On October 11, 2022 BridgeBio Pharma, Inc., (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported that the first patient with non-small cell lung cancer (NSCLC) has been dosed in its Phase 1/2 clinical trial of BBP-398, an investigational SHP2 inhibitor, with Amgen Inc.’s (Amgen) LUMAKRAS (sotorasib), the first and only currently approved targeted treatment for patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, in advanced solid tumors with the KRAS G12C mutation (Press release, BridgeBio, OCT 11, 2022, View Source [SID1234621877]).

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Approximately 30,000 people are diagnosed with KRAS G12C-mutated NSCLC in the US each year and the KRAS G12C mutation is one of the most frequent oncogenic mutations in the US and Europe. By combining SHP2 inhibition with KRAS G12C inhibition in patients with the KRAS G12C mutation, there is potential to prevent oncogenesis and overactive cellular proliferation.

"The survival rate following a diagnosis of NSCLC with a KRAS mutation is extremely poor. We are hopeful that by launching this clinical trial with Amgen, we may be able to fill the current gap in unmet medical need for these cancer patients," said Frank McCormick, Ph.D., chairman of oncology at BridgeBio. "We are grateful the FDA has granted our program Fast Track designation and are hopeful it will allow us to address the needs of these patients more quickly following diagnosis."

The Phase 1/2 study will include a dose escalation period followed by dose expansion and optimization, and is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of BBP-398 in combination with LUMAKRAS. The dose escalation period will enroll patients with all solid tumors with a KRAS G12C mutation and participants will be eligible regardless of previous exposure to a KRAS G12C inhibitor. The dose expansion period will enroll patients with NSCLC with a KRAS G12C mutation who have not previously been exposed to a KRAS G12C inhibitor. Initial data is expected by the end of 2024.

Additionally, the US Food and Drug Administration (FDA) granted Fast Track designation for the investigation of BBP-398 in combination with LUMAKRAS for adult patients with previously treated, KRAS G12C-mutated, metastatic NSCLC. The FDA’s Fast Track designation is designed to drive the development and expedite the review process for medicines under investigation for serious conditions with unmet medical needs.

"To date, preclinical data for SHP2 inhibition has shown promise in unlocking possible combination strategies to treat patients suffering from a range of cancers, including NSCLC. By combining SHP2 inhibition with KRAS G12C inhibition, there is potential for this therapeutic arsenal to be impactful for patients since it could prevent overactive cellular proliferation and oncogenesis. I am extremely pleased to see that work from our group and others has now reached the clinic, where we will be able to study the benefit it could have for cancer patients with KRAS G12C mutations," said Benjamin G. Neel, M.D., Ph.D., Co-founder of Navire Pharma Inc. (Navire), a BridgeBio company, and Director of the L/I Perlmutter Cancer Center at NYU Langone and Professor of Medicine at NYU Grossman SoM.1

"People with metastatic NSCLC with a KRAS mutation often do not respond well to standard chemotherapy and immunotherapy options. They might have a worse prognosis than patients without a KRAS mutation and it is essential to deliver better therapeutic options to people with this difficult-to-treat cancer. I am hopeful that by partnering with BridgeBio on this study we may be able to provide substantial relief for patients with a serious unmet need," said Rohit Joshi, M.D., Director for Cancer Research SA (CRSA) and Associate Professor at the University of Adelaide.

In May 2022, BridgeBio entered into an exclusive license agreement with Bristol Myers Squibb to develop and commercialize BBP-398 in oncology worldwide, except for in mainland China and other Asian markets. These territories are part of BridgeBio’s separate strategic collaboration with LianBio announced in 2020. The 2022 agreement with Bristol Myers Squibb expands upon the earlier agreement between the companies signed in 2021 to investigate the combination of BBP-398 with OPDIVO (nivolumab) in patients with advanced solid tumors with KRAS mutations.

BridgeBio has a non-exclusive clinical collaboration with Amgen to evaluate the combination of BBP-398 with LUMAKRAS in patients with advanced solid tumors with the KRAS G12C mutation.

BBP-398, as a monotherapy or in combination with other targeted therapies, could potentially be a promising therapy for patients with the KRAS G12C mutation. Initial Phase 1 data from the ongoing BBP-398 trial is expected in 2023.

OPDIVO (nivolumab) is a trademark of Bristol-Myers Squibb Company.

About BBP-398
BBP-398 is a SHP2 inhibitor that is being developed for difficult-to-treat cancers and was founded through a collaboration with The University of Texas MD Anderson Cancer Center’s Therapeutics Discovery division. SHP2 is a protein-tyrosine phosphatase that links growth factor, cytokine and integrin signaling with the downstream RAS/ERK MAPK pathway to regulate cellular proliferation and survival. In May 2022, BridgeBio entered an exclusive license with Bristol Myers Squibb to develop and commercialize BBP-398, a potentially best-in-class SHP2 inhibitor. Additionally, BridgeBio has a strategic collaboration with LianBio for clinical development and commercialization of BBP-398 in combination with various agents in solid tumors such as non-small cell lung cancer, colorectal and pancreatic cancer, in mainland China and other Asian markets and clinical collaborations; with Bristol Myers Squibb for combination with OPDIVO (nivolumab) in patients with advanced solid tumors with KRAS mutations; and with Amgen for combination with LUMAKRAS (sotorasib), Amgen’s KRAS G12C inhibitor, in patients with advanced solid tumors with KRAS G12C mutations.

On October 11, 2022 Biodesix, Inc. (NASDAQ: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that the Company expects to report third quarter 2022 total revenue to be in the range of $10.6 million to $11.2 million, representing growth of 62% to 71% over the third quarter 2021 (Press release, Biodesix, OCT 11, 2022, View Source [SID1234621876]). The strength in the third quarter 2022 total revenue reflects continued growth in the Company’s core lung diagnostic testing. The financial results included in this release pertaining to the third quarter 2022 are preliminary, subject to completion of internal procedures and review.

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Third Quarter 2022 Financial Highlights

For the three-month period ended September 30, 2022, as compared to the same period of 2021 (where applicable):

Total quarterly revenue estimated to be in the range of $10.6 million to $11.2 million, an increase of $4.1 million to $4.7 million, or 62% to 71%;
Total quarterly lung diagnostic testing revenue estimated to be in the range of $8.9 million to $9.2 million, an increase of $4.4 million to $4.7 million, or 96% to 103%;
Total quarterly COVID diagnostic testing revenue estimated to be in the range of $1.1 million to $1.3 million, an increase of $0.6 million to $0.8 million, or 117% to 157%;
Total quarterly biopharma services revenue estimated to be in the range of $0.6 million to $0.7 million, a decrease of $0.8 million to $0.9 million, or 53% to 60%;
Cash and cash equivalents of $15.2 million as of September 30, 2022.
"We had another strong quarter that builds upon recent momentum and again was highlighted by record revenue and volume growth from our core lung diagnostic testing business," stated Scott Hutton, Chief Executive Officer. "Our lung diagnostic portfolio consists of five Medicare-covered tests to help physicians quickly and confidently decipher the risk of malignancy of a lung nodule and then help guide treatment decisions if a patient has been diagnosed with lung cancer. While we are pleased with our COVID testing results for the quarter, we do not expect any significant continued revenue generation from this testing given the previously disclosed expiration of our contract with the State of Colorado. We continue to be pleased with the interest and ongoing discussions around our BioPharma services although the revenue represents the continued delay in clinical study enrollment and sample shipping logistics impacting timelines for existing and new agreements. At Biodesix we have worked hard to build one of the most comprehensive suites of precision diagnostic tests to support clinical decision-making across the lung cancer continuum and are very pleased with the increased adoption of our tests by physicians to help improve patient care."

The Company expects to be at the high end of the range of its previously disclosed total revenue guidance for 2022 of $37.5 million and $39.5 million. We expect the fourth quarter 2022 to maintain continued growth in our core lung diagnostic business while COVID revenue is expected to decline to an immaterial amount based on current trends in COVID testing.

On October 11, 2022 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, reported that initial safety data from patients who received monotherapy treatment in the Phase 1/2 trial of AU-007 will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting (Press release, Aulos Bioscience, OCT 11, 2022, View Source [SID1234621875]). AU-007 is a monoclonal antibody computationally designed by Biolojic Design that is highly selective for the CD25-binding portion of interleukin-2 (IL-2). The SITC (Free SITC Whitepaper) meeting is being held virtually and in Boston, Massachusetts, from November 8-12, 2022.

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"As the first computationally designed human monoclonal antibody ever to enter a clinical trial, AU-007 offers a novel approach for treating solid tumor cancers by redirecting IL-2, tipping the balance toward immune activation and away from immune suppression and vascular leak," said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. "As we continue to enroll patients in the AU-007 Phase 1/2 study in Australia, we look forward to presenting initial safety results at the SITC (Free SITC Whitepaper) Annual Meeting."

Poster Title: Initial results from dose escalation of a phase 1/2 first-in-human, open label study of AU-007, a monoclonal antibody that binds to IL-2 and prevents its binding to CD25, in patients with solid tumors
Abstract: 775
Date and Time: Thursday, November 10, 2022, 9:00 a.m.-9:00 p.m. EST
Presenter: Jim Vasselli, M.D., Chief Medical Officer, Aulos Bioscience

The poster will be presented in the Poster Hall, Hall C at the Boston Convention and Exhibition Center. It will also be available as an ePoster on display on the SITC (Free SITC Whitepaper) 2022 virtual meeting platform.

About AU-007
AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by T effector cells, from binding to trimeric receptors on T regulatory cells while still allowing IL-2 to bind and expand T effector and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to trimeric receptors on vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

Aulos is evaluating AU-007 in an open label, first-in-human Phase 1/2 clinical trial designed to assess the safety, tolerability, immunogenicity and clinical activity of AU-007 in patients with unresectable locally advanced or metastatic cancer. To learn more about the clinical trial program, visit ClinicalTrials.gov (NCT05267626).

On October 11, 2022 Roche reported that it will publish its Sales Results for the 3rd Quarter of 2022 prior to the opening of the Swiss Stock Exchange on Tuesday, 18 October 2022 (Press release, Hoffmann-La Roche, OCT 11, 2022, View Source [SID1234621874]).

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On October 11, 2022 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, reported the initiation of a Phase 1b/2a trial evaluating bemcentinib in combination with the current standard of care, checkpoint inhibitor pembrolizumab and doublet chemotherapy, for the treatment of 1st line (1L) Non-Small Cell Lung Cancer (NSCLC) patients harboring STK11 mutations (STK11m) (Press release, BerGenBio, OCT 11, 2022, View Source [SID1234621873]).

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"Real-world data continues to reinforce that the presence of STK11m currently result in particularly poor outcomes for NSCLC patients," said Martin Olin, Chief Executive Officer of BerGenBio. "We believe that bemcentinib’s proficiency in blocking AXL overexpression may result in the reversal of an immunosuppressive tumor microenvironment leading to activation of immune response, restoration of sensitivity to immune checkpoint therapy and potentiation of chemotherapy effects in this large, underserved patient population."

Bemcentinib, is a potent, first-in-class highly selective inhibitor of the receptor tyrosine kinase AXL, which is overexpressed in response to cellular stress, inflammation, hypoxia and chemotherapy. STK11 mutations are detected in approximately 20% of non-squamous NSCLC patients and are known to create a more immunosuppressive tumor microenvironment limiting the response to checkpoint inhibition. Preclinical data have demonstrated that by selectively blocking AXL activation, bemcentinib restores sensitivity to immune checkpoint inhibitor therapy, enhances chemotherapy, while also, pertinently, driving the expansion of CD8+ T cells in STK11m models. Early clinical data also point to the activity of bemcentinib in NSCLC patients, including those harboring STK11m.

The global, open-label Phase 1b/2a trial is designed to determine the safety, tolerability and efficacy of bemcentinib with standard of care in untreated advanced/metastatic non-squamous NSCLC patients with STK11 mutations and no actionable mutations. The Phase 1b portion of the study will evaluate the safety and feasibility of bemcentinib in combination with pembrolizumab and doublet chemotherapy in 1L advanced/metastatic non-squamous NSCLC patients, regardless of STK11 status. The Phase 2a expansion part will assess the efficacy of bemcentinib in the same treatment combination in 1L advanced/metastatic non-squamous NSCLC patients with STK11 mutations. The first patient is expected to begin treatment in the fourth quarter of 2022.