TAIPEI, Nov. 9, 2020 /PRNewswire/ -- TaiGen Biotechnology Company, Limited ("TaiGen") announced today that they have signed an exclusive agreement with GPCR Therapeutics, Inc. ("GPCR"), a leading Korean biotechnology company, for the continued development of Burixafor worldwide and the commercialization of Taigexyn (nemonoxacin) in South Korea.

Burixafor is a highly potent CXCR4 inhibitor currently under clinical development. It can be used as a stem cell mobilizer for hematopoietic stem cell transplantation and a chemosensitizer in hematological and solid tumors. It can also be used for stem cell collection in healthy individuals for personalized regenerative medicine. Taigexyn is a novel safe and effective antibiotic for the treatment of bacterial infections including those caused by drug-resistant bacteria.

Under the terms of the agreement, GPCR Therapeutics will be wholly responsible for the development, registration, and commercialization of Taigexyn in S. Korea and Burixafor worldwide. Apart from upfront fees, TaiGen will receive shares of GPCR Therapeutics as well as future milestone and royalty payments.

GPCR Therapeutics is a world leader in the field of GPCR heteromer science and hasproprietary expertise and technology applicable to the development of this class of anti-cancer targets. CXCR4 antagonism is a well-accepted avenue towards cancer therapy and GPCR Therapeutics is well experienced and possesses the necessary know-how to develop Burixafor in the oncology field.

Dongseung Seen, CEO of GPCR Therapeutics, said, "This collaboration with TaiGen, which is a leading biotech company engaged in innovative molecular-based platforms with strong R&D capabilities, will lead to a long-term strategic and productive partnership. Further, it is our goal that our work together will position us to be a pre-eminent developer of anti-CXCR4 oncology drugs."

Kuo-Lung Huang, Chairman and Chief Executive Officer of Licensor, said, "This agreement and collaboration with GPCR is a tremendous progress in the continued development of Burixafor. Through the collaboration with GPCR Therapeutics, a novel and effective treatment for cancer patients possessing CXCR4 heteromers is on the horizon while a highly effective antibiotic will enter the S. Korea market to address their unmet medical needs in the near future."

About Burixafor

A stem cell mobilizer, Burixafor, is TaiGen's first fully in-house developed product, a First-in-Class drug with an IND under US FDA. With a variety of potential applications in a number of disease indications, if proven effective in clinical trials, Burixafor will be able to address several unmet medical needs. The molecule is a potent and selective chemokine receptor antagonist which can rapidly mobilize stem cells and progenitor cells from the bone marrow into peripheral circulation. Burixafor also has potential application in chemosensitization treatment of leukemia patients, delaying relapse after chemotherapy.

About Taigexyn

Taigexyn is a novel non-fluorinated quinolone available in both oral and intravenous formulations. The oral formulation of Taigexyn have received market approval in Taiwan and mainland China shown activity against drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and quinolone-resistant MRSA as well as quinolone-resistant Streptococcus pneumonia. TaiGen partnered with Zhejiang Medicaine Co., Holding Distribution, R-Pharm of Russia, Productos Cientficos S.A. de C.V., Luminarie Canada Inc. and GPCR Therapeutics, Inc. in 36 countries worldwide. In addition to the oral formulation, TaiGen granted NDA approval for intravenous formulation in Taiwan and is going to obtain the market approval in mainland China.

About GPCR Therapeutics, Inc.

Based in Seoul, S. Korea, GPCR Therapeutics is a biopharmaceutical company developing drugs based on the novel science of GPCR (G Protein-Coupled Receptor) heteromers. GPCR Therapeutics is specifically focused on the development of cancer therapeutics with a precision oncology approach.

About TaiGen Biotechnology

TaiGen Biotechnology is a leading research-based and market-driven biotechnology company in Taiwan with a wholly-owned subsidiary in Beijing, China. In addition to Taigexyn and Burixafor, TaiGen has two other in-house discovered NCEs: TG-1000, a novel pan-influenza antiviral effective against influenza-A, influenza-B, avian flu H7N7, and Tamiflu-resistant viruses, and Furaprevir, a HCV protease inhibitor for treatment of chronic hepatitis infection. TG-1000 is currently in Phase 1 clinical study in China and is granted IND approval by FDA in the U.S., and Furaprevir is currently in Phase 3 clinical development.

SOURCE TaiGen

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TaiGen Partners with GPCR to develop Burixafor & Taigexyn(R) - PRNewswire

REGINA -- Saskatchewans hockey community is mourning the loss of Rick Schwartz, who died suddenly in his Regina home on Monday evening from a heart attack at age 59.

To the public, Schwartz is known as the father of a Stanley Cup champion. His son, Jaden, is a member of the St. Louis Blues who won the cup in 2019.

Schwartz is also known for the dedication that he and his wife, Carol, have for the Mandi Schwartz Foundation. It is named after their daughter who lost a public battle to cancer in 2011. The foundation has focused on advocating for bone marrow drives and donations.

However, to those closest to Schwartz, hes being remembered as a man who put family and community before anything.

FAMILYS FIRST

Ramona and Patrick Vigneron, who are long-time close family friends of the Schwartzes, say theyll remember Ricks jokes, smile and laughter the most.

And just how much he absolutely loves his family, Ramona said. He always said familys first.

Schwartz had three children: Jaden, Rylan and Mandi.

The two families would travel together, often to watch their children play hockey. Some of their trips took them to Colorado, North Dakota, St. Louis and Germany.

With the celebrations hed always include family and friends, Ramona said.

Whether it was during the kids minor hockey days in Wilcox or watching a Stanley Cup Championship, Schwartz always provided a fun time for those around him.

One of the most entertaining things you could do is watch a hockey game with Rick with one of the kids playing, Patrick said.

It was great watching games with Ricky because he got pretty emotional as he watched the boys and Mandi play, Ramona said. It was really part of Rickys life, you could just see him come to life watching the kids play.

BONE MARROW DRIVES

In honour of Mandi, the Schwartz family launched a foundation that is often involved in bone marrow drives in hopes of helping people who need a donor find their perfect match.

Rick was determined to make sure Mandis foundation continued on with the stem cells, and match program was very important, Ramona said.

Bone marrow drives continue at Yale University, where Mandi played. The St. Louis Blues also held a drive in 2013. Four years later, an 18-year-old woman was able to find her perfect match from a man who was swabbed at that Blues game.

The Schwartz family hosted both the donor and the recipient, both from the United States, in 2019 for the annual Run for Mandi in Saskatchewan.

ATHOL MURRAY COLLEGE OF NOTRE DAME

Rick and Carols three children all attended Athol Murray College of Notre Dame in their childhood and teenage years.

They participated in multiple sports, but hockey was the biggest. Its been about a decade since any of the kids played there, but the Schwartzes have always stayed involved in the community.

The great thing about Rick was that he loves hockey, Rob Palmarin, the president of Athol Murray College of Notre Dame, said. Hed still come out to our arena and would visit with our coaches who were the coaches of his sons and daughter, and our hockey staff. He was a frequent visitor to our arena so he was just one of the family.

After Mandis passing in 2011, the Schwartz family helped to honour her at the school.

The Schwartz family has set up an endowment fund and that supports a number of our female athletes, particularly hockey players, on an annual basis, Palmarin said. That came out of the tragedy of Mandi Schwartz dying of cancer in 2011. So its been almost a decade of them working to keep her memory alive.

Palmarin said Rick and Carol were role models of parents who had children playing hockey.

One of the mottos painted in the rink at Notre Dame reads Never Lose Heart.

That motto is painted up there not only as an inspiration to our student athletes when they practice and play, but its also an inspirational motto for all of us to remember the Notre Dame Hounds family, both living and deceased, Palmarin said. Rick is now going to be part of that.

RECENT MEMORIES

Most recently, Schwartz worked with the Saskatchewan Safety Council. Patrick worked there with him for the past five years.

Weve got a couple of projects on the board right now and Im not sure where theyre going to end up, but well try to make them work for him, Patrick said.

Ramona said right now, the Schwartz family is cherishing the time they were able to spend together over the summer.

One of the blessings of COVID-19 was that Rylan came home from Germany and then Jaden came home from St. Louis and they were with their parents for literally four months, Ramona said. Carol kept repeating these last few days it has been awesome how much time Rick got to spend with his sons for the last four months.

She said the memories of playing golf and cards will long be remembered by the family.

The death is a shock. Theres a lot of people who have been affected by Ricky and just how passionate he is, Ramona said. He has a heart of gold.

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'A heart of gold': Rick Schwartz remembered for his commitment to family, community - CTV News

VANCOUVER, Washington, Nov. 11, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it completed an additional non-dilutive convertible debt offering with an institutional investor, which provides $25 million of immediately available capital. The note has a two-year maturity, bears interest at the rate of 10% per annum and is secured by all assets of the Company, excluding its intellectual property. The note may be converted at the option of the investor into shares of the Companys common stock at a conversion price of $10.00 per share.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, We are very pleased with the institutions demonstration of confidence and their understanding of leronlimabs positioning on its regulatory trajectory. This infusion of capital will enable us to accelerate efforts to file BLAs in Canada and the U.K. for leronlimab as a combination therapy for HIV patients with one dose (one 350 mg subcutaneous injection) per week. We continue to expedite enrollment in CD12 (currently at 260 patients), in addition to now accelerating a COVID-19 trial for long-hauler patients, who have no alternative therapy and are rapidly emerging as a widespread health concern. We are well-positioned to supply $2 billion worth of leronlimab to treat COVID-19, if emergency use authorization is approved in the next 2-4 months based on anticipated successful CD12 results.

About Coronavirus Disease 2019 CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. Enrollment continues in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals and clinics throughout the U.S., which are identified on the Companys website under the Clinical Trial Enrollment section of the homepage; an interim analysis on the first 195 patients was conducted mid-October and is expected to occur again after enrollment reaches 293 patients.

About Leronlimab (PRO 140) The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells.CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDyn CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.

CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The FDA met telephonically with Company key personnel and its clinical research organization and provided written responses to the Companys questions concerning its recent Biologics License Application (BLA) for this HIV combination therapy in order to expedite the resubmission of its BLA filing for this indication.

CytoDyn has completed a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than six years.

CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking StatementsThis press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company's cash position, (ii) the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv) the Company's ability to enter into partnership or licensing arrangements with third parties, (v) the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company's ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company's clinical trials, (viii) the results of the Company's clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company's products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company's control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CONTACTSInvestors: Michael MulhollandOffice: 360.980.8524, ext. 102mmulholland@cytodyn.com

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CytoDyn Completes Second Non-dilutive $28.5 Million Convertible Note Financing with Conversion Rate at $10.00 Per Share Without Warrants to Help...

– European Medicines Agency (EMA) validated the Marketing Authorisation Application (MAA) for TransConTM hGH (lonapegsomatropin) in pediatric growth hormone deficiency (GHD) –

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Ascendis Pharma A/S Reports Third Quarter 2020 Financial Results

SOUTH SAN FRANCISCO, Calif., Nov. 11, 2020 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody® technology platform, today announced that Sean McCarthy, D.Phil., president, chief executive officer, and chairman, will participate in the following virtual healthcare conferences in November.

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CytomX Therapeutics to Present at Upcoming Investor Conferences

MALVERN, Pa., Nov. 11, 2020 (GLOBE NEWSWIRE) -- TELA Bio, Inc. ("TELA") (Nasdaq: TELA), a commercial-stage medical technology company focused on designing, developing and marketing a new category of tissue reinforcement materials to address unmet needs in soft tissue reconstruction, today reported financial results for the third quarter ended September 30, 2020.

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TELA Bio Announces Third Quarter 2020 Financial Results

WESTLAKE VILLAGE, Calif., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced that Frank Watanabe, President and CEO, will present a corporate overview during the Stifel 2020 Virtual Healthcare Conference taking place November 16-18, 2020.

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Arcutis Biotherapeutics to Present at the Stifel 2020 Virtual Healthcare Conference

Conference Call and Live Audio Webcast Scheduled for Today, November 11, 2020, at 4:30 p.m. ET Conference Call and Live Audio Webcast Scheduled for Today, November 11, 2020, at 4:30 p.m. ET

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Salarius Pharmaceuticals Reports Business Highlights and Third Quarter 2020 Financial Results

FLORHAM PARK, N.J., Nov. 11, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology, today announced its financial results for the third quarter ended September 30, 2020 and provided a business update.

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PDS Biotechnology Reports Financial Results for the Third Quarter 2020 and Provides Business Update

PRISM Trial of Haduvio™ for Severe Pruritus in Patients with Prurigo Nodularis

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Trevi Therapeutics Announces Third Quarter 2020 Financial Results and Business Update

Data shows CPI-006 provided enhanced and prolonged polyclonal humoral immunity to SARS-CoV-2

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Corvus Hosting R&D Symposium on November 12 to Highlight COVID-19 Program and Updated Study Data Presented at SITC Annual Meeting

SAN DIEGO, Nov. 11, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing long-acting therapeutics designed to transform the standard of care for patients facing serious fungal or viral infections, today announced that Jeffrey Stein, Ph.D., President and Chief Executive Officer, will participate in two upcoming conferences: the Stifel 2020 Virtual Healthcare Conference and 3rd Annual Evercore ISI HealthCONx Conference.

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Cidara Therapeutics to Participate in Two Upcoming Investor Conferences

Conference call to be held at 4:30 p.m. Eastern Time today

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OpGen Reports Third Quarter 2020 Financial Results and Provides Business Update

- Conference Call Scheduled November 11, 2020 at 4:30 p.m. ET - - Conference Call Scheduled November 11, 2020 at 4:30 p.m. ET -

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Cyclacel Pharmaceuticals Reports Third Quarter 2020 Financial Results

Submitted a premarket approval (PMA) to the FDA for LungFit™ PH to treat persistent pulmonary hypertension of the newborn (PPHN)

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Beyond Air® Reports Financial Results for Second Quarter of Fiscal Year 2021 and Provides Business Update

SAN DIEGO, Nov. 11, 2020 (GLOBE NEWSWIRE) -- Retrophin, Inc. (NASDAQ: RTRX) today announced that Company management will present at the following upcoming virtual investor conferences in November and December:

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Retrophin to Present at Upcoming Investor Conferences

DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that John F. Thero, Amarin's president and chief executive officer, is scheduled to present general company updates at the following investor conferences scheduled in November:

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Amarin to Present at the Stifel 2020 Virtual Healthcare and Jefferies Virtual London Healthcare Conferences

– Event will provide an overview of how Ascendis is applying its TransCon™ technology platform and its unique algorithm for product innovation to the therapeutic area of oncology –

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Ascendis Pharma A/S to Host Virtual Oncology R&D Day on Friday, November 20

ROCKVILLE, Md., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the Company's management will present an overview and update, as well as host investor meetings, at the following virtual investor conferences in November 2020.

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Supernus to Present at Two November Investor Conferences

GHENT, Belgium, Nov. 12, 2020 (GLOBE NEWSWIRE) -- Sequana Medical NV (Euronext Brussels: SEQUA), an innovator in the management of fluid overload in liver disease, malignant ascites and heart failure, today announces that Ian Crosbie, Chief Executive Officer, will present at the Jefferies 2020 Virtual London Healthcare Conference taking place from 17 to 19 November 2020.

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Sequana Medical to present at Jefferies 2020 Virtual London Healthcare Conference