On December 21, 2017 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported initiation of the Phase 3 GENESIS clinical trial, in which BL-8040 will be compared to placebo, on top of granulocyte colony-stimulating factor (G-CSF), for the mobilization of hematopoietic stem cells (HSCs) used for autologous transplantation in multiple myeloma patients (Press release, BioLineRx, DEC 21, 2017, View Source;p=RssLanding&cat=news&id=2323740 [SID1234522740]).

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The GENESIS study is a Phase 3, randomized, placebo-controlled, multicenter study, evaluating the safety, tolerability and efficacy of BL-8040 and G-CSF, compared to placebo and G-CSF, for the mobilization of HSCs for autologous transplantation in multiple myeloma patients. The study will commence with a lead-in period for dose confirmation, which will include 10-30 patients, and progress to the placebo-controlled main part, which is designed to include 177 patients in more than 15 centers. Treatment will include 5-8 days of G-CSF, with a single dose of BL-8040 or placebo on day 4. Apheresis for stem cell collection will be performed on day 5. Further apheresis sessions may be conducted if needed in order to reach the benchmark of ≥ 6×106 mobilized HSCs.

The primary objective of the study is to demonstrate that BL-8040 on top of G-CSF is superior to G-CSF alone in the ability of mobilize ≥ 6×106 HSCs in up to 2 aphereses. Secondary objectives include time to engraftment of neutrophils and platelets and durability of engraftment, as well as other efficacy and safety parameters.

Philip Serlin, Chief Executive Officer of BioLineRx, stated, "The initiation of our first Phase 3 trial for BL-8040 is an important milestone in the robust development plan of our lead oncology platform. Treatment with BL-8040 as a single administration and up-to-two-day collection regimen for rapid mobilization of stem cells could represent a significant improvement over the current treatment, which requires up to four apheresis sessions. We look forward to top-line results from the study expected in 2020."

Dr. John F. DiPersio, Chief, Division of Oncology at the Washington University School of Medicine, and lead investigator of the study, stated, "I am very excited to test the role of BL-8040, a novel CXCR4 inhibitor with G-CSF for the mobilization of peripheral blood stem cells from patients undergoing autologous transplant for multiple myeloma. I am hopeful that this will provide another approach to the optimal hematopoietic stem cell collection in this challenging group of patients".

About BL-8040

BL-8040 is a short peptide for the treatment of stem cell mobilization, acute myeloid leukemia and solid tumors. BL-8040 has demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, T, B and NK cells. It functions as a high-affinity antagonist for CXCR4, with long receptor occupancy. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of cancer cells and immune-cells from the bone marrow, thereby sensitizing cancer cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing cell death (apoptosis) and mobilizing immune-cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

On December 21, 2017 bluebird bio, Inc. (Nasdaq: BLUE), a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies for cancer, reported that members of the management team will present at the following upcoming investor conferences (Press release, bluebird bio, DEC 21, 2017, View Source [SID1234522749]):

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Goldman Sachs 10th Annual Healthcare CEOs Unscripted, Thursday, January 4, at 3:15 p.m. ET at the InterContinental, Boston, Massachusetts.
36th Annual J.P. Morgan Healthcare Conference, Tuesday, January 9, at 7:30 a.m. PT, followed by Q&A, at the Westin St. Francis Hotel, San Francisco, California.
To access the live webcasts of bluebird bio’s presentations, please visit the "Events & Presentations" page within the Investors and Media section of the bluebird bio website at View Source Replays of the webcasts will be available on the bluebird bio website for 90 days following the event.

On December 21, 2017 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age‐related macular degeneration and fibrotic diseases, and Ambrx, Inc., reported that they have entered into a licensing agreement for the development and commercialization of TRACON’s proprietary endoglin antibody, TRC105 (carotuximab), in China (Press release, Tracon Pharmaceuticals, DEC 21, 2017, View Source;p=RssLanding&cat=news&id=2323733 [SID1234522743]).

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The transaction grants Ambrx the exclusive rights to develop and commercialize TRC105 in all indications (excluding ophthalmology, which are held by Santen Pharmaceutical Co., Ltd.) in China (including Hong Kong and Macau) and Taiwan. TRACON will receive an upfront payment of $3 million, and is eligible to receive development and regulatory milestones of up to $10.5 million, and commercial sales milestones of up to $130 million. TRACON is also eligible to receive tiered royalties from the high single digits to low teens on net sales of TRC105 in the Ambrx territories.

"We are excited to expand the development and commercialization opportunities for TRC105 into the Chinese market with a strong partner. The Ambrx management team has a strong track record of drug development in China and are backed by a top-tier syndicate of investors," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We look forward to Ambrx filing a Clinical Trial Application (CTA) for TRC105 in China, which we expect to occur in 2018, contributing to the ongoing enrollment of the Phase 3 TAPPAS trial in angiosarcoma, and leading the development of TRC105 in hepatocellular carcinoma (HCC) in China."

"Ambrx is delighted to partner with TRACON to develop this potential first-in-class medicine that we believe can benefit patients with significant unmet medical needs, including HCC, in China. With Ambrx’s proven expertise in pre-clinical, regulatory and clinical development, especially in the area of cancer therapeutics, we are uniquely positioned to bring this innovative molecule to China for patients with angiosarcoma and HCC," said Alex Qiao, Chief Executive Officer of Ambrx.

Ambrx intends to file an initial CTA with the Chinese Food and Drug Administration (CFDA) in 2018.

About TRC105 (carotuximab)

TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in the pivotal Phase 3 TAPPAS trial in angiosarcoma and multiple Phase 2 clinical trials, in combination with VEGF inhibitors. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a randomized Phase 2 trial for patients with wet AMD. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.

On December 21, 2017 Humanigen, Inc. (OTCQB: HGEN), a biopharmaceutical company pursuing cutting-edge science to develop its proprietary monoclonal antibodies for immunotherapy and oncology treatments, reported it has entered into definitive agreements with its lenders to, among other things, exchange the entire balance of approximately $16.3 million in term loans for common stock of the company (Press release, KaloBios, 21 21, 2017, View Source [SID1234522783]). The transactions are expected to close in the first quarter of 2018 subject to the satisfaction of certain conditions contained in the definitive agreements.

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Humanigen will also receive a new $3 million investment from an affiliate of Black Horse Capital, one of the lenders, to fund the company and its transformational new strategy of developing the monoclonal antibodies lenzilumab and ifabotuzumab in the fast-growing and exciting areas of immunotherapy and oncology.

The company has begun work with leading key opinion leaders in the chimeric antigen receptor T-cell (CAR-T) therapy field to advance lenzilumab into phase 1 trials for the prevention of neurotoxicity associated with CAR-T therapy. Lenzilumab is an antagonist of circulating granulocyte-macrophage colony-stimulating factor (GM-CSF). GM-CSF is thought to be a potential key factor in neurotoxicity, and perhaps other side-effects, associated with CAR-T therapy.

By neutralizing circulating GM-CSF, and upon demonstrating meaningful effects on neurotoxicity without hampering the efficacy of CAR-T, lenzilumab has the potential to make CAR-T therapy:
·
safer by lessening neurotoxicity
·
more effective by allowing higher CAR-T doses, greater CAR-T expansion, and potentially reducing myeloid-derived suppressor cells (MDSC) that inhibit T cell function
·
a more routine out-patient procedure

Humanigen also continues to enroll patients in its phase 1 study of lenzilumab for the treatment of chronic myelomonocytic leukemia (CMML), a rare hematologic cancer, with interim data expected in the first half of 2018.

In addition, the other key asset in the Humanigen monoclonal antibody portfolio, ifabotuzumab, has been dosed in the first patient in an investigator-sponsored phase 0/1 radio-labeled imaging trial in glioblastoma multiforme (GBM), a particularly aggressive and deadly brain cancer. According to the investigators at the Olivia Newton-John Cancer Research Institute in Australia, the trial will seek to confirm the safety of ifabotuzumab and potentially determine the best dose to effectively penetrate brain tumors. The investigators expect 12 patients to participate in the trial, for which eligibility criteria are recurrent GBM and receipt of only one type of chemotherapy for disease recurrence. The company also is exploring partnering opportunities to enable further development of ifabotuzumab as a potential treatment for certain solid and hematologic cancers as an antibody-drug conjugate (ADC) and as a CAR-T construct.

"This transaction resets Humanigen as a cutting-edge science immunotherapy and oncology biotechnology company," said Cameron Durrant, MD, chairman and CEO. "By following the recent, exciting, ground-breaking science related to lenzilumab’s potential utility to help in CAR-T therapy, as well as a new clinical trial for ifabotuzumab, we are writing a new history for Humanigen driven by science to help patients with new medical innovations."

At the transactions’ closing, the company will issue 59,786,848 new shares of common stock to the lenders in exchange for the satisfaction and extinguishment of the company’s obligations with respect to its outstanding secured loans. In addition, at closing, Humanigen will assign all of its assets and rights related to its former benznidazole drug candidate to a new entity formed and controlled by one of the lenders. As previously reported, these assets and rights are no longer relevant to the company’s forward-looking business plan as described above. And the company will issue 32,028,669 new shares of common stock to an affiliate of Black Horse Capital for $3 million, of which $1.5 million in new capital is expected to be received by the company on December 22, 2017 in the form of a secured loan that will be converted into common stock at the close. In total, these transactions provide $19.3 million of value to the company in return for the issuance of approximately 91.8 million shares of stock; common stock currently outstanding will represent 14% of the post-closing total outstanding shares.

The total number of new shares to be issued to affiliates of Black Horse Capital at the closing of these transactions, when combined with their existing ownership stakes, will result in Black Horse Capital and its affiliates owning more than 50% of the company’s outstanding shares of common stock.

On December 21, 2017 Integra LifeSciences Holdings Corporation (NASDAQ:IART), a leading global medical technology company, reported that its President and Chief Executive Officer Peter Arduini will speak at the 36th Annual J.P. Morgan Healthcare Conference in San Francisco, California at 3:30 p.m. PT (6:30 p.m. ET) on Wednesday, January 10, 2018 (Press release, IsoTis, DEC 21, 2017, View Source [SID1234522751]).

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A live audio webcast of the presentation will be available on the Investors section of the company’s website at www.integralife.com.