On November 3, 2022 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 two upcoming data presentations at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2022 Annual Meeting (Press release, Affimed, NOV 3, 2022, View Source [SID1234623127]).

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Dr. Yago Nieto, M.D., Ph.D., Professor of Stem Cell Transplantation and Cellular Therapy at The University of Texas MD Anderson Cancer Center and principal investigator of the study, will provide a clinical update from the ongoing phase 1/2 trial with Affimed’s lead innate cell engager (ICE) AFM13 precomplexed with cord blood-derived natural killer (cbNK) cells followed by three weekly infusions of AFM13 in patients with CD30-positive relapsed or refractory Hodgkin and non-Hodgkin lymphomas in an oral presentation, on Saturday, December 10 at 1:15 p.m. CST.

Since the last study update in April 2022 until the end of July, an additional 11 patients were enrolled, resulting in 24 patients treated at the recommended phase 2 dose (RP2D) with up to 4 cycles; a total of 30 patients have now been enrolled in the study. The combination treatment continues to show a 100% overall response rate (ORR) at the highest dose level and a further improvement in the complete response (CR) rate, from the previously reported 62% to 70.8%.

Affimed will also present updated preclinical data from its AFM28 program in a poster on December 12 from 6:00 – 8:00 p.m. CST, demonstrating the highly potent and selective killing of CD123-positive leukemic cells as well as leukemic stem cells and progenitor cells, supporting AFM28’s potential to achieve durable responses in relapsed or refractory Acute Myeloid Leukemia patients.

"Our ICE possess very high affinity to CD16A on NK cells and are considered highly efficient in redirecting such cells, both allogeneic and autologous, to attack tumor cells," said Dr. Andreas Harstrick, Chief Medical Officer at Affimed. "The extremely high efficacy seen with AFM13 in combination with NK cells is the basis of taking forward our other ICE, such as AFM24 and AFM28, to develop therapies that can serve the high unmet needs of cancer patients."

Details of AFM13 Oral Presentation and Abstract
Title: Innate Cell Engager AFM13 Combined with Preactivated and Expanded Cord Blood-Derived NK Cells for Patients with Double Refractory CD30+ Lymphoma
Session: Cellular Immunotherapies: Early Phase and Investigational Therapies: Lymphoma Presentation Date & Time: Saturday, December 10, 2022, 1:15 p.m. CST
Location: Ernest N. Morial Convention Center, La Nouvelle Orleans Ballroom AB

The AFM13-104 study is evaluating a combination of the ICE AFM13 with cbNK in late-stage patients with relapsed or refractory CD30+ Hodgkin and non-Hodgkin lymphoma. As of the abstract data cut-off on July 31, the study had enrolled 30 patients across three different dose levels DL1 (106 NK/kg), DL2 (107NK/kg) and DL3 (108 NK/kg); a total of 24 patients had been treated at DL3 (108 NK/kg) which was established as the RP2D. Each cycle of treatment consists of a lymphodepletion, followed by single dose of AFM13 precomplexed with cbNK cells and three subsequent infusions of AFM13 monotherapy. Two cycles of therapy were administered to patients 1 – 19 and up to four cycles were administered starting with patient 20.

At the data-cut-off, across all dose cohorts, the ORR was 97% with a CR rate of 63%. At the RP2D, the study continued to demonstrate a 100% ORR in all 24 patients treated, with 17 patients achieving a CR (70.8%).

Across all dose levels at median follow-up of 8 months (range 1-23) months, an event-free survival (EFS) rate of 57% and an overall survival (OS) rate of 83% was observed. Five patients had a response consolidated with a stem cell transplant. Analyses of patient serum from day one after infusion with AFM13 precomplexed with cbNK cells suggest that no sensitization effects in patients occur.

Overall, the treatment continues to show a manageable safety profile. There were no infusion-related reactions (IRR) after infusing AFM13-NK and 11 IRR in 182 infusions of AFM13 alone (6%) (1 grade 3, 10 grade 2). In addition, no cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS) or graft versus host disease (GVHD) of any grade.

A more in-depth analysis of the data will be presented in Dr. Nieto’s oral presentation at ASH (Free ASH Whitepaper) and through a company press release.

Details of AFM28 Poster Presentation and Abstract
Title: The Novel Bispecific Innate Cell Engager (ICE) AFM28 Efficiently Directs Allogeneic NK Cells to CD123-positive leukemic cells
Session: Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster III Presentation Date & Time: Monday, December 12, 2022, 6:00 p.m. – 8:00 p.m. CST
Location: Ernest N. Morial Convention Center, Hall D

Innate Cell Engager (ICE) AFM28 aims to direct a patient’s own or allogeneic NK cells towards CD123-positive AML blasts and leukemic stem cells (LSC) providing a promising approach to achieving long-term remissions. Data from a collaboration between Affimed and the Department of Hematology and Oncology, Medical Faculty Mannheim, Heidelberg University will be presented at the ASH (Free ASH Whitepaper) conference. The study evaluated the efficacy of AFM28 in preclinical AML models. In a panel of AML cell lines, AFM28 successfully engaged allogeneic NK cells to destroy CD123-positive tumor cells through antibody-dependent cytotoxicity (ADCC). ADCC induced by AFM28 was independent of leukemic cell mutational profiles and was also effective in targeting cells with low levels of CD123 surface expression.

Residual leukemic stem cells are a frequent cause for relapse and associated with poor prognosis. Patient-derived AML cell cultures incubated with AFM28 and allogeneic NK cells showed significantly reduced numbers of outgrowing colonies compared to controls. That indicates that LSCs and progenitor cells were eliminated. These results were confirmed in an AML mouse model demonstrating complete inhibition of tumor growth throughout a 42-day treatment period in comparison to untreated control mice who all developed systemic disease.

AFM28 is currently being prepared for a first-in-human clinical investigation as monotherapy and in combination with allogeneic NK cells.

The full abstracts for both presentations are available on the ASH (Free ASH Whitepaper) conference website via the following link: View Source

About the AFM13-104 Phase 1/2 Study
The University of Texas MD Anderson Cancer Center is studying AFM13 in an investigator-sponsored phase 1/2 trial in combination with cord blood-derived allogeneic NK cells in patients with recurrent or refractory CD30-positive lymphomas. The study is a dose-escalation trial of precomplexed NK cells, followed by an expansion phase, recruiting up to 40 patients with r/r CD30 positive lymphomas, treated with the RP2D (and 1×108 NK cells/kg followed by three weekly doses of 200 mg AFM13 monotherapy.

MD Anderson has an institutional financial conflict of interest with Affimed related to this research and has therefore implemented an Institutional Conflict of Interest Management and Monitoring Plan. Additional information about the study can be found at www.clinicaltrials.gov (NCT04074746).

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 is currently being evaluated as monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma (REDIRECT). Additional details can be found at www.clinicaltrials.gov (NCT04101331).

About AFM28
AFM28, a tetravalent, bispecific CD123- and CD16A-binding ICE developed on Affimed’s ROCK platform, is designed to bring a new immunotherapeutic treatment to patients with CD123+ myeloid malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). It engages NK cells to initiate tumor cell killing via antibody-dependent cellular cytotoxicity (ADCC), even at low CD123 expression levels. Clinical development is planned as both monotherapy and in combination with allogeneic NK cells in patients with relapsed/refractory CD123-positive leukemias.

On November 3, 2022 Aeterna Zentaris Inc. (Nasdaq: AEZS) (TSX: AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, reported its financial and operating results for the third quarter ended September 30, 2022 (Press release, AEterna Zentaris, NOV 3, 2022, View Source;id=245519&p=2247083&I=1206939-c7Z3G6f3m8 [SID1234623125]).

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"Our priorities remain advancing our preclinical and clinical studies and aiming to explore all options for our Macrilen asset," commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna.

Recent Highlights

Announced the Company will regain full rights to Macrilen for the U.S. and Canada, following Novo’s termination of the development and commercialization license agreement, which termination will become effective May 23, 2023. Until then, Novo is expected to continue to commercialize Macrilen and fund the cost for the ongoing pivotal pediatric Phase 3 DETECT-trial. The Company is actively engaged in exploring all options for Macrilen; and
Entered into a sponsored research agreement with Massachusetts General Hospital to further evaluate the Company’s targeted, highly specific immunosuppressive therapeutic proteins (AIM Biologicals) in preclinical research for the potential treatment of neuromyelitis optica spectrum disorder.
Results of operations for the three-month period ended September 30, 2022

All amounts in this press release are in U.S. dollars unless otherwise noted.

For the three-month period ended September 30, 2022, Aeterna reported a consolidated net loss of $3.4 million, or $0.70 loss per common share (basic), compared to a consolidated net loss of $1.9 million, or $0.40 loss per common share (basic) for the three-month period ended September 30, 2021. The $1.5 million increase in net loss is primarily the result of $0.8 million higher revenues, offset partially by an increase in operating expenses of $2.5 million primarily due to a $1.8 increase in research and development, a $0.9 million increase in general and administrative expenses, offset by a $0.2 million decrease in selling expenses, and an increase of $0.2 million in Net Finance income.

Revenues

Total revenue for the three-month period ended September 30, 2022 was $1.9 million, an increase of $0.8 million from $1.1 million in the same period in 2021. Quarterly revenue was comprised of $0.6 million in licensing revenue (2021 – $0.3 million), $1.2 million in development revenue (2021 – $0.7), $0.04 million in supply chain revenue (2021 – $0.06 million), $0.01 million in royalty income (2021 – $0.02 million).
Operating expenses

Total operating expenses for the three-month period ended September 30, 2022 was $5.6 million compared with $3.1 million for the same period in 2021, representing an increase of $2.5 million. This increase was primarily due to a $1.8 increase in research and development, $0.9 million increase in general and administrative expenses, offset by a $0.2 million decrease in selling expenses.
Net finance income (cost)

Net finance income (costs) for the three-month period ended September 30, 2022 was $0.3 million compared with net finance income (costs) of $0.1 million for the same period in 2021, representing an increase in net finance income of $0.2 million.
The Company had $53.8 million cash and cash equivalents at September 30, 2022 (December 31, 2021 – $65.3 million).

Consolidated Financial Statements and Management’s Discussion and Analysis

Management’s Discussion and Analysis of Financial Condition and Results of Operations for the second quarter, as well as the Company’s unaudited consolidated interim financial statements as of September 30, 2022, will be available on the Company’s website (www.zentaris.com) in the Investors section or at the Company’s profile at www.sedar.com and www.sec.gov.

On November 3, 2022 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase biology platform, reported that it will report third quarter 2022 financial results and provide a corporate update after the market close on Thursday, November 10, 2022 (Press release, aTyr Pharma, NOV 3, 2022, https://investors.atyrpharma.com/news-releases/news-release-details/atyr-pharma-webcast-conference-call-reporting-third-quarter-2022 [SID1234623124]). Management will host a conference call and webcast to review the results and provide an operational update.

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Participants who wish to join the conference call by telephone must register at the above dial-in registration link in order to receive the dial-in number and a personalized PIN code that will be required to access the call. Participants may join the live webcast by accessing it at the above webcast registration link on the aTyr Events page. For more information or questions, please contact aTyr’s investor relations team at [email protected].

On November 3, 2022 Merus N.V. (Nasdaq: MRUS) ("Merus", the "Company," "we", or "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported financial results for the third quarter that ended September 30, 2022 and provided a business update (Press release, Merus, NOV 3, 2022, View Source [SID1234623123]).

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"We continue to advance numerous programs which now demonstrate important clinical activity across the portfolio," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "For MCLA-129, we have recently shared early efficacy and safety data at the ENA ‘triple’ meeting and are now enrolling expansion cohorts in lung and other cancers; for Zeno, potentially first and best in class for NRG1 fusion cancer, we are continuing to enroll the eNRGy study consistent with recent feedback from the FDA; and for petosemtamab, we are looking forward to providing a clinical update in the first half of 2023. Later this year, Incyte plans to start a clinical study of INCA32459, a novel LAG3xPD-1 bispecific antibody developed in collaboration with Merus."

Zenocutuzumab (Zeno or MCLA-128: HER3 x HER2 Biclonics): NRG1+ cancer and other solid tumors
Enrollment continues in the eNRGy trial; enrollment in combination study in NRG1+ NSCLC as well as monotherapy in castration resistant prostate cancer (CRPC) planned to begin enrollment in 4Q2022

At the end of October, Merus met with the U.S. Food and Drug Administration (FDA) regarding a potential Biologics License Application (BLA) filing for Zeno in NRG1 fusion (NRG1+) cancer. Based on the FDA feedback, Merus believes that a potential registrational path remains viable in a NRG1+ cancer tumor agnostic indication or separate applications for NRG1+ lung and NRG1+ pancreatic cancer, which could then be followed by a potential tumor agnostic filing. The majority of the eNRGy trial and Early Access Program enrollment to date has been NRG1+ non-small cell lung cancer (NSCLC) and NRG1+ pancreatic cancer. The FDA recommended that Merus enroll additional patients under either approach (tissue agnostic or tumor-type specific), to obtain further supportive data for a potential registrational data set, consistent with the recent FDA draft guidance on Tissue Agnostic Drug Development in Oncology. The amount of data needed for a potential filing under either approach will depend upon the magnitude and durability of responses and the overall risk benefit assessment.

Merus is assessing the impact on the timeline for a potential BLA filing for Zeno in NRG1+ cancer. Enrollment continues in the phase 1/2 eNRGy trial to assess the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancers. Merus believes Zeno has the potential to be a first and best in class and a new standard of care for patients with NRG1+ cancer.

Details of the eNRGy trial can be found at www.ClinicalTrials.gov and Merus’ trial website at www.nrg1.com, or by calling 1-833-NRG-1234.

Further, Merus is initiating a clinical trial evaluating Zeno in combination with afatinib for NRG1+ NSCLC, and a clinical trial evaluating Zeno outside of NRG1+ cancer, as a treatment for castration resistant prostate cancer. The Company is also actively exploring the ways in which targeting both HER2 and HER3 with Zeno has potential for the treatment of other cancers.

Petosemtamab (MCLA-158: Lgr5 x EGFR Biclonics): Solid Tumors
Dose expansion continues in the phase 1 trial: clinical update planned for 1H2023

Petosemtamab is currently enrolling patients with advanced solid tumors in the expansion phase of a phase 1 open-label, multicenter study.

Merus plans to provide a clinical update for petosemtamab at a medical conference in the first half of 2023. The planned presentation will provide the opportunity to present a robust update across the program, including approximately 40 patients with head and neck squamous cell carcinoma (HNSCC) with meaningful clinical follow up, and an update on the gastro-esophageal cohort, to inform clinical development strategy and planned regulatory interactions.

MCLA-145 (CD137 x PD-L1 Biclonics): Solid Tumors
Phase 1 trial continues including in combination with a PD1 inhibitor

MCLA-145 is currently enrolling a global, phase 1, open-label, single-agent clinical trial evaluating MCLA-145 in patients with solid tumors. The trial consists of a dose escalation phase, followed by a planned dose expansion phase. Merus is also evaluating the combination of MCLA-145 with a PD-1 blocking antibody, with first patient dosed and enrollment ongoing.

MCLA-129 (EGFR x c-MET Biclonics): Solid Tumors
Phase 1 continues with enrollment in expansion cohorts

MCLA-129 is currently enrolling patients in a phase 1/2, open-label clinical trial evaluating patients with MCLA-129 monotherapy in MetEx14 NSCLC, EGFRex20 NSCLC, and in HNSCC, as well as in combination with a third generation EGFR TKI in treatment naïve EGFR mutant (m) NSCLC and in patients with EGFR m NSCLC that have progressed on Tagrisso (osimertinib).

Merus presented initial clinical data regarding MCLA-129 at the 34th EORTC/NCI/AACR (ENA) Symposium. Twenty patients, (14 patients with EGFR m lung cancer, 2 with c-MET exon 14 skipping m NSCLC, 1 patient with c-MET amplified gastric adenocarcinoma, 1 patient with esophageal squamous cell cancer, 2 patients with HNSCC), were treated with MCLA-129 across dose levels of 100 mg-1500 mg. As of an August 15, 2022 data cutoff date, these initial clinical data in 18 evaluable patients show clinical activity at a variety of dose levels with two confirmed partial responses and four additional patients with >20% tumor shrinkage. MCLA-129 was observed to be well tolerated with no dose limiting toxicities. The most frequent adverse events (AEs) observed were infusion-related reactions (IRR); 90% of patients experienced IRR AEs of any grade, one patient (5%) experienced a grade 3, no grade 4 or 5 AEs were observed. Based on pharmacokinetic and pharmacodynamic data, and the safety profile, an initial recommend phase 2 dose was selected at 1500 mg every two weeks. As of the data cutoff date the median duration of exposure was 12.6 weeks and six of 20 patients remained on treatment.

As October 2022, 33 patients have been enrolled in the dose escalation and dose expansion phases of the trial. The additional 13 patients enrolled did not yet have an opportunity to be evaluated as of the August 15, 2022 data cutoff.

MCLA-129 is also subject to a collaboration and license agreement with Betta Pharmaceuticals Co. Ltd. (Betta), which permits Betta to exclusively develop MCLA-129 in China, while Merus retains global rights outside of China.

Collaborations

Incyte

Since 2017, Merus has been working together with Incyte Corporation under global collaboration and license agreement, which grants Incyte exclusive rights for up to ten bispecific and monospecific antibody programs from Merus’ Biclonics platform. The collaboration is progressing, with multiple programs in various stages of preclinical development. Further, Incyte announced this quarter that it plans to start a clinical study of INCA32459, a novel Lag3xPD-1 bispecific antibody developed in collaboration with Merus using Merus’ Biclonics antibody platform. For each program under the collaboration, Merus receives reimbursement for research activities and is eligible to receive potential development, regulatory and commercial milestones and sales royalties for any products, if approved.

Loxo Oncology at Lilly

In January 2021 Merus and Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (Lilly) announced a research collaboration and exclusive license agreement to develop up to three CD3-engaging T-cell re-directing bispecific antibody therapies utilizing Merus’ Biclonics platform and proprietary CD3 panel along with the scientific and rational drug design expertise of Loxo Oncology at Lilly. The collaboration is progressing with multiple active research programs underway.

Cash Runway, Merus expects to be funded beyond 2024

As of September 30, 2022, Merus had $372.9 million cash and cash equivalents sufficient to fund company operations beyond 2024.

Third Quarter 2022 Financial Results

Collaboration revenue for the three months ended September 30, 2022 decreased by $7.1 million as compared to the three months ended September 30, 2021, primarily as a result of a decrease in Lilly upfront payment amortization and reimbursement revenues and Incyte upfront payment amortization. The change in exchange rates did not significantly impact collaboration revenue.

Research and development expense for the three months ended September 30, 2022 increased by $16.3 million as compared to the three months ended September 30, 2021, primarily as a result of an increase in external clinical services and drug manufacturing costs.

General and administrative expense for the three months ended September 30, 2022 increased by $2.3 million as compared to the three months ended September 30, 2021, primarily as a result of an increase in stock-based compensation expense and consulting costs.

Collaboration revenue for the nine months ended September 30, 2022 decreased by $3.5 million as compared to the nine months ended September 30, 2021, primarily in Lilly upfront payment amortization and reimbursement revenues and Incyte upfront payment amortization.

Research and development expense for the nine months ended September 30, 2022 increased by $29.0 million as compared to the nine months ended September 30, 2021, primarily as a result of an increase in external clinical services and drug manufacturing costs.

General and administrative expense for the nine months ended September 30, 2022 increased by $6.8 million as compared to the nine months ended September 30, 2021, primarily as a result of an increase in stock-based compensation expense, personnel related expenses, and consultancy costs.

Other income (loss), net consists of interest earned and fees paid on our cash and cash equivalents held on account, accretion of investment earnings and net foreign exchange (losses) gains on our foreign denominated cash, cash equivalents and marketable securities. Other gains or losses relate to the issuance and settlement of financial instruments.

On November 3, 2022 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported that it will report its third quarter 2022 financial results on Thursday, November 10, 2022 and will provide a business update (Press release, Altimmune, NOV 3, 2022, View Source [SID1234623122]).

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Altimmune management will host a conference call at 8:30 am E.T. on November 10 to discuss financial results and provide a business update. The conference call will be webcast live on Altimmune’s Investor Relations website at View Source

Participants who would like to join the call may register here to receive the dial-in numbers and unique PIN to access the call. Shortly after the call, a replay will be available on the Investor Relations website for up to twelve months.