On April 25, 2023 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported the publication of results in the Journal of Clinical Oncology from the expansion arm of a Phase 1b open label study evaluating pan-RAF inhibitor naporafenib plus MEK inhibitor trametinib (MEKINIST) in patients with NRAS-mutant (NRASm) melanoma (Press release, Erasca, APR 25, 2023, View Source [SID1234639358]).

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"These data support the promising anti-tumor potential of naporafenib in combination with trametinib in patients with NRASm melanoma. There are currently no approved targeted therapies for tumors with NRAS mutations, a mutation type associated with poor prognosis that afflicts about 20% of patients with melanoma," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "The post-immune checkpoint inhibitor setting is an area of high unmet medical need with the current standard of care being chemotherapy. The NEMO trial evaluating chemotherapy in patients with treatment-naïve NRASm melanoma demonstrated an objective response rate (ORR) of 7% and a median progression-free survival (mPFS) of 1.5 months. By comparison, the combination confirmed ORR of 47% and an mPFS of 5.5 months with 200 mg BID of naporafenib and 1 mg QD of trametinib observed by de Braud et al. support the initiation of our pivotal Phase 3 SEACRAFT-2 trial in NRASm melanoma. The higher response rates and prolonged PFS also further reinforce the advantage of this specific dosing regimen. We look forward to working with health authorities this year in order to support first patient dosing in SEACRAFT-2 during the first half of 2024."

Publication Highlights
Initial Evidence for the Efficacy of Naporafenib in Combination with Trametinib in NRAS-Mutant Melanoma: Results From the Expansion Arm of a Phase 1b, Open-Label Study
Dual blockade of the RAS/MAPK pathway has proven to be highly efficacious in patients with BRAF-mutant melanoma. However, similar dual blockade has not been approved in patients with NRASm melanoma. This Novartis-sponsored Phase 1b study evaluated the safety and preliminary efficacy of naporafenib plus trametinib at two recommended doses for expansion in patients with NRAS-mutant melanoma.

Naporafenib plus trametinib demonstrated promising preliminary antitumor activity in heavily pretreated patients
The safety profile of the combination was manageable with low discontinuation rates due to adverse events
Naporafenib 200 mg BID + trametinib 1 mg QD vs. naporafenib 400 mg BID + trametinib 0.5 mg QD:
Confirmed objective response rate: 46.7% (7 of 15 patients) vs. 13.3% (2 of 15 patients)
Median duration of response: 3.75 months vs. 3.75 months
Median progression-free survival: 5.5 months vs. 4.2 months
About Naporafenib

Naporafenib (formerly LXH254) is a potent and selective pan-RAF inhibitor, with a potential first-in-class and best-in-class profile. Naporafenib has been dosed in over 500 patients to date, whereby safety, tolerability, pharmacokinetics, and pharmacodynamics have been established in both monotherapy and in certain combinations, with clinical proof-of-concept (PoC) data in combination with trametinib for NRAS-mutant (NRASm) melanoma, which includes NRAS Q61X melanoma, and preliminary clinical PoC data with trametinib for RAS Q61X in non-small cell lung cancer (NSCLC). Erasca plans to focus initially on advancing and securing regulatory approval for naporafenib plus trametinib in NRASm melanoma as part of the planned Phase 3 SEACRAFT-2 trial and in RAS Q61X tissue agnostic solid tumors as part of the planned Phase 1b SEACRAFT-1 trial, respectively. Erasca is also exploring additional combinations of naporafenib with other proprietary therapeutic agents in our pipeline.

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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