On December 18, 2019 Vaccitech Ltd reported that its strategic collaboration with the Ludwig Institute for Cancer Research (Ludwig), Vaccitech Oncology Limited (VOLT), has entered into a clinical partnership with Cancer Research UK to develop VOLT’s VTP-600 immunotherapy as a treatment option for patients with non-small cell lung cancer (NSCLC) (Press release, Vaccitech, DEC 18, 2019, View Source [SID1234553211]).

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VTP-600 is a cancer immunotherapy comprised of Vaccitech’s proprietary heterologous prime-boost T cell induction platform; ChAdOx1 and Modified Vaccinia Ankara (MVA). The two viral vectors are engineered to express the tumour-associated antigens MAGE-A3 and NY-ESO-1, previously discovered and clinically validated by Ludwig. MAGE-A3 and NY-ESO-1 are aberrantly expressed by tumour cells and elicit strong immune responses. The VTP-600 therapeutic vaccine is administered intramuscularly and designed to stimulate the immune system to produce sustained cytotoxic CD8+ T cells specific for cancers that highly express the antigens, which include NSCLC. To maximise therapeutic benefit, VTP-600 can be administered selectively to patients whose tumours express MAGE-A3 alone, and those which also express NY-ESO-1. This novel design may help boost an optimal, highly specific, anti-tumour immune response to destroy cancer cells.

Cancer Research UK’s Centre for Drug Development (CDD) will sponsor and manage a Phase I/IIa clinical trial of VTP-600 in combination with current standard of care and first-line treatment (chemotherapy and anti-PD-1) in approximately 80 patients with NSCLC. The trial is anticipated to begin in Q4 2020 across multiple clinical sites in the UK. VOLT holds an option to licence the results of the trial in order to undertake further clinical development and commercialisation of VTP-600.

Vaccitech’s CEO, Bill Enright, said: "We are delighted to enter into a clinical development partnership with two of the world’s most prestigious cancer research institutions. We believe that this partnership is an important validation of our prime boost platform’s utility in oncology as well as infectious disease."

Jonathan Skipper, Executive Vice President for Technology Development, Ludwig Institute for Cancer Research, commented, "Previous clinical trials of experimental cancer vaccines targeting MAGE and NY-ESO antigens have demonstrated that these antigens are highly specific to cancer and capable of eliciting strong immune responses. We believe that Vaccitech’s highly effective T cell induction platform should provide a potent immunotherapeutic that, in combination with checkpoint blockade, is capable of inducing sustained levels of cancer antigen-specific CD8+ T cells and the desired therapeutic effect in patients."

Dr Nigel Blackburn, Cancer Research UK’s director of drug development, said: "This partnership with VOLT is an important step to help accelerate this promising immunotherapy and could help more people survive lung cancer, which remains very hard to treat. This novel approach using a modified adenovirus to prime the immune system and alert it to the presence of cancer cells could offer a completely new way to treat the disease."

On December 18, 2019 Selecta Biosciences, Inc. (the "Company") reported that it has entered into a Securities Purchase Agreement (the "Purchase Agreement") with the purchasers named therein (the "Investors"), including certain members of the board of directors of the company (Filing, 8-K, Selecta Biosciences, DEC 18, 2019, View Source [SID1234552606]).

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Pursuant to the Purchase Agreement, the Company agreed to sell (i) an aggregate of 37,634,883 shares of its common stock (the "Shares"), par value $0.0001 per share (the "Common Stock"), at a purchase price equal to $1.46 per share, which was equal to the most recent consolidated closing bid price on the Nasdaq Global Market on December 18, 2019, (ii) warrants to purchase an aggregate of 22,988,501 shares of Common Stock (the "Common Warrants"), at a purchase price equal to at $0.125 per share underlying each Common Warrant , and (iii) pre-funded warrants to purchase an aggregate of 8,342,128 shares of Common Stock (the "Pre-Funded Warrants" and, together with the Common Warrants, the "Warrants"), at a purchase price equal to at $1.46 per share underlying each Pre-Funded Warrant, to the Investors for aggregate gross proceeds of approximately $70.0 million (collectively, the "Offering"). The closing of the Offering occurred on December 23, 2019.

Each Common Warrant has an exercise price per share of Common Stock equal to $1.46 per share. Each Pre-Funded Warrant has an exercise price per share of Common Stock equal to $0.0001 per share. The exercise price and the number of shares of Common Stock issuable upon exercise of each Warrant is subject to appropriate adjustments in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock. In addition, in certain circumstances, upon a fundamental transaction, a holder of Warrants will be entitled to receive, upon exercise of the Warrants, the kind and amount of securities, cash or other property that such holder would have received had they exercised the Warrants immediately prior to the fundamental transaction; provided, however, that in the event of a fundamental transaction where the consideration consists solely of cash, solely of marketable securities or a combination thereof, each Warrant will be deemed to be exercised in full in a cashless exercise effective immediately prior to and contingent upon the consummation of such fundamental transaction. Each Warrant is exercisable from the date of issuance and has a term of five years.

The Company may not effect the exercise of certain Common Warrants, and the applicable holder will not be entitled to exercise any portion of any such Common Warrant, which, upon giving effect to such exercise, would cause the aggregate number of shares of Common Stock beneficially owned by the holder of the Common Warrant (together with its affiliates) to exceed 4.999% or 9.999%, as applicable, of the number of shares of Common Stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the Common Warrants. However, any holder may increase or decrease such percentage to any other percentage not in excess of 19.99% upon at least 61 days’ prior notice from the holder to the Company subject to the terms of the Common Warrants.

On December 23, 2019, in connection with the Purchase Agreement, the Company entered into a Registration Rights Agreement (the "Registration Rights Agreement") with the Investors. Pursuant to the Registration Rights Agreement, the Company agreed to prepare and file a registration statement with the Securities and Exchange Commission (the "SEC") within 45 days after the closing of the Offering for purposes of registering the resale of the Shares, shares of Common Stock issuable upon exercise of the Warrants, and any shares of Common Stock issued as a dividend or other distribution with respect to the Shares or shares of Common Stock issuable upon exercise of the Warrants. The Company agreed to use its reasonable best efforts to cause this registration statement to be declared effective by the SEC within 90 days after the closing of the Offering (or within 120 days if the SEC reviews the registration statement).

The Company has also agreed, among other things, to indemnify the Investors, their officers, directors, members, employees and agents, successors and assigns under the registration statement from certain liabilities and to pay all fees and expenses (excluding any legal fees of the selling holder(s), and any underwriting discounts and selling commissions) incident to the Company’s obligations under the Registration Rights Agreement

The Offering is exempt from registration pursuant to Section 4(a)(2) of the Securities Act and Regulation D promulgated thereunder, as a transaction by an issuer not involving a public offering. The Investors have acquired the securities for investment only and not with a view to or for sale in connection with any distribution thereof, and appropriate legends have been affixed to the securities issued in this transaction.

On December 18, 2019 Medivir AB (Nasdaq Stockholm: MVIR) reported that the first patient has been enrolled and is being dosed with remetinostat gel 1% in an investigator-initiated phase II clinical study in patients with squamous cell carcinoma (SCC) (Press release, Medivir, DEC 18, 2019, View Source [SID1234552489]). This clinical study is conducted at the Stanford University School of Medicine in California, USA under the leadership of the principal investigator, Dr Kavita Sarin. Medivir is providing remetinostat drug supply for this study, and has full access to, and the rights to use, all clinical data after the study is complete.

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The primary objective of the study is to assess the effects of topical remetinostat on biopsy-proven SCC and SCC in situ tumors and could establish that remetinostat has the potential for use in other skin-associated cancers in addition to MF-CTCL. Further details of the study can be found at www.clinicaltrials.gov, reference number NCT03875859.

"This study together with the ongoing study in basal cell carcinoma explore the potential of remetinostat to be used in multiple conditions beyond cutaneous T-cell lymphoma," said Dr. Uli Hacksell, CEO of Medivir. He continues, "We are eagerly looking forward to the results from these studies."

About squamous cell carcinoma

Squamous cell carcinoma (SCC) is the second most common form of cancer in humans occurring in the skin. Surgery is standard of care and there are currently no marketed products approved for the treatment of SCC. There is a need for efficacious and safe treatments when surgery is impractical, e.g. multiple lesions and/or difficult treatment sites.

About remetinostat

Remetinostat is a histone deacetylase (HDAC) inhibitor. The unique design of remetinostat enables topical application, making it active only in the skin. As soon as it reaches the blood stream, it is degraded, avoiding the side effects associated with orally administered HDAC inhibitors. The effect of remetinostat on basal cell carcinoma is investigated in an ongoing phase II study.

On December 18, 2019 Voluntis (Paris:VTX) (Euronext Paris, Ticker: VTX – ISIN: FR0004183960), a leader in digital therapeutics, reported a collaboration with Novartis to evaluate the use of Voluntis’ digital therapeutic platform for Breast Cancer patients with the goal to empower patients with tools to more effectively manage symptoms and, thereby, improve patient experience and outcomes (Press release, Voluntis, DEC 18, 2019, View Source [SID1234552531]). This collaboration will leverage Voluntis’ Theraxium Oncology, the company’s core platform for digital therapeutics in the field of oncology.

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In addition to enabling self-management of symptoms, data analytics and automated triage capabilities will make it possible for integrated care teams to monitor patients remotely and engage directly with them at the appropriate time. The digital therapeutic will be evaluated in an upcoming prospective clinical trial. The new collaboration uses Voluntis’ multi-disciplinary expertise in implementing digital therapeutics intended to support real-world use of a cancer therapy.

"We are delighted to work with Novartis, a leader in cancer therapies, to empower patients and care teams to manage their breast cancer treatment journey with best-in-class digital innovation," said Pierre Leurent, CEO, Voluntis. "This new collaboration also reinforces Theraxium Oncology as the backbone for digital therapeutics that support patients and their care teams across the spectrum of cancer care."

On December 18, 2019 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that it will host a conference call and webcast on Thursday, December 19, 2019 to discuss the U.S. Food and Drug Administration approval of PADCEVTM (enfortumab vedotin-ejfv) (Press release, Seattle Genetics, DEC 18, 2019, View Source [SID1234552522]). Access to the event can be obtained as follows:

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LIVE access on Thursday, December 19, 2019
6:00 a.m. Pacific Time / 9:00 a.m. Eastern Time

Telephone 800-367-2403 (domestic) or +1 334-777-6978 (international); conference ID 7236397
Webcast available at www.seattlegenetics.com in the Investors section
REPLAY access

Telephone replay will be available beginning at approximately 9:00 a.m. PT on Thursday, December 19, 2019 through 9:00 a.m. PT on Sunday, December 22, 2019 by calling 888-203-1112 (domestic) or +1 719-457-0820 (international); conference ID 7236397
Webcast replay will be available on the Seattle Genetics website at www.seattlegenetics.com in the Investors section