Entry into a Material Definitive Agreement

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.

Investigator-initiated Phase II Clinical Study of Remetinostat Started in Patients With Squamous Cell Carcinoma

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.

Voluntis Announces New Pharma Collaboration in Oncology

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."

Seattle Genetics to Host Conference Call and Webcast on December 19, 2019 to Discuss PADCEVTM (enfortumab vedotin-ejfv) Approval

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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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

Epizyme Submits New Drug Application to the U.S. FDA for Tazemetostat for the Treatment of Patients with Follicular Lymphoma

On December 18, 2019 Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, reported that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for accelerated approval of tazemetostat for the treatment of patients with relapsed or refractory follicular lymphoma (FL), both with or without EZH2 activating mutations, who have received at least two prior lines of systemic therapy (Press release, Epizyme, DEC 18, 2019, View Source [SID1234552521]). Tazemetostat is an oral, first-in-class EZH2 inhibitor being developed for a range of cancers and treatment settings.

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"We are very pleased to have submitted this NDA in hopes of bringing tazemetostat to FL patients and their physicians," said Dr. Shefali Agarwal, chief medical officer of Epizyme. "FL remains a devastating and incurable disease. We believe that if approved, the durable responses and favorable safety observed in patients both with and without an EZH2 activating mutation support tazemetostat’s potential to make a meaningful difference for these patients. This FL NDA submission, on the heels of a positive Oncology Drug Advisory Committee meeting for our epithelioid sarcoma program just yesterday, sets us up for a transformational year in 2020. We are grateful to the patients and medical teams who have meaningfully contributed to advancing tazemetostat to this stage."

Epizyme’s FL NDA submission follows a pre-NDA meeting held with FDA in October 2019, in which the Agency indicated that it considered the proposed clinical package to be sufficient for inclusion as part of the NDA for accelerated approval. The submission is based primarily on updated Phase 2 efficacy and safety data on tazemetostat in this patient population, which were presented at the 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The data demonstrated that treatment with tazemetostat resulted in clinical benefit as assessed by both investigators and an Independent Review Committee (IRC), and was shown to be generally well tolerated in FL patients with EZH2 activating mutations (n=45) and FL patients with wild-type EZH2 (n=54).

To support a full approval of tazemetostat for FL, Epizyme is conducting a single, global, randomized, adaptive trial to evaluate the combination of tazemetostat with "R2" (Revlimid plus Rituxan), an approved chemo-free treatment regimen, for FL patients in the second-line or later treatment setting. The trial is expected to enroll approximately 500 FL patients, stratified based on their EZH2 mutation status. Site initiation is underway, and the safety run-in portion of the trial has begun.

"Today’s submission marks the second NDA for tazemetostat that Epizyme executed this year, a significant milestone for our company, and a strong conclusion to 2019 across all aspects of our business," said Robert Bazemore, president and chief executive officer of Epizyme. "I am incredibly proud of what this team has achieved this year, which includes two NDA submissions, a favorable ODAC meeting for our epithelioid sarcoma program, important clinical data readouts, expansion of our tazemetostat clinical program into new indications and combinations, and a significant strengthening of our balance sheet with capital to support our planned operations into 2022. We are on the cusp of a potential first approval of tazemetostat, and are ready to make the transition to a commercial-stage organization in early 2020."

The FDA has a 60-day review period to determine whether the FL NDA submission is complete and acceptable for filing.