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 13, 2024 Zumutor Biologics Inc. "Zumutor", a Boston-based clinical stage Oncology Company developing first-in-class monoclonal antibody molecules targeting innate immunological pathways, reported that the first patient was dosed in its Phase 1 clinical trial, with ZM008 (Press release, Zumutor Biologics, JUN 12, 2024, View Source [SID1234644293]). The dose escalation trial is evaluating ZM008 in patients with advanced solid tumors, as a single agent and in combination with pembrolizumab.

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ZM008 is a novel fully human IgG1 monoclonal antibody against LLT1 (CLEC2D), which disrupts the interaction of LLT1-CD161 between NK cells and tumor cells. ZM008-mediated NK cell activation and subsequent T cell activation will modify the immune infiltrate in the tumor microenvironment driving eventual antitumor effects. The mode of action of ZM008 is to convert the ‘cold’ or less immune responsive cancers (TME) into ‘hot’ or highly immune responsive tumors. This approach could provide significant benefits to patients resistant to available immunotherapy treatments.

"While immunotherapy has made a significant and positive impact on patient outcomes, there remains a significant unmet need. ZM008 is a first-in-class antibody that could help patients, both as a single agent as well as in combination with anti-PD-1 directed therapy. We are pleased to participate in the study and are optimistic that early clinical activity may be observed in this heavily pre-treated patient population based on clinical evaluation and translational data," commented Dr. Ildefonso Ismael Rodriguez, MD, Principal Investigator at NEXT Oncology.

Understanding the Trial Design

The ZM008-001 trial is an open-label, first-in-human, multicenter, Phase 1 dose escalation trial of ZM008 administered alone or combined with Pembrolizumab. The trial will assess the safety, pharmacokinetics, establish the maximum tolerated dose, pharmacodynamic biomarkers, and initial antitumour activity of ZM008. The study will recommend the Phase 2 dose.

In stage 1A, increasing doses of ZM008 will be administered to patients with solid tumors, without standard therapeutic options. This will be followed by stage 1B, where ZM008 will be given in combination with the anti PD1 drug, Pembrolizumab. Multiple solid cancer indications will be enrolled: non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), head and neck squamous cell carcinoma (HNSCC), prostate cancer, colorectal cancer (CRC), high-grade serous ovarian cancer (HGSOC), and others. Clinical responses and detailed translational studies will be performed, to evaluate the activation of the immune system, safety and patient benefits, after ZM008 monotherapy and combination therapy.

Knowing the Criteria

The ZM008-001 clinical trial is for adults, aged 18 or older, with advanced metastatic solid tumors. Patient must have adequate hematologic, renal and hepatic functions. Patients with a history of auto-immune reactions and toxicities with previous anti-cancer therapies (irAEs) are not eligible. ZM008 will be administered intravenously once every three weeks. This trial requires multiple visits to NEXT Oncology sites for lab tests, safety evaluations, and other follow-up appointments each month.

"Advancing our first novel drug ZM008 into clinical development is an important inflection point for Zumutor and underscores the power of our Antibody discovery engine, INABLR, supporting the immuno-oncology pipeline," said Maloy Ghosh, PhD, Chief Scientific Officer at Zumutor Biologics. "We are excited to enroll patients in this first-in-human Phase 1 study, focused on advanced solid tumor patients. Activation of immune pathways, by targeting this novel mechanism with ZM008, will be a viable option for patients to fight advanced solid cancers."

"We are looking forward to see safety and efficacy data from the ZM008-001 clinical trial," said Kavitha Iyer Rodrigues, Founder/CEO of Zumutor. "There is such a tremendous unmet need for patients suffering from multiple solid cancers. We are eager to see this novel monoclonal antibody advance through clinical trials and hope it will one day be available for these patients in need."

"ZM008 is a very exciting molecule. The preclinical work, including the ex-vivo studies, have shown remarkable activity both as a single agent and in combination with pembrolizumab. We are hoping this will translate to beneficial activity in patients and are thankful to the trial sites for joining us in developing ZM008," said Dr. Debasish Roychowdhury, MD, Medical Oncologist.

Additional information on this clinical trial will be updated on www.clinicaltrials.gov (NCT06451497).

For questions or to enroll in this study, the patient’s treating physician can contact Jordan Georg. Phone: 210-580-9521

On June 12, 2024 Immorta Bio Inc, a science-based Life Extension company reported positive preclinical findings utilizing its senescent cell-killing immunotherapeutic product SenoVax in a model of non-small cell lung cancer (Press release, Immorta Bio, JUN 12, 2024, View Source [SID1234644294]). The results, which are reported in a filed patent, demonstrate successful induction of immunity to senescent cells surrounding lung cancer cells, and reproducible regression of established tumors. The SenoVax immunotherapy was administered in absence of other cancer killing therapeutics.

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"It has been published that tumors surround themselves with senescent cells, with negative correlations between the amount of senescent cells and patient survival1. Furthermore, increased resistance to cancer therapies such as chemotherapy2, radiation therapy3, and immunotherapy4 is associated with accumulation of senescent cells," said Dr. Thomas Ichim, President and CSO of Immorta Bio. "The fact that we are able to induce regression of tumors by simply killing the senescent cells that surround them, without other interventions, points to the potency of our approach."

The Company is currently in the late phase of preclinical development and plans to file an Investigational New Drug (IND) application with the FDA shortly to initiate treatment of advanced lung cancer patients.

"Immorta Bio is a Scientific Longevity Company. In that regard we are developing two longevity therapeutics platforms: Cellular Rejuvenation and Senolytic Immunotherapy (SenoVax)," said Dr. Boris Reznik, Chairman and CEO of Immorta Bio. "The results disclosed today are part of our second technology platform, which augments the immune system’s natural tendency to ‘clean up’ dysfunctional and senescent cells. Application of SenoVax to cancer treatment not only can potentially produce some effective oncology drug, but also is proving its potency in Senolytic life extension applications."

On June 12, 2024 Day One Biopharmaceuticals presented its corporate presentation (Presentation, Day One, JUN 12, 2024, View Source [SID1234644279]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On June 12, 2024 Accuray Incorporated (NASDAQ: ARAY) reported that the registration dossier for the Accuray Precision Treatment Planning System (TPS) has been approved by the Chinese National Medical Products Administration (NMPA) (Press release, Accuray, JUN 12, 2024, View Source [SID1234644295]). The Accuray Precision TPS is now available for use with the CNNC-Accuray joint venture Tomo C radiation therapy system and in combination, will provide medical care teams with a new option for delivering extremely precise and accurate radiotherapy treatments, ultimately expanding access to care for more cancer patients in China.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We couldn’t be more pleased about the approval of the Accuray Precision Treatment Planning System and the potential it represents, in combination with the Tomo C System, for cancer patients in China, a country which accounted for approximately 25 percent of new cancer cases diagnosed worldwide in 20201. With this approval our China joint venture can begin shipping the Tomo C System to their end customers, an important step forward in helping to address an unmet need for precision radiation therapy," said Suzanne Winter, president and CEO of Accuray.

Continued Ms. Winter, "Customers in China who use our organization’s CyberKnife, Radixact and TomoTherapy Systems are familiar with the Accuray Precision Treatment Planning System, a powerful, full-featured system that enables clinicians to efficiently generate high quality radiation therapy treatment plans. The availability of the treatment planning solution for the Tomo C System, a domestic made radiation therapy delivery device, will expand our portfolio in China and enhance our access in the regional Type B market."

The Accuray Precision TPS was developed to facilitate the creation and adaptation of precise treatment plans in less time. The planning solution enables clinicians to routinely incorporate modifications to treatment planning into the course of treatment to account for changes in tumor size, shape and location – as well as subtle changes in the location of organs and other healthy tissue – thereby increasing treatment precision.

The Tomo C platform features helical imaging and radiation delivery. With fully-integrated treatment planning, centralized data management and ultra-precise treatment delivery using patented beam-shaping technology, the system enables greater control of the radiation dose so it conforms precisely to the tumor and helps minimize dose to healthy tissue. The system is designed to enable medical care teams to optimize outcomes for standard radiation therapy indications including breast, prostate, lung, and head and neck cancers, in addition to complex treatments such as total marrow irradiation.