On February 10, 2022 Ucello Therapeutics ("Ucello"), a biotechnology company developing universal CAR-T therapies, reported the successful completion of a US$25 million Series A financing (Press release, Ucello Therapeutics, FEB 10, 2022, View Source [SID1234609738]).

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The funding round was led by Matrix Partners China, along with other investors Co-Win Ventures, Northern Light Venture Capital, and Elikon Venture. Also joining the round was existing angle investor Chengdu Bio-town Fund.

Proceeds from the financing will be used to advance the company’s development of proprietary universal CAR-T technology platform CBT-X20, progress pipeline programs including lead asset AT19 through to US and China IND filings, and build a state of the art GMP-ready clinical manufacturing facilities.

"We are delighted to have achieved this significant milestone, which allows us to welcome several top caliber investors such as Matrix Partners China, Co-Win Ventures, Northern Light Venture Capital, Elikon Venture, and Chengdu Bio-town Fund," said Dr. Qiang Zou, Chairman and CEO of Ucello. "With this funding, we will further accelerate our goal of developing breakthrough universal CAR-T therapies and move our pipeline towards clinical development where we hope to help patients worldwide as soon as possible."

"Cell therapy is a fast-moving field and the next generation of therapies could be off-the-shelf in nature," said Matrix Partners China partner Dr. Eric Yu. "Allogeneic cell therapy, like the universal CAR-T that Ucello is developing, could potentially address huge unmet medical needs by making cell therapy a lot more accessible and readily available. Ucello’s universal CAR-T cell therapy platform has demonstrated great potential through excellent early clinical results in investigator-initiated trials with global leading safety and efficacy profiles. We believe the company is well-positioned to bring benefits to patients in China and globally as early as possible."

"Ucello’s products at this stage have demonstrated unparalleled advantages for patients who have previously received bone marrow transplants, as well as for those whose conditions continue to progress after autologous CAR-T treatment. It is not only cost-controlled, but also truly meets the clinical need for timeliness," said Dr. Xin Huang, Managing Partner of the Co-Win Ventures. "This obvious advantage in performance is mainly thanks to the team’s commitment to benefits for patients alongside years of research and deep knowledge in the field of cord blood-derived CAR-T cell technology. We are pleased to have the opportunity to help Ucello build on its success and accelerate the clinical application of its products to bring sustainable clinical benefits to more patients."

"Universal CAR-T is a very competitive field for players in the cell therapy sector, in which few breakthroughs having been made so far due to many technical hurdles," stated Mr. Feng Deng, Founding and Managing Partner of the Northern Light Venture Capital. "With a deep understanding of the immunotherapy and years of continuous efforts, the Ucello team has developed a unique platform technology which started to produce excellent clinical outcome with great potential to develop future blockbusters. We are very pleased to continually support the development of Ucello."

Dr. Jianfeng Zhou, Director of the Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, said

"Universal CAR-T cell therapy is the current focus and hotspot of clinical research in the field of hematological oncology worldwide. We expect Ucello to achieve breakthroughs in this highly challenging field in both China and globally."

On February 10, 2022 Apmonia Therapeutics reported a 4 M€ fundraising round to complete regulatory preclinical studies of its anti-cancer immunotherapy drug candidate (AP-01) Success for Apmonia Therapeutics’ technology platform developing a portfolio of therapeutic peptides targeting tumor microenvironment in solid tumors (Press release, Apmonia Therapeutics, FEB 10, 2022, View Source [SID1234609536]).

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On February 10, 2022, Twist Bioscience Corporation (the "Company") reported that entered into an underwriting agreement (the "Underwriting Agreement") with J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, and Cowen and Company LLC, as the representatives of the several underwriters named therein (collectively, the "Underwriters"), pursuant to which the Company agreed to issue and sell an aggregate of 5,227,272 shares of its common stock, including 681,818 shares pursuant to an option granted to the Underwriters to purchase such additional shares that was exercised in full (collectively, the "Shares"), to the Underwriters (the "Offering") (Filing, 8-K, Twist Bioscience, FEB 10, 2022, View Source [SID1234608109]). The Shares will be sold to the Underwriters at a public offering price of $55.00 per share, less the underwriting discount and commissions. The Underwriting Agreement contains customary representations and warranties, conditions to closing, market standoff provisions, termination provisions and indemnification obligations, including for liabilities under the Securities Act of 1933, as amended.

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The Offering is being made pursuant to the Company’s registration statement on Form S-3 (Registration No. 333-238906), which was filed with the Securities and Exchange Commission (the "SEC") on June 3, 2020, and the prospectus supplement dated February 10, 2022 filed by the Company with the SEC. The Offering is scheduled to close on or about February 15, 2022, subject to customary closing conditions.

On February 10, 2022 Innovent Biologics reported that The U.S. Food and Drug Administration (FDA) held a public Oncology Drug Advisory Committee (ODAC) for sintilimab, which is under review for the first-line treatment of people with non-squamous non-small cell lung cancer (nsqNSCLC) based on the ORIENT-11 trial conducted exclusively in China (Press release, Innovent Biologics, FEB 10, 2022, View Source [SID1234608050]). On the single voting question, the advisory committee voted that additional clinical trial(s) should be required to demonstrate applicability to the U.S. population and U.S. medical practice prior to a final regulatory decision. Sintilimab is a novel PD-1 inhibitor being developed and commercialized under a collaboration agreement between Innovent and Lilly.

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"We appreciate this opportunity to share our data of ORIENT-11 with FDA and the advisory committee. While conducted in China, ORIENT-11 was well designed and conducted in compliance with ICH GCP standards. The data of sintilimab generated from ORIENT-11 has suggested a positive risk and benefit profile, with no safety issue identified by the FDA." said Dr. Yongjun Liu, President of Innovent. "While we are disappointed by the ODAC outcome, we together with Lilly will continue to work with FDA as the agency completes its review of our BLA application. We remain confident in the value of sintilimab, and the interaction with FDA will help us to pave the way to advance our exciting pipeline and globally develop innovative medicines for patients around the world."

"While we are disappointed with the outcome of today’s ODAC as it relates to the investigational product sintilimab, we appreciated the opportunity to publicly discuss the application and broader issues related to single-country clinical trials," said Jacob Van Naarden, President, Lilly Oncology. "Along with Innovent, we will continue to work with the FDA as it completes its review of the sintilimab application."

The ODAC provides the FDA with independent advice and recommendations from outside experts on marketed and investigational medicines for use in the treatment of cancer. The FDA will consider the vote as it reviews the application and is not bound by the committee’s guidance. Innovent and Lilly will continue to work closely with the agency as they complete their review of the application.

About the ORIENT-11 Trial

ORIENT-11 is a randomized, double-blind, Phase 3 clinical trial conducted in China assessing the efficacy and safety of sintilimab in combination with pemetrexed and platinum chemotherapy compared to placebo in combination with pemetrexed and platinum chemotherapy as a first-line treatment for patients with advanced or metastatic nonsquamous non-small cell lung cancer (nsqNSCLC), with no sensitizing EGFR mutations or ALK rearrangements. The primary endpoint is progression-free survival (PFS) as assessed by Independent Radiographic Review Committee (IRRC) based on RECIST v1.1., and secondary endpoints include overall survival (OS), ORR and safety profile.

A total of 397 patients were enrolled and randomized 2:1 to receive either sintilimab injection 200mg or placebo in combination with pemetrexed and platinum chemotherapy every three weeks for up to four cycles, followed by either sintilimab injection or placebo plus pemetrexed maintenance therapy. Patients received treatment until radiographic disease progression, unacceptable toxicity or any other conditions that required treatment discontinuation. Conditional crossover was permitted. The results of the ORIENT-11 study were published in 2020.

About Lung Cancer

Globally, lung cancer is the leading cause of cancer death, killing nearly 1.8 million people worldwide each year.[i] In the U.S., lung cancer is the second most common cancer (not counting skin cancer) and the leading cause of cancer death, responsible for nearly 25 percent of all cancer deaths – more than those from colorectal, breast and prostate cancers combined.[ii] Non-small cell lung cancer (NSCLC) accounts for approximately 85 percent of all lung cancers, and about 70 percent of those with NSCLC have the nonsquamous subtype.[iii] Fifty percent of NSCLC patients present with advanced or metastatic disease at diagnosis.[iv]

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Lilly. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, sintilimab has been approved and included in the National Reimbursement Drug List (NRDL) for four indications, including:

The treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy;
In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of non-squamous non-small cell lung cancer;
In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer;
In combination with bevacizumab biosimilar for the first-line treatment of unresectable or advanced hepatocellular carcinoma.
Additionally, Innovent currently has three regulatory submissions under review in China’s NMPAfor sintilimab:

In combination with cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil for the first-line treatment of esophageal squamous cell carcinoma;
In combination with chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma;
In combination with bevacizumab biosimilar and chemotherapy for EGFR-mutated non-squamous NSCLC following EGFR-TKI treatment.
Additionally, two clinical studies of sintilimab have met their primary endpoints:

Phase 2 study as second-line treatment of esophageal squamous cell carcinoma;
Phase 3 study as second-line treatment for squamous NSCLC with disease progression following platinum-based chemotherapy.

On February 10, 2022 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported that senior management will participate in a virtual fireside chat at the 11th Annual SVB Leerink Global Healthcare Conference on Wednesday, February 16, 2022 at 1:00 p.m. ET (Press release, Celldex Therapeutics, FEB 10, 2022, View Source [SID1234608034]).

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A webcast of the presentation will be available on the "Events & Presentations"(opens in a new tab) page of the "Investors & Media"(opens in a new tab) section of the Celldex website. A replay will be available for 30 days following the event.