On November 24, 2020 vTv Therapeutics Inc. (Nasdaq: VTVT) reported it has entered into a common stock purchase agreement ("Purchase Agreement") for up to $47 million with Lincoln Park Capital Fund, LLC ("LPC"), a Chicago-based institutional investor (Press release, vTv Therapeutics, NOV 24, 2020, View Source [SID1234571746]).

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"The LPC financing will help us reach a number of potential value-driving events over the next six to nine months, including the upcoming topline results of our phase 2 Elevage Study in patients with Alzheimer’s disease and type 2 diabetes in December," said Steve Holcombe, President and CEO of vTv Therapeutics. "In addition, these funds will help us conduct a mechanistic study of TTP399, our oral treatment for patients with type 1 diabetes focused on its impact on diabetic ketoacidosis, and additionally a multiple-ascending dose study of HPP737 as a potential oral treatment for psoriasis."

vTv will have the option, but not the obligation, to sell to LPC up to $47.0 million in shares of Class A common stock over a thirty-six-month period subject to certain conditions, including a registration statement being filed and declared effective by the SEC. There are no upper limits to the price LPC may pay to purchase Class A common stock from vTv and the purchase price of the shares will be based on the prevailing market prices of vTv’s shares at the time of each sale to LPC.

LPC has agreed not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of vTv’s shares of Class A common stock. No warrants, derivatives, or other share classes are associated with this agreement. In consideration for entering into the agreement, vTv has issued shares of Class A common stock to LPC as a commitment fee. The Purchase Agreement may be terminated by vTv at any time, at its sole discretion, without any additional cost or penalty.

vTv intends to use the net proceeds from the transaction for general corporate purposes and to support its clinical development strategy, including finalizing and reporting topline results from the Company’s ongoing Elevage Study of azeliragon for the treatment of Alzheimer’s disease in patients with type 2 diabetes in December 2020, conducting a mechanistic study of TTP399 in patients with type 1 diabetes, and conducting a multiple-ascending dose study of HPP737 as part of a development program of the product as an oral therapy for psoriasis.

A more detailed description of the agreement is set forth in vTv’s Current Report on Form 8-K to be filed with the SEC.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor will there be any sale of these securities in any jurisdiction in which such offer solicitation or sale are unlawful prior to registration or qualification under securities laws of any such jurisdiction.

On November 24, 2020 Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, reported that Savara Management will participate in virtual fireside chats at the following investor healthcare conferences (Press release, Savara, NOV 24, 2020, View Source [SID1234571745]):

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Piper Sandler Annual Healthcare Conference: The recorded fireside chat will be available to registered attendees on the Piper Sandler Conference website from today through December 3, 2020. A replay of the event will be available on the Investors page of Savara’s website at www.savarapharma.com/investors/events-presentations/.
Evercore ISI Annual HealthCONx Conference on Thursday, December 3, 2020 at 12:35 PM EST/9:35 AM PST. A live webcast will be available on the Investors page of the Savara website at www.savarapharma.com/investors/events-presentations/. Please connect at least 15 minutes prior to the start of the event to ensure sufficient time for any software download that may be required.
Replays of both events will remain available on Savara’s website for 90 days.

On November 24, 2020 PreGene, a Shenzhen biotech, reported that it closed a $21 million B financing as it looks forward to an IPO on the Hong Kong exchange. The funding was led by Haier Biomedical (Press release, PreGene, NOV 24, 2020, View Source [SID1234571741]). PreGene claims to have the world’s only fusion drug and nano-antibody drug biotechnology R&D platform. Founded in 2012, PreGene is also developing TCR-T, CAR-T and stem cell candidates. Its BCMA CAR-T candidate is approved to start clinical trials in China.

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On November 24, 2020 Biopharmaceutical company Alvotech hf. and Alvotech & CCHT Biopharmaceutical Co., Ltd., which is the China joint venture company of Alvotech hf. and Changchun High & New Technology Industries (Group) Inc., reported that have partnered with Yangtze River Pharmaceutical Group, a leading Chinese pharmaceutical company, to form an exclusive strategic partnership for the commercialization of eight biosimilar medicines in China (Press release, Alvotech, NOV 24, 2020, View Source [SID1234571699]). The initial pipeline contains biosimilar candidates for treatment in the fields of autoimmunity, ophthalmology, and oncology, as well for treating severe immune and inflammatory conditions.

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Robert Wessman, founder and chairman of Alvotech, commented, "As our progression continues, we are excited to announce this new partnership with Yangtze River Pharmaceutical Group, one of the largest pharmaceutical companies in China. Through this commercial relationship, Alvotech and Alvotech & CCHT Biopharmaceutical Co., Ltd are gaining an extremely valuable access to Yangtze River Pharmaceutical’s strong brand reputation and market experience in China. This will give patients in China better access to high quality biosimilar medicines and creates a powerhouse in the introduction and adoption of biosimilars in the region."

Under this distribution and marketing agreement, Alvotech and Alvotech & CCHT Biopharmaceutical Co., Ltd will be jointly responsible for the development, registration, and supply of their biosimilars in China, while Yangtze River Pharmaceutical will exclusively commercialize the biosimilar candidates. China is the world’s second largest pharmaceutical market, and this new collaboration follows Alvotech’s recent global partnerships including: Teva Pharmaceuticals in the U.S. market, Stada for key European markets and several others.

Mr. Xu, Jingren, founder and Chairman of Yangtze River Pharmaceutical Group, said, "The commercial partnership with Alvotech and Alvotech & CCHT Biopharmaceutical Co., Ltd. is an attempt on international collaboration of biosimilar medicines. Develop, Manufacture and introduce high quality biosimilars is also Yangtze River’s vision. We aim to make full use of our brand advantage and market experience to deliver the biosimilars with extensive clinical needs to the broad China market. This will help us fulfil our purpose of ‘Committed for the better and Dedicated to caring for all.’"

Alvotech and Alvotech & CCHT Biopharmaceutical Co., Ltd.’s leading innovative capability and technology allow us to have confidence to provide Chinese patients with safe, effective and affordable biosimilar medicines which improves the lives of patients. We sincerely hope that this partnership will be constructive, complementary and have positive outcomes for all involved," Mr. Xu Jingren concluded.

The manufacturing of these biosimilar candidates for the Chinese market will be made in a new state-of-the-art biopharmaceutical facility, currently being built in Changchun, China, through the Alvotech & CCHT Biopharmaceutical Co., Ltd partnership1. The manufacturing site will include the latest best in class technology, including disposable single use bioreactors. The first Phase of the facility is expected to be completed in 2021.

Mr. Ma, Ji, chairman of CCHT, and chairman of Alvotech & CCHT Biopharmaceutical Co., Ltd, added, "Innovation and sharing are the core value of CCHT, establishing Changchun Alvotech & CCHT Biopharmaceutical Co., Ltd with Alvotech is aiming to build a global standard antibody drug producing and manufacturing platform. The cooperation with Yangtze River Pharmaceutical Group, a leading company in the industry, is strategic, constructive, and complementary; both parties could give full play to their advantages in exploring China’s biosimilar drug market, so as to improve the availability and accessibility of the drugs and ameliorate people’s life. We will further discuss cooperation with YZR on more levels in the future."

1 Footnote: Alvotech & CCHT Biopharmaceutical Co., Ltd is a Chinese limited liability Sino-foreign equity joint venture company owned jointly by Alvotech hf and Changchun High & New Technology Industries (Group) Inc.

On November 24, 2020 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, reported 18-month follow-up data from the randomized phase I/II trial of ONCOS-102 in combination with standard-of-care (SoC) chemotherapy in patients with malignant pleural mesothelioma (MPM) (Press release, Targovax, NOV 24, 2020, View Source [SID1234571697]).

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The study is an open-label, exploratory phase I/II trial adding ONCOS-102 to SoC chemotherapy (pemetrexed/cisplatin) in first- and second- (and later) line treatment of MPM to assess safety, immune activation and efficacy versus SoC only. In total, 31 patients have been included in the trial, with 20 patients in the experimental group receiving the ONCOS-102 and SoC combination (8 randomized in first-line), and 11 patients in the control group receiving SoC only (6 in first-line).

At the 18-month follow-up, more than half of the patients in the first-line ONCOS-102-treated group were still alive, and the mOS was not yet reached. Based on current survival data the mOS will be 18.2 months or longer. For the first-line SoC-only control group, less than half of the patients were alive, and mOS will be 14.2 months or less, which is similar to outcomes from previously reported trials where patients received the same chemotherapy treatment1. An analysis of all the first-line patients, including 3 experimental safety lead-in patients, shows similar results as the randomized first-line patients. The next survival analysis is planned in first half of 2021.

In June, it was reported that ONCOS-102 treatment induces broad and powerful immune activation in MPM, far beyond what is achieved with SoC alone. Importantly, this immune activation is associated with better survival outcomes at the 18-month analysis, indicating that the immunological activity of ONCOS-102 drives the observed clinical benefit.

The powerful immune activation generated by ONCOS-102 builds a strong rationale for combining ONCOS-102 with a checkpoint inhibitor in MPM. This combination could provide further clinical benefits in this indication. Targovax and Merck (known as MSD outside of the USA) are currently reviewing next steps for combining ONCOS-102 and pembrolizumab (Keytruda) in MPM. Recently, the U.S. Food and Drug Administration (FDA) approved the combination of ipilimumab and nivolumab (Yervoy and Opdivo) for the first-line treatment of MPM based on mOS of 18.1 months (Baas 2020), and this is expected to serve as a benchmark for further approvals.

Magnus Jäderberg, Chief Medical Officer of Targovax, said: "We are very pleased that overall survival in first-line patients, is tracking well in the ONCOS-102 treated group. We have already established in the current study that ONCOS-102 drives favorable remodeling of the tumor microenvironment, and we are now starting to see this immune activation translating into the encouraging improved survival outcomes in these 18-month results. This is exactly what we had hoped to see and prepares the way for combining ONCOS-102 with checkpoint inhibition. The immune data suggest to us that survival outcomes in combination with Keytruda may be further improved from the results reported today."

The first results from the trial were announced in January 2020 (see press release here), while immunological data and 12-month survival rate were reported in June 2020 (see press release here) and presented at the SITC (Free SITC Whitepaper) annual meeting in November 2020 (see poster here).