On September 21, 2018 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that its collaborator, Takeda Pharmaceutical Company Limited (Takeda), has received approval from the Japanese Ministry of Health, Labour and Welfare for ADCETRIS (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) as a frontline treatment option for CD30-positive Hodgkin lymphoma patients in Japan (Press release, Seattle Genetics, SEP 21, 2018, View Source;p=RssLanding&cat=news&id=2368435 [SID1234529705]). As a result, Seattle Genetics will receive a milestone payment from Takeda of $10 million. The approval in Japan was based on the positive outcome from the phase 3 ECHELON-1 trial.

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"This approval marks another important milestone in expanding the ADCETRIS brand globally and redefining the way newly diagnosed Hodgkin lymphoma patients are treated around the world," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "ADCETRIS is approved in 71 countries and generated global sales of approximately $640 million in 2017, underscoring its progress toward becoming the foundation of therapy for patients with CD30-expressing lymphomas."

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs. Seattle Genetics is entitled to receive progress- and sales-dependent milestone payments. In addition, Seattle Genetics receives tiered double-digit royalties with percentages ranging from the mid-teens to mid-twenties based on net sales of ADCETRIS within Takeda’s territories.

About Hodgkin Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Classical Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell expresses CD30. According to the Lymphoma Coalition, over 62,000 people worldwide are diagnosed with Hodgkin lymphoma each year and approximately 25,000 people die each year from this cancer.

About ADCETRIS (brentuximab vedotin)

ADCETRIS is being evaluated broadly in more than 70 clinical trials, including the ongoing phase 3 ECHELON-2 trial in frontline peripheral T-cell lymphomas (also known as mature T-cell lymphoma), the completed phase 3 ALCANZA trial in cutaneous T-cell lymphoma (CTCL) and the completed ECHELON-1 trial in previously untreated Hodgkin lymphoma, as well as trials in many additional types of CD30-positive lymphomas.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream, but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS injection for intravenous infusion has received FDA approval for five indications in adult patients with: (1) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy, (2) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (3) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (4) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (5) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-autologous stem cell transplantation (ASCT) consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression.

ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, and (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

ADCETRIS has received marketing authorization by regulatory authorities in 71 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See select important safety information, including Boxed Warning, below.

On September 20, 2018 AIVITA Biomedical reported that it has dosed its first of 10 patients currently enrolled as part of its Phase 2 trial in patients with advanced ovarian cancer (Press release, AIVITA Biomedical, SEP 20, 2018, View Source [SID1234529879]). The trial is designed to investigate AIVITA Biomedical’s patient-specific cancer treatment consisting of autologous dendritic cells loaded with autologous antigens from the patient’s tumor-initiating cells.

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AIVITA is enrolling approximately 99 patients in the Company’s ROOT OF CANCER ovarian cancer trial to be randomized in a 2:1 ratio to receive either the Company’s patient-specific cancer treatment or a control agent consisting of autologous monocytes. The treatment will be administered in a series of injections along with standard care.

"We’re proud of the manufacturing team here at AIVITA who have made this important moment possible," said Dr. Bob Dillman, Chief Medical Officer at AIVITA. "The team has contributed manufacturing efficiencies which have greatly improved the success rate and speed of creating this treatment, allowing us to treat more patients more reliably. We’ve since randomized several additional patients in this trial and activity is accelerating as we sign on more hospitals and receive additional tumors."

Previously, this treatment was tested in two Phase 2 trials in patients with advanced melanoma and approved for Phase 3 testing. The first Phase 2 trial demonstrated a 54% 5-year survival rate compared to a 29% 5-year survival rate for an active control arm. The second randomized Phase 2 trial demonstrated similar results, with a significantly longer median survival compared to the control arm.

AIVITA’s ROOT OF CANCER technology is also the subject of an ongoing Phase 2 clinical trial treating glioblastoma in the USA. The Company is also currently applying for conditional approval to commercialize the treatment for melanoma in Japan and is considering Japanese strategic partners for this program.

About Ovarian Cancer

Ovarian cancer is the fifth most common cause of female cancer deaths, with an estimated 22,240 new diagnoses in 2018 and 14,070 deaths. The median age at diagnosis is 63, with a 5-year survival rate of less than 50% for all, and about 35% for the two thirds who have advanced disease (stage III or IV) at the time of initial diagnosis. Current standard of care includes surgical debulking and several courses of chemotherapy.

About ROOT OF CANCER

AIVITA’s treatment is a platform technology applicable to most solid tumor types and consists of autologous dendritic cells loaded with autologous tumor antigens from autologous self-renewing tumor-initiating cells.

The ovarian Phase 2 double-blind study will enroll approximately 99 patients who will be randomized in a 2:1 ratio to receive either the autologous dendritic cell vaccine 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.

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

On September 20, 2018 Molecular Templates, Inc. (Nasdaq: MTEM) ("Molecular"), a clinical-stage oncology company focused on the discovery and development of proprietary engineered toxin bodies (ETBs), which are differentiated, targeted, biologic therapeutics for cancer, reported the pricing of its underwritten public offering of 8,200,000 shares of its common stock at a public offering price of $5.50 per share (Press release, Molecular Templates, SEP 20, 2018, View Source [SID1234529615]). The gross proceeds to Molecular from the offering, before deducting the underwriting discounts and commissions and estimated offering expenses payable by Molecular, are expected to be $45.1 million. All of the shares of common stock to be sold in the offering are being sold by Molecular. In addition, Molecular has granted to the underwriters a 30-day option to purchase up to 1,230,000 additional shares of common stock.

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Molecular intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, to fund: its ongoing Phase Ib and Phase II clinical studies and planned additional Phase II clinical studies for MT-3724 in DLBCL; its share of development expenses in its CD38 collaboration with Takeda; its programs targeting HER2 and PD-L1; further preclinical development and drug discovery activities in its other programs and for working capital and general corporate purposes. The offering is expected to close on or about September 25, 2018, subject to the satisfaction of customary closing conditions.

Cowen, Evercore ISI and UBS Investment Bank are acting as joint book-running managers for the offering. Laidlaw & Company (UK) Ltd. is acting as lead manager for the offering. Ladenburg Thalmann is acting as financial advisor to Molecular.

The shares are being offered by Molecular pursuant to a shelf registration statement on Form S-3 that was previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC. A preliminary prospectus supplement relating to the offering was filed with the SEC and a final prospectus supplement relating to the offering will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or by telephone at (631) 274-2806; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at 888-474-0200, or by email at [email protected] or UBS Securities LLC, Attention: Prospectus Department, 1285 Avenue of the Americas, New York, NY 10019, by telephone at 1-888-827-7275 or by emailing [email protected]. You may also obtain these documents free of charge by visiting the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities, in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On September 20, 2018 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported the pricing of an underwritten public offering of 9,259,260 shares of its common stock at a public offering price of $13.50 per share, before underwriting discounts, for an aggregate offering of approximately $125.0 million (Press release, Fate Therapeutics, SEP 20, 2018, View Source [SID1234529896]). Fate Therapeutics has granted the underwriters a 30-day option to purchase up to an additional 1,388,889 shares of its common stock. The proceeds to Fate Therapeutics from this offering are expected to be approximately $117.2 million after deducting underwriting discounts and commissions and other estimated offering expenses but excluding any exercise of the underwriters’ option. Fate Therapeutics intends to use the net proceeds from the offering to fund clinical trials and nonclinical studies, the manufacture of clinical product candidates and the conduct of preclinical research and development, and for general corporate purposes. All shares of common stock to be sold in the offering are being offered by Fate Therapeutics. The offering is expected to close on or about September 25, 2018, subject to customary closing conditions.

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Jefferies, Piper Jaffray, and Wells Fargo Securities are acting as joint book-running managers for the offering. Wedbush PacGrow is acting as a co-manager for the offering.

The securities described above are being offered by Fate Therapeutics pursuant to a shelf registration statement on Form S-3 (File No. 333-224680) previously filed with and declared effective by the Securities and Exchange Commission (the "SEC"). The securities may be offered only by means of a prospectus. A preliminary prospectus supplement related to the offering was filed with the SEC on September 20, 2018 and is available on the SEC’s website at View Source and a final prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website at View Source. Copies of the final prospectus supplement and the accompanying prospectus for the securities being offered may also be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 821-7388; Piper Jaffray & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by e-mail at [email protected] or by telephone at (800) 747-3924; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York 10152, by email at [email protected] or by telephone at (800) 326-5897.

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

On September 20, 2018 ERYTECH Pharma (Euronext Paris: ERYP – Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating drug substances inside red blood cells, reported that the first three patients have been enrolled in its pivotal Phase 3 clinical trial, named ‘TRYbeCA1’, evaluating its lead product candidate eryaspase for the treatment of second line metastatic pancreatic cancer (Press release, ERYtech Pharma, SEP 20, 2018, View Source;p=RssLanding&cat=news&id=2368155 [SID1234529509]).

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The TRYbeCa1 (NCT03665441) trial will enroll approximately 500 patients with second line metastatic pancreatic cancer in 120-130 clinical sites in Europe and the US. Patients who meet the eligibility criteria are randomized 1-to-1 to receive eryaspase in combination with standard chemotherapy (gemcitabine/abraxane or irinotecan -based regimen) or chemotherapy alone until disease progression. The primary endpoint is overall survival. An interim analysis is foreseen when approximately two-thirds of events have occurred.

The launch of the TRYbeCA1 Phase 3 trial follows the positive Phase 2b results in the same patient population, that were reported in September 2017. This open-label, multi-center, 2-to-1 randomized study in 141 patients demonstrated significant improvement in both overall survival and progression-free survival. Overall, eryaspase was well tolerated and showed a safety profile comparable to that of standard chemotherapy.

"The results from our landmark Phase 2b study are highly promising and underscore the importance of targeting tumor metabolism pathways in pancreatic cancer. We are hopeful to provide a novel treatment modality for this highly unmet medical need. We are very pleased that eryaspase has now moved into Phase 3 and patient enrollment has started as planned. Our first three enrolled patients mark the initiation of the trial in Europe. Early next year, we expect sites in the United States will begin enrolling as well," commented Iman El-Hariry, Chief Medical Officer.

About pancreatic cancer

Pancreatic cancer is a disease in which malignant (cancer) cells are found in the tissues of the pancreas. Every year, there are approximately 150,000 new cases of pancreatic cancer diagnosed in Europe and the United States. Advanced pancreatic cancer is a particularly aggressive cancer, with a five-year survival rate of less than 10%. It is currently the fourth leading cause of cancer death in Europe and the United States and is projected to rise to the second leading cause by 2030. Limited therapeutic options are currently available for this indication, thereby reinforcing the need to develop new therapeutic strategies and rational drug combinations with the aim of improving overall patient outcomes and quality of life.