On August 9, 2023 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics to improve patient care, reported financial results for the second quarter ended June 30, 2023 and provided a corporate update (Press release, Immunome, AUG 9, 2023, View Source [SID1234634077]).

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"We believe combining Immunome and Morphimmune’s technologies represents a major step in our long-term strategy of creating a preeminent oncology therapeutics company," stated Purnanand Sarma, PhD, President and CEO of Immunome. "Targeted cancer therapies have made great strides in recent years, and the possible synergy between Morphimmune’s Targeted Effector Platform and Immunome’s proprietary Discovery Engine presents an opportunity to discover and develop truly novel therapies that can help cancer patients. We look forward to completing the merger by the end the year."

Highlights

· Immunome and Morphimmune Announce Definitive Merger Agreement and Simultaneous Private Placement Investment of $125 Million to Develop Targeted Cancer Therapies. In June 2023, Immunome and Morphimmune, a private biotechnology company focused on developing targeted oncology therapeutics, announced that the two companies entered into a definitive merger agreement. The closing of the transaction is subject to customary closing conditions, including the effectiveness of the registration statement on Form S-4 to be filed by Immunome, and the receipt of required stockholder approvals from Immunome and Morphimmune stockholders.

o The combined company, which will operate as Immunome, will feature a synergistic platform expected to enable the development of best-in-class targeted cancer therapies across multiple modalities
o Clay B. Siegall, Ph.D., current Morphimmune President & CEO and former co-founder & CEO of Seagen, Inc., to serve as Chairman and CEO of combined company
o A concurrent $125 million private placement investment with leading institutional investors will support development of a combined pipeline expected to submit three investigational new drug applications (INDs) within 18 months of closing

· Immunome Published Preclinical Research Demonstrating that Inhibition of IL-38 Using an Antibody Leads to Anti-Tumor Activity. In May 2023, Immunome announced the publication of data highlighting efficacy of its preclinical IL-38 blocking antibody, titled "IL-38 blockade induces anti-tumor immunity by abrogating tumor-mediated suppression of early immune activation," in the peer-reviewed journal mAbs. The data in the article demonstrates that antibody-based targeting of IL-38 leads to activation of the immunostimulatory anti-tumor mechanisms within the tumor microenvironment in preclinical testing.

Financial Highlights

· Collaboration Revenue: Collaboration Revenue from the Collaboration Agreement with AbbVie for the three months ended June 30, 2023 was $4.3 million.
· Research and development (R&D) expenses: R&D expenses for the three months ended June 30, 2023 were $5.7 million.
· General and administrative (G&A) expenses: G&A expenses for the three months ended June 30, 2023 were $4.2 million.
· Net loss: Net loss for the three months ended June 30, 2023 was $5.6 million, or $0.46 per share.
· Cash and cash equivalents: As of June 30, 2023, cash and cash equivalents totaled $38.4 million.

On August 9, 2023 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immuno-oncology company developing novel T cell engagers, reported financial results for the second quarter ended June 30, 2023 and provided a corporate update (Press release, Harpoon Therapeutics, AUG 9, 2023, View Source [SID1234634076]).

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"Following successful completion of the planned Phase 1 enrollment in the HPN217 trial, we are eager to reach additional important milestones in 2023," said Julie Eastland, President and CEO of Harpoon Therapeutics. "We are on track to present data from our two TriTAC clinical programs later this year at leading medical conferences and select the Phase 2 monotherapy regimens for both HPN217 and HPN328. Harpoon’s financial resources are expected to fund current operations into the second half of 2024 and we remain focused on advancing our key programs."

Corporate Update / Recent Highlights and Upcoming Milestones

Tri-specific T cell Activating Construct (TriTAC) Platform

HPN217 (BCMA) Phase 1 trial for relapsed, refractory multiple myeloma

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Completed planned patient enrollment in the Phase 1 trial in June 2023 with 97 patients.

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Recommended Phase 2 regimen(s) expected to be identified by the end of 2023.

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An abstract detailing the 12mg cohort from the Phase 1 trial has been accepted for poster presentation at the 30th International Myeloma Society (IMS) Annual Meeting, being held September 27-30, 2023 in Athens.

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Presentation of full Phase 1 data set, including 24mg cohorts, expected by the end of 2023.

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Harpoon expects to deliver the Phase 1 data package to AbbVie by the end of 2023.

HPN328 (DLL3) Phase 1/2 trial in small cell lung cancer (SCLC) and other neuroendocrine cancers

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Phase 1/2 dose and schedule optimization ongoing with monotherapy cohorts enrolling at 12mg and 24mg target doses. Early observations in the monotherapy cohorts included encouraging signs of anti-tumor activity, with two confirmed partial responses per RECIST in patients with SCLC and in patients with other neuroendocrine tumor types.

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Abstract with interim data accepted for poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) being held October 20-24, 2023 in Madrid.

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Enrollment in combination therapy of HPN328 with atezolizumab (Tecentriq) in patients with SCLC, as part of the Phase 1/2 dose escalation trial, is anticipated to initiate in the third quarter of 2023.

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Completion of the Phase 1 monotherapy regimen exploration is expected in the second half of 2023, including the identification of the recommended Phase 2 regimen(s) in the monotherapy setting by the end of 2023.

ProTriTAC

HPN601 (EpCAM)

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HPN601 is the first conditionally active T cell engager based on the ProTriTAC platform. EpCAM is expressed in a broad range of solid tumors, potentially enabling HPN601 to address multiple indications with high unmet medical need.

TriTAC-XR

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The proprietary TriTAC-XR extended-release T cell engager platform is designed to minimize on-target CRS, a characteristic of many T cell engagers that can lead to dose limiting toxicities and can reduce the efficacy of these potent anti-tumor drugs.

Corporate Update

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Haibo Wang joined Harpoon in August 2023 as Senior Vice President of Business Development, with 15 years of biopharma business development, finance, and M&A transaction experience, including a focus in both BCMA and DLL3 targeted bi-specific T cell engagers. He most recently served as Vice President of Business Development at Hummingbird Bioscience. Prior to Hummingbird, Mr. Wang was Director of Business Development at Amgen, where he played a major role in the Teneobio and Five Prime Therapeutics acquisitions, the oncology collaboration with BeiGene, and many clinical collaborations to advance Amgen’s oncology pipeline.

Second Quarter 2023 Financial Results

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Harpoon ended the second quarter of 2023 with $45.6 million in cash, cash equivalents, short-term marketable securities, compared to $53.1 million as of December 31, 2022. Current cash, cash equivalents, short-term marketable securities are expected to fund planned operations into the second half of 2024.

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Revenue for the second quarter ended June 30, 2023 was $20.2 million, compared to $8.3 million for the second quarter ended June 30, 2022. For the six months ended June 30, 2023, revenue was $28.8 million compared to $14.2 million for the six months ended June 30, 2022. The increase for both periods was primarily due to an increase in revenue recognized related to Harpoon’s Development Option Agreement with AbbVie and the remaining deferred revenue recognized under the AbbVie Restated Research and Discovery Collaboration Agreement, due to the delivery of the remaining targets in the second quarter of 2023 that fulfilled the performance obligation.

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Research and development (R&D) expense for the second quarter ended June 30, 2023 was $12.2 million, compared to $20.7 million for the second quarter ended June 30, 2022. For the six months ended June 30, 2023, R&D expense was $27.4 million compared to $41.5 million for the six months ended June 30, 2022. The decrease for both periods was primarily due to a decrease in personnel and research activities associated with the corporate restructuring and winddown of HPN424 and HPN536 studies.

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General and administrative (G&A) expense for the second quarter ended June 30, 2023 was $3.8 million, compared to $5.1 million for the second quarter ended June 30, 2022. For the six months ended June 30, 2023, G&A expense was $8.0 million compared to $10.5 million for the six months ended June 30, 2022. The decrease for both periods was primarily due to lower personnel-related expenses, primarily attributable to a decrease in stock-based compensation and a decrease in other professional services.

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Impairment of long-lived assets charge for the three and six months ended June 30, 2023 was $1.7 million, compared to zero for the three and six months ended June 30, 2022. The charge is due to subleasing all office and lab space at the Cove facility as part of Harpoon’s previously announced restructuring plan which required reducing the carrying values of long-lived assets to their fair values.

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Net income attributable to common stockholders for the second quarter ended June 30, 2023 was $1.1 million compared to a net loss attributable to common stockholders of $17.4 million for the second quarter ended June 30, 2022. Net loss attributable to common stockholders for the six months ended June 30, 2023 was $10.3 million compared to $37.7 million for the six months ended June 30, 2022.

On August 9, 2023 Perspective Therapeutics, Inc. ("Perspective" or "the Company") (NYSE AMERICAN: CATX), a precision oncology company developing alpha-particle therapies and complementary diagnostic imaging agents and an innovator in seed brachytherapy treatment options for multiple cancers, reported a collaborative initiative focused on increasing access to Cesium-131 brachytherapy for the treatment of certain brain cancers in the form of GT Medical Technologies, Inc.’s ("GT MedTech") GammaTile Therapy (Press release, GT Medical Technologies, AUG 9, 2023, View Source [SID1234634075]).

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"We are delighted to announce the expansion of our collaboration with GT MedTech to increase our manufacturing in support of their objective of bringing GammaTile Therapy to more patients with difficult to treat brain cancers," said Thijs Spoor, Chief Executive Officer of Perspective. "As the sole producer of Cesium-131 brachytherapy seeds, the therapeutic agent in GammaTile, we value our long-term partnership with GT MedTech and will increase seed production to allow them the capacity to address short notice orders with increased confidence."

GammaTile Therapy is a radiation treatment option implanted during the last five minutes of brain tumor resection surgery. It is composed of bioresorbable collagen tiles embedded with Cesium-131 radiation seeds supplied by Perspective Therapeutics. GammaTile delivers targeted Cesium-131 radiation to help prevent brain tumor cell regrowth in newly diagnosed and recurrent brain tumors, including glioblastomas, metastatic brain tumors, aggressive meningiomas, and other brain tumor types.

Matthew Likens, CEO of GT MedTech, commented, "We are thrilled that Perspective is offering to increase production of Cesium-131 brachytherapy sources for our short notice orders, this will allow us to increase access to GammaTile Therapy, especially in cases where a last-minute opportunity to improve clinical outcomes presents itself. I know our customers will appreciate this increased commitment to patient care."

Perspective Therapeutics is the world’s only producer of Cesium-131 brachytherapy which powers expanded internal radiation treatment options throughout the body, for prostate cancer as well as difficult to treat lung, brain, gynecological, head and neck, pelvic, and colorectal cancers.

On August 9, 2023 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, reported financial results for the second quarter ended June 30, 2023 and provided recent corporate and clinical updates (Press release, Gritstone Bio, AUG 9, 2023, View Source [SID1234634073]).

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"We are pleased with the pace at which our randomized GRANITE Phase 2/3 trial is advancing. Completing enrollment for the Phase 2 portion underscores the enthusiasm for this trial, related to the high unmet need for better treatments in common, immunologically cold tumors, such as CRC," said Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer of Gritstone bio. "Our partnership with Friends of Cancer Research on ctMoniTR, a project to collate data across the industry to validate the use of circulating tumor DNA (ctDNA) as an early predictor of treatment outcomes, will help further define the emerging potential of ctDNA as a superior method over radiology-based approaches to evaluate early treatment effects of immunotherapy. Molecular response, or reduction in ctDNA, is the primary efficacy endpoint for the Phase 2 portion of the GRANITE trial. GRANITE has the potential to be the first neoantigen-based PCV to demonstrate efficacy in a randomized study against a cold tumor, which would be a transformational advance for the field. We look forward to sharing preliminary Phase 2 efficacy data in frontline MSS-CRC in the first quarter of 2024."

Dr. Allen continued, "Additionally, the promising data we continue to see from our CORAL (SARS-CoV-2 vaccine) program highlights the differentiation and potential advantages of self-amplifying mRNA (samRNA) over current vaccines against infectious diseases. Our recent publication in Nature Communications demonstrates the scientific rigor of our work to date and the ability of our samRNA platform to drive potent and durable immune responses. We believe our samRNA vaccine candidates have demonstrated strong potential to serve as next-generation vaccine solutions to COVID-19 and other infectious diseases."

Corporate Update

In August 2023, Gritstone announced it is partnering with the Friends of Cancer Research (Friends) in support of its ctDNA for Monitoring Treatment Response (ctMoniTR) Project. The ctMoniTR Project is a collaboration between industry, academia and government to provide data to inform the application and adoption of circulating tumor DNA (ctDNA) in drug development. Per the agreement, Gritstone will be providing data to help inform the use of change in ctDNA as an early indicator of long-term clinical benefit in cancer patients.
Clinical Program Updates
Tumor-Specific Neoantigen Oncology Programs
GRANITE – Individualized neoantigen vaccine against cold tumors
SLATE – "Off-the-shelf" neoantigen vaccine program

Enrollment is now complete in the Phase 2 portion of the Phase 2/3 study, which is evaluating GRANITE as a maintenance therapy in first-line metastatic microsatellite-stable colorectal cancer (MSS-CRC). The company has met its target of 100 patients randomized. Preliminary efficacy data on approximately 50 patients who have completed at least 4 months of maintenance treatment is expected in the first quarter of 2024.

Gritstone delivered multiple presentations detailing advances in neoantigen prediction capabilities and cancer vaccine programs at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) (AACR 2023, in April 2023).
GRANITE (individualized neoantigen program) presentation: Longitudinal analysis of participants in the GRANITE Phase 1/2 supports vaccine-elicited priming and boosting of antigen-specific T cell populations associated with conversion of "cold" to "hot" tumors and molecular responses.
EDGE (Epitope Discovery for Genomes Platform) poster: Advances in EDGE models (Gritstone’s AI-driven neoantigen prediction platform) enable potential best-in-class prediction of class II HLA-presented neoantigens that could drive CD4+ T cell responses.
SLATE ("off-the-shelf" neoantigen vaccine program) poster: Description of a novel KRAS G12C class II epitope with evidence of clinical benefit associated with vaccine-elicited T cell response.
The clinical trial collaboration with the National Cancer Institute (NCI) to evaluate an autologous T cell therapy in combination with Gritstone’s KRAS-directed vaccine candidate, SLATE-KRAS, is ongoing. Under the terms of the collaboration, Gritstone will provide the SLATE-KRAS vaccine as requested by NCI. NCI will be responsible for conducting the study.

Gritstone expects to initiate a randomized Phase 2 clinical trial within SLATE ("off-the-shelf" neoantigen vaccine program) in 2024.
Infectious Disease Programs
CORAL – Second-generation SARS-CoV-2 vaccine program that serves as proof-of-concept for Gritstone’s infectious disease approach and the potential application of samRNA in infectious diseases.

In June 2023, interim results from the ongoing CORAL-BOOST study (Phase 1 study evaluating the company’s self-amplifying mRNA (samRNA) vaccine as a boost against COVID-19) were published in Nature Communications. The results demonstrate that Gritstone’s samRNA vaccine candidate boosted immunity for at least 6 months in previously vaccinated older adults and support our initial findings from a separate Phase 1 study in previously unvaccinated subjects (CORAL-CEPI).

In April 2023, Gritstone presented new data from two ongoing Phase 1 studies demonstrating persistence of high neutralizing antibodies for at least 6 months following samRNA vaccine across multiple settings and subject populations. Both datasets were presented at the 33rd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2023).
CORAL-CEPI poster: Results from Part A of the CORAL-CEPI study (total study n = 342), primary series samRNA vaccination shown to elicit strong neutralizing antibody (nAb) responses that persist for at least 6 months, including variant cross-reactive nAb, in previously unvaccinated ("vaccine-naïve") South African subjects. Enrollment in CORAL-CEPI completed in February 2023.

CORAL-BOOST poster: Results from cohorts 3 and 4 of the CORAL-BOOST study showed the samRNA elicited robust nAbs, and that these nAbs persisted for at least 6 months regardless of primary series (adenovirus or mRNA). These results are generally consistent with 6-month neutralizing antibody results from cohorts 1 and 2 of the study, which evaluated samRNA as a boost following Vaxzevria (adenovirus) only (August 2022).

Enrollment in the CORAL-NIH trial completed in 2022. This study is sponsored and executed by NIAID.

Gritstone expects to share additional data from the CORAL-CEPI and CORAL-BOOST studies in Fall 2023.
HIV – Collaboration with Gilead under Gilead’s HIV Cure Program to research and develop vaccine-based HIV immunotherapy treatment.

The collaboration with Gilead to research and develop a vaccine-based HIV immunotherapy treatment remains active and ongoing.
Second Quarter 2023 Financial Results

Cash, cash equivalents, marketable securities and restricted cash were $122.3 million as of June 30, 2023, compared to $185.2 million as of December 31, 2022.

Research and development expenses were $31.0 million for the three months ended June 30, 2023, compared to $27.3 million for the three months ended June 30, 2022. The increase of $3.6 million was primarily due to increases of $1.0 million in personnel-related expenses, $1.0 million in laboratory supplies, and $2.5 million in facilities-related costs, offset by decreases of $0.8 million in outside services, consisting primarily of clinical trial and other chemistry, manufacturing and controls ("CMC") related expenses and $0.1 million in milestone and license payments.

General and administrative expenses were $6.7 million for the three months ended June 30, 2023, compared to $7.8 million for the three months ended June 30, 2022. The decrease of $1.1 million was primarily due to decreases of $1.3 million in outside services and $0.1 million in personnel-related expenses, offset by an increase of $0.3 million in facilities-related costs.

Collaboration, license, and grant revenues were $2.0 million for the three months ended June 30, 2023, compared to $5.5 million for the three months ended June 30, 2022. During the three months ended June 30, 2023, we recorded $0.1 million in collaboration revenue related to the Gilead Collaboration Agreement, $0.3 million in collaboration revenue related to the 2seventy Agreement, $1.1 million in grant revenue from the CEPI Funding Agreement, and $0.5 million in grant revenue from the Gates Foundation.

On August 9, 2023 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Company’s New Drug Application (NDA) for avasopasem manganese (avasopasem) for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer undergoing standard-of-care treatment (Press release, Galera Therapeutics, AUG 9, 2023, View Source [SID1234634072]).

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In the CRL, the FDA communicated that the results from the Phase 3 ROMAN trial together with the supporting data from the GT-201 trial are not sufficiently persuasive to establish substantial evidence of avasopasem’s effectiveness and safety for reducing severe oral mucositis in patients with head and neck cancer. FDA stated that results from an additional clinical trial will be required for resubmission.

The Company intends to request a Type A meeting with the FDA to understand the FDA’s rationale for its decision and discuss next steps to support an NDA resubmission seeking approval of avasopasem. The Company will also explore strategic alternatives, including partnering, for the continued development of avasopasem and rucosopasem.

"This response from the FDA is deeply disappointing for Galera and for patients who suffer from severe oral mucositis," said Mel Sorensen, M.D., Galera’s President and CEO. "We continue to believe in avasopasem’s potential to bring a meaningful benefit to these patients, who currently have no FDA-approved drugs for this debilitating condition."

Restructuring and Financial Update

"As we explore a potential approval path for avasopasem, we are taking decisive actions to extend our cash runway," continued Dr. Sorensen. "Unfortunately, this necessitates reducing our workforce by approximately 70%. We are grateful for the many contributions our talented team has made over the years and their commitment to avasopasem."

Galera’s restructuring plan includes a wind-down of commercial readiness efforts and headcount reductions across several departments. The Company will focus resources to define the path forward for avasopasem and to progress the ongoing clinical trials for rucosopasem. Rucosopasem is the Company’s second product candidate in development to augment the anti-cancer efficacy of stereotactic body radiation therapy (SBRT) for patients with non-small cell lung cancer and locally advanced pancreatic cancer.

"We will continue our focus on completing enrollment of our rucosopasem GRECO trials," continued Dr. Sorensen. "Our GRECO-2 trial is a 220-patient trial in locally advanced pancreatic cancer intended to build upon the positive results observed in our placebo-controlled pilot trial, where we saw meaningful improvements in multiple endpoints including overall survival and tumor outcomes. There is an urgent need for novel therapies to extend survival in patients with pancreatic cancer, and we believe rucosopasem’s unique mechanism of action in combination with SBRT could offer a transformative treatment option."

Galera estimates that its balance of cash, cash equivalents and marketable securities as of June 30, 2023 was $38.8 million. This figure is preliminary and is subject to completion of the Company’s financial closing procedures. The Company plans to file its Quarterly Report on Form 10-Q for the quarter ended June 30, 2023 on August 14, 2023. The Company now expects that its current cash will be sufficient to support operations into the second quarter of 2024.

The NDA submission for avasopasem included data from a total of 678 patients enrolled in two randomized, double-blind, placebo-controlled trials (Phase 3 ROMAN and Phase 2b GT-201). The FDA granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy. The NDA was accepted for priority review, which is granted to applications for therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to available therapies.

Conference Call and Webcast
Galera will host a conference call and live audio webcast tomorrow, August 10, 2023 at 8:30 a.m. ET. The conference call dial-in numbers are (877) 869-3847 (domestic) or +1(201) 689-8261 (international). The live audio webcast of the event will be accessible from the Investors page of Galera’s website, investors.galeratx.com. The webcast replay will be available shortly after conclusion of the event for 90 days.

About Avasopasem
Avasopasem manganese (avasopasem) is a selective dismutase mimetic in development for the reduction of radiotherapy-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) and for the reduction of radiotherapy-induced esophagitis in patients with lung cancer. The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy.

About Rucosopasem
Rucosopasem manganese (rucosopasem) is a next-generation selective dismutase mimetic in development to increase the anti-cancer efficacy of stereotactic body radiation therapy (SBRT), a type of high fraction dose radiotherapy, in patients with non-small cell lung cancer and locally advanced pancreatic cancer. The FDA has granted orphan drug designation to rucosopasem for the treatment of pancreatic cancer.