On August 20, 2024 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that the first patient has joined its Multi-Cancer Early Detection (MCED) Falcon Registry Real-World Evidence (RWE) study at Baylor Scott & White, the primary study site and largest not-for-profit health system in Texas (Press release, Exact Sciences, AUG 20, 2024, View Source [SID1234646006]). The multi-site study will enroll up to 25,000 patients, evaluating the clinical performance, patient and provider experience, and psychological impact of MCED testing over a five-year period. Endeavor Health, a Chicago-area health system serving more than 1.4 million patients, will start enrolling patients this fall. The U.S. Food and Drug Administration (FDA) recently authorized an investigational device exemption (IDE) for the Exact Sciences MCED test, allowing its use in the Falcon Registry. This study will provide valuable insight to further inform the development and commercialization of the company’s future MCED test and support discussions with regulatory agencies, payers, and guideline bodies.

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"Exact Sciences is dedicated to advancing an MCED test, as it offers a highly promising way to make an impact on the burden of cancer," said Tom Beer, M.D., chief medical officer and vice president, multi-cancer early detection, Exact Sciences. "Too often, cancers go undetected until symptoms appear, resulting in diagnoses at advanced, less treatable stages. Early detection through screening improves outcomes, yet two-thirds of cancer cases and deaths are due to cancers that do not have recommended screening options. 1 Our collaboration with Baylor Scott & White and Endeavor Health is a crucial step forward and represents a tremendous opportunity to help transform cancer care."

To better understand the impact of MCED testing on patient care, the study will use a registry approach, tracking patient data over time to evaluate outcomes and improve future treatments. Up to 25,000 patients ages 50-80 with no history of cancer will participate in annual MCED testing for three years and two additional years of follow-up data collection. Data will also be collected for a comparator cohort of up to 50,000 patients, demographically and clinically similar to the study cohort but receiving standard care without the MCED test. The Exact Sciences MCED test features two high-performing biomarker classes known for their ability to identify cancer early, offering sensitivity and specificity that can detect aggressive cancers and those lacking current standard of care screening. 2

"With this important work, we aim to intercept cancer earlier than ever before," said Ronan Kelly, M.D., principal investigator of the MCED Falcon Registry Real-World Evidence study. Dr. Kelly is the director of oncology, Baylor Scott & White Charles A. Sammons Cancer Center at Baylor University Medical Center — Dallas, and chief of oncology, North Texas Division, Baylor Scott & White Health. "We are eager to do our part in the national effort to decrease cancer mortality by 50% over the next 25 years, as outlined in the U.S. government’s Cancer Moonshot initiative. This important study is helping advance proactive cancer detection efforts, and we are excited to help close gaps in existing cancer screening programs."

Cancer remains the second leading cause of death in the United States, with over 2 million new cases and approximately 611,000 deaths projected for 2024. 3 Advancing early detection through innovative approaches like MCED testing has never been more critical. Baylor Scott & White and Endeavor Health, located in distinct parts of the country and serving a diverse range of communities, will help reach a broad representative group of Americans and provide insights on the potential benefits of early detection across diverse populations.

"Implementing MCED testing and advancing preventative genomics are crucial steps in addressing the ‘last mile’ problem in health care," said Peter Hulick, M.D., the Janardan D. Khandekar, M.D., chair of personalized medicine and the director of the Mark R. Neaman Center for Personalized Medicine at Endeavor Health. "The Falcon Registry is a pivotal research study to meet the real-world challenges of implementation and aligns with the broader vision of the Davis Family Center for Preventive Genomics at Endeavor Health, which is to assist patients, their families, and caregivers in making better-informed decisions about early diagnosis, prevention strategies, and personalized treatment options."

The Exact Sciences MCED test is available to patients who have consented and enrolled in the Falcon Registry study. It has not been cleared or approved by the U.S. Food and Drug Administration or other notified regulatory authority. The test was developed and its performance characteristics validated by Exact Sciences Laboratories following College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) regulations. The test is performed at Exact Sciences Laboratories. Exact Sciences Laboratories is accredited by CAP, certified under CLIA regulations, and qualified to perform high-complexity clinical laboratory testing.

On August 20, 2024 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, reported the 2024 interim results and corporate update as of 30 June 2024 (Press release, InnoCare Pharma, AUG 20, 2024, View Source [SID1234646022]).

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Revenue of orelabrutinib increased by 30.0% year-on-year (YoY) to RMB417.0 million in the first half of 2024, with a YoY growth of 48.8% in the second quarter. This is attributed to the rapid growth of marginal zone lymphoma (MZL) as well as effective sales execution.
The Loss decreased by 37.6% YoY to RMB268.0 million in the first half of 2024.
Cash and Related Accounts Balance stood at about RMB7.99 billion as of 30 June 2024. This robust cash position provides the Company with flexibility to expedite clinical development and invest in a competitive pipeline.
Gross Profit increased by 19.3% to RMB359.6 million in the first half of 2024. Gross profit margin was 85.7%, representing an increase of 5.8 percentage points, which was primarily due to the sales combination change of drugs and service.
Research and Development Expenses increased by 17.5%1 to RMB420.8 million in the first half of 2024 primarily due to mainly due to more resources to increased investment in advanced technology platform innovation and Phase III clinical trials aimed at accelerating the Group’s transformation.
Total Revenue reached RMB419.7 million in the first half of 2024, which was primarily attributable to rapid ramp-up of orelabrutinib sales volume. All three approved indications of orelabrutinib, including relapsed and refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (r/r CLL/SLL), relapsed and refractory mantle cell lymphoma (r/r MCL) and relapsed and/or refractory marginal zone lymphoma (r/r MZL) have been covered under the updated National Reimbursement Drug List (NRDL) 2023. Orelabrutinib has been approved as the first and only BTK inhibitor for r/r MZL in China. Orelabrutinib was officially included as a class I recommended regimen for the treatment of r/r MZL patients in the 2024 Chinese Society of Clinical Oncology (CSCO) Guidelines. The Company’s commercial capabilities have undergone significant enhancements, including an optimized and upgraded commercial team, which has developed more executable strategies. The dedicated team has been optimized to operate with heightened efficiency and strategic focus, ensuring effective execution of market initiatives. This optimization has bolstered the team’s ability to penetrate markets swiftly and effectively. These advancements underscore InnoCare’s commitment to delivering value and driving sustainable growth in the Company’s commercial endeavors.

Benefiting Patients Worldwide

Entering InnoCare version 2.0, the Company is continuing to strengthen the entire value chain and rapidly advance the clinical trials of its pipeline. Over the next three to five years, five to six innovative drugs are expected to be approved for marketing, addressing unmet treatment needs and benefiting patients worldwide.

Becoming a Leading Player in Hemato-Oncology

Hemato-oncology, including lymphoma, leukemia, and myeloma, is known for its high mortality rates. InnoCare is dedicated to developing therapeutics with diverse mechanisms of action (MoA) to achieve comprehensive coverage of blood tumor indications, with the aspiration of becoming a leader in this field.

Beyond the approved indications, InnoCare is advancing the first line registrational clinical trials and new drug application (NDA) for orelabrutinib. Tafasitamab (CD19 monoclonal antibody), another key product, is expected to be approved for marketing in the first half of next year, further strengthening the Company’s market presence. InnoCare is also accelerating the development of BCL2 inhibitor ICP-248, which has significant combination synergy with orelabrutinib. Notably, BCL2 inhibitors are the preferred therapeutic option following resistance to BTK inhibitors, creating an optimal sequential treatment strategy. With these assets in the pipeline, along with the molecule glue ICP-490, monoclonal antibody ICP-B05 and bispecific antibody ICP-B02, and potential future developments from internal and external sources, the Company is aimed at becoming a leading player in hemato-oncology both in China and worldwide.

Orelabrutinib

The clinical trial of orelabrutinib in combination with ICP-248, a BCL2 inhibitor developed by InnoCare, for first-line treatment of CLL/SLL was initiated in May of this year, and patient enrollment of the Phase II trial has been completed as of this announcement.
The Company is accelerating the registrational trials and NDA of the first line indications of orelabrutinib, including CLL/SLL, SCL and diffuse large B-cell lymphoma (DLBCL).
Orelabrutinib continues to gain attention from top international academic conferences. Five studies of orelabrutnib were selected for the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024, with a prospective study of orelabrutinib regimen in treatment-naive MZL as an oral presentation at the conference. 10 studies on orelabrutinib have been selected for the European Hematology Association (EHA) (Free EHA Whitepaper) 2024 Hybrid Congress.
Tafasitamab

The biologics license application (BLA) for tafasitamab in combination with lenalidomide for adult patients with r/r DLBCL who are not eligible for Autologous Stem Cell Transplant (ASCT) was accepted and granted priority review in China in June 2024. DLBCL is the most common type of non-Hodgkin’s lymphoma (NHL), accounting for 31%~34% of NHL patients globally. In China, DLBCL accounts for 45.8% of all NHLs2.
Tafasitamab regimen was approved by the Department of Health, the Hong Kong Special Administrative Region, China, and approved for use in Bo’ao and Greater Bay Area with first prescription issued respectively.
ICP-248

ICP-248 is a novel, orally bioavailable BCL2 selective inhibitor. The clinical trial of ICP-248 in combination with orelabrutinib for first line (1L) CLL/SLL was initiated, and patient enrollment for the Phase II trial has been completed.
So far, 47 patients have been dosed, and among 28 evaluable patients with BTK inhibitor failure r/r MCL, the overall response rate (ORR) was 71.4%.
The investigational new drug (IND) filing for ICP-248 for Acute Myeloid Leukemia (AML) has been accepted by the CDE.
ICP-490

Developed from InnoCare’s molecular glue platform, ICP-490 shows strong potential to revolutionize the treatment of MM, NHL, and other hemato-oncology indications, whether as a monotherapy or in combination with other therapies.
The Phase I dose escalation study is ongoing in China with multiple myeloma (MM) and NHL patients, demonstrating a good tolerability and safety profile. This safety profile has supported the decision to continue dose escalation to the next dosage level.
ICP-B02 (CM355)

ICP-B02 is a CD20xCD3 bispecific antibody co-developed with Keymed. Data from both the intravenous infusion (IV) and the subcutaneous (SC) formulations have shown good efficacy of ICP-B02 in patients with follicular lymphoma (FL) and DLBCL. All 15 patients who were treated with ICP-B02 at doses ≥6mg achieved response, resulting in an ORR of 100%. All patients who achieved CR maintained the remission as of the cutoff date.
Based on the encouraging results of ICP-B02 as a single agent, the Company is planning for a dose expansion study of ICP-B02 in combination with other immunochemotherapies targeting earlier lines of treatment in NHL patients. The IND application for the combination therapies was approved in China in June 2024.
ICP-B05 (CM369)

ICP-B05 (CM369) is a potential first-in-class anti-CC chemokine receptor 8 (CCR8) monoclonal antibody, co-developed by InnoCare and Keymed as a monotherapy or in combination with other therapies for the treatment of various cancers.
The Phase I trial is ongoing, aiming to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of ICP-B05 in subjects with advanced solid tumors and r/r NHL.
Preliminary efficacy was observed in NHL patient. ICP-B05 was well tolerated with no dose-limiting toxicities (DLTs).
Advancing Research and Development in Solid Tumors

InnoCare strives to expand the breadth of its pipeline to cover solid tumor diseases areas through a combination of targeted therapy and immune-oncology approaches. The Company believes that potential best-in-class molecule, zurletrectinib (ICP-723), will enable InnoCare to establish a solid footprint in the field of solid tumor treatment. To benefit a broader range of patients, InnoCare’s rapidly maturing early-stage pipeline, including the cornerstone therapy ICP-189 and ICP-B05 immune-oncology treatment, aims to offer competitive treatment solutions for a large array of solid tumors, both in China and worldwide.

Zurletrectinib (ICP-723)

The fusion mutation of NTRK gene is a carcinogenic factor for many cancers, including lung cancer, colorectal cancer, breast cancer, pancreatic cancer and melanoma. Zurletrectinib is a second generation TRK inhibitor developed by InnoCare. The Company is accelerating the registrational trial of zurletrectinib in China, which has entered the pre-NDA stage.
Zurletrectinib has demonstrated good efficacy and safety profile. It was shown to overcome acquired resistance to the first generation TRK inhibitors, bringing hope for patients who failed prior TRKi therapy.
The clinical study with zurletrectinib has covered neurotrophic tyrosine receptor kinase (NTRK) gene fusion adult patients, adolescent patients (12 to 18 years old) and pediatric patients (2 to 12 years old). The efficacy has been observed in both adolescent and pediatric patients. The dose escalation trial for pediatric patients has been completed.
ICP-189

The novel SHP2 allosteric inhibitor, ICP-189, is being developed for the treatment of solid tumors as a single agent and/or in combination with other antitumor agents. The clinical trial of the combination of InnoCare’s lCP-189 with ArriVent’s third generation EGFR inhibitor furmonertinib in patients with advanced non-small cell lung cancer (NSCLC) is ongoing, with the preliminary efficacy observed. NSCLC is the predominant subtype of lung cancer, accounting for approximately 85% of all cases3.
Preliminary efficacy was observed in ICP-189 monotherapy. As a potential first-in-class SHP2 inhibitor, ICP-189 is an ideal partner for combination with multiple targeted and immune-oncology therapies in solid tumors. ICP-189 has demonstrated significant anti-tumor effect in tumor models driven by KRASG12C mutation and Epidermal Growth Factor Receptor (EGFR) over-expression. The SHP2 combination therapy provides a promising treatment option for NSCLC patients who are resistant to the third generation EGFR inhibitors.
As of this announcement, the study of the 120mg QD group has been completed, with no DLT observed, and it has shown a favorable PK profile with a long half-life. The patient enrollment at 160mg QD is ongoing.
InnoCare is also actively exploring preclinical development in solid tumors, and developing small molecule and large molecule innovative drugs by building a differentiated platform for the treatment of solid tumors such as lung cancer and gastric cancer, so as to meet huge unmet medical needs.

Comprehensive Coverage in Autoimmune Diseases

Autoimmune diseases can affect almost every organ in the body and can occur at any age. The global market for autoimmune disease therapeutics anticipated to reach $185 billion by 20294. The Company has fortified its powerful discovery engine focusing on global frontier targets for the development of differentiated autoimmune therapeutics through B-cell and T-cell pathways, aiming to offer first-in-class or best-in-class treatments to the massive unmet medical needs with promising market potential worldwide and/or regionally.

Orelabrutinib

ITP: The Company has achieved proof of concept (PoC) for orelabrutinib in the treatment of primary immune thrombocytopenia purpura (ITP), and has completed enrollment of over 50% of patients in the Phase III registrational trial. The annual incidence rate of adult ITP is about 2-10 per 100,000 people5. Only about 70% of patients respond to first-line treatment. Orelabrutinib has potential to provide a better treatment option for ITP patients6. From blood tumor to autoimmune diseases in the hematological field, orelabrutinib will demonstrate its huge commercial potential. The ITP Phase II result was published by the American Journal of Hematology in April 2024. For details, please refer to View Source
SLE: The Phase IIa trial for systemic lupus erythematosus (SLE) demonstrated positive results, with remarkable SLE Responder Index (SRI)-4 response rates observed in a dose dependent manner, along with trends indicating a reduction in proteinuria levels. Orelabrutinib is global first and only BTK inhibitor ever shown efficacy in Phase II SLE trials. A Phase IIb trial is ongoing, and the patients enrollment has been nearly completed as of this announcement.
SLE is a systemic disease that often leads to damage to organs, especially the kidneys and nervous system, skin, blood system, respiratory system, and almost all systems may be affected. According to Frost Sullivan analysis, it is expected that there will be 8.18 million SLE patients worldwide by 2025. The Chinese Systemic Lupus Erythematosus Development Report 2020 points out that there are about one million SLE patients in China, ranking first in the world in number of patients and second in incidence rate.

ICP-332

ICP-332 is a novel tyrosine kinase 2 (TYK2) inhibitor that is being developed for the treatment of various T-cell related autoimmune disorders, including atopic dermatitis (AD), vitiligo, inflammatory bowel disease, etc., with broad market prospects.
The latest data of ICP-332 for the treatment of patients with moderate-to-severe AD has been released at the 2024 American Academy of Dermatology (AAD) Annual Meeting as a late-breaking oral presentation.
ICP-332 achieved multiple efficacy endpoints in the China Phase II study for the treatment of patients with moderate-to-severe AD, demonstrating an outstanding efficacy and safety profile. ICP-332 showed better efficacy profile across different classes/MoAs of therapies for the treatment of AD patients (not a head-to-head comparison).
In the ICP-332 80 mg once-daily (QD) and 120 mg QD groups for four weeks, the response rates of EASI 90 (improvement of at least 90% in EASI score from baseline) and NRS (Pruritus Numerical Rating Scale) score from baseline ≥4 points demonstrated a 40% and 56% improvement respectively compared with the placebo group, both of which were superior to competitors.
ICP-332 was safe and well tolerated in AD patients. The overall incidence rates of adverse events (AEs) in the two treatment groups were comparable to that of the placebo group.
The Company expects to start the patient enrollment of the Phase III trial for AD in China in the fourth quarter of 2024, and to submit IND for the Phase II/III trial for a second indication of vitiligo. The US trials have been initiated.
ICP-488

Data shows that 100 million people worldwide are affected by various types of psoriasis7. ICP-488 is a potent and selective TYK2 allosteric inhibitor that binds to the pseudo kinase JH2 domain of TYK2 and blocks IL-23, IL12, type 1 IFN, and other cytokine receptors. The Phase II study of ICP-488 in psoriasis has completed patient enrollment in May 2024. The Company expects the data readout by the end of 2024.
A total of 129 patients were enrolled in this study. Patients were randomly assigned to two treatment groups and placebo group, for 12 consecutive weeks of treatment.
ICP-488 demonstrated good efficacy and safety in the Phase I study of ICP-488 in psoriasis patients.
Novel Small Molecule Inhibitor of IL-17

IL-17 is a pro-inflammatory cytokine that plays an important role in immune functional responses. Orally administered small molecules targeting IL-17 may represent a convenient alternative to IL-17-targeting monoclonal antibodies for patients. This novel orally available small molecule can potently block the binding of both IL-17AA and IL-17AF to IL-17R.
Dr. Jasmine Cui, the Co-founder, Chairwoman and CEO of InnoCare, said, "In the first half of 2024, our commercial team exceeded pre-set goals, with a significant increase in revenue. We have developed innovative drugs with huge unmet medical needs, with three NDAs submitted in the first half of this year. We have also been actively exploring preclinical innovation, laying a solid foundation for future development. Looking ahead to the second half of the year, we will continue to make concerted efforts in the fields of new drug R&D, clinical development, commercialization and globalization, focusing on key goals to achieve high-quality development."

To know more about the detailed financial data and business updates of InnoCare 2024 annual results, please log in to View Source .

Conference Call Information

InnoCare will host a conference call at 9:30 a.m. Beijing time on August 21 in Chinese and at 8:30 p.m. Beijing time in English on August 21, 2024. Participants must register in advance of the conference call. Details are as follows:

For English conference call, please register through the below link:
View Source

For Chinese conference call, please register through the below link:
View Source

On August 19, 2024 Peptomyc S.L., a company developing foundational mini-protein therapeutics for the treatment of cancer, reported that the Company has been issued a patent by the Hong Kong Patent Office protecting its Methods and Composition of Matter (Press release, Peptomyc, AUG 19, 2024, View Source [SID1234645985]).

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"We are delighted to announce further protection of our mini-protein therapeutics in Hong Kong. This patent grant strengthens our patent portfolio that protects our unique mini-protein therapeutics, which are able to inhibit MYC, the most dysregulated oncogene in human cancer, in the major geographical areas in oncology," said Laura Soucek, CEO at Peptomyc S.L.

The Company currently maintains over 10 different patent families worldwide covering applications protecting Peptomyc S.L. first-in-modality mini-protein therapeutics in multiple oncological indications, and counts on the services of ABG Intellectual Property and Dechert LLP for the protection of its IP assets.

On August 19, 2024 Purple biotech presented its corporate presentation (Presentation, Purple Biotech, AUG 19, 2024, View Source [SID1234645986]).

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On August 20, 2024 Scorpius Holdings, Inc. (NYSE American: SCPX), ("Scorpius", or the "Company"), an integrated contract development and manufacturing organization (CDMO), reported the closing of its underwritten public offering of 14,375,000 shares of common stock (and/or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof), including full exercise of the underwriter’s over-allotment option (Press release, Scorpius BioManufacturing, AUG 19, 2024, View Source [SID1234645987]). Each share of common stock (or Pre-Funded Warrant) was offered at a public offering price of $1.00 per share (inclusive of the Pre-Funded Warrant exercise price), for gross proceeds of $14,375,000, before deducting underwriting discounts and offering expenses.

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The Company intends to use the net proceeds of the offering to fund working capital and for general corporate purposes.

ThinkEquity acted as sole book-running manager for the offering.

A registration statement on Form S-1 (File No. 333-280887) relating to the securities being offered was filed with the Securities and Exchange Commission ("SEC") and became effective on August 6, 2024. This offering is being made only by means of a prospectus. Copies of the final prospectus may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. The final prospectus has been filed with the SEC and is available on the SEC’s website located at View Source

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.