Eureka Therapeutics to Present at the Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting

On October 31, 2019 Eureka Therapeutics, Inc., a clinical stage biotechnology company developing novel T-cell therapies to treat cancers, reported a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting, November 6-10, 2019, in National Harbor, Maryland (Press release, Eureka Therapeutics, OCT 31, 2019, View Source [SID1234550143]). The presentation will highlight the company’s proprietary ARTEMIS antibody T-cell receptor (AbTCR) platform used to develop ET140202 for the treatment of hepatocellular carcinoma (HCC), the most predominant type of liver cancer. ET140202 features ARTEMIS T-cell receptors engineered with a TCR-mimic antibody to target the alpha-fetoprotein (AFP) peptide/ major histocompatibility complex (MHC) on HCC cancer cells.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

SITC Poster Presentation Details:

Title: ET140202 T-cell Therapy for the Treatment of Liver Cancer is Built upon a Novel Antibody-T cell Receptor (AbTCR) ARTEMIS T-cell Platform

Poster Presentation Date: Saturday, November 9, 2019

Poster Presentation Time: 12:35 – 2:05 pm EST and 7:00 – 8:30 pm EST

Presenter: Jun Cui, Ph.D.

Poster Number: P166

Abstract Category: Cellular Therapies

Location: Poster Hall (Prince George AB)

Cytotron® Granted ‘Breakthrough Device Designation’ by U.S. FDA for Treatment of Breast, Liver, and Pancreatic Cancers

On October 31, 2019 The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) granted Shreis Scalene Sciences (Shreis), in Gaithersburg, MD, ‘Breakthrough Device Designation’ for the CYTOTRON – a CE marked, whole-body therapeutic medical device (Press release, Shreis Scalene Sciences, OCT 31, 2019, View Source [SID1234550159]). "We are confident that the FDA will continue to interact with Shreis under the premises of the recent guidance (Breakthrough Devices Program), to enable the marketing submission, with the clinical datasets needed to support it," said Prof. Meena Augustus, Co-Founder CEO & CSO of Shreis. The company’s designation request stated that "The Cytotron is intended to be used to cause degeneration of uncontrolled growth of tissues. It is indicated for treating protein-linked, abnormally regenerating disorders such as neoplastic disease, by selectively targeting and enabling tissue apoptosis, allowing extended progression-free survival, with pain relief, palliation, improved quality and dignity of life. It is indicated for the treatment of solid tumors of the breast, liver, and pancreas."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Dr. Rajah Vijay Kumar D.Sc., Inventor of the Cytotron and Shreis’ technology partner, at Scalene Cybernetics Ltd (SCL), and the Scalene Center for Advanced Research & Development (S-CARD), located in Bengaluru, India, said, "The clinical trial with this non-invasive, tissue engineering platform technology called Quantum Magnetic Resonance Therapy (QMRT) could eventually help to establish the Cytotron as an integral adjunct to existing standards of care in the cancer armamentarium."(Cytotron Publication, 2016)

"We are very encouraged by the breakthrough designation that will expedite review of an Investigational Device Exemption and future marketing application by the FDA, " said Rayol John Augustus Ph.D., Founder-President and COO of SSS-LLC. The diligent support of Dr. R.V. Kumar D.Sc., the dedicated efforts of Emergo by UL based in Austin, Texas, the Shreis’ regulatory team, the staff of SCL and S-CARD, helped ensure a favorable decision by the FDA.

Shreis, while actively pursuing collaborations for clinical trials in the current proposed indications for use, intend to also submit a request for Breakthrough designation in other solid tumors such as adult and pediatric brain tumors, lung cancer, and other life-limiting diseases.

Savara to Report Third Quarter 2019 Financial Results and Provide Business Update

On October 31, 2019 Savara Inc. (NASDAQ: SVRA), an orphan lung disease company, reported that the Company will report third quarter 2019 financial results and provide a business update on Thursday, November 7, 2019 (Press release, Savara, OCT 31, 2019, View Source [SID1234550182]). Savara management will host a conference call/webcast with an accompanying slide deck at 4:30 p.m. Eastern Time (ET)/1:30 p.m. Pacific Time (PT).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Shareholders and other interested parties may access the call by dialing (855) 239-3120 from the U.S., (855) 669-9657 from Canada, and (412) 542-4127 from elsewhere outside the U.S. and requesting the "Savara Inc." call. A live webcast of the call can be accessed on the Investors page of Savara’s website at View Source

Approximately one hour after the call, a telephone replay will be available and will remain available through November 14, 2019 by dialing (877) 344-7529 from the U.S., (855) 669-9658 from Canada and (412) 317-0088 from elsewhere outside the U.S. and entering the replay access code 10135923. A webcast replay will be available on the Investors page of Savara’s website and will remain available for 30 days.

Tmunity Raises $75 Million in Series B Financing to Advance Next-Generation T-Cell Therapies

On October 31, 2019 Tmunity Therapeutics, in pursuit of its vision to save and improve lives by delivering the full potential of next-generation T-cell immunotherapy, reported that it closed a $75 million Series B financing (Press release, Tmunity Therapeutics, OCT 31, 2019, View Source [SID1234550201]). The financing was led by Andreessen Horowitz (also known as "a16z"), a venture capital firm that backs bold entrepreneurs building the future through technology and includes participation from a16z’s Cultural Leadership Fund. Joining the Series B financing are Westlake Village BioPartners, Gilead Sciences, The University of Pennsylvania, Be The Match BioTherapies and BrightEdge, the philanthropic impact fund of the American Cancer Society.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The proceeds from the Series B will continue to fund ongoing and planned research, clinical development of product candidates, the continued build-out of the Company’s proprietary, vertically-integrated viral vector and cell therapy product manufacturing, working capital and other general purposes. Since inception, Tmunity has raised $231 million.

"We are fortunate to be funded by impressive investors who share our commitment to patients and our vision to dramatically change the way cancer is treated," said Usman "Oz" Azam, MD, President and Chief Executive Officer of Tmunity. "We see ourselves leading the innovation of the future of oncology treatment by uniting our foundational competences in cell therapy with expertise in building new constructs, translating them and getting them into the clinic."

As part of the Series B financing, Jorge Conde, General Partner at a16z, will join the Company’s Board of Directors. Mr. Conde leads a16z’s investments that are at the cross section of biology, computer science and engineering.

"To win the war on cancer, we need smarter weapons. Tmunity’s founders Carl June and Bruce Levine invented CAR-T, one of the most profound breakthroughs against cancer in recent history. Together with Oz Azam, who with his team, brought the first CAR-T therapy to market, the company has built a pioneering platform that has produced an unrivaled therapeutic pipeline with programs already in human clinical trials for both solid and liquid tumors. This is the dream team to deliver on the bold and promising mission to cure disease using engineered T-cells," said Conde.

Entry into a Material Definitive Agreement.

On October 31, 2019, Myovant Sciences Ltd. ("Myovant") and Sumitomo Dainippon Pharma Co., Ltd. ("DSP") reported that it has entered into a letter agreement (the "Letter Agreement") pursuant to which Myovant and DSP agreed to take certain actions in connection with the transactions described in the publicly announced Memorandum of Understanding entered into by Roivant Sciences Ltd. ("Roivant") and DSP, which matters have been agreed to in a Transaction Agreement dated October 31, 2019 between DSP, Roivant and other parties (the "DSP-Roivant Agreement") (Filing, 8-K, Myovant Sciences, OCT 31, 2019, View Source [SID1234550112]). Upon the closing under the DSP-Roivant Agreement (the "Closing"), DSP, or an entity that will become a subsidiary of DSP (DSP or such entity, the "Acquiring Entity"), will acquire Roivant’s ownership interest in Myovant and become a significant shareholder of Myovant (the "Transactions"). Myovant understands that Roivant has committed in the DSP-Roivant Agreement that, at or prior to the closing, Roivant will ensure that the Acquiring Entity will obtain not less than a majority of the outstanding shares of Myovant by purchasing additional Myovant shares at prices not below market trading prices and delivering such shares, or voting rights with respect thereto, to the Acquiring Entity.

The terms of the Letter Agreement provide, among other things:

1.The Myovant Board of Directors has approved the Transactions and, subject to and at or prior to the Closing, the appointment of the Acquiring Entity’s director designees to the Myovant Board as described below.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

2. At or promptly following the Closing, Myovant and DSP will enter into a secured low-interest Loan Agreement under which DSP will commit to provide Myovant a five-year term loan facility of US$350 million with a total interest rate in the single digits subject to further transfer pricing analysis and otherwise on mutually agreed terms (the "Loan Agreement").

3. The Myovant Board will (i) replace the three currently serving Roivant-selected directors with three DSP-selected directors who will be appointed to the Myovant Board, (ii) appoint two DSP-selected directors to the Nominating and Corporate Governance Committee to replace two currently serving members, and (iii) appoint one DSP-selected director to the Compensation Committee to replace one currently serving member.

4. At or prior to the Closing, the Myovant Bye-Laws will be amended to (i) remove the requirement that each of the Nominating and Corporate Governance Committee and the Compensation Committee be made up solely of Independent Directors (as defined below), provided that the Audit Committee shall continue to be made up solely of Independent Directors; and (ii) provide that the Board delegates to the Nominating and Corporate Governance Committee the right to fix the size of the Board and fill vacancies on the Board, other than three Independent Directors and their direct or indirect successors.

5. At the Closing, Myovant and the Acquiring Entity will enter into an Investor Rights Agreement that contains, among others, the following provisions:

(a) At all times that DSP and its affiliates (including the Acquiring Entity) hold 50% or more of the outstanding shares of Myovant (the "Ownership Threshold"):

(i) (A) the Myovant Board will include a minimum of three directors who each meet the definition of "independent director" as is required by New York Stock Exchange rules and who are independent of DSP and the Acquiring Entity ("Independent Directors") and at least one of whom is a financial expert, and (B) DSP has agreed that, provided that the existing Independent Directors serving on the Myovant Board continue to satisfy the requirements to serve as an independent director, the term of the current independent directors serving on the Myovant Board will continue;

(ii) the Audit Committee of the Myovant Board shall comprise the Independent Directors; the Nominating and Corporate Governance Committee shall comprise two DSP-selected directors and one Independent Director; and the Compensation Committee shall comprise two Independent Directors and one DSP-selected director;

(iii)the Bye-Law pursuant to which the Board delegates its right to the Nominating and Corporate Governance Committee will not be revised without prior written consent by DSP; and

(iv)DSP will vote its shares in connection with each election of Independent Directors in the same proportion as the shares held by shareholders other than DSP and its subsidiaries and will not, with respect to the election of Independent Directors, engage in any solicitation of proxies.

(b)Until such time as DSP or its subsidiaries hold less than 35% of the outstanding shares of Myovant and its subsidiaries, Myovant will not be permitted to take or commit to taking the following actions without prior approval of the Independent Directors:

(i)participation in specified "related-party transactions" between Myovant and DSP or any affiliate of DSP including use of DSPs commercial infrastructure (other than pursuant to the Loan Agreement in accordance with its terms);

(ii)any amendment of Myovant’s Certificate of Incorporation, Memorandum of Association, Committee Charters or Bye-Laws that would remove the Independent Directors, cause the appointment of any member of the Audit Committee who is not an Independent Director or change the right of the Independent Directors to approve the "related-party transactions"; or

(iii) making any modification of or causing Myovant to waive any rights under the Loan Agreement or the Investor Rights Agreement to expand DSP’s or the Acquiring Entity’s, as the case may be, rights thereunder.

6. A standstill provision, which provides that until such time as DSP or its subsidiaries hold less than 35% of the outstanding shares of Myovant, any transaction proposed by DSP or its controlled affiliates that would cause DSP or its subsidiaries to hold beneficial ownership of greater than 60% of the outstanding voting power of Myovant must be either:

(a)(i) made on a confidential basis to the Independent Directors; provided that after the three-year anniversary of the Closing, this requirement will only require a period of confidential discussions with the Independent Directors prior to making a public announcement thereof and shall except disclosures that are required by law;

(ii)until the three-year anniversary of the Closing, subject to approval by a majority of the Independent Directors; and

(iii)subject to a non-waivable condition requiring approval or acceptance by the holders of a majority of the Myovant shares voting and that are not beneficially owned by DSP or its affiliates;

or

(beffected under the circumstances set forth in a specified section of Myovant’s Bye-Laws having to do with third-party acquisition proposals.

7.Myovant has agreed, until the Closing, to reasonably assist and reasonably cooperate with Roivant in complying with the interim operating covenants contained in the DSP-Roivant Agreement that relate to Myovant, in which Roivant has agreed, among other things, to cause Myovant to (a) afford to DSP reasonable access to its offices, properties, employees and business and financial records, (b) furnish to DSP such additional information concerning its assets, properties, operations and businesses as DSP may reasonably request, and (c) conduct its business in the ordinary course, including refraining from taking a list of actions without DSP’s consent, including (subject to certain limitations) but not limited to incurrence of additional indebtedness, issuance of equity securities, granting of liens, and sales of assets.