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Inhibrx Announces $200 Million Private Placement Financing

On August 29, 2023 Inhibrx, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company dedicated to the development of therapeutics for oncology and rare diseases, reported that it has entered into a securities purchase agreement for a private placement financing (the "PIPE") that is expected to result in gross proceeds of approximately $200 million (Press release, Inhibrx, AUG 29, 2023, View Source [SID1234634746]). The financing was limited to certain of the Company’s existing investors, which included participation from RA Capital Management as the lead investor, Viking Global Investors, Perceptive Advisors, and TCGX.

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In the PIPE, Inhibrx is selling an aggregate of 3,621,314 shares of its common stock at a price of $19.35 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to an aggregate of 6,714,636 shares of common stock at a purchase price of $19.3499 per pre-funded warrant. Each pre-funded warrant has an exercise price of $0.0001 per share of common stock and is immediately exercisable and remains exercisable until exercised in full. The PIPE is expected to close by August 31, 2023, subject to customary closing conditions.

The securities to be sold in the PIPE, including the shares of common stock underlying the pre-funded warrants, have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Inhibrx has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock and the shares of common stock underlying the pre-funded warrants issued in the PIPE.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

HUTCHMED Receives Breakthrough Therapy Designation in China for Savolitinib for Gastric Cancer

On August 29, 2023 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that the Center for Drug Evaluation of China’s National Medical Products Administration ("NMPA") has granted Breakthrough Therapy Designation ("BTD") to savolitinib for the treatment of locally advanced or metastatic gastric cancer or gastroesophageal junction ("GEJ") adenocarcinoma patients with mesenchymal epithelial transition factor ("MET") amplification who have failed at least two lines of standard therapies (Press release, Hutchison China MediTech, AUG 29, 2023, View Source [SID1234634745]).

The study of savolitinib is a single-arm, multi-center, open-label, Phase II registration study to evaluate the efficacy, safety and tolerability of savolitinib in treating gastric cancer or GEJ adenocarcinoma patients with MET amplification. Primary endpoint is objective response rate ("ORR") evaluated by the Independent Review Committee ("IRC") (RECIST 1.1). Secondary endpoints include progression free survival (PFS) and incidence of various adverse events (AE), among others. The study is expected to enroll approximately 60 patients. Further details may be found at clinicaltrials.gov using identifier NCT04923932.

About Breakthrough Therapy Designation in China

NMPA grants BTD to new drugs that treat life-threatening diseases or serious conditions for which there are no effective treatment options, and where clinical evidence demonstrates significant advantages over existing therapies. Drug candidates with BTD may be considered for conditional approval and priority review when submitting a New Drug Application ("NDA"). This indicates that the development and review of the therapy for this disease indication may be expedited, to address patients’ unmet needs more quickly.

About Gastric Cancer with MET Amplification

MET-driven gastric cancer has a very poor prognosis.1 The ongoing registration trial follows multiple Phase II studies that have been conducted in Asia to study ORPATHYS in MET-driven gastric cancer patients, including VIKTORY.2 VIKTORY is an investigator initiated Phase II umbrella study in gastric cancer in South Korea in which a total of 715 patients were successfully sequenced into molecular-driven patient groups, including those with MET amplified gastric cancer. Patients whose tumors harbor MET amplification were treated with ORPATHYS monotherapy. The VIKTORY study reported a 50% ORR.

At American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 (AACR 2023), it was reported that the interim results from a China Phase II study of savolitinib in patients with MET-amplified GEJ adenocarcinomas or gastric cancer showed a 45% ORR confirmed by IRC and a 50% ORR in patients with high MET gene copy number. Duration of response (DOR) rate at 4-month was 85.7% with median follow up time of 5.5 months. The most common grade≥3 treatment-related adverse events ("TRAE") (≥5%) were platelet count decreased, hypersensitivity, anemia, neutropenia and hepatic function abnormal. Only 1 patient discontinued treatment due to grade 4 liver function abnormal (TRAE) and no patient died due to TRAE.

It is estimated that MET amplification accounts for approximately 4-6% of gastric cancer patients.2,3 The annual incidence of MET amplification gastric cancer is estimated to be approximately 24,000 in China.4

About Savolitinib

Savolitinib is an oral, potent and highly selective MET tyrosine kinase inhibitor that has demonstrated clinical activity in advanced solid tumors. Іt blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression.

Savolitinib is marketed in China under the brand name ORPATHYS for the treatment of patients with non-small cell lung cancer ("NSCLC") with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. Іt is currently under clinical development for multiple tumor types, including lung, kidney and gastric cancers, as a single treatment and in combination with other medicines. Starting on March 1, 2023, ORPATHYS was included in the National Reimbursement Drug List (NRDL) for the treatment of locally advanced or metastatic NSCLC adult patients with MET exon 14-skipping alterations who have progressed after or unable to tolerate platinum-based chemotherapy.

Іn 2011, AstraZeneca and HUTCHMED entered a global licensing and collaboration agreement to jointly develop and commercialize savolitinib. Joint development of savolitinib in China is led by HUTCHMED, while AstraZeneca leads development outside of China. HUTCHMED is responsible for the marketing authorization, manufacturing and supply of savolitinib in China. AstraZeneca is responsible for the commercialization of savolitinib in China and worldwide. Sales of savolitinib are recognized by AstraZeneca.

Erasca, Inc. today announced dosing of the first patient in the SEACRAFT-1 Phase 1b trial in patients with RAS Q61X solid tumors

On August 29, 2023 Erasca, Inc. (the Company) reported dosing of the first patient in the SEACRAFT-1 Phase 1b trial evaluating the Company’s pan-RAF inhibitor naporafenib in combination with the MEK inhibitor trametinib (MEKINIST) in patients with RAS Q61X solid tumors (Press release, Erasca, AUG 29, 2023, View Source [SID1234634744]). RAS Q61X solid tumors affect over 150,000 patients in the United States and Europe. The Company expects to share signal-seeking efficacy data in relevant tumor types from SEACRAFT-1 between the second and fourth quarters of 2024. In addition, the Company is on track to initiate SEACRAFT-2, a pivotal Phase 3 trial to evaluate naporafenib plus trametinib in patients with NRAS-mutant melanoma, in the first half of 2024.

Lilly to Participate in Morgan Stanley 21st Annual Global Healthcare Conference

On August 29, 2023 Eli Lilly and Company (NYSE: LLY) reported that it will attend the Morgan Stanley 21st Annual Global Healthcare Conference, Sept. 11-12, 2023. Daniel Skovronsky, M.D., Ph.D., executive vice president, chief scientific and medical officer, and president of Lilly Research Laboratories, will participate in a fireside chat on Sept. 11 at 2:55 p.m., Eastern time (Press release, Eli Lilly, AUG 29, 2023, View Source [SID1234634743]).

A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

Eagle Pharmaceuticals Announces Positive Type C Meeting with FDA for EA-114, an Estrogen Receptor Antagonist Used in the Treatment of Metastatic Breast Cancer in Post-Menopausal Women

On August 29, 2023 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported a positive Type C meeting with the U.S. Food and Drug Administration ("FDA"). Eagle and the FDA agreed on a path forward to advance the clinical development of EA-114, an estrogen receptor antagonist used in the treatment of breast cancer in post-menopausal women (Press release, Eagle Pharmaceuticals, AUG 29, 2023, View Source [SID1234634742]). EA-114 has the potential to provide healthcare providers with a formulation that meaningfully optimizes the dosing regimen for all fulvestrant patients. Eagle currently anticipates filing a new drug application ("NDA") for EA-114 in 2024. If approved for all uses, EA-114 would allow physicians to provide a personalized treatment regimen to all patients, including specific sub-populations.

Over the course of five years and multiple studies, Eagle has dosed more than 800 people with the brand formulation of fulvestrant and multiple Eagle internally developed formulations. The Company’s rigorous analysis of the data from these studies yielded significant insights which led Eagle to develop a novel formulation, EA-114, which if approved would optimize the dosing regimen of fulvestrant to allow for a more personalized treatment approach. EA-114 has the potential to improve treatment for all fulvestrant patients, including multiple subpopulations. These subpopulations collectively represent approximately half of the total patient population. EA-114 may additionally result in improved patient outcomes.

Eagle is committed to conducting the necessary clinical program to support approval of this novel formulation of fulvestrant. It is anticipated that EA-114 would be approved as a monotherapy and for use in combination with CDK4/6 inhibitors as described in the approved labeling for Faslodex. According to IQVIA, products anticipated to be co-administered with EA-114 have had sales of $7 billion in the 12 months ending June 30th, 2023, and grew by 27% over the prior 12-month period.1

Eagle anticipates filing the NDA in 2024 while pursuing a label expansion for the subpopulations in parallel.

"We are very pleased that the Eagle team’s perseverance, motivated by our desire to help breast cancer patients, has resulted in this novel formulation. We anticipate EA-114 being a very important part of a more personalized treatment regimen for post-menopausal metastatic breast cancer patients," stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. "Eagle is very proud that this development program has been created in-house by the company’s formulation, clinical, and regulatory teams. We believe EA-114 has the potential to become an ever-increasing part of the personalized medicine paradigm in cancer care," concluded Tarriff.

Eagle continues to advance personalized medicine in the oncology sector by working to bring critically needed novel and complementary therapies to market. If approved, this will be Eagle’s seventh internally developed NDA, highlighting the depth of Eagle’s pipeline and its research and development capabilities in the area of medical oncology.

Eagle has filed a patent application pertaining to EA-114 and anticipates pursuing a robust patent portfolio over time. The Company believes EA-114 is eligible for a unique J-code from CMS under the current regulatory framework. In addition, Eagle believes EA-114, if the label expansion for subpopulations is approved, may be eligible for a period of regulatory exclusivity of three years and a separate period of potential patent protection, including potential patents eligible for listing in the Orange Book.

Currently, fulvestrant is indicated as monotherapy first-line endocrine treatment in post-menopausal women with hormone receptor-positive metastatic breast cancer (MBC) and in combination therapy to treat hormone receptor positive, advanced breast cancer in women whose breast cancer has spread or worsened after being treated with anti-estrogen medications.

Eagle intends to provide additional updates on the progress of the EA-114 development program for the sub-populations as discussions with the FDA progress.