On September 21, 2022 NKGen Biotech, a biotechnology company harnessing the power of the body’s immune system through the development of natural killer cell therapies, reported a publication in the peer-reviewed Journal of Cancer Research and Cellular Therapeutics entitled "Durable responses using SNK01 autologous enhanced natural killer cells and pembrolizumab for chemotherapy-resistant advanced sarcoma: Case reports, review of literature, and future perspectives (Press release, NKMax America, SEP 21, 2022, View Source [SID1234621303])."

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The paper by Gordon et al. discloses enduring response data in chemotherapy resistant metastatic sarcoma patients who were treated with SNK01, autologous enhanced natural killer cell therapy, and pembrolizumab, an immune checkpoint inhibitor, along with a review of literature and future perspectives on the use of SNK01 in advanced sarcoma.

"We are pleased to be able to share the promising results of our SNK01 natural killer cell therapy in combination with pembrolizumab, in these two important case studies since metastatic sarcoma is typically associated with poor outcomes when treated with standard regimens," commented Paul Song, M.D., Vice Chairman of NKGen Biotech. "It is encouraging to see that Patient #1, despite being PD-L1 negative and having failed prior pembrolizumab, eventually showed a gradual tumor reduction with a 47% partial response, after which the patient underwent two surgical resections and achieved a sustained remission. Of note is that the patient has safely been on this regimen for almost 35 months without any toxicity at all and remains no evidence of disease."

"Patient #2 has low PD-L1 expression and had failed prior nivolumab. The patient showed a gradual reduction in tumor size, achieving a 38% partial response," added Dr. Song, "This response data is very promising especially since both patients had failed prior immune checkpoint inhibitor therapy. It appears that SNK01 might be able to change the tumor microenvironment and suggests that SNK01 plus pembrolizumab has the potential to be a viable therapeutic option for patients with metastatic sarcoma, and especially in PD-L1 negative and low expressing tumors. Further studies are warranted, and we look forward to confirming these findings in a Phase II clinical trial."

The encouraging data from these two case reports suggests SNK01 combined with pembrolizumab may be a viable salvage therapy regimen for chemotherapy-resistant advanced sarcoma with manageable toxicity. The data also supports existing evidence that natural killer cells mediate a favorable response to immune checkpoint inhibitor therapy while reducing immune-related adverse events.

On September 21, 2022 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported determination of the recommended phase 2 dose (RP2D) of NBTXR3 in combination with pembrolizumab or nivolumab for the treatment of patients suffering from inoperable locoregional recurrent (LRR) or recurrent and metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) that is resistant to prior immunotherapy (Press release, Nanobiotix, SEP 21, 2022, View Source [SID1234621302]). RP2Ds were determined for NBTXR3 plus pembrolizumab or nivolumab for patients with LRR or R/M HNSCC that has not received prior immunotherapy, lung metastases (mets) from any primary tumor, or liver mets from any primary tumor as well.

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The combined dose escalation and dose expansion parts of Study 1100 are expected to enroll up to 141 patients. The complete dose escalation part enrolled 29 patients in three cohorts: (i) head and neck lesions from LRR or R/M HNSCC eligible for anti-PD-1 therapy; (ii) lung mets from any primary cancer eligible for anti-PD-1 therapy; and (iii) liver mets from any primary cancer eligible for anti-PD-1 therapy. Study participants received a one-time intratumoral injection of NBTXR3 prior to their first radiotherapy session. They then received radiotherapy, followed by anti-PD-1. Based on the study’s results, the RP2D for all three cohorts was determined to be 33% of gross tumor volume.

Nanobiotix aims to deliver an industry-leading head and neck cancer treatment franchise powered by NBTXR3, and to replicate that approach across other solid tumor indications. Pursuant to this strategy, the Company has amended the ongoing expansion phase of Study 1100 to further strengthen the rationale behind a registrational protocol evaluating NBTXR3 plus anti-PD-1 for patients with R/M HNSCC that is resistant to prior immunotherapy.

The amended dose expansion part of study 1100 also has three cohorts, however the cohorts have been re-designed to further explore NBTXR3 plus anti-PD-1 in several immunotherapy-eligible indications, with a particular focus on the treatment of patients with LRR or R/M HNSCC primary lesions that are either naïve or resistant to prior immunotherapy. The expansion part cohorts are as follows: (i) LRR or R/M HNSCC that is resistant to prior immunotherapy; (ii) LRR or R/M HNSCC that has not received prior immunotherapy; (iii) lung, liver, or soft tissue mets from inoperable NSCLC, malignant melanoma, hepatocellular carcinoma, renal cell carcinoma (RCC), urothelial cancer, cervical cancer, or triple negative breast cancer (TNBC) primary tumors.

The Company expects to provide updated clinical data from Study 1100 in Q4 2022. The registrational phase 3 protocol submission is expected in Q1 2023, followed by modification of the study design.

About NBTXR3

NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across solid tumors that can be treated with radiotherapy and across different therapeutic combinations.

On September 21, 2022 MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative therapeutic products for patients with endocrine and orphan lung diseases, reported that its Chief Executive Officer, Michael Castagna, PharmD, will participate in the Lytham Partners Fall 2022 Investor Conference taking place virtually on September 28-29, 2022 (Press release, Mannkind, SEP 21, 2022, View Source [SID1234621301]).

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The Company’s webcast presentation will be available for viewing at 9:00am ET on Wednesday, September 28, 2022, on the Company’s website at Events & Presentations or View Source The webcast will also be archived and available for replay.

Management will be participating in virtual one-on-one meetings throughout the event. To arrange a meeting with management, please contact Lytham Partners at 1×[email protected].

On September 21, 2022 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a clinical-stage precision oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Kinnate’s investigational pan-RAF inhibitor, KIN-2787, for treatment of patients with BRAF Class II or III alteration-positive and/or NRAS mutation-positive stage IIb to IV malignant melanoma that is metastatic or unresectable (Press release, Kinnate Biopharma, SEP 21, 2022, View Source [SID1234621300]).

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According to the FDA, Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need. A therapeutic candidate that receives Fast Track designation is eligible for more frequent interactions with the FDA to discuss the candidate’s development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.

KIN-2787 is an orally available, potent and selective small molecule pan-RAF inhibitor being evaluated in KN-8701 (NCT04913285), an ongoing Phase 1 global clinical trial in patients with solid tumors harboring BRAF alterations or who have NRAS mutant melanoma. Unlike currently available treatments that target only Class I BRAF kinase mutations, Kinnate has designed KIN-2787 to target Class II and Class III BRAF alterations, where it has the potential to be a first-line targeted therapy, in addition to covering Class I BRAF alterations, and as a potential treatment for NRAS mutation-positive melanoma.

The company previously announced that the FDA granted Orphan Drug Designation (ODD) for KIN-2787 for the treatment of stage IIb-IV melanoma. An ODD is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the U.S.

On September 21, 2022 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a developer of next-generation biopharmaceuticals and pioneer of the sustainable FastPharming Manufacturing System, reported that it closed on the acquisition of substantially all of the assets of its partner, RubrYc Therapeutics, Inc. ("RubrYc") after it entered into a definitive asset purchase agreement (the "Purchase Agreement") (Press release, iBioPharma, SEP 21, 2022, View Source [SID1234621298]). The transaction marks another important step toward iBio’s mission to bring more – and better – immunotherapies to the clinic, faster, with its continued transformation into a biopharmaceutical discovery and development company.

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The acquired assets include:

AI Drug Discovery Platform: A patented system that uses artificial intelligence ("AI") to design 3D models of epitopes to facilitate the creation of better antibody drug candidates. Unlike other traditional and newer AI-driven methods of drug discovery that often focus upon dominant epitopes, the RubrYc Discovery Engine uses predictive algorithms to identify and model subdominant and conformational epitopes, prospectively enabling the discovery of new antibody treatments for hard-to-target cancers and other diseases.
Previously Licensed Candidates: All rights – with no future milestone payments or royalty obligations – to two molecules. These include IBIO-101, an IL-2 sparing anti-CD25 antibody for depletion of regulatory T cells, as well as "Target 6" that was discovered in Q2 FY2022 using the Discovery Engine.
New Therapeutic Candidates: Three promising immuno-oncology candidates, plus a partnership-ready PD-1 agonist for serious autoimmune diseases, such as systemic lupus erythematosus and multiple sclerosis.
Purchase terms include:

An upfront payment of $1 million in iBio’s common stock to RubrYc investors.
Eligibility for RubrYc’s investors to receive up to $5 million in development milestones over the next five years, to be paid in common stock or cash, at iBio’s sole discretion.
In an effort to focus its resources on the promising new discovery platform and entering the clinic with its lead compounds, iBio has initiated a review of opportunities to accelerate its transformation while extending its cash runway beyond previous guidance of September 30, 2023. These include asset sales, partnerships, portfolio decisions, cost reductions, and non-dilutive efforts to raise additional capital.

"We are excited to pair our new AI Discovery Engine with our existing platforms to create a biotech company with its own end-to-end discovery capabilities and an expanded pipeline of immunotherapy candidates," said Tom Isett, Chairman & Chief Executive Officer of iBio. "We are also happy to welcome four of RubrYc’s talented and experienced computational biology pioneers to our team, the majority of whom will make the move to iBio’s new Drug Discovery Center that is slated to open in San Diego in the coming weeks."

"Instead of relying on traditional ‘trial-and-error’ drug screening methods, we believe adding an AI-powered discovery capability to the front end of our process will enable us to bring better molecules into the clinic faster and more cost-effectively," commented Martin Brenner, DVM. Ph.D., iBio’s Chief Scientific Officer. "This was clearly demonstrated with iBio’s pipeline Target 6, a mutated form of a protein expressed in a number of tumors. RubrYc’s Discovery Engine enabled the rapid identification of antibodies that selectively bind the mutated protein, without binding the wild-type version, which is more commonly expressed in healthy tissues. Due to the unique characteristics of the RubrYc Discovery Engine, we were able to expeditiously advance the program from the Early Discovery to the Late Discovery stage."

The closing of the acquisition was conditioned upon approval of the NYSE American and both parties meeting other customary closing conditions.

Webcast and Conference Call

​The Company will report its fiscal fourth quarter and full year 2022 financial results after market close on Tuesday, September 27, 2022, and will host a webcast and conference call at 4:30 p.m. Eastern Time to discuss the results, give more information on the RubrYc transaction and strategic review, and provide additional updates. The live and archived webcast may be accessed on the Company’s website at www.ibioinc.com under "News and Events" in the Investors section. To access the live call by phone, participants should go to this registration link, where they will be provided with the dial-in details.