On December 29, 2020 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX) (Paris:ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported the initiation of manufacturing of NOX-A12, the company’s lead drug candidate, in preparation for upcoming clinical studies (Press release, NOXXON, DEC 29, 2020, View Source [SID1234573318]).

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As previously communicated, NOXXON’s clinical development strategy for NOX-A12 will focus on two indications: brain and pancreatic cancer. The company will evaluate different combination approaches enabling multiple avenues to successfully develop NOX-A12 and to advance the company’s pipeline in underserved indications.

NOXXON is preparing to initiate a two-arm clinical trial in H2 2021 for pancreatic cancer. The study will test two different standard of care chemotherapy combinations with NOX-A12 plus anti-PD-1 immunotherapy in second-line patients. This strategic approach will enable NOXXON to choose the optimal combination therapy to move forward into a randomized, controlled pivotal study.

In its clinical development strategy for brain cancer, the company plans to expand the ongoing Phase 1/2 dose escalation study of NOX-A12 combined with radiotherapy. The expansion of the dose cohort chosen for the anticipated pivotal trial would provide additional safety and efficacy data in a larger group of patients for discussions with regulatory agencies. The initiation of the expansion study is planned for 2021.

In order to secure manufacturing commitments that will allow continued advancement of these programs, the company drew down tranches dedicated to drug manufacturing for a total amount of €2.5 million from the Atlas Special Opportunities, LLC (ASO) convertible bond vehicle and issued to ASO 2,546 convertible bonds (including 46 convertible bonds issued in relation to the transaction fee) with a nominal value of €1,000 each on December 29, 2020. The amended and improved conditions of this financing vehicle were disclosed on October 14, 2020.

"As our clinical studies advance and the results give us further insight into the potential of NOX-A12, we have made the decision to invest in the supply of NOX-A12 to meet upcoming milestones. The source of funding that we put in place with ASO in April 2020 allows us to specifically draw funds for manufacturing commitments in order to ensure our clinical development strategy moves forward in a timely manner," commented Aram Mangasarian, CEO of NOXXON.

"NOXXON’s cash position was significantly strengthened throughout the course of 2020. This improved financial runway supports our discussions with industrial partners and allows us to fully develop our strategic plans, including an initial market approval for NOX-A12 in 2025. Our goal is to maximize the therapeutic potential of targeting the tumor microenvironment, particularly by inhibiting chemokines, an area in which NOXXON is striving to become a global leader. By securing NOX-A12’s manufacturing and, through it, the successful continuation of NOXXON’s clinical trials, we intend to enhance the positioning of our unique pipeline for both investors and industrial partners. We plan to maintain a cash position that will allow the continued advancement of our products and secure our position in partnering discussions," added Aram Mangasarian, CEO of NOXXON.

On December 29, 2020 Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its product candidate, HyNap-Nilo, for the treatment of chronic myeloid leukemia (CML) (Press release, Xspray, DEC 29, 2020, View Source [SID1234649572]). HyNap-Nilo is under development as an improved version of TasignaTM (nilotinib), a leading drug for CML.

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The FDA’s Orphan Drug Designation (ODD) has been granted to Xspray Pharma for nilotinib oral formulation intended for the treatment of chronic myeloid leukemia. The ODD program provides orphan status to drugs intended for the treatment of rare disorders that affect fewer than 200,000 people in the United States. This designation allows developers benefits such as the waiver of filling fees under Prescription Drug User Fee Act (PDUFA), as well as potential marketing exclusivity in the U.S for a period of 7 years, should clinical superiority over the originator drug be demonstrated upon approval of the product.

"We are pleased to have received the orphan designation from the FDA based on the potential clinical benefit of HyNap-Nilo. In this case, the reference product has a food effect on drug exposure that is clearly described in a black box safety warning," says Per Anderson, CEO of Xspray Pharma.

A black box warning appears on a prescription drug’s label and is designed to call attention to serious or life-threatening risks associated with the treatment. In an earlier reported study in healthy volunteers, the results showed that HyNap-Nilo can eliminate the clinically relevant food effect.

"This is also a strong confirmation of our strategy, showing that products developed based on our unique technology platform can play a key role in improving established cancer drugs for the clinical benefit of the patients," continues Per Andersson.

About HyNap-Nilo
HyNap-Nilo is being developed as an improved version of the originator drug TasignaTM (nilotinib) with potential to significantly reduce food effect on the plasma concentration and absorption, increase bioavailability as demonstrated in a previous pilot clinical trial, and decrease the drug-drug interactions with gastric pH modulating drugs. According to the drug label for the marketed PKI nilotinib, patients need to refrain from food intake for two hours before and one hour after administration of the drug which is given twice daily. In a completed cross-over Phase I clinical trial, Xspray Pharma measured the exposure of its proprietary HyNap-Nilo formulation in healthy individuals. When administered in the fasted state, a HyNap-Nilo dose of 150 mg produced the same area under the curve values as those reported for a dose of 400 mg of the marketed product. After a high-fat meal the study showed an increase in drug exposure of 25% for HyNap-Nilo, measured both as peak concentration (Cmax) and AUC. For the marketed product, the corresponding increases after a high-fat meal are reported to be 112% and 82%, respectively. In 2019 sales of TasignaTM amounted to USD 804 million in the U.S.

Chronic myeloid leukemia – CML
CML is a type of blood cancer where the body produces malignant white blood cells. Almost all patients with CML have an abnormality known as the "Philadelphia chromosome," which produces a protein called BCR-ABL. This protein aids the proliferation of malignant white blood cells in affected patients. About 15% of all leukemia is CML. In 2020 it is projected that 8,450 people in the US will be diagnosed with CML and in 2017, there were an estimated 58,000 people living with the disease in the US.

On December 29, 2020 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that Jim Clemmer, President and Chief Executive Officer, and Stephen Trowbridge, Executive Vice President and Chief Financial Officer, will present at the 23rd Annual Needham Virtual Growth Conference at 1:15 p.m. ET on Monday, January 11, 2021 (Press release, AngioDynamics, DEC 29, 2020, View Source [SID1234573319]).

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A live webcast of the presentation will be accessible through the "Investors" section of the Company’s website at www.angiodynamics.com and will be available for replay following the event.

On December 29, 2020 Invitae Corporation (NYSE: NVTA), a leading medical genetics company, reported that Sean George, co-founder and chief executive officer of Invitae, will present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021 at 10:50 a.m. Eastern/7:50 a.m. Pacific (Press release, Invitae, DEC 29, 2020, View Source [SID1234573320]). Following the company presentation, management will participate in a virtual breakout session at 11:10 a.m. Eastern/8:10 a.m. Pacific.

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The 2021 J.P. Morgan Healthcare Conference is being held virtually via webinar. A live webcast of both the presentation and the breakout session may be accessed at the following direct link or by visiting the investors section of the company’s website at ir.invitae.com.

Public listeners can access an audio and slide recording of the session, which will be available shortly after the conclusion of the presentation and breakout session on the investors section of the company’s website at ir.invitae.com.

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.

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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.