the Phase 1/2a combination study of AFM24 and atezolizumab, an anti-PD-L1 checkpoint inhibitor, in patients with advanced EGFR-expressing solid tumors. Expansion cohorts for AFM24-102 initiated during the first quarter 2023 and are actively enrolling patients with (1) EGFR-wildtype NSCLC (2) gastric /gastroesophageal junction adenocarcinoma and (3) a basket cohort evaluating pancreatic, hepatocellular, and biliary tract cancer. Based on the results from the monotherapy study, a fourth expansion cohort of patients with EGFR-mutant NSCLC has been added to the AFM24-102 study and is open for recruitment. Interim data from the first three cohorts is expected in the fourth quarter 2023.

Phase 1/2a combination data from the AFM24 and SNK01, NKGen Biotech’s ex vivo expanded and activated autologous NK cell therapy was recently presented at ASCO (Free ASCO Whitepaper) Breakthrough. In the study, seven patients with a mean number of five prior therapies received the combination of AFM24 and SNK01. No unexpected or dose-limiting toxicities were observed, and the PK properties of AFM24 were similar to AFM24 monotherapy. The best objective response was stable disease in three out of the seven patients, including patients with heavily pretreated microsatellite stable colorectal cancer (MSS CRC). This data forms the basis for a potential combination of AFM24 with an allogeneic, off-the-shelf NK cell product.
AFM28 (CD123/CD16A)

AFM28-101, a multi-center Phase 1 open label, dose escalation study of AFM28 monotherapy is treating patients with CD123-positive r/r AML. The second dose cohort was completed without any dose limiting toxicities. Currently, patients are being treated in the third dose cohort. Clinical development of AFM28 is planned as both single-agent and in combination with an allogeneic off-the-shelf NK cell product.
PARTNERSHIPS AND COLLABORATIONS
Affimed has completed its work on novel molecules for both Genentech and Affivant. Further development of these product candidates is at the discretion of the respective companies.

POTENTIAL UPCOMING MILESTONES
Follow-up data from AFM13-104 expected at ASH (Free ASH Whitepaper) in December 2023
Based on FDA guidelines, Type C meeting for LuminICE-203 is expected in the fourth quarter 2023
Data from Phase 1/2a AFM24+atezolizumab combination study planned in the fourth quarter 2023
Further progress updates from AFM28-101 dose escalation expected in the second half 2023
Initial data readout from the LuminICE-203 study expected in the first half 2024
SECOND QUARTER 2023 FINANCIAL HIGHLIGHTS
Affimed’s consolidated financial statements are prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standard Board (IASB). The consolidated financial statements are presented in Euros (€), the Company’s functional and presentation currency.

As of June 30, 2023 cash and cash equivalents totaled €120.1 million compared to €190.3 million on December 31, 2022. Based on our current operating plan and assumptions, we anticipate that our cash and cash equivalents will support operations into 2025.

Net cash used in operating activities for the quarter ended June 30, 2023 was €33.3 million compared to €26.5 million for the quarter ended June 30, 2022. Operating cash flow for the quarter ended June 30, 2023 was adversely impacted by a change in working capital of €7.5 million, primarily due to €4.3 million for changes in trade and other payables and €2.7 million for changes in other assets and prepaid expenses. The change in trade and other payables was driven primarily by payment of manufacturing costs for AFM13 and AFM24 that were expensed in prior periods, while the change in other assets and prepaid expenses was driven by €3.1 million of prepayments associated with the AFM13 LuminICE-203 trial, partially offset by the reduction in the amount of certain insurance prepayments.

Total revenue for the quarter ended June 30, 2023, was €1.4 million compared with €7.3 million for the quarter ended June 30, 2022. Revenue in 2022 and 2023 predominantly relates to the Roivant and Genentech collaborations.

Research and development expenses for the quarter ended June 30, increased by 21.3% from €20.8 million in 2022 to €25.3 million in 2023. The increase was primarily due to higher expenses associated with the development of the AFM13 and AFM24 programs, a result of an increase in procurement of clinical trial material, increased clinical trial costs and manufacturing costs and, an increase in costs associated with other early-stage programs and infrastructure.

General and administrative expenses decreased 25.1% from €8.4 million in the quarter ended June 30, 2022, to €6.3 million in the quarter ended June 30, 2023. The decrease was due to a decline in legal, consulting and insurance expenses, as well as share-based payment expenses.

Net finance income/costs for the quarter ended June 30, 2023 decreased from income of €2.3 million in the quarter ended June 30, 2022, to income of €0.0 million in the quarter ended June 30, 2023. Net finance income/costs are largely due to foreign exchange gains/losses related to assets denominated in U.S. dollars as a result of currency fluctuations between the U.S. dollar and Euro during the year.

Net loss for the quarter ended June 30, 2023, was €29.4 million, or €0.20 loss per common share compared with a net loss of €19.4 million, or €0.13 loss per common share, for the quarter ended June 30, 2022.

The weighted number of common shares outstanding for the for quarter ended June 30, 2023 was 149.3 million.

Additional information regarding these results will be included in the notes to the consolidated financial statements as of June 30, 2023, included in Affimed’s filings with the U.S. Securities and Exchange Commission (SEC).

Note on International Financial Reporting Standards (IFRS)
Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the IASB. None of the financial statements were prepared in accordance with U.S. Generally Accepted Accounting Principles. Affimed maintains its books and records in Euro.

CONFERENCE CALL AND WEBCAST INFORMATION
Affimed will host a conference call and webcast on August 10, 2023, at 8:30 a.m. EDT / 14:30 CET to discuss second quarter 2023 financial results and corporate developments.

The conference call will be available via phone and webcast. The live audio webcast of the call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source To access the call by phone, please use link: https://register.vevent.com/register/BI1a95f0d05ae14e099ffc1c7872731338, and you will be provided with dial-in details and a pin number.

Note: To avoid delays, we encourage participants to dial into the conference call 15 minutes ahead of the scheduled start time. A replay of the webcast will be accessible at the same link for 30 days following the call.