On November 15, 2022 RadioMedix and Vect-Horus reported that they have successfully dosed the first patients in an exploratory Investigational New Drug (eIND) application to evaluate 68Ga-RMX-VH for the diagnostic of Glioblastoma Multiforme (GBM) and Pancreatic ductal adenocarcinoma (PDAC) (Press release, Vect-Horus, NOV 15, 2022, View Source [SID1234624208]). This radiotracer will serve as a companion diagnostic for future Targeted Alpha Therapy (TAT) for these cancers. 68Ga-RMX-VH is a positron-emitting tomography (PET) agent that targets the Low-Density Lipoprotein Receptor (LDLR) overexpressed in some solid tumors such as GBM and PDAC. The objective of this exploratory study is to evaluate the safety, dosimetry, and bio-distribution of 68Ga-RMX-VH in patients with solid tumors. GBM is the most common malignant primary brain tumor in adults and is a serious and life-threatening disease. PDAC is one of the most chemo-resistant and radio-resistant types of cancers due to the dense pancreatic connective tissue and the diversity of genetic mutations. RadioMedix and Vect-Horus have already signed a co-development and a licensing agreement. Both parties will share the costs of development until Phase 1 for diagnostic and radiotherapy. RadioMedix is leading the clinical development and future commercialization.

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"Both GBM and PDAC are considered among the most aggressive human cancers. Our current therapeutic approaches for these cancers are invasive and fail meaningful results while adversely effects on the quality of life of our patients. Our approach starts with PET/CT imaging of the diagnostic version of the drug to confirm adequate targeting of the cancers and then applying a therapeutic version of the drug to mainly target the malignant cells while sparing normal organs. All these are accomplished with simple intravenous administration of the drugs." said Dr Ebrahim Delpassand, Chairman and CEO of RadioMedix. "Another complexity of treating GBM is being able to deliver the drug to the tumor by crossing the blood-brain barrier. Our preliminary results suggest that RMX-VH ligand can accomplish this task". Added Dr. Delpassand

"The favorable results of the first PET/CT imaging scans of GBM and PDAC patients are the culmination of the extensive pre-clinical studies done by RadioMedix and Vect-Horus teams. RadioMedix is serving as a Sponsor and manufacturer of the clinical doses of 68Ga-RMX-VH.", said Dr. Izabela Tworowska, CSO of RadioMedix. "Our company has a track record in the translation of radiotheranostics drugs, and we are committed to improving diagnosis and therapy of GBM and PDAC", added Dr. Tworowska.

"We are excited to have successfully treated the first patients with 68Ga-RMX-VH. The preclinical and preliminary clinical data to date indicates potential diagnostic of this agent and we look forward to generating further evidence as we progress" said Dr. Temsamani, Director of Drug Development of Vect-Horus.

"The initiation of this clinical trial is an important milestone for Vect-Horus as it marks the initiation of the clinical program of the imaging candidate, 68Ga-RMX-VH and our transition to a clinical-stage Company. We are looking forward to generating clinical data together with our partner RadioMedix with the aim of improving both diagnostic and therapy for cancer patients and addressing this significant unmet medical need," said Alexandre Tokay, CEO of Vect-Horus.

On November 15, 2022 Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, reported that Linda Neuman, M.D., M.B.A. has been appointed chief medical officer (Press release, Aeglea BioTherapeutics, NOV 15, 2022, View Source [SID1234624165]). Dr. Neuman’s appointment is an internal promotion from her previous role as Aeglea’s senior vice president of clinical development.

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"Linda brings significant medical expertise and drug development experience to the Aeglea leadership team and will play an important role in helping to guide the development strategy for pegtarviliase and the rest of our portfolio," said Jim Kastenmayer, Ph. D., J.D., interim chief executive officer and general counsel of Aeglea. "Linda has proven that she has the creative and flexible leadership required to navigate the complexities of drug development and has made a significant impact on our medical strategy since joining our team. I am excited to continue working closely with Linda as a valued member of our executive leadership team."

Prior to joining Aeglea in 2021, Dr. Neuman served as vice president, clinical development at Catalyst Biosciences where she led the clinical development of their late-stage development program for a novel hemophilia treatment. Before Catalyst, she served as the interim chief medical officer at Adverum Biotechnologies, where she directed the early phase development for three gene therapy programs, including two Investigational New Drug Applications (IND) in rare disease and ophthalmology indications. She previously worked at Sunesis Pharmaceuticals where she led the filing of an Investigational New Drug (IND) application and initiated a Phase 1b/2 clinical study and Puma Biotechnology, Inc., where she contributed to the successful New Drug Application (NDA) and Market Authorization Application (MAA) for neratininb. She began her career as an internist and practiced medicine for 10 years prior to joining industry. Dr. Neuman earned an M.D. from Southern Illinois University School of Medicine, a B.S. in biology from Southern Illinois University, and an M.B.A from Indiana Wesleyan University.

On November 15, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its executives will be speaking at the following investor conferences (Press release, Gilead Sciences, NOV 15, 2022, View Source [SID1234624164]):

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Evercore ISI Annual HealthCONx Conference on Tuesday, November 29 at 1:00 PM Eastern Time

Piper Sandler Healthcare Conference on Wednesday, November 30 at 11:30 AM Eastern Time

Nasdaq Investor Conference on Wednesday, December 7 at 1:00 PM Greenwich Mean Time

The live webcasts can be accessed at the company’s investors page at investors.gilead.com. The replays will be available for at least 30 days following the presentation.

On November 15, 2022 Palisade Bio, Inc. (Nasdaq: PALI), a clinical stage biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, reported a 1-for-50 reverse split of its common stock, par value $0.01 ("Common Stock") (Press release, Seneca Biopharma, NOV 15, 2022, View Source [SID1234624155]). Beginning on November 16, 2022, the Company’s Common Stock will continue to trade on The Nasdaq Capital Market ("Nasdaq") on a split adjusted basis under the trading symbol "PALI," but will trade under the following new CUSIP number starting November 16, 2022: 696389204.

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The reverse stock split was approved by Palisade Bio’s stockholders at the special meeting of stockholders held on October 4, 2022. The reverse stock split is primarily intended to increase the Company’s per share trading price and bring the Company into compliance with the Nasdaq’s listing requirement regarding minimum share price.

As a result of the reverse stock split, every 50 shares of Common Stock issued and outstanding as of the effective date will be automatically combined into one share of Common Stock. Outstanding warrants, equity-based awards and other outstanding equity rights will be proportionately adjusted by dividing the shares of Common Stock underlying the securities by 50 and multiplying the exercise/conversion price, as the case may be, by 50. No fractional shares will be issued as a result of the reverse stock split. Stockholders of record otherwise entitled to receive a fractional share as a result of the reverse stock split will receive a cash payment in lieu of such fractional shares. The par value of the Common Stock will remain unchanged at $0.01 per share after the reverse split. The reverse split affects all stockholders uniformly and will not alter any stockholder’s percentage interest in the Company’s equity, except to the extent that the reverse split results in some stockholders owning a fractional share as described above.

Additional information concerning the reverse stock split can be found in Palisade Bio’s definitive proxy statement filed with the Securities and Exchange Commission on August 31, 2022.

On November 15, 2022 WuXi Vaccines, a leading global Contract Development and Manufacturing Organization (CDMO), reported that it has entered into an agreement with Harbour BioMed under which Harbour BioMed’s manufacturing facility in Suzhou will be transferred to WuXi Vaccines (Press release, Harbour BioMed, NOV 15, 2022, View Source [SID1234624150]).

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The 8,500-square-meter facility includes multiple 250L, 500L and 1000L single-use bioreactors as well as sterile drug-product manufacturing lines. This facility, a new node within WuXi Vaccines global network, will be renovated to provide industry-leading vaccine development and GMP manufacturing services for its global partners. It will also be WuXi Vaccines’ first standalone vaccine development and GMP manufacturing site in China.

Mr. Jian Dong, CEO of WuXi Vaccines, commented, "We are very pleased to enter into this agreement with Harbour BioMed. This is a win-win agreement for both of our companies. The new facility will expand our capabilities and capacities to better serve our global partners in developing and manufacturing vaccines. We are committed to advancing the accessibility and affordability of high-quality vaccines, with integrated technology platforms that enable our global partners to enhance the well-being of people worldwide."

This agreement on the additional Suzhou facility marks another 2022 milestone for WuXi Vaccines. In July of this year, the company’s QC Potency Lab, located in Dundalk, Ireland, received a GMP certificate from Ireland Health Products Regulatory Authority. And in October, the Dundalk vaccine manufacturing facility reached its mechanical completion.