On February 4, 2020 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "the Company" ) reported the status and the completion of acquisition of its own shares based on the resolution of the Board of Directors’ meeting held on October 31, 2019, pursuant to the Articles of Incorporation in accordance with Article 459, paragraph 1 of the Companies Act (Press release, Astellas, FEB 4, 2020, View Source [SID1234553798]).

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 Company also announced the number of shares to be canceled on February 14, 2020 pursuant to Article 178 of the Companies Act has been finalized.

Particulars

1. Status of acquisition of own shares
(1) Class of shares acquired: Common stock of the Company
(2) Total number of shares acquired: 7,009,900 shares
(3) Total amount of acquisition cost: 13,133,509,050 yen
(4) Period of acquisition: From January 1, 2020 to January 31, 2020
(5) Method of acquisition: Purchased on the Tokyo Stock Exchange

2. Details of the cancellation of treasury stock
(1) Class of shares to be cancelled: Common stock of the Company
(2) Number of shares to be cancelled: 27,036,100 shares
(Ratio to the total number of shares outstanding [excluding treasury stock]:
1.45 %)
(3) Cancellation date: February 14, 2020

2
(Reference)
1. Details of the resolution at the meeting of the Board of Directors on October 31,
2019

(1) Class of shares to be acquired: Common stock of the Company
(2) Total number of shares to be acquired: Up to 32 million shares
(Ratio to the total number of shares outstanding [excluding treasury stock):
1.70%]
(3) Total amount of acquisition cost: Up to 50 billion yen

(4) Period of acquisition: From November 1, 2019 to January 31, 2020
2. Accumulated Company’s own shares acquired pursuant to the above board resolution
(1) Total number of shares acquired: 27,036,100 shares
(2) Total amount of acquisition cost: 49,999,815,550 yen
(Ratio to the total number of shares outstanding [excluding treasury stock]:
1.45 %)

3. Details of the decided cancellation of treasury stock (October 31, 2019)

(1) Class of shares to be cancelled: Common stock of the Company
(2) Total number of shares to be cancelled: All of the shares repurchased
as stated in 2 above
(3) Scheduled cancellation date: February 14, 2020

4. Status of shares after cancellation
(1) Number of shares issued: 1,861,787,075 shares (expected)
(2) Number of the Company’s treasury stock: 3,381,929shares (expected)
[Estimated numbers of shares described above (1) and (2) were calculated on the basis of the issued shares and the Company’s treasury stock as of January 31, 2020, respectively.]

On February 4, 2020 AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, reported that it has reached its patient enrollment target in the Company’s Phase 2 clinical trial for glioblastoma (Press release, AIVITA Biomedical, FEB 4, 2020, View Source [SID1234553797]). The trial has achieved its enrollment target ahead of schedule and under budget, with a notable 94% treatment manufacturing success rate.

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!

AIVITA’s eight-site, single-arm study is investigating AV-GBM-1, a novel immunotherapy targeting autologous tumor-initiating cells that are responsible for the rapid growth and proliferation of the disease.

The highly sophisticated immunotherapy product requires short term cell culture and a successful leukapheresis in order to generate the final treatment product. AIVITA achieved a 97% success rate growing tumor-initiating cells from each patient, and 97% success rate in collecting sufficient monocytes from the peripheral blood from which to derive dendritic cells, resulting in a 94% overall success rate for manufacturing a final product.

"An extremely high manufacturing success rate combined with a very low cost of goods makes this approach highly desirable from both a clinical and commercial viability perspective," said Bob Dillman, M.D., Chief Medical Officer of AIVITA. "We’re already exploring new ways to further increase efficiency and expand the applicability of this approach."

AIVITA is investigating the clinical efficacy of its immunotherapy alone and in combination with PD-1 inhibitors, having determined that a significant portion of unresponsive subjects from a previous trial had elevated PD-1 levels. The Company is also exploring ways in which the technology could be deployed as a maintenance treatment, recognizing that cancer recurrence may come from dormant cancer cells that go undetected by conventional treatments.

"I want to thank the investigators and clinical sites who have done such an excellent job of managing patient care for the trial and helped us reach this important milestone," said Hans S. Keirstead, Ph.D., Chairman and Chief Executive Officer of AIVITA. "These successes are certainly challenging prior expectations of personalized medicine."

AIVITA is currently conducting three distinct clinical studies in the USA investigating its platform immunotherapy, in patients with ovarian cancer, glioblastoma and melanoma. AIVITA is also seeking conditional commercial approval of its melanoma treatment in Japan.

CLINICAL TRIAL DETAIL

OVARIAN CANCER

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous tumor-initiating cell-targeting immunotherapy or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy. The trial is not open to patients with recurrent ovarian cancer.

For additional information about AIVITA’s AVOVA-1 trial patients can visit: www.clinicaltrials.gov/ct2/show/NCT02033616

GLIOBLASTOMA

AIVITA’s glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the tumor-initiating cell-targeting immunotherapy.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC). The trial is not open to patients with recurrent glioblastoma.

For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917

MELANOMA

AIVITA’s melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AIVITA’s tumor-initiating cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients. This trial is not yet open for enrollment.

Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.

On February 3, 2020 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported that President and CEO Athena Countouriotis, M.D., will participate in a question and answer session at the Guggenheim Healthcare Talks Oncology Day in New York on Feb. 13 (Press release, Turning Point Therapeutics, FEB 3, 2020, View Source [SID1234564380]).

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. Countouriotis’ session is scheduled to begin at 10 a.m. ET and will be accessible via audio webcast through the Investors page of www.tptherapeutics.com.

On February 3, 2020 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported the closing of its previously announced sale of a number of its bioengineering assets and the related sale of $35 million of its common stock to an affiliate of Third Security LLC (Press release, Intrexon, FEB 3, 2020, View Source [SID1234553806]). Additionally, effective February 1, 2020, the Company has changed its name to Precigen, Inc. from Intrexon Corporation and its Nasdaq stock symbol to PGEN from XON. The new Precigen enters 2020 with a promising portfolio of investigational gene and cell therapies, derived from the Company’s transformative therapeutic platforms, including UltraCAR-T, AdenoVerse cytokine therapies, multifunctional therapeutics and off-the-shelf AdenoVerse immunotherapies, as well as innovative approaches from our subsidiaries ActoBio Therapeutics, Exemplar Genetics, and Triple-Gene.

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!

"With multiple data read-outs on track for our internal pipeline and partnered programs, we believe 2020 will be an exciting year for Precigen," said Helen Sabzevari, Ph.D., President and CEO of Precigen. "At the same time, we plan to further optimize our portfolio this year through a renewed commitment to financial rigor and fiscal discipline."

"We are particularly enthusiastic about the opportunity to advance our UltraCAR-T platform as current CAR-T treatments rely on a long, complex, and relatively inefficient manufacturing process that delays treatment for cancer patients and leads to high pricing. By contrast, UltraCAR-T is designed to overcome many of these obstacles by eliminating the need for ex vivo expansion, reducing overall manufacturing time, and enabling patients to be treated with CAR-T therapy only one day after non-viral gene transfer at the cancer center. UltraCAR-T has the potential to democratize patient care by simplifying this life-saving cancer immunotherapy which should improve availability throughout the world," added Dr. Sabzevari.

Two non-healthcare businesses remain with Precigen and the Company will continue to evaluate strategic and operational options for these businesses.

Dr. Sabzevari presented an overview of Precigen at the 38th Annual J.P. Morgan Healthcare Conference on January 14, 2020, and a replay of the presentation is available on Precigen’s website in the Events section at View Source

On February 3, 2020 Anchiano Therapeutics Presented the Corporate Presentation (Presentation, Anchiano Therapeutics, FEB 3, 2020, View Source [SID1234553804]).

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!