On May 29, 2020 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer, reportted interim data from an ongoing Phase II clinical trial in which oral paclitaxel and encequidar ("Oral Paclitaxel", formerly known as Oraxol) monotherapy showed encouraging efficacy and tolerability in elderly patients with unresectable cutaneous angiosarcoma, an aggressive malignancy with poor prognosis (Press release, Athenex, MAY 29, 2020, View Source [SID1234573876]). The interim results are being presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 (ASCO20) Virtual Scientific Program, being held from May 29 to 31, 2020, and reflect data from 22 evaluable patients out of 26 enrolled patients (16 males and 10 females, median age 75 years (range: 49-93 years)).

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The interim data showed a clinical benefit rate (CR+PR+SD) of 100% in 22 evaluable patients receiving Oral Paclitaxel treatment, who reached their first post treatment efficacy evaluation. All 22 patients experienced reduction in tumor size. Complete responses (CR) were observed in 27.3% of patients (6/22), partial responses (PR) were observed in 22.7% of patients (5/22), and stable disease was observed in 50% of patients (11/22). Oral Paclitaxel has been generally well tolerated in this predominantly elderly population.

"The responses to Oral Paclitaxel observed thus far are very encouraging, especially given the highly aggressive nature of cutaneous angiosarcoma and the lack of approved treatment options for this disease," said lead investigator Vinod Ravi, MD, MBA, associate professor in the Department of Sarcoma Medical Oncology in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston, Texas. "Oral Paclitaxel appears to be well tolerated, even in older patients. We look forward to continue advancing the study, which will allow us to further characterize this potentially valuable treatment option for angiosarcoma."

Dr. Rudolf Kwan, Chief Medical Officer of Athenex, commented, "The interim data in this Phase II trial add to the growing body of evidence supporting the potential broad clinical utility of Oral Paclitaxel, which has already shown strong clinical data in a Phase III pivotal trial in patients with metastatic breast cancer."

The interim Phase II data, presented as Poster #11517 A Phase II Study of Oral Paclitaxel with Encequidar in the Treatment of Unresectable Cutaneous Angiosarcoma will be part of the Sarcoma Highlights Session on Sunday, May 31 at 3:30pm ET, at the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program. A copy of the poster presentation is available on Athenex’s website here.

About the Phase II Study of Oral Paclitaxel in Angiosarcoma

This single-arm Phase II study evaluates the activity, safety and tolerability of Oral Paclitaxel administered once daily for three consecutive days per week in patients with unresectable cutaneous angiosarcoma. Enrollment is ongoing at sites in the U.S., United Kingdom, Hong Kong and Taiwan, with a planned total enrollment of 43 subjects. For more information, refer to ClinicalTrials.gov Identifier: NCT03544567.

In April 2018, the U.S. Food and Drug Administration granted an Orphan Drug Designation for Oral Paclitaxel for the treatment of angiosarcoma. In addition, in October 2019, the Company received Orphan Designations from the European Commission for oral paclitaxel and encequidar for the treatment of soft tissue sarcoma.

The Orascovery platform, based on P-gp pump inhibition technology, was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

On May 29, 2019 Sihuan Pharmaceutical Holdings Group Ltd. (HKEx: 0460), the largest cardio-cerebral vascular ("CCV") drug manufacturer in China’s prescription drug market, reported the third generation of EGFR inhibitor XZP-5809, a Category 1 innovative drug developed by the Group, has been granted drug clinical trial approval by the National Medical Products Administration of the PRC (Press release, Sihuan Pharmaceutical, MAY 29, 2019, View Source [SID1234570979]).. The New Drug is a Category 1 innovative drug of the PRC developed by the Group .

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The New Drug is a novel third-generation epithelial growth factor receptor-tyrosine kinase inhibitor (”EGFR-TKI”) that has strong targeting capability, and can be taken orally. It features innovative structure, established mechanism and irreversible binding to EGFR. The New Drug has better selection with higher activity against gene-mutation EGFR and lower activity against wild-type EGFR.

Compared with products of the same type, the New Drug has distinct advantages in its activity and safety, based on the data collected from the completed preclinical trial. The New Drug and its metabolite have demonstrated lower activity against wild-type EGFR. With its better safety profile and global competitive advantage, the New Drug will be considered as a new treatment option for cancer patients.

Dr. Che Fengsheng, Chairman and CEO of Sihuan Pharmaceutical, said, "Significant progress has been made in the field of lung cancer treatment, including anti-cancer immunotherapy, but targeted therapy is still considered the best choice for non-small cell lung cancer (‘NSCLC’) with EGFR mutation."

The preclinical pharmacodynamic data and toxicological data indicate that the New Drug has the following characteristics: good efficacy against EGFR sensitive mutations (exon 19 deletion and L858R mutation) and against acquired resistance mutations (T790M mutation); potential clinical efficacy for patients with lung cancer brain metastasis; better safety profile and less impact on cardiac function when compared with drugs of the same type on the market. The clinical indication for the New Drug candidate is potential to be solid tumors such as locally advanced or metastatic lung cancer with EGFR-sensitive mutations (exon 19 deletion and L858R mutation) and acquired resistance mutations (T790M mutation).

Dr. Che stated, "The Group is committed to the fundamental research of innovative drugs, and finally obtains the clinical trial approval of the New Drug by overcoming the technical difficulties encountered. The obtained clinical trial approval for the New Drug will further enrich the Group’s product line layout in innovative drugs. In addition to the New Drug, the Group currently has Janagliflozin, an innovative drug in the field of anti-diabetes and a number of small molecule targeted innovative drugs such as Birociclib in the field of anti-tumor are in clinical trials and are making progress well. The layout of innovative drugs in various therapeutic fields has established a solid foundation for the Group’s research and development platform of innovative drugs."

Lung cancer is one of the malignant tumors with the highest morbidity and mortality in the world. In 2018, the number of cases of lung cancer around the world was 2.093 million. According to the cancer report statistics of the PRC, in terms of the number of cases, lung cancer ranks the first in the incidence of malignant tumors with approximately 781 thousand as the annual incidence cases number. According to the World Health Organization’s forecast, the number of lung cancer deaths in the PRC will exceed 1 million each year by 2025.

On May 29, 2020 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported at the ASCO (Free ASCO Whitepaper) Annual Meeting presented a preclinical update for its novel, clinical-stage, selective RET-inhibitor drug candidate, TPX-0046 (Press release, Turning Point Therapeutics, MAY 29, 2020, View Source [SID1234564371]).

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In the updated preclinical studies comparing proxy molecules for approved and investigational RET inhibitors, TPX-0046 demonstrated potent in vitro and in vivo activity against a range of RET alterations, including greater potency against solvent-front mutations, G810S, G810R, G810C and G810N.

A phase 1/2 trial of TPX-0046 in RET TKI-naïve and -pretreated patients is ongoing.

"TPX-0046 was designed as a potent RET inhibitor with the potential to address TKI-naïve and RET inhibitor-resistant RET-dependent cancers," said Alexander Drilon, M.D., medical oncologist and acting chief of the Early Drug Development Service, Memorial Sloan Kettering Cancer Center, and a principal investigator for the TPX-0046 clinical study. "Specifically, in preclinical studies, TPX-0046 inhibited RET solvent front mutations that have been observed in biopsies from patients with progression on a prior RET inhibitor. Developing a next-generation RET inhibitor is an unmet need."

In enzymatic and cellular assays presented at ASCO (Free ASCO Whitepaper), TPX-0046 was potent against wildtype RET and multiple RET mutations and fusions.TPX-0046 also demonstrated antitumor activity in RET-driven cell-derived and patient-derived xenograft tumor models, including those that harbor a RET G810R solvent-front mutation.

The ongoing Phase 1/2 open-label, single-arm, multi-center clinical study of TPX-0046 is enrolling TKI-naïve and -pretreated patients with RET-altered non-small-cell lung, thyroid, and other advanced cancers in a Phase 1 dose escalation study of approximately 50 patients, and Phase 2 expansion study of approximately 300 patients with multiple cohorts, to assess safety, tolerability, pharmacokinetics (PK) and clinical activity. The study design allows intra-patient dose escalation based on tolerability. For more information, visit clinicaltrials.gov and search NCT04161391.

"The preclinical studies we are presenting today support a potential role for TPX-0046 in both TKI-naïve and TKI-pretreated patients," said Athena Countouriotis, M.D., president and chief executive officer of Turning Point Therapeutics. "With a compact design, and lower molecular weight than other investigational or approved RET inhibitors, TPX-0046 has shown encouraging preclinical activity against multiple RET G810 mutations, where there are currently no approved therapeutic options for patients."

TPX-0046 is a multi-targeted RET and SRC kinase inhibitor with a novel three-dimensional macrocyclic structure that is smaller and structurally distinguished from other approved or investigational RET inhibitors. Activation of RET– a receptor tyrosine kinase –through gain-of-function mutations or fusions has been found in multiple tumor types, including non-small-cell lung and thyroid cancers. In preclinical studies TPX-0046 spared vascular endothelial growth factor (VEGF) receptors 1, 2 and 3. According to research published in the European Journal of Cancer1, hypertension was the most common adverse effect (up to 46 percent) among multiple anti-cancer therapeutics that inhibit VEGF. Dual inhibition of RET and SRC represents a novel therapeutic strategy to target abnormal RET signaling in cancers. Inhibition of SRC family kinases has the potential to reduce bypass resistance from signaling through multiple receptor tyrosine kinases and therefore has the potential to increase the therapeutic effect of TPX-0046.

On May 29, 2020 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, reported the presentation of two new studies at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting demonstrating the ability of Myriad’s riskScore test to provide personalized breast cancer risk information that allows patients and physicians to make better informed clinical treatment decisions (Press release, Myriad Genetics, MAY 29, 2020, View Source [SID1234561736]).

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"We are excited to further demonstrate Myriad’s commitment to providing the best possible risk assessment tools to patients through innovation," said Nicole Lambert, president of Myriad Oncology, Myriad Women’s Health and Myriad International. "The validation data we are presenting at ASCO (Free ASCO Whitepaper) this year will support a broader launch of riskScore to even more women in the coming year with more personalized information and the unique ability to modify carrier risk through a clinically validated tool."

Summaries of the studies are below. Follow Myriad on Twitter via @myriadgenetics and keep up to date with ASCO (Free ASCO Whitepaper) meeting news and updates by using the #ASCO20 hashtag.

riskScore Presentations at 2020 ASCO (Free ASCO Whitepaper):

Title: Comprehensive breast cancer (BC) risk assessment for CHEK2 carriers incorporating a polygenic risk score (PRS) and the Tyrer-Cuzick (TC) model
Presenter: Mark E. Robson, MD, Memorial Sloan Kettering Cancer Center
Location: View Source

In this study, 358,471 women with hereditary cancer risk who were tested with a multigene panel were assessed to find 4,331 women who were carriers of deleterious CHEK2 mutations. These patients were used to develop a mathematical model to assess risk status using family history information and Myriad’s riskScore test. This model was then validated in an independent cohort of 459 women. In CHEK2 pathogenic variant carriers, a significant correlation was detected of CHEK2 status with family history (FH) (p=4.1 × 10-17) and of polygenic risk scores with FH among CHEK2 carriers (p=1.7× 10-5). Among the patients in the validation cohort, 24.0% of CHEK2 carriers were categorized as low risk (<20%), and 62.6% were categorized as moderate risk (20-50%). For 13.4% of CHEK2 carriers, risk estimation incorporating PRS and TC generated BC risks of greater than 50%, consistent with genes recognized as highly penetrant.

To view Graph 1: Precision Breast Cancer Risk Categorization of CHEK2 Carriers, please visit the following link:
View Source

Title: Performance of the IBIS/Tyrer-Cuzick (TC) Model by Race/Ethnicity in the Women’s Health Initiative
Presenter: Allison W. Kurian, M.D., M.Sc, Stanford University
Location: View Source

In this study, 91,893 women of differing racial identities with no personal history of breast cancer were followed for a median of 18.9 years to assess incidence of breast cancer. 6,836 new cases of breast cancer were diagnosed among the women. The Tyrer-Cuzick model was used to assess risk of breast cancer and then actual cases of breast cancer were compared to expected cases based upon the Tyrer-Cuzick risk assessment. The study found that the Tyrer-Cuzick model was an accurate predictor of breast cancer risk among various ethnicities except for Hispanic women where it overestimated breast cancer risk (ratio of observed versus expected cases overall was 0.95).

About riskScore
riskScore is a new clinically validated personalized medicine tool that enhances Myriad’s myRisk Hereditary Cancer test. riskScore helps to further predict a women’s lifetime risk of developing breast cancer using clinical risk factors and genetic-markers throughout the genome. The test incorporates data from more than 80 single nucleotide polymorphisms identified through 20 years of genome wide association studies in breast cancer and was validated in our laboratory to predict breast cancer risk in women of European descent. This data is then combined with a best-in-class family and personal history algorithm, the Tyrer-Cuzick model, to provide every patient with individualized breast cancer risk.

About Myriad myRisk Hereditary Cancer
The Myriad myRisk Hereditary Cancer test uses an extensive number of sophisticated technologies and proprietary algorithms to evaluate 35 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma.

On May 29, 2020 Isofol Medical AB’s (publ) (Nasdaq First North Premier Growth Market: ISOFOL) ("Isofol" or the "Company"), reported that it has been informed by Professor Bengt Gustavsson – founder and largest owner of Isofol – that Professor Gustavsson has initiated that all the subscription rights held by Biofol AB (an affiliated company to Professor Gustavsson), obtained in connection with the fully guaranteed preferential rights issue of approximately SEK 150 million, has been purchased by a consortium of investors (Press release, Isofol Medical, MAY 29, 2020, View Source [SID1234561578]).

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The consortium of investors has committed to Professor Gustavsson that they will subscribe for new shares in the rights issue by utilizing the purchased subscription rights.

Furthermore, Isofol has been informed by Professor Gustavsson that he intends to subscribe for new shares in the rights issue by utilizing the subscription rights Professor Gustavsson holds privately.