On April 24, 2024 ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, reported that Tim McCarthy, CEO and Dr Tim Franklin, COO, will be attending BIO-Equity (Press release, ImmuPharma, APR 24, 2024, View Source [SID1234642284]). The event will be held from 12-14 May 2024, in San Sebastian, Spain.

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!

BIO-Equity is an annual premier partnering event, designed to provide biotechnology companies with the opportunity to present to and connect with investors together with the global biopharma community. This event provides an important continuum for ImmuPharma to facilitate ongoing discussions regarding potential global partnering deals across its pipeline portfolio.

Commenting on the event, Tim McCarthy, CEO of ImmuPharma said: "Further to our clinical progress with P140 in SLE and CIDP, attending BIO-Equity 2024 offers the opportunity to continue discussions on our unique portfolio with specific bioPharma companies and investment specialists, particularly in relation to SLE, CIDP and potentially other autoimmune diseases within our P140 technology platform. Our focus remains on track to establish global partnering opportunities across all our programs."

On April 24, 2024 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported that it will present Phase 1 expansion data for brenetafusp (IMC-F106C), the first off-the-shelf ImmTAC therapy targeting PRAME, in patients with late-line cutaneous melanoma, all previously treated with anti-PD1 and the vast majority having received ipilimumab, at the 2024 American Society of Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting commencing on 31 May (Press release, Immunocore, APR 24, 2024, View Source [SID1234642283]).

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 also present four posters, including one trial-in-progress poster of the Phase 3 PRISM-MEL301 trial with brenetafusp in combination with nivolumab versus standard nivolumab regimens in HLA-A*02:01+ patients with first-line advanced melanoma, and three posters sharing clinical and translational data about KIMMTRAK in metastatic uveal melanoma.

Presentation and poster details

Title: Phase 1 safety and efficacy of IMC-F106C, a PRAME×CD3 ImmTAC bispecific, in post-checkpoint cutaneous melanoma
Presenting author: Omid Hamid
Session: Oral Abstract Session – Melanoma/Skin Cancers, Friday 31 May 2024; 2:45-5:45 p.m. CT / 1:45-4:45 p.m. ET

Title: A Phase 3 trial of IMC-F106C (PRAME × CD3) plus nivolumab versus standard nivolumab regimens in HLA-A*02:01+ patients with previously untreated advanced melanoma (PRISM-MEL-301)
Presenting author: Georgina Long
Session: Poster Session – Melanoma/Skin Cancers, Saturday 1 June 2024, 1:30-4:30 p.m. CT / 12:30-3:30 p.m. ET

Title: Stable disease with confirmed tumor reduction has a similar clinical outcome as RECIST partial response for tebentafusp in metastatic uveal melanoma
Presenting author: Alexandra Ikeguchi
Session: Poster Session – Melanoma/Skin Cancers, Saturday 1 June 2024, 1:30-4:30 p.m. CT / 12:30-3:30 p.m. ET

Title: Association between clinical and disease characteristics and detectable or undetectable baseline ctDNA in patients with metastatic uveal melanoma
Presenting author: Paul Nathan
Session: Poster Session – Melanoma/Skin Cancers, Saturday 1 June 2024, 1:30-4:30 p.m. CT / 12:30-3:30 p.m. ET

Title: Baseline and serial ctDNA dynamics predicts outcomes in patients treated with first-line tebentafusp including those who were and were not treated beyond progression
Presenting author: Ryan Sullivan
Session: Poster Session – Melanoma/Skin Cancers, Saturday 1 June 2024, 1:30-4:30 p.m. CT / 12:30-3:30 p.m. ET

Conference Call
Immunocore will host an investor and analyst event and webcasted conference call on Friday 31 May 2024 at 6:15 p.m. CT with Dr. Diwakar Davar. The webcast will be available under ‘News & Events’ in the Investor Relations section of Immunocore Holdings’ website at www.immunocore.com.

On April 24, 2024 ImmunityBio, Inc. (NASDAQ: IBRX), an immunotherapy company, reported positive overall survival results in the QUILT 3.055 study of 2nd- and 3rd-line NSCLC patients who progressed after checkpoint inhibitor therapy (pembrolizumab, nivolumab, or atezolizumab) and standard-of-care chemotherapy to be discussed during the upcoming conference call (Press release, ImmunityBio, APR 24, 2024, View Source [SID1234642282]). The results continue to reinforce ImmunityBio’s belief in the unique mechanism of action of ANKTIVA (N-803, or nogapendekin alfa inbakicept-pmln) and its potential efficacy as a next-generation immunotherapy across multiple solid and liquid tumor types.

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!

In NSCLC patients who relapsed or were refractory to checkpoint inhibitors, ANKTIVA was administered together with the same checkpoint inhibitor. The addition of ANKTIVA resulted in the rescue of the checkpoint therapy efficacy, with significant prolongation of overall survival. These positive results were noted regardless of the patient’s PD-L1 status, consistent with the mechanism of action of ANKTIVA in activating and proliferating natural killer cells, and stimulating CD8+ Killer Memory T cells. This prolongation of survival in NSCLC following checkpoint failure is consistent with ImmunityBio’s findings of durable complete responses following BCG failure in NMIBC.

A meeting with the FDA has been scheduled for June to discuss the company’s overall survival results in PD-L1 negative and positive patients and registration plans for 2nd-line and 3rd-line NSCLC patients whose cancer did not respond or continue to respond to checkpoint therapy and for whom few alternative therapies are available.

The positive overall survival data of patients enrolled in QUILT 3.055, a basket trial across multiple tumor types, in which checkpoint inhibitors failed will be discussed, along with the status of launch readiness for ANKTIVA for its recently approved indication in NMIBC on an investor conference call Friday, April 26 at 8 am PDT/11 am EDT.

"The results we noted with the completion of the QUILT 3.055 basket trial across multiple tumor types in patients with late-stage cancers for whom standard of care plus checkpoints failed, validates our hypothesis that orchestration of NK cells with killer T cells and memory T cells could result in meaningful clinical improvements to current standards of care. We hypothesized that activation and proliferation of natural killer cells through IL-15 stimulation could rescue T cells after checkpoint failure, regardless of tumor type or of tumor location. As with non-muscle invasive bladder cancer, we believe that ANKTIVA enhanced the NK and T cell activity critical for targeting and killing cancer cells which have entered the phase of tumor evasion and resistance, "said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. "QUILT 3.055 was the initial and seminal study of our Cancer Moonshot program launched in January 2016 (see related video here). The findings of a significant extension of overall survival in 2nd- and 3rd-line lung cancer affirms that combination therapy, with the orchestration of the innate and adaptive immune system, could potentially lead to the evolution of immunotherapy beyond T cells for all cancer patients. We are excited that these results continue to demonstrate the broad potential for ANKTIVA across multiple tumor types and its role as the next-generation immunotherapy. We are committed to pursuing additional indications for ANKTIVA in our pipeline with a mission to deliver new hope to patients with serious, advanced cancers where standard therapies have failed."

The QUILT trials initiated since the launch of the Cancer Moonshot program across multiple tumor types can be found on ImmunityBio.com and is summarized in the figure accompanying this announcement. As can be seen ANKTIVA (N-803) serves as the backbone to the immunotherapy vaccine across multiple tumor types at late-stage with exploratory evidence of complete remissions. Updates to this figure denoting the QUILT trials at the time of publication in 2021 will be forthcoming.

According to the American Cancer Society, lung cancer is the second most common cancer in the U.S. In 2023, it is estimated that 238,340 new cases of lung cancer will be diagnosed in the U.S. and 127,070 deaths will be attributed to the disease. NSCLC accounts for about 80% to 85% of all lung cancers diagnoses and there are very few successful treatment options for these patients once the cancer spreads beyond the lungs.

The development of checkpoint inhibitors in NSCLC has been revolutionary, doubling the median overall survival in some settings; however, patient response may be short lived, due to late response and/or progression after achieving an initial response. Historical and real-world experience (RWE) data show that the median overall survival rates in these patients range from 7 to 9 months.

In addition, the company will provide information about the status of launch readiness of ANKTIVA for NMIBC. Presentations by the company on ANKTIVA data in NMIBC are scheduled at the upcoming American Urological Association (AUA) conference in San Antonio, Texas from May 3-6, 2024. It is anticipated the first vials of ANKTIVA will be available for shipment the week of May 6, 2024.

Further details regarding ANKTIVA as the backbone of ImmunityBio’s late-stage clinical pipeline across multiple solid and liquid tumor types will be discussed during the conference call, along with commercial launch readiness details, and the corporate financial position to support launch of ANKTIVA for the U.S. market.

Conference call details:

Investors may access the live audio webcast of the call via this weblink. A replay of the webcast will be available at View Source All participants may join the call by dialing (800) 579-2543 (U.S. and Canada Toll-Free) or (785) 424-1789 and using the access code ANKTIVA.

On April 24, 2024 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that the Company has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for HB-700, a novel arenaviral therapeutic vaccine for the treatment of KRAS-mutated cancers (Press release, Hookipa Biotech, APR 24, 2024, View Source [SID1234642281]).

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!

HOOKIPA’s HB-700 program is designed to treat KRAS-mutated lung, colorectal, pancreatic and other cancers by targeting the five most prevalent KRAS mutations in these disease indications: G12D, G12V, G12R, G12C and G13D. This program has the potential to benefit more patients than single mutation inhibitors.

The IND submission achieves a final $10 million milestone payment from Roche. Effective April 25, 2024, the Company will regain full control of the associated intellectual property portfolio and have full collaboration and licensing rights for the HB-700 program. The Company will publish preclinical data in an abstract at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2024 Annual Meeting.

"We are proud to have another IND cleared for a potentially powerful oncology program. Our HB-700 program targets five KRAS-mutations found in multiple cancer indications with a single product candidate," said Joern Aldag, Chief Executive Officer at HOOKIPA. "Importantly, the submission of the IND results in us receiving a final $10 million milestone payment. We continue to define our clinical development strategy which includes the possibility of collaboration or partnership for this program."

About KRAS-mutated cancers
KRAS is a gene that acts as an on/off switch for cell growth. When there is a mutation, or error, in the gene, cells can grow out of control. KRAS mutations are among the most common mutations that cause cancer. While KRAS-mutated, tumor-specific treatments exist, there remains an opportunity to target a broader range of KRAS-mutations simultaneously and thereby potentially help more people impacted by these cancers.

About HB-700
HB-700 is an investigational arenaviral immunotherapy designed to treat KRAS-mutated lung, colorectal, pancreatic and other cancers. HB-700 is a replicating 2-vector therapy that targets the most common KRAS mutations (G12D, G12V, G12R, G12C and G13D) and may benefit more patients than single mutation inhibitors.

On April 24, 2024 GSK plc (LSE/NYSE: GSK) reported the US Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) in combination with standard-of-care chemotherapy (carboplatin and paclitaxel) to expand treatment to all adult patients with primary advanced or recurrent endometrial cancer (Press release, GlaxoSmithKline, APR 24, 2024, View Source [SID1234642280]). This would include patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours.

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!

Currently, Jemperli is FDA-approved in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is either mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H).

The FDA granted Priority Review for this application and assigned a Prescription Drug User Fee Act action date of 23 August 2024.

The sBLA is based on results from Part 1 of the RUBY phase III trial. The trial met its primary endpoints of investigator-assessed progression-free survival (PFS) and overall survival (OS), demonstrating a statistically significant and clinically meaningful benefit in the overall population of patients treated with dostarlimab plus carboplatin-paclitaxel versus chemotherapy alone. RUBY Part 1 is the only clinical trial to show a statistically significant survival benefit in the overall patient population. The safety and tolerability analysis from RUBY showed a safety profile for dostarlimab and carboplatin-paclitaxel that was generally consistent with the known safety profiles of the individual agents.

OS data were presented at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer on 16 March 2024.

About endometrial cancer
Endometrial cancer is found in the inner lining of the uterus, known as the endometrium. Endometrial cancer is the most common gynaecologic cancer in developed countries, with approximately 417,000 new cases reported each year worldwide1, and incidence rates are expected to rise by almost 40% between 2020 and 2040.2,3 Approximately 15-20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis.4 Among patients with primary advanced or recurrent endometrial cancer, approximately 70-75% have MMRp/MSS tumours.5

About RUBY
RUBY is a two-part global, randomised, double-blind, multicentre phase III trial of patients with primary advanced or recurrent endometrial cancer. Part 1 is evaluating dostarlimab plus carboplatin-paclitaxel followed by dostarlimab versus carboplatin-paclitaxel plus placebo followed by placebo. Part 2 is evaluating dostarlimab plus carboplatin-paclitaxel followed by dostarlimab plus niraparib versus placebo plus carboplatin-paclitaxel followed by placebo.

In Part 1, the dual-primary endpoints are investigator-assessed PFS based on the Response Evaluation Criteria in Solid Tumours v1.1 and OS. The statistical analysis plan included pre-specified analyses of PFS in the dMMR/MSI-H and overall populations and OS in the overall population. Pre-specified exploratory analyses of PFS and OS in the MMRp/MSS population and OS in the dMMR/MSI-H populations were also performed. RUBY Part 1 included a broad population, including histologies often excluded from clinical trials and had approximately 10% of patients with carcinosarcoma and 20% with serous carcinoma.

In Part 2, the primary endpoint is investigator-assessed PFS in the overall population, followed by PFS in the MMRp/MSS population, and OS in the overall population is a key secondary endpoint. Additional secondary endpoints in Part 1 and Part 2 include PFS per blinded independent central review, PFS2, overall response rate, duration of response, disease control rate, patient-reported outcomes, and safety and tolerability.

RUBY is part of an international collaboration between the European Network of Gynaecological Oncological Trial groups (ENGOT), a research network of the European Society of Gynaecological Oncology (ESGO) that consists of 22 trial groups from 31 European countries that perform cooperative clinical trials, and the GOG Foundation, a non-profit organisation dedicated to transforming the standard of care in gynaecologic oncology.

About Jemperli (dostarlimab)
Jemperli is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2.6

In the US, Jemperli is indicated in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is dMMR, as determined by a US FDA-approved test, or MSI-H, and as a single agent for adult patients with dMMR recurrent or advanced endometrial cancer, as determined by a US FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation. The sBLA supporting this indication in combination with carboplatin and paclitaxel for dMMR/MSI-H primary advanced or recurrent endometrial cancer received Breakthrough Therapy designation and Priority Review from the US FDA. Jemperli is also indicated in the US for patients with dMMR recurrent or advanced solid tumours, as determined by a US FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. The latter indication is approved in the US under accelerated approval based on tumour response rate and durability of response. Continued approval for this indication in solid tumours may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Jemperli was discovered by AnaptysBio, Inc. and licensed to TESARO, Inc., under a collaboration and exclusive license agreement signed in March 2014. Under this agreement, GSK is responsible for the ongoing research, development, commercialisation, and manufacturing of Jemperli, and cobolimab (GSK4069889), a TIM-3 antagonist.