First Cancer Patient Treated with Varian ProBeam Compact Proton Therapy System at Treatment Center in Florida

On November 18, 2019 Varian (NYSE: VAR) reported the South Florida Proton Therapy Institute (SFPTI), a Proton International facility, on the campus of Delray Medical Center, reported that it has treated its first patient utilizing the Varian ProBeam Compact single-room proton therapy system (Press release, Varian Medical Systems, NOV 18, 2019, View Source [SID1234551426]). Proton therapy can be used to treat many types of tumors including in the brain, head and neck, central nervous system and lung, and more precisely targets cancer cells while reducing side effects, minimizing risk to surrounding tissue and organs.

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!

"Proton therapy is the latest and by far the most advanced radiation treatment available, and at SFPTI we use these highly precise particle beams instead of traditional x-rays to treat tumors more precisely, with much less exposure to the surrounding normal tissues," said Tim Williams medical director, SFPTI. "Proton therapy can be used to treat children with cancer as well as adult tumors of the brain, spine, head and neck, lung, prostate, GI tract, and breast tumors. I am truly grateful to finally be able to make this long-standing vision of bringing this world-class technology to south Florida a reality."

"We are proud of the partnership between Varian, SFPTI and Proton International to help bring this advanced treatment technology to more cancer patients who are in need of this life-saving therapy," said Kolleen Kennedy, president, Proton Solutions and chief growth officer at Varian. "This first patient treatment is another important step in the growing availability of proton therapy for more patients and continues Varian’s mission of creating a world without fear of cancer."

Proton therapy uses protons, accelerated to about two-thirds the speed of light, or more than 100,000 miles per second, to destroy cancer cells, while minimizing exposure to nearby healthy tissues. SFPTI will treat a variety of oncology patients with the Varian system, including brain and spine, head and neck, breast, liver, lung, pancreatic, prostate and pediatric cancers.

Currently 27 leading proton centers have selected the Varian solution, 12 of the centers are in clinical operation and eight more are expected to begin treating patients within the next 12 months. To learn more about the Varian proton therapy solutions, visit View Source

About South Florida Proton Therapy Institute
The South Florida Proton Therapy Institute (SFPTI), a Proton International facility, is a radiation oncology center that opened in 2018 on the campus of Delray Medical Center. Led by Medical Director Tim R. Williams, M.D. and featuring the most innovative technology available, SFPTI provides those in Palm Beach County and the surrounding communities with a tremendous new resource in the fight against cancer. For more information, visit View Source

TG Therapeutics to Present at the Jefferies London Healthcare Conference

On November 18, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, will present at the Jefferies London Healthcare Conference, being held at the Waldorf Hilton on Aldwych, in London, UK (Press release, TG Therapeutics, NOV 18, 2019, View Source [SID1234551425]). The presentation is scheduled to take place on Wednesday, November 20, 2019 at 11:20 AM GMT.

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!

A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source

ProMIS Neurosciences Completes First Closing of Private Placement

On November 18, 2019 ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, is reported that, further to its news release dated November 13, 2019, it completed on November 15, 2019, the first closing of its private placement of up to $6.5M (Press release, ProMIS Neurosciences, NOV 18, 2019, View Source [SID1234551424]). In the first closing, the Company issued 10,276,666 Units for gross proceeds of approximately CDN$2,055,333.

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!

"We are pleased to announce this first closing and given the interest expressed look forward to the final closing in the coming weeks," stated Dr. Elliot Goldstein, ProMIS President and CEO.

Each Unit issued in the first closing consisted of one common share of the Company and one share purchase warrant of the Company. Each warrant entitles the holder thereof to purchase one share at an exercise price of $0.35 per share at any time for five years. The Company also issued 162,400 finders warrants having the same terms as the unit warrants.

All securities issued in connection with the Offering are subject to a four-month statutory hold period in accordance with applicable provincial securities laws. Net proceeds from the offering are intended to be used to advance the company’s antibody therapeutic candidates selectively targeting toxic oligomers implicated in neurodegenerative diseases, for working capital and general corporate purposes.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful. The securities issued, or to be issued, under the Offering have not been, and will not be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

Nurix Therapeutics Announces Scientific Presentations on its BTK Program at the 61st American Society of Hematology Annual Meeting

On November 18, 2019 Nurix Therapeutics, Inc., a company developing novel therapies that control disease-causing proteins, reported an oral presentation on its wholly-owned, BTK degrader program for chronic lymphocytic leukemia will be delivered by the Company’s collaborators from the National Institutes of Health at the upcoming 61st American Society of Hematology (ASH) (Free ASH Whitepaper) meeting (ASH) (Free ASH Whitepaper) (Press release, Nurix Therapeutics, NOV 18, 2019, View Source [SID1234551423]). A poster presentation will also be presented on the BTK degradation mechanism of action. ASH (Free ASH Whitepaper) is being held on December 7-10, 2019 at the Orange County Convention Center in Orlando, Fla.

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!

ORAL PRESENTATION DETAILS:
Title: Highly Potent BTK Degradation Induced by NRX0492 As a Therapeutic Strategy for CLL
Session: 605. Molecular Pharmacology, Drug Resistance—Lymphoid and Other Diseases I

Hematology Disease Topics & Pathways: Diseases, Leukemia, Biological, Therapies, CLL, immune cells, Lymphoid Malignancies, TKI

Presenter: Deyi Zhang, Laboratory of Lymphoid Malignancies, Hematology Branch, NHLBI, NIH, Bethesda, MD

Date: Saturday, December 7, 2019
Time: 1:15 p.m. EST
Location: W414AB, Level 4

POSTER PRESENTATION DETAILS:
Title: Targeted Protein Degradation of BTK As a Unique Therapeutic Approach for B Cell Malignancies
Session: 605. Molecular Pharmacology, Drug Resistance—Lymphoid and Other Diseases: Poster III

Hematology Disease Topics & Pathways: Diseases, Leukemia, Biological, Therapies, CLL, immune cells, Lymphoid Malignancies, TKI

Date: Monday, December 9, 2019
Time: 6:00 – 8:00 p.m. EST
Location: Hall B, Level 2

MorphoSys’s B-MIND trial of tafasitamab in DLBCL has successfully passed futility analysis

On November 18, 2019 MorphoSys AG (Prime Sector Segment, MDAX & TecDAX, NASDAQ: MOR) reported that the ongoing Phase 3 B-MIND study with the drug candidate tafasitamab has successfully passed the pre-planned, event-driven interim futility analysis (Press release, MorphoSys, NOV 18, 2019, View Source [SID1234551422]). The data was evaluated by an independent data control committee (IDMC). This recommended increasing the number of patients from the current 330 to 450. The B-MIND study compares the efficacy of the CD19 antibody tafasitamab in combination with bendamustine versus rituximab in combination with bendamustine in patients with relapsed or refractory diffuse large B-cell lymphoma (r / r DLBCL).

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!

As part of the futility interim analysis, the IDMC examined the data for the likelihood of a positive outcome of the study at the time of graduation. The IDMC evaluated the efficacy data in the entire patient population as well as in the biomarker-positive patient subpopulation. The biomarker, which describes patients with a low number of natural killer cells at baseline, was implemented as a co-primary endpoint in the first quarter of 2019 in a supplement to B-MIND. The IDMC’s recommendation to include more patients in the trials aims to increase the statistical power of the study in both the biomarker-positive patient subpopulation and the entire study population. The data from the analysis was not shared with MorphoSys.

Continuing the B-MIND study protocol, patient recruitment will be performed according to the original inclusion and exclusion criteria. This should further enable the comparison of efficacy in the whole as well as the biomarker-positive patient group. Topline results are expected to be available in the first quarter of 2022.

"We are delighted with the IDMC’s recommendation and see it as an important step in the clinical development of tafasitamab," said Drs. Malte Peters, Chief Development Officer of MorphoSys. "DLBCL is a difficult-to-treat disease with a high unmet medical need, so new treatment options are urgently needed, and we are well on our way to approving our BLA approval application for tafasitamab in combination with lenalidomide, regardless of B-MIND positive clinical trial results L-MIND and Re-MIND by the end of 2019. "

About B-MIND
The pivotal Phase 2/3 B-MIND trial is investigating tafasitamab in combination with the chemotherapeutic agent bendamustine in patients with relapsed or refractory diffuse large B-cell lymphoma (R / R DLBCL) who are not eligible for high-dose chemotherapy and subsequent chemotherapy Autologous stem cell transplantation compared to the combination of the anti-CD20 antibody rituximab plus bendamustine A low number of natural killer cells in the peripheral blood at baseline was implemented as a biomarker in coordination with the FDA in the first quarter of 2019. A pre-planned, event-driven futility interim analysis in the B-MIND study took place in November 2019 and resulted in an increase in patient count to 450 (out of 330).

About CD19 and tafasitamab (MOR208)
CD19 is broadly and homogeneously expressed in several malignant B-cell diseases including DLBCL and CLL. It has been shown that CD19 participates in the B cell receptor (BCR) signaling pathway, which is considered to be important for B cell survival and makes CD19 a potential target in B cell disease.
Tafasitamab (MOR208) is a humanized Fc-modified monoclonal antibody against CD19. The Fc modification of tafasitamab should lead to a significant increase in antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus improving a key mechanism of tumor cell killing. Tafasitamab has been studied in preclinical models to induce direct apoptosis by binding to CD19, which is considered to be a critical component for B cell receptor (BCR) signaling.
In addition to B-MIND, MorphoSys is investigating tafasitamab as a therapeutic option in B-cell malignancies in a series of ongoing combination trials. The open-label Phase 2 combination trial (L-MIND trial) is investigating the safety and efficacy of tafasitamab in combination with lenalidomide in patients with relapsed / refractory DLBCL who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT) in Question come. Based on preliminary data from L-MIND, the FDA granted the status of breakthrough therapy for tafasitamab plus lenalidomide in this patient population in October 2017.
Re-MIND, the real world data trial in a control group treated with lenalidomide monotherapy, reached its primary endpoint in October 2019 and demonstrated clinical superiority of the tafasitamab / lenalidomide combination compared to lenalidomide alone. In addition, tafasitamab is currently being studied in patients with relapsed / refractory CLL / SLL following the discontinuation of previous bron-tyrosine kinase inhibitor therapy (eg ibrutinib) in combination with idelalisib or venetoclax.