On July 26, 2021 LifeGift, the organ procurement organization (OPO) facilitating organ and tissue donation in Southeast, West, and North Texas, and Ossium Health, a therapeutics company harnessing the power of stem cell science to improve treatment for patients with blood and immune diseases, reported a collaborative partnership (Press release, Ossium Health, JUL 26, 2021, View Source [SID1234585438]). In 2017, LifeGift was the first OPO to work with Ossium and this ongoing partnership resulted in the successful banking of cells from their first clinically transplantable donor at the beginning of 2020. Cell banking systems are set up to assure a uniform population of cells is preserved, their integrity maintained, and a sufficient supply of material is accessible for the life of the product.

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Bone marrow recovered by LifeGift and Ossium Health’s other OPO partners is processed for future use in transplant tolerance for individuals receiving organ and tissue transplants, bone marrow transplant for blood cancer patients, and regenerative medicine cell therapies for patients with a variety of inflammatory, autoimmune, and degenerative conditions.

Roughly 20,000 new U.S. patients seek a bone marrow transplant each year, but only 30 percent have a relative who provides a match. Of the remaining 14,000 patients, fewer than 5,000 receive transplants from unrelated donors. The living donor bone marrow registry, autologous bone marrow transplants, and umbilical cord blood banks have provided lifesaving solutions for thousands of patients with hematologic diseases. However, these methods still experience significant limitations driven by the scarcity of matched bone marrow.

LifeGift’s partnership with Ossium Health enables transformative clinical work such as Ossium’s recently approved clinical trial for intestinal transplants. Intestinal transplantation is rare because of historically high rejection rates. However, by infusing bone marrow cells from the same donor as the transplanted intestines, the immune system could see the donor organ as "self" so that long-term graft acceptance can be achieved without life-long immunosuppression.

"We are thrilled to have been the first collaborating partner with Ossium Health among all organ procurement organizations more than four years ago," says Kevin Myer, president and CEO of LifeGift. "This partnership aligns perfectly with LifeGift’s focus on research and innovation to support our efforts to increase transplantation. We are relentless in our goal to save more lives through donation, and Ossium Health’s initiatives will drive clinical advancements allowing us to help more patients and advance important clinical research."

"Ossium’s first of its kind bone marrow bank combined with bone marrow recovered by LifeGift establishes a powerful new platform for bringing cell therapies to patients across the globe," says Ossium co-founder, president and CEO, Kevin Caldwell. "The future looks bright as the partnership moves forward to improve the health, vitality, and longevity of human beings through bioengineering."

On July 26, 2021 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that the Company has entered into licensing agreements and strategic partnerships with Seqirus Pty Ltd ("Seqirus"), a subsidiary of CSL Limited, and AVIR Pharma Inc. ("AVIR") for tirbanibulin (Press release, Athenex, JUL 26, 2021, View Source [SID1234585172]).

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Under the terms of the agreements, Seqirus will have an exclusive license to commercialize tirbanibulin in Australia and New Zealand, and AVIR will have an exclusive license to commercialize tirbanibulin in Canada.

The addition of these territories enhances the global coverage of the marketing and sales of Klisyri (tirbanibulin ointment) for the treatment of actinic keratosis (AK). Athenex currently has strategic partnerships for tirbanibulin in the U.S., Europe, China, Taiwan, Japan and now also Australia, New Zealand and Canada, among several other territories. In addition to upfront payments and milestone payments, the royalty/transfer prices generally range from 15% to 30% of annual sales across different territories.

"These new partnerships with Seqirus and AVIR will expand tirbanibulin access to more patients around the world," said Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex. "Tirbanibulin, or Klisyri, is approved and launched in the United States for the treatment of actinic keratosis of the face or scalp, and is a significant step forward because of its short treatment protocol, proven efficacy, and favorable safety profile. Klisyri has recently also received approval for marketing by the European Commission. The expansion of our international partnerships represents an important step in Athenex’s strategy to optimize the potential value of this important drug and create value for our stakeholders."

Tirbanibulin is a novel, topical first-in-class microtubule inhibitor with a selective antiproliferative mechanism of action. Athenex received approval from the U.S. Food and Drug Administration for the commercialization of tirbanibulin, under the brand name Klisyri, for the topical treatment of AK of the face or scalp. Klisyri was launched in the U.S. in February 2021, led by the Company’s partner, Almirall. In July, Almirall received European Commission approval of Klisyri (tirbanibulin) for the topical treatment of AK of the face or scalp, which followed a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency in May.

"We are delighted to collaborate with Athenex to commercialize KlisyriTM in Australia and New Zealand," said Dani Dowell, Seqirus Head of Commercial Australia and New Zealand. "This is an exciting opportunity, building on Seqirus’ strong presence as a successful in-license partner in Australia and New Zealand. The addition of Klisyri will broaden our portfolio and is another example of our work to deliver innovative offerings to meet unmet patient need."

Actinic keratosis is one of the most common diagnoses in dermatology practices.[1] Australia has one of the highest prevalence of AK, with an estimated prevalence of 40-50% in the Australian Caucasian population over 40 years of age.[2] Treatment is a critical aspect in the management of the disease as it may progress to invasive skin squamous cell carcinoma.

On July 26, 2021 Nuvo Pharmaceuticals Inc. (TSX:MRV; OTCQX:MRVFF) d/b/a Miravo Healthcare (Miravo or the Company), a Canadian focused, healthcare company with global reach and a diversified portfolio of commercial products, reported it expects to release its second quarter 2021 financial results before markets open on Monday, August 9, 2021 (Press release, Nuvo Pharmaceuticals, JUL 26, 2021, View Source [SID1234585187]).

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The Company will subsequently hold a conference call the same day, Monday, August 9, 2021 at 11:00 a.m. ET, hosted by Jesse Ledger, Miravo’s President & Chief Executive Officer and other senior management. A question-and-answer session will follow the corporate update.

On July 26, 2021 Harbour BioMed ("HBM", HKEX: 02142) reported that the abstract detailing clinical data from its Australian phase I study of next-generation anti-CTLA-4 antibody in patients with advanced solid tumors will be presented as an e-poster at the 2021 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, which is expected to be held 16-21 September 2021 (Press release, Harbour BioMed, JUL 26, 2021, View Source [SID1234585203]).

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As the first fully human heavy chain only antibody (HCAb) under the clinical investigation, HBM4003 is generated from Harbour Mice platform. This Study is an open-label, dose-escalating monotherapy study in treatment of advanced solid tumors. The preliminary clinical data demonstrate encouraging anti-tumor efficacy of HBM4003 with the good safety profile and tolerability. The data obtained from the Study have further validated pre-clinical findings of HBM4003’s unique PK/PD profile, novel mechanism of action and low immunogenicity. The Company has proceeded with multiple global phase Ib/IIa trials in solid tumors in light of the encouraging clinical efficacy and safety profile.

About HBM4003

HBM4003 is the fully human anti-CTLA-4 monoclonal heavy chain only antibody (HCAb) generated from Harbour Mice. By enhancing antibody-dependent cell cytotoxicity (ADCC) killing activity, HBM 4003 has demonstrated significantly improved depletion specific to high CTLA-4 Treg cells in tumor tissues. The potent anti-tumor efficacy and differentiated pharmacokinetics with durable pharmacodynamic effect presents a favorable product profile. This novel and differentiated mechanism of action has the potential to improve efficacy while significantly reducing the toxicity of the drug in monotherapy and combo-therapy.

On July 26, 2021 Eversana, a provider of global commercial services to the life sciences industry, reported tha it has acquired Accelera Canada, along with its partner companies Patient Access Solutions, Podium Strategic Partners, Inc. and Advocacy Solutions (Press release, EVERSANA, JUL 26, 2021, View Source [SID1234585220]). Based in Toronto, Accelera Canada is an end-to-end commercialization service provider that is helping 50 companies operate in the Canadian pharma market. Financial terms of the deal were not disclosed, but with this latest development, Eversana is able to expand its Canada-based team.

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"We are rapidly scaling our global commercialization services by finding and partnering with the best service providers in every region," says Jim Lang, Eversana’s CEO. "The Accelera Canada team adds decades of experience navigating the fields of product launch, market access and patient advocacy in the Canadian marketplace, making them the perfect partner to support the growing needs of our clients."

Accelera Canada’s founding partners and owners, Michael Cloutier, Charles Pirraglia, Deborah Brown, Lindy Forte and Ryan Clarke, as well as extended team members, will join Eversana immediately. And over the next few months, legacy brands will be integrated.