On May 14, 2024 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its consolidated financial results for the quarter ending March 31, 2024 (Press release, Innate Pharma, MAY 14, 2024, View Source [SID1234643227]).

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"We are executing our strategy of building on our partnered drug candidates while advancing our next generation of proprietary medicines," said Hervé Brailly, Chief Executive Officer ad interim of Innate Pharma. "Our second generation ANKET, IPH6501 began clinical development for NHL. We presented preclinical data for IPH45, our Nectin-4 ADC, at the recently held AACR (Free AACR Whitepaper) Annual Meeting. Our partner Sanofi also advanced SAR443579, a tri-functional NK Cell Engager targeting CD123, to Phase 2 in blood cancer. We expect to have several data presentations at ASCO (Free ASCO Whitepaper), including data from the TELLOMAK Phase 2 trial with lacutamab in mycosis fungoides, as we prepare to submit an IND for IPH45 later this year."

[1] Including short term investments (€21.3 million) and non-current financial instruments (€10.1 million).

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

The live webcast will be available at the following link: View Source

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

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 (MF).

•Top-line results in MF patients will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting 2024 being held May 31 – June 4 in Chicago. Title of the abstract is: Lacutamab in patients with relapsed and/or refractory mycosis fungoides: results

from the TELLOMAK Phase 2 trial. The full abstract will be released at 5:00 PM ET on Thursday, May 23, 2024 on the ASCO (Free ASCO Whitepaper) Annual Meeting website.

•In January 2024, Innate announced that the US Food and Drug Administration (FDA) has lifted the partial clinical hold previously placed on the lacutamab IND on October 2023 following a patient death in the TELLOMAK study. The FDA decision to lift the partial clinical hold is based on the FDA review of the fatal case which Innate, together with a steering committee of independent experts, determined to be related to aggressive disease progression and lacutamab unrelated.

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 in combination with 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 public drug candidates born from the ANKET platform: SAR443579 (SAR’579/IPH6101) (CD123-targeted), SAR445514 (SAR’514/IPH6401) (BCMA-targeted), IPH62 (B7-H3-targeted), IPH67 (target undisclosed, solid tumors) and tetra-specific IPH6501 (CD20-targeted with IL 2v). Several other undisclosed proprietary preclinical targets are being explored.

IPH6501 (proprietary)

IPH6501 is Innate’s proprietary CD20-targeted IL-2v bearing second-generation ANKET.

•Innate will present 2 posters on IPH6501 at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting 2024, being held from May 31 to June 4 in Chicago. Titles of the abstract are:
oA Phase 1/2, Open-Label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Antineoplastic Activity of IPH6501 in Patients With Relapsed and/or Refractory CD20-expressing Non-Hodgkin Lymphoma
oPreclinical assessment of IPH6501, a first-in-class IL2v-armed tetraspecific NK Cell Engager directed against CD20 for R/R B-NHL, in comparison to a CD20-targeting T Cell Engager
The full abstracts will be released at 5:00 PM ET on Thursday, May 23, 2024 on the ASCO (Free ASCO Whitepaper) Annual Meeting website.
•In March 2024 the first patient was dosed in the Phase 1/2 clinical trial evaluating IPH6501 in B cell Non-Hodgkin’s lymphoma (B-NHL). The study is planned to enroll up to 184 patients.

SAR443579, SAR445514, IPH62 and IPH67 (under development by Sanofi)

SAR443579/IPH6101

The Phase 1/2 clinical trial, currently under development, by Sanofi is progressing well, evaluating SAR443579 / IPH6101, a trifunctional anti-CD123 NKp46×CD16 NK cell engager and ANKET platform lead asset, in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high-risk myelodysplastic syndrome (HR-MDS).

•In April 2024, Sanofi advanced SAR443579 / IPH6101, to the Phase 2 dose expansion of the trial. Under the terms of the 2016 research collaboration with Sanofi, the progression to the dose expansion part of the trial has triggered a milestone payment from Sanofi to Innate of €4m (which has been booked as revenue in the first quarter but had not been received from Sanofi in the quarter, and has therefore not been included in the cash position).

SAR445514/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

IPH62 is a NK cell engager program targeting B7-H3 from Innate’s ANKET platform under development. Upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization.

IPH67

IPH67 is a NK cell engager program in solid tumors from Innate’s ANKET platform under development. Following a research collaboration period, Sanofi will be responsible for all development, manufacturing and commercialization.
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 develops different approaches for the treatment of cancer utilizing its antibody engineering capabilities to deliver novel assets, with its innovative ANKET platform and is also exploring Antibody Drug Conjugates (ADC) formats.
Beyond its proprietary programs, Innate has an ongoing agreement with Takeda on ADCs.

IPH45 (Nectin-4 ADC):

IPH45 is Innate’s proprietary and differentiated exatecan-Antibody Drug Conjugate (ADC) targeting Nectin-4.

•First preclinical data were presented in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024. In preclinical studies, IPH45 shows anti-tumor efficacy in vivo, in Nectin-4 expressing tumors including in Enfortumab Vedotin (EV) refractory models. Importantly, IPH45 shows stronger activity than EV, in multiple urothelial carcinoma patient-derived xenografted (PDX) mice models, across Nectin-4 high and Nectin-4 low expression levels. In addition, IPH45 has anti-tumor activity in combination with anti-PD1 treatment in PD-1 resistant model in vivo and has a favorable safety profile in relevant animal toxicology models.

•IPH45 continues towards IND filing in 2024.

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.

AstraZeneca will present a poster at ASCO (Free ASCO Whitepaper) titled: "Updated results from COAST, a phase 2 study of durvalumab (D) ± oleclumab (O) or monalizumab (M) in patients (pts) with stage III unresectable non-small cell lung cancer (uNSCLC)."

A poster at ASCO (Free ASCO Whitepaper) will also be presented titled "A phase II trial of monalizumab in combination with durvalumab (MEDI4736) plus platinum-based chemotherapy for first-line treatment of extensive stage small cell lung cancer (MOZART): Hoosier Cancer Research Network LUN21-530 study."

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.

IPH5301 (anti-CD73):

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

Corporate Update:
•Early January 2024, two new Executive Board members were appointed. Arvind Sood, Executive Vice President (EVP), President of US Operations, Dr Sonia Quaratino, EVP, Chief Medical Officer, joining Hervé Brailly, interim Chief Executive Officer and Yannis Morel, EVP, appointed Chief Operating Officer.

•In connection with Innate’s previous announcement that it had established an at-the-market ("ATM") program, on January 16, 2024 Innate filed a new Registration Statement on Form F-3 (Registration No. 333-276164). On February 6, 2024, Innate filed a prospectus supplement relating to its previously established 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"). Each ADS represents one ordinary share of Innate. As of March 31, 2024, no sales have been made under the program.

Financial Results:
Cash, cash equivalents and financial assets of the Company amounted to €113.9 million as of March 31, 2024. At the same date, financial liabilities amounted to €37.7 million. Cash, cash equivalents and financial assets as of March 31, 2024 do not include the €4.0 million payment to be received from Sanofi.

Revenues for the first three months of 2024 amounted to €6.6 million (€26.0 million for the same period in 2023). For the three-month period, ended March 31, 2024, revenue from collaboration and licensing agreements mainly results from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca and Sanofi.

On May 14, 2024 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported financial results for the first quarter ended March 31, 2024, and provided a business update (Press release, Immunome, MAY 14, 2024, View Source [SID1234643225]).

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"Immunome continues to build momentum. We have completed the integration of AL102 and are executing activities necessary for regulatory submissions," said Clay B. Siegall, Ph.D., President and Chief Executive Officer. "We have also completed the integration of IM-1021 and are advancing that program and IM-3050 towards clinical trials."

Dr. Siegall continued, "In addition, we are working internally to design and develop additional next-generation ADC technology. Those efforts are complemented by our ongoing business development efforts, which seek to identify and procure high-quality technologies and clinical programs. Both our internal and external efforts are focused on expanding Immunome’s pipeline with additional programs that have first-in-class or best-in-class potential and can improve the lives of cancer patients."

Pipeline Highlights

The purchase of AL101 and AL102 from Ayala Pharmaceuticals closed on March 25, 2024. Full enrollment for the Phase 3 RINGSIDE Part B study of AL102 for the treatment of desmoid tumors was completed in February 2024. Immunome expects to report topline data for RINGSIDE Part B in the second half of 2025. In parallel, Immunome continues to perform additional manufacturing and pharmacology work required to support a new drug application filing for AL102.

Immunome anticipates submitting INDs for two preclinical candidates in the first quarter of 2025: IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted RLT.

First Quarter 2024 Financial Results

· As of March 31, 2024, cash, cash equivalents and marketable securities totaled $309.7 million. Immunome’s current cash runway is expected to extend into 2026.

· Research and development expenses for the quarter ended March 31, 2024 were $15.4 million, including stock-based compensation costs of $0.4 million.

· In-process research and development expenses for the quarter ended March 31, 2024 were $112.0 million. These expenses were related to Immunome’s acquisition of AL101 and AL102 from Ayala Pharmaceuticals, Inc. and the exclusive license of IM-1021 and related ADC platform technology from Zentalis Pharmaceuticals, Inc., both of which closed in the quarter ended March 31, 2024.

· General and administrative expenses for the quarter ended March 31, 2024 were $6.0 million, including stock-based compensation expense of $1.8 million.

· Immunome reported a net loss of $129.5 million, or basic and diluted net loss per share attributable to common stockholders of $2.51, for the quarter ended March 31, 2024.

On May 14, 2024 Immatics N.V. (NASDAQ: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported a business update and announced financial results for the quarter ended March 31, 2024 (Press release, Immatics, MAY 14, 2024, View Source [SID1234643224]).

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"Our lead cell therapy candidate, IMA203, continues to show deep and durable responses in a significantly expanded data set since our last data readout in November 2023. This update emphasizes the meaningful impact our novel immunotherapy may have on the lives of metastatic cutaneous, uveal and mucosal melanoma patients and the medical needs that IMA203 has a real opportunity to address. We continue to plan to move IMA203 into a registration-enabling clinical trial within this year while also continuing to ramp up our commercial manufacturing buildout," said Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. "In addition to IMA203’s progress, we also look forward to presenting the first clinical data on the two lead candidates from our bispecifics pipeline in the second half of the year."

First Quarter 2024 and Subsequent Company Progress

ACTengine Cell Therapy Program

ACTengine IMA203 monotherapy
Today, Immatics is providing a data update on IMA203 monotherapy targeting PRAME from the ongoing Phase 1 trial at the recommended Phase 2 dose (RP2D, 1 to 10 billion total TCR-T cells) in 30 heavily pretreated metastatic melanoma patients evaluable for efficacy. The treated patient population is composed of patients with a median of 3 lines of prior systemic treatments, consisting of cutaneous melanoma patients (N=17), uveal melanoma patients (N=10), mucosal melanoma patients (N=2) and a patient with melanoma of unknown primary (N=1). The current data represent an update to the previously communicated interim data readout in the IMA203 melanoma efficacy population of November 8, 2023.

As of the data cut-off on April 25, 2024, treatment with IMA203 monotherapy in the efficacy population has demonstrated:

Confirmed objective response rate (cORR) of 55% (16/29)
Disease control rate of 90% (27/30)
Tumor shrinkage in 87% (26/30) of patients
Median duration of response (mDOR) was 13.5 months (min 1.2+, max 21.5+ months) including 11 of 16 confirmed objective responses ongoing at data cut-off and longest duration of response ongoing at >21 months after infusion
Confirmed response rates are similar across all melanoma subtypes (56% (9/16) in cutaneous melanoma; 54% (7/13) in other melanoma subtypes)

To date, IMA203 has maintained a favorable safety profile with no treatment-related grade 5 events in the safety population (N=65 patients across all dose levels and all tumor types).

Best overall response for IMA203 at RP2D in melanoma

More information and details on the IMA203 clinical data update in melanoma are available in the Immatics corporate presentation: View Source

The next data update with translational and clinical data for IMA203 is planned for 2H 2024 at a medical conference.

Immatics’ late-stage clinical cell therapy development is supported by its differentiated manufacturing related to timeline, capabilities and facilities. ACTengine IMA203 cell therapy products are manufactured within 7 days, followed by a 7-day QC release testing at a success rate of >95% to reach the target dose. The company has also recently completed construction of a ~100,000 square foot R&D and GMP manufacturing facility with a modular design for efficient and cost-effective scalability intended to serve early-stage and Phase 2/3 clinical trials, as well as initial commercial supply. The new site will start GMP manufacturing of cell therapy products in early 2025. Meanwhile, the existing GMP facility, which is run in collaboration with UT Health, will remain active until YE 2025 and will also initially serve the Phase 2/3 registrational trial.

Following an RMAT designation in October 2023 and productive interactions with the FDA, Immatics plans to initiate a randomized Phase 2/3 trial in 4Q 2024 for IMA203 in patients with second-line or later (2L+) cutaneous melanoma, potentially also including uveal melanoma patients.

The Phase 2/3 trial is expected to assess IMA203 targeting PRAME in HLA-A*02:01-positive cutaneous melanoma patients versus a control arm. This approach is consistent with the FDA’s "one-trial" approach2, i.e., a single randomized controlled trial to support accelerated approval and the verification of clinical benefit to achieve full approval. The high prevalence of PRAME (≥95%) in cutaneous melanoma may enable the company to enroll patients without PRAME pre-testing. This would enhance trial operations and would remove the need to develop a companion diagnostic for PRAME testing in this indication. The full trial design is currently being developed and is subject to further alignment with the FDA as part of the ongoing discussions. Further details of the final clinical trial design will be provided in 2H 2024.

IMA203 is being developed to treat patients with metastatic melanoma, a prevalent cancer type with increasing incidence both inside and outside the United States. Currently, eligible PRAME-positive melanoma patients for the ongoing trials, i.e., 2L+, HLA-A*02:01 positive, include ~3,000 cutaneous melanoma patients and ~300 eligible uveal melanoma patients3 in the US.

ACTengine IMA203CD8 (GEN2) monotherapy

As of the previously reported interim clinical update from November 8, 2023, the first data on the company’s second-generation product candidate, IMA203CD8 (consisting of PRAME-specific functional CD8+ and CD4+ cells), demonstrated 56% (5/9) cORR with enhanced pharmacology compared to IMA203. mDOR was not reached (min 2.0+ months, max 11.5+ months) at a mFU of 4.8 months. As of the reported September 30, 2023, cut-off date, IMA203CD8 (GEN2) exhibited a manageable tolerability profile.

For IMA203CD8 (GEN2), Immatics cleared dose level 4a (DL4a, up to ~1.6×109 TCR-T cells) in December 2023. Immatics plans to continue dose escalation with the goal to define the optimal dose for further development. In addition to treating melanoma patients, Immatics has also started to expand its clinical footprint outside of melanoma to address a broader patient population with a particular focus on ovarian and uterine cancers.

A next data update for IMA203CD8 (GEN2) is planned for 2H 2024.

TCR Bispecifics Programs

Immatics’ T cell engaging receptor (TCER) candidates are next-generation, half-life extended TCR Bispecific molecules. They are designed to achieve a patient-convenient dosing schedule and to maximize efficacy while minimizing toxicities in patients through the proprietary format using a high-affinity TCR domain against the tumor target and a low-affinity T cell recruiter binding to the T cell.

Upcoming milestones for Immatics’ clinical TCER pipeline
Immatics seeks to deliver clinical proof-of-concept for its novel TCER platform as quickly as possible and plans to provide first clinical data for IMA401 (MAGEA4/8) and IMA402 (PRAME) in 2H 2024.

Key objectives include:

Demonstrating tolerability of the novel, next-generation, half-life extended TCR Bispecifics format;
Optimizing dosing schedule to a less frequent regimen during dose escalation based on pharmacokinetics data;
Demonstrating initial clinical anti-tumor activity (i.e., confirmed objective responses according to RECIST 1.1).

TCER IMA401 (MAGEA4/8)

The Phase 1 dose escalation basket trial to evaluate safety, tolerability and initial anti-tumor activity of TCER IMA401 in patients with recurrent and/or refractory solid tumors is ongoing. IMA401 targets an HLA-A*02:01-presented peptide that occurs identically in two different proteins, MAGEA4 and MAGEA8. This target peptide has been selected based on natural expression in native solid tumors at particularly high target density (peptide copy number per tumor cell identified by Immatics’ proprietary quantitative mass spectrometry engine XPRESIDENT is >5x higher than for a MAGEA4 peptide target used in other clinical trials).

MAGEA4 and MAGEA8 are expressed in multiple solid cancers, including lung cancer, head and neck cancer, melanoma, ovarian cancer, sarcoma and others. Tolerability continues to be manageable with transient low-grade CRS, lymphopenia and neutropenia at high doses, all of which are expected for a bispecific T cell engager. A premedication with low doses of dexamethasone administered prior to the first 4 infusions, as used with other approved bispecific products, has been implemented as a preventative measure for continued dose escalation. Since the implementation of this premedication, to date, no cases of high-grade neutropenia among the patients treated have been observed. Based on pharmacokinetics data, the treatment schedule for IMA401 was switched from weekly to bi-weekly dosing. Confirmed objective responses have been observed in multiple patients.

IMA401 is being developed in collaboration with Bristol Myers Squibb. First clinical data in at least 25 patients in dose escalation across all doses and multiple solid cancers is expected to be announced in 2H 2024.

TCER IMA402 (PRAME)

Immatics initiated the Phase 1/2 trial investigating the company’s fully owned TCER candidate IMA402 in patients with recurrent and/or refractory solid tumors in August 2023 and the first patients have been dosed. Initial focus indications are ovarian cancer, lung cancer, uterine cancer and cutaneous and uveal melanoma, among others. IMA402 targets an HLA-A*02:01-presented peptide derived from the tumor antigen PRAME. This target peptide has been selected based on natural expression in native solid primary tumors and metastases at particularly high target density (peptide copy number per tumor cell identified by Immatics’ proprietary quantitative mass spectrometry engine XPRESIDENT).

Immatics has recently engaged Patheon UK Limited, a subsidiary of ThermoFisher Scientific Inc., for the manufacturing of clinical IMA402 batches for its use within a potential registration-enabling trial. Patient recruitment and dose escalation continue to scale. First clinical data in at least 15 patients in dose escalation across multiple solid cancers, but initially focused on melanoma, is anticipated to be announced in 2H 2024.

Corporate Development

On January 22, 2024, Immatics completed an offering of 18,313,750 ordinary shares at a public offering price of $11.00 per share. The gross proceeds from the offering, before deducting the underwriting discount and offering expenses, were approximately $201.5 million.

First Quarter 2024 Financial Results

Cash Position: Cash and cash equivalents, as well as other financial assets, total €564.0 million ($609.7 million1) as of March 31, 2024, compared to €425.9 million ($460.4 million1) as of December 31, 2023. The increase is mainly due to the public offering in January 2024, partly offset by ongoing research and development activities. The company projects a cash runway into 2027.

Revenue: Total revenue, consisting of revenue from collaboration agreements, was €30.3 million ($32.8 million1) for the three months ended March 31, 2024, compared to €9.8 million ($10.6 million1) for the three months ended March 31, 2023. The increase is mainly the result of the release of the deferred revenue following the termination of the Genmab collaboration.

Research and Development Expenses: R&D expenses were €32.1 million ($34.7 million1) for the three months ended March 31, 2024, compared to €27.6 million ($29.8 million1) for the three months ended March 31, 2023. The increase mainly resulted from costs associated with the advancement of the clinical pipeline candidates.

General and Administrative Expenses: G&A expenses were €11.6 million ($12.5 million1) for the three months ended March 31, 2024, compared to €9.6 million ($10.4 million1) for the three months ended March 31, 2023.

Net Profit and Loss: Net loss was €3.1 million ($3.4 million1) for the three months ended March 31, 2024, compared to a net loss of €19.7 million ($21.3 million1) for the three months ended March 31, 2023. The decrease of net loss resulted mainly from the one-time revenue related to the termination of the Genmab collaboration, as reported previously.

Full financial statements can be found in the 6-K filed with the Securities and Exchange Commission (SEC) on May 14, 2024, and published on the SEC website under www.sec.gov.

Upcoming Investor Conferences

Bank of America Health Care Conference, Las Vegas (NV) – May 14 – 16, 2024
Jefferies Global Healthcare Conference, New York (NY) – June 5 – 7, 2024
To see the full list of events and presentations, visit www.investors.immatics.com/events-presentations.

On May 14, 2024 Icosagen, a CRDMO with expertise in innovative antibody research and production, reported a strategic partnership on selected projects with Lead Discovery Center GmbH (LDC), a translational drug discovery organization tapping on a broad network in academia and industry (Press release, Icosagen Cell Factory, MAY 14, 2024, View Source [SID1234643223]). This alliance is focused on the discovery of monoclonal antibody portfolios targeting therapeutically relevant proteins, including a pivotal G-protein coupled receptor (GPCR), which are often challenging to address.

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Scope of Collaboration
Antibody-based inhibitors have gained relevance in the field of drug discovery due to their exceptional affinity, selectivity and physicochemical properties. Within this collaboration, Icosagen will generate, identify, and discover potent antibodies against innovative and therapeutically relevant targets, supplying them to LDC for further development.

Utilizing its proprietary technology, Icosagen will produce the proteins of interest and enhance their display on the surface of virus-like particles, which serve as vehicles for the production of antibodies with affinity for the targets. Subsequently, an extensive library will be established to facilitate the selection of high-affinity monoclonal antibodies, which will undergo further analysis at LDC through a streamlined process of high-throughput screening. This partnership highlights Icosagen’s capability to scale its proprietary platforms and synergize effectively with LDC’s workflow.

"Partnering with LDC will further help expand the opportunities for antibody therapeutics, especially in the challenging field of GPCR-targeted treatments" said professor Mart Ustav, CEO of Icosagen. "This will not only highlight our technological expertise but also perfectly aligns with our mission to transform scientific discoveries into life-changing treatments."

"We are excited to partner up with Icosagen, a competent and highly experienced player in the field of antibody research" remarked Bert Klebl, CEO and CSO of LDC. "This project will greatly benefit from Icosagen´s expertise and state-of-the-art capabilities as we pursue our shared goal: the development of novel therapeutics that can make a meaningful difference in healthcare."

Future Prospects
LDC takes on promising early-stage projects from academia and transforms them into innovative pharmaceutical leads and antibodies that reach initial proof-of-concept in animals as well as candidate nomination. In close collaboration with high-profile partners from research and industry, LDC is building a strong and growing portfolio of small molecule and antibody leads with exceptional medical and commercial potential.

The partnership between Icosagen and LDC holds promise in advancing targeted therapeutics, with the potential to revolutionize treatment approaches and improve outcomes for patients worldwide. The successful development of these monoclonal antibodies is anticipated to significantly advance the understanding and treatment of diseases.

On May 14, 2024 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that the first patient has been enrolled and dosed in the Company’s Phase 1 dose escalation portion of the Acclaim-3 clinical study of Reqorsa (quaratusugene ozeplasmid) Immunogene Therapy in combination with Genentech’s Tecentriq to treat patients with extensive-stage small cell lung cancer (ES-SCLC) (Press release, Genprex, MAY 14, 2024, View Source [SID1234643222]).

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"We are excited to take this next step in our fight against lung cancers as we work to advance an innovative therapy that we believe provides hope to patients suffering with ES-SCLC, an especially aggressive form of lung cancer that has extremely limited treatment options," said Ryan Confer, President and Chief Executive Officer at Genprex. "With a median progression free survival (PFS) of 5.2 months, ES-SCLC has a particularly poor prognosis. Additionally, patients receiving Tecentriq as maintenance therapy have a median PFS of 2.6 months after the start of maintenance therapy. With such limited benefit from current treatments, we believe the combination of REQORSA and Tecentriq can provide a promising new therapeutic option for the treatment of small cell lung cancer."

"The Phase 1 dose escalation portion of the Acclaim-3 study is expected to determine the maximum tolerated dose for the Phase 2 expansion study," stated Mark Berger, M.D., Chief Medical Officer of Genprex. "The favorable results from our Phase 1 Acclaim-1 study in non-small cell lung cancer (NSCLC) enabled us to shorten the Phase 1 portion of Acclaim-3. This should allow us to complete the Phase 1 portion of the study during the second half of 2024 and to advance more quickly into the Phase 2 expansion portion of Acclaim-3 in the second half of 2024. We look forward to providing study updates as we advance this potentially life-saving therapy to benefit patients battling ES-SCLC."

Genprex has a novel cancer treatment platform that re-expresses tumor suppressor genes in cancers. Tumor suppressor genes are often deleted or inactivated early in the process of cancer development. REQORSA contains a plasmid that expresses TUSC2, a tumor suppressor gene protein. Nearly 100% of SCLCs have reduced or no TUSC2 protein expression, and 41% completely lack TUSC2 protein expression. Nonclinical studies in mice support the hypothesis that re-expressing the TUSC2 protein may lead to improved clinical efficacy in combination with Tecentriq.

About the Acclaim-3 Clinical Trial

The Acclaim-3 clinical trial is a Phase 1/2 open-label, dose escalation and clinical response study of maintenance therapy evaluating REQORSA in combination with Tecentriq in patients with ES-SCLC. The Acclaim-3 clinical trial will enroll patients who did not develop tumor progression after receiving Tecentriq and chemotherapy as standard initial treatment, and who are therefore eligible for maintenance therapy.

The Phase 1 dose escalation portion of the Acclaim-3 clinical study is expected to enroll up to 12 patients at approximately ten U.S. clinical sites to determine the Maximum Tolerated Dose (MTD). If no dose limiting toxicities occur during the Phase 1 study, the highest dose evaluated will be the Recommended Phase 2 Dose. The Phase 2 portion of the study is expected to enroll approximately 50 patients at ten to fifteen U.S. sites. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. Genprex expects to initiate the Phase 2 expansion study in the second half of 2024.

The primary endpoint of the Phase 2 portion of the trial is to determine the 18-week progression-free survival rate from the time of the start of maintenance therapy with REQORSA and Tecentriq treatment in patients with ES-SCLC. Patients will also be followed for survival. A Phase 2 futility analysis will be performed after the 25th patient enrolled and treated reaches 18 weeks of follow up.

Genprex has received U.S. Food and Drug Administration (FDA) Ophran Drug and Fast Track designations for Reqorsa Immunogene Therapy, in combination with Genentech, Inc’s Tecentriq in patients with ES-SCLC who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Additional information about the Acclaim-3 clinical trial can be found by visiting ClinicalTrials.gov.

About Reqorsa Immunogene Therapy
Reqorsa (quaratusugene ozeplasmid) Immunogene Therapy for NSCLC and SCLC consists of the TUSC2 gene expressing plasmid encapsulated in non-viral nanoparticles made from lipid-based molecules in a lipoplex form (Genprex’s Oncoprex Delivery System) with a positive electrical charge. REQORSA is injected intravenously and specifically targets cancer cells, which generally have a negative electrical charge. REQORSA is designed to deliver the functioning TUSC2 gene to cancer cells while minimizing their uptake by normal tissue. REQORSA has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for programmed cell death, or apoptosis, in cancer cells, and modulates the immune response against cancer cells. In addition, REQORSA disrupts the metabolism of cancer cells by decreasing glycolysis and ATP production in cancer cells with decreased TUSC2.

Genprex’s strategy is to develop REQORSA in combination with currently approved therapies and believes that REQORSA’s unique attributes position it to provide treatments that improve on current therapies for patients with NSCLC, SCLC, and possibly other cancers.

Tecentriq is a registered trademark of Genentech, Inc.