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MacroGenics Announces Departure of Chief Medical Officer

On March 4, 2020 MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that Jon Wigginton, M.D., Senior Vice President, Clinical Development & Chief Medical Officer, will be leaving the Company effective March 27, 2020 to pursue a new opportunity (Press release, MacroGenics, MAR 4, 2020, View Source [SID1234555178]).

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"Over the past seven years, Jon has played a leadership role in establishing and executing the clinical development strategy to advance our immuno-oncology product candidates. I would like to thank him for his significant contributions to MacroGenics, and wish him the best in his future endeavors," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Our clinical programs are progressing as planned, and we look forward to a productive 2020."

While the executive search for a new Chief Medical Officer is ongoing, Ezio Bonvini, M.D., Senior Vice President, Research and Chief Scientific Officer, will assume Dr. Wigginton’s responsibilities on an interim basis, including overseeing clinical development and related functions. Dr. Bonvini joined MacroGenics in June 2003. He was previously with the Food and Drug Administration (FDA) in the Center for Biologics Evaluation and Research (CBER) for 18 years, ultimately serving as Acting Deputy Director, Division of Monoclonal Antibodies. Dr. Bonvini received his M.D. and Specialty Certification in Clinical Hematology from the University of Genoa, School of Medicine.

INmune Bio, Inc. Schedules Conference Call to Report 2019 Fourth Quarter and Full Year Financial Results

On March 4, 2020 INmune Bio, Inc., an immunotherapy company developing therapies that reprogram the patient’s innate immune system to treat disease, reported that it will release financial results for its 2019 fourth quarter and year end on Wednesday, March 11, 2020 (Press release, INmune Bio, MAR 4, 2020, View Source [SID1234555177]).

The Company will hold a conference call at 11AM Eastern (U.S.) time on March 11, 2020. To participate in the live conference call, please dial 1-877-407-2988 five minutes prior to the scheduled conference call time. International callers should dial 1-201-389-0923.

Participants can also use this link for instant telephone access to the event.

IGM Biosciences to Present at Two Upcoming Investor Conferences

On March 4, 2020 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that members of the management team will present at two upcoming investor conferences (Press release, IGM Biosciences, MAR 4, 2020, View Source [SID1234555176]):

Barclays Global Healthcare Conference on Wednesday, March 11 at 3:20 p.m. ET in Miami.
Oppenheimer 30th Annual Healthcare Conference on Wednesday, March 18 at 8:35 a.m. ET in New York.
A live webcast of the events will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcasts will be archived on the Company’s website for 90 days following the presentation.

DelMar Pharmaceuticals [Nasdaq:DMPI] Reports Over 50% Enrollment in Phase 2 Clinical Trial of VAL-083 For Adjuvant Treatment of Brain Tumors

On March 4, 2020 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported it has exceeded 50% enrollment in the adjuvant arm of the Company’s ongoing Phase 2 clinical study investigating adjuvant treatment (pre-temozolomide — or TMZ – maintenance therapy) of MGMT-unmethylated glioblastoma multiforme (GBM) with VAL-083 (Press release, DelMar Pharmaceuticals, MAR 4, 2020, View Source [SID1234555175]). The 24-patient, open label study arm has now enrolled 14 patients and continues to enroll at an encouraging rate.

The adjuvant arm of the Phase 2 study of VAL-083 being conducted at the MD Anderson Cancer Center (MDACC) is designed to enroll up to 24 newly-diagnosed patients who have undergone surgery and chemoradiation with TMZ but will now receive VAL-083 in place of standard of care TMZ for adjuvant therapy.

"The pace of enrollment for the adjuvant arm of the study has been very encouraging and we hope to see both that arm, and the recurrent arm continue to enroll patients steadily. We will continue to provide updates as they become available," commented Saiid Zarrabian, DelMar’s Chief Executive Officer. "In the meantime, having completed enrollment of our first-line study, we continue to anticipate an initial data readout before the end of August 2020."

The Company’s second study arm being conducted at MDACC is the recurrent trial arm, which is enrolling patients who have typically been heavily pre-treated with TMZ prior to disease recurrence. In the recurrent setting, the Company previously announced that MDACC had approved up to 35 additional patients to this recurrent GBM study at a dose of 30 mg/m2, allowing for a total of up to 83 patients to be enrolled. To-date, 68 recurrent patients have been enrolled in the recurrent arm. DelMar is actively enrolling patients for both trial arms of the clinical study at MDACC.

About VAL-083

VAL-083 (dianhydrogalactitol) is a "first-in-class," bifunctional DNA-targeting agent that introduces inter-strand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute (NCI). DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by common mechanisms of chemoresistance, including MGMT, in cancer cell models and animal studies. Further details regarding these studies can be found at:

View Source

Alopexx Oncology Announces Licensing Agreement with Beijing Shenogen Pharma Group for Development and Commercialization of Novel Immunocytokine for the Treatment of B-Cell Lymphomas in China/Asia

On March 4, 2020 Alopexx Oncology, LLC reported that it has entered into an exclusive license agreement with Beijing Shenogen Pharma Group to develop and commercialize DI-Leu16-IL2 in China and other parts of Asia (Press release, Alopexx Pharmaceuticals, MAR 4, 2020, View Source [SID1234555174]). Alopexx will receive an upfront payment, various development and commercial milestones and royalties on sales.

DI-LEU16-IL2 is a novel antibody-cytokine fusion protein (or immunocytokine) targeting the B cell antigen, CD20. The CD20 antibody recognizes the same target on B cells as Rituxan and maintains the activities of both the antibody and cytokine components. In addition, it is also involved in tumor targeting, engagement of the immune system, and induction of an anti-cancer vaccine effect.

In a Phase I study of DI-LEU16-IL2 conducted in the 3 US centers, fifteen of 18 patients with relapsed or refractory B-cell CD20 positive lymphoma who received 2 or more cycles of therapy had tumor regression or stabilization including 3 complete and 2 partial responses. The durations of response were over 12 months in many cases. The durability of those responses was maintained in patients months after stopping treatment suggesting a vaccine effect had occurred. These study results are similar to a previous investigator sponsored Phase 1 study conducted at the City of Hope by Dr. Andrew Raubitschek.

"We believe that DI-Leu16-IL2 will significantly help individuals with B-cell malignancies," said Dr. Daniel Vlock, founder and CEO of Alopexx Enterprises. "We are delighted to be working with Shenogen to advance the development of this promising therapeutic."

Dr. Kun Meng, Chairman of Shenogen Pharma Group, commented, "We are very excited with this exclusive in-license opportunity of DI-Leu16-IL2 antibody-cytokine fusion protein from Alopexx, which opens the door for us to get into the B-cell lymphoma space of immunotherapy." Given the advantage of combining the benefits of anti-CD20 and IL2, two targets with approved anti-cancer drugs, Dr. Meng said, "We believe DI-Leu16-IL2 can offer superior efficacy and better serve the unmet medical needs of patients with B-cell lymphomas, especially with the relapsed and refractory forms of diseases." Shenogen plans to develop this drug as a potential single agent, or as combination therapy with other drugs.

About DI-Leu16-IL2

CD20 is a protein frequently expressed on cancer cells associated with NHL. Pre-clinical studies have shown that DI-Leu16-IL2, which has activities of both the anti-CD20 antibody and cytokine components, targets the tumor cells, engages the immune system and has the potential to produce an anti-cancer vaccine effect. As a result of this vaccine-like effect, long- term anti-cancer activity should continue and future cancer cells could be destroyed even without the need for re-dosing.

"The fusion of the anti-CD20 antibody and the cytokine IL2 creates an effect that is far more powerful than administering those therapeutics individually or in combination," explained Stephen Gillies, Ph.D., Chief Scientific Officer of Alopexx Oncology. "In this therapeutic approach the drug elicits a T-cell response and also activates the innate immunity to kill tumor cells, and that is a very important distinction between this and other treatments."