On January 4, 2022 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that company management will participate at the following upcoming investor conferences in January (Press release, Jounce Therapeutics, JAN 4, 2022, View Source [SID1234598080]):

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H.C. Wainwright BioConnect Virtual Conference: Presentation will be available for on-demand viewing starting on January 10, 2022 at 7:00 a.m. ET.
40th Annual J.P. Morgan Healthcare Conference: A live presentation will take place on Thursday, January 13, 2022 at 12:00 p.m. ET.
A webcast of each presentation will be available by visiting "Events and Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. A replay of the webcasts will be archived for 30 days following the presentation.

On January 4, 2022 Inhibrx, Inc. (Nasdaq: INBX), a biotechnology company with four clinical programs in development and a strong emerging pipeline, reported initial results from Part 3 (combination dose escalation) of the 4-part Phase 1 trial of INBRX-106, a novel hexavalent OX40 agonist, in combination with Keytruda, in development for the treatment of patients with solid tumors (Press release, Inhibrx, JAN 4, 2022, View Source [SID1234598078]). Additionally, an update on single agent data from Part 1 (single agent dose escalation) and Part 2 (single agent dose expansion) of the trial was provided.

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In the all-comer Part 3 of this Phase 1 trial, the dose of INBRX-106 was escalated in combination with Keytruda in 21 patients with locally advanced or metastatic solid tumors. INBRX-106 in combination with Keytruda was observed to be well tolerated, with predominantly mild or moderate immune-related toxicities noted. The maximum administered dose of INBRX-106 was 0.3 mg/kg, at which dose-limiting, immune-related toxicities such as dermatitis were observed. Accordingly, 0.1 mg/kg dosed every three weeks was determined to be the maximum tolerated dose (MTD) of INBRX-106 in combination with Keytruda.

Out of five response evaluable patients with tumor types responsive to immunotherapy in the active dose range of INBRX-106 in combination with Keytruda, two durable partial responses were achieved in checkpoint inhibitor naïve nasopharyngeal carcinoma and uveal melanoma patients with duration greater than six months with treatment ongoing. Additionally, a third checkpoint inhibitor exposed cutaneous melanoma patient has a double-digit reduction in tumor volume and duration greater than four months with treatment ongoing.

Part 2, which was run in parallel with Part 3, is ongoing and aimed at investigating single agent INBRX-106 dosed at 0.03 mg/kg in two different dosing schedules in patients with tumor types responsive to checkpoint inhibitors. Four of ten response evaluable non-small cell lung cancer (NSCLC) and melanoma patients receiving INBRX-106 in either Part 1 or 2 of the trial have been on treatment with INBRX-106 for at least six months. Of those four patients, three had previous exposure to checkpoint inhibitors and the fourth, a uveal melanoma patient, was checkpoint inhibitor naïve. To date, the longest duration on treatment with single agent INBRX-106 is 90 weeks (approximately 21 months) and ongoing in a NSCLC patient refractory to Keytruda.

"We believe the early activity of single agent INBRX-106 and INBRX-106 in combination with Keytruda observed in patients who relapsed or are refractory to checkpoint inhibitors as well as in patients with tumor types responsive to immunotherapy that respond poorly to checkpoint inhibitors is very encouraging" said Mark Lappe, CEO of Inhibrx. "We are pleased to see that our preclinical data, which demonstrated that hexavalent valency is required to properly agonize OX40, appear to be translating clinically."

Part 4 (combination dose expansion) of the trial initiated in a NSCLC cohort and a basket cohort in patients who relapsed or were refractory to checkpoint inhibitors, as well as in selected checkpoint inhibitor naive patient cohorts including cutaneous melanoma, uveal melanoma, head and neck squamous cell carcinoma and nasopharyngeal carcinoma. We expect to have initial data from Part 4 of this trial late this year.

About INBRX-106
INBRX-106 is a hexavalent product candidate agonist of OX40. OX40 is a co-stimulatory receptor expressed on immune cells that is enriched in the tumor microenvironment. OX40 ligand is a trimeric protein that activates OX40 signaling through clustering. We engineered INBRX-106 to bind and cluster six OX40 receptors and has been shown preclinically to significantly outperform bivalent antibodies in co-stimulatory capacity and anti-tumor activity.

The trial for INBRX-106 is a first-in-human, multicenter, open-label, non-randomized, 4-part Phase 1 trial in patients with locally advanced or metastatic solid tumors designed to determine the safety profile and identify the MTD and/or recommended Phase 2 dose of INBRX-106 administered as a single agent or in combination with Keytruda (pembrolizumab), a programmed death receptor-1 (PD-1) checkpoint inhibitor.

About the Inhibrx sdAb Platform
Inhibrx utilizes diverse methods of protein engineering in the construction of therapeutic candidates that can address the specific requirements of complex target and disease biology. A key tool for this effort is the Inhibrx proprietary sdAb platform, which enables the development of therapeutic candidates with attributes superior to other monoclonal antibody and fusion protein approaches. This platform allows the combination of multiple binding units in a single molecule, enabling the creation of therapeutic candidates with defined valency or multiple specificities, potentially capable of enhanced cell signaling or conditional activation. An additional benefit of this platform, these optimized and/or multi-functional entities can be manufactured using the established processes that are commonly used to produce therapeutic proteins.

Inhibrx is pursuing targets with early validation where other therapeutics have demonstrated liabilities as well as a portfolio of sdAb based therapeutic candidates in a variety of indications for novel targets.

On January 4, 2022 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported that it has been granted a U.S. patent (11,207,350 B2) for a novel natural killer (NK) cell therapy composition and method for treating cancer that combines the company’s genetically modified NK-92 cells with CD16 receptors to enhance binding and activity of monoclonal antibodies (Press release, ImmunityBio, JAN 4, 2022, View Source [SID1234598077]). The combination of these engineered NK-92 cells with current monoclonal antibody therapies has the potential to augment the overall cytotoxic effects of monoclonal antibody treatment alone and help to address relapse by bolstering the patient’s own natural immune system response.

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ImmunityBio’s NK-92 cells are specifically modified versions of the NK cells that are a core element of the human immune system. First discovered in the blood of a non-Hodgkins lymphoma patient, these cells retain most of the activating receptors of NK cells but lack the major inhibitory receptors, giving them higher baseline cytotoxicity against tumor cells. The cells have been included in more than 450 published papers covering a wide range of research and they are currently being studied in clinical trials for pancreatic cancer, triple-negative breast cancer, and non-Hodgkin lymphoma.

The off-the-shelf NK cell platform can be easily expanded, genetically modified and cryopreserved. By inserting chimeric antigen receptors (CARs) in the NK-92 cells, they have the potential for multi-specific killing including direct NK cell killing via stress ligands, CD16-mediated killing via tumor-targeted antibodies, and CAR-mediated killing.

The patent, which protects this therapeutic approach for 20 years from its original filing, covers the use of these NK-92 cells in conjunction with the mAbs that are a standard of care in many cancer cases.

"While monoclonal antibodies have significantly improved the clinical outcomes in patients with cancer, many of these patients ultimately relapse," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. "A growing body of research suggests that clinically meaningful responses to these antibody therapies is dependent upon the overall health of the patient’s own natural killer cells and whether the cells express the high-affinity variant of the CD16 receptors, which are found on the surface of natural killer cells. Only about 10% of NK cells in the blood of healthy people have the high-affinity CD16 receptors for monoclonal antibody binding—the majority of NK cells have the intermediate- and low-affinity receptor—therefore an infusion of these NK-92 cells engineered with a high-affinity CD16 receptor supercharges the monoclonal antibodies, potentially enabling the antibodies to be therapeutically more effective in combination with the killing activity of these engineered NK-92 cells."

The new patent adds another asset to ImmunityBio’s strong intellectual property portfolio, which includes more than 1,100 issued and pending patents worldwide across multiple categories including biologics, vaccine vectors, natural killer cells, and GMP devices. Patents for key areas such as N-803 (Anktiva), adenovirus vaccine vectors, yeast vaccine vectors, NK-92 cells and therapies extend to 2036 and beyond.

On January 4, 2022 Immix Biopharma reported that The FDA has granted a rare pediatric disease designation (RPDD) to IMX-110 for the treatment of rhabdomyosarcoma, according to an announcement from Immix Biopharma, Inc., the drug developer (Press release, Immix Biopharma, JAN 4, 2022, View Source [SID1234598076]).1

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The novel product is a Tissue-Specific Therapeutic that was built on the clinical-stage biopharmaceutical company’s TME Normalization Technology, which allows for the agent to circulate in the bloodstream, subsequently exit through porous tumor blood vessels, and accumulate in the tumor microenvironment.2

Then, IMX-110 simultaneously attacks the following 3 components of the microenvironment: cancer-associated fibroblasts, tumor-associated macrophages/immune cells, and the cancer itself; this severs the lifelines between the tumor and its metabolic and structural support. The product’s technology causes tumor apoptosis.

RPDD is only given to products developed to treat serious and life-threatening diseases that primarily affect children aged up to 18 years of age, and impact fewer than 200,000 individuals in the United States. If a new drug application for the agent is approved in the country, the company may be eligible to receive a priority review voucher from the agency, which can then be redeemed to obtain priority review for any subsequent marketing application.

"We are pleased by the FDA’s acknowledgement of the urgent need for a safe and effective treatment for children with this devastating disease," Ilya Rachman, MD, PhD, chief executive officer of Immix Biopharma, Inc., stated in a press release.

Clinical findings across several soft tissue sarcoma subtypes in several heavily pretreated patients indicated that the investigational agent resulted in a median progression-free survival (PFS) of 4.0 months.3 Tumor shrinkage was observed in 75% of these patients. Moreover, no treatment-related serious adverse effects (AEs), nor dose interruptions due to toxicity, were reported.

"We are encouraged by our phase 1b/2a clinical data in soft tissue sarcoma," Rachman added. "IMX-110 is a tissue-specific therapeutic that simultaneously attacks all 3 components of the tumor microenvironment, severing the critical lifelines between the tumor and its metabolic and structural support. We believe our SMARxT platform generating Tissue-Specific Therapeutics represents a distinct alternative to the traditional ‘single target, single mutation’ development model."

The safety, tolerability, and pharmacokinetics of IMX-110 in patients with advanced solid tumors is currently under investigation as part of an open-label, multicenter, dose-escalation/-expansion phase 1/2 trial (NCT033892340).4

To be eligible for enrollment, patients need to be at least 18 years of age, have a confirmed advanced solid tumor as per histology and have progressed or are refractory or intolerant to standard treatment. Patients need to have an ECOG performance status ranging from 0 to 2, a life expectancy of at least 3 months, acceptable cardiac function, and must meet certain laboratory requirements.

If patients have a history of severe allergic reactions to any unknown allergens or any components of the study drug formulation, received chemotherapy within 14 days of dosing, immunotherapy within 28 days of dosing, or a biologic of hormonal therapy within 28 days of dosing, they will be excluded.

Other exclusion criteria include having participated in any other drug study up to 4 weeks before study drug administration, requiring surgery or benefit from other anticancer agents, a history of and/or risk factors for ischemic heart disease, no recovery of toxicities from prior treatment, and being positive for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus.

The primary outcome measures are examining the number of treatment-related AEs and identifying the maximum tolerated dose of IMX-110 and the recommended phase 2 dose of the agent. Secondary outcome measures include evaluating plasma concentrations of IMX-110, response rate, PFS, overall survival, and duration of response.

Investigators will also examine the pharmacodynamic activity of the agent with appropriate biomarkers.

Previously, in September 2021, the FDA granted an orphan drug designation to IMX-110 for use as a potential therapeutic in patients with soft tissue sarcoma.2

On January 4, 2022 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a developer of next-generation biopharmaceuticals and pioneer of the sustainable, plant-based FastPharming Manufacturing System, reported that it will participate in the H.C. Wainwright BioConnect Conference, to be held virtually January 10-13, 2022 (Press release, iBioPharma, JAN 4, 2022, View Source [SID1234598075]).

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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

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iBio’s pre-recorded presentation will be available on demand during the event for all registered attendees. Beginning on Monday, January 10, 2022, the presentation will also be available on the Company’s website at www.ibioinc.com under "News & Events" in the Investors section.