On November 16, 2022 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported positive topline results from the Phase 3 SPOTLIGHT clinical trial evaluating the efficacy and safety of zolbetuximab in combination with mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil) (Press release, Astellas Pharma, NOV 16, 2022, View Source [SID1234624177]). Zolbetuximab is an investigational first-in-class monoclonal antibody targeting Claudin 18.2 (CLDN18.2), for the first-line treatment of patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

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The SPOTLIGHT trial enrolled 566 patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. The study met its primary endpoint showing statistical significance in progression-free survival (PFS) for patients treated with zolbetuximab plus mFOLFOX6 compared to placebo plus mFOLFOX6. In addition, the study met a secondary endpoint, overall survival (OS), showing statistical significance for patients treated with zolbetuximab plus mFOLFOX6 compared to placebo plus mFOLFOX6. The most frequent treatment-emergent adverse events (TEAEs) in patients treated with zolbetuximab plus mFOLFOX6 were nausea, vomiting, and decreased appetite. Detailed results will be presented at a future scientific congress and submitted for publication.

"I am excited by the potential for a new treatment option to help patients with advanced-stage gastric cancer or GEJ cancer," said Kohei Shitara, MD, Primary Investigator for the SPOTLIGHT trial and Chief, Department of Gastrointestinal Oncology, the National Cancer Center Hospital East in Kashiwa, Japan. "Gastric and GEJ cancers still have very limited treatment options available for patients with an advanced diagnosis."

"We’re delighted and excited about the positive topline results from the SPOTLIGHT trial of zolbetuximab in combination with mFOLFOX6, and we have increased confidence in advancing development of zolbetuximab for the first-line treatment of patients with locally advanced or metastatic gastric cancer," said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas. "These topline results further support the role of CLDN18.2 as an emerging biomarker in gastric and GEJ cancer. We look forward to presenting the full results at a scientific congress in the near future."

Zolbetuximab acts by binding to CLDN18.2 on the cancer cell surface of gastric epithelial cells. In pre-clinical studies, this binding interaction then induces cancer cell death by activating two distinct immune system pathways — antibody-dependent cellular toxicity and complement-dependent cytotoxicity.1 CLDN18.2 is a type of transmembrane protein found in normal gastric cells and is a major component of epithelial and endothelial tight junctions controlling the flow of molecules between cells.2 Pre-clinical studies have shown that CLDN18.2, which can also be present in gastric tumors, may become more exposed and accessible to targeted therapies with antibodies as gastric tumors develop.3,4,5 Based on this study, approximately 38% of screened patients have CLDN18.2-positive tumors, defined as CLDN18.2 expression in ≥75% of tumor cells with strong-to-moderate staining intensity based on a validated immunohistochemistry assay.6

The Phase 3 SPOTLIGHT trial is a global, multi-center, double-blind, randomized study assessing the efficacy and safety of zolbetuximab plus mFOLFOX6 compared to placebo plus mFOLFOX6. Specifically, this study and the Phase 3 GLOW trial, which is evaluating the efficacy and safety of zolbetuximab plus capecitabine and oxaliplatin (CAPOX) compared to placebo plus CAPOX, are being conducted to provide foundational data for regulatory submissions in the U.S., Europe, Asia and other countries globally.

Gastric cancer is often diagnosed in the advanced or metastatic stage, or once it has spread from the tumor’s origin to other body tissues or organs.7 The five-year relative survival rate for patients at the metastatic stage is approximately six percent.8

About Zolbetuximab
Zolbetuximab is an investigational, first-in-class chimeric IgG1 monoclonal antibody (mAb) that targets and binds to CLDN18.2, a transmembrane protein. Zolbetuximab acts by binding to CLDN18.2 on the cancer cell surface of gastric epithelial cells. In pre-clinical studies, this binding interaction then induces cancer cell death by activating two distinct immune system pathways — antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).1 The safety and efficacy of zolbetuximab are under investigation in gastric, gastroesophageal and pancreatic cancers and have not been established. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated.

About SPOTLIGHT Phase 3 Clinical Trial
SPOTLIGHT is a Phase 3, global, multi-center, double-blind, randomized study, assessing the efficacy and safety of zolbetuximab (IMAB362) plus mFOLFOX6 (combination regimen of oxaliplatin, leucovorin and fluorouracil) compared to placebo plus mFOLFOX6 as a first-line treatment of patients with CLDN18.2-positive, HER2- negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction cancer. The study enrolled 566 patients at 220 study locations in the U.S., United Kingdom, Australia, Europe, South America and Asia. The primary endpoint is progression-free survival of participants treated with combination of zolbetuximab plus mFOLFOX6 compared to those treated with placebo plus mFOLFOX6. Secondary endpoints include overall survival, objective response rate, duration of response, safety and tolerability and quality-of-life parameters.

For more information, please visit clinicaltrials.gov under Identifier NCT03504397.

About Locally Advanced Unresectable Metastatic Gastric and Gastroesophageal Junction Cancer
Gastric cancer, also commonly known as stomach cancer, is the fifth most commonly diagnosed cancer worldwide.9 Signs and symptoms can include indigestion or heartburn; pain or discomfort in the abdomen; nausea and vomiting; diarrhea or constipation; bloating of the stomach after meals; and loss of appetite and sensation of food getting stuck in the throat while eating.10 Signs of more advanced gastric cancer can include unexplained weight loss; weakness and fatigue; and vomiting blood or having blood in the stool.7 Risk factors associated with gastric cancer can include older age, male gender, family history, H. pylori infection, smoking and gastroesophageal reflux disease (GERD).7,11 Because early-stage gastric cancer symptoms frequently overlap with more common stomach-related conditions, gastric cancer is often diagnosed in the advanced or metastatic stage, or once it has spread from the tumor’s origin to other body tissues or organs.7 The five-year relative survival rate for patients at the metastatic stage is approximately six percent.8 Gastroesophageal junction (GEJ) adenocarcinoma is a cancer that starts at the area where the esophagus joins the stomach.12

On November 16, 2022 Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") reported the approval of the Investigational New Drug (IND) application by China National Medical Products Administration (NMPA) for the in-house developed oral PD-L1 small molecule inhibitor, ASC61, for the treatment of advanced solid tumors. While the ASC61 Phase I dose escalation study is ongoing in the U.S., IND approval in China will accelerate the global development of ASC61 (Press release, Ascletis, NOV 16, 2022, View Source [SID1234624176]).

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ASC61 is an oral small molecule inhibitor prodrug. Its active metabolite, ASC61-A, is a potent and highly selective inhibitor which blocks PD-1/PD-L1 interaction through inducing PD-L1 dimerization and internalization. As a single agent, ASC61 demonstrated significant antitumor efficacy in multiple animal models including humanized mouse model. Preclinical studies showed that ASC61 has good safety and pharmacokinetic profiles in animal models.

In a head-to-head comparison study using the human PD-L1 expressing cells and fresh peripheral blood mononuclear cells (PBMCs) co-culture assay, ASC61-A treatment induced secretion of IFNγ in a concentration dependent manner, with an EC50 of 2.86 nM. Maximal levels of IFNγ induced by ASC61-A were similar to that induced by Keytruda, a marketed PD-1 antibody.

Compared with PD-1/PD-L1 antibody injections, the oral PD-L1 inhibitor ASC61 has the following benefits: (1) higher patient compliance with easy and safe administration with no need of hospital visits for injections; (2) ease of all oral combination therapies with other oral anti-tumor drugs; (3) easier to manage immune-related adverse effects (irAEs) with dose adjustment; (4) relatively lower cost; and (5) higher permeability to distribute into targeted tissues.

"Immunogenicity and the poor permeability into tumor tissues are the major limitations of therapeutic antibodies, which can cause a low response rate of PD-1/PD-L1 antibodies. As a highly differentiated small molecule PD-L1 inhibitor, ASC61 showed promising safety profile in the dose escalation study in patients with advanced solid tumors in the U.S. so far. With two IND approvals in the U.S. and China, we expect to accelerate the global development of ASC61 and provide more options for patients with advanced solid tumors." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis.

On November 16, 2022 Genome Insight, a precision medicine whole genome platform company, and Kun-hee Lee Child Cancer & Rare Disease Project Team of SNUH (Seoul National University Hospital), funded by the family of ex-Samsung Group Chairman Kun-hee Lee, reported a collaborative study for a whole genome sequencing (WGS)-based approach to pediatric solid cancer diagnosis in the clinical setting (Press release, Genome Insight, NOV 16, 2022, View Source [SID1234624175]).

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The partnership’s shared goal is to accelerate the widespread access and use of a WGS diagnosis platform in the clinical setting. Under their partnership, Genome Insight and Kun-hee Lee Child Cancer & Rare Disease Project Team will co-develop a pediatric solid cancer whole genome-based clinical system. This clinical system will cover from sample collection through multi-omics-based analysis to clinical utilization.

WGS captures a near-complete overview of the genomic characteristics of a tumor in one test. In contrast, targeted sequencing panels, a form of testing currently used in the clinical setting, selectively detects about 0.01%-1% of the genome due to technical limitations. The comprehensive WGS approach enables the discovery of all types of genomic mutations, including single nucleotide variants, copy number alterations, insertions/deletions, and structural variants as well as whole genome-wide pattern-based biomarkers such as mutational signature, homologous recombination deficiency, etc. These characteristics can inform diagnosis and treatment decisions but are often not detected through other medical testing.

Genome Insight will provide bioinformatics-powered digital solutions that read and translate a cancer patient’s genome into medically meaningful insights. Furthermore, Genome Insight’s web-based interactive user-friendly real-time report of genomic insights will replace the conventional paper-based reports. Through the implementation of this whole genome-based clinical system, the study aims to improve the quality and accuracy of pediatric solid cancer diagnosis and treatment selection.

"We are delighted to introduce a whole genome-based pediatric solid cancer diagnosis platform to our partner hospital through this collaboration. Our goal is to speed up the accumulation of whole genome datasets and real-world experience, thereby creating a world-class research cohort that would enhance our partner hospitals’ precision medicine research capabilities and bring better care to their patients through whole genome-based precision diagnosis," said Baek-lok Oh, Chief Medical Officer, Genome Insight.

"We expect that Genome Insight’s platform will have a positive impact on improving pediatric solid cancer diagnosis and treatment rates of pediatric cancer patients across Korea," said Professor Ji Hoon Phi, the principal investigator of this study.

On November 16, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that it has obtained a term loan facility for up to $50 million from Perceptive Advisors, a leading healthcare investment firm focused on supporting progress in the life sciences industry by identifying opportunities and directing financial resources toward the most promising technologies in modern healthcare (Press release, Biodesix, NOV 16, 2022, View Source [SID1234624174]). This debt capital, which is conditioned on the Company raising at least $30 million in gross proceeds through sale of its equity securities, is part of a strategic fundraising effort to strengthen the Company’s balance sheet, reduce near term cash use and enable the continued growth trajectory of the core lung diagnostics business. The proceeds from this debt offering will be used for repayment of existing debt facilities, working capital, and general corporate purposes, including expansion of the commercialization activities for the Company’s five Medicare reimbursed lung diagnostic tests.

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"This financing provides Biodesix with significant flexibility and strengthens our balance sheet thereby positioning us to continue building on the growth momentum we have seen the past few quarters," said Robin Harper Cowie, Chief Financial Officer of Biodesix. "We are pleased to have the support from Perceptive, which is a recognized leader in growth capital financing."

"Perceptive is delighted to provide capital to support the continued growth of Biodesix’s lung diagnostics portfolio," said Sam Chawla, Portfolio Manager of Perceptive Advisors. "With a comprehensive set of five Medicare covered tests on the market today that address the diagnostic needs of caregivers and patients across the lung continuum of care, Biodesix represents a unique opportunity to impact the lives of patients. We are excited to collaborate with Biodesix and look forward to participating in the Company’s growth."

Under the terms of the agreement, Biodesix will receive an initial $30 million funding, subject to closing conditions, including the equity issuance noted above. An additional $20 million will be available in two separate $10 million tranches under the same terms and collateral, subject to certain timelines and other defined criteria that will be subject to the lender’s approval. The credit facility is interest only for the term of the facility, which is five years from the initial funding date. The term loan bears interest at a per annum rate equal to the greater of the forward looking one-month SOFR and 3.00% per annum, plus an applicable margin of 9.00%, payable monthly in arrears. The term loan is secured by a first lien on all Company assets.

In connection with the closing of the initial funding, the Company will issue to Perceptive warrants to purchase up to 5,000,000 shares of the Company’s common stock, with warrants exercisable into 3,000,000 shares of the Company’s common stock to be issued on the funding date of the initial $30 million funding (the "Initial Warrants"). The per share exercise price for the Initial Warrants will be equal to the lower of (i) the 10-day volume weighted average price (the "10-day VWAP") ending on the business day immediately preceding the funding date of initial loan and (ii) the per share public offering price of the Company’s shares of common stock issued in connection with the required equity raise. In addition to the Initial Warrants, additional warrants will become exercisable into 1,000,000 shares of the Company’s common stock concurrently with the borrowing of each additional $10 million term loan funding. The per share exercise price for the additional warrants will be equal to the lower of (i) the Initial Warrant exercise price or (ii) the 10-day VWAP ending on the business day immediately preceding the funding date of each funding date. Each warrant will be exercisable, in whole or in part, until the 10th anniversary of the applicable date of issuance, subject to certain expiration events as set described in the warrants.

On November 16, 2022 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported results for the third quarter and the first nine months of 2022 (Press release, MorphoSys, NOV 16, 2022, View Source [SID1234624173]).

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"As we approach the end of this year, I am proud of what we have achieved so far. I want to highlight the progress we have made with the patient enrollment of our pivotal studies for pelabresib and tafasitamab as well as the preliminary phase 1/2 results we released for tulmimetostat suggesting anti-tumor activity across multiple tumors", said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "We are highly engaged to ensure increasing awareness and use of Monjuvi for appropriate patients with relapsed or refractory diffuse large B-cell lymphoma. Looking ahead we are focused on continued execution and delivering on the pelabresib pivotal study timeline."

Monjuvi/Minjuvi Highlights:

Monjuvi (tafasitamab-cxix) U.S. net product sales of US$ 22.2 million (€ 21.9 million) for the third quarter 2022 (Q3 2021: US$ 22.0 million (€ 18.6 million)) and US$ 64.1 million (€ 60.2 million) for first nine months 2022 (9M 2021: US$ 55.5 million (€ 46.4 million)).

Minjuvi royalty revenue of € 0.9 million for sales outside of the U.S. in the third quarter 2022 and € 2.3 million for the first nine months of 2022.

Conference Data Highlights:

New data presented at SOHO conference in September 2022

Data from the ongoing L-MIND study presented at the Society of Hematologic Oncology (SOHO) conference suggests that tafasitamab plus lenalidomide followed by tafasitamab monotherapy provided durable response in patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) treated for at least two years, including six patients on treatment for 5 years or more.

Preliminary results of tulmimetostat (CPI-0209) study presented in October 2022

Preliminary results from the ongoing phase 1/2 study of the investigational EZH2 inhibitor tulmimetostat were presented at the ENA Symposium on Molecular Targets and Cancer. Tulmimetostat monotherapy in heavily pretreated patients with advanced cancers showed responses or disease stabilization in five cohorts with evaluable patients.

Pelabresib and tafasitamab presentations and posters at ASH (Free ASH Whitepaper) in December 2022

MorphoSys will contribute 14 presentations – including four oral presentations – on the investigational BET inhibitor pelabresib and on tafasitamab to the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH) (Free ASH Whitepaper) from December 10-13, 2022 in New Orleans, Louisiana, USA.

Corporate Developments:

On August 31, 2022, MorphoSys announced Tim Demuth, M.D., Ph.D. as new Chief Research and Development Officer, following the retirement of Malte Peters, M.D. Tim Demuth started his new role on October 1, 2022.

Significant Events After the End of the Third Quarter of 2022:

On October 27, 2022, MorphoSys’ license partner GSK provided an update on the ContRAst phase III program for otilimab in moderate to severe rheumatoid arthritis.

On November 14, 2022, MorphoSys’ license partner Roche disclosed that the GRADUATE studies with gantenerumab in early Alzheimer’s disease did not meet the primary endpoint of slowing clinical decline.

Financial Results for the Third Quarter of 2022 (IFRS):

Total revenues for the third quarter 2022 were € 95.8 million compared to € 41.2 million for the same period in 2021. This increase resulted mainly from higher revenues from licenses due to the out-licensing agreements with HI-Bio.

Cost of Sales: In the third quarter of 2022, cost of sales was € 8.1 million compared to € 7.5 million for the comparable period in 2021.

Research and Development (R&D) Expenses: In the third quarter 2022, R&D expenses were € 77.8 million (Q3 2021: € 64.4 million). The increase in R&D expenses is primarily due to higher investments to support the advancement of clinical programs.

Selling, General and Administrative (SG&A) Expenses: Selling expenses in the third quarter 2022 were € 23.5 million (Q3 2021: € 32.4 million). The decrease was driven by higher investments in 2021 made into the commercial organization, the first full year after the Monjuvi launch. General and administrative (G&A) expenses amounted to € 15.6 million (Q3 2021: € 19.4 million). The decrease was driven by the transaction costs for the Constellation acquisition which was completed in the third quarter of 2021.

Operating Loss: Operating loss amounted to € 29.3 million in the third quarter 2022 (Q3 2021: operating loss of € 82.4 million).

Consolidated Net Loss: For the third quarter 2022, consolidated net loss was € 122.9 million (Q3 2021: consolidated net loss of € 112.8 million).

Financial Results for the first nine months (IFRS):

Revenues for the first nine months of 2022 were € 196.7 million (9M 2021: € 126.7 million). The increase resulted mainly from higher revenues from licenses due to the out-licensing agreements with HI-Bio. Revenues include € 60.2 million from the recognition of Monjuvi product sales in the U.S. Royalties in the first nine months included € 2.3 million from the sale of Minjuvi outside of the U.S. by our partner Incyte and € 68.5 million from Tremfya sales which is fully passed on to Royalty Pharma.

Cost of Sales: For the first nine months of 2022, cost of sales were € 33.2 million compared to € 22.7 million in 2021. The increase was primarily driven by higher sales of Monjuvi in the U.S. and Minjuvi outside of the U.S.

R&D Expenses: In the first nine months of 2022, R&D expenses were € 203.8 million compared to € 138.2 million in 2021. The R&D expenses increased primarily due to higher development activity and the inclusion of expenses from the Constellation acquisition since Q3 2021.

SG&A Expenses: Selling expenses decreased in the first nine months of 2022 to € 69.4 million compared to € 89.0 million in 2021. The decrease was primarily driven by higher investments made into the commercial organization in 2021, the first full year after the Monjuvi launch. G&A expenses amounted to € 42.6 million compared to € 60.1 million in the first nine months of 2021. The decrease was driven primarily by the transaction costs related to the Constellation and Royalty Pharma agreements in 2021.

Operating Loss: Operating loss amounted to € 152.3 million in the first nine months of 2022 compared to an operating loss of € 183.3 million in 2021.

Consolidated Net Loss: For the first nine months of 2022, consolidated net loss was € 480.5 million compared to a net loss of € 133.5 million in 2021.

Cash and Other Financial Assets: As of September 30, 2022, the Company had cash and other financial assets of € 1,038.1 million compared to € 976.9 million on December 31, 2021.

Number of shares: The number of shares issued totaled 34,231,943 on September 30, 2022, no change compared to December 31, 2021.

53% to 58% of mid-point of SG&A expenses represent Monjuvi U.S. selling costs of which 100% are recorded in MorphoSys’ income statement. Incyte reimburses MorphoSys for half of these selling expenses.

Additional information related to 2022 Financial Guidance:

Tremfya royalties will continue to be recorded as revenue without any cost of sales in MorphoSys’ income statement. These royalties, however, will not contribute any cash to MorphoSys as 100% of the royalties will be passed on to Royalty Pharma.
MorphoSys anticipates receiving royalties for Minjuvi sales outside of the U.S.
MorphoSys does not anticipate any significant cash-accretive revenues from the achievement of milestones in 2022.
MorphoSys anticipates sales of commercial and clinical supply of tafasitamab outside of the U.S. to its partner Incyte. Revenue from this supply is recorded in the "Licenses, milestones and other" category in MorphoSys’ income statement. These sales result in a zero gross profit/margin. As such, MorphoSys does not provide guidance for these sales.
While R&D expense is anticipated to grow year-over-year due to investments in three pivotal studies, the growth is partially being offset by the consolidation of research/discovery activities.
SG&A expense guidance range reflects savings from synergies following the acquisition of Constellation and streamlined commercialization efforts.
MorphoSys Group Key Figures (IFRS, end of the third quarter: September 30, 2022)

*Value as of December 31, 2021

MorphoSys will hold its conference call and webcast tomorrow, November 17, 2022, at 2:00pm CET (1:00pm GMT/8:00am EST) to present the results for the third quarter and the first nine months 2022.

Participants for the conference call and webcast may pre-register and will receive dedicated dial-in details to easily and quickly access the call:

View Source;linkSecurityString=5f6d0a600

Please dial in 10 minutes before the beginning of the conference.

A live webcast and slides will be made available at the Investors section under "Events & Conferences" on MorphoSys’ website, View Source and after the call, a slide-synchronized audio replay of the conference will be available at the same location.

The statement for the third quarter and the first nine months 2022 (IFRS) are available for download at:

View Source/en/investors/financial-information