On May 30, 2023 Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or associated companies, "Sun Pharma")) and Philogen S.p.A (BIT: PHIL) reported that they have entered into a licensing agreement for commercializing Philogen’s specialty product, Nidlegy (Daromun) in the territories of Europe, Australia and New Zealand (Press release, Philogen, MAY 30, 2023, View Source [SID1234632219]). Nidlegy, currently in Phase III clinical trials, is a new anti-cancer biopharmaceutical which is being developed by Philogen for the treatment of melanoma and non-melanoma skin cancers.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, Sun Pharma will have exclusive rights to commercialise Nidlegy for indications of skin cancers in the territories of Europe, Australia and New Zealand. Philogen will complete pivotal clinical trials for the product in Europe, pursue Marketing Authorization with the regulatory authorities and manufacture commercial supplies. Sun Pharma will be responsible for commercialization activities. The two partner companies will share post-commercialization economics in about 50:50 ratio. Other financial terms were not disclosed. Philogen will retain the IP rights for Nidlegy for other territories and indications other than skin cancers.

Hellen De Kloet, Business Head-Western Europe and ANZ, Sun Pharma, said "We are delighted to partner with Philogen for Nidlegy, a close to market, new immunotherapy treatment in skin cancers. This collaboration is in line with our goal to bring innovative products to patients. With the expected addition of Nidlegy to our existing Odomzo franchise, we will be well-positioned to provide patient solutions across a broad spectrum of skin cancers in various disease stages."

Prof. Dr. Dario Neri, CEO and CSO of Philogen, commented: "We are pleased to establish a collaboration with Sun Pharma, a leading global pharmaceutical company, in the oncodermatology space. This collaboration will focus on the commercialization of Nidlegy, a new immunotherapy that brings promise to improve the therapeutic options for patients suffering from melanoma and non-melanoma skin cancers, high-risk conditions with unmet medical need. Both companies are committed to the development and commercialization of Nidlegy making it widely available to patients who may benefit from it.

About Nidlegy (Daromun)

Nidlegy is a biopharmaceutical product, proprietary to Philogen, designed for the treatment of skin cancer. It consists of two active ingredients, L19IL2 and L19TNF which are manufactured independently, and which are mixed prior to intralesional administration. The L19 antibody is specific to the Extra Domain B of Fibronectin, a protein expressed in tumors (and other diseases) but absent in most healthy tissues. Interleukin 2 (IL2) and Tumor Necrosis Factor (TNF) are pro-inflammatory cytokines with anti-tumor activity. Nidlegy is currently being investigated in two Phase III clinical trials for the treatment of locally advanced melanoma, and in Phase II clinical trials for the treatment of High-Risk Basal Cell Carcinoma and other non-melanoma skin cancers.

On May 30, 2023 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that a late-breaking abstract with updated data from the Phase 1 trial of the Company’s menin inhibitor, ziftomenib, has been accepted for oral presentation at the 2023 European Hematology Association (EHA) (Free EHA Whitepaper) Congress in Frankfurt, Germany (Press release, Kura Oncology, MAY 30, 2023, View Source [SID1234632216]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Late-breaking abstract # LB2713, entitled "Activity, tolerability, and resistance profile of the menin inhibitor ziftomenib in adults with relapsed/refractory NPM1-mutated AML," will be presented at the late-breaking oral session from 9:45-11:15 CET on Sunday, June 11, 2023. Late-breaking abstracts are scheduled for publication on the EHA (Free EHA Whitepaper) website at 16:00 CET on Thursday, June 1, 2023.

Management will host a virtual investor event featuring company management and investigators from the Phase 1 trial of ziftomenib at 8:00 a.m. ET on Monday, June 12, 2023. The event will be webcast live and can be accessed on the Investors section of Kura’s website at www.kuraoncology.com. An archived replay will be available shortly after the conclusion of the live event.

On May 30, 2023 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing IgM antibodies, reported that it will host a conference call and live webcast to provide an update on its clinical development program for IGM-8444, a novel multivalent DR5 agonist, on Friday, June 2, 2023 at 7:00 p.m. ET (Press release, IGM Biosciences, MAY 30, 2023, https://investor.igmbio.com/news-releases/news-release-details/igm-biosciences-host-conference-call-and-webcast-provide-igm [SID1234632215]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company will be providing a clinical data update on 3 mg/kg IGM-8444 + FOLFIRI (± bevacizumab) in median third line metastatic colorectal cancer patients from a non-randomized clinical trial cohort. The event will feature a principal investigator from this trial, Susanna Ulahannan, MD, MMed, Assistant Professor, Section of Hematology/Oncology, Oklahoma University Health Stephenson Cancer Center. In this presentation, the Company will not be providing a clinical data update from its recently initiated randomized study of IGM-8444 + FOLFIRI and bevacizumab in second line colorectal cancer patients.

The webcast can be accessed by clicking the link: View Source, and will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website. A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

About IGM-8444

IGM-8444 is an IgM antibody targeting Death Receptor 5 (DR5) that is being developed for the treatment of patients with solid and hematologic malignancies. DR5 is a member of the tumor necrosis factor receptor superfamily (TNFrSF) and is often expressed on the surface of cancer cells. Strong activation of the DR5 pathway requires multiple receptors to be cross-linked simultaneously by an antibody or other binding agent to create an apoptotic death signal to the cell. Unlike traditional IgG antibodies, IGM-8444 has 10 binding units, enabling it to cross-link multiple DR5 receptors at the same time, sending a stronger signal to cause cancer cell death. The Company is currently conducting a multicenter, open-label clinical trial to determine the safety, tolerability, and pharmacokinetics of IGM-8444 as a single agent and in combination in subjects with relapsed and/or refractory solid or hematologic cancers.

On May 30, 2023 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 it has completed the Phase 1 portion of the Acclaim-1 Phase 1/2 clinical trial of REQORSA in combination with Tagrisso (osimertinib) to treat late-stage non-small cell lung cancer (NSCLC), and the Safety Review Committee (SRC) has approved continuation to the Phase 2 expansion portion of the trial (Press release, Genprex, MAY 30, 2023, View Source [SID1234632214]). The combination of REQORSA and osimertinib received U.S. Food and Drug Administration’s (FDA) Fast Track Designation for treatment of the Acclaim-1 patient population.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Based on full safety data which showed no dose limiting toxicities, the SRC determined that the recommended Phase 2 dose of REQORSA will be 0.12 mg/kg. This was the highest dose level delivered in the Phase 1 portion and is twice the highest dose level delivered in Genprex’s prior clinical trial combining REQORSA with Tarceva for the treatment of late-stage lung cancer. The SRC also recommended the trial advance to the Phase 2 expansion portion of the study, which the Company expects to begin in the third quarter of 2023.

"We are proud of the notable progress we made during the Phase 1 portion of the Acclaim-1 clinical trial, and the SRC recommendation to move into the Phase 2 expansion portion of the trial is another validation for our REQORSA development program," said Rodney Varner, Chairman, President and Chief Executive Officer of Genprex. "As we move into the Phase 2 expansion portion of the trial, we remain steadfast in our efforts to bring new therapies to lung cancer patients with unmet medical need."

Genprex recently announced positive preliminary clinical data from the Phase 1 dose escalation portion of its Acclaim-1 clinical trial in an abstract published at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The results showed that REQORSA was generally well tolerated, and there were no dose limiting toxicities. Genprex also reported that encouraging evidence of efficacy was observed in the Phase 1 portion of the study. The full abstract can be accessed here.

The SRC is comprised of three physicians who are principal investigators in the trial. The SRC may recommend that the trial continues at the same dose or at a lower dose, that it escalates to a higher dose, or that the study be terminated altogether due to safety concerns.

The Phase 2 expansion portion of the study is expected to enroll approximately 66 patients; half will be patients who received only prior Tagrisso treatment and the other half will be patients who received prior Tagrisso treatment and chemotherapy, in order to determine toxicity profiles of patients with different eligibility criteria, as well as efficacy and other endpoints. There will be an interim analysis following the treatment of 19 patients in each cohort.

About Acclaim-1

The Acclaim-1 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating the Company’s lead drug candidate, REQORSA, in combination with Tagrisso in patients with late-stage NSCLC with activating epidermal growth factor receptor ("EGFR") mutations whose disease progressed after treatment with Tagrisso.

The enrollment of the dose escalation Phase 1 portion of the Acclaim-1 trial has been completed. The Phase 2 expansion portion of the study is expected to enroll approximately 66 patients, half of whom will have received only Tagrisso treatment and the other half will have received Tagrisso treatment and chemotherapy, to determine toxicity profiles of patients with different eligibility criteria, as well as efficacy and other endpoints. There will be an interim analysis following the treatment of 19 patients in each cohort. The Phase 2 randomized portion of the study is expected to enroll approximately 74 patients to be randomized 1:1 to receive either REQORSA and Tagrisso combination therapy or platinum-based chemotherapy. The primary endpoint of the Phase 2 portion of the trial is progression-free survival, which is defined as time from randomization to progression or death. An interim analysis will be performed at 28 events.

About REQORSA Immunogene Therapy

REQORSA Immunogene Therapy (quaratusugene ozeplasmid) for non-small cell lung cancer (NSCLC) uses Genprex’s unique, proprietary ONCOPREX Nanoparticle Delivery System, which is the first systemic gene therapy delivery platform used for cancer in human clinical trials. The active agent in REQORSA is a plasmid that expresses the TUSC2 tumor suppressor gene. REQORSA consists of the TUSC2 gene expressing plasmid encapsulated in non-viral lipid nanoparticles made from lipid molecules with a positive electrical charge. REQORSA is injected intravenously and specifically targets cancer cells. Once REQORSA is taken up into a cancer cell, the TUSC2 gene is expressed, and the TUSC2 protein is capable of restoring certain defective functions arising in the cancer cell. 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.

Tagrisso is a registered trademark of AstraZeneca plc and is its top-selling drug with 2022 sales of more than $5 billion.

On May 30, 2023 Exelixis, Inc. (Nasdaq: EXEL) reported that members of the company’s management team will participate in fireside chats at the following investor conferences in June (Press release, Exelixis, MAY 30, 2023, View Source [SID1234632213]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

William Blair 43rd Annual Growth Stock Conference: Exelixis is scheduled to present at 10:20 am ET / 9:20 am CT/ 7:20 am PT on Tuesday, June 6 in Chicago.
2023 Jefferies Global Healthcare Conference: Exelixis is scheduled to present at 10:30 am ET/ 7:30 am PT on Wednesday, June 7 in New York.
Goldman Sachs 44th Annual Global Healthcare Conference: Exelixis is scheduled to present at 7:00 pm ET / 4:00 pm PT on Tuesday, June 13 in Dana Point, CA.

To access the webcast links, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentations to ensure adequate time for any software download that may be required to listen to the webcasts. Replays will also be available at the same location for at least 30 days.