HUTCHMED announces savolitinib approved in China for patients with lung cancer with MET exon 14 skipping alterations

On June 22, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM) reported that AstraZeneca PLC ("AstraZeneca") and HUTCHMED’s savolitinib has been granted conditional approval in China for the treatment of patients with non-small cell lung cancer ("NSCLC") with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy (Press release, Hutchison China MediTech, JUN 22, 2021, View Source [SID1234586912]). This approval follows a priority review designation by China’s National Medical Products Administration ("NMPA") and marks the first regulatory approval globally for this oral, potent and selective MET tyrosine kinase inhibitor ("TKI").

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Approximately 2-3% of newly diagnosed NSCLC patients have MET exon 14 skipping alterations, a specific genetic mutation.

The approval by the NMPA was based on positive results from a Phase II trial conducted in China in patients with NSCLC with this mutation, including patients with the more aggressive pulmonary sarcomatoid carcinoma subtype. Savolitinib demonstrated effective anti-tumor activity based on an independent review of objective response rate ("ORR") and disease control rate ("DCR"). The approval is conditional upon successful completion of a confirmatory study in this patient population.

Christian Hogg, Chief Executive Officer of HUTCHMED, said: "It is with great pleasure that today we announce the first regulatory approval of savolitinib globally, HUTCHMED’s third self-discovered oncology drug to be commercialized. Our collaboration with AstraZeneca in 2011 has been an important driver in the development of this novel targeted oncology drug, involving both a China-based biotech and a global pharma company. This approval is a testament to the perseverance and scientific ingenuity of this long-standing alliance, and we are hopeful that this is only the beginning of the progress we can achieve for patients with MET-altered tumors."

Dave Fredrickson, Executive Vice President, Oncology Business Unit of AstraZeneca, said: "This approval makes savolitinib the only targeted medicine approved for these biomarker-selected patients in China, and it adds another novel medicine to our already diverse lung cancer portfolio. We are proud that this first-ever regulatory approval of savolitinib is in China, where we have a long-standing commitment to improving patient outcomes and working with the right partners to achieve that goal. Alongside HUTCHMED, we look forward to the continued development of this medicine across a range of cancers where MET alterations and amplification are drivers of tumor growth and treatment resistance."

About savolitinib
Savolitinib is an oral, potent and selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations).

Savolitinib is currently under development for multiple tumor types, including lung, kidney and gastric cancers, as a single treatment and in combination with other medicines.

HUTCHMED and AstraZeneca collaboration
In 2011, HUTCHMED and AstraZeneca entered a global licensing agreement with respect to the development and commercialization of savolitinib. HUTCHMED is responsible for the manufacturing and supply of savolitinib, and AstraZeneca is responsible for its commercialization in China and worldwide.

Tempest and Millendo Announce Stockholder Approval of Merger

On June 22, 2021 Tempest Therapeutics, Inc. ("Tempest"), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, and Millendo Therapeutics, Inc. (Nasdaq: MLND) ("Millendo"), reported the results for the proposals voted upon by Millendo stockholders at a Special Meeting on June 22, 2021 (Press release, Tempest Therapeutics, JUN 22, 2021, View Source [SID1234585165]). The stockholders voted in favor of all proposals at the Special Meeting, including to approve the proposed merger between the companies.

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The closing of the merger is anticipated to take place on or around Friday, June 25, 2021. Following the closing of the merger, the combined company will be renamed Tempest Therapeutics and shares will begin trading with the open of the market on Monday, June 28, 2021 under the ticker "TPST."

Entry into a Material Definitive Agreement

On June 22, 2021, BioXcel Therapeutics, Inc. (the "Company") reported that entered into an underwriting agreement (the "Underwriting Agreement") with BofA Securities, Inc., as representative of the several underwriters named therein (collectively, the "Underwriters") and the selling stockholder named therein (the "Selling Stockholder"), in connection with the issuance and sale by the Company in a public offering of 3,155,000 shares of the Company’s common stock at a public offering price of $31.70 per share, less underwriting discounts and commissions, pursuant to an effective shelf registration statement on Form S-3ASR (Registration No. 333-240118) and a related prospectus supplement filed with the Securities and Exchange Commission (the "SEC") (Filing, 8-K, BioXcel Therapeutics, JUN 22, 2021, View Source [SID1234584368]). Under the terms of the Underwriting Agreement, the Selling Stockholder has also granted the Underwriters an option exercisable for 30 days to purchase up to an additional 473,250 shares of common stock at the public offering price, less underwriting discounts and commissions. The Company will not receive any of the proceeds from any sale of shares in the offering by the Selling Stockholder.

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The Company received net proceeds from the offering of approximately $96.8 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The Company intends to use the net proceeds of the offering to fund ongoing clinical trials, commercialization preparation and for general corporate purposes.

The Underwriting Agreement contains customary representations, warranties and agreements by the Company and the Selling Stockholder, customary conditions to closing, indemnification obligations of the Company, the Selling Stockholder and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions.

The foregoing description of the Underwriting Agreement is not complete and is qualified in its entirety by reference to the full text of the Underwriting Agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated by reference herein. An opinion of Latham & Watkins LLP regarding the validity of the shares to be issued and sold in the offering by the Company is filed as Exhibits 5.1 and an opinion of the Company’s Chief Legal Officer regarding the validity of the shares to be sold in the offering by the Selling Stockholder is filed as Exhibit 5.2.

Based on the planned use of proceeds from the offering, the Company believes that the net proceeds from the offering and its existing cash and cash equivalents will be sufficient to enable it to fund operating expenses and capital expenditure requirements into the first half of 2023. The Company has based this estimate on assumptions that may prove to be incorrect, and could utilize available capital resources sooner than currently expected. The amounts and timing of the Company’s actual expenditures will depend on numerous factors, including the progress of the Company’s clinical trials and other development efforts and other factors, as well as the amount of cash used in the Company’s operations.

AI-driven biotech firm Insilico Medicine raises $255 mln in new financing

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)

Digital therapy maker Pear Therapeutics shakes the money tree, with plans to go public in $1.6B SPAC deal

On June 22, 2021 Pear Therapeutics reported that it is taking the SPAC track, going public through a deal expected to provide about $400 million in new funding as the company looks to expand its prescription apps to a wider range of conditions (Press release, Pear Therapeutics, JUN 22, 2021, View Source [SID1234584359]).

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Those proceeds include $125 million gathered from private investments in Pear’s newfound public equity, plus $276 million held by Thimble Point Acquisition Corp., a blank-check company backed by the Pritzker Vlock Family Office, whose investment portfolio spans several medtech and biotech companies.

Following the closure of the deal—which represents a total pro forma equity value of about $1.6 billion—the newly combined Pear Holdings Corp. is expected to begin trading on the Nasdaq, under the ticker PEAR, before the end of this year with its current management in place.

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"In our view, Pear is at a commercial inflection point, with the potential for rapid expansion," President and CEO Corey McCann said in a statement.

The company’s ultimate goal is to provide a platform for clinically validated prescription digital therapeutics, or PDTs, either as stand-alone software treatments or alongside pharmaceuticals for major medical conditions, McCann said.

RELATED: SoftBank’s Vision Fund backs Pear Therapeutics in $80M VC round to forge new market paths for digital treatment apps

The private investment round includes participation from 5AM Ventures, Arboretum Ventures, Blue Water Science Advisors, Novartis’ dRx Capital, The Eleven Fund, FORTH Management, Health Innovation Capital, JAZZ Venture Partners, Neuberger Berman funds, Palantir, Pilot House, QUAD Investment Management, Sarissa Capital, Shanda Group, SoftBank Vision Fund 2, Temasek and Trustbridge Partners.

Earlier this year, Pear announced plans to make its digital therapies a little more tangible, with the addition of wearable sensors and activity trackers through a partnership with the medical smartwatch maker Empatica, plus a digital pill project with etectRx for tracking drug adherence.

Previously, Pear focused on treating addiction and substance use disorders by offering cognitive behavioral therapy through its FDA-cleared reSET and reSET-O software programs, with the latter focused on opioids.

RELATED: Pear Therapeutics launches digital insomnia app through direct-to-patient telehealth model

In November 2020, the former Fierce 15 winner launched its app for insomnia, Somryst, through a direct-to-patient telehealth model, combining telemedicine visits with the digital delivery of the prescription app.

Late last year also saw Pear raise $80 million in a venture capital round backed by SoftBank’s Vision Fund 2, among others, to help support the company’s push to secure reimbursement coverage for Somryst and its reSET offerings.

Around the same time, the Institute for Clinical and Economic Review—the U.S. drug pricing watchdog known as ICER—threw cold water on multiple digital therapeutics for opioid use disorder, including reSET-O, saying it could not find strong evidence that the apps provided benefits over long time periods.

Pear, meanwhile, pointed to real-world data showing that users were able to complete the software’s therapy modules outside of normal clinic hours, with 88% passing drug screenings and 85% remaining in active treatment for months. An additional, retrospective economic analysis showed fewer hospitalizations and emergency room visits.

RELATED: Pear Therapeutics to take digital treatments physical with sensor, activity tracker deals

Since then, the company raised another $100 million through a series D round closed in March. Its pipeline currently has 14 product candidates, including for alcohol use disorder, schizophrenia, post-traumatic stress disorder, bipolar disorder, anxiety and depression, as well as chronic pain, migraines, multiple sclerosis, cancer and a range of chronic conditions.