On September 12, 2019 GT Biopharma, Inc. (OTCQB: GTBP) (GTBP.PA) an immuno-oncology company focused on innovative treatments based on the Company’s proprietary NK cell engager (TriKE) platform and Multi-Target Directed Bispecific Drug Conjugate platform, reported that it notified FDA that it was commencing enrollment in its first-in-human GTB-3550 Phase I/II clinical trial (Press release, GT Biopharma , SEP 12, 2019, View Source [SID1234539478]). The clinical trial is being conducted at the University of Minnesota’s Masonic Cancer Center in Minneapolis, Minnesota under the direction of Dr. Erica Warlick.

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The open-label, dose-escalation Phase I portion of the trial will evaluate GTB-3550 in patients with CD33-expressing, high risk myelodysplastic syndromes, refractory/relapsed acute myeloid leukemia or advanced systemic mastocytosis, and will determine safety and tolerability as well as the pharmacologically active dose and maximum tolerated dose of GTB-3550. The Phase II portion of the trial is planned to further evaluate the recommended dose of GTB-3550 in this patient population.

Mr. Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma commented "we are pleased to begin patient enrollment in this population of advanced cancer patients." Mr. Cataldo further stated, "We appreciate the support Dr. Warlick and the University of Minnesota have provided, and are looking forward to furthering our relationship as we advance other TriKEs into the clinic."

About GTB-3550 Trispecific NK cell Engager (TriKE)

GTB-3550 (OXS-3550) is the Company’s first Tri-specific NK cell Engager (TriKE) product candidate being initially developed for the treatment AML. GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15. The natural killer (NK) cell stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill. We intend to study GTB-3550 in CD33 positive leukemias such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies.

About GTB-1550 Multi-Target Directed Bispecific Drug Conjugate

GTB-1550 targets cancer cells expressing the CD19 receptor or CD22 receptor or both receptors thereby maximizing cancer cell recognition by binding to CD19+, CD22+ and CD19+/CD22+ cancer cells. When GTB-1550 binds to cancer cells, the cancer cells internalize GTB-1550, and are killed due to the action of drug’s cytotoxic diphtheria toxin payload.

On September 12, 2019 Cannabics Pharmaceuticals Inc. (OTC-QB: CNBX), a leader in personalized cannabis based cancer medicine, reported that its Scientific Director, Dr. Ilan Hochman, is scheduled to present research data from cannabinoid tests on live cancer biopsies at the 2nd International Cannabinoid Derived Pharmaceuticals Summit, to be held in Boston, MA, on September 10-12, 2019 (Press release, Cannabics Pharmaceuticals, SEP 12, 2019, View Source [SID1234539477]). The company has been focusing on developing solutions for bringing cannabis based solutions into the mainstream of cancer treatments together with existing therapeutic approaches.

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The preliminary results were obtained in an ex-vivo clinical study in which live biopsies from cancer patients were treated with large arrays of cannabis extracts, chemotherapies and mixtures. Viability of the cancer cells was evaluated showing differential sensitivity both to cannabis extracts and chemotherapies. Moreover, synergistic effects were also revealed, whereas some cannabinoid compounds enhanced the sensitivity of cells to chemotherapy drugs. We believe that these results indicate the importance of optimizing the integration of cannabis medicine with conventional treatment regimens even if it is primarily intended as a palliative treatment.

The 2nd Annual International Cannabinoid Derived Pharmaceuticals Summit is the primary forum for leaders in cannabinoid pharmaceuticals and biotechnology to discuss, share and network with the leading companies and key opinion leaders in the field. The summit will be focusing on the most critical issues that drug developers face in the space, including; cannabinoid synthesis and sourcing, the impact of biosynthesis, formulation and delivery methods, the regulatory landscape and the challenges it presents, and will also look at the challenges within preclinical assessment and clinical trials in the field. We believe that this conference is indicative of a growing number of medical, scientific and pharmaceutical professionals who know that the time has come to unlock the promises of cannabis medicine for cancer and other indications backed up with proper scientific proof.

Dr. Hochman has vast knowledge and experience in cancer and immuno-oncology research, managing research and development teams and expertise in cell biology and high throughput screening. Dr. Hochman’s presentation is scheduled for Thursday, September 12th at 9:30 a.m. EST, as part of the session named "Improving Formulation, Drug Delivery & Preclinical Testing for Greater Clinical Efficacy." The presentation is entitled "Bringing Personalization to Cannabinoid Based-Cancer Medicine."

"We are excited to engage with fellow companies and specialists in the field and are pleased to be able to share preliminary results of our work in our lab in Israel," said Dr. Eyal Ballan, Cannabics’ CTO, who will also attend the event alongside Dr. Hochman.

On September 12, 2019 Amgen (NASDAQ:AMGN) reported that new data from its oncology portfolio and pipeline will be presented at the 17th International Myeloma Workshop (IMW) 2019 in Boston, Sept. 12-15, 2019 (Press release, Amgen, SEP 12, 2019, View Source [SID1234539476]).

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Data featured from Amgen’s hematology franchise will include oral presentations from Phase 1 studies of AMG 420, the anti-B-cell maturation antigen (BCMA) bispecific T cell engager (BiTE) and AMG 176, the MCL-1 inhibitor in patients with relapsed or refractory multiple myeloma. Other data being presented will include safety and efficacy results of once-weekly dosing of KYPROLIS (carfilzomib) in different regimens across several patient populations, and Phase 3 results from the first KYPROLIS trial to be conducted in China.

"We are proud to build on the success of KYPROLIS and look to advance the next generation of multiple myeloma therapies through our evolving pipeline," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We are excited by the initial results we have seen in our ongoing BCMA BiTE program and are focusing our efforts on the investigation of intermittent dosing paradigms that don’t involve continuous infusion. Our goal is to bring forward effective molecules that have the greatest potential to provide patient-friendly, convenient treatment options and support the healthcare professionals who fight these difficult-to-treat diseases."

A complete listing of abstracts can be found on the IMW website. Notable abstracts of interest include:

Oncology Pipeline

The Anti-BCMA Bispecific T-Cell Engager (BiTE) Molecule AMG 420 Induced MRD-Negative Complete Responses in R/R Multiple Myeloma in a FIH Study
Abstract #OAB-025, Oral Presentation, Friday, Sept. 13, at 2:30 p.m. ET in Veterans Auditorium
The Phase 1b study examining AMG 420 in patients with relapsed and/or refractory multiple myeloma is ongoing. The Company is also exploring intermittent dosing options with AMG 420 that could be evaluated following the Phase 1b study.

A Phase 1 dose escalation study of AMG 701, a half-life extended anti-BCMA BiTE molecule that can be dosed intermittently is underway with data expected for presentation in 2020.

A Phase 1, First-in-Human Study of AMG 176, a Selective MCL-1 Inhibitor, in Patients With Relapsed or Refractory Multiple Myeloma
Abstract #OAB-080, Oral Presentation, Saturday, Sept. 14, at 4 p.m. ET in Hynes Ballroom
The Phase 1 dose escalation clinical trial for AMG 397 (NCT03465540) is on a clinical hold to evaluate a safety signal for cardiac toxicity. In keeping with Amgen’s commitment to patient safety, the AMG 176 Phase 1 trial (NCT02675452) has been placed on a voluntary hold for new enrollment.

KYPROLIS

Safety and Efficacy of Once-Weekly Carfilzomib (K) Dosing in Frail Patients (pts): A Subgroup Analysis from the Phase 3 A.R.R.O.W. Study
Abstract #OAB-046, Oral Presentation, Saturday, Sept. 14, at 10:15 a.m. ET in Veterans Auditorium
Efficacy and Safety of Carfilzomib-Pomalidomide-Dexamethasone in Relapsed and/or Refractory Multiple Myeloma: Pooled Analysis of 2 Single Arm Studies
Abstract #OAB-049, Oral Presentation, Saturday, Sept. 14, at 11 a.m. ET in Veterans Auditorium
A Phase 1b Study of Once-Weekly Carfilzomib Combined with Lenalidomide and Dexamethasone (wKRd) in Patients (pts) with Newly Diagnosed Multiple Myeloma (NDMM)
Abstract #OAB-078, Oral Presentation, Saturday, Sept. 14, at 3:30 p.m. ET in Hynes Ballroom
Trial in Progress: Once-Weekly vs. Twice-Weekly Dosing of Carfilzomib-Lenalidomide-Dexamethasone in Patients w/ Relapsed or Refractory Multiple Myeloma
Abstract #SP-114, Poster Session II, Saturday, Sept. 14, from 12:30-2 p.m. ET in Hynes Auditorium
A Phase 3 Study of Carfilzomib and Dexamethasone (Kd) in Patients with Relapsed and Refractory Multiple Myeloma (MM) in China
Abstract #SP-115, Poster Session II, Saturday, Sept. 14, from 12:30-2 p.m. ET in Hynes Auditorium
A Patient-Physician Tool to Improve CoMMunication in Relapsed Refractory Multiple Myeloma (RRMM)
Abstract #SP-071, Poster Session II, Saturday, Sept. 14, from 12:30-2 p.m. ET in Hynes Auditorium
Carfilzomib (K) in Relapsed and Refractory Multiple Myeloma (RRMM): Frailty Subgroup Analysis from Phase 3 ASPIRE and ENDEAVOR
Abstract #SP-113, Poster Session II, Saturday, Sept. 14, from 12:30-2 p.m. ET in Hynes Auditorium
Real-World Use of Carfilzomib Therapy Among Patients with Existing Cardiovascular Medical History: An Analysis of a Prospective Observational Study
Abstract #SP-138, Poster Session II, Saturday, Sept. 14, from 12:30-2 p.m. ET in Hynes Auditorium
Depth of Response and Outcomes by Initial Therapy Prior to Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma
Abstract #SP-164, Poster Session II, Saturday, Sept. 14, from 12:30-2 p.m. ET in Hynes Auditorium
Real-World Evidence of the Use of Carfilzomib and Dexamethasone According to Age Subgroup: An Interim Analysis from a Prospective Observational Study
Abstract #SP-139, Poster Session II, Saturday, Sept. 14, from 12:30-2 p.m. ET in Hynes Auditorium
Completion of the Phase 3 CANDOR study evaluating KYPROLIS in combination with dexamethasone and DARZALEX (daratumumab) (KdD) compared to KYPROLIS and dexamethasone alone in patients with relapsed or refractory multiple myeloma is expected in the second half of 2019.

About BiTE Technology
Bispecific T cell engager (BiTE) technology is a targeted immuno-oncology platform that is designed to engage patients’ own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens. The BiTE platform leads to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing more than a dozen BiTE molecules across a broad range of hematologic malignancies and solid tumors, further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential.

On September 12, 2019 Varian (NYSE: VAR) reported its fourth quarter fiscal year 2019 earnings release date (Press release, Varian Medical Systems, SEP 12, 2019, View Source [SID1234539475]).

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The Company will report results for the fourth quarter of fiscal year 2019 after market close on Wednesday, October 23, 2019. The news release will be followed by a teleconference available to all interested at 1:30 p.m. Pacific Time. To access the teleconference call and replay:

Teleconference: Access from within the U.S. by dialing 1-877-869-3847, and from outside the U.S. by dialing 1-201-689-8261.

Replay: Access from within the U.S. by dialing 1-877-660-6853 and from outside the U.S. by dialing 1-201-612-7415 and enter conference ID 13694509. The teleconference replay will be available until 5:00 p.m. Pacific Time, Friday, October 25, 2019.

Webcast: To access the live webcast and replay, visit the company website at: www.varian.com/investors and click on the link for Fourth Quarter Earnings Results.

For automatic e-mail alerts regarding Varian news and events, investors can subscribe on the company website: View Source

On September 12, 2019 Heska Corporation (Nasdaq: HSKA; "Heska" or the "Company"), a provider of advanced veterinary diagnostic and specialty healthcare products, reported the pricing of $75.0 million aggregate principal amount of convertible senior notes due 2026 (the "Notes") in a private offering (the "Offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Heska, SEP 12, 2019, View Source;300917636.html [SID1234539474]). In addition, the Company has granted J.P. Morgan Securities LLC and Piper Jaffray & Co., the initial purchasers of the Notes, a 13-day option to purchase up to an additional $11.25 million aggregate principal amount of the Notes, solely to cover sales in excess of the principal amount of the Notes set forth above, if any.

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The sale of the Notes to the initial purchasers is expected to settle on September 17, 2019, subject to customary closing conditions, and is expected to result in approximately $72.1 million in net proceeds to the Company (or approximately $83.0 million if the initial purchasers exercise their option to purchase additional Notes in full) after deducting the initial purchasers’ discount and estimated offering expenses payable by the Company.

The Company expects to use the net proceeds of the Offering (including from any exercise by the initial purchasers of their option to purchase additional Notes) to repay all outstanding indebtedness of approximately $12.8 million under its existing credit facility, to fully fund a $2.0 million cash collateral account contemplated to secure its obligations under its credit facility as amended in connection with the Offering, to fund its intended expansion efforts, including through acquisitions of complementary businesses or technologies or other strategic transactions, and for working capital and other general corporate purposes. From time to time, the Company evaluates and is currently evaluating potential acquisitions or other strategic transactions. The Company has no current agreements or commitments with respect to any such acquisition or strategic transaction, however, and there can be no assurance that it will be able to enter into any definitive agreements with respect to, or otherwise consummate, any such transaction.

The Notes will be senior unsecured obligations of the Company, and will bear interest at a rate of 3.750% per year. Interest will be payable semi-annually in arrears on March 15 and September 15 of each year, beginning on March 15, 2020. The Notes will mature on September 15, 2026, unless earlier converted, redeemed or repurchased. The Company may not redeem the Notes prior to September 20, 2023; on or after September 20, 2023, the Company may redeem the Notes, at its option, at a cash redemption price equal to 100% of the principal amount thereof, plus accrued and unpaid interest, if the last reported sale price of the Company’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which the Company provides notice of redemption.

Holders of the Notes will have the right to require the Company to repurchase all or a portion of their Notes upon the occurrence of a fundamental change (as defined in the indenture governing the Notes) at a cash purchase price of 100% of their principal amount plus any accrued and unpaid interest. In connection with certain corporate events, or if the Company issues a notice of redemption, the Company will, under certain circumstances, increase the conversion rate for holders who elect to exchange their Notes in connection with such corporate event or during the relevant redemption period.

The Notes will be convertible based on an initial conversion rate of 11.5434 shares of the Company’s common stock per $1,000 principal amount of Notes (equivalent to an initial conversion price of approximately $86.63 per share, which represents a conversion premium of approximately 35.0% to the last reported sale price of the Company’s common stock on The Nasdaq Capital Market on September 12, 2019). Prior to the close of business on the business day immediately preceding March 15, 2026, the Notes will be convertible at the option of the holders of the Notes only upon the satisfaction of specified conditions and during certain periods. On or after March 15, 2026 until the close of business on the business day immediately preceding the maturity date, the Notes will be convertible at the option of the holders of the Notes at any time regardless of these conditions. Conversion of the Notes will be settled in cash, shares of the Company’s common stock or a combination thereof, at the Company’s election.

The Notes will be sold only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act. The sale of the Notes and the shares of the Company’s common stock issuable upon conversion of the Notes, if any, have not been, and will not be, registered under the Securities Act or the securities laws of any other jurisdiction, and unless so registered, the Notes and such shares, if any, may not be sold in the United States except pursuant to an applicable exemption from such registration requirements.

This press release does not constitute an offer to sell or solicitation of an offer to buy, nor shall there be any offer or sale of, the Notes (or any shares of the Company’s common stock issuable upon conversion of the Notes) in any state or jurisdiction in which the offer, solicitation, or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any such state or jurisdiction.