On September 15, 2021 AbCellera (Nasdaq: ABCL) reported that it entered into a multi-year, multi-target research collaboration and license agreement with Moderna to leverage AbCellera’s AI-powered technology to search and analyze natural immune responses to identify therapeutic antibodies against up to six targets selected by Moderna (Press release, AbCellera, SEP 15, 2021, View Source [SID1234587738]).

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"Over the past year, Moderna has demonstrated the speed and impact of its mRNA vaccine technology in helping to protect people around the world," said Carl Hansen, Ph.D., CEO and President of AbCellera. "We are excited to work alongside their team to advance RNA-encoded antibodies as a new frontier in genetic medicines."

Under the terms of the agreement, Moderna will have the rights to develop and commercialize antibodies resulting from the collaboration. AbCellera will receive research payments and is eligible to receive from Moderna downstream clinical and commercial milestone payments and royalties on net sales of products.

On September 15, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a clinical stage biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, reported that it has commenced an underwritten public offering of shares of its common stock (Press release, aTyr Pharma, SEP 15, 2021, View Source [SID1234587755]). In addition, aTyr expects to grant the underwriters a 30-day option to purchase additional shares of its common stock. All of the shares to be sold in the offering are to be sold by aTyr. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

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Piper Sandler and RBC Capital Markets are acting as joint book-running managers for the offering.

The proposed offering is being made pursuant to a shelf registration statement on Form S-3, including a base prospectus, filed by aTyr that was declared effective by the Securities and Exchange Commission ("SEC") on August 23, 2021. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. An electronic copy of the preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the website of the SEC at www.sec.gov. Copies of the preliminary prospectus supplement, when available, and the accompanying prospectus relating to the offering may be obtained by contacting Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924 or by email at [email protected]; or RBC Capital Markets, LLC, Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, New York 10281, by telephone at (877) 822-4089 or by email at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or the 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 September 15, 2021 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that the poster "A pilot study of Engineered Adenovirus ONCOS-102 in combination with pembrolizumab (pembro) in checkpoint inhibitor refractory advanced or unresectable melanoma" is now available at the ESMO (Free ESMO Whitepaper) congress website and on the Company’s website (Press release, Targovax, SEP 15, 2021, View Source [SID1234587773]). The poster will be presented as an e-poster at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress by Dr Alexander N. Shoushtari, Memorial Sloan Kettering Cancer Center.

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The poster presents the pilot study of ONCOS-102 in combination with pembrolizumab (pembro) in checkpoint inhibitor refractory advanced or unresectable melanoma. The poster concludes that co-administration of ONCOS-102 and pembrolizumab is safe and feasible for patients with melanomas progressing on PD-1 blockade. Rapid clinical objective responses were seen in patients treated both sequentially and in combination, and immune markers demonstrating induction of beneficial tumor microenvironment changes support the role of ONCOS-102 as a complementary treatment with aPD1 and other IO modalities.

E-poster title:

A pilot study of Engineered Adenovirus ONCOS-102 in combination with pembrolizumab (pembro) in checkpoint inhibitor refractory advanced or unresectable melanoma

E-poster number:

1083P

Presenter:

Dr Alexander N. Shoushtari, Memorial Sloan Kettering Cancer Center

Please see the poster here: Targovax ESMO (Free ESMO Whitepaper) 2021 poster.pdf

On September 14, 2021 LeaderMed Health Group Limited, a pharmaceutical development company with operations based in Asia, and OPKO Health, Inc. (NASDAQ: OPK), a diversified healthcare company focused on diagnostics and pharmaceuticals, reported the formation of a joint venture to develop, manufacture and commercialize two of OPKO’s clinical stage, long-acting drug products in Greater China and eight other Asian territories (Press release, Opko Health, SEP 14, 2021, View Source [SID1234587674]).

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Under the terms of the agreements, OPKO will grant the joint venture exclusive rights to develop, manufacture and commercialize (a) OPK88003, an oxyntomodulin analog being developed for the treatment of obesity and diabetes, and (b) Factor VIIa-CTP, a novel long-acting coagulation factor being developed to treat hemophilia, in exchange for a 47% ownership interest in the joint venture. In addition, OPKO will receive an upfront payment of $1 million and will be reimbursed for clinical trial material and technical support it provides the joint venture.

LeaderMed will be responsible for funding the joint venture’s operations, development and commercialization efforts and will, with its syndicate partners, initially invest $11 million in exchange for a 53% ownership interest. OPKO retains full rights to oxyntomodulin and Factor VIIa-CTP in all other geographies.

"Through this joint venture, we have an opportunity to extend the global availability of two of our novel long-acting development products and to establish a presence in China in partnership with collaborators who have significant experience and deep knowledge of the Asian biopharmaceutical opportunity," said Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO.

"LeaderMed Group is an innovative pharmaceutical development company with its own pipeline of licensed products. Our capabilities include an experienced management team with demonstrated success in bringing biopharmaceutical and pharmaceutical products to market in China and globally, cGMP facilities to manufacture clinical-grade products, and a corporate charter that acknowledges and protects client IP. We are excited about the opportunity to expeditiously deliver a novel and superior treatment for obesity and diabetes to hundreds of millions of patients in China and Asia, as well as a treatment for hemophilia, an orphan indication," added Dr. Joanne Jiang, Chief Executive Officer of LeaderMed Group and architect of the joint venture.

About Oxyntomodulin
Oxyntomodulin is a naturally occurring hormone produced in the colon that binds the GLP-1 and glucagon receptors, regulating both blood glucose appetite and lipid metabolism. OPKO Health is developing OPK88003, a long-acting, once-weekly oxyntomodulin analog for the treatment of type 2 diabetes and obesity. OPK88003 has been successfully studied in two Phase 2 clinical trials enrolling type 2 diabetes patients, studying weight loss and reduction in glycosylated hemoglobin (HbA1c or A1c), a marker of sugar metabolism. Driven by the LeaderMed-OPKO joint venture, it is positioned to be the first dual-targeted drug approved for diabetes and obesity in the Chinese and Asia markets.

About Factor VIIa-CTP
Factor VIIa-CTP is a novel, long-acting recombinant Factor VIIa utilizing OPKO’s proprietary technology to extend its circulatory half-life without the use of polymers, encapsulation techniques or nanoparticles. The technology is based on a naturally occurring peptide, the C-terminal peptide (CTP) of the beta chain of human chorionic gonadotropin. The CTP technology is also used in OPKO’s hGH-CTP (somatrogon), a long-acting recombinant human growth hormone product that successfully completed Phase 3 clinical trials in children with growth hormone deficiency. hGH-CTP has been submitted for approval in the United States, Europe and Japan and is partnered with Pfizer for global commercialization. Factor VIIa-CTP has been granted orphan drug designation in the U.S. and Europe.

In China, hemophilia was designated as a rare disease in 2018. LeaderMed expects to seek fast regulatory approval for Factor VIIa-CTP through a special national rare disease channel.

On September 14, 2021 Harbour BioMed ("HBM", HKEX: 02142) reported that the China National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) applications for HBM4003, a next-generation, fully human anti-CTLA-4 monoclonal heavy chain only antibody in combination with PD-1 antibody in patients with advanced hepatocellular carcinoma (HCC) and other solid tumors, as well as advanced neuroendocrine tumor/neuroendocrine carcinoma (NET/NEC) and other solid tumors (Press release, Harbour BioMed, SEP 14, 2021, View Source [SID1234587690]).

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HBM4003 has already received an IND approval from the U.S. FDA, IND approvals from the China NMPA and the clinical trial approval from the Australia Institutional Review Board (IRB). The Company is proceeding multiple clinical trials for HBM4003 monotherapy and combination therapy across the world.

"HBM4003 has already demonstrated encouraging safety and anti-tumor activity in patients in our ongoing trials. The NMPA’s two IND approvals are the continuing recognition of this next-generation anti-CTLA-4 antibody, reminding us of our responsibility and mission. We look forward to bringing this novel combination therapeutic to HCC and NET/NEC patients soon," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed.

About HBM4003

HBM4003 is a fully human anti-CTLA-4 monoclonal heavy chain only antibody (HCAb) generated from Harbour Mice. By enhancing antibody-dependent cell cytotoxicity (ADCC) killing activity, HBM4003 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.

About Hepatocellular Carcinoma (HCC)

Liver cancers are the fourth most common cause of cancer-related death and rank sixth in terms of incident cases worldwide. On the basis of annual projections, the World Health Organization estimates that more than 1 million patients will die from liver cancer in 2030.1 Hepatocellular carcinoma (HCC)2 is the most common form of liver cancer and accounts for ~90% of cases. The majority of HCC occur in patients with underlying liver diseases, mostly as results of hepatitis B or C virus (HBV or HCV) infection or alcohol abuse. Systemic therapies are recommended for advanced stage of HCC, including inhibitors of multiple kinases and immune-based therapies, with increased median survival of 10.6~15.6 months.1 Although the clinical management of advanced stage of HCC has improved in the past 10 years, there is still high unmet medical needs to explore new, effective and life-prolonged therapies for HCC.

About Neuroendocrine Neoplasms (NEN, including NET and NEC)

NEN is a neoplasm that arise from neuroendocrine cells. There are two fundamentally different groups of NEN: well-differentiated, low-proliferating NEN, called neuroendocrine tumor (NET) and poorly differentiated, highly proliferating NEN, called neuroendocrine carcinoma (NEC). NEN can occur almost everywhere in the body but are most common in the gastrointestinal tract, the pancreas, and the lungs.3 Surgery, radiation therapy, chemotherapy and a variety of drug treatments are common therapies for patients with NET/NEC. Prognosis is worse in metastatic tumors, with the 5-year survival rate about 4.7% in metastatic gastroenteropancreatic neuroendocrine cancer (GEP-NEC).4 Consequently, there is still high unmet medical needs to explore new, effective and convenient therapies for NET/NEC.