On November 13, 2024 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its business update and financial results for the first nine months of 2024 (Press release, Innate Pharma, NOV 13, 2024, View Source
[SID1234648197]).

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"I’m honored to join Innate Pharma at such a pivotal moment in its evolution," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma. "We achieved notable regulatory milestones during the quarter including encouraging initial feedback from the FDA for lacutamab’s development plans and the IND approval for IPH4502, our nectin-4 ADC, which paves the way for its entry into clinical development. With presentations at ASH (Free ASH Whitepaper) and SITC (Free SITC Whitepaper) showcasing the depth of our translational science and patient-centered data, we are well-positioned to advance our mission of bringing transformative treatments to patients. Our cash position, with runway to the end of 2025, allows us to continue driving forward, and I am excited to lead the Company into its next phase of growth."

Webcast and conference call will be held today at 2:00pm CET (8:00am ET)

The live webcast will be available at the following link:

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Participants may also join via telephone using the following registration link:

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This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com. A replay of the webcast will be available on the Company website for 90 days following the event.

Pipeline highlights:

Lacutamab (anti-KIR3DL2 antibody):

Cutaneous T Cell Lymphoma

TELLOMAK is a global, open-label, multi-cohort Phase 2 clinical trial evaluating lacutamab in patients with Sézary syndrome and mycosis fungoides.

During the financial quarter ending September 30, 2024, the FDA provided encouraging initial feedback on the Company’s proposed regulatory pathway, which could potentially include Accelerated Approval for Sézary syndrome, and the Company continues to align with the FDA around the confirmatory Phase 3 trial.
Results from the study in Sézary syndrome and mycosis fungoides were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2023 Annual Meeting and the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2024 Annual Meeting respectively.
Quality of life data and translational analysis from the TELLOMAK trial in patients with relapsed/refractory cutaneous T-cell lymphoma will be presented at the ASH (Free ASH Whitepaper) Annual Meeting 2024.
Peripheral T Cell lymphoma (PTCL)

The Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial, an investigator-sponsored, randomized controlled trial led by the Lymphoma Study Association (LYSA) to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine and oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL is ongoing and continues to recruit patients.

ANKET (Antibody-based NK cell Engager Therapeutics):

ANKET is Innate’s proprietary platform for developing next-generation, multi-specific NK cell engagers to treat certain types of cancer. Innate’s pipeline includes five drug candidates that have merged from the ANKET platform: SAR443579/IPH6101 (SAR’579; trifunctional anti-CD123 NKp46xCD16 NKCE), SAR445514/IPH6401 (SAR’514 trifunctional anti-BCMA NKp46xCD16 NKCE), IPH62 (anti-B7-H3), IPH67 (target undisclosed, solid tumors) and tetra-specific IPH6501 (anti-CD20 with IL-2v). Several other undisclosed proprietary preclinical targets are being explored.

IPH6501 (proprietary)

IPH6501 is Innate’s proprietary tetra-specific second-generation ANKET targeting CD20 with an IL-2v. The Phase 1/2 clinical trial evaluating IPH6501 in B cell Non-Hodgkin’s lymphoma (B-NHL) is ongoing and enrolling patients.

Preclinical data supporting the evaluation of IPH6501 in relapsed or refractory B-NHL subtypes and post-CAR-T therapy were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2024 Annual Meeting.
SAR’579/IPH6101, SAR’514/IPH6401, IPH62 and IPH67 (partnered with Sanofi)

SAR’579/IPH6101

The Phase 1/2 clinical trial by Sanofi is progressing well, evaluating SAR’579 / IPH6101, a trifunctional anti-CD123 NKp46xCD16 NK-cell engager and ANKET platform lead asset, in patients with relapsed or refractory acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia (B-ALL) or high-risk myelodysplastic syndrome (HR-MDS).

SAR’514/IPH6401

The Sanofi led Phase 1/2 clinical trial with SAR’514 / IPH6401, a trifunctional anti-BCMA Nkp46xCD16 NK-cell engager, in patients with Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Light-chain Amyloidosis is ongoing.

IPH62, IPH67 and option

IPH62 is a NK-cell engager program targeting B7-H3 under development from Innate’s ANKET platform. Following a research collaboration period and upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization.
During the third quarter of 2024, Sanofi terminated the IPH67 license during the research collaboration period. As a consequence, Innate plans to regain the full rights to IPH67, an NK-cell engager program in solid tumors from Innate’s ANKET platform. The rest of the 2022 research collaboration and license agreement remains unchanged.
Sanofi still retains the option of one additional ANKET target under the terms of the 2022 research collaboration and license agreement.
Antibody Drug Conjugates:

Innate is leveraging its antibody engineering capabilities and is also exploring Antibody Drug Conjugates (ADC) formats.

IPH4502 (Nectin-4 ADC):

IPH4502 is Innate’s novel and differentiated topoisomerase I inhibitor ADC targeting Nectin-4.

In September, the U.S Food and Drug Administration (FDA) cleared Innate’s investigational new drug (IND) application to initiate a Phase 1 clinical study of IPH4502 in Nectin-4 expressing solid tumor indications. Innate expects to initiate the Phase 1 study by Q1 2025.
The Phase 1, open-label, multi-center study, will include a Part 1 Dose Escalation and a Part 2 Dose Optimization, and will assess the safety, tolerability, and preliminary efficacy of IPH4502 as a single agent in advanced solid tumors known to express Nectin-4, including but not limited to urothelial carcinoma, non-small cell lung, breast, ovarian, gastric and colorectal cancers.
Preclinical data of IPH4502 in Nectin-4 expressing tumors were presented at the SITC (Free SITC Whitepaper) 2024 Annual Meeting.
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

The Phase 3 PACIFIC-9 trial run by AstraZeneca evaluating durvalumab (anti-PD-L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following definitive platinum-based concurrent chemoradiation therapy (CRT) is ongoing. This follows the Independent Data Monitoring Committee recommendation for the continuation of the Phase 3 PACIFIC-9 trial based on a pre-planned analysis.
IPH5201 (anti-CD39), partnered with AstraZeneca:

The MATISSE Phase 2 clinical trial conducted by Innate in neoadjuvant lung cancer for IPH5201, an anti-CD39 blocking monoclonal antibody developed in collaboration with AstraZeneca, is ongoing and recruitment is on track. Following a pre-planned interim analysis, the MATISSE Phase 2 trial continues according to plans.
IPH5301 (anti-CD73):

The investigator-sponsored CHANCES Phase 1 trial of IPH5301 by Institut Paoli-Calmettes is ongoing.
Corporate update

The Supervisory Board appointed Jonathan Dickinson as the Company’s new Chief Executive Officer (CEO) and Chairman of the Executive Board, effective November 1, 2024. Jonathan Dickinson succeeds Hervé Brailly, co-founder of the Company, who was interim CEO, during the search process.

Jonathan Dickinson most recently served as Executive Vice President and General Manager, Europe at Incyte, a role he held since 2016. Prior to Incyte, he gained significant leadership experience through several senior positions at ARIAD Pharmaceuticals, a US oncology focused biotechnology company and Bristol-Myers Squibb. This followed a distinguished 13-year tenure at Hoffmann-La Roche, where he was instrumental in driving the success of several of the company’s flagship oncology therapies. Mr. Dickinson began his career at Novartis, holding roles of increasing responsibility within the oncology and endocrinology divisions. He holds a Bachelor of Science degree in Genetics and a Master of Business Administration from the University of Nottingham.
The ATM program, pursuant to which it may, from time to time, offer and sell to eligible investors a total gross amount of up to $75 million of American Depositary Shares ("ADS") is still in place. As of September 30, 2024, no sales have been made under the program.
Financial Results

Cash, cash equivalents and financial assets of the Company amounted to €96.4 million as of September 30, 2024. At the same date, financial liabilities amounted to €33.2 million.

Revenues for the first nine months of 2024 amounted to €10.2 million (€36.5 million for the same period in 2023). For the nine-month period, ended September 30, 2024, revenue from collaboration and licensing agreements mainly resulted from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca and Sanofi.

On November 13, 2024 Aurealis Therapeutics, a synthetic biology company developing multi-targeting, scalable, low cost of goods cell and gene therapies for high unmet medical needs, reported that it has raised CHF 8 million from existing investors and shareholders (Press release, Aurealis Therapeutics, NOV 13, 2024, View Source [SID1234648194]).

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The funds will be primarily used to complete Phase 2 clinical studies with Aurealis lead product AUP-16 for Chronic Wounds, such as Diabetic Foot Ulcer (DFU), and accelerate the preclinical and CMC development of the lead candidate AUP-55 for cancers such as ovarian cancer, other peritoneal carcinomatosis and bladder cancer.

Chronic Wounds, deadly cancers, and inflammatory conditions are complex, multi-factorial diseases which represent massive unmet medical needs and require multi-targeting to be cured. Aurealis Therapeutics is committed to developing multi-targeting therapies based on its unique, proprietary platform. Aurealis platform consists of live, biosafety level 1 lactic acid bacteria, genetically modified to synthesize multiple human therapeutic proteins, acting as millions of nanoscale drug bioreactors in the human body, directly at the disease site. The company’s ambition is to create solid clinical and health economic data in Chronic Wounds, deadly cancers and beyond. This, while engaging with strategic partners to enable market entry and ensure this game-changing technology platform will benefit millions of patients throughout the world.

"We are excited to announce this successful funding round and want to express our gratitude for the trust and support that we have received from the investors. We have exciting times ahead as our Phase 2 study in Diabetic Foot Ulcer is close to completion, and our oncology program is moving towards the clinic" said Juha Yrjänheikki, CEO of Aurealis Therapeutics.

"We have successfully developed our platform and key assets AUP-16 for Chronic Wounds and AUP-55 for Cancer. Positive clinical data, existing and new partnerships, and growing investor base and interest at the market makes us highly confident about completing our next CHF 35M equity round and creating substantial value to all stakeholders" continued Laurent Décory, COO of Aurealis Therapeutics.

On November 12, 2024 AstraZeneca reported its nine month and third quarter 2024 results (Presentation, AstraZeneca, NOV 12, 2024, View Source [SID1234648671]).

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On November 12, 2024 Wugen, Inc., a clinical-stage U.S. biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological and solid tumor malignancies, reported it will initiate a pivotal Phase 2 study in the first quarter of 2025 for the company’s potential first-in-class, investigational, anti-CD7 CAR-T cell therapy, WU-CART-007, in patients with relapsed or refractory (R/R) T cell acute lymphoblastic leukemia or T cell lymphoblastic lymphoma (T-ALL/LBL) (Press release, Wugen, NOV 12, 2024, View Source [SID1234648291]).

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"T-ALL/LBL is an aggressive cancer with a significant need for new therapies given that many patients will progress on standard of care," said Kumar Srinivasan, Ph.D., Wugen president and chief executive officer. "Wugen is well positioned for this critical stage of research and development for WU-CART-007. Recently, we generated positive Phase 1/2 results; received significant new regulatory designations – RMAT and PRIME – to expedite our clinical development path in the United States and Europe; and deepened our cell therapy expertise with Cherry T. Thomas, M.D. joining our team as chief medical officer."

The pivotal Phase 2 study is a single-arm trial evaluating the efficacy and safety of WU-CART-007 in patients with R/R T-ALL/LBL and T-ALL/LBL. The study will evaluate the efficacy of WU-CART-007 in two groups: a R/R cohort and an exploratory minimum residual disease (MRD)-positive cohort. The trial will enroll pediatric and adult patients at oncology centers in the United States, Europe, Asia and Australia.

"With a 20-year void of new medicines to treat patients with relapsed or refractory T-ALL/LBL, many of whom are young, we believe off-the-shelf allogeneic CD7-targeted CAR-T cell therapies may offer hope and innovation," said Dr. Thomas, Wugen’s chief medical officer.

"Wugen’s progress in advancing WU-CART-007 also includes a robust, scalable and efficient commercial manufacturing process, developed with our partners to create a CD7-targeted therapy for off-the-shelf use," said Matt Cooper, Ph.D., Wugen’s co-founder and chief scientific officer, who invented WU-CART-007 as a researcher at Washington University in St. Louis, MO.

Wugen previously announced positive results from a Phase 1/2 cohort expansion study showing clinically manageable safety and evidence of anti-leukemic activity (overall response rate of 91%) in heavily pre-treated patients with R/R T-ALL/LBL. Researchers will present a data update at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH) (Free ASH Whitepaper) 2024, Dec. 7-10 in San Diego.

Follow Wugen’s LinkedIn page to see abstracts to be presented at ASH (Free ASH Whitepaper) 2024 for WU-CART-007 and for WU-NK-101, Wugen’s investigational off-the-shelf memory natural killer cell therapy.

About WU-CART-007

WU-CART-007 is an allogeneic, off-the-shelf, fratricide-resistant CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat CD7+ hematological malignancies. Wugen is deploying CRISPR/Cas9 gene editing technology to delete CD7 and the T cell receptor alpha constant (TRAC), preventing CAR-T cell fratricide and mitigating the risk of graft-versus-host-disease (GvHD). WU-CART-007 is manufactured using healthy donor-derived T cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. WU-CART-007 is currently being evaluated in a global Phase 1/2 clinical trial for the treatment of relapsed or refractory (R/R) T cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL). More information on the Phase 1/2 trial is available on clinicaltrials.gov, identifier NCT# 04984356 and on the Phase 2 pivotal trial on clinicaltrials.gov, identifier NCT06514794.

WU-CART-007 has received Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration and Priority Medicines (PRIME) Scheme designation in the European Union for the treatment of relapsed/refractory (R/R) T cell acute lymphoblastic leukemia (T-ALL) and T cell lymphoblastic lymphoma (T-LBL). RMAT and PRIME designations provide increased agency support to expedite the development and review of promising therapies for patients in need.

On November 12, 2024 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported financial results for the third quarter of 2024 and provided an overview of its clinical programs and anticipated milestones (Press release, Vincerx Pharma, NOV 12, 2024, View Source [SID1234648289]).

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"As we direct our efforts and resources toward our ADC technologies and programs, we are committed to advancing VIP943 based on the encouraging safety, efficacy, and tolerability results observed to date. We look forward to presenting additional data from patients at efficacious dose cohorts by early next year," said Ahmed Hamdy, M.D., Chief Executive Officer. "Securing the funding necessary to advance our programs remains a priority. Alongside exploring financing options, we remain focused on strategic partnerships, particularly as pharmaceutical companies intensify their search for truly differentiated and transformative technologies."

THIRD QUARTER 2024 CLINICAL PROGRAM HIGHLIGHTS AND ANTICIPATED MILESTONES

VIP943

VIP943 is a novel CD123-targeted ADC developed with the Company’s next-generation VersAptx platform.
VIP943 has shown promising safety, efficacy, and tolerability in an ongoing Phase 1 dose-escalation study for patients with relapsed/refractory acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and B-cell acute lymphoblastic leukemia (B-ALL) (NCT06034275). In October, the Company reported two complete responses in this Phase 1 study: one out of four patients with relapsed AML in the 1 mg/kg dose cohort achieved complete remission with incomplete hematologic recovery (CRi), and one out of one patient with higher-risk MDS in the 1.3 mg/kg dose cohort achieved complete remission with limited count recovery (CRL).
VIP943 has shown effective target engagement and elimination of CD123+ malignant cells, with pharmacodynamic data demonstrating decreases in CD123+ blasts after dosing. Preliminary pharmacokinetic data indicates minimal payload release (≤1% in plasma), signifying a stable linker.
Given the favorable safety and tolerability observed for VIP943, the Company continues dose escalation to assess potential for additional efficacy. Enrollment in the once-weekly and twice-weekly (as an induction therapy) dosing schedules is ongoing.
Vincerx expects to share additional Phase 1 study data for VIP943 by early 2025.
Enitociclib

Enitociclib is a highly selective CDK9 inhibitor designed to block the activation of RNA polymerase II, leading to inhibition of oncogenes, including MYC and MCL1.
Enitociclib is currently in a Phase 1 dose-escalation study (NTC05371054) evaluating the combination of enitociclib, venetoclax, and prednisone in diffuse large B-cell lymphoma (DLBCL) and peripheral T-cell lymphoma (PTCL). This study is being conducted in collaboration with the National Institutes of Health (NIH). As of September 2024, the study reported four partial responses (PRs) in seven patients (57% overall response rate), including one patient with double hit lymphoma (DH-DLBCL) and three patients with PTCL.
Enitociclib has successfully completed its Phase 1 dose-escalation study as a monotherapy (NCT02635672), enrolling 63 patients across dose-escalation and expansion cohorts. The treatment demonstrated a favorable safety profile, dose-proportional pharmacokinetics, and on-target pharmacodynamic activity. Clinical benefits included durable complete metabolic remissions in two patients with DH-DLBCL, lasting 3.7 and 2.3 years, with both remissions continuing more than two years after treatment cessation. In addition, a transformed follicular (tFL) patient achieved a PR with a 63% tumor reduction after nearly two years, a meaningful outcome given the historically poor prognosis of tFL. Furthermore, 13 patients with solid tumors achieved stable disease as their best response, including five ovarian cancer patients—indicating a promising path for future combination studies in this indication.
The Company is actively focused on finding a strategic partner to continue the development of this asset.
VIP236

VIP236 is a αVβ3 SMDC conjugated to an optimized camptothecin (CPT) payload developed with the Company’s VersAptx platform.
VIP236 has completed its Phase 1 dose-escalation study (NCT05712889), identifying the maximum tolerated dose that could be utilized in future studies. As reported in October, a total of 29 patients were enrolled in the Phase 1 study, resulting in a 45% disease control rate. The drug demonstrated a favorable safety profile, distinguishing itself from other CPTs by showing no instances of common dose-limiting side effects such as life-threatening diarrhea, severe stomatitis/mucositis, or interstitial lung disease.
The Company intends to identify a partner to champion VIP236 through further development.

THIRD QUARTER 2024 FINANCIAL RESULTS

Vincerx had approximately $10.1 million in cash, cash equivalents, and marketable securities as of September 30, 2024, as compared to approximately $16.3 million as of June 30, 2024. Based on its current business plans and assumptions, Vincerx believes its available capital will be sufficient to meet its operating requirements into early 2025.
Research and development expenses for the third quarter ended September 30, 2024, were approximately $3.9 million, as compared to approximately $6.1 million for the same period in 2023. This decrease is primarily the result of decreases in research services of approximately $2.4 million and personnel-related expenses of approximately $0.8 million, offset by an increase in clinical-related expenses of approximately $0.9 million.
General and administrative expenses for the third quarter ended September 30, 2024, were approximately $3.9 million, as compared to approximately $3.5 million for the same period in 2023. This increase was due to a $0.5 million increase in professional services, partially offset by a decrease in personnel-related expenses of $0.1 million.
For the third quarter ended September 30, 2024, Vincerx reported a net loss of approximately $7.8 million, or $0.17 per share. For the third quarter ended September 30, 2023, Vincerx reported a net loss of approximately $9.0 million, or $0.42 per share.