On January 23, 2023 Chimeric Therapeutics (ASX:CHM, "Chimeric" or the "Company"), a clinical stage cell therapy company and an Australian leader in cell therapy, is pleased to provide an update to 22 December 2022 reported and confirm that all patients dosed in the 3rd patient cohort in City of Hope National Medical Center’s phase 1A CHM 1101 (CLTX CAR T) cell therapy clinical trial have now advanced beyond the 28-day follow up period without experiencing doselimiting toxicities (Press release, Chimeric Therapeutics, JAN 23, 2023, View Source [SID1234626447]).

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Patients in the 3rd dose cohort received a total dose of 240 X 106 CHM 1101 (CLTX CAR T) cells through dual routes of intratumoral (ICT) and intraventricular (ICV) administration.

Achievement of this milestone enables the trial to advance to the 4th and final dose cohort wherein subjects will be treated with a total dose of 440 X 106 CHM 1101 CAR T cells by ICT and ICV administration.

City of Hope, one of the largest cancer research and treatment organizations in the United States, initiated and is leading the current Phase 1A CHM 1101 (CLTX CAR T) cell therapy clinical trial. Chimeric Therapeutics has licensed the exclusive global rights to intellectual property covering the chlorotoxin CAR-T cells from City of Hope.

The Phase 1A study aims to enroll 18-36 patients with MMP2+ recurrent or progressive GBM across four dose levels. Study objectives are to evaluate the safety and efficacy of CLTX CAR T and to establish recommended dosing for a phase 2 trial.

On January 23, 2023 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported the company has entered into a collaboration with Swixx BioPharma AG to commercialize ORLADEYO (berotralstat) in Central and Eastern Europe (CEE) (Press release, BioCryst Pharmaceuticals, JAN 23, 2023, View Source [SID1234626446]).

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"We continue to build partnerships with companies that have deep expertise in commercializing rare disease therapies as we advance our mission of bringing ORLADEYO to patients living with hereditary angioedema around the world. The team at Swixx is highly skilled at launching rare disease therapies in Central and Eastern Europe, and we are thrilled to work alongside them to bring our oral, once-daily prophylactic treatment for HAE to patients in this region," said Charlie Gayer, chief commercial officer of BioCryst.

"Based on our unrivaled understanding of the rare disease landscape in CEE, we believe we are best suited to help BioCryst bring ORLADEYO to patients living with HAE in the countries within this region. It goes without saying that there are significant unmet needs among HAE patients in CEE, and our experienced commercial team is well equipped to bring this important long-term prophylactic therapy to the people who need it most," said Jean-Michel Lespinasse, chief executive officer of Swixx.

Under the terms of the agreement, Swixx will be responsible for commercializing ORLADEYO in 15 markets within CEE.

Swixx is a Swiss-based biopharmaceutical company that has extensive experience with providing end-to-end services to its partner companies to bring therapies for rare diseases to patients living in CEE, with a strategic business unit focused on rare and ultra-rare diseases.

About ORLADEYO (berotralstat)
ORLADEYO (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older. One capsule of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.

U.S. Indication and Important Safety Information

INDICATION

ORLADEYO (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.

Limitations of use

The safety and effectiveness of ORLADEYO for the treatment of acute HAE attacks have not been established. ORLADEYO should not be used for the treatment of acute HAE attacks. Additional doses or dosages of ORLADEYO higher than 150 mg once daily are not recommended due to the potential for QT prolongation.

IMPORTANT SAFETY INFORMATION

An increase in QT prolongation was observed at dosages higher than the recommended 150 mg once-daily dosage and was concentration dependent.

The most common adverse reactions (≥10% and higher than placebo) in patients receiving ORLADEYO were abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease.

A reduced dosage of 110 mg taken orally once daily with food is recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C) and in patients taking chronically administered P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) inhibitors (eg, cyclosporine).

Berotralstat is a substrate of P-gp and BCRP. P-gp inducers (eg, rifampin, St. John’s wort) may decrease berotralstat plasma concentration, leading to reduced efficacy of ORLADEYO. The use of P-gp inducers is not recommended with ORLADEYO.

ORLADEYO at a dose of 150 mg is a moderate inhibitor of CYP2D6 and CYP3A4. For concomitant medications with a narrow therapeutic index that are predominantly metabolized by CYP2D6 or CYP3A4, appropriate monitoring and dose titration is recommended. ORLADEYO at a dose of 300 mg is a P-gp inhibitor. Appropriate monitoring and dose titration is recommended for P-gp substrates (eg, digoxin) when coadministering with ORLADEYO.

The safety and effectiveness of ORLADEYO in pediatric patients <12 years of age have not been established.

There are insufficient data available to inform drug-related risks with ORLADEYO use in pregnancy. There are no data on the presence of berotralstat in human milk, its effects on the breastfed infant, or its effects on milk production

On January 23, 2023 BIOASIS TECHNOLOGIES INC. (OTCQB:BIOAF; TSX.V:BTI) (the "Company" or "Bioasis"), a multi-asset rare and orphan disease biopharmaceutical company developing clinical stage programs based on epidermal growth factor and a differentiated, proprietary xB3 platform for delivering therapeutics across the blood-brain barrier ("BBB") and the treatment of central nervous system ("CNS") disorders in areas of high unmet medical need, reported that it has terminated the arrangement agreement (the "Arrangement Agreement") dated December 13, 2022, as amended December 18, 2022, between Bioasis and Midatech Pharma plc ("Midatech") (Press release, Bioasis Technologies, JAN 23, 2023, View Source [SID1234626445]). The Arrangement Agreement provided for Midatech’s acquisition of all of Bioasis’ issued and outstanding shares in exchange for ordinary shares of Midatech by way of a statutory plan of arrangement under the laws of British Columbia (the "Arrangement").

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One of the conditions precedent to completion of the Arrangement was approval of the Arrangement and a number of related matters by the Midatech shareholders. Midatech has announced that its shareholders did not approve the Arrangement at the general meeting of Midatech shareholders held earlier today.

As a result, the Arrangement cannot proceed and Bioasis has provided written notice to Midatech that it has exercised its right to terminate the Arrangement Agreement. Under the terms of the Arrangement Agreement, Midatech is required to make an expense reimbursement payment to Bioasis of US$225,000. A copy of the Arrangement Agreement is available on Bioasis’ company profile at www.sedar.com.

Bioasis is disappointed that the Midatech shareholders did not support the Arrangement, which it believes would have been in the best interests of both companies and their respective stakeholders. With the termination of the Arrangement Agreement, Bioasis will continue to explore and evaluate strategic alternatives to enhance shareholder value, including continuing as a standalone company and evaluating potential strategic transactions or partnerships as well as any financing alternatives that may be available.

Bioasis’ existing cash reserves, together with the proceeds of the expense reimbursement payment and the final US$250,000 instalment of the bridge loan payable by Midatech on February 6, 2023, are currently expected to allow Bioasis to continue operations until approximately March 2023. Bioasis will require additional financing to continue as a going concern and to satisfy its ongoing obligations under the convertible security funding agreement between Bioasis and Lind Global Macro Fund, LP ("Lind") and to repay the US$750,000 bridge loan from Midatech and the C$350,000 bridge loan from Lind, both of which mature on June 30, 2023 and are secured by a pledge of all of Bioasis’ assets.

On January 23, 2023 Bayer reported that its iodine-based contrast agent Ultravist-300, -370 is now approved for contrast-enhanced mammography (CEM) in the EU (Press release, Bayer, JAN 23, 2023, View Source [SID1234626444]). The product can be used to evaluate and detect lesions of the breast as an adjunct to mammography (with or without ultrasound) or as an alternative when a magnetic resonance imaging (MRI) is contraindicated or unavailable. Following the approval of the European Workshare Procedure (a decentralized mutual recognition process on EU level), the first national approvals in the EU are expected in the first quarter of 2023. CEM is an emerging modality that combines digital mammography with the administration of a contrast agent, such as Ultravist, to support the diagnosis of breast cancer and guide treatment decisions. The approval expands Bayer’s radiology portfolio, which includes contrast media, injectors as well as digital and artificial intelligence (AI) enabled solutions, supporting radiologists across a broad range of diseases including breast cancer.

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"Breast cancer is the most common cancer worldwide, impacting millions of women and their loved ones around the world," said Dr. Julia Camps Herrero, Corporate Chief of Breast Health, Ribera Salud Hospitals Spain. "Early detection of cancer can save lives. Imaging options such as contrast-enhanced mammography can help improve diagnostic accuracy, potentially identifying cancers that otherwise might have been missed."

"The approval of Ultravist-300 and -370 in contrast-enhanced mammography gives physicians a new imaging option where conventional mammography might not be enough," said Dr. Konstanze Diefenbach, Head of Radiology Research and Development, Bayer. "We are pleased to be able to offer additional options for breast imaging to healthcare professionals, as we aim to support them in their role of providing clear direction from diagnosis to care for patients."

About breast cancer and contrast-enhanced mammography

In 2020, there were 2.3 million women diagnosed with breast cancer and 685 000 deaths globally, according to the World Health Organization (WHO). Breast cancer treatment can be very effective, especially when the disease is identified early. CEM is a highly sensitive and relatively low-cost breast imaging examination, with an increasing number of independent scientific publications affirming its value as an adjunct to mammography. It is easy to perform in everyday clinical practice and can be used in various clinical settings, such as inconclusive findings in previous imaging procedures, or preoperative assessment of the extent of the disease. It can also be a helpful tool when MRI is unavailable or contraindicated.

Public health education about early detection and imaging options is a key factor in fighting breast cancer. Bayer is committed to driving information about this important topic. The company recently launched a global digital information hub to help encourage women to take an active role and make informed decisions about their health: View Source

About Ultravist

Ultravist is an iodine-based contrast medium for X-ray techniques requiring contrast enhancement such as conventional radiography, angiography and computed tomography. Available in more than 100 countries, Ultravist is currently being applied more than 18 million times a year. Depending on the country, Ultravist is approved for use across a vast range of indications such as CT of the head, chest, heart, abdomen, and liver; multi-detector CT for stroke/ischemic damage and imaging of the abdominal viscera; CT angiography of vessels in the head, heart and peripheral parts of the body; conventional radiology for duct systems/body cavities and urography; contrast enhancement of body cavities, e.g., arthrography; and pediatric imaging, including in very young children.

About Radiology at Bayer

As a true life-science company with a heritage of over 100 years in Radiology, Bayer is committed to providing excellence, from innovative products to high-quality services, to support efficient and optimized patient care. Bayer offers a leading portfolio of contrast media for computed tomography (CT), X-Ray, and magnetic resonance imaging (MRI), devices for their precise administration, informatics solutions and a medical imaging platform delivering access to applications, including those enabled by AI. Bayer’s Radiology products generated a total of €1.8bn sales in 2021. Based on the company’s ambition to outperform the radiology market’s average annual growth rate of 5% by 2030, Bayer is highly committed to research and development, which includes leveraging artificial intelligence and driving innovation in medical imaging. Each of these offerings provides effective tools to support radiologists in their mission to deliver treatment-critical answers and a clear direction – from diagnosis to care.

On January 21, 2023 Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, reported preclinical data on WU-NK-101, the company’s lead memory natural killer (NK) cell therapy product, in combination with cetuximab (Ctx), at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium taking place January 19-21, 2023, in San Francisco, California (Press release, Wugen, JAN 21, 2023, View Source [SID1234626433]).

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"Our best-in-class memory NK cell platform is uniquely designed to have broad applications across solid and liquid tumors," said Jan Davidson-Moncada, M.D., Ph.D., Chief Medical Officer of Wugen."WU-NK-101 has a unique CIML phenotype with enhanced metabolic fitness/flexibility and decreased susceptibility to immunosuppression—key properties that in combination with these data, build our conviction in the development trajectory for WU-NK-101 as a novel treatment for solid tumor cancers. We plan to initiate a first-in-human study of WU-NK-101 in combination with cetuximab for CRC in addition to SCCHN later this year."

Today’s presentation highlighted the following:

WU-NK-101 potency against colorectal cancer (CRC) cells was further enhanced when combined with Ctx in vitro and in vivo, confirming an antibody-dependent cellular cytotoxicity (ADCC) mechanism of action. WU-NK-101 in combination with Ctx showed improved CRC cell killing compared to WU-NK-101 and Ctx monotherapy.

WU-NK-101 showed robust homing to the TME, which was further improved when combined with monoclonal antibodies (mAbs). Intra-tumor penetration and persistence was also increased when combined with mAb in in vivo models.

WU-NK-101 displayed enhanced metabolic fitness/flexibility and maintained cytotoxicity within adverse, immunosuppressive tumor microenvironment (TME)-aligned media as compared to conventional NK (cNK) and T-cells. WU-NK-101 cells maintained cytotoxicity in a 3D TME model with native cellular components from primary CRC samples.

A Phase 1b clinical trial of WU-NK-101 in combination with Ctx for advanced and/or metastatic CRC and advanced and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) is in development.

The details of Wugen’s presentation at ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium are as follows:

Title: WU-NK-101, an Enhanced Memory Natural Killer (NK) Cell Therapy, with Cetuximab (Ctx) for the Treatment of Advanced Colorectal Cancer (CRC).
Abstract Number: 170
Session Name: Poster Session C: Cancers of the Colon, Rectum, and Anus
Session Date and Time: Saturday, January 21, 2023 from 9:30 a.m. – 10:55 a.m. ET
Location: On Demand | Level 1, West Hall
Presenting Author: John Muth, Wugen

Additional meeting information can be found at View Source

About WU-NK-101

WU-NK-101 is a novel immunotherapy harnessing the power of memory natural killer (NK) cells to treat liquid and solid tumors. Memory NK cells are hyper-functional, long-lasting immune cells that exhibit enhanced anti-tumor activity and a cytokine-induced memory-like (CIML) phenotype. This rare cell population has a superior phenotype, proliferation capacity, and metabolic fitness that makes it better suited for cancer therapy than other NK cell therapies. Wugen is applying its proprietary MonetaTM platform to advance WU-NK-101 as a commercially scalable, off-the-shelf cell therapy for cancer. WU-NK-101 is currently in development for acute myelogenous leukemia (AML) and solid tumors.

About Wugen