On January 13, 2021 Inhibrx, Inc. (Inhibrx), a clinical-stage biotechnology company with a broad pipeline of biotherapeutics in development, reported the U.S. Food and Drug Administration (FDA) granted Fast Track designation to INBRX-109 for the treatment of patients with unresectable or metastatic conventional chondrosarcoma (Press release, Inhibrx, JAN 13, 2021, View Source [SID1234573954]). INBRX-109 is a precisely engineered tetravalent single domain antibody (sdAb)-based therapeutic candidate that agonizes death receptor 5 (DR5) to induce tumor selective programmed cell death.

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Fast Track designation is granted by the FDA upon the request of the sponsor to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening diseases. Depending upon the stage of the product’s development, the sponsor must also provide FDA with nonclinical or clinical data to demonstrate the drug’s potential to address unmet medical needs for such a disease or condition. Investigational drug products with Fast Track designation may benefit from early and frequent communication with the FDA, and are eligible for rolling submission and FDA review of its future marketing application. The designation was granted to INBRX-109 based on preliminary data from the chondrosarcoma expansion cohort of the Phase 1 clinical trial of INBRX-109.

"There are currently no approved agents for the treatment of unresectable or metastatic conventional chondrosarcoma, and we are excited about the potential of this treatment to meaningfully improve the outcome for patients," said Mark Lappe, CEO of Inhibrx. "We look forward to working closely with the FDA throughout the clinical development of INBRX-109."

A potential registration-enabling Phase 2 study of INBRX-109 has been discussed with the FDA and will be designed as a randomized, blinded, placebo-controlled study in unresectable or metastatic conventional chondrosarcoma with progression-free survival as the primary endpoint. Inhibrx expects to start dosing patients in this potentially registration-enabling study in the second or third quarter of this year.

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, multi-functional entities can be manufactured using the established processes that are commonly used to produce therapeutic proteins.

Initially, Inhibrx is pursuing targets with early clinical validation, such as DR5, where other therapeutics have demonstrated liabilities. In addition, Inhibrx is developing a portfolio of sdAb based therapeutic candidates in a variety of indications for both known and novel targets.

On January 13, 2021 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 met all specifications and passed all of the final release tests for its first scaled-up clinical-grade manufacturing run of REQORSA immunogene therapy, in advance of its upcoming Acclaim-1 and Acclaim-2 clinical trials for the treatment of non-small cell lung cancer (NSCLC) (Press release, Genprex, JAN 13, 2021, View Source [SID1234573953]).

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"The successful completion of this final step in our scaled-up clinical grade manufacturing of REQORSA marks a key manufacturing milestone for Genprex, and is credited to the hard work and commitment of both our internal manufacturing group and our manufacturing partners," said Rodney Varner, President and Chief Executive Officer of Genprex. "This production provides supply of REQORSA for our two upcoming Acclaim clinical trials and advances our mission to develop innovative new treatments for non-small cell lung cancer patients greatly in need of effective therapy options."

Genprex recently announced the successful completion of the technology transfer of its manufacturing process for the production of REQORSA from the major research institution where it was previously manufactured to experienced commercial Contract Development and Manufacturing Organizations (CDMOs). The Company also reported the completion of the manufacturing scale-up for the clinical-grade production of REQORSA, subject to final testing that was underway. Passing all lot release specifications marks the successful completion of Genprex’ manufacture of REQORSA in a scaled-up clinical production in accordance with the current Good Manufacturing Practices (cGMP) required by the U.S. Food and Drug Administration (FDA) in advance of commercial approval of a drug product.

Clinical-grade REQORSA has been shipped and delivered to its first cold storage depot. From there, REQORSA supply will be delivered to the clinical trial sites pending FDA clearance to commence the clinical trials. This production run will supply the Company’s upcoming Acclaim-1 and Acclaim-2 clinical trials that combine REQORSA with Tagrisso (marketed by AstraZeneca) and with Keytruda (marketed by Merck & Co., Inc.), respectively, both of which are on track to be initiated in the first-half of 2021.

On January 13, 2021 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that Dr. Amit Kumar, Anixa’s Chief Executive Officer, will present at B. Riley’s Inaugural Oncology Investor Conference to be held January 20-21, 2021 (Press release, Anixa Biosciences, JAN 13, 2021, View Source [SID1234573952]).

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Dr. Kumar will participate in a fireside chat presentation to discuss Anixa’s recent accomplishments and anticipated milestones. Company management will also be available to participate in online one-on-one meetings with investors who are registered to attend the conference.

Anixa’s presentation will be live webcast at 10:30 a.m. PST on January 21, 2021. The presentation will be open to registered conference attendees, institutional investors and investor relations professionals, who may register to view the live webcast at https://b-riley-oncology-investor-conference.events.issuerdirect.com/signup. After completion of the event, a replay of the presentation will be publicly available on the Anixa website at View Source

On January 13, 2021 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported the initiation of patient enrollment in the INNATE Phase 1 clinical study of its lead macrophage program JTX-8064 as a monotherapy and in combination with either JTX-4014, its internal PD-1 inhibitor, or pembrolizumab in patients with advanced solid tumors (Press release, Jounce Therapeutics, JAN 13, 2021, View Source [SID1234573951]). JTX-8064, the first tumor-associated macrophage candidate developed from Jounce’s Translational Science Platform, is a humanized IgG4 monoclonal antibody designed to specifically bind to the macrophage receptor Leukocyte Immunoglobulin Like Receptor B2 (LILRB2/ILT4), inhibiting LILRB2 binding with its ligands and reprogramming immune-suppressive macrophages to enhance anti-tumor immunity.

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"We are pleased to announce we have dosed the first patient in our INNATE Phase 1 study which is designed to progress quickly through dose escalation and demonstrate proof of concept in tumor specific expansion cohorts," said Beth Trehu, M.D., chief medical officer at Jounce Therapeutics. "Expansion cohorts in INNATE will address multiple different patient populations, including PD-(L)1 inhibitor naïve patients with both PD-(L)1 inhibitor sensitive and resistant tumor types, and PD-(L)1 inhibitor experienced patients whose tumors were resistant to PD-(L)1 inhibitors. Patients with PD-(L)1 inhibitor resistant tumors represent a large and growing unmet medical need. We believe LILRB2 may function as an immune checkpoint for macrophages and JTX-8064 may have the potential to restore PD-(L)1 inhibitor activity in otherwise resistant settings. INNATE will also assess pharmacodynamic and potential predictive biomarkers to guide future development, aligning with Jounce’s philosophy of developing the right immunotherapies for the right patients."

The Phase 1 INNATE study will consist of 4 parts:

JTX-8064 monotherapy dose escalation in solid tumors
JTX-8064 dose escalation in combination with Jounce’s PD-1 inhibitor, JTX-4014, and also with pembrolizumab in solid tumors
JTX-8064 monotherapy in indication-specific expansion cohorts
JTX-8064 in combination with JTX-4014 or pembrolizumab in indication-specific expansion cohorts
ClinicalTrials.gov identifier: NCT04669899

About JTX-8064
JTX-8064 is a humanized IgG4 monoclonal antibody designed to specifically bind to Leukocyte Immunoglobulin Like Receptor B2 (LILRB2/ILT4) and block interactions with its ligands. JTX-8064 is the first tumor-associated macrophage candidate developed from Jounce’s Translational Science Platform. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s Annual Meeting and the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting support the development of JTX-8064 as a novel immunotherapy to reprogram immune-suppressive macrophages and enhance anti-tumor immunity. A Phase 1 clinical study named INNATE (NCT04669899), for JTX-8064 as a monotherapy and in combination with JTX-4014 or pembrolizumab, is currently enrolling patients with advanced solid tumors.

About JTX-4014
JTX-4014 is a well-characterized fully human IgG4 monoclonal antibody designed to block binding to PD-L1 and PD-L2. JTX-4014 demonstrated a 17% durable overall response rate in a Phase 1 trial of 18 heavily pre-treated PD-(L)1 inhibitor naïve patients, which excluded all tumor types for which PD-(L)1 inhibitors were approved. In this Phase 1 trial, JTX-4014 was shown to have an acceptable safety profile. JTX-4014 is currently being assessed in the INNATE Phase 1 trial (NCT04669899) in combination with JTX-8064, a LILRB2 (ILT4) inhibitor. JTX-4014 is also being assessed in the SELECT Phase 2 clinical trial (NCT04549025) in combination with vopratelimab, a clinical-stage monoclonal antibody that binds to and activates ICOS, the Inducible T cell CO-Stimulator, a protein on the surface of certain T cells commonly found in many solid tumors. The SELECT trial compares vopratelimab plus JTX-4014 to JTX-4014 alone in immunotherapy naïve NSCLC patients who have been pre-selected with the TISvopra predictive biomarker, an 18 gene RNA tumor inflammation signature which predicted the emergence of ICOS hi CD4 T cells and clinical benefit in the ICONIC trial of vopratelimab alone and in combination with a PD-1 inhibitor.

On January 13, 2021 IO Biotech, a clinical-stage biopharmaceutical company developing novel, immune-modulating anti-cancer therapies based on its proprietary T-win technology, reported that it has raised EUR 127 million in Series B financing (Press release, IO Biotech, JAN 13, 2021, View Source [SID1234573924]). The financing round was led by HBM Healthcare Investments, and other new investors joining the round included Vivo Capital, Kurma Partners, Avoro Capital, RA Capital Management, Samsara Biocapital, Idinvest Partners1, PFM Health Sciences, Soleus Capital, Eir Ventures and Serrado Capital, with the participation of existing investors Novo Seeds, Lundbeckfonden Emerge and Sunstone Life Science Ventures. Additionally, Dr. Priyanka Belawat of HBM Partners, Jack B. Nielsen of Vivo Capital and Vanessa Malier of Kurma Partners will join IO Biotech’s board of directors as part of the closing of the financing.

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On December 15, 2020, the U.S. Food and Drug Administration (FDA) granted IO Biotech breakthrough therapy designation for a combination of the potential therapies IO102 and IO103 with anti-PD-1 monoclonal antibodies for patients with unresectable or metastatic melanoma. IO Biotech intends to use the net proceeds of the transaction towards the funding of clinical trials for its early and late-stage immuno-oncology programs, including a large randomized trial for IO102 and IO103 with anti-PD-1 monoclonal antibodies in metastatic melanoma.

"We are excited to have such a strong group of investors backing our company at this stage, and I am proud that this financing round had such high interest and can close oversubscribed," said Mai-Britt Zocca, PhD, Chief Executive Officer, and founder of IO Biotech. "The funding will enable us to execute on our breakthrough therapy designation grant and advance our lead programs in late-stage clinical development, as we are committed to bringing our treatment to patients as soon as possible."

"HBM is excited to be joining IO Biotech as a shareholder. IO Biotech offers a unique treatment modality in oncology, harnessing novel immunomodulatory mechanisms through proprietary vaccine candidates. The financing will help the company bring forward its promising clinical and pre-clinical pipeline closer to the patients in medical need," said Dr. Priyanka Belawat, Investment Advisor at HBM Partners.

"IO Biotech is building a significant immunotherapy pipeline based on compelling scientific and clinical validation. On behalf of existing investors, I warmly welcome the new investors to the company," said Christian Elling, Managing Partner at Lundbeckfonden Emerge. "Together we can accelerate the development of the company’s unique breakthrough cancer medicines to the benefit of patients and physicians."

About IO102 and IO103
IO102 and IO103 are IO Biotech’s lead immuno-oncology candidates. Both compounds are based on IO Biotech’s proprietary T-win technology platform which enables the identification of compounds with a dual mechanism of action targeting and directly killing immunosuppressive cells and tumor cells while indirectly activating other T-effectors, leading to strong anti-tumor responses without adding additional safety concern. Specifically, IO102 and IO103 are first-in-class, immune modulatory vaccines designed to engage and activate IDO and PD-L1 specific human T-cells.

The FDA decision to grant breakthrough therapy designation was based on data from the MM1636 Phase 1/2 clinical trial of 30 patients with metastatic melanoma receiving IO102, IO103 and anti-PD-1 monoclonal antibodies. According to the data recently presented in a late-breaking abstract at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, the combination of IO102 and IO103 vaccines and nivolumab was shown to be safe with encouraging early efficacy data; an overall response rate (ORR) of 79 percent was reached and 45 percent of patients achieved a complete response (CR), or complete disappearance of their tumors. Vaccine specific T-cells were located in the peripheral blood mononuclear cells (PBMCs) and at the tumor site.