On November 14, 2023 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, USOTC: DTCFF, FSE: DTC), one of the leading Canadian biotechnology companies working in the field of immune-oncology reported that it has successfully submitted on November 9, 2023 an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its ACCUM-002TM Dimer CDCA-SV40 commonly named "AccuTOX", an injectable anticancer molecule, for the treatment of solid cancer tumors (Press release, Defence Therapeutics, NOV 14, 2023, View Source;utm_medium=rss&utm_campaign=defences-successful-submission-of-an-investigational-new-drug-ind-application-for-accutox-as-an-injectable-anticancer-treatment-for-solid-tumors [SID1234637621]).

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AccuTOX is a derivative of the initial Accum molecule, which has been reported to target cancer on multiple fronts. AccuTOX disrupts endosomal membranes resulting in impaired intracellular transport mechanisms. AccuTOX also triggers genotoxic effects, blocks DNA repair mechanisms normally used by cancer cells to repair its damaged genome and induces a form of immunogenic cell death capable of turning "ON" the immune system. When previously tested in preclinical animal models under the supervision of Dr. Moutih Rafei, AccuTOX impaired tumor growth resulting in "70-100% survival" of animals with solid T-cell lymphoma, melanoma or breast cancer.

The IND application includes data, reports and overview summaries of numerous studies to evaluate the pharmacology, pharmacokinetics, and toxicology of AccuTOX both in vitro and in vivo, including cancer models. In addition, the application describes the manufacture of the drug substance and drug product to be used in human clinical trials. The main purpose of the IND is to share with the FDA the extensive non-clinical data supporting an acceptable safety profile when AccuTOX will be first administered to humans. The FDA will review the application and determine the acceptability of the data before Defence begins the Phase I clinical trial, which could be as early as Q1-Q2 2024.

"We are thrilled and excited that Defence has achieved a successful submission on its first IND, which represents an important milestone towards advancing AccuTOX into the clinic. We look forward to work with clinical investigators at City of Hope to study this important and novel candidate for the treatment of melanoma and potentially other solid tumors," said Sébastien Plouffe, President & CEO of Defence Therapeutics. "With the continued difficulties encountered in the oncology clinic, we believe that the therapeutic use of AccuTOX provides a novel and powerful approach to combat cancer," he added.

The primary objective of this upcoming Phase I clinical trial, when approved, is to identify the best therapeutic dosing range that would allow clinicians to co-administer the AccuTOX compound with Opdulag, a BMS product containing both anti-LAG3 and anti-PD-1. Several other secondary parameters including therapeutic efficacy will be monitored in treated patients in preparation for a Phase IIa trial on a basket of tumors.

According to Precedence Research, the global cancer therapeutics market size is expected to be worth around US$ 393.61 billion by 2032 from at US$ 164 billion in 2022, growing at a CAGR of 9.20% during the forecast period 2023 to 2032.

ON November 14, 2023 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, reported financial results for the third quarter and nine months ended September 30, 2023 and provided an update on recent business events (Press release, CorMedix, NOV 14, 2023, View Source [SID1234637620]).

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Recent Corporate Highlights:

The FDA completed a preapproval inspection for CorMedix’s primary finished dosage CMO site in September and the Company is pleased with the outcome. In addition, the FDA has also conducted preapproval inspections for DefenCath at suppliers of active pharmaceutical ingredients, contract laboratories involved in testing of product specifications and packaging facilities, and CorMedix is not aware of any outstanding deficiencies or review issues at this time.
CorMedix has intensified preparations for commercial launch with a number of new hires in market access, sales training, pricing and contracting, commercial operations, field medical, and drug safety and pharmacovigilance.
In the event CorMedix receives final FDA approval over the coming days, the Company is targeting a commercial launch before the end of the first quarter of 2024.
The United States Patent and Trademark Office (USPTO) issued a patent with claims directed to the composition of a catheter lock solution for preventing infection and reduced blood flow in central venous catheters. This Patent reflects the unique and proprietary nature of DefenCath, and will extend the Company’s intellectual property protection with an expiration date of April 15, 2042.
Cash and short-term investments, excluding restricted cash, at September 30, 2023 amounted to $86.6 million.
Joe Todisco, CorMedix CEO, commented, "I am very pleased with the Company’s progress on all fronts, most notably the outcomes of the preapproval inspections at our primary CMO facility and other key vendors, as well as our preparations toward commercial readiness. We have accelerated multiple work streams aimed at commercial launch, and made a number of key hires over the past quarter that are essential to ensuring a successful commercial launch following a potential FDA approval of DefenCath. We look forward to providing additional updates over the coming days as we anticipate a response from FDA on or around our target action date."

Third Quarter and Nine Month 2023 Financial Highlights

For the third quarter of 2023, CorMedix recorded a net loss of $9.7 million, or $0.17 per share, compared with a net loss of $6.9 million, or $0.17 per share, in the third quarter of 2022. The higher net loss recognized during the third quarter of 2023 compared with 2022 was attributable to net increase in operating expenses primarily due to increased pre-launch commercial activities for DefenCath.

Operating expenses in the third quarter of 2023 increased approximately 50% to $10.5 million, compared with $7.0 million in the third quarter of 2022. R&D expense increased approximately 14% to $2.7 million compared to $2.3 million in the third quarter of 2022, mainly due to a net increase in costs related to medical affairs activities and increase in personnel related expenses due to additional hires in 2023 as compared with 2022. SG&A expense increased approximately 69% to $7.8 million compared with $4.6 million in the third quarter of 2022. This increase was driven primarily by an increase in costs related to market research studies and pre-launch activities in preparation for the potential marketing approval of DefenCath and as a result of additional hires in 2023 as compared with 2022.

For the nine months ended September 30, 2023, CorMedix recorded a net loss of $31.6 million, or $0.65 per share, compared with a net loss of $21.5 million, or $0.54 per share, in the first nine months of 2022. The increase in net loss in the first nine months of 2023 was driven primarily by an increase in operating expenses.

Operating expenses in the first nine months of 2023 were $33.3 million compared with $22.3 million during the comparable period in 2022, an increase of approximately 49%. This increase was primarily attributable to costs related to market research studies and pre-launch activities in preparation for the potential marketing approval of DefenCath, and an increase in personnel expenses due to additional hires in 2023.

Total cash on hand and short-term investments as of September 30, 2023 was $86.6 million, excluding restricted cash of $0.2 million. The Company believes that, based on the Company’s cash resources at September 30, 2023, it has sufficient resources to fund operations at least twelve months from the filing of its Quarterly Report on Form 10-Q for the quarter ended September 30, 2023.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, November 14, 2023, at 4:30 PM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information is as follows:

Domestic: 1-888-886-7786
International: 1-416-764-8658
Conference ID: 16013968
Webcast: Webcast Link

On November 14, 2023 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, reported financial results for the third quarter ended September 30, 2023, and announced that the Company is implementing a further reduction in its workforce of approximately 40% while maintaining the necessary support to continue exploring potential strategic transactions and business alternatives (Press release, Atreca, NOV 14, 2023, View Source [SID1234637619]).

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"Since our founding, Atreca has leveraged a unique discovery platform to identify numerous antibodies binding novel targets in oncology, as well as infectious and autoimmune disease," said John Orwin. "We remain focused on advancing APN-497444 through preclinical testing and continue to believe that our approach has potential to unlock meaningful tumor targets undiscoverable by conventional approaches. Nevertheless, given current financial market conditions and the funding needs required to advance ‘444 and our other antibody-drug conjugate programs into clinical development, we have made the difficult decision to further reduce our headcount as we explore strategic alternatives. I’d like to thank all employees impacted for their contributions."

Third Quarter 2023 Financial Results

As of September 30, 2023, cash and cash equivalents and investments totaled $21.4 million.
Research and development expenses for the three months ended September 30, 2023, were $10.4 million, including non-cash stock-based compensation expense of $1.0 million.
General and administrative expenses for the three months ended September 30, 2023, were $5.4 million, including non-cash stock-based compensation expense of $1.3 million.
Atreca reported a net loss of $36.2 million, or basic and diluted net loss per share attributable to common stockholders of $0.92, for the quarter ended September 30, 2023.

On November 14, 2023 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported the publication of results from the Phase 1 study at Roswell Park Comprehensive Cancer Center in patients with metastatic triple-negative breast cancer using chemokine modulation therapy, including AIM ImmunoTech Inc.’s drug candidate Ampligen (also known as rintatolimod), interferon α-2b and celecoxib, followed by pembrolizumab (Press release, AIM ImmunoTech, NOV 14, 2023, View Source [SID1234637617]). The data were published in a manuscript titled, "Systemic Infusion of TLR3-Ligand and IFNα in Breast Cancer Patients Reprograms Local Tumor Microenvironment for Selective CTL Influx," in The Journal for ImmunoTherapy of Cancer.

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The pilot study evaluated the safety of systemic CKM composed of intravenous rintatolimod (Ampligen; selective TLR3 ligand), interferon α-2b and celecoxib, and the combination’s ability to promote local CTL influx to mTNBC lesions. Principal investigator and first author Shipra Gandhi, MD, of the Department of Medicine at Roswell Park, led the study under the scientific leadership of Pawel Kalinski, MD, PhD, senior author of the paper, Chair of Immunology and Senior Vice President for Team Science at Roswell Park. For more information about the study, please visit ClinicalTrials.gov: NCT03599453.

For more information, please visit Roswell Park’s website to read its press release titled "Novel Immunotherapy Approach at Roswell Park Shows Promise in Metastatic Triple-Negative Breast Cancer."

On November 14, 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 third quarter of 2023 (Press release, Affimed, NOV 14, 2023, View Source [SID1234637616]).

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"We initiated our phase 2 clinical study of acimtamig in combination with AlloNK and received encouraging feedback on the design of our LuminICE-203 trial from the FDA," said Dr. Adi Hoess, CEO of Affimed. "We also continued to make progress with AFM24 in combination with atezolizumab and advanced AFM28 in the dose escalation. This positions our company well to report further updates on all three clinical programs within the next few months."

Program Updates

Acimtamig (CD30/CD16A)

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Initiated LuminICE-203, a phase 2 clinical study to investigate acimtamig in combination with Artiva’s AlloNK natural killer (NK) cells in patients with relapsed / refractory (r/r) classical Hodgkin lymphoma (HL). The study will also include a cohort of 20 r/r PTCL patients. The Company expects to report initial efficacy and safety data from the LuminICE-203 study in the first half of 2024.

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Received encouraging feedback from FDA regarding questions for the Type C meeting: The FDA is highly engaged in supporting the progress and design of the study evaluating the combination of acimtamig and AlloNK as evidenced by the fast-track designation and Type C meeting feedback. According to written feedback for the Type C meeting, the LuminICE-203 study, designed based on the FDA’s recommendations and guidelines, could support accelerated approval, depending on the demonstrated magnitude of clinical benefit. In addition, the FDA agrees with Affimed’s approach to address the contribution of single components by adding a cohort to the study evaluating AlloNK/IL-2 only.

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AFM13-104 abstract selected for oral presentation at the ASH (Free ASH Whitepaper) 2023 Annual Meeting. The oral presentation by Dr. Yago Nieto, M.D., Ph.D., professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson at the ASH (Free ASH Whitepaper) 2023 Annual Meeting will include data on a total of 42 r/r CD30-positive Hodgkin lymphoma (HL) and Non-Hodgkin lymphoma (NHL) patients enrolled in the study with 36 patients treated at the recommended phase 2 dose (RP2D). All patients were heavily pretreated and refractory to their most recent line of therapy with active progressive disease at the time of enrollment. The acimtamig precomplexed NK cells treatment followed by three weekly infusions of acimtamig achieved an overall response rate (ORR) of 94.4% with a complete response rate of 72.2% at RP2D. Acimtamig in combination with NK cells continues to demonstrate a good safety and tolerability profile with no cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS) or graft versus host disease (GVHD) of any grade. An in-depth analysis including updated EFS/OS data will be presented during Dr. Nieto’s oral presentation.

AFM24 (EGFR/CD16A)

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On track to report data in December 2023 from the first three expansion cohorts of AFM24-102, a Phase 1/2a combination study of AFM24 in patients with advanced EGFR-expressing solid tumors. Expansion cohorts of the study enrolled patients with (1) EGFR-wildtype non-small cell lung cancer (NSCLC) (2) gastric /gastroesophageal junction adenocarcinoma and (3) a basket cohort evaluating pancreatic, hepatocellular, and biliary tract cancer. Based on the results from the AFM24 monotherapy study, a fourth expansion cohort of patients with EGFR-mutant NSCLC has been added to the AFM24-102 study and is enrolling and treating patients. Data from this cohort is expected in the first half of 2024.

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AFM24 combination with NK cells. The Company is continuing to investigate the possibility of a combination of AFM24 with an allogeneic, off-the-shelf NK cell product.

AFM28 (CD123/CD16A)

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AFM28 is investigated in a multi-center Phase 1 open-label, dose-escalation study (AFM28-101), in r/r AML. Dose level three was completed with no dose-limiting toxicities; completed enrollment in the fourth 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

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Affimed has completed its work on novel molecules for both Genentech and Roivant. Further development of these product candidates is at the discretion of the respective companies.

Planned Upcoming Milestones:

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Follow-up data from AFM13-104 to be presented at the ASH (Free ASH Whitepaper) Annual Meeting in December 2023.

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Initial data readout from the LuminICE-203 study planned in H1 2024.

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Data release from the first three expansion cohorts of the Phase 1/2a study AFM24+atezolizumab combination study planned in December 2023.

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Data from the EGFR-mutant NSCLC cohort planned in H1 2024.

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Further progress updates from AFM28-101 dose escalation planned in H1 2024.

Third 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 September 30, 2023 cash, cash equivalents and financial assets totaled €97.5 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 September 30, 2023 was €18.2 million compared to €19.0 million for the quarter ended September 30, 2022.

Total revenue for the quarter ended September 30, 2023, was €2.0 million compared with €14.9 million for the quarter ended September 30, 2022. Revenue in 2022 and 2023 predominantly relates to the Roivant and Genentech collaborations, for which we have completed the work assigned to us under the respective collaboration agreements.

Research and development expenses for the quarter ended September 30, decreased by 17.7% from €26.1 million in 2022 to €21.5 million in 2023. The decrease is primarily due to the completion of our work under the Roivant and Genentech collaborations, together with a decline in head count and related costs after the reorganization, also resulting in a decline in the share-based payment expense which is further impacted by the decline in the underlying fair value of share options. The decline in research and development expenses have, however, been partially offset by the increase in higher expenses associated with the development of AFM13.

General and administrative expenses decreased 33.5% from €8.1 million in the quarter ended September 30, 2022 to €5.4 million in the quarter ended September 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 September 30, 2023 decreased from income of €2.7 million in the quarter ended September 30, 2022, to income of €0.6 million in the quarter ended September 30, 2023. Finance income/costs in the three months ended September 30, 2023 primarily consisted of the interest expense incurred on the Bootstrap (formerly Silicon Valley Bank) loan, set-off by the interest earned on the financial assets, term deposits and cash balances. 2022 primarily consisted of foreign exchange gains/losses related to cash and cash equivalents denominated in U.S. dollars as a result of the change in the value of the U.S. dollar compared to the Euro.

Net loss for the quarter ended September 30, 2023, was €24.4 million, or €0.16 loss per common share compared with a net loss of €16.5 million, or €0.11 loss per common share, for the quarter ended September 30, 2022.

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

Additional information regarding these results will be included in the notes to the consolidated interim financial statements as of September 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 November 14, 2023, at 8:30 a.m. EST / 14:30 CET to discuss third 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/BId6f0cfc054b84432a7272424edf98afd, 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.