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Ionpath Showcases Real-Time Spatial Phenotyping Using MIBI Spatial Proteomics Technology at the Annual Meeting of the Society for Immunotherapy of Cancer

On November 8, 2022 Ionpath, a pioneer in high-definition spatial proteomics, reported that the results of several studies enabled by multiplexed ion beam imaging (MIBI) technology will be presented in posters at this week’s annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, IONpath, NOV 8, 2022, View Source [SID1234623439]). Ionpath will also be featuring a first-of-its-kind data acquisition with real-time spatial phenotyping on the MIBIscope, shared via live feed at its exhibit hall booth (#200). The novel feature is part of the 24-hour sample-to-answer workflow. A demo of the novel AI-powered analysis portion of the workflow will also be available at the booth.

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Ionpath’s MIBI technology system delivers actionable insights of single cells in their complex tissue microenvironment with the throughput and reproducibility required for clinical studies. The MIBI platform is based on highly multiplexed, quantitative protein imaging with unmatched sensitivity and true subcellular resolution. It allows researchers to visualize 40 proteins simultaneously, enabling deep phenotypic profiling and spatial analysis of the tumor microenvironment.

"Across the oncology and immunotherapy communities, many scientists have already produced remarkable new results and insights about disease progression and treatment response with MIBI technology," said Sander Gubbens, PhD, CEO of Ionpath. "We are pleased that SITC (Free SITC Whitepaper) conference attendees will have the opportunity to explore a few of these results in poster presentations and to see our platform in action at our conference booth for a better understanding of how high-definition spatial proteomics can support critical cancer studies."

SITC 2022 Poster Presentations

Poster #89
"Multiplexed Ion Beam Imaging (MIBI) uncovers adaptive immune responses associated with clinical outcomes in oral cavity squamous cell carcinoma treated with neoadjuvant PD-1 inhibitor"
Raghav Padmanabhan, Hannah M. Knochelmann, Monirath Hav, Mate L. Nagy, Peng Si, Sweta Bajaj, Gregory B. Lesinski, David Neskey, and Chrystal M. Paulos

Poster #1292
"A reproducible pipeline for analysis of multiplex imaging (MIBI) data with application to uncovering novel features of the tumor-immune microenvironment"
Jessica Maxey, Marshall A. Thompson, Katie Campbell, Benjamin Kamphaus, Zaid Bustami, Sandra Santulli-Marotto, Daniel Wells, Silvia Boffo, Lisa M. Salvador, Philip O. Scumpia, Christine N. Spencer, Adam Schoenfeld, Antoni Ribas, and Lacey J. Kitch

Poster #1294
"An Automated Machine Learning Framework for Rapid Quantification and Analysis of Multiplexed Ion Beam Images (MIBI)"
Raghav Padmanabhan, Mate L. Nagy, Stanislaw Nowak, Peng Si, Sweta Bajaj, and Monirath Hav

Poster #1446
Multiplexed ion beam imaging identifies B-cell enrichment in the RHAMM-high invasive niche of breast cancer
Yuyu He, Grant M. Barthel, Raghav Padmanabhan, Colleen Forster, Hanna Root, Mate L. Nagy, Stanislaw Nowak, James B. McCarthy, Kathryn L. Schwertfeger, and Andrew C. Nelson

Turnstone Biologics to Present Preclinical Data From Novel TIL Therapy Demonstrating Tumor-Reactive T-Cell Selection at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting

On November 8, 2022 Turnstone Biologics Corp, a clinical-stage biotechnology company developing next-generation immunotherapies to treat and cure solid tumors, reported that two posters showing preclinical data from the Company’s novel tumor-infiltrating lymphocyte (TIL) therapy will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting, being held in Boston, Massachusetts, November 8-12, 2022 (Press release, Turnstone Biologics, NOV 8, 2022, View Source [SID1234623438]).

The posters, one of which is to be presented in collaboration with Moffitt Cancer Center, will showcase data demonstrating the successful expansion and enrichment of tumor-reactive TILs from colorectal cancer tumor samples, providing support for the application of TIDAL-01 as a therapy for solid tumors. TIDAL-01, Turnstone’s lead TIL therapy candidate, focuses on selecting and manufacturing the most potent tumor-reactive T-cells (Selected TILs) to overcome the limitations of current TIL-based therapies.

"Over the years, we have witnessed remarkable durable responses in a limited number of solid tumor types following treatment with TILs," said Stewart Abbot, Ph.D., Chief Scientific Officer, Turnstone Biologics. "Our preclinical datasets demonstrate greater promise for our Selected TILs compared to conventional TIL-based therapies to target a broader range of solid tumors. With our recently accepted INDs for TIDAL-01, we are eager to translate these promising results into the clinic, including through our strategic alliance with Moffitt."

Fusion Pharmaceuticals Announces Third Quarter 2022 Financial Results and Clinical Program Updates

On November 8, 2022 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported financial results for the third quarter ended September 30, 2022 and provided an update on clinical and corporate developments (Press release, Fusion Pharmaceuticals, NOV 8, 2022, View Source [SID1234623436]).

Chief Executive Officer John Valliant, Ph.D. commented, "During the third quarter of 2022, we continued to advance our pipeline of targeted alpha therapy programs to treat multiple cancer types not currently addressed by available radiopharmaceutical therapies. Leveraging our platform and radiopharmaceutical expertise, we now have three Phase 1 clinical programs. Our lead program, FPI-1434, remains on track to report Phase 1 data in the first half of 2023. Following the initiation of dosing in our Phase 1/2 study of FPI-1966, we have opened multiple study sites and are actively recruiting patients with FGFR3-expressing solid tumors. We also continue to make progress in our newest clinical program, FPI-2059, which, based on clinical imaging and preclinical data, we believe has the potential to precisely target and kill tumor cells in colorectal, pancreatic and neuroendocrine prostate cancers. Furthermore, we’ve demonstrated Fusion’s proficiency in targeted alpha therapy (TAT) development with the first candidate under our collaboration agreement with AstraZeneca moving promptly through investigational new drug (IND) enabling studies. Our rich pipeline of cancer therapies is underpinned by an experienced internal radiopharmaceutical R&D team, and early investments in actinium supply, bolstered by our manufacturing capabilities. We look forward to providing meaningful updates on our diverse and growing pipeline of TATs in the months ahead."

Portfolio Update

FPI-1434

In the Phase 1 study, Fusion is exploring various dose levels of FPI-1434 as well as two dosing regimens: one with FPI-1434 alone, and another in which a small dose of cold antibody (naked IGF-1R antibody without the isotope) is administered prior to each dose of FPI-1434. The Company anticipates reporting Phase 1 safety, pharmacokinetics, and imaging data, including any evidence of anti-tumor activity, and details on the dosing regimen, in the first half of 2023. Fusion continues to anticipate the initiation of a Phase 1 combination study with FPI-1434 and KEYTRUDA (pembrolizumab) to occur six to nine months following determination of the recommended Phase 2 dose of FPI-1434 monotherapy.

FPI-1966

The Phase 1, non-randomized, open-label clinical trial of FPI-1966 in patients with solid tumors expressing FGFR3 is intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose. Patient enrollment and dosing is ongoing. The company plans to provide updated guidance for preliminary pharmacokinetic, imaging and safety data from the first patient cohort following experience with patient screening in order to better predict the cadence of patient enrollment.

FPI-2059

FPI-2059 is a small molecule radioconjugate in development as a targeted alpha therapy for various solid tumors, including neuroendocrine differentiated (NED) prostate, colorectal, and pancreatic cancers. The molecule targets neurotensin receptor 1 (NTSR1), a promising target for cancer treatment, which is overexpressed in several solid tumors. FPI-2059 is based upon Ipsen’s IPN-1087 (previously studied in a Phase 1 clinical trial as a beta-emitting radiopharmaceutical), which Fusion acquired in 2021, and converted to an alpha-emitting radiopharmaceutical using actinium-225.

The U.S. Food and Drug Administration (FDA) cleared Fusion’s IND application for FPI-2059 in June 2022 and study initiation activities are ongoing in a Phase 1, non-randomized, open-label clinical trial in patients with solid tumors expressing NTSR1, intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose. Fusion plans to provide guidance on timelines for the FPI-2059 program following site activations and initial experience with patient screening and patient enrollment.

Recent Updates

In August, Fusion announced first patient dosed in Phase 1/2 study of FPI-1966 in patients with advanced solid tumors expressing FGFR3. The Phase 1/2 multi-center, open-label clinical trial is designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics of FPI-1966 in patients with FGFR3-expressing advanced, inoperable, metastatic, and/or recurrent solid tumors. The study employs a 3 + 3 dose escalation design to evaluate multiple ascending doses of FPI-1966. The first cohort will comprise sub-groups in which various doses of non-radiolabeled vofatamab ("cold antibody") will be evaluated to assess the impact of pre-dosing on tumor uptake and pharmacokinetics. As part of the trial, patients will be administered an imaging analogue of FPI-1966, FPI-1967, and only those who upon imaging meet predefined tumor uptake will go on to receive FPI-1966. The Phase 2 portion of the study will consist of two tumor-specific cohorts and one basket cohort.
In September, Fusion drew down $25 million under the previously announced debt agreement with Oxford Finance LLC. To date, the Company has drawn down a total of $35 million. The loan agreement, as amended, provides for up to four tranches totaling $75 million. With the additional $25 million in debt funding, Fusion now expects its cash, cash equivalents and investments will be sufficient to fund operations into the third quarter of 2024.
On November 7, Fusion announced the appointment of Dmitri Bobilev, M.D., as chief medical officer. Dr. Bobilev joins Fusion from Checkmate Pharma, where he was vice president, head of clinical development until the company’s acquisition by Regeneron earlier in 2022. At Checkmate, he was responsible for clinical development and registration strategy for vidutolimod.
Third Quarter 2022 Financial Results

Cash and Investments: As of September 30, 2022, Fusion held cash, cash equivalents and investments of $205.5 million, compared to cash, cash equivalents and investments of $220.8 million as of December 31, 2021. Fusion expects its existing cash, cash equivalents and investments as of September 30, 2022, will be sufficient to fund operations into the third quarter of 2024.
Collaboration Revenue: For the third quarter of 2022, Fusion recorded $0.2 million of revenue under the AstraZeneca collaboration agreement.
R&D Expenses: Research and development expenses for the third quarter of 2022 were $16.6 million, compared to $12.7 million for the same period in 2021. The increase was primarily due to discrete items that occurred during the third quarter of 2022, including a common share issuance and cash payment pursuant to our asset purchase agreement to acquire vofatamab from Rainier Therapeutics. Additionally, there was an increase in direct costs related to FPI-2059, specifically related to the initiation of the Phase 1 clinical trial as well as preclinical research and manufacturing costs.
G&A Expenses: General and administrative expenses for the third quarter of 2022 were $7.4 million, compared to $7.2 million for the same period in 2021. The increase was primarily due to an increase in personnel-related costs, partially offset by a decrease in corporate costs and professional fees.
Net Loss: For the third quarter of 2022, Fusion reported a net loss of $24.0 million, or $0.55 per share, compared with a net loss of $19.4 million, or $0.45 per share, for the same period in 2021.

Corbus Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Corporate Update

On November 8, 2022 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), an oncology company, today provided a corporate update and reported financial results for the third quarter of 2022 (Press release, Corbus Pharmaceuticals, NOV 8, 2022, View Source [SID1234623435]).

Key Corporate and Program Updates:

Anti-integrin monoclonal antibody (mAb) programs targeting the inhibition of TGFβ are progressing on schedule
CRB-601, an anti-αvβ8 mAb, is being developed as a potential treatment for solid tumors.
Across models explored to-date, CRB-601 demonstrates an enhancement of anti-tumor activity when combined with anti PD-1 therapy compared to either single agent alone. Latest data to be presented this Thursday at SITC (Free SITC Whitepaper) 2022.
Data supports the hypothesis that blockade of latent TGFb production by CRB-601 can lead to changes in immune cell infiltration in the tumor microenvironment, potentially enhancing the benefit of PD-1 blockade.
IND-enabling activities for CRB-601 are ongoing and the program is on schedule for an IND submission in mid-2023.
Recent clinical updates from investigational therapies also targeting latent TGFb reinforce the promise of this novel approach in oncology.
CB1 inverse agonist program for obesity / metabolism
CRB-913, a novel CB1 inverse agonist with highly differentiated PK from other members of its class, has demonstrated weight loss and improvement in multiple metabolic parameters, as monotherapy and in combination within liraglutide, semaglutide and tirzepatide in animal models of diet-induced obesity.
New data was shared in an oral presentation at the annual meeting of the European Association for the Study of Diabetes (EASD) in September 2022. View the presentation here.
Data is being prepared for publication.
Corbus is actively exploring partnerships to advance CRB-913 into clinical studies.
A detailed update on the Corbus pipeline can be found in the most recent Corporate Presentation available on the Company’s website here.
"We continue to progress CRB-601 toward the clinic on schedule and on budget. Our latest pre-clinical data, to be presented this Thursday at SITC (Free SITC Whitepaper) 2022, further reinforces our belief that this could be a highly impactful drug in oncology therapy, and we look forward to the latest clinical updates from this field," commented Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. "We continue to be actively engaged in business development activities with the goal of expanding our pipeline while also bringing in non-dilutive funding by monetizing our portfolio of endocannabinoid assets through new partnerships."

Financial Results for Third Quarter Ended September 30, 2022:

The Company reported a net loss of approximately $8.8 million, or a net loss per diluted share of $0.07, for the three months ended September 30, 2022, compared to a net loss of approximately $2.2 million, or a net loss per diluted share of $0.02, for the same period in 2021. The prior year third quarter included a $12.3 million refundable tax credit received from a foreign tax authority.

Operating expenses for Q3 2022 decreased by $5.8 million to approximately $8.2 million for the three months ended September 30, 2022, compared to $14.0 million in the comparable period in the prior year. The decrease was primarily attributable to decreased clinical trial and drug manufacturing costs, and an overall reduction in compensation expense.

In October of 2022, the Company amended its debt agreement with K2 HealthVentures LLC to defer commencement of principal payments by one year until September 2023 which improved the Company’s liquidity and cash runway. As of September 30, 2022, the Company has $67 million of cash and investments on hand which is expected to fund operations through the second quarter of 2024, based on the current planned expenditures.

Mirati Therapeutics Reports Third Quarter 2022 Financial Results and Recent Corporate Updates

On November 8, 2022 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results for the third quarter of 2022 and recent corporate updates (Press release, Mirati, NOV 8, 2022, https://www.prnewswire.com/news-releases/mirati-therapeutics-reports-third-quarter-2022-financial-results-and-recent-corporate-updates-301672203.html [SID1234623434]).

"In the third quarter, we made notable advancements within our targeted oncology portfolio, while executing on strategic priorities to position Mirati for continued success," said David Meek, chief executive officer, Mirati Therapeutics, Inc. "The fourth quarter includes several exciting milestones for Mirati, including our anticipated Prescription Drug User Fee Act (PDUFA) date for adagrasib, which we are prepared to launch upon approval, the release of topline interim data for our phase 3 SAPPHIRE study, and an expected update on our KRYSTAL-7 first-line non-small cell lung cancer (NSCLC) study in combination with pembrolizumab. We continue to advance our pipeline and capabilities, further enabling Mirati to transform the lives of people living with cancer."

"Additionally, as we shared earlier today, we are thrilled to celebrate the successful career of Dr. Chuck Baum, Mirati’s founder, president and head of research and development, who will retire in the second quarter of 2023. Chuck helped build Mirati into a leading targeted oncology company based on a dedication to patients and we are grateful for his leadership," continued Meek. "We are also excited to welcome Dr. Alan Sandler, our new chief medical officer (CMO) who brings a tremendous amount of experience and expertise to the team."

Pipeline Updates
Adagrasib (Potent and selective KRASG12C inhibitor)

PDUFA action date of December 14, 2022 as a treatment for patients with NSCLC harboring a KRASG12C mutation who have received at least one prior systemic therapy

Presented late-breaking data from the Phase 1/2 cohort of the KRYSTAL-1 study evaluating adagrasib with or without cetuximab in patients with advanced CRC harboring a KRASG12C mutation at the 2022 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. (View Release)

Announced the Company entered into a clinical collaboration with Aadi Bioscience to evaluate the combination of adagrasib and nab-sirolimus, an mTOR inhibitor complexed with human albumin, in KRASG12C-mutant NSCLC and other solid tumors. (View Release)

Announced the Company entered into a clinical trial collaboration and supply agreement with Incyte to evaluate the combination of adagrasib and INCB099280, an oral PD1 inhibitor, in patients with KRASG12C-mutant solid tumors. (View Release)

Shared plans to present preliminary safety and efficacy results from the KRYSTAL-7 study evaluating adagrasib in combination with pembrolizumab in patients with advanced NSCLC harboring a KRASG12C mutation at a medical meeting in December.
Sitravatinib (Potent TAM receptor inhibitor)

The Company expects to provide topline results from the interim analysis of the global, registration-enabling Phase 3 SAPPHIRE study evaluating sitravatinib plus nivolumab (OPDIVO)1 in second or third line non-squamous NSCLC in the fourth quarter of 2022.
MRTX1719 (MTA cooperative PRMT5 inhibitor)

In August 2022, the Food and Drug Administration (FDA) granted Fast Track designation to MRTX1719, an MTA cooperative PRMT5 inhibitor, in MTAP-deleted cancers. The Company is enrolling in an ongoing Phase 1/2 clinical trial in patients whose tumors harbor an MTAP deletion. The Company expects to share the initial clinical data for this program in 2023.
MRTX0902 (Potent SOS1 inhibitor)

In August 2022, the FDA cleared the Investigational New Drug (IND) application for MRTX0902, a selective SOS1 inhibitor. The Company recently initiated a Phase 1 clinical study.
MRTX1133 (Potent and selective KRASG12D inhibitor)

The Company plans to file an IND application for this program by year-end 2022.
Recent Corporate Updates
Announced the appointment of Alan Sandler, M.D., as CMO and the planned retirement of Charles Baum, M.D., Ph.D., president, founder and head of research and development in the second quarter of 2023. Dr. Baum remains on the Mirati board of directors. (View Release)
Third Quarter 2022 Financial Results
Cash, cash equivalents, and short-term investments of approximately $1.2 billion as of September 30, 2022.

Sold approximately 1.9 million shares of common stock under its At the Market Facility, which generated net proceeds of $155.0 million.

Revenue for the third quarter of 2022 was $5.4 million, which was driven by the recognition of a $5 million milestone payment from Zai Lab that was contingent on starting a pivotal clinical study for adagrasib in a second indication in the Zai Lab designated territories. This compares to revenue of $71.8 million in third quarter of 2021, where we recognized $66.6 million of revenue associated with the transfer of the license and know-how of adagrasib as part of our agreement with Zai Lab, and a $5 million milestone payment from BeiGene, associated with the start of the first pivotal sitravatinib clinical study in the BeiGene designated territories.

Research and development expenses for the third quarter of 2022 were $131.1 million, compared to $116.1 million for the same period in 2021. Research and development expenses for the nine months ended September 30, 2022 were $390.4 million, compared to $354.8 million for the same periods in 2021. The increases were primarily related to an increase in headcount-related costs, including share-based compensation and salaries, due to the growth of our portfolio, offset by a decrease in manufacturing costs that occurred after our 2021 NDA filing for the adagrasib program. The Company recognized research and development-related share-based compensation expenses of $28.3 million during the third quarter of 2022, compared to $15.7 million for the same period in 2021, and $77.3 million during the nine months ended September 30, 2022, compared to $46.7 million for the same period in 2021.

General and administrative expenses for the third quarter of 2022 were $60.8 million, compared to $35.2 million for the same period in 2021. General and administrative expenses for the nine months ended September 30, 2022 were $169.0 million, compared to $93.1 million for the same period in 2021. The increases were primarily due to an increase in commercial readiness costs, including increases in headcount-related costs, as we prepare for a potential product launch. The Company recognized general and administrative-related share-based compensation expenses of $14.7 million in the third quarter of 2022, compared to $11.2 million for the same period in 2021, and $47.2 million during the nine months ended September 30, 2022, compared to $32.9 million for the same period in 2021.

Net loss for the third quarter of 2022 was $173.6 million, or $3.09 per share basic and diluted, compared to a net loss of $80.1 million, or $1.55 per share basic and diluted for the same period in 2021. Net loss for the nine months ended September 30, 2022 was $538.4 million, or $9.66 per share basic and diluted, compared to a net loss of $382.2 million, or $7.45 per share basic and diluted for the same period in 2021.
Conference Call Information
There will be a conference call on November 8, 2022 at 4:30 p.m. ET / 1:30 p.m. PT during which company executives will review financial information for the third quarter of 2022 and provide corporate updates.

Investors and the general public are invited to listen to a live webcast of the call at the "Investors and Media" section on Mirati.com or by dialing the U.S. toll free +1 773-305-6853 or international +1 866-409-1555, confirmation code: 8269398.

A replay of the call will be available approximately 2 hours after the event has ended at the same website.