On August 9, 2022 Bridge Biotherapeutics (KQ288330), a South Korean clinical-stage biotechnology company focused on developing novel drugs for cancer, fibrosis and inflammation, reported that promising interim clinical data from its Phase I study of BBT-176, a fourth-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) (Press release, Bridge Biotherapeutics, AUG 9, 2022, View Source [SID1234617968]). The data, presented at the International Association for the Study of Lung Cancer 2022 World Conference on Lung Cancer (IASLC WCLC 2022), show promising early evidence of efficacy and favorable tolerability in patients with non-small cell lung cancer (NSCLC).

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The oral presentation delivered by Sun Min Lim, M.D., Ph.D., assistant professor at Yonsei University College of Medicine, discussed the correlation between molecular response and radiologic response in patient participants in the study. One patient with advanced NSCLC showing C797S triple mutations, confirmed as one of the partial response (PR) cases, showed up to 53 percent decrease of EGFR mutant allele frequency compared to the baseline. Data from the five patients who had been treated with BBT-176 over 100 days suggested that circulating tumor DNA (ctDNA) analysis enabled with liquid biopsy may be useful not only in identifying those most likely to benefit from fourth-generation EGFR TKI treatments such BBT-176, but also monitoring therapeutic response with treatment of a fourth-generation EGFR TKI.

The study also confirmed the preliminary efficacy of BBT-176 in treating advanced NSCLC patients harboring an EGFR mutation who had previously been treated with at least one EGFR TKI. Adverse events were primarily low grade, with GI toxicities and skin rash being most common, necessitating dose modifications in some patients. The pharmacokinetic profile of BBT-176 was shown to be dose-proportional in the study.

As the study continues, investigators will explore the recommended Phase 2 dose (RP2D) based on the overall safety, efficacy and tolerability information collected. Upon determination of the RP2D, investigators are expected to initiate the Phase 2 study next year.

Session and Presentation Information
Title: BBT-176, a 4th-generation EGFR TKI, for Progressed NSCLC after EGFR TKI Therapy: PK, Safety and Preliminary Efficacy from Phase 1 Study
Session Title: Overcoming Resistance to EGFR Inhibitors
Session Number: MA07.09
Presentation Session: August 8, 2022, 12:52 pm CET
Presenting Author: Sun Min Lim, M.D., Ph.D., Yonsei University College of Medicine
Session Discussant: Pasi A. Jänne, M.D., Ph.D., Dana-Farber Cancer Institute

On August 9, 2022 Catalent, Inc. (NYSE: CTLT), the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, reported that it has reached an agreement to acquire Metrics Contract Services (Metrics), a full-service specialty Contract Development and Manufacturing Organization (CDMO) with a facility in Greenville, North Carolina, for $475 million from Mayne Pharma Group Limited (ASX: MYX) (Mayne Pharma) (Press release, Catalent, AUG 9, 2022, View Source [SID1234617965]). Upon completion, the acquisition will strengthen Catalent’s capabilities in integrated oral solid formulation development, manufacturing, and packaging to help customers simplify and accelerate their programs, while also expanding Catalent’s capacity to handle highly potent compounds.

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The 333,000 square-foot Greenville facility features comprehensive capabilities to accelerate and de-risk customer programs from early development through commercial launch through a streamlined one-site solution. Over the past five years, the facility has seen more than $100 million in capital improvements and now includes 16 manufacturing suites, with 11 designed to handle highly potent compounds, as well as two packaging lines that can support a large variety of development and commercial supply programs. The facility’s estimated annual production capacity exceeds one billion oral solid dose units.

"This acquisition will further expand Catalent’s ability to meet our customers’ expectations in fast-growing areas of the business and patient need. The experienced team and consistently improved, state-of-the-art facility in Greenville will provide Catalent’s customers with immediate, fit-for-scale capacity for in-demand highly potent drugs and other oral solid small-to-mid-size batch needs. This capacity is particularly important for customers with R&D pipelines featuring accelerated, orphan, and rare disease programs for oncology and other important therapeutic areas," said Dr. Aris Gennadios, Group President of Catalent’s Pharma & Consumer Health segment.

"Over the past several years, Metrics has undergone a period of transformational change to expand its footprint and service offering, becoming a global end-to-end novel oral solid CDMO. Catalent, a global leader in advanced drug development and manufacturing, is well-positioned to continue to invest in and accelerate the growth of Metrics and we believe this transaction will be extremely positive for our Greenville team and customers," said Scott Richards, Chief Executive Officer of Mayne Pharma.

The new facility will seamlessly integrate into Catalent’s industry-leading oral development and manufacturing network, which includes flagship sites for large-scale and controlled release oral solids manufacturing in Winchester, Kentucky; softgel development and manufacturing in St. Petersburg, Florida; and additional facilities with bioavailability enhancement technologies and complex oral solids manufacturing platforms.

The acquisition is expected to close before the end of this calendar year, subject to customary closing conditions, and the entire team of over 400 employees will join Catalent. Mayne Pharma and Catalent have also agreed on the terms of a long-term supply agreement whereby the Greenville facility will continue to manufacture multiple Mayne Pharma products. Catalent will pay the purchase price for this all-cash acquisition using a combination of cash on hand, existing credit facilities, and, depending on market conditions, potentially new debt financing. The closing of the acquisition is not contingent on any financing activity.

On August 9, 2022 HCA Healthcare, Inc. (NYSE: HCA), one of the nation’s leading healthcare providers, reported that it will collaborate with Johnson & Johnson to address key healthcare industry issues (Press release, Johnson & Johnson, AUG 9, 2022, View Source [SID1234617964]).

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The two leading healthcare companies initially will focus on improving health equity, enhancing nursing support, and improving patient outcomes:

HCA Healthcare and Johnson & Johnson will collaborate on a scalable program to improve health outcomes through early-stage lung cancer detection for the Black community. Lung cancer is the number one cause of cancer death among Black patients1, and the two companies will begin to work together on a pilot program in the coming months to increase early identification.
HCA Healthcare, which has more than 93,000 nurses in its system, and Johnson & Johnson have a long-standing commitment to advocating for and supporting nurses. The two healthcare leaders will work together to incorporate Johnson & Johnson’s nursing resources within HCA Healthcare and its affiliate Galen College of Nursing. The companies will work together on health equity issues focused on educational programming, training and other programs that elevate and support nurses with a goal of enriching the nursing experience and skillsets and improving patient outcomes.
HCA Healthcare, through its HCA Healthcare Research Institute, and Johnson & Johnson will collaborate on cardiovascular health initiatives including a retrospective analysis of patients who suffer from heart arrhythmia, as well as research to understand the role digital health technology plays in impacting clinical outcomes for patients with Coronary Artery Disease (CAD) and Peripheral Artery Disease (PAD) diseases.
"HCA Healthcare and Johnson & Johnson have had a long and productive relationship, and both companies have worked very hard to address many of our country’s healthcare challenges," said Sam Hazen, chief executive officer of HCA Healthcare. "We believe strongly in the power of strategic partnerships, and we are excited to collaborate to advance health equity, enhance patient care and provide even greater support to our nurses."

"No one company can solve society’s most pressing health challenges alone — it takes collaboration," said Joaquin Duato, chief executive officer of Johnson & Johnson. "That’s why we’re working with HCA Healthcare to improve patient access and outcomes, address the nursing crisis, and advance health equity. We are united in our focus to improve patient care."

HCA Healthcare uses data from more than 35 million annual patient encounters to continually improve care. In addition, with more than 93,000 Registered Nurses (RN), HCA Healthcare is one of the country’s top employers of RNs and invests significantly in nurses and nursing through education and professional development, equipment and technology, resources to promote their physical and emotional wellbeing, and representation at every level of the organization from the bedside to senior leadership.

On August 9, 2022 BioMarker Strategies reported that the journal CANCER BIOTHERAPY AND RADIOPHARMACEUTICALS has published a manuscript by the Company’s scientists entitled "Functional Profiling of Head and Neck/Esophageal Squamous Cell Carcinoma to Predict Cetuximab Response" (Press release, BioMarker Strategies, AUG 9, 2022, View Source [SID1234617963]). The manuscript describes the company’s progress in identifying predictive dynamic biomarkers to help identify the subset of patients with head and neck/esophageal squamous cell carcinoma (SCC) who may benefit from treatment with cetuximab (Erbitux) and biosimilars.

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Cetuximab is an antibody that targets an epidermal growth factor receptor (EGFR), and remains the only targeted therapy approved by the U.S. Food and Drug Administration (FDA) for SCC of head and neck/esophagus. For primary SCC, cetuximab is approved for use in combination with radiation. In metastatic SCC, it is approved for use in combination with platinum chemotherapy and fluorouracil.

The authors note that responses to cetuximab can be dramatic, but the response rate was only about 15% in the landmark clinical trial. The authors also note that cetuximab therapy is accompanied by a risk of serious adverse events that results in interrupted therapy in 3%-10% of patients. The cost of treatment is approximately $100,000 per patient. Additionally, immune checkpoint inhibitors are now an option in SCC. Therefore, methods to identify patients who are most likely to respond to cetuximab are needed.

SCC is the world’s sixth most common cancer. Worldwide, there are approximately 900,000 new cases and 450,000 deaths per year. In the United States alone there are approximately 66,630 new cases and 14,620 deaths per year.

"To minimize risk and maximize the therapeutic benefit of cetuximab, predictive tests to better identify patients likely to be responsive to cetuximab therapy are clearly an important need," said Jerry Parrott, President and CEO of BioMarker Strategies. "From my perspective, based on the results reported here, I would agree with the authors that further studies are warranted to test in more complex samples, including patient-derived tumor tissues."

The research described in the manuscript discussed here was supported by a Small Business Innovation Research (SBIR) award from the National Cancer Institute (NCI) of the National Institutes of Health (NIH).

On August 9, 2022 AbCellera (Nasdaq: ABCL), a technology company with a centralized operating system for next-generation antibody discovery, reported financial results for the second quarter of 2022 (Press release, AbCellera, AUG 9, 2022, View Source [SID1234617962]). All financial information in this press release is reported in U.S. dollars, unless otherwise indicated.

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"We have further strengthened our balance sheet as we execute on our strategy, extending our competitive advantage in antibody discovery and creating value through partnerships," said Carl Hansen, Ph.D., CEO and President of AbCellera. "We continue to invest in technology development, including advancements in our CD3 bispecific platform for creating optimal T-cell-engager therapies for cancer, which we believe will create significant value for patients, our partners, and our shareholders."

Q2 2022 Business Summary

Earned $46 million in total revenue.
Incurred net loss of $7 million, compared to a net loss of $2 million in Q2 2021.
Added six programs under contract with two new partners, resulting in a cumulative total of 164 programs under contract with 38 different partners.
Started discovery on four programs, bringing the cumulative number of program starts to 88.
Continuing to report six molecules cumulatively advanced to the clinic.
Key Business Metrics

AbCellera added six discovery programs in Q2 to reach a cumulative total of 164 discovery programs as of June 30, 2022 (up from 138 on June 30, 2021), that are either completed, in progress, or under contract with 38 different partners (up from 33 on June 30, 2021). AbCellera started discovery on an additional four programs in Q2 to reach a cumulative total of 88 program starts (up from 60 on June 30, 2021). AbCellera’s partners have advanced a cumulative total of six molecules into the clinic.

Discussion of Q2 2022 Financial Results

Revenue – Total revenue was $45.9 million, compared to $27.6 million in Q2 2021. Royalties associated with bebtelovimab were $33.2 million. The partnership business produced research fees of $12.5 million, compared to $5.2 million in Q2 2021. Licensing revenue was $0.1 million.
Research & Development (R&D) Expenses – R&D expenses were $26.7 million, compared to $15.0 million in Q2 2021, reflecting continuing investments in the capacity and capabilities of AbCellera’s discovery and development platform.
Sales & Marketing (S&M) Expenses – S&M expenses were $3.1 million, compared to $1.3 million in Q2 2021.
General & Administrative (G&A) Expenses – G&A expenses were $14.4 million, compared to $11.2 million in Q2 2021, with the increase driven by investments to support the growth of the company.
Net Loss – Net loss was $6.8 million, or ($0.02) per share on both a basic and diluted basis compared to a net loss of $2.3 million, or ($0.01) per share on a basic and diluted basis in Q2 2021.
Liquidity – $1,022 million of cash, cash equivalents, and marketable securities.
Conference Call and Webcast

AbCellera will host a conference call and live webcast to discuss these results today at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time).

The live webcast of the earnings conference call can be accessed on the Events and Presentations section of AbCellera’s Investor Relations website. A replay of the webcast will be available through the same link following the conference call.