On August 24, 2020 Kronos Bio, Inc., a private clinical-stage biopharmaceutical company dedicated to the discovery and development of novel cancer therapeutics designed to transform patient outcomes through a precision medicine strategy by targeting dysregulated transcription, reported a private financing of approximately $155 million of convertible notes, with $148 million in funding received to date and the remaining $7 million to be funded by mid-September pursuant to binding commitments (Press release, Kronos Bio, AUG 24, 2020, View Source [SID1234563984]). The financing was led by Perceptive Advisors and included funds and accounts managed by BlackRock, Inc., funds affiliated with Casdin Partners, Commodore Capital, EcoR1 Capital, Fidelity Management and Research Company, Surveyor Capital (a Citadel company), funds and accounts advised by T. Rowe Price Associates, Inc., Woodline Partners, and a large diversified asset manager on the west coast, as well as existing investors including GV (formerly Google Ventures), Invus, Nextech Invest, Omega Funds, Polaris Partners, and Vida Ventures, LLC.

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"We appreciate the strong support from this group of investors and believe this capital will help propel Kronos through our upcoming period of clinical development," said Norbert Bischofberger, Ph.D., President and Chief Executive Officer of Kronos. "Importantly, this capital will help advance our lead spleen tyrosine kinase (SYK) inhibitor, which we recently acquired from Gilead, including potentially into a registrational trial in 2021. It will also help us advance our second lead pipeline candidate, KB-0742, a differentiated CDK9 inhibitor, into a Phase 1/2 clinical trial for treatment of MYC-amplified solid tumors, as well as to further invest in our product discovery engine to drive multiple oncology programs targeting dysregulated transcription factors."

Jefferies LLC acted as the sole placement agent for the financing.

On August 24, 2020 NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for the combination of its lead drug candidate, NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), and Kymriah (tisagenlecleucel), a CD19 CAR T-cell therapy, for the treatment of patients with relapsed/refractory large B cell lymphoma (r/r LBCL) (Press release, NeoImmuneTech, AUG 24, 2020, View Source [SID1234563983]). This IND clearance allows NeoImmuneTech (NIT) to initiate a multicenter Phase 1b study evaluating the safety, tolerability, and preliminary anti-tumor activity of NT-I7 administration following standard-of-care Kymriah CAR T-cell therapy.

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Diffuse large B-cell lymphoma is the most commonly occurring subtype of non-Hodgkin lymphoma (NHL), accounting for 25% to 30% of all NHL and >20,000 cases in the U.S. annually. Despite improvement in therapeutic options, treatment is often not curative with as many as 50% of patients with adverse risk factors developing relapsed or refractory disease.

"CAR T-cell therapy has undoubtedly changed the treatment paradigm of LBCL; however there is still a large patient population who will relapse or develop refractory disease," commented John DiPersio, M.D., Ph.D., Chief, Division of Oncology; Director, Center for Gene and Cellular Immunotherapy; and Deputy Director, Siteman Cancer Center at Washington University School of Medicine and Barnes-Jewish Hospital. "In multiple animal models, the addition of NT-I7 to CAR T cells substantially increased CAR T cell proliferation, persistence, and target-specific tumor killing, resulting in significantly prolonged survival of the treated animals. In the clinic, treatment with NT-I7 has shown to increase T cell counts in the blood and is well tolerated. Administration of NT-I7 following Kymriah may increase the expansion and persistence of Kymriah and facilitate the reconstitution of patients’ own immune system to fight cancer."

In addition to establishing the safety, tolerability, and assessing the preliminary anti-tumor activity of NT-I7 following Kymriah, this Phase 1b study will determine the recommended Phase 2 dose to be used for further clinical development of the combination.

"This latest IND clearance marks another achievement for our robust clinical development program of NT-I7, which has multiple ongoing trials in both cancer and infectious diseases," said NgocDiep Le, M.D., Ph.D., Executive Vice President and Chief Medical Officer of NeoImmuneTech. "As CAR T cell expansion is a strong predictor of response to CAR T-cell therapy, we believe that treatment with NT-I7 following Kymriah could potentially enhance the response rate and duration of response to Kymriah, and ultimately improve the clinical outcome for patients with r/r LBCL. We eagerly look forward to executing this important clinical trial as soon as possible to hopefully deliver another breakthrough treatment for these patients."

Kymriah is a registered trademark of Novartis AG.

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On August 24, 2020 Finance executives at respected Taiwanese wealth management company Crest View International has commented on Takeda Pharmaceutical Co. reported that they agree to sell their Japanese consumer health-care business for $2.3 billion (242 billion yen) to U.S. investment fund, Blackstone Group Inc (Press release, Takeda, AUG 24, 2020, View Source [SID1234563982]).

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"Takeda is a global manufacturer of over-the-counter (OTC) drugs and health products and according to our researchers, Blackstone is planning to take this business unit public in around five years"

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"Takeda is a global manufacturer of over-the-counter (OTC) drugs and health products and according to our researchers, Blackstone is planning to take this business unit public in around five years," commented Michael Kennedy, Head of Corporate Trading at Crest View International.

Japan’s largest pharmaceuticals company has been attempting to reduce its OTC assets worldwide as it aims to refocus its business and lower debt following its $59 billion acquisition of biopharmaceutical firm Shire.

According to analysts at Crest View International, the unit, which sold for a lower price than anticipated, likely due to Covid-19’s impact on its finances, may benefit from the governments push to curb the costs of health-care, including prescription medicine.

Takeda said proceeds from the sale would boost its net profit by $992 million (105 billion yen). In addition, the Blackstone takeover could also help rejuvenate the selling of household brands such as Alinamin energy drinks and Benza Block cold medication.

"Blackstone is aiming to invest 50 billion yen into the OTC business. It has a three-year strategy to strengthen the business throughout Asia, with networks in China Taiwan and Thailand, and to launch new products based on its already-popular offerings," commented John Harrison, Head of Wealth Management at Crest View International.

Since Takeda acquired Shire, it has extended its therapy areas to include gastroenterology, oncology, neuroscience, rare diseases and plasma-derived therapies. Its asset sales centred on cutting business lines that are not aligning with these core target areas. In June, Takeda decided to sell a separate portfolio of over-the-counter medication to South Korea’s Celltrion Inc. in a deal worth approximately $278 million, which is subject to certain post-sale conditions.

On August 24, 2020 Bio-Thera Solutions, Ltd., a commercial stage biopharmaceutical company (688177.SH) and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), reported that the companies have executed a license, distribution, and supply agreement for China for Bio-Thera’s BAT1706, an investigational biosimilar to Avastin (bevacizumab) (Press release, BioThera Solutions, AUG 24, 2020, View Source [SID1234563981]). The China National Medical Products Administration (NMPA) recently accepted Bio-Thera’s Biologics License Application (BLA) for BAT1706. Bevacizumab has been approved in China for advanced, metastatic, or relapsed non-small cell lung cancer and metastatic colorectal cancer. The agreement is subject to approval by the shareholders of Bio-Thera at a meeting to be held in September 2020.

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Under the terms of the agreement, Bio-Thera has agreed to grant BeiGene the right to develop, manufacture, and commercialize BAT1706 in China, including Hong Kong, Macau, and Taiwan. Bio-Thera will retain rights outside of the partnered territory. Bio-Thera will receive an upfront payment and is eligible to receive payments upon the achievement of regulatory and commercial milestones up to a total of $165 million. Bio-Thera will also be eligible to receive tiered double-digit royalties on future net product sales.

"We are focused on bringing impactful and affordable medicines to people around the world. BAT1706, a potential biosimilar for Avastin (bevacizumab), could become an important treatment option for solid tumor indications in China such as colorectal, lung, and liver cancers. It brings us the opportunity to broaden our portfolio of commercial and registration-stage products in China and is complementary to our in-licensed and internally discovered medicines, such as tislelizumab, our marketed anti-PD-1 antibody that has also been filed in China for lung and liver cancer indications," said Xiaobin Wu, Ph.D., General Manager of China and President of BeiGene.

"We are delighted to enter a collaboration with BeiGene, a company with significant expertise and a robust pipeline in oncology, as it will enable us to deliver BAT1706 to more patients as soon as possible," said Dr. Shengfeng Li, CEO of Bio-Thera. "This collaboration allows Bio-Thera to leverage BeiGene’s experience and expertise to accelerate the development and commercialization of BAT1706 as a single agent regimen or as a component of combinational therapies, and to help increase patient access to this important cancer therapeutic at affordable prices."

About BAT1706

BAT1706 is a monoclonal antibody (mAb) that is in development by Bio-Thera Solutions as a potential biosimilar to Avastin. BAT1706 works by binding to the vascular endothelial growth factor (VEGF) protein. In the United States, Avastin is indicated for the treatment of patients with metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, persistent, recurrent, or metastatic cervical cancer, epithelial ovarian, fallopian tube, or primary peritoneal cancer, and hepatocellular carcinoma. BAT1706 is an investigational compound and has not received regulatory approval in any country. The China NMPA accepted the Biologics License Application (BLA) for BAT1706 in June 2020. Bio-Thera plans to file for marketing approval of BAT1706 in the United States and European Union in the fourth quarter of 2020.

On August 24, 2020 Celldex Therapeutics, Inc. (Nasdaq:CLDX) reported that enrollment has opened in its open-label, Phase 1 study of CDX-527 in patients with advanced or metastatic solid tumors that have progressed during or after standard of care therapy (Press release, Celldex Therapeutics, AUG 24, 2020, View Source [SID1234563980]). CDX-527 is the first candidate from Celldex’s bispecific antibody platform. It uses Celldex’s proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 costimulation with blockade of the PD-L1/PD-1 pathway to help prime and activate anti-tumor T cell responses through CD27 costimulation, while preventing PD-1 inhibitory signals that subvert the immune response.

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"CDX-527 builds on our prior clinical experience where the combination of CD27 activation and PD-1 blockade was well tolerated and demonstrated biological and clinical activity when the individual agents were dosed together," said Tibor Keler, Ph.D., Executive Vice President and Chief Scientific Officer of Celldex Therapeutics. "We believe this bodes well for the potential safety and activity profile of CDX-527, which incorporates the two mechanisms into one molecule. Importantly, preclinical studies of CDX-527 also demonstrated greater activity than the combination of individual antibodies, adding to our enthusiasm that this next-generation checkpoint inhibitor could be an important addition to the Celldex pipeline."

This study, which is expected to enroll up to approximately 90 patients with solid tumors, is designed to determine the maximum tolerated dose, or MTD, during a dose-escalation phase and to recommend a dose level for further study in a subsequent expansion phase. The expansion phase is designed to further evaluate the tolerability and biologic effects of selected dose level(s) of CDX-527 in specific tumor types. Secondary objectives of the study include analyses of safety and tolerability, pharmacokinetics, immunogenicity and assessment of anti-tumor activity across a broad range of endpoints, such as objective response rate, clinical benefit rate, duration of response, progression-free survival and overall survival. More information about this study is available on www.clinicaltrials.gov (Identifier: NCT04440943).

About CDX-527
CDX-527 is a bispecific antibody composed of Celldex’s proprietary PD-L1 and CD27 human antibodies. CDX-527 combines blockade of the PD-1 pathway with T cell costimulation through CD27 into one molecule using an IgG1-ScFv format. Preclinical data demonstrate CDX-527 is more potent than the combination of anti-PD-L1 and anti-CD27 antibodies in T cell activation and anti-tumor activity. CDX-527 has direct antibody-dependent cellular cytotoxicity (ADCC) against CD27 or PD-L1 expressing tumor cells. In addition, CDX-527 exhibits an antibody-like pharmacokinetic profile without concerning toxicity in preclinical models. Prior clinical data with Celldex’s CD27 antibody as monotherapy and in combination with PD-1 inhibitors supports combining these pathways in patients with cancer. The Company believes that the potential for CDX-527 will include both monotherapy and combination studies with other immunotherapies or conventional cancer treatments.