On November 14, 2024 Azurity Pharmaceuticals reported that the U.S. Food and Drug Administration (FDA) has approved Danziten, the first and only nilotinib with no mealtime restrictions indicated for adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase and adult patients with chronic phase (CP) and acute phase (AP) resistant or intolerant to prior therapy that included imatinib (Press release, Azurity Pharmaceuticals, NOV 14, 2024, View Source [SID1234648420]).

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"Danziten offers a new nilotinib treatment option with the equivalent efficacy to Tasigna, but without the fasting requirements of Tasigna," said Richard Blackburn, CEO of Azurity Pharmaceuticals, Inc. "Unlike Tasigna, the boxed warning on the Danziten label has no requirement for patients to take their medication in a fasted state, liberating CML patients from mealtime restrictions."

Tasigna has established efficacy in adults with newly diagnosed Ph+ CML-CP and resistant or intolerant Ph+ CML-CP and CML-AP.1 However, Tasigna has variable bioavailability that considerably increases when taken with food. In a concentration dependent manner, Tasigna may significantly prolong QT interval on surface electrocardiogram (ECG) when inappropriately taken with food. As such, strict fasting with Tasigna is crucial to avoid cardiotoxicity.2

Danziten is a re-engineered formulation of nilotinib without mealtime restrictions that offers equivalent efficacy to Tasigna but with improved bioavailability, allowing for a lower dose.1,3,4 Danziten demonstrates consistent pharmacokinetics, with no clinically significant differences in nilotinib exposure regardless of fasting state or meal type, while offering the proven efficacy expected from nilotinib.1,5,6 With optimal tyrosine kinase inhibitor (TKI) therapy, patients can achieve deep molecular responses, and some may even attain treatment-free remission.7 The life expectancy of newly diagnosed CP-CML patients who have responded to appropriate treatment is now approaching that of the general population. However, challenges remain, including patient adherence to treatment. Danziten has the potential to improve adherence due to the removal of fasting requirements.7,8

Danziten will be available in the coming weeks through Biologics by McKesson and Limited Specialty Distribution. For full prescribing information including boxed warning, please visit www.Danziten.com.

Azurity will offer patient support through DanzitenCONNECT, a comprehensive program, subject to terms and conditions, that includes Prior Authorization support and Benefits Investigation, a free first month of Danziten, a co-pay of as little as $0, and a Patient Assistance Program (PAP).

On November 14, 2024 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE:DTC, OTCQB: DTCFF, FSE: DTC) a Canadian biopharmaceutical company developing radiopharmaceuticals and ADC products using its proprietary platform and drug delivery technologies in addition to novel immune-oncology vaccines, reported that it offers new unsecured convertible debentures (the "New Debentures") for aggregate gross proceeds of up to CAD$1,570,000 (the "Offering") in consideration for the settlement of the principal amounts owing to holders of the Previous Debentures (as defined below) (the "Outstanding Debt") (Press release, Defence Therapeutics, NOV 14, 2024, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-announces-securities-for-debenture-financing [SID1234648440]).

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The New Debentures will be issued on a non-brokered private placement basis, bear interest at the rate of 8.0% per annum, be subject to a Conversion Event (as defined below), and mature on November 16, 2025 (the "Maturity Date"). Each New Debenture is unsecured and rank pari passu in right of payment of principal and interest with all the existing and future unsecured indebtedness of the Company. The principal amount of each New Debenture is convertible at the option of the holder into common shares in the capital of the Company (the "Common Shares") at a price of $0.60 per Common Share at any time up to and including the Maturity Date (the "Conversion Event"). Assuming each New Debentures holder exercises their respective Conversion Event, the Company would issue an aggregate total of 2,616,666 Common Shares to the holders thereof.

The Outstanding Debt was incurred in connection with the Previous Debentures that were underlying previously issued units of the Company (the "Units") at a price of $1,000 per Unit on November 16, 2022. Each Unit consisted of: (i) one $1,000 principal amount 8.0% convertible debenture (the "Previous Debenture"), and (ii) 636 common share purchase warrants.

Upon closing of the Offering, their will be no Previous Debentures outstanding; and concurrent with the closing of the Offering, the total accrued interest owing on the Previous Debentures in the amount of approximately $251,200 will be settled via the conversion of such outstanding amount into Common Shares at a price per share equal to the closing market price of the Common Shares as of the trading day prior to such issuance, and in accordance with the terms and conditions of the Previous Debentures.

All securities issued in connection with the Offering are subject to a statutory hold period of four months plus a day in accordance with applicable securities legislation. The closing of the Offering and issuance of the New Debentures and the Common Shares to settle outstanding interest owing from the Previous Debentures are subject to receipt of all necessary regulatory and corporate approvals, including but not limited to approval from the Canadian Securities Exchange.

On November 14, 2024 ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported financial results for the third quarter ended September 30, 2024, and highlighted recent Company progress (Press release, ArriVent Biopharma, NOV 14, 2024, View Source [SID1234648388]).

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"Our lead clinical program of firmonertinib in non-small cell lung cancer (NSCLC) is strongly advancing with encouraging potential to expand across EGFR mutant types. In September, we announced compelling monotherapy data for firmonertinib from our FURTHER study supporting rapid and robust anti-tumor activity across EGFR PACC mutations building on the strong activity observed in patients with EGFR exon 20 insertion mutations," said Bing Yao, Chairman and Chief Executive Officer of ArriVent. "Importantly, the high activity in tough to treat patients with central nervous system (CNS) metastases or compound mutations points to firmonertinib as a promising candidate for front-line patients with PACC mutations. Collectively, the broad activity in EGFR PACC mutations, the high responses in the CNS, and consistent, manageable safety profile across trials reinforces the promise firmonertinib holds to address unmet needs across the spectrum of EGFR mutant NSCLC."

Dr. Yao continued, "We expect several near-term catalysts for our firmonertinib program including initiating dose expansion for the combination study in classical EGFR mutant NSCLC with SHP2 inhibitor ICP-189 in the fourth quarter of the year, an update on the Phase 1b PACC study and plans for our potential registration study in the first half of 2025, and topline pivotal data from our global Phase 3 FURVENT study in front-line EGFR exon 20 mutant NSCLC in 2025. With our strong balance sheet and operating runway into 2026, we are well-positioned to execute across our near-term catalysts."

Third Quarter 2024 and Recent Highlights

Firmonertinib

● Positive proof-of-concept data in EGFR PACC mutant NSCLC. In September, ArriVent presented interim FURTHER Phase 1b clinical data for first-line firmonertinib monotherapy in patients with EGFR PACC mutant NSCLC during the Presidential Symposium at the 2024 annual World Conference on Lung Cancer and hosted a virtual webinar. In what we believe to be the first clinical dataset testing an EGFR inhibitor in a randomized defined population of EGFR PACC

mutant NSCLC, firmonertinib demonstrated robust systemic and CNS anti-tumor activity with a manageable safety profile consistent with previous trials.
Upcoming Milestones

● Dose expansion for SHP2 inhibitor combination. Initiation of dose expansion cohort for the ongoing Phase 1b trial evaluating firmonertinib in combination with SHP2 inhibitor ICP-189 by InnoCare in patients with classical EGFR mutations expected in the fourth quarter of 2024.
● EGFR PACC pivotal study plan. Data from the FURTHER Phase 1b (NCT05364043) trial continues to mature for first-line firmonertinib monotherapy in patients with EGFR PACC mutant NSCLC. ArriVent expects to provide an update on EGFR PACC plans in the first half of 2025.
● Selection of next-generation antibody drug conjugate (ADC) candidate. ArriVent and its partner, Aarvik Therapeutics, Inc., continue to make progress, including initiating CMC activities, on selecting a multi-target multivalent ADC candidate for the treatment of solid tumors in the ARR-002 program, and expect to complete selection of a candidate that will be advanced into IND enabling studies in late 2024 or early 2025.
● Top-line pivotal Phase 3 data in 2025. Firmonertinib is currently being studied as a monotherapy in the pivotal, global Phase 3 FURVENT trial (NCT05607550) evaluating firmonertinib in previously untreated NSCLC patients whose tumors contain EGFR exon 20 insertion mutations with topline data expected in 2025.
Third Quarter 2024 Financial Results

● As of September 30, 2024, the Company had cash and cash equivalents of $282.9 million, which is expected to fund operations into 2026. Net cash used in operations was $54.1 million and $40.9 million for the nine months ended September 30, 2024 and 2023, respectively.

● Research and development expenses were $58.9 million and $44.9 million for the nine months ended September 30, 2024 and 2023, respectively. The increase in expense was primarily due to increased headcount and clinical expense related to firmonertinib.

● General and administrative expenses were $11.8 million and $6.6 million for the nine months ended September 30, 2024 and 2023, respectively. The increase in expense was primarily due to expenses related to expanding the infrastructure necessary for operating as a public company.

● Net loss was $59.9 million and $48.1 million for the nine months ended September 30, 2024 and 2023, respectively.

On November 14, 2024 Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumors, reported corporate updates and financial results for the third quarter ended September 30, 2024 (Press release, Marker Therapeutics, NOV 14, 2024, View Source [SID1234648404]).

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"As we approach the end of 2024, we continue to build momentum across our clinical and corporate programs," said Juan Vera, M.D., President and Chief Executive Officer of Marker Therapeutics. "During the third quarter, we made significant progress in our ongoing Phase 1 APOLLO study investigating MT-601 in patients with lymphoma who have relapsed after anti-CD19 chimeric antigen receptor (CAR)-T cell therapy or where CAR-T cells are not an option. Enrollment is ongoing and we expect to be able to report preliminary safety and efficacy data by the end of this year. We, along with our study investigators, have been encouraged by the promising activity shown in this platform and look forward to continuing assessments from the trial."

"We also recently strengthened our financial position with the receipt of two, $2 million Small Business Innovation Research (SBIR) grants from the National Institutes of Health (NIH). The non-dilutive funding will be used to support further development of MT-601 in patients with non-Hodgkin’s lymphoma who have relapsed following anti-CD19 CAR-T cell therapy, as well as assist in funding the clinical investigation of MT-601 in pancreatic cancer. We continue to make meaningful progress and remain focused on execution as we move our programs through the clinical trials," added Dr. Vera.

PROGRAM UPDATES & EXPECTED MILESTONES

MT-601 (Lymphoma)

- Marker’s lead program is investigating MT-601 in the nationwide multicenter Phase 1 APOLLO study (clinicaltrials.gov identifier: NCT05798897) in patients with lymphoma who have relapsed after anti-CD19 CAR-T cell therapy or where CAR-T cells are not an option.

- The Company previously reported that one of the Principal Investigators presented preliminary safety and efficacy with sustained objective responses observed in three study participants treated at City of Hope National Medical Center (Press Release, April 8, 2024). Treatment was well tolerated among all study participants with no observation of severe adverse effects such as immune effector cell associated neurotoxicity syndrome (ICANS).

- All study participants continue to be observed for long-term treatment effects and durability of response.

- The Company is enrolling additional study participants in the Phase 1 APOLLO trial and expects to provide an update on safety and durability during the fourth quarter of 2024.

- Marker Therapeutics was awarded a $2 million grant from NIH Small Business Innovation Research Program (SBIR) to support the clinical investigation of MT-601 in patients with lymphoma who have relapsed following anti-CD19 CAR-T cell therapy (Press Release, August 12, 2024).

MT-601 (Pancreatic)

- The Company was awarded a $2 million grant from NIH Small Business Innovation Research (SBIR) Program to support the clinical investigation of MT-601 in patients with metastatic pancreatic cancer.

- The Company expects to start the clinical program of MT-601 in patients with metastatic pancreatic cancer in 2025.

MT-401-OTS (Acute Myeloid Leukemia or Myelodysplastic Syndrome)

- The Company previously secured non-dilutive funding to support the clinical investigation of MT-401-OTS in patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) and anticipates clinical program initiation during the first half of 2025.

THIRD QUARTER 2024 FINANCIAL HIGHLIGHTS

Cash Position and Guidance: At September 30, 2024, Marker had cash and cash equivalents of $9 million. The Company believes that its existing cash and cash equivalents will fund its operating expenses into October 2025. This estimate is subject to the Company’s ability to effectively manage its costs and utilize drawdowns of available grant funds.

R&D Expenses: Research and development expenses were $3.5 million for the quarter ended September 30, 2024, compared to $2.0 million for the quarter ended September 30, 2023 as a result of our increased clinical trial activity in the quarter.

G&A Expenses: General and administrative expenses were $0.9 million for the quarter ended September 30, 2024, compared to $1.4 million for the quarter ended September 30, 2023 reflecting the savings from the reorganization that was completed in late 2023.

Net Loss: Marker reported a net loss from continuing operations of $2.3 million for the quarter ended September 30, 2024, compared to $3.0 million for the quarter ended September 30, 2023.

About multiTAA-specific T cells

The multi-tumor associated antigen (multiTAA)-specific T cell platform is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient’s/donor’s blood capable of recognizing a broad range of tumor antigens. Unlike other T cell therapies, multiTAA-specific T cells allow the recognition of hundreds of different epitopes within up to six tumor-specific antigens, thereby reducing the possibility of tumor escape. Since multiTAA-specific T cells are not genetically engineered, Marker believes that its product candidates will be easier and less expensive to manufacture, with an improved safety profile, compared to current engineered T cell approaches, and may provide patients with meaningful clinical benefits.

On November 14, 2024 Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, reported that its novel Nectin-4 targeting ADC (R&D code: 9MW2821) has received IND approval for two clinical studies (Press release, Mabwell Biotech, NOV 14, 2024, View Source [SID1234648421]). The first will explore its use in combination with a PD-1 monoclonal antibody in the treatment of perioperative urothelial carcinoma, while the second will investigate its combination with other antitumor agents for the treatment of advanced solid tumors.

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The recent approval of a multi-drug combination treatment program for cervical cancer and esophageal squamous cell carcinoma, along with the expansion of 9MW2821’s indication to include the perioperative stage for urothelial carcinoma, is anticipated to significantly broaden the therapeutic reach of 9MW2821, potentially benefiting a larger patient population.

9MW2821 is a novel Nectin-4 targeting ADC developed by Mabwell. It stands out as the first clinical-stage drug candidate among Chinese companies for this specific target. Clinical studies for 9MW2821 are underway across a range of tumor indications:

Urothelial Carcinoma (UC):

Monotherapy has advanced to Phase III clinical trials and is included in the CDE’s Breakthrough Therapy Designation (BTD) list.
Combination therapy with PD-1 has entered Phase III clinical trials.
Combination therapy with PD-1 for perioperative UC has been approved for clinical research.
Cervical Cancer (CC):

The first drug candidate targeting Nectin-4 to enter Phase III clinical trials globally.
Combination therapy with PD-1 and other drugs has been approved for clinical research.
Received FDA Fast Track Designation (FTD).
Triple-Negative Breast Cancer (TNBC):

Monotherapy (post-chemotherapy and topoisomerase ADC treatment) has entered Phase II clinical trials.
Combination therapy with PD-1 has entered Phase II clinical trials.
Received FDA FTD.
Esophageal Cancer (EC):

Monotherapy has entered Phase II clinical trials.
Combination therapy with PD-1 and other drugs has been approved for clinical research.
Received FDA FTD for esophageal squamous cell carcinoma (ESCC); received FDA Orphan Drug Designation (ODD).