On February 9, 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 a proposed underwritten public offering in which it intends to offer and sell shares of its common stock and, in lieu of common stock, to offer and sell to certain investors pre-funded warrants to purchase shares of its common stock (Press release, Aeglea BioTherapeutics, FEB 9, 2022, View Source [SID1234607932]). Aeglea expects to grant the underwriters a 30-day option to purchase additional shares of common stock. All of the securities are being offered by Aeglea. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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JonesTrading Institutional Services LLC and LifeSci Capital LLC are acting as joint book-running managers in the offering.

Aeglea intends to use the net proceeds from the offering, together with its existing cash resources, to fund its ongoing Biologics License Application submission activities for pegzilarginase and its potential commercialization in the United States, complete its ongoing Phase 1/2 clinical trial of AGLE-177 and prepare for a potential pivotal study in Homocystinuria, advance AGLE-325 for Cystinuria through IND-enabling studies, and the remainder to fund continued research and development, manufacturing, working capital and general corporate purposes.

The securities are being offered by Aeglea pursuant to a registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission (SEC). The offering will be made only by means of the written prospectus and prospectus supplement that forms a part of the registration statement. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying base prospectus may also be obtained, when available, from JonesTrading Institutional Services LLC at [email protected] or LifeSci Capital LLC at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Aeglea, 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 registration or qualification under the securities laws of any such state or jurisdiction.

On February 9, 2022 Johnson & Johnson (NYSE: JNJ) reported that it will participate in the Raymond James 43rd Annual Institutional Investors Conference on Tuesday, March 8th. Joseph J. Wolk, Executive Vice President and Chief Financial Officer, will represent the Company in a session scheduled at 1:05 p.m. (Eastern Time) (Press release, Johnson & Johnson, FEB 9, 2022, View Source;johnson-to-participate-in-the-raymond-james-43rd-annual-institutional-investors-conference-301479192.html [SID1234607931]).

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This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.

A webcast replay will be available approximately 48-hrs after the live webcast.

On February 9, 2022 NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, reported that its Chief Business Officer, Sam Zhang, Ph.D., MBA, will present at the upcoming BIO CEO and Investor Conference, to be held February 14-17 in New York, NY (Press release, NeoImmuneTech, FEB 9, 2022, View Source [SID1234607930]).

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Additionally, Dr. Zhang was invited as a speaker on the panel "Maximize Your Asset’s Potential Value for Deal Making" at the Fierce BD&L Summit for Life Sciences, to be held March 15-16 in San Francisco, CA, where he will present "NT-I7 Strategic Positioning via Clinical Collaborations with Global I-O Leaders" as a case study. Subsequently, he will join a panel discussion titled "Getting your House in Order: Strategies for Sellers to Best Prepare for a Diligence Review".

The details of the company’s presentations are as follows:

BIO CEO and Investor Conference
Date: Tuesday, February 15th, 2022
Time: 11:15am ET
Website: BIO CEO & Investor Conference | BIO

Fierce BD&L Summit for Life Sciences
Date: Wednesday, March 16th, 2022
Time: 9:30am PT (case study), 9:45am PT (panel discussion)
Website: Agenda | BDL Summit

About NT-I7
NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and enhanced functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On February 9, 2022 AKSO Biopharmaceutical, Inc. ("AKSO"), a global biopharmaceutical company with an innovative and comprehensive approach to treat cancer, autoimmune disease, and genetic disorder, and Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (SZ.000963) ("Huadong Medicine"), a leading pharmaceutical company in Asia, reported that the companies have entered into an exclusive collaboration to develop and commercialize AB002, a bi-functional fusion protein inhibiting immune checkpoint and activating natural killer (NK) cells for the treatment of solid tumors, in the Asia Pacific Ex-Japan region. AKSO will retain all rights to AB002 in the rest of the world (Press release, AKSO Biopharmaceutical, FEB 9, 2022, View Source [SID1234607929]).

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This strategic collaboration enables AKSO to leverage Huadong Medicine’s leading expertise in clinical development, regulatory approval, and commercialization to access the second largest pharmaceutical market in the world, while augmenting Huadong Medicine’s portfolio of first-in-class innovative drug candidates and further cementing Huadong Medicine’s leadership position in the region.

"The strategic collaboration is an important milestone for AB002 as Huadong Medicine’s expertise and experience in drug development, and mature clinical and sales network will enable us to become the first to market in the critical region," said Amato Giaccia, Ph.D., Senior Scientific Strategist and Chairman of AKSO. "AB002 is a first-in-class molecule that leverages AKSO’s proprietary DEEP platform to neutralize PD-L2 and PD-L1, while activating NK cells via an IL-15 agonist. This unique approach addresses the immune-suppressive environment frequently found in patients not responding to immune checkpoint inhibitors. Furthermore, AB002’s precision cell targeting ability promotes NK cell activation in the tumor microenvironment. We are excited to partner with Huadong Medicine to accelerate AB002’s development and deliver this innovative therapeutic to patients with unmet urgent needs."

"AKSO Biopharmaceutical is a promising biopharmaceutical company innovating to treat cancer. AB002, which is a dual-target bi-specific fusion protein, represents the addition of an exciting cancer immunotherapy asset to Huadong Medicine’s increasing cancer therapy pipeline," stated Dongzhou J. Liu, Ph.D., Chief Scientific Officer of Huadong Medicine. "The cancer patient population is substantial in China, with unmet medical needs. Leveraging Huadong Medicine’s R&D capabilities, we will work closely with AKSO Biopharmaceutical to accelerate the development of AB002 to benefit the cancer patients all over the world."

Under the terms of the agreement, AKSO will be eligible to receive upfront and milestone payments of up to $75 million, as well as royalties from future product sales. Huadong Medicine will be responsible for clinical development, regulatory submissions and commercialization of AB002 in the region and jointly steer IND-enabling tasks with AKSO via the Joint Research Committee. AKSO will continue to be responsible for AB002’s development in the rest of the world.

AKSO is advised by Dragon Financial Partners Ltd. as financial advisor and Morrison Forrester LLP as legal counsel.

ABOUT AB002

AB002 is a late preclinical stage first-in-class bifunctional fusion protein comprising of a DEEP-engineered soluble PD-1 decoy receptor for immune checkpoint inhibition, and an IL-15 agonist for NK cell activation. AB002 traps PD-L2 and PD-L1 with ultra-high binding affinities, while activating NK cells with high precision and extended half-life.

On February 9, 2022 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported the publication of a peer-reviewed case study by researchers at The University of Texas MD Anderson Cancer Center in Clinical and Translational Radiation Oncology (Press release, Nanobiotix, FEB 9, 2022, View Source [SID1234607928]). The case study reports on the first patient experience of treatment with potential first-in-class radioenhancer, NBTXR3, in pancreatic ductal adenocarcinoma (PDAC; pancreatic cancer).

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Given the nature of NBTXR3 as a therapeutic candidate with potentially broad applicability across solid tumor indications and therapeutic combinations, Nanobiotix and MD Anderson are collaborating to expand development of NBTXR3 beyond the Company’s priority pathways in locally advanced head and neck squamous cell carcinoma and immunotherapy. This ongoing phase I pancreatic cancer study is one of five active phase I or phase II studies currently being conducted as part of the collaboration.

The phase I clinical trial is designed to determine the safety profile of NBTXR3 activated by radiotherapy (RT) for patients with locally advanced or borderline resectable PDAC, and the recommended phase II dose (RP2D) for future efficacy evaluation. The case study in Clinical and Translational Radiation Oncology reports on the first patient ever to receive local endoscopic delivery of NBTXR3 to a deep visceral tumor. The patient is a 66-year-old male with unresectable, locally advanced PDAC who received local endoscopic delivery of NBTXR3 followed by intensity modulated RT. CT imaging demonstrated no visible leakage of the radioenhancer outside of the injected tumor. At initial follow-up evaluation, the lesion remained radiographically-stable, the patient did not demonstrate treatment-related toxicity, and the report concluded that the treatment was feasible.

PDAC is one of the leading causes of cancer-related death in the world today. For patients with PDAC who are not eligible for surgery, RT has been shown to improve local disease control. However, safely delivering therapeutic doses of radiation remains challenging due to off-target toxicities in surrounding healthy tissues. While systemic radiosensitizers have been evaluated in this indication, these agents increase the sensitivity of both tumor tissues and healthy tissues. In contrast, due to the potential of NBTXR3 to increase the dose of RT within the tumor without increasing the dose in surrounding healthy tissues, the radioenhancer is being evaluated as a new option to address this urgent unmet need.

"There is a critical need to develop an effective therapy to improve treatment outcomes while mitigating off-target toxicities for patients with locally advanced pancreatic cancer," said Eugene Koay, MD, PhD, associate professor of Radiation Oncology at MD Anderson. "The initial feasibility for NBTXR3 injection outlined in this case study provides an important step forward as we determine the recommended phase II dose and the potential for the radioenhancer to help patients with this challenging disease."

Nanobiotix expects to establish the recommended phase II dose for NBTXR3 in pancreatic cancer in 2022.

About NBTXR3
NBTXR3 is a novel, potentially first-in-class oncology product, composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physics-based mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly, with immune checkpoint inhibitors.

NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as the primary development pathway. The company-sponsored phase I dose escalation and dose expansion study has produced favorable safety data and early signs of efficacy. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy.

Nanobiotix has also prioritized an Immuno-Oncology development program—beginning with a Company sponsored phase I clinical study, evaluating NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors for patients with locoregional recurrent or recurrent/metastatic HNSCC and for patients with lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy, either naïve or resistant to prior PD-1 (either primary or secondary as per SITC (Free SITC Whitepaper) criteria).

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in strategic collaborations to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several phase I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations. In 2021, the Company entered into an additional strategic collaboration agreement with LianBio to support its global phase III study in Asia along with four future registrational studies.