On November 16, 2022 Precision Biologics, Inc. ("Precision"), a clinical-stage immunotherapy and targeted oncology company, reported that it will present at the SITC (Free SITC Whitepaper) 37th Annual Meeting (2022) in Boston, MA (Press release, Precigen, NOV 16, 2022, View Source [SID1234623581]).

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The first poster presentation will discuss the novel target for its NEO-201 monoclonal antibody and mechanism of action for this drug including the specific O-glycan epitope recognized by NEO-201 and that NEO-201 kills target cells expressing core 1 and/or extended core 1 O-glycans through Antibody-Dependent Cellular Cytotoxicity (ADCC)

The second poster presentation will discuss the ongoing Phase 2 clinical trial being conducted at the National Cancer Institute that combines NEO-201 with Pembrolizumab in patients with treatment refractory solid tumors. The study is enrolling patients at the National Cancer Institute, Bethesda, MD, with metastatic Non-Small Cell Lung Cancer (NSCLC), Head and Neck Cancers, Endometrial Cancer and Cervical Cancer, who have already been treated with checkpoint inhibitor therapy (including prior Keytruda). (View Source)

Posters will be presented in person at the at the Boston Convention and Exhibition Center on Thursday November 10th, 2022.

On November 15, 2022 NextCure and LegoChem Biosciences reported a collaboration and co-development agreement focused on generating a B7-H4 antibody drug conjugate (ADC) and options for two additional targets (Press release, NextCure, NOV 15, 2022, View Source [SID1234638589]). The B7-H4 ADC will utilize NextCure’s B7-H4 antibody and LCB’s ConjuAllTM ADC technology.

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Under the terms of the agreement, both parties will equally share the costs to develop the molecules and profits on commercialized products. The parties will utilize their respective product development capabilities to generate the B7-H4 ADC and advance it to the clinic. In addition, there are options for the parties to nominate two additional targets for ADC development beyond B7-H4.

"We are excited to work with LCB, and apply ConjuAllTM, a leading ADC technology, to add a new treatment modality to our B7-H4 program," said Timothy Mayer, NextCure’s Chief Operating Officer. "We remain committed to developing novel immunomedicines using multiple modalities to address the significant unmet needs of cancer patients not adequately addressed by available therapies."

"The initiation of this collaboration with NextCure represents another important milestone for LCB as we continue to build our ADC pipeline and seek to demonstrate the potential of our ADC platform in a wide range of different tumors," said Yong-Zu Kim, LCB’s Chief Executive Officer. "B7-H4 ADC would potentially offer a first-in-class opportunity for a target expressed on a broad range of tumor types, and I look forward to progress in early stage studies."

On November 15, 2022 Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage clinical pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, reported that it has entered into definitive agreements for a private placement of its securities for gross proceeds of approximately $18.9 million, prior to deducting placement agent commissions and estimated offering expenses (Press release, OncoGenex Pharmaceuticals, NOV 15, 2022, View Source [SID1234624241]).

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The private placement will be for up to 4,093,141 units at a price of $4.625 per unit, with each unit consisting of two shares of common stock and one warrant to purchase one share of common stock. The private placement was priced at $2.3125 per common share, an 8.6% premium to the closing price of the Company’s common stock the day prior to entering into the subscription agreements, including a one-half warrant per share. The private placement is expected to close on or about November 18, 2022, subject to customary closing conditions. The warrants will have an initial per share exercise price of $4.50. All warrants will be exercisable beginning on the six-month anniversary of the closing of the offering and will have a seven-year term. The Company intends to use the proceeds from the private placement to fund clinical research and development, and for general working capital. It estimates that the net proceeds, plus its existing financial resources, are sufficient to fund operations into late 2023.

The private placement includes a new life sciences focused investment fund, participation from Achieve management, as well as new and existing investors. Lake Street Capital Markets, LLC is acting as the exclusive placement agent in connection with this offering.

The securities being issued and sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state’s securities laws, and are being issued and sold in reliance on Section 4(a)(2) of the Securities Act and Regulation D promulgated thereunder. The securities 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 of the Securities Act. Achieve has agreed to file a registration statement to register the resale of the shares of common stock included in the units and underlying the warrants within 60 days of the closing of the offering. 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.

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.