On December 29, 2020 Oasmia Pharmaceutical AB, an innovation-focused specialty pharmaceutical company,reported that it secures further valuable IP rights in Australia and Brazil (Press release, Oasmia, DEC 29, 2020, View Source [SID1234573306]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

XMeNa platform patent granted in Australia – a major market within the Oceania region

The XMeNa patent protects an improved method for producing Oasmia’s nanotechnology platform XR-17, a drug-delivery system currently used with paclitaxel and other cancer drugs. The patent is important for Oasmia as it expands the territories for exclusivity of the key technology XR‑17 used in our lead product Apealea (paclitaxel micellar), which is being launched in key markets globally.

Francois Martelet, Chief Executive Officer of Oasmia commented "The XMeNa patent is already approved in several major pharmaceutical markets, including the US. With the XMeNa patent now approved in Australia, Oasmia has secured valuable IP protection for the major Oceania market with a significant pharmaceutical market."

"Water Soluble" patent granted in Brazil

The newly approved "Water soluble" patent is related to a novel nanoparticular formulation of a water soluble pharmaceutically active substances, such as doxorubicin, in combination with Oasmia’s patented technology XR-17. Doxorubicin is used to treat a variety of different forms of cancer such as acute lymphoblastic leukemia, acute myeloblastic leukemia, chronic leukemia, Hodgkin’s disease and non-Hodgkin’s lymphoma, amongst others.
The patent is also related to the product candidate Doxophos Vet which Oasmia developed for the treatment of lymphoma, the most common cancer in dogs.

Brazil is among the Top 10 Pharmaceutical Markets Worldwide and Oasmia is now positioned to secure market exclusivity in Brazil under its national patent law.

"Tax-dox-mix" patent receives notice of allowance in Brazil

The tax-dox-mix patent is related to the Oasmia project OAS-19 and focuses on the treatment of various cancers in humans. The patent covers a combination of a wide range of water soluble and water insoluble chemotherapeutic drugs in a single XR-17 containing solution. With an innovative dual chemotherapeutic agent encapsulation and release mechanism, this approach is intended to allow the administration of one single infusion containing two active pharmaceutical ingredients.

On December 29, 2020 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that the company has appointed Dr Christina Reimer as Chief Medical Officer (Press release, Alligator Bioscience, DEC 29, 2020, View Source [SID1234573305]). She most recently comes from a position as Senior Medical Director at Ferring Pharmaceuticals in Copenhagen.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr Reimer will replace Dr Charlotte Russel and be overall medically responsible for Alligator’s drug development candidates, with an emphasis on bringing mitazalimab and ATOR-1017 into Phase II efficacy studies. She will report to Head of R&D, EVP Malin Carlsson, and be part of the management team.

"I am very pleased with the successful recruitment of Christina Reimer to Alligator. Her international experience in leading clinical development and in building development organizations will significantly strengthen our clinical capacity. This is crucial in the phase we are in now, with two products on the way to Phase II and another product in clinical Phase I. We look forward to welcoming Christina to Lund and to our management team", said Per Norlén, CEO of Alligator Bioscience.

Christina Reimer is a medical doctor with specialist qualifications and a PhD in gastroenterology. She also has considerable experience from leading clinical programs within the industry. Christina Reimer will assume the role of Chief Medical Officer (CMO) at Alligator on February 1, 2021.

"Alligator’s solid science-based approach to discover new cancer treatments and the fact that they have several assets in clinical development is what makes this opportunity unique. I hope to be able to apply my many years of clinical experience with cancer patients and my clinical drug development skills to progress Alligator’s assets through the next important steps of development. I look very much forward to become part of the team at Alligator", said Christina Reimer.

On December 28, 2020 Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer immunotherapies to fight multiple cancer types, reported the closing of the previously announced $110 million private investment in public equity (PIPE) financing, as well as a newly executed PIPE financing for an additional $15 million in gross proceeds resulting from the sale of shares of its common stock at a price per share of $3.71 (Press release, Gritstone Oncology, DEC 28, 2020, View Source [SID1234573686]). Gross proceeds from the two PIPE financings total $125 million, before deducting placement agent fees and offering expenses. The PIPE financings are supported by a consortium of high quality new and existing institutional investors with expertise in health care, including Redmile Group, Avidity Partners, EcoR1 Capital, BVF Partners L.P. and Versant Ventures.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The newly executed PIPE financing is subject to customary closing conditions and is expected to close on December 30, 2020, and was done in compliance with applicable Nasdaq rules and priced at the "Minimum Price" (as defined in the Nasdaq rules). Cowen served as the sole placement agent for each of the PIPE financings.

The securities sold in these private placements have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the U.S. except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Gritstone has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock issued in these private placements.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction.

On December 28, 2020 GT Biopharma, Inc. (OTCQB: GTBP) (GTBP.PA) an immuno-oncology company focused on innovative therapies based on the Company’s proprietary NK cell engager (TriKE) technology platform reported the filing of U.S. and international patent applications, and the initiation of clinical development of TriKE therapy for the treatment of HER2+, HER3+ and HER2+/HER3+ heterodimer complex breast and gastrointestinal cancers (Press release, GT Biopharma, DEC 28, 2020, View Source [SID1234573302]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Building upon the success of GTB-3550, where in FDA clinical trials patient #7 showed a 61.7% reduction in cancer cells for high-risk Myelodysplastic Syndromes (HR-MDS), GT Biopharma is expanding the therapeutic utility of its TriKE platform to attack solid tumor cancers. The Company’s HER2 TriKE is based on its modular therapeutic platform, which is composed of a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-HER2 antibodies, and a modified form of IL-15. The natural killer (NK) cell stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill cancer cells.

Anthony Cataldo, Chairman and Chief Executive Officer of GT Biopharma commented, "We are pleased our HER2 TriKE therapeutic product candidate has shown good efficacy in animal models enabling us to initiate GMP manufacturing for FDA clinical trial development. We anticipate submitting our IND application to FDA next year requesting allowance to proceed with an evaluation in patients with complex breast and gastrointestinal cancers. The TriKE platform lends itself to liquid and solid tumors as well as infectious diseases."

HER2, HER3 and HER2/HER3 Heterodimer Complex

About 15% of breast cancer cells have a high density of human epidermal growth factor receptor 2 (HER2) expressed on the cell’s surface. The frequency of HER2 overexpression in gastric and gastroesophageal cancer ranges from 4.4% to 53.4%, with a mean of 17.9%1. HER2 is responsible for telling the cell to divide. Cells with too many HER2 receptors divide uncontrollably which causes the cancer to grow. HER3 is another receptor in the same family as HER2 whose levels can also be increased in cancer cells. HER2 and HER3 can bind together, and collectively accelerate the growth of cancer cells. While targeted therapy against HER2 is an effective first-line treatment in HER2+ breast cancer, acquired resistance remains a clinical challenge.

Breast Cancer

Breast cancer is a group of diseases in which cells in the breast divide in an uncontrolled manner, typically resulting in a lump or mass. Most breast cancers begin in the milk glands (lobules), or in the ducts that connect the lobules to the nipple. In 2020, it is estimated there will be 276,480 new cases of female breast cancer in the USA2. More than 3.8 million women in the USA have been diagnosed with breast cancer as of January 20193. Approximately 13% of women will be diagnosed with invasive breast cancer in their lifetime and 3% will die from breast cancer4.

Gastrointestinal Cancer

Gastrointestinal cancer is the fifth most common cancer worldwide, and accounts for 6.8% of all cancers. It is third most common cause of cancer-specific mortality worldwide according to the World Health Organization. In the USA, gastrointestinal cancers represent 1.5% of all new cancers with estimated annual new cases to be 26,240 and estimated deaths to be 10,800. Gastrointestinal cancer is often diagnosed at an advanced stage, defined as unresectable locoregional or metastatic disease, which has very poor prognosis with 5-year survival not exceeding 5–20%5.

On December 28, 2020 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase"), a clinical-stage pharmaceutical company developing therapeutics for Parkinson’s disease and related disorders that arise inside and outside of the brain, reported the closing of its initial public offering of 1,800,000 shares of common stock at a public offering price of $10.00 per share (Press release, Inhibikase Therapeutics, DEC 28, 2020, View Source [SID1234573300]). The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Inhibikase, were $18 million. In addition, Inhibikase has granted the underwriters a 45-day option to purchase up to an additional 270,000 shares of Inhibikase’s common stock at the initial public offering price, less underwriting discounts and commissions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Inhibikase’s common stock began trading on the Nasdaq Capital Market on December 23, 2020 under the ticker symbol "IKT."

ThinkEquity, a division of Fordham Financial Management, Inc., is acting as sole book-running manager for the offering.

A registration statement relating to the securities being sold in the offering was declared effective by the Securities and Exchange Commission (SEC) on December 22, 2020. This offering was made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained from the offices of ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, or by email at [email protected]. These documents may also be obtained free of charge, when they are available, by visiting the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.