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SOTIO’s DCVAC/OvCa Significantly Improves Survival in Patients with Recurrent Ovarian Cancer

On March 19, 2019 SOTIO, a biotechnology company owned by the PPF Group, reported results from SOV02, its Phase II clinical trial evaluating DCVAC/OvCa, an active cellular immunotherapy product, in patients with recurrent ovarian cancer at 2019 SGO’s 50th Annual Meeting on Women’s Cancer today (Press release, SOTIO, MAR 19, 2019, View Source [SID1234534471]). Final analysis of SOV02 shows that DCVAC/OvCa decreased the risk of death significantly compared to patients who did not receive DCVAC/OvCa. Clinical trial results were presented during today’s SGO 2019 Plenary Session by SOV02 principal investigator David Cibula, MD, PhD from General University Hospital in Prague (Czech Republic).

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In the randomized, open label SOV02 clinical trial, patients with recurrent ovarian cancer received DCVAC/OvCa in combination with platinum-based chemotherapy. Compared to patients who did not receive DCVAC, it decreased the risk of death by 62%. The combination of chemotherapy and immunotherapy corresponded with 73% survival at two years, compared to 41% survival when chemotherapy was used alone. Overall survival results are statistically significant with a p-value of 0.0032. Progression Free Survival (PFS) increased from 9.5 to 11.3 months. Treatment with DCVAC/OvCa was very well tolerated and did not lead to any treatment discontinuation.

"Results from final data analysis of SOV02 clinical trial show that patients with recurrent ovarian cancer treated with DCVAC/OvCa are living significantly longer than patients in the control group. This outcome stands out very positively in this highly competitive clinical development landscape," said David Cibula, MD, PhD, General University Hospital (Prague, Czech Republic), Past-President of European Society of Gynaecological Oncology (ESGO), principal investigator of SOV02 study.

Radek Spisek, MD, PhD, Chief Executive Officer of SOTIO commented: "We are very happy that the results of SOV02 study in the second line treatment of ovarian cancer confirm the promising data of SOV01 trial in the first line, reported at ASCO (Free ASCO Whitepaper) 2018. In cooperation with ENGOT, we are now setting up the design of the pivotal trial that will build on the results of the Phase II program. With the development of DCVAC/OvCa and the latest result we are addressing the medical need in this harmful disease."

More information and details about the SOV02 clinical trial results can be found in the slides from the oral presentation at SGO 2019 posted on SOTIO’s webpage.

About SOV02 clinical trial:
SOV02 is a randomized, open-label, parallel-group, multi-center Phase II clinical trial evaluating the effect of adding DCVAC/OvCa to standard chemotherapy (carboplatin and gemcitabine) in women with first relapse of platinum-sensitive epithelial ovarian cancer.

Bristol-Myers Squibb Files Investor Presentation Highlighting Significant Benefits of Pending Transaction with Celgene

On March 19, 2019 Bristol-Myers Squibb Company (NYSE: BMY) reported that it has filed a new investor presentation with the Securities and Exchange Commission (SEC) in connection with its previously announced definitive merger agreement with Celgene Corporation (NASDAQ: CELG) (Press release, Bristol-Myers Squibb, MAR 19, 2019, View Source [SID1234534470]).

The investor presentation is available on the SEC’s website at www.SEC.gov and on Bristol-Myers Squibb’s website at View Source Highlights of the presentation include:

The Celgene acquisition is a financially and strategically compelling transaction.
Enhanced product leadership and pipeline: The combined company will be #1 in oncology, #1 in cardiovascular, and top 5 in immunology and inflammation with nine current products over $1 billion in annual sales, six near-term launches, and robust early-stage pipeline and cutting edge technologies and discovery platforms;
Attractive value: Value of approximately $55 billion from marketed products and in excess of $20 billion from synergies implies that the Celgene pipeline was acquired for a highly attractive price when compared to the aggregate purchase price of $90 billion;
Ideal timing: Trading ratio at two-year lows and Celgene P/E near an all-time low when deal was announced;
Sustainable financial strength: Sales and earnings projected to grow every year through 2025; Significant margin improvement of approximately 800 basis points to 36% on a 2018 pro forma basis before the impact of cost synergies compared to 28% on a standalone basis.
Bristol-Myers Squibb has generated a track-record of financial and operational outperformance.
Strong operating performance drives long-term value creation: Five year CAGRs for net revenue and adjusted EPS of 7% and 17%, respectively, both in excess of peer median, with adjusted operating margin up 725 basis points over that time period. Bristol-Myers Squibb has met or exceeded top line and EPS guidance and estimates on an annual basis each year since 2013;
Industry-leading commercialization: Opdivo is one of the most successful commercial oncology launches and has a leadership position in 16 FDA approved indications and delivered $6.7 billion in 2018 sales, up 36% year-over-year. Additionally, Eliquis is the #1 world-wide novel anti-coagulant despite being the third entrant to market and generated $6.4 billion in 2018 sales, up 32% year-over-year;
Portfolio transition success: Transitioned portfolio through multiple Losses of Exclusivity over the last five years, with approximately 60% of 2018 sales coming from new products launched during that period.
The transaction is the result of a robust process characterized by strong oversight, extensive diligence and focused planning.
Comprehensive process: Prioritized more than 20 transformational and ‘string-of-pearls’ opportunities, and Celgene selected as most attractive opportunity;
Thorough Board oversight: Consistent Board involvement throughout process, with eight meetings to discuss Celgene opportunity;
Extensive diligence: Six-month deep-dive analysis and five subsequent weeks of confidential due diligence provided comprehensive view of Celgene’s opportunities and risks;
Focused and committed to a successful integration: Complementary nature of businesses, strong team in place to manage integration and rigorous planning approach.
The Bristol-Myers Squibb Board unanimously recommends that Bristol-Myers Squibb shareholders vote their shares "FOR" the approval of the issuance of shares of the Company’s common stock in connection with our proposed acquisition of Celgene prior to the Special Meeting, which will be held on April 12, 2019. All Bristol-Myers Squibb shareholders of record as of the close of business on March 1, 2019 will be entitled to vote their shares.

Bristol-Myers Squibb urges shareholders to discard any blue proxy cards and disregard any related solicitation materials sent to you by Starboard Value LP, which is soliciting proxies from Bristol-Myers Squibb shareholders against approving the merger. Irrespective of whether shareholders previously submitted a blue proxy card pertaining to the proposals contained in Bristol-Myers Squibb’s definitive proxy statement, the Company urges shareholders to cast their vote on the WHITE proxy card "FOR" the proposal to approve the transaction.

Omeros Corporation Announces Upcoming Educational Event at the Annual Meeting of the European Society of Blood and Marrow Transplantation

On March 19, 2019 Omeros Corporation (Nasdaq: OMER) reported an upcoming educational event at the 2019 Annual Meeting of the European Society of Blood and Marrow Transplantation to be held in Frankfurt, Germany on March 24-27, 2019 (Press release, Omeros, MAR 19, 2019, View Source [SID1234534469]). Sponsored by Omeros, the educational session entitled "How Do I … Diagnose HSCT-TMA" will be held on Tuesday, March 26, at 2:00-3:30 PM local time. There is growing recognition that hematopoietic stem-cell transplant-associated thrombotic microangiopathy (HSCT-TMA), a potentially lethal complication of stem-cell transplants, is underdiagnosed in the U.S. and worldwide. A study from the Dana Farber Cancer Institute reported that, while 39% of patients receiving allogeneic HSCT developed TMA, the disorder was often unrecognized during clinical care.

The session, conducted by an international panel of experts, will focus on the diagnosis of HSCT-TMA and on the relationship between HSCT-TMA and the broader syndrome of disorders caused by endothelial injury. In addition to TMA, endothelial injury is associated with several complications of HSCT, including graft-versus-host disease, veno-occlusive disease, and diffuse alveolar hemorrhage. Narsoplimab, Omeros’ antibody to inhibit the lectin pathway of complement, has received breakthrough therapy designation from FDA and is in Phase 3 development for the treatment of HSCT-TMA.

About Omeros’ MASP Programs

Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2, a novel pro-inflammatory protein target involved in activation of the complement system, which is an important component of the immune system. The complement system plays a role in the inflammatory response and becomes activated as a result of tissue damage or microbial infection. MASP-2 is the effector enzyme of the lectin pathway, one of the principal complement activation pathways. Importantly, inhibition of MASP-2 does not appear to interfere with the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection, and its abnormal function is associated with a wide range of autoimmune disorders. MASP-2 is generated by the liver and is then released into circulation. Gene-targeted MASP-2-deficient mice and humans with MASP-2 gene polymorphisms that affect MASP-2 serum levels and MASP-2 functional activity are generally healthy with no obvious adverse phenotype.

Phase 3 clinical programs are in progress for narsoplimab, Omeros’ lead MASP-2 inhibitor also referred to as "OMS721," in hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), in immunoglobulin A (IgA) nephropathy, and in atypical hemolytic uremic syndrome (aHUS). Narsoplimab can be administered both intravenously and subcutaneously, and Omeros expects to commercialize each formulation of narsoplimab for different therapeutic indications. In parallel, Omeros is developing small-molecule inhibitors of MASP-2. Based on requests from treating physicians, Omeros has established a compassionate-use program for narsoplimab, which is active in both the U.S. and Europe. The FDA has granted narsoplimab breakthrough therapy designation for IgA nephropathy and for HSCT-TMA, orphan drug status for the prevention (inhibition) of complement-mediated thrombotic microangiopathies, for the treatment of IgA nephropathy, for the treatment of HSCT-TMA, and fast track designation for the treatment of patients with aHUS. The European Medicines Agency has granted orphan drug designation to narsoplimab for treatment of primary IgA nephropathy and for treatment in HSCT.

Omeros also has identified MASP-3 as responsible for the conversion of pro-factor D to factor D and as a critical activator of the human complement system’s alternative pathway. The alternative pathway is linked to a wide range of immune-related disorders. In addition to its lectin pathway inhibitors, the company is advancing its development of antibodies and small-molecule inhibitors against MASP-3 to block activation of the alternative pathway. Omeros has initiated the manufacturing scale-up process of its MASP-3 antibodies in preparation for clinical trials.

Moleculin Announces First Patients Enrolled in Lymphoma Clinical Trial

On March 19, 2019 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported that the first two patients have been enrolled in its European clinical trial of WP1220 for the topical treatment of cutaneous T-cell lymphoma (CTCL) (Press release, Moleculin, MAR 19, 2019, View Source [SID1234534468]).

"This now marks four clinical trials with patients enrolled," commented Walter Klemp, Moleculin’s Chairman and CEO. "In this case, we are targeting CTCL with a topical p-STAT3 inhibitor in light of the significant role that STAT3 appears to play in CTCL skin lesions. Our intent is to take an early read on the first five patients in this trial to assess whether we think topical delivery is viable, so we expect preliminary data to be available during 2019."

VBL Presents New Data on Potential of VB-111 to Stimulate the Immune System and Drive Immune Cells to Infiltrate Tumor Microenvironment

On March 19, 2019 VBL Therapeutics (Nasdaq: VBLT), reported the presentation of human data indicating that the viral anti-cancer investigational therapy VB-111 has potential to stimulate the immune system to induce a strong and durable response against ovarian tumors (Press release, VBL Therapeutics, MAR 19, 2019, View Source [SID1234534461]). Administration of VB-111 was associated with an infiltration of immune cells within the tumor, which was followed by tumor necrosis and sustained clinical response. VBL’s study entitled "VB-111, an anti-cancer gene therapy, induces immunotherapeutic effect in platinum resistant ovarian cancer" was presented last evening at the SGO 50th Annual Meeting on Women’s Cancer at the Hawaii Convention Center in Honolulu, Hawaii. The presentation was delivered by Dr. Ronnie Shapira-Frommer from Sheba Medical Center, Tel Aviv and Dr. Richard Penson from Massachusetts General Hospital, Boston.

Ofranergene obadenovec (VB-111) is a targeted anti-cancer investigational gene therapy with a dual mechanism: disruption of the tumor vasculature and induction of an anti-tumor directed immune response. In a Phase 2 clinical trial, VB-111 in combination with chemotherapy (paclitaxel) prolonged survival in patients with recurrent platinum resistant ovarian cancer (median OS 498 days for therapeutic dose VB-111 + paclitaxel combination therapy, compared to 172 days for low dose VB-111 + paclitaxel (p=0.03)). OVAL, VBL’s ongoing pivotal Phase 3 trial, is designed to repeat the successful Phase 2 protocol, with the primary endpoint of improvement in overall survival. An interim analysis of the OVAL study is expected at year-end 2019.

"Cancer cells utilize various mechanisms to proliferate and survive, including silencing of, and escape from, the immune system. We believe that treatment strategies should therefore aim both to target the cancer cells and to stimulate the immune system to attack the tumor," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "While we initially designed VB-111 as anti-tumor therapy targeting tumor blood supply, it is now evident that VB-111 can also drive immune cells into immunologically `cold` tumors turning the tumors ‘hot,` enabling the immune system to fight the tumor. These clinical findings provide encouraging evidence of the therapeutic potential of VB-111, as we continue to advance our clinical program in ovarian cancer and additional indications."

For a link to VBL’s poster at the SGO 50th Annual Meeting on Women’s Cancer refer to: SGO Poster

About Ofranergene Obadenovec (VB-111)
VB-111, a potential first-in-class anticancer therapeutic candidate, is the Company’s lead oncology product currently being studied in the OVAL potential-registration Phase 3 pivotal trial for ovarian cancer (ClinicalTrials.gov Identifier: NCT03398655). VB-111 has received orphan drug designation in both the US and Europe, and fast track designation in the US for prolongation of survival in patients with rGBM. In addition, VB-111 successfully demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer and recurrent platinum-resistant ovarian cancer (NCT01711970). VB-111 has received an Orphan Designation for the treatment of ovarian cancer from the European Commission.