On June 22, 2021 Iksuda Therapeutics, the developer of a new generation of antibody drug conjugates (ADCs) with raised therapeutic index, reported that it has expanded its research collaboration and License Agreement with LegoChem Biosciences, Inc. ("LCB") to explore additional ADC programmes which leverage LCB’s proprietary ADC platform technology (Press release, Iksuda Therapeutics, JUN 22, 2021, View Source [SID1234584236]).

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In April 2020, Iksuda licensed global development and commercialisation rights for three ADC programmes using LCB’s ADC linker/toxin platform1. Under this expanded Agreement, Iksuda has now been granted rights for three additional targets, bringing the total number of potential ADC programmes using LCB’s ADC platform technologies to six. Iksuda also gains access to LCB’s innovative and recently discovered novel DNA-modifying payload, supplementing LCB’s proprietary tumour-activated DNA toxins which were included in last year’s License Agreement.

Dr Dave Simpson, Chief Executive Officer, Iksuda Therapeutics, said: "During a successful partnership since signing the multi-target License Agreement last year, Iksuda has nominated two ADC candidates which leverage the differentiated advantages of LCBs prodrug payload technology, with preclinical development underway. We are excited to expand our research into next generation best-in-class ADCs through this wider arrangement with LCB which includes a new payload. We anticipate the discovery of additional candidates for Iksuda’s growing ADC pipeline as a result of this agreement."

Dr. Yong-Zu Kim, CEO and President of LCB, commented: "We have built a strong partnership with Iksuda through the multi-target ADC platform license and LCB73 (CD19 ADC) product license agreements, completed last April and May respectively. Our partnership has validated the superiority of LCB’s ADC platform technology and the competitive potential of IKS03 (formerly known as LCB73) as an innovative ADC drug. This validation has led to the execution of this expanded license agreement. We will continue to cooperate closely with Iksuda to accelerate the advancement of all LCB-related ADC candidates into clinic."

Iksuda recently announced that it has completed a $47 million financing round, co-led by Celltrion, Mirae Asset Capital and its subsidiaries, and Premier Partners to support the advancement of its lead ADC assets, including IKS03, and the expansion of its payload platform technologies. This expanded agreement with LCB enables research and development of a new class of payload, adding to Iksuda’s proprietary Protein Alkylating (ProAlk) tumour-activated payload platform, licensed from Göttingen University.

Iksuda’s ADC programmes target tumours that currently have limited treatment options and high relapse rates. The Company’s drug development pipeline is centred on the improved safety and efficacy conferred by tumour activated, prodrug payloads in combination with stable conjugation technologies, including its proprietary novel PermaLink platform.

On June 22, 2021 Hong Kong-based company Insilico Medicine, which uses artificial intelligence (AI) for drug discovery and development, reported that it has raised $255 million in a new funding round by U.S. private equity firm Warburg Pincus , it said on Tuesday (Press release, Insilico Medicine, JUN 22, 2021, View Source [SID1234584360]).

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The fundraising attracted nearly 20 investors according to the company’s announcement, including CPE, Sequoia Capital China and Mirae Asset Capital.

Existing investors including Qiming Venture Partners, Sinovation Ventures and Baidu Ventures also joined in the funding round.

Insilico did not disclose its valuation in the release.

Founded in 2014 by Scientist Alex Zhavoronkov, Insilico develops AI systems that utilize deep generative models, reinforcement learning (RL), transformers, and other modern machine learning techniques for the generation of new molecular structures with specific properties.

It also develops software for the generation of synthetic biological data, target identification, and the prediction of clinical trials outcomes.

The new funds raised will be used to progress Insilico’s current therapeutic programs into human clinical trials, initiate multiple new programs for novel and difficult targets, and further develop its AI and drug discovery capabilities, the company said.

The company is known for its 2019 research about its development of an AI system that was able to design a drug in 21 days and was named a 2020 breakthrough technology by MIT Technology Review.

It now operates in six locations worldwide with over 160 scientists, according to its website.

The company has raised over $310 million from expert pharmaceutical, and technology investors since its inception, it said. (Reporting by Kane Wu)

On June 22, 2021 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported preliminary results from its Phase 3 RELIANT trial of relacorilant combined with nab-paclitaxel in patients with metastatic pancreatic cancer (Press release, Corcept Therapeutics, JUN 22, 2021, https://ir.corcept.com/news-releases/news-release-details/preliminary-results-reliant-trial-relacorilant-plus-nab [SID1234584221]).

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"RELIANT evaluated relacorilant plus nab-paclitaxel in pancreatic cancer patients who had relapsed following at least two prior lines of therapy, including treatment with nab-paclitaxel in almost all cases," said Andreas Grauer, MD, Corcept’s Chief Medical Officer. "Two of 31 evaluable patients exhibited tumor shrinkage designated as a partial response, a response rate of six percent, while 15 patients achieved stable disease for at least 12 weeks. The combination was well-tolerated. These data are similar to those of our Phase 1 study.

"Metastatic pancreatic cancer is a dire disease and patients who have relapsed following multiple lines of therapy have no effective treatment options. While our interim analysis suggests that the combination of relacorilant and nab-paclitaxel is active in these patients, the apparent level of benefit does not justify its further study as a treatment for end-stage pancreatic cancer."

"All of the cancers we are studying are aggressively lethal and we will not pursue an approval unless we believe our candidate therapy offers a substantial benefit," added Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "Our development program in solid tumors continues to advance. Based on the positive results of our controlled Phase 2 trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer, we are very excited to initiate a pivotal trial for that indication in the first quarter of 2022. Our trials of relacorilant plus pembrolizumab in patients with adrenal cancer and of exicorilant plus enzalutamide in patients with castration-resistant prostate cancer continue to enroll. Based on the promising clinical trial results we have observed across our oncology programs, we are evaluating relacorilant as a potential treatment for patients with earlier stages of pancreatic cancer and with other glucocorticoid receptor-expressing tumors."

Trial Design and Preliminary Results

RELIANT is a single-arm, multicenter, open-label, Phase 3 trial of relacorilant combined with nab-paclitaxel in patients with metastatic pancreatic cancer, with a planned enrollment of 80 patients and a planned interim analysis of outcomes in the first 40 patients. Patients received 100 mg of relacorilant every day and 80 mg/m2 nab-paclitaxel on Days 1, 8 and 15 of each 28-day cycle. RELIANT’s primary endpoint is objective response rate.

At the planned interim analysis, the study had enrolled 43 patients with metastatic pancreatic cancer who had received 2-4 prior lines of therapy (median prior lines of therapy: three), including 40 patients who were previously treated with nab-paclitaxel. As of the database cutoff date of April 15, 2021, there were 31 efficacy-evaluable patients. Two of these patients (six percent) had a partial response (best response based on RECIST v1.1); and 15 patients (48 percent) had stable disease, with two patients (six percent) with stable disease greater than 18 weeks. Safety was consistent with known profiles for relacorilant and nab-paclitaxel.

About Relacorilant

Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor that does not bind to other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including ovarian, pancreatic and castration-resistant prostate cancer, as well as Cushing’s syndrome. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents. It has received orphan drug designation in the United States for the treatment of Cushing’s syndrome and pancreatic cancer.

On June 22, 2021 Legend Biotech Corporation (Legend Biotech, NASDAQ: LEGN), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported the establishment of a state-of-the-art manufacturing facility in Belgium, as part of a joint investment with Janssen Pharmaceutica NV (Janssen), to expand global manufacturing capacity of innovative cellular therapies (Press release, Legend Biotech, JUN 22, 2021, View Source [SID1234584239]).

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Legend has a collaboration and license agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel, an investigational CAR-T therapy currently under review by several health authorities around the world including the United States and Europe for the treatment of patients with relapsed and refractory multiple myeloma.

"The new location in Belgium is an ideal choice for Legend to launch our European manufacturing presence allowing us to tap into the area’s vast talent pool and leverage the strong Belgian life sciences ecosystem," said Liz Gosen, Senior Vice President, Global Technical Operations. "We are excited to expand our existing robust manufacturing network to support the production and delivery of cilta-cel for patients across the globe."

This facility adds to Legend’s existing manufacturing facilities and presence in Nanjing, China and in Raritan and Somerset, N.J., U.S. The facility is anticipated to be operational by 2023.

On June 22, 2021 Genmab A/S (Nasdaq: GMAB) reported that at a board meeting the board decided to grant 15,241 restricted stock units and 16,335 warrants to employees of the company and three of the company’s subsidiaries (Press release, Genmab, JUN 22, 2021, View Source [SID1234584260]).

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Each restricted stock unit is awarded cost-free and provides the owner with a right to receive one share in Genmab A/S of nominally DKK 1. The fair value of each restricted stock unit is equal to the closing market price on the date of grant of one Genmab A/S share, DKK 2,698.

The restricted stock units will vest on the first banking day of the month following a period of three years from the date of grant. Furthermore, the restricted stock units are subject to vesting conditions set out in the restricted stock unit program adopted by the board of directors in accordance with the Remuneration Policy adopted by the shareholders at the annual general meeting. Information concerning Genmab’s restricted stock unit program can be found on www.genmab.com under Investors > Governance > Compensation > Restricted stock units.

The exercise price for each warrant is DKK 2,698. Each warrant is awarded cost-free and entitles the owner to subscribe one share of nominally DKK 1 subject to payment of the exercise price. By application of the Black-Scholes formula, the fair value of each warrant can be calculated as DKK 839.14.

The warrants vest three years after the grant date, and all warrants expire at the seventh anniversary of the grant date. The new warrants have been granted on the terms and conditions set out in the warrant program adopted by the board of directors on February 23, 2021. Information concerning Genmab’s warrant schemes can be found on www.genmab.com under Investors > Governance > Compensation > Warrants.