On November 29, 2021 Ablaze Pharmaceuticals ("Ablaze"), a clinical-stage pharmaceutical company focused on the development and commercialization of innovative targeted radiopharmaceutical therapies (TRT) against tumor targets, reported a $75 million Series A financing round (Press release, Ablaze Pharmaceuticals, NOV 29, 2021, View Source [SID1234596220]). The financing was co-led by Vivo Capital and AdvanTech Capital with participation from RAYZ Investments, Nan Fung Life Sciences, Pivotal bioVenture Partners China, venBio Partners, Samsara BioCapital and Venrock Healthcare Capital Partners.

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"Targeted radiopharmaceutical therapies represent the next foundational modality to treat cancer," said Dr. Ken Song, co-founder and Chairman of the Board of Ablaze and President and CEO of RayzeBio, Inc. "In forming Ablaze, we realized to be successful, it was critical to have a company focused on the China market and focused on radiopharmaceuticals."

With TRT gaining broader interest and adoption, Ablaze was formed to become the leading radiopharmaceutical company to introduce TRT products to the Greater China market. Led by an experienced team and a strong investor syndicate, Ablaze started on a solid footing, anchoring with a strategic RayzeBio in-licensing agreement, and a partnership with an academic institution on a clinical stage asset. Upon closure of the Series A, Ablaze is also actively exploring other potential partnerships, and building strong internal development capabilities.

"TRT is an emerging field that has already demonstrated tremendous clinical efficacy in treating cancer worldwide. We are privileged to have an opportunity to partner with Ablaze and the RayzeBio team in developing this category of potentially life-saving therapeutics for cancer patients in China." said Dr. Hongbo Lu, Managing Partner of Vivo Capital.

Proceeds from the Series A financing will be used by Ablaze to establish a leading pipeline of advanced TRT products for the treatment of solid tumors, expand the leadership team, build up infrastructure for radiopharmaceuticals and secure further strategic collaborations. The board of directors include Dr. Alex Qiao, co-founder and President and CEO of Ablaze Pharmaceuticals, Dr. Hongbo Lu, Benjamin Qiu, Partner at AdvanTech Capital, Dr. Aaron Royston, Managing Partner at venBio Partners, and Dr. Ken Song as well as Norman Tse, Vice President at Nan Fung Life Sciences as board observer.

"We believe Ablaze is bringing world class design of TRT products as well as clinical expertise to China through collaborations with global leaders in TRT, and is determined to be a leading player in China’s TRT innovations" said Mr. Benjamin Qiu.

"We are excited about this opportunity to bring a novel class of therapeutic products to benefit patients in China," said Dr. Alex Qiao. "This investment from top tier investors in China and abroad provides a strong endorsement to Ablaze’s vision and business model. We look forward to creating the best and differentiated medicines to address unmet medical needs in China."

On November 29, 2021 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, NOV 29, 2021, View Source [SID1234596242]). This programme is part of the overall share repurchase programme of up to DKK 20 billion to be executed during a 12- month period beginning 3 February 2021.

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Under the programme initiated 5 November 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.7 billion in the period from 11 November 2021 to 1 February 2022

With the transactions stated above, Novo Nordisk owns a total of 29,392,732 B shares of DKK 0.20 as treasury shares, corresponding to 1.3% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 20 billion during a 12- month period beginning 3 February 2021. As of 26 November 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 30,639,181 B shares at an average share price of DKK 560.81 per B share equal to a transaction value of DKK 17,182,675,592.

On November 29, 2021 OPKO Health, Inc. (NASDAQ: OPK) reported that management will be participating in the Piper Sandler 33rd Annual Virtual Healthcare Conference taking place November 30 through December 2, 2021 (Press release, Opko Health, NOV 29, 2021, View Source [SID1234596185]). A pre-recorded company fireside chat is available for registered attendees via the Piper Sandler conference site and at this link.

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Management will be available for one-on-one virtual meetings with investors on Wednesday, December 1st, which can be requested through Piper Sandler.

On November 29, 2021 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that the Company has initiated a Phase 2, single arm, open-label study of trilaciclib administered prior to the antibody-drug conjugate (ADC), Trodelvy (sacituzumab govitecan-hziy) in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) (Press release, G1 Therapeutics, NOV 29, 2021, View Source [SID1234596203]). Antitumor efficacy and myeloprotective endpoints are being assessed in this trial. Initial results of this study are expected in the second half of 2022.

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"All of our clinical programs are designed to maximize the utility of trilaciclib and evaluate its ability to transform treatments for patients living with cancer, including potential synergies with newer promising agents, such as ADCs," said Raj Malik, M.D., Chief Medical Officer at G1 Therapeutics. "We are excited to develop this combination in TNBC, an area where trilaciclib in our Phase 2 trial and Trodelvy have both shown clinically meaningful and substantial improvements in overall survival and could act synergistically to improve patient outcomes with fewer myelosuppressive side effects. We believe strongly in the clinical rationale underlying this combination and that the data generated from this study will be instructive as we contemplate combinations of trilaciclib and ADCs in other treatment settings and tumor types."

Patient recruitment in this trial is now underway. Approximately 40 patients will be enrolled in this exploratory Phase 2, multicenter, open-label, single arm study evaluating the safety and efficacy of trilaciclib administered prior to sacituzumab govitecan-hziy in patients with unresectable, locally advanced or metastatic TNBC who received at least 2 prior treatments, at least 1 in the metastatic setting. Trilaciclib will be administered as a 30-minute IV infusion completed within 4 hours prior to the start of sacituzumab govitecan-hziy treatment on day 1 and day 8 of each 21-day cycle.

Study drug administration will continue until progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or clinical progression as determined by the Investigator, unacceptable toxicity, withdrawal of consent, Investigator decision, or the end of the study, whichever occurs first.

The primary objective is to evaluate the anti-tumor efficacy of trilaciclib when administered prior to sacituzumab govitecan-hziy as measured by progression-free survival (PFS). Key secondary endpoints include evaluation of the anti-tumor efficacy as measured by the objective response rate (ORR), duration of objective response (DOR), clinical benefit rate (CBR), and overall survival (OS); and evaluation of the myeloprotective effects of trilaciclib.

About Triple Negative Breast Cancer (TNBC)

According to the American Cancer Society, nearly 300,000 new cases of invasive breast cancer are diagnosed annually in the U.S. Triple-negative breast cancer makes up approximately 15-20% of such diagnosed breast cancers. TNBC is cancer that tests negative for estrogen receptors, progesterone receptors, and excess HER2 protein. Because mTNBC cells lack key growth-signaling receptors, patients do not respond well to medications that block estrogen, progesterone, or HER2 receptors. Instead, treating mTNBC typically involves chemotherapy, radiation, and surgery. TNBC is considered to be more aggressive and have a poorer prognosis than other types of breast cancer. In general, survival rates tend to be lower with mTNBC compared to other forms of breast cancer, and mTNBC is also more likely than some other types of breast cancer to return after it has been treated, especially in the first few years after treatment. It also tends to be higher grade than other types of breast cancer.

On November 29, 2021 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to proceed with a Phase 1b/2 clinical trial of its anti-CTLA-4 monoclonal antibody (mAb), ADG116, in combination with the anti-PD-1 antibody, pembrolizumab (Press release, Adagene, NOV 29, 2021, View Source [SID1234596225]). The global trial (ADG116-P001 / KEYNOTE-C97) will evaluate patients with advanced/metastatic solid tumors at multiple sites in the U.S. and Asia Pacific (APAC).

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ADG116 utilizes Adagene’s proprietary NEObody platform technology and is designed to target a unique conserved epitope of CTLA-4 with enhanced efficacy by potent Treg depletion in the tumor microenvironment (TME). ADG116 is designed with a soft ligand blocking to address safety concerns associated with existing CTLA-4 therapeutics.

"The FDA clearance of this trial represents a significant milestone for our anti-CTLA-4 program as we advance our evaluation of ADG116 in combination with anti-PD-1 therapy," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "By applying NEObody technology, ADG116 can overcome existing safety limitations of anti-CTLA-4 therapies to achieve improved clinical benefit. Our exploration of ADG116 with pembrolizumab aims to unleash the dual CTLA-4/PD-1 blockade and realize the full potential of this combination therapy approach as a cornerstone of cancer treatment – balancing safety and efficacy."

The ADG116-P001 trial is expected to dose the first patient in early 2022, and is designed to evaluate the safety and tolerability, determine the maximum tolerated dose, and assess preliminary efficacy of the combination of ADG116 and pembrolizumab.

Additionally, the ongoing ADG116-1003 trial is on track to expand with two combination cohorts investigating safety and preliminary efficacy of ADG116 with either toripalimab or ADG106 in patients with advanced/metastatic solid tumors.