On June 12, 2024 Affimed N.V., 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 quarter ended March 31, 2024 (Press release, Affimed, JUN 12, 2024, View Source [SID1234644698]).

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"We continue to make remarkable progress across our three clinical programs, AFM24, acimtamig, and AFM28," said Dr. Andreas Harstrick, Chief Medical Officer, and acting Chief Executive Officer of Affimed. "The data that we are presenting today mark an important point for our company as we see clinical validation of our strategy to use the power of the innate immune system to fight cancer with all three assets. The initial data for the LuminICE-203 study, combining acimtamig and allogeneic NK cells (AlloNK) are impressive with nearly 86% objective responses and more than 50% complete remissions in treatment refractory Hodgkin lymphoma patients. These data validate our approach of co-administration of ICE molecules with allogeneic, off-the-shelf, cryopreserved NK cells. The results with AFM24 in combination with atezolizumab support our second strategy in which we leverage the combined forces of the innate and the adaptive immune system. We see objective responses in heavily pretreated NSCLC patients, both in the EGFRwt and EGFRmut subpopulations. The long duration of responses observed in the EGFRwt cohort, where 3 of 4 responses now continue for more than 7 months is very promising in these poor prognosis patients and demonstrate that this chemotherapy free approach is capable of providing long-lasting tumor control. Finally, for AFM28 we have established a pharmacodynamically and clinically active dose with a good safety profile. 5 of 6 patients in cohort 6 derived clinical benefit including two patients with an objective response. These results and the efficacy data observed with acimtamig plus allogeneic NK cells strongly support our strategic intention to develop AFM28 in combination with allogeneic NK cells for the treatment of refractory AML."

Program Updates

Acimtamig (AFM13; CD30 / CD16A)
Independent read data from the first 7 patients show an ORR of 85.7 % with 4 CRs and 2 PRs.

All patients were heavily pretreated with a median of 4 lines of prior treatment including combination chemotherapy, brentuximab vedotin and checkpoint inhibitors; 71 % (5/7 patients) had also failed after prior autologous stem cell transplantation (ASCT).
Treatment related adverse events were consistent with previous experience and were mainly mild to moderate IRR/CRS in nearly two thirds of the patients (4/7). One patient developed a short-lasting grade 3 CRS but was also diagnosed to have acute cytomegalovirus infection. All side effects were well manageable with standard of care treatment and there were no treatment discontinuations due to acimtamig or AlloNK related adverse events. No cases of bleeding, immune effector cell-associated neurotoxicity syndrome or graft-versus-host disease were observed. Enrollment in cohorts 1 and 2 is completed; cohorts 3 and 4 are now open and enrolling.
Continued updates from the study to be provided on upcoming earnings calls and scientific conferences.
AFM24 (EGFR / CD16A)
In the AFM24-102 trial (combination with atezolizumab): 4 confirmed responses (1CR, 4PR) and 8SD in 17 heavily pretreated EGFRwt NSCLC patients; mPFS of 5.9 months; 3 out of 4 responses ongoing for more than 7 months.

All patients were pretreated with platinum-based chemotherapy and checkpoint inhibitors PD [L]-1.
On May 29, the Company announced that it received FDA Fast Track designation for the combination treatment of AFM24 with atezolizumab for EGFRwt NSCLC patients.
In 13 response-evaluable, heavily pretreated EGFRmut NSCLC patients, the combination of AFM24 with atezolizumab showed encouraging signals of clinical activity, including 1 CR, 3 PRs and 6 SDs. All responses are ongoing and have been confirmed by follow up scan.
ORR and PFS data from the 25 patient EGFRmut NSCL cohort is expected in Q3 2024; data from the 40 patient EGFRwt cohort is expected in Q4 2024.
AFM28 (CD123 / CD16A)

Completed enrollment of the sixth and final cohort in the multi-center Phase 1 open-label, dose-escalation study (AFM28-101), of AFM28 monotherapy in CD123-positive r/r acute myeloid leukemia (AML).

Of 6 patients treated at dose level 6 at 300mg, 1 patient showed a CR, 1 patient a CRi and 3 patients achieved SD, a CR/CRi rate of 33%.
Of 6 patients treated at dose level 5 at 250 mg, 1 patient showed a CR, ongoing after 5 months; 5 patients achieved a SD as best response.
No dose-limiting toxicities were reported in dose levels 5 and 6.
Data from the study is expected to be presented at a future scientific conference.
Further clinical development of AFM28 to be pursued in combination with an allogeneic, off-the-shelf NK cell product.
Upcoming Milestones:

Data readout from the 12 patients in cohorts 1 and 2 of the LuminICE-203 (AFM13 combination with AlloNK cells) study in Q3 2024.
ORR and PFS data from the 25 patients in the EGFRmut cohort of the AFM24-102 study in Q3 2024.
ORR and PFS data from the 40 patients in the EGFRwt cohort of the AFM24-102 study in Q4 2024.
First Quarter 2024 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 March 31, 2024, cash, cash equivalents and short-term investments totaled €48.5 million. Based on our current operating plan and assumptions, we anticipate that our cash, cash equivalents and short-term investments will support operations into H2 2025.

Net cash used in operating activities for the quarter ended March 31, 2024 was €23.8 million compared to €33.2 million for the quarter ended March 31, 2023. The decline was mainly due to lower research and development expenditure.

Total revenue for the quarter ended March 31, 2024, was €0.2 million compared with €4.5 million for the quarter ended March 31, 2023. Revenue in 2024 only related to a platform license provided to Genentech and 2023 predominantly related to the Roivant and Genentech research collaborations.

Research and development expenses for the quarter ended March 31, 2024, were €15.4 million compared to €29.5 million in 2023. The decrease was primarily a result of lower expenses associated with the development of the AFM13 and AFM24 programs, due to a decrease in procurement of clinical trial material, clinical trial costs and manufacturing costs, decrease in head count due to the corporate restructuring which is compensated in quarter one by one-time costs, such as severance payments and impairment losses.

General and administrative expenses for the quarter ended March 31, 2024, were €4.5 million compared to €6.9 million for the quarter ended March 31, 2023. The decrease was due to declines in head count, in legal and consulting expenses, insurance expenses and share-based payment expenses.

Net finance income/costs for the quarter ended March 31, 2024 were €0.4 million income compared to €0.5 million costs for the quarter ended March 31, 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, interest on the Bootstrap loan and interest earned on the treasury bonds.

Net loss for the quarter ended March 31, 2024, was €19.2 million, or €1.27 loss per common share compared with a net loss of €32.0 million, or €2.14 loss per common share, for the quarter ended March 31, 2023.

The weighted number of common shares outstanding for the quarter ended March 31, 2024, was 15,129,952 shares.

Additional information regarding these results will be included in the notes to the consolidated financial statements as of March 31, 2024, 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 June 12, 2024, at 8:30 a.m. EDT / 14:30 CET to discuss first quarter 2024 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/BId697f70815a8448d80b68becf533be98, 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.

On June 12, 2024 City of Hope reported that treating prostate cancer with immunotherapy is currently difficult to do (Press release, City of Hope, JUN 12, 2024, View Source [SID1234644300]). But preliminary results from a first in-human phase 1 trial using a chimeric antigen receptor (CAR) T cell therapy developed by researchers from City of Hope, one of the largest cancer research and treatment organizations in the United States, showed that patients with advanced prostate cancer had minimal side effects with the cellular immunotherapy and had promising therapeutic activity, according to a study published today in Nature Medicine.

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The trial treated 14 prostate stem cell antigen (PSCA)-positive patients who had metastatic castration resistant prostate cancer (mCRPC), which had spread beyond the prostate and no longer responded to hormone treatment, using CAR T cell therapy. More than 34,000 men with this type of prostate cancer die each year in the United States.

Saul Priceman, Ph.D., City of Hope associate professor, Department of Hematology & Hematopoietic Cell Transplantation, and team developed CAR T cells that target prostate stem cell antigen (PSCA) found to be highly expressed in prostate cancer. The treatment took a patient’s immune cells – known as T cells – from the bloodstream, and reprogrammed the cells in a laboratory with a CAR to recognize and attack the PSCA protein on the surface of cancer cells. CAR T cells were then infused back into the patient’s system to destroy cancer cells.

"Prostate cancer has been called an immune desert — the tumor microenvironment is difficult to treat with immunotherapies because you don’t get a lot of T cells inside the tumor," said Tanya Dorff, M.D., City of Hope section chief, Genitourinary Disease Program, and professor, Department of Medical Oncology & Therapeutics Research. "It takes something really powerful to overcome that. Our study showed that City of Hope’s CAR T cell therapy for prostate cancer could be a step closer to doing that."

"Our trial’s preliminary major finding is that PSCA-directed CAR T cells may be effective against mCRPC," Priceman added. "This opens up the opportunity to continue to develop this type of cellular immunotherapy for these patients, who currently have no other effective treatment options."

The trial’s goals were to examine the therapy’s safety and dose-limiting toxicities, or side effects that limit the amount of treatment that can be administered, as well as preliminary data on the treatment’s efficacy in patients.

The study’s findings were:

Patients received a single infusion of 100 million CAR T cells without prior lymphodepletion chemotherapy, which is used routinely in blood cancers to improve the efficacy of CAR T cell treatment. Since this was a first-in-human CAR T cell trial, it was important to assess the safety of CAR T cells alone in patients.
At that same CAR T cell dose and with lymphodepletion, there was a side effect of dose-limiting toxicity of cystitis, or irritation of the bladder. Dorff explained that PSCA is also found in the bladder so the CAR T cells most likely attacked the bladder cells, causing inflammation. Researchers then added a new cohort to the study using reduced lymphodepletion, which mitigated this toxicity.
Four out of 14 patients had declines in their PSA levels, which is a serum marker of disease progression in people with prostate cancer, including one patient with a significant decline. Imaging showed therapeutic responses in a subset of treated patients.
Five out of 14 patients had mild or moderate cytokine release syndrome, which can be caused by a large, rapid release of cytokines into the blood from immune cells and is a common side effect after CAR T cell therapy. CRS was a treatable side effect.
CAR T cells did not persist at high levels beyond the 28-day monitoring period, which limits the therapy’s effectiveness. This presented a common challenge in the solid tumor CAR T cell field that researchers plan to address in a follow-up City of Hope trial using the therapy that is now open for enrollment.
One patient who had received several prior therapies responded well to the CAR T cell therapy. His PSA level decreased by 95% and cancer in his bones and soft tissue also declined. He experienced this positive response for approximately eight months.

"The patient’s results were very encouraging, and we are deeply grateful for his participation in our study as well as other patients and their families," Dorff said. "We want to continue with this therapy and increase the amount of CAR T cells, and continue to carefully monitor for any health problems, as we think this can improve the therapy’s effectiveness."

The phase 1b trial using the PSCA-CAR T cell therapy in combination with radiation to enhance anti-tumor activity aims to enroll up to 24 patients.

City of Hope, a recognized leader in CAR T cell therapies, has treated nearly 1,500 patients since its CAR T program started in the late 1990s. The institution continues to have one of the most comprehensive CAR T cell clinical research programs in the world — it currently has about 70 ongoing CAR T clinical trials, which include 13 different solid tumor types. The trials use City of Hope-developed therapies and industry-sponsored products. A recent study published in Nature Medicine featured City of Hope’s CAR T cell therapy for brain tumors.

City of Hope manufactured the CAR T cells in its own facility, the Cell Therapy Production Center on its Los Angeles campus.

The Prostate Cancer Foundation helped fund the trial.

On June 12, 2024 Foundation Medicine, Inc., reported that it has formed a collaboration with Repare Therapeutics, a leading clinical-stage precision oncology company, to provide prospective genomic profiling to patients in Repare’s ongoing Phase I/Ib MYTHIC study (NCT04855656) of lunresertib alone or in combinations in genomically-defined patient populations (Press release, Foundation Medicine, JUN 12, 2024, View Source [SID1234644299]). The companies are also exploring opportunities to develop FoundationOneCDx, a tissue-based comprehensive genomic profiling test, as a companion diagnostic for the lunresertib program.

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Lunresertib is a first-in-class, selective and potent oral small molecule inhibitor of PKMYT1, a cancer target Repare discovered and identified as synthetic lethal with CCNE1 amplification, FBXW7 and PPP2R1A alterations in solid tumors. Lunresertib is being evaluated alone and in combinations across several studies in the United States, Canada, European Union and United Kingdom. Repare has presented positive initial Phase 1 data, including compelling safety and anti-tumor activity, demonstrating proof of concept for lunresertib alone and in combination with camonsertib, a potential best-in-class ATR inhibitor developed by Repare and in Phase 1/2 development.

Using a tissue sample, the U.S. Food and Drug Administration-approved FoundationOne CDx test analyzes more than 300 cancer-related genes for genomic alterations in a patient’s tumor. The test currently has over 35 companion diagnostic indications. Foundation Medicine is the global leader in companion diagnostic approvals with approximately 60% of all U.S. companion diagnostic approvals for next generation sequencing testing.

"High-quality companion diagnostics are critical to inform treatment decisions, and they are especially important for detecting complex biomarkers in patients without any therapeutic options," said Troy Schurr, Chief Biopharma Business Officer at Foundation Medicine. "We’re proud to partner with Repare Therapeutics as they work to advance this potential first-in-class therapy for patients with high unmet need."

Foundation Medicine and FoundationOne are registered trademarks of Foundation Medicine, Inc.

On June 12, 2024 Ensem Therapeutics, Inc. reported that its partner BeiGene has dosed the first five patients in its first-in-human Phase 1 trial to evaluate BG-68501, a small molecule cyclin-dependent kinase 2 (CDK2) inhibitor for the treatment of solid tumors (Press release, ENSEM Therapeutics, JUN 12, 2024, View Source [SID1234644298]). The achievement triggers a milestone payment from BeiGene, which licensed the compound (formerly ETX-197) from ENSEM in November 2023. BG-68501 is the first clinical stage compound to emerge from ENSEM’s Kinetic Ensemble platform, a suite of novel AI/ML, computational and experimental technologies to uncover cryptic pockets in target proteins for drug discovery.

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"CDK2 hyperactivity plays a well-recognized role in many cancers but has been an extremely challenging target for drug discovery," said Shengfang Jin, CEO and Co-Founder of ENSEM. "Through our partner BeiGene, which has a proven track record of innovative clinical development, we have an initial opportunity to test our novel approach to targeting cryptic sites, which are not obvious in static protein structures."

The Phase 1 clinical trial, conducted by BeiGene, is evaluating BG-68501 in advanced or metastatic solid tumors potentially associated with CDK2 dependency, including HR+/HER2- breast cancer, platinum refractory or resistant serous ovarian, fallopian tube, primary peritoneal cancer, small cell lung cancer, and others (NCT06257264).

"The complete nonclinical development of ETX-197 by ENSEM, from conceptualization to IND submission in two years, has validated ENSEM’s platform and demonstrated expeditious project execution," noted Dr. Jin. ENSEM is currently advancing multiple early-stage programs targeting oncogenic drivers, anticipating nomination of two development candidates in 2024.

On June 12, 2024 IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of the ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, reported that data from an interim analysis of its ICESECRET kidney cancer trial were presented at the 3rd Annual Israeli Conference on Interventional Radiology in Tel Aviv, Israel on June 10, 2024 (Press release, IceCure Medical, JUN 12, 2024, View Source [SID1234644297]). Dr. Avivit Shoham, Deputy Director of the Vascular and Interventional Radiology Unit at Beilinson Rabin Medical Center, presented a session on Cryotherapy of Renal Malignancies in Israel, which included data previously shared in December 2022 at the Urological Association Conference in Eilat, Israel.

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Professor Sarel Halachmi, the Principal Investigator of the ICESECRET clinical trial, said, "Cryoablation is a safe and effective, minimally invasive ablative approach for treating renal cell carcinoma presenting with tumors ≤3 centimeters, resulting in shorter hospitalization than nephrectomy and minor side effects on the renal function and on hemoglobin levels. Further studies are needed to confirm cryoablation as a viable option to treat kidney lesions."

IceCure’s CEO Eyal Shamir added, "The data were very well received by interventional radiologists attending the conference from around the world and locally here in Israel. We are pleased to advance ProSense’s applications across numerous indications. Kidney cancer is an indication in which our minimally invasive cryoablation system may offer significant benefits."

About ICESECRET
ProSense is being evaluated for the indication of kidney cancer in ICESECRET, a prospective, multicenter, single-arm clinical trial performed at Bnai-Zion Medical Center, Haifa, Israel, and Shamir Medical Center, Zerifin, Israel. The trial includes 115 patients (138 lesions) with localized small renal masses of ≤5 centimeters who were treated with ProSense cryoablation under CT guidance. Full engulfment of the renal lesion, including a safety margin of 0.5 centimeters was achieved in approximately 96% of the procedures where there was no anatomical limitation. Follow-up visits are performed 6 weeks, 6 months, 1 year, and then annually up to 5 years after the procedure. During the follow-up visits, data related to local recurrence, based on CT imaging, is collected. Safety was determined by monitoring procedure-related adverse events throughout the study.

About ProSense
The ProSense Cryoablation System provides a minimally invasive treatment option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including breast, kidney, lung, and liver.

ProSense enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense opens that door to fast and convenient office-based procedure for breast tumors.