On January 20, 2020 Transcenta Holding Limited ("Transcenta"), a global biotherapeutics company with fully-integrated capabilities in discovery, R&D and manufacturing of antibody-based therapeutics, reported that an investigational new drug (IND) application of its humanized Claudin 18.2 (CLDN18.2) monoclonal antibody (also known as TST001 internally) for the treatment of solid tumors submitted by its Suzhou subsidiary Mabspace Biosciences has been accepted by the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) of China (Press release, Transcenta, JAN 20, 2020, View Source [SID1234553350]). The IND enabling CMC work was done in its Hangzhou subsidiary HJB. TST001 is the first program developed by Transcenta since merger and it took less than 12 months from the identification of preclinical candidate to IND filing.

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TST001 is a humanized mAb targeting CLDN18.2, which is strictly expressed by the differentiated epithelial cells of the gastric mucosa in normal tissues and typically overexpressed in gastroesophageal cancer, pancreatic cancer, and other solid tumors. TST001 mainly kills tumor cells by antibody-dependent cellular cytotoxicity (ADCC). TST001 displayed significantly higher binding affinity to CLDN18.2 relative to a competitor molecule, lower fucose content, binds to a different binding epitope, which resulted in over 100-fold improved ADCC activity in tumor cells with varying CLDN18.2 expression, especially in CLDN18.2 low expressing tumors.

"We are very glad to be able to file the first IND at the anniversary of our merger. The advantage with an integrated platform is fully reflected in this program. TST001 provides us an important opportunity to target not only first line gastric cancer with Claudin18.2 expression, which are highly prevalent in Asia, but also several other globally prevalent tumor types with CLDN18.2 expression. These tumors, usually neither PDL1 positive nor responsive to checkpoint inhibitors, are an area of significant unmet medical needs. The development of TST001 will be guided by a novel companion diagnostic antibody developed by Transcenta which only binds CLDN18.2 but not CLDN18.1, a closely related isoform expressed in normal lung tissue. The US IND filing will be followed shortly. We look forward to expediting the development of TST001 to bring more effective treatment to a large number of cancer patients," said Xueming Qian, Transcenta’s Co-Founder and Chief Executive Officer.

On January 20, 2020 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported that it will report fourth quarter and year-end 2019 financial results after the Nasdaq market closes on Tuesday, Feb. 4, 2020 (Press release, Neurocrine Biosciences, JAN 20, 2020, View Source [SID1234553349]). Neurocrine will then host a conference call and webcast to discuss its financial results and provide a company update that day at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time).

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Participants can access the live conference call by dialing 877-876-9173 (US) or 785-424-1667 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine’s website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

On January 20, 2020 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that following discussions with investors it has received commitments for an investment of another €0.5 million through a private placement to complement the private placement of €0.5 million announced on January 14, 2020 (Press release, NOXXON, JAN 20, 2020, View Source [SID1234553345]).

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"With this capital increase we welcome a new group of European investors to NOXXON. Consistent with our recent capital increases, for which we have attracted long-term equity investors, there are no warrants or other option-like instruments attached to this financing," said Aram Mangasarian, CEO of NOXXON.

The price agreed with investors was aligned with the private placement of the previous week at €0.51 per share. As such, it is anticipated that 980,391 new shares will be issued in the context of this financing. Closing and settlement of this transaction is expected within the next seven days.

See the annex of this press release for further details on the dilution related to this transaction.

On January 20, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the presentation of clinical utility data for its cutaneous squamous cell carcinoma (SCC) prognostic test, DecisionDx-SCC, for patients diagnosed with high-risk cutaneous SCC (Press release, Castle Biosciences, JAN 20, 2020, View Source [SID1234553344]). The test is expected to be launched commercially in the second half of 2020.

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The poster titled, "Integrating the 40-Gene Expression Profile (40-GEP) Test into Management of High-Risk Cutaneous Squamous Cell Carcinoma," was presented during the 2020 Winter Clinical Dermatology Conference, January 17-22 in Hawaii.

The data presented support a framework for integration of DecisionDx-SCC into risk-appropriate management of high-risk cutaneous SCC patients (as defined by the National Comprehensive Cancer Network [NCCN]).

Disease and Study Background

Approximately 1 million patients are diagnosed with cutaneous SCC in the U.S. each year, and the incidence continues to grow.
As with other cancer types, NCCN guidelines define treatment pathways based on risk of metastasis. In the case of cutaneous SCC, there are two clinicopathologically defined categories: low-risk and high-risk.
The Company believes two important issues exist in implementing a high-risk treatment pathway. First, the NCCN risk criteria, as well as available staging systems, have low positive predictive value (PPV) – meaning that the majority of high-risk patients do not develop metastasis; and, second, the high-risk treatment pathways are broad.
The clinical implication being that many patients categorized as high risk, but who have a low biological risk of metastasis, may be overtreated with radiation, chemotherapy or other interventions; and those patients categorized as high risk and who also have a high biological risk of metastasis may be undertreated if clinical decisions are to follow a conservative treatment plan within the broad boundaries of NCCN high-risk pathways.
The Company believes improved stratification for implementation of risk-appropriate treatment plans for patients within NCCN-defined high-risk cutaneous SCC is needed. NCCN defines high risk as cutaneous SCC patients with a single high-risk feature, e.g., immunodeficiency; tumor diameter greater than or equal to 2cm; any tumor of the mask area, genitals, hands, or feet; or poor tumor differentiation.
DecisionDx-SCC was developed and validated to stratify risk of regional or distant metastasis at three years after diagnosis in high-risk cutaneous SCC patients, classifying patients as low (Class 1), high (Class 2A) or highest (Class 2B) risk of metastasis.
This study was designed to evaluate the integration of DecisionDx-SCC (40-GEP test) with AJCC and Brigham and Women’s Hospital (BWH) T stage criteria into management of 300 NCCN high-risk cutaneous SCC patients.
Within the broad framework of NCCN recommendations for high-risk cutaneous SCC, the aim is to identify those high-risk patients who would be eligible for a conservative, reduced treatment plan, thus avoiding unnecessary adjuvant interventions, and identifying those patients who would most benefit from aggressive adjuvant treatment strategies.
Study Findings

Integration of DecisionDx-SCC for NCCN-defined high-risk cutaneous SCC patients with T staging identified a group of 159 patients (Class 1, T1-T2) with a 7.5% rate of metastasis, which approaches that of the general cutaneous SCC patient population. A low intensity management strategy, within the broad NCCN high-risk guidelines, could spare this patient group unnecessary adjuvant procedures and potential adverse effects.
Conversely, those patients (n=24) with rates of metastasis surpassing 50% (Class 2B), regardless of AJCC or BWH T stage, would warrant a high intensity strategy, also within the broad NCCN high-risk guidelines, that increases follow-up visits, utilizes imaging and/or biopsies for nodal assessment, and offers adjuvant treatments and clinical trials for probable metastatic events.
The data support a framework for risk-aligned treatment plans when DecisionDx-SCC is incorporated into management of NCCN high-risk cutaneous SCC patients.
"There is a clear need to improve identification of true high-risk and lower-risk patients diagnosed with high-risk cutaneous SCC, so that risk-directed treatment plans can be implemented," said Aaron Farberg, M.D., study investigator, Icahn School of Medicine at Mount Sinai, New York and Arkansas Dermatology Skin Cancer Center, Little Rock, Arkansas. "Clinical use of DecisionDx-SCC, along with current staging systems, may better identify patients with cutaneous SCC at high risk for metastasis and enable more informed clinical decisions regarding adjuvant therapy and other management options."

The DecisionDx-SCC test is the second skin cancer test discovered, developed and validated by Castle Biosciences.

About Cutaneous Squamous Cell Carcinoma

Cutaneous squamous cell carcinoma (SCC), a nonmelanoma skin cancer, is one of the most common cancers. Approximately 1,000,000 patients are diagnosed with cutaneous SCC each year in the U.S. Most patients have a favorable prognosis, but a subset of patients will develop metastasis, and up to 15,000 patients each year die from their disease, exceeding the number of deaths from cutaneous melanoma. As current staging parameters have a low positive predictive value, many more patients are considered high risk than actually develop metastatic disease. Conversely, many patients who develop metastatic disease are misidentified as low risk. This may lead to over and undertreatment of a substantial number of cutaneous SCC patients. To address this clinical need, Castle Biosciences has developed a gene expression profile test designed to improve upon current staging systems and identify patients with cutaneous SCC at high risk for metastasis or recurrence, in order to enable more informed clinical decisions regarding adjuvant therapy and other management options.

On January 20, 2020 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the submission of a Type II variation application to the European Medicines Agency (EMA) seeking to expand the label of IMBRUVICA (ibrutinib) to include ibrutinib in combination with rituximab for the first-line treatment of patients with chronic lymphocytic leukaemia (CLL) (Press release, Johnson & Johnson, JAN 20, 2020, View Source [SID1234553343]).

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The submission is supported by data from the Phase 3 E1912 study, designed and conducted in the United States (U.S.) by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute (NCI), which is part of the U.S. National Institutes of Health. The study evaluated 529 patients with previously untreated CLL aged 70 years or younger, who were randomly assigned in a 2:1 ratio to receive ibrutinib plus rituximab (n=354) or the chemo-immunotherapy FCR (n=175). The primary endpoint was progression-free survival (PFS) and one of the secondary endpoints was overall survival (OS).1 The primary study results were previously published in The New England Journal of Medicine, and the extended four-year median follow-up results were presented at the 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.1,2

"The ECOG-ACRIN’s E1912 study demonstrated that ibrutinib in combination with rituximab has shown superior PFS and OS versus FCR, a chemotherapy-based standard of care for younger patients with newly diagnosed CLL," said Dr Patrick Laroche, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag. "We look forward to working with regulatory authorities to bring ibrutinib to more patients with CLL who may benefit from treatment."

"The E1912 study demonstrated the important clinical benefit of ibrutinib in combination with rituximab in the frontline setting," said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Janssen Research & Development, LLC. "We remain committed to replacing long-standing use of chemotherapy with ibrutinib-based combination regimens for the treatment of patients with CLL in the frontline setting."

About ibrutinib

Ibrutinib is a once-daily, first-in-class Bruton’s tyrosine kinase (BTK) inhibitor that is administered orally.3 Ibrutinib blocks the BTK protein; the BTK protein sends important signals that tell B cells to mature and produce antibodies. BTK signaling is needed by specific cancer cells to multiply and spread.4 By blocking BTK, ibrutinib may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs.5

Ibrutinib is currently approved in Europe for:3

Chronic lymphocytic leukaemia (CLL): As a single agent or in combination with obinutuzumab for the treatment of adult patients with previously untreated CLL, and as a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy
Mantle cell lymphoma (MCL): As a single agent for the treatment of adult patients with relapsed or refractory MCL
Waldenström’s macroglobulinemia (WM): As a single agent for the treatment of adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemo-immunotherapy, and in combination with rituximab for the treatment of adult patients
Ibrutinib is approved in more than 95 countries for at least one indication, and to date, has been used to treat more than 170,000 patients worldwide across its approved indications.6

The most common adverse reactions seen with ibrutinib include diarrhoea, neutropenia, haemorrhage (e.g., bruising), musculoskeletal pain, nausea, rash, and pyrexia.3

For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.

About chronic lymphocytic leukaemia

Chronic lymphocytic leukaemia (CLL) is typically a slow-growing blood cancer of the white blood cells.7 The overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year and is about 1.5 times more common in men than in women.8 CLL is predominantly a disease of the elderly, with a median age of 72 years at diagnosis.9

The disease eventually progresses in the majority of patients, and they are faced with fewer treatment options with each relapse. Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.