On September 3, 2021 Eckert & Ziegler Radiopharma GmbH reported that it has successfully submitted an amendment to their Drug Master File (DMF) to the U.S. Food and Drug Administration for GalliaPharm (Press release, Eckert & Ziegler Radiopharma, SEP 3, 2021, View Source [SID1234587245]). Their proprietary Ge-68/Ga-68 generator from now on will additionally be available in sizes of up to 100 mCi with a shelf-life of 12 months or for a maximum of 700 elutions. Gallium-68 from GalliaPharm is used for the preparation of diagnostic imaging drugs in Positron Emission Tomography (PET).

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"With the development of generators with higher Ge-68 activity and the amendment of our DMF, we are responding to the increasing demand for Ga-68 based diagnostics in the United States," explained Dr Harald Hasselmann, Eckert & Ziegler Executive Director and responsible for the Medical segment. "The soon to be available preparations for imaging of prostate cancer as well as upcoming novel Ga-68 drugs and their theranostic pair, mostly labeled with Lu-177, allow Eckert & Ziegler to strongly support the trend towards higher activity generators and we are currently working to provide comprehensive solutions to the healthcare providers and their patients."

"Higher activity GalliaPharm generators will enable nuclear medicine institutions and radiopharmacies across the United States to prepare their Ga-68 PET imaging products with the same flexibility as they are used to, while being able to offer the procedures to a greater number of patients and with an expanded service area," added Jay Simon, General Manager of Eckert & Ziegler Radiopharma, Inc. in Wilmington, MA. "Users can obtain additional doses from a single generator elution and are at the same time able to significantly increase the number of daily elutions. Both will contribute to enhanced medical care and assure the supply to American patients."

GalliaPharm is mainly used in combination with tracer kits for diagnosis of neuroendocrine tumors and prostate cancer. Gallium generators offer a low-cost alternative for the radiolabeling of biomolecules with Gallium-68 in PET, an imaging examination method used to detect the presence or absence of diseased tissue. PET imaging is primarily used in the diagnosis of cancer, cardiology or neurology. Radioisotopes such as Fluorine-18 can be used alternatively but require investments of millions of dollars in large-scale equipment (cyclotrons). The Ge-68/Ga-68 generator on the other hand, is an easily transportable, small system that is much more cost-efficient, leading to cost reductions for nuclear medicine providers while increasing flexibility.

On September 3, 2021 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the Morgan Stanley 19th Annual Global Healthcare Conference on Tuesday, September 14, 2021 (Press release, Eli Lilly, SEP 3, 2021, View Source [SID1234587229]). Michael Mason, senior vice president, president of Lilly Diabetes, will participate in a virtual fireside chat at 1:15 p.m., Eastern Time.

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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.

On September 3, 2021 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of antibody therapeutics, reported that the company has received Human Research Ethics Committee (HREC) clearance to commence the Phase II combination trial of olinvacimab, PharmAbcine’s anti-VEGFR2 antibody, and KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 molecule, for the treatment of metastatic Triple-Negative Breast Cancer (mTNBC) in Australia (Press release, PharmAbcine, SEP 3, 2021, View Source [SID1234587247]).

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The Phase II clinical trial is an open-label and multicenter trial that will enroll 36 immuno-oncology drug naïve mTNBC patients regardless of their PD-L1 expression level. The study will evaluate the clinical efficacy, safety, pharmacodynamics, and the expression level of VEGFR-2 and PD-L1 after the administration of 16mg/kg of olinvacimab, and 200mg of pembrolizumab. PharmAbcine will sponsor the clinical trial that will take place in Australia, and MSD will supply pembrolizumab.

PharmAbcine and MSD decided to enter this collaboration based on the promising clinical data obtained from the Phase Ib olinvacimab and pembrolizumab study in mTNBC which is still ongoing in Australia. According to the interim result presented at San Antonio Breast Cancer Symposium (SABCS) 2020, olinvacimab in combination with pembrolizumab showed a clear safety profile and certain encouraging efficacy data, including 50% Overall Response Rate (ORR) and 67% Disease Control Rate (DCR) in the high-dose olinvacimab (16mg/kg) cohort (n=6pts). In addition, one patient in Partial Response (PR) showed Complete Response (CR) in the target lesion and another PR patient showed CR in a non-target lesion.

mTNBC is a highly malignant type of cancer that shows a high recurrence rate within the first five years after the diagnosis. mTNBC accounts for 15-20% of all breast cancers and shows a 5-year survival rate of approximately 11%. Unlike some other breast cancers, mTNBC does not express estrogen or progesterone receptors or human epidermal growth factor receptor 2 (HER2), and it does not respond to existing cancer drugs designed to target these markers. mTNBC is very difficult to treat, and there are very few FDA approved treatment options for these patients.

"This is a significant milestone for the company, as we strongly believe that olinvacimab could be a new therapeutic option for mTNBC patients," said Dr. Jin-San Yoo, CEO of PharmAbcine. "We are excited to initiate this study and expect the first patient enrollment to take place in October 2021.

About Olinvacimab

PharmAbcine’s leading pipeline, olinvacimab is an anti-VEGFR2 neutralizing fully human IgG. It is currently in a Phase II study for bevacizumab-nonresponding rGBM (recurrent glioblastoma multiforme) patients in both US and Australia. In addition to the ongoing Phase Ib olinvacimab and pembrolizumab combo trial in mTNBC, another olinvacimab plus pembrolizumab Phase Ib trial for rGBM is ongoing in Australia.

On September 3, 2021, Inhibrx, Inc. (the "Company") reported that it entered into an Open Market SaleSM Agreement (the "Sales Agreement") with Jefferies LLC, as sales agent (the "Agent"), pursuant to which the Company may offer and sell, from time to time, through the Agent (the "Offering") shares of its common stock (the "Shares") (Filing, 8-K, Inhibrx, SEP 3, 2021, View Source [SID1234587232]). Any Shares offered and sold in the Offering will be issued pursuant to the Company’s Registration Statement on Form S-3, as supplemented by the Company’s prospectus supplement dated as of September 3, 2021, filed with the Securities and Exchange Commission (the "Registration Statement"). Pursuant to the Registration Statement, the Company may offer and sell from time to time up to $200,000,000 Shares pursuant to the Sales Agreement.

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Subject to the terms and conditions of the Sales Agreement, the Agent will use its commercially reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions. Under the Sales Agreement, the Agent may sell the Shares by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended (the "Securities Act"), including sales made directly on the Nasdaq Global Market or on any other existing trading market for the Shares.

The Company has no obligation to sell any of the Shares, and may at any time suspend offers under the Sales Agreement. The Offering will terminate as permitted in the Sales Agreement. The Sales Agreement contains representations and warranties for the benefit of the Company and the Agent and other terms customary for similar agreements.

Under the terms of the Sales Agreement, the Agent will be entitled to a commission at a rate equal to 3.0% of the gross proceeds from each sale of Shares under the Sales Agreement. The Company will also reimburse the Agent for certain expenses incurred in connection with the Sales Agreement, and has agreed to provide indemnification and contribution to the Agent with respect to certain liabilities, including liabilities under the Securities Act.

The Company currently intends to use any net proceeds from the Offering for working capital and general corporate purposes, including research and development expenses and capital expenditures.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of the form of the Sales Agreement filed as Exhibit 1.1 hereto, which is incorporated herein by reference.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Shares, nor shall there be any offer, solicitation or sale of the Shares in any state or country in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or country.
The opinion of the Company’s counsel regarding the validity of the Shares is incorporated herein by reference as Exhibit 5.1 to the Company’s Registration Statement.

On September 3, 2021 Perrigo Company plc (NYSE; TASE: PRGO), reported that Perrigo President and CEO, Murray S. Kessler, and CFO, Ray Silcock, are scheduled to participate in investor meetings at the Barclays Global Consumer Staples Conference on Thursday, September 9 (Press release, Perrigo Company, SEP 3, 2021, View Source [SID1234587233]). The Company will not be making a formal presentation.

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