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 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 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, reported that Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer, will depart the company to pursue a new opportunity (Press release, ADC Therapeutics, SEP 3, 2021, View Source [SID1234587244]). ADCT is pleased to announce that Joseph Camardo, MD, will be appointed Senior Vice President and Chief Medical Officer.

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"Jay Feingold has played a key role in the growth of ADC Therapeutics over the last seven years and was instrumental in establishing our clinical team and strategy leading to the approval of our first commercial therapy, ZYNLONTA," said Chris Martin, PhD, Chief Executive Officer. "We are grateful for his leadership, expertise and steadfast dedication to patients, and we wish him well in his next endeavor." Dr. Feingold will continue to consult with ADCT through 2022 to ensure a smooth transition.

Dr. Camardo joined ADC Therapeutics from Celgene Corporation, where he was most recently Senior Vice President of Celgene Global Health after having served as Senior Vice President of Global Medical Affairs and Corporate Medical Operations. Prior to Celgene, Dr. Camardo was Senior Vice President of Clinical Development and Medical Affairs at Forest Research Institute and spent more than 20 years at Wyeth Research before its acquisition by Pfizer. At Wyeth, he held several leadership roles including Senior Vice President of Clinical Research and Development.

"Dr. Camardo’s extensive background in clinical development and Medical Affairs makes him the ideal successor and ensures a seamless evolution of our company. Dr. Camardo worked closely with Dr. Feingold for the last 18 months and together they ensured our first marketed product was well-received by the physician community in the United States and beyond," continued Chris Martin.

"On behalf of the Board of Directors, I am delighted to welcome Dr. Camardo to the pivotal role of Chief Medical Officer," said Ron Squarer, Chairman of the Board and an advisor to the company. "The Board has worked closely with Joe Camardo on several critical projects and appreciates his vast and deep industry experience, as well as his passion for patients."

On September 3, 2021 argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, reported that members of management will participate in several upcoming conferences (Press release, argenx, SEP 3, 2021, View Source [SID1234587241]):

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KBC Life Sciences & Biotech Virtual Conference. Management will participate in investor meetings on Tuesday, September 7, 2021.
Morgan Stanley Global Healthcare Conference. Fireside chat on Friday, September 10, 2021 at 4:15 p.m. ET.
BofA Global Healthcare Conference. Fireside chat on Thursday, September 16, 2021 at 4:45 p.m. BST.
SVB Leerink CybeRx Series: Neuromuscular, Rare Diseases & Genetic Medicines 1×1 Event. Management will participate in investor meetings on Wednesday, September 22, 2021.
Additional information regarding these events will be available on the Investors section of the argenx website at argenx.com/investors.

On September 3, 2021, VBI Vaccines Inc. (the "Company") reported that it entered into an Open Market Sale AgreementSM (the "Sales Agreement") with Jefferies LLC to act as the Company’s sales agent and/or principal ("Agent"), with respect to the issuance and sale of up to $125,000,000 of the Company’s common shares, no par value per share (the "Shares"), from time to time in an at-the-market public offering (Filing, 8-K, VBI Vaccines, SEP 3, 2021, View Source [SID1234587236]).

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Upon delivery of an issuance notice and subject to the terms and conditions of the Sales Agreement, 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 Company may sell the Shares in amounts and at times to be determined by the Company from time to time subject to the terms and conditions of the Sales Agreement, but it has no obligation to sell any of the Shares under the Sales Agreement. In addition, if expressly authorized by the Company, Agent may also sell the Shares in privately negotiated transactions.

The Company or Agent may suspend or terminate the offering of Shares upon notice to the other party and subject to other conditions. Agent will use its commercially reasonable efforts consistent with its normal sales and trading practices to place the Shares, subject to the terms of the Sales Agreement. The Sales Agreement will automatically terminate when the sale of the Shares reaches an aggregate offering amount equal to $125,000,000, or sooner if terminated as permitted therein.

The Company will pay Agent a commission of up to 3.0% of the gross proceeds from the sale of the Shares pursuant to the Sales Agreement.

The Sales Agreement contains representations, warranties and covenants that are customary for transactions of this type. In addition, the Company has agreed to indemnify Agent against certain liabilities, including liabilities under the Securities Act of 1933, as amended. A copy of the Sales Agreement is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference. The description of the Sales Agreement is qualified in its entirety by reference to Exhibit 1.1 to this Current Report on Form 8-K.

The Shares will be sold and issued pursuant to a shelf registration statement on Form S-3 (File No. 333-240266), which became automatically effective upon filing with the Securities and Exchange Commission on July 31, 2020, and a prospectus supplement and the accompanying prospectus relating to the at-the-market offering have been filed with the Securities and Exchange Commission on September 3, 2021.

This Current Report on Form 8-K, including the exhibits filed herewith, is not an offer to sell or the solicitation of an offer to buy the Shares or any other securities of the Company, nor shall there by any offer, solicitation or sale of the Shares or any other securities of the Company in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state.