On June 20, 2024 4 Redx Pharma (JPJ:REDX), the clinical-stage, small molecule biotechnology company,
reported that Phase 2 data from zamaporvint (RXC004), a Porcupine inhibitor targeting Wnt-ligand dependent GI cancers, will be presented at the European Society for Medical Oncology Gastrointestinal Cancers Congress (ESMO GI), 26-29th June, Munich, Germany (Press release, Redx Pharma, JUN 20, 2024, View Source [SID1234644454]).

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Zamaporvint is a potent, selective, orally-active Porcupine inhibitor in development for hard-to-treat GI cancers. The principal efficacy hypothesis for zamaporvint is for use in combination, which has been investigated in Phase 2 signal searching patient cohorts with anti-PD-1 therapy. Monotherapy for single agent activity has also been investigated. The PORCUPINE study was in genetically-selected patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) as monotherapy and immuno-oncology combination (clinicaltrials.gov NCT04907539). The PORUPINE2 study was in all-comers biliary tract cancer as monotherapy and immuno-oncology combination, and in genetically selected pancreatic cancer as monotherapy (clinicaltrials.gov NCT04907851).

The data will be presented in two posters, one on the PORCUPINE study and one on the PORCUPINE2 study. Notably, these data demonstrate that zamaporvint, in combination with an anti-PD-1 agent in genetically-selected patient populations has the potential to improve upon efficacy outcomes achieved with standard of care alone.
Details of the poster presentations are as follows:

1)
Abstract Title: Phase 2 results of the Porcupine (PORCN) inhibitor zamaporvint
(RXC004) in genetically selected microsatellite stable colorectal
cancer patients
Session Title: Poster Session
Date/Time: Thursday 27 June 3:35 – 4:30pm CEST
Poster Number: 37P

2)
Abstract Title: Phase 2 results of the porcupine (PORCN) inhibitor zamaporvint
(RXC004) in patients with pancreatic and biliary tract cancer
Session Title: Poster Session
Date/Time: Thursday 27 June 3:35 – 4:30pm CEST
Poster Number: 391P
A copy of the posters will be made available on Company’s website following the presentation at:
View Source

On June 20, 2024 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapeutics for oncology, reported the dosing of the first patient in the new GOBLET study cohort evaluating pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab (Tecentriq) in newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) patients (Press release, Oncolytics Biotech, JUN 20, 2024, View Source [SID1234644453]). The co-primary endpoints of the cohort are objective response rate (ORR) and safety. It is supported by the US$5M Pancreatic Cancer Action Network (PanCAN) Therapeutic Accelerator Award, an innovative program established to accelerate the development of new treatments for pancreatic cancer patients. It will be conducted in collaboration with AIO-Studien-gGmbH (AIO), a clinical trial group within the German Cancer Society, as part of GOBLET, a Phase 1/2 multiple indication study evaluating pelareorep-based combinations in gastrointestinal cancers.

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"Initiation of dosing in the mFOLFIRINOX cohort of the GOBLET study is an important milestone for Oncolytics, and we’re excited to begin evaluating another pelareorep combination therapy that could result in a second pancreatic cancer registration program for the company," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "The combination of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel in pancreatic cancer patients more than doubled tumor response rates compared to earlier trials of chemotherapy alone. That combination received Fast Track Designation from the FDA and is expected to be evaluated in an adaptive registration-enabling trial through the Global Coalition for Adaptive Research (GCAR). If the combination of pelareorep and mFOLFIRINOX also demonstrates a promising efficacy signal, we could have two pancreatic cancer treatment regimens on the path to registration. I want to highlight PanCAN’s important support for this program with gratitude. The US$5M Therapeutic Accelerator Award has made it possible for us to broaden our evaluation of potential therapies that have the potential to improve outcomes for pancreatic cancer patients."

Anna Berkenblit, MD, MMSc, Chief Scientific and Medical Officer at PanCAN said, "Working toward our vision to create a world in which all patients with pancreatic cancer will thrive, PanCAN launched the Therapeutic Accelerator Award to speed the drug development process and bring new options to patients faster. Dosing the first patient in this new cohort of the GOBLET study is an important step toward further evaluation of this investigational immunotherapeutic approach."

Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg and primary investigator of the GOBLET trial commented, "I have been pleased to observe the strength of the clinical response data for pelareorep in multiple cohorts of the GOBLET gastrointestinal study, especially in pancreatic and anal cancer. mFOLFIRINOX is currently considered the best treatment option for many pancreatic cancer patients. Therefore, the evaluation of pelareorep and mFOLFIRINOX, with or without atezolizumab, presents an important opportunity to identify a novel therapeutic approach that may broaden the population of metastatic pancreatic cancer patients who could benefit from pelareorep-based therapies."

"Oncolytics is in a favorable position as we prepare to advance multiple pelareorep programs toward registration track studies and continue to expand pelareorep’s potential as a backbone immunotherapy that can impact various tumor types. The collaboration with GCAR on a registration-enabling study for the combination of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel in pancreatic cancer, meeting with the FDA to align on next steps for our breast cancer program, expanded enrollment in the GOBLET anal cancer cohort, and now the initiation of dosing in the mFOLFIRINOX cohort of GOBLET, announced today, are all important elements of our corporate plan," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "The ability to improve the lives of cancer patients is something that motivates everyone at Oncolytics, and beginning to treat pancreatic cancer patients in the mFOLFIRINOX cohort of GOBLET is hopefully yet another step towards that goal."

About GOBLET cohort 5
The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed PDAC patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. There will be a three-patient safety run-in to evaluate the tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon two-stage study. The co-primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2 in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples will also be collected for translational evaluations.

About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:

1.Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;

2.Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;

3.Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients

4.Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and

5.Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.

Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients.

On June 20, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported follow-up results from the second, third and fourth patients enrolled in its Deltacel-01 Phase 1 clinical trial (Press release, Kiromic, JUN 20, 2024, View Source [SID1234644452]). This trial is evaluating Deltacel (KB-GDT-01), the Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies.

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The third and fourth patients showed stable disease at their four- and two-month follow-up visits, respectively. Both patients are doing well, and neither showed any dose-limiting toxicities. Patients three and four are being treated at the Beverly Hills Cancer Center (BHCC).

The second patient, also being treated at the BHCC, previously had stable disease and showed a complete response in their brain metastasis. At the four-month follow-up visit, while stable disease of previously treated sites and a clean brain MRI were confirmed, a new site of disease, a sub-cutaneous metastasis, was detected by CT and PET scans. This patient is in generally good condition and tolerated their initial treatment well. As such, the Institutional Review Board (IRB) and the U.S. Food and Drug Administration (FDA) approved a single-use, single-patient protocol, and on June 19, the patient started a new course of treatment with low-dose radiation and gamma-delta T cells under a single patient IND.

"We are optimistic the latest targeted treatment with Deltacel will control the second patient’s new lesion, which is suspected to have originated from a micro-metastasis not detected and therefore not targeted with radiation during the first course of treatment. This new protocol might be applied to all patients who received or will receive the Deltacel treatment and could be instrumental in controlling any new tumor lesions or progressing lesions," said Pietro Bersani, CEO of Kiromic BioPharma.

Kiromic BioPharma also reports submitting a request for Fast Track designation for Deltacel to the FDA. Fast Track designation facilitates and expedites the development and review of drugs that treat serious conditions and address unmet medical needs. For further information on Fast Track designation, please visit the FDA’s website.

"We continue to be encouraged by the favorable results of the Deltacel-01 trial, which reinforce our confidence in the potential of Deltacel to provide meaningful clinical benefits to patients in need. This confidence underscores the recent open-market purchases of common stock by several Kiromic directors and executive officers, as reported on Form 4 filings," noted Mr. Bersani.

"Proceeding with a single-use, single-patient protocol of Deltacel supports our commitment to advancing innovative therapies that address unmet clinical needs in unique ways, which include the possibility for retreatment," he added. "We are also excited about the potential of expediting Deltacel clinical development through Fast Track designation."

The fifth patient in the trial completed their 30-day safety visit at the BHCC with no toxicities reported, and the sixth patient is expected to be enrolled in July.

About Deltacel-01

In Kiromic’s open-label Phase 1 clinical trial, titled "Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer" (NCT06069570), patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the Deltacel-01 trial is to evaluate safety, while secondary measurements include objective response, progression-free survival, overall survival, time to progression, time to treatment response and disease control rates.

About Deltacel

Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of stage 4 metastatic NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is the leading candidate in Kiromic’s GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial clinical focus on NSCLC, which represents about 80% to 85% of all lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.

On June 20, 2024 Mendus AB ("Mendus" publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies targeting tumor recurrence, reported that updated clinical data from the ALISON clinical trial with its lead product vididencel in ovarian cancer will be presented at the ESMO (Free ESMO Whitepaper) Gynaecological Cancers Annual Congress, being held from June 20-22, 2024 in Florence, Italy (Press release, mendus, JUN 20, 2024, View Source [SID1234644451]). The trial reached its primary objective of inducing tumor-directed immune responses in at least 10 patients treated with vididencel.

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Ovarian cancer is the deadliest gynaecological cancer, mainly due to its high recurrence rate. Improving disease free and overall survival in advanced high grade serous ovarian carcinoma (HGSC) after primary treatment remains challenging. The Phase 1 ALISON trial explores the potential of vididencel to induce clinically relevant immune responses in ovarian cancer. The trial is fully enrolled (17 participants) and all participants have completed the vididencel treatment phase per April 2024. Vididencel-induced immune responses against tumor antigens that are regularly upregulated in HGSC were observed in 10 out of 15 patients evaluated so far, with 3 patients not reaching a vaccine induced response (VIR) due to high baseline responses. Vididencel treatment only gave mild adverse reactions, predominantly at the site of injection. The observed immune responses following vididencel treatment may provide the basis for an effective anti-tumor response. At week 22, 10 patients had stable disease and 7 patients had imaging-confirmed recurrence. To further evaluate clinical benefit, long-term follow-up of patients is ongoing.

Mendus anticipates to report the primary read-out of the ALISON trial based on immune response evaluation of all treated patients in 2024Q4.

Please see below for abstract details:

Abstract Number: 50P (poster presentation)

Abstract Title: Vididencel, a cell-based cancer vaccine, induces tumor-directed immune responses in high-grade serous ovarian carcinoma patients

Authors: A. Vledder, H. van Zeeburg, K. Brummel, A.L. Eerkens, N. van Rooij, A. Plat, J. Rovers, M. de Bruyn, H. Nijman

Session Date & Time: Thursday, 20 June 2024 between 12:30 – 13:30 CEST

After presentation, the poster will be made available on the Mendus website.

On June 20, 2024 ImmunityBio, Inc. (NASDAQ: IBRX) reported the initial treatment of multiple patients in the United States to receive therapy with ANKTIVA (nogapendekin alfa inbakicept-pmln), ImmunityBio’s recently approved immunotherapy for Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (Press release, ImmunityBio, JUN 20, 2024, https://immunitybio.com/immunitybio-announces-insurance-coverage-of-anktiva-across-multiple-states-with-first-commercial-doses-administered-just-weeks-after-fda-approval-opening-new-era-for-immunotherapy-beyond/ [SID1234644450]). ANKTIVA was approved by the U.S. Food and Drug Administration (FDA) on April 22, 2024 for the treatment of patients with BCG-unresponsive NMIBC CIS with or without papillary tumors.

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The intravesical therapy employs a combination of ANKTIVA, an IL-15 agonist in combination with BCG. The combination is the first FDA-approved immunotherapy in NMIBC that functions by activating the body’s NK and killer T-cell immune system to attack tumor cells, while simultaneously activating memory T cells, leading to a prolonged duration of complete response exceeding 47 months for some patients.

"We are grateful to be able to offer this first-in-class immunotherapy to qualified bladder cancer patients less than two months after the therapeutic was approved by the FDA," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. "The interest in this next era of immunotherapy beyond checkpoint inhibitors—the era of cytokines—from urologists treating NMIBC patients has been strong and we look forward to offering more patients an alternative to bladder removal."

The first patients to receive commercial doses are located throughout the U.S. and several are being treated by community urologists, as the therapy does not require any special handling or equipment that would limit its use to specialty medical centers.

"In addition to its unique mechanism of action, ANKTIVA can be readily administered by urologists in their own offices and clinics enabling more patients to receive it in familiar settings from their own providers," said Richard Adcock, President and CEO of ImmunityBio. "We look forward to ANKTIVA reaching more and more eligible NMIBC patients and for our science to deliver even more therapies from our pipeline."

ANKTIVA received Breakthrough Therapy Designation and approval from the FDA based on the safety and efficacy outcome of complete responses (CR) and duration of complete response (DOR) in BCG-unresponsive NMIBC CIS. The 77 evaluable patients in this single-arm, multicenter trial received ANKTIVA with BCG maintenance therapy for up to 37 months. The tumor status was assessed with cystoscopy and urine cytology and will continue for up to five years after each patient began their participation in the trial.

The CR rate for the 77 evaluable patients was 62% with the upper end of the confidence interval being 73%. The duration of complete response as of the November 2023 cut-off was more than 47 months and is ongoing to date. These prolonged duration of complete response results beyond 24 months with ANKTIVA and BCG exceed the benchmark for the magnitude of meaningful clinical results suggested by a panel of experts at the International Bladder Cancer Group.

In May, ImmunityBio announced it had drug substance sufficient for 170,000 doses of ANKTIVA for commercial and clinical trial use.

ImmunityBio CARE

The ImmunityBio CARE program is designed to help patients access ImmunityBio’s innovative treatment for NMIBC CIS. The program offers services and resources for benefits investigation, prior authorization support and tracking, coding and billing assistance, claim denial guidance and payer specific appeal assistance. More information for patients and healthcare professionals is available on Anktiva.com.

How ANKTIVA Works
The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response.

ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo.

Selected Safety Information for ANKTIVA

The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia.