On November 7, 2022 Inhibrx, Inc. (Nasdaq: INBX), a biopharmaceutical company with four clinical programs in development and a strong emerging pipeline, reported financial results for the third quarter of 2022 and provided an update on recent corporate highlights (Press release, Inhibrx, NOV 7, 2022, View Source [SID1234623336]).

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Recent Corporate Highlights

On August 15, 2022, Inhibrx announced that the European Commission, based on a positive opinion issued by the European Medicines Agency, has granted orphan medicinal product designation to INBRX-109 for the treatment of chondrosarcoma.
On October 4, 2022, Inhibrx announced that, based on discussions with the U.S. Food and Drug Administration (FDA), there is potential to pursue an accelerated approval in the United States for INBRX-101 in patients with emphysema due to Alpha-1 Antitrypsin Deficiency (AATD) using functional alpha-1 antitrypsin (AAT) serum levels as the surrogate endpoint. Inhibrx plans to initiate in the first quarter of 2023 a potential registration-enabling clinical trial using functional AAT as a surrogate endpoint with the intent to submit for regulatory approval under the FDA’s Accelerated Approval Program.
On October 4, 2022, Inhibrx announced the detection of INBRX-101 in the bronchoalveolar lavage fluid samples from all AATD patients tested in the Phase 1 study.
On October 26, 2022, Inhibrx announced the draw of its final tranche under its loan and security agreement with Oxford Finance LLC and received gross proceeds of $30.0 million.
Financial Results

Cash and Cash Equivalents. As of September 30, 2022, Inhibrx had cash and cash equivalents of $146.1 million, compared to $131.3 million as of December 31, 2021. As of October 31, 2022, Inhibrx had cash and cash equivalents of $290.2 million.
R&D Expense. Research and development expenses were $24.9 million during the third quarter of 2022, compared to $18.5 million during the third quarter of 2021. During the third quarter of 2022, Inhibrx’s clinical trial expenses increased, both for its Phase 1 trials as they continue to progress, as well as its continued expenses related to the INBRX-109 potentially registration-enabling Phase 2 trial which was initiated during the second quarter of 2021. The organization also incurred increased contract manufacturing expenses due to greater production run costs at its contract development and manufacturing organization partners, including drug substance batch manufacturing in preparation for a Phase 2 trial supply and pilot batch production for one of its preclinical candidates. Personnel-related costs also increased during the period, which is attributable to an increase in headcount as Inhibrx continues to expand its clinical operations and technical operations teams.
G&A Expense. General and administrative expenses were $5.3 million during the third quarter of 2022, compared to $2.8 million during the third quarter of 2021. This overall increase was primarily driven by an increase in additional personnel-related costs due to an increase in headcount as the organization builds out its commercial strategy team. In addition, Inhibrx incurred market research and other scientific publication expenses related to its continued pre-commercialization efforts for INBRX-101 and INBRX-109.
Net Loss. Net loss was $35.3 million during the third quarter of 2022, or $0.90 per share, compared to $20.6 million during the third quarter of 2021, or $0.54 per share.
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 single-domain antibody (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 that can achieve enhanced cell signaling or conditional activation. An additional benefit of this platform is that these optimized, multi-functional entities can be manufactured using the established processes that are commonly used to produce therapeutic proteins.

On November 7, 2022 FibroGen, Inc. (NASDAQ: FGEN) reported a royalty monetization financing with NovaQuest Capital Management (NovaQuest) that will result in proceeds to FibroGen in the amount of $50 million, bringing non-dilutive capital to drive innovation and growth (Press release, FibroGen, NOV 7, 2022, View Source [SID1234623335]).

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NovaQuest is a strategic financial partner that is aligned with the company’s growth ambitions and demonstrates confidence in the anticipated commercial opportunity and launch performance of EVRENZO. The financing provides capital to expand and advance the company’s wholly-owned late-stage pipeline toward commercialization.

"This transaction reflects the meaningful value roxadustat can generate in the territories partnered with Astellas, and FibroGen’s ability to execute a non-dilutive transaction to strengthen our balance sheet," said Enrique Conterno, Chief Executive Officer, FibroGen. "Part of the proceeds will be used to further fund our wholly-owned pamrevlumab program, as we anticipate multiple pivotal Phase 3 readouts in 2023 and 2024. Executing this deal in the current market environment speaks to the quality of the assets and the aligned confidence in the commercial opportunity of EVRENZO by NovaQuest Capital Management."

The deal includes the following terms:

$50 million cash upfront in exchange for 22.5% of future EVRENZO royalties in the territories partnered with Astellas – Japan, Europe, and certain other territories.
The aggregate payments to be received by NovaQuest Capital under this Agreement are capped at certain fixed multiples of the upfront payment based upon time. Once NovaQuest receives an aggregate of either:
$100 million (2.0x the upfront) by the end of 2028, or
$112.5 million (2.25x the upfront) by the end of 2029, or
$125 million (2.50x the upfront) by the end of 2030,
the Agreement will expire resulting in FibroGen retaining all subsequent EVRENZO royalties.

"NovaQuest is excited to utilize its differentiated Product Finance solution and support FibroGen in creating innovative, first-in-class medicines for chronic and life-threatening conditions by leveraging patients’ natural pathways," said Ryan Wooten, Managing Director at NovaQuest. "We look forward to FibroGen continuing to execute on their pipeline and delivering new therapeutics to the global patient community."

Morgan Stanley & Co. LLC acted as the sole structuring agent and Goodwin Procter LLP acted as counsel to FibroGen. Wyrick Robbins Yates & Ponton LLP acted as counsel to the investor.

On November 7, 2022 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported that it will release its financial results for the third quarter 2022 and provide a business update on Monday, November 14, 2022 (Press release, Protalix, NOV 7, 2022, View Source [SID1234623322]).

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Management will host a conference call with investors to discuss the financial results and provide an update on recent corporate and regulatory developments.

The conference will be webcast live from the Company’s website and will be available via the following links:

Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company’s website, at the above link.

On November 7, 2022 Lunit (KRX: 328130.KQ) reported that it will present three abstracts at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting, to be held in Boston, MA, and virtually from Nov. 8 – 12 (Press release, Lunit, NOV 7, 2022, View Source [SID1234623321]).

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As a leading provider of state-of-the-art cancer diagnostic technology, Lunit has focused on developing novel AI biomarkers for application in immunotherapy. Since 2019, the company has released groundbreaking findings based on its AI-powered tissue analysis platform, Lunit SCOPE, demonstrating the software’s predictive value in identifying patients eligible for immunotherapy.

This year, Lunit’s presentations at SITC (Free SITC Whitepaper) 2022 will highlight the effectiveness of Lunit SCOPE IO in accelerating immunotherapy clinical trials and drug development.

Lunit SCOPE IO analyzes a patient’s cancer tissue slide image by observing the distribution of tumor-infiltrating lymphocytes (TILs) — one of the representative immunocytes that fight cancer cells. Based on the spatial distribution of TILs and cancer cells in the tumor microenvironment, Lunit SCOPE IO identifies the tissue sample as one of three immune phenotypes: inflamed, immune-excluded, or immune-desert.

One of the studies to be presented aimed to analyze the multi-cancer landscape of HER2-low expression using clinical data, pathological slides, and genetic expression registered in the National Cancer Institute’s "The Cancer Genome Atlas" (TCGA).

To understand the immune microenvironment of HER2-expressing tumors, Lunit’s researchers performed a spatial analysis of tumor-infiltrating lymphocytes (TILs) in association with HER2 status. As a part of this study, Lunit SCOPE IO was applied to analyze pathological slides from 7,322 patients across 22 cancer types obtained from the TCGA data set.

"The recently approved next-generation HER2 antibody-drug conjugate (ADC) has opened the door to more effective treatments for HER2-low breast cancer, which previously had limited treatment options. Based on the existing studies that HER2-expressed cancer exhibits a lower immune response, it has become important to gain more insight into the tumor microenvironment for future combinatory strategies with immune checkpoint inhibitors," explained Chan-Young Ock, Chief Medical Officer of Lunit.

"Lunit SCOPE IO, an artificial intelligence-powered H&E analyzer, can provide immune phenotypes by performing spatial analysis of tumor-infiltrating lymphocytes (TILs). This study shows Lunit SCOPE IO’s possibility to further identify possible responders for the combination therapy," he added.

Lunit will also present findings from a meta-analysis study comparing the discontinuation rates of immunotherapy alone (IO-only) and immunotherapy combined with chemotherapy (chemo-IO), respectively, due to treatment-related adverse events (TRAE). 41 clinical trials, including over 13,000 patient cases, were examined. Compared to IO-only, the results indicated that chemo-IO has a significantly higher TRAE-related discontinuation rate.

TRAE-related discontinuation may lead to suboptimal treatment outcomes, warranting the discovery of a novel biomarker that can accurately predict which patients will achieve a durable response from IO-only without early treatment discontinuation. Thus, this study can be a key reference to prove Lunit SCOPE IO’s clinical validity to omit the unnecessary potential risks that may result from chemo-IO.

Another study co-authored by Lunit aims to evaluate the clinical efficacy of NeoImmuneTech’s NT-I7 (efineptakin alfa) and pembrolizumab to support T-cell infiltration in microsatellite-stable colorectal (MSS-colorectal) and pancreatic cancer patients with no standard treatment option.

In this clinical trial, pre-treatment and on-treatment biopsies were analyzed by Lunit SCOPE IO to objectively measure the increase in TIL infiltration. While objective measurement of TIL in small biopsied samples can be challenging, Lunit SCOPE IO is able to sensitively detect TIL in these difficult-to-analyze tissues — this indicates a practical application for the AI model in a clinical trial space.

"We are pleased to return to SITC (Free SITC Whitepaper) this year to showcase new findings validating the effectiveness of Lunit’s AI biomarker platform as a practical research tool for clinical study," said Lunit CEO Brandon Suh. "We will continue to work toward our goal to offer optimized treatment to cancer patients through AI."

On November 7, 2022 Cytovia Therapeutics, Inc., a biopharmaceutical company empowering natural killer (NK) cells to fight cancer through stem cell engineering and bispecific antibodies, reported new preclinical data for its TALEN gene-edited, iPSC-derived NK (iNK) cells and GPC3-targeted Flex-NK bispecific antibodies (Press release, Cytovia Therapeutics, NOV 7, 2022, View Source [SID1234623320]). The data will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 37th Annual Meeting (SITC 2022) taking place in Boston, MA, and virtually November 8-12th, 2022.

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"We’re delighted to see further progress on our lead GPC3-targeted Flex-NK bispecific antibody program, with a pre-clinical package that supports clinical evaluation in 2023," commented Cytovia CEO Dr. Daniel Teper. "Additionally, we have now generated TALEN gene-edited iNK cells and demonstrated enhanced antitumor activity. Cytovia is the first company to develop both its own immune cell engagers and natural killer cells, with the potential for enhanced efficacy in cancers with significant unmet medical needs such as Hepatocellular Carcinoma."

The presentations show that Cytovia’s allogeneic iNK cell product CYT-100 demonstrated increased time-dependent killing of Hep3B tumor spheroids and sensitivity to cytokine activation & expansion potential. Cytovia’s GPC3-targeted bispecific antibody CYT-303 demonstrated potent ADCP and CDC against Hep3B tumors as well as Hep3B tumor spheroid and serial killing activities in the presence Cytovia’s allogeneic iNK cell product CYT-100 and PBNKs in a dose-dependent manner. Preclinical pharmacokinetics and safety study results in monkeys fully support CYT-303 clinical development.

Cytovia’s next-generation iNK cell platform combined with TALEN gene-editing robustly and reliably generated single-cell edited iPSC clones, which were expanded and differentiated into functionally improved iNK cells. The data shows that iNK cells edited with an IL-15 knock-in and TGFβR2 knock-out result in enhanced antitumor activity. The editing and manufacturing process will enable clinical evaluation of these product candidates, both alone in combination with CYT-303.