On April 25, 2023 AnHorn Medicines, a private biotechnology company focused on the development of precision medicines for degrading disease-causing proteins, reported the successful completion of a $10 million Series A financing (Press release, AnHorn Medicines, APR 25, 2023, View Source [SID1234632788]). This financing will enable AnHorn Medicines to expedite the growth of its pipeline, advance development of drug candidates, and enhance its platform capabilities to rationally design bi-functional degraders and molecular glues that target the known drivers of cancers and other diseases currently unaddressed by conventional methods.

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The Series A financing was led by Taiwania Capital with participation from new investors included TaiAn Technologies, Industrial Technology Investment Corporation, Hong Tai Electric Industrial, Black Marble Capital Management, Mega Venture Capital and Sunplus Technology.

In addition to financial resources, this round of investment brings impressive experience and intellectual resources to AnHorn Medicines in the form of two new members of the Board of Directors:

Bryan Kao, Ph.D., Sr. Investment Manager, Taiwania Capital;

Jo Shen, Ph.D., Common Director;

Chu-Chiang Lin, Ph.D., President and Chief Executive Officer of AnHorn Medicines.

"We are pleased to have the support of this strong group of investors who share our vision and believe in our approach to expand the field of protein degradation into a broader array of diseases." said Chu-Chiang Lin, Ph.D., CEO of AnHorn Medicines.

AnHorn Medicines has built a next-generation protein degradation platform with highly focused and scalable chemical libraries that target critical disease-causing proteins. The team comprise diverse specialties which consists of medicinal chemistry, structural biology, machine learning-based chemistry, and pharmacology.

On April 28, 2023 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, reported FDA orphan drug designation for INB-400 and INB-410, covering a broad range of malignant glioma treatments, including newly diagnosed GBM (Press release, In8bio, APR 25, 2023, View Source [SID1234630669]). As an industry leader in gamma-delta T cell development, this milestone marks the first genetically modified gamma-delta T cell therapy to receive this designation, which offers potential incentives such as 7-year market exclusivity.

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In December 2022, the FDA cleared IN8bio’s investigational new drug application (IND) for a Phase 2 clinical trial in newly diagnosed GBM for INB-400. With Institutional Review Board (IRB) review and site initiation ongoing, patient enrollment is expected to begin in the second half of 2023.

"Our goal is to achieve our Mission of Cancer Zero by eradicating cancer cells and improving patient outcomes," said IN8bio CEO and co-founder, William Ho. "Our novel approach combines engineered, chemo-resistant gamma-delta T cells with standard-of-care treatments to amplify immune signals, maximize tumor killing, and eliminate more cancer cells. We eagerly anticipate enrolling our first Phase 2 patients for INB-400 later this year."

GBM, a highly aggressive and difficult-to-treat brain cancer, has remained largely unchanged in treatment options for over 18 years, with a median progression-free survival of 6-7 months and overall survival of 14-16 months.

Orphan drug designation benefits IN8bio through incentives such as potential additional market exclusivity following approval, tax credits on qualified US clinical trials, eligibility for orphan drug grants, and exemption from certain fees. With this milestone, IN8bio continues to progress its pipeline programs and will provide further clinical updates on its pipeline at medical meetings throughout the year.

About INB-400

INB-400 is IN8bio’s DeltEx chemotherapy resistant autologous and allogeneic DRI technology. Allogeneic INB-400 will expand the application of DRI gamma-delta T cells into other solid tumor types through the development of allogeneic or "off-the-shelf" DeltEx DRI technology.

On April 26, 2023 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that the Company expects to report financial and business results for the first quarter of 2023 after the market closes on Tuesday, May 9, 2023 (Press release, Supernus, APR 25, 2023, View Source;2023.htm [SID1234630549]).

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Jack Khattar, President and CEO, and Tim Dec, Senior Vice President and CFO, will host a conference call to present the first quarter 2023 financial and business results on Tuesday, May 9, 2023 at 4:30 p.m. ET. Following management’s prepared remarks and discussion of business results, the call will be open for questions.

A live webcast will be accessible in the Events & Presentations section of the Company’s Investor Relations website www.supernus.com/investors.

Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.

Following the live call, a replay will be available on the Company’s Investor Relations website www.supernus.com/investors. The webcast will be available on the Company’s website for 60 days following the live call.

Biogen has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On April 25, 2023 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported new data showing DecisionDx-Melanoma can improve risk stratification over American Joint Committee on Cancer (AJCC) staging alone in patients with stage I cutaneous melanoma (CM) (Press release, Castle Biosciences, APR 25, 2023, View Source [SID1234630503]). DecisionDx-Melanoma uses a patient’s tumor biology to provide the patient’s personalized risk of recurrence and metastasis, while AJCC staging is based on the clinical and pathologic risk factors of a patient’s melanoma tumor.

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"Patients with stage I cutaneous melanoma are considered to have a lower risk of recurrence and melanoma-specific mortality; however, due to the large number of patients diagnosed with stage I disease, this patient group accounts for the largest number of deaths from melanoma," said Sebastian Podlipnik, M.D., Department of Dermatology, Hospital Clinic of Barcelona, Spain. "As the study showed, DecisionDx-Melanoma provides more precise risk stratification over staging alone to better predict which patients have a low risk of experiencing a poor outcome and those with more aggressive tumor biology who may benefit from increased clinical surveillance."

The data were presented at the 19th European Association of Dermato-Oncology (EADO) Congress, held in Rome, Italy, in a poster titled, "The 31-gene expression profile outperforms AJCC in stratifying risk of recurrence in patients with stage I cutaneous melanoma." In the study, DecisionDx-Melanoma provided significant and independent risk stratification of patients with stage I CM. Additionally, as reported in the study, the test added valuable prognostic information to AJCC staging to better stratify recurrence-free survival (RFS) and melanoma-specific survival (MSS) among patients with stage I CM.

RFS

AJCC staging

Risk-stratification according to AJCC staging provided low-risk stage IA vs. high-risk stage IB RFS rates of 93.3% vs. 87.6%.

DecisionDx-Melanoma

DecisionDx-Melanoma demonstrated improved risk-stratification of RFS with low-risk Class 1A vs. high-risk Class 2B RFS rates of 97.3% vs. 77.3%.

MSS

AJCC staging

Risk-stratification according to AJCC staging provided low-risk stage IA vs. high-risk stage IB MSS rates of 97.6% vs. 97.9%.

DecisionDx-Melanoma

DecisionDx-Melanoma demonstrated improved risk-stratification of MSS with low-risk Class 1A vs. high-risk Class 2B MSS rates of 98.0% vs. 92.3%.

Importantly, the data demonstrate that patients with AJCC stage I CM who had a high-risk (Class 2B) DecisionDx-Melanoma test result were 5.4 times more likely to die from melanoma compared to patients staged as IB according to AJCC staging. The results of the study support the use of DecisionDx-Melanoma to guide better risk-aligned care in patients considered low risk by staging by identifying high-risk patients who may be missed using only AJCC staging criteria.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile risk stratification test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node (SLN) positivity and a patient’s personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 10,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by more than 40 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through Dec. 31, 2022, DecisionDx-Melanoma has been ordered 120,287 times for patients diagnosed with cutaneous melanoma. More information about the test and disease can be found at www.CastleTestInfo.com.