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Tocagen Appoints Lori Kunkel, M.D. as Acting Chief Medical Officer

On November 15, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported that Lori Kunkel, M.D. has been named acting chief medical officer, effective November 26, 2018 (Press release, Tocagen, NOV 15, 2018, View Source;p=RssLanding&cat=news&id=2377408 [SID1234531471]). Asha Das, M.D., senior vice president and chief medical officer will be leaving the company effective November 23, 2018 to allow her to focus on unforeseen and immediate personal matters. The company has initiated a search process to fill the position.

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"On behalf of the management team and Board of Directors, we are thankful for the significant contributions Asha has made over the past three years," said Marty J. Duvall, chief executive officer of Tocagen. "With Lori’s remarkable track record in the biotechnology industry coupled with her deep familiarity of our program and clinical data we look forward to working closely with her to advance our cancer-selective gene therapy platform, and our lead product candidate. This transition is not expected to impact our current business plans or development timelines."

Among other responsibilities, Dr. Kunkel previously served as acting chief medical officer of Loxo Oncology, Inc, chief medical officer of Pharmacyclics LLC, acquired by AbbVie Inc., and chief medical officer of Proteolix, Inc., acquired by Onyx Pharmaceuticals. Dr. Kunkel currently serves on the board of directors of Loxo Oncology, Inc., a publicly held biotechnology company, Curis, Inc., a publicly held biotechnology company, and Maverick Therapeutics, Inc., a privately held biotechnology company. A full biography is available here. In connection with Dr. Kunkel’s appointment as acting chief medical officer of Tocagen, Dr. Kunkel will be temporarily leaving the board of directors of Tocagen in order for the company to maintain compliance with the Nasdaq listing rules regarding independent directors.

"Being dedicated to the development of new treatment options for patients with brain cancer, I am extremely grateful to have worked closely with the Tocagen team on advancing Toca 511 & Toca FC and regret having to leave the company at this time," said Dr. Das. "I am excited about the potential of the Toca 5 trial and future development in newly diagnosed brain cancer to positively impact patients around the world."

Slide presentation dated November 15, 2018

On November 15, 2018, Syros Pharmaceuticals, Inc. (the "Company") reported that it held a conference call and webcast in which the Company’s management reviewed a slide presentation describing, among other things, data from the dose-escalation portion of the Company’s Phase 1 clinical trial of SY-1365 (Presentation, Syros Pharmaceuticals, NOV 15, 2018, View Source [SID1234531470]). This slide presentation is attached as Exhibit 99.1 to this Form 8-K and incorporated herein by reference.

DCprime announces first patient dosed in phase 2 ADVANCE-II study with DCP-001 in patients with Acute Myeloid Leukemia

On November 15, 2018 DCprime bv, a clinical stage biotechnology company focused on cancer immunotherapies, reported that the first patient has been dosed with DCP-001 in a phase 2 study, called ADVANCE-II (Press release, DCPrime, NOV 15, 2018, View Source [SID1234531456]). Patients with Acute Myeloid Leukemia (AML) in complete remission after induction therapy but with persistence of measurable residual disease (MRD) will be included in this multi-centre study. Effects on MRD and cellular and humoral immune responses will be monitored to evaluate the efficacy of this cancer vaccine.

Prof Dr Arjan van de Loosdrecht, Amsterdam UMC, VU University Medical Center, The Netherlands commented: "We are very glad that the first patient was treated with the DCP-001 vaccine in the ADVANCE-II study. This is an important study to show the potential efficacy of this cancer vaccine in patients who have measurable residual disease and are at great risk of disease relapse."

The study is currently open for recruitment of patients in The Netherlands and Germany, with additional request for regulatory approval in Norway, Sweden and Finland pending.

Dr Jeroen Rovers, Chief Medical Officer at DCprime added: "Start of the phase 2 study marks an important step for DCprime in development of its technology. It will provide additional evidence whether DCP-001 can initiate immunological control of aggressive cancers, such as AML. We are grateful to all investigators and patients committed to contribute to this study."

Last month data from the phase 1 study with DCP-001 in AML were published in Cancer Immunology, Immunotherapy (van de Loosdrecht, A.A., van Wetering, S., Santegoets, S.J.A.M. et al. Cancer Immunol Immunother (2018) 67: 1505.).

Nanobiotix revenues for the 3rd quarter of 2018

On November 15, 2018 NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported its unaudited revenues for the third quarter of 2018 (Press release, Nanobiotix, NOV, 15, View Source [SID1234531455]).

Activity and results
Total revenue for the third quarter of 2018 amounted to € 21,816. This brings total revenue for the first nine months of 2018 to € 95,120, which is in line with the Company’s expectations.
All of the revenues generated by the Company during the third quarter of 2018 come from services that Nanobiotix
crossed-charged to its partners in accordance with our agreed upon development program operational activities.
In July 2018, Nanobiotix launched a non-dilutive financial partnership with the European Investment Bank (EIB) to boost its research, development and innovation activities. The financing agreement permits the Company to borrow up to €40 million in loans from EIB over the next five years subject to the Company’s achievement of a set of agreed performance criteria. We expect this financing agreement to enable Nanobiotix to accelerate both the development of the Company’s NBTXR3 clinical trial in advanced Head and Neck cancers and to support its European go-to-market strategy.

In September 2018, Nanobiotix presented an update on data from its NBTXR3 development program at the International Conference on Immunotherapy Radiotherapy Combinations. The presentation included updated data related to the Company’s follow-up for its Phase I/II clinical trial in advanced Head and Neck cancers in elderly and frail patients ineligible for cisplatin or intolerant to cetuximab. The data suggests the potential of NBTXR3 to impact survival for this advanced cancer patient population. In addition, the Company presented data obtained from the immuno biomarker study in its randomized Phase II/III clinical trial in soft tissue sarcoma. This data indicated that NBTXR3 activated by EUI- 1202982973v22 radiation therapy could modulate the antitumor immune response.
Finally, the Company’s in vivo investigation of NBTXR3’s mode of action inducing distant immune response on CT26
tumoral model produced data that continues to support the rationale for the use of NBTXR3 activated by radiation
therapy to seek to transform tumors into an in situ cancer vaccine and its potential use in combination with
immunotherapeutic agents.
***
Next financial press release: revenue for Q4 2018 by February 28, 2019
About NBTXR3
NBTXR3 is a first-in-class product designed to destroy, when activated by radiotherapy:
• tumors through physical cell death
• metastasis due to immunogenic cell death leading to activation of the immune system
NBTXR3 has a high degree of biocompatibility, requires one single administration before the whole radiotherapy treatment and
Nanobiotix believes it has the ability to fit into current worldwide standards of radiation care.
Nanobiotix’s broad clinical program includes 10 patient populations evaluated in 7 clinical trials.
In June 2018, Nanobiotix established human proof of concept for this first-in-class product in its Soft Tissue Sarcoma (STS) Phase III
clinical trial.
NBTXR3 is actively being evaluated in head and neck cancer with locally advanced squamous cell carcinoma of the oral cavity or
oropharynx in elderly and frail patients that are unable to receive chemotherapy or cetuximab and have very limited therapeutic
options. Promising results have been observed from the ongoing Phase I/II trial regarding the local control of tumors.
Nanobiotix is running an Immuno-Oncology development program. In the United States, Nanobiotix has received approval from the
U.S. Food and Drug Administration (FDA) to launch a clinical study of NBTXR3 activated by radiotherapy in combination with anti-PD1
antibodies in lung, and head and neck cancer patients (head and neck squamous cell carcinoma and non-small cell lung cancer).
The other ongoing NBTXR3 trials are treating patients with liver cancers (hepatocellular carcinoma and liver metastasis), locally
advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent
chemotherapy, and prostate adenocarcinoma.
The first market authorization process (CE Marking) is ongoing in Europe in the STS indication.

Diffusion Pharmaceuticals Chief Scientific Officer Dr. John L. Gainer to Present at 2018 Annual Meeting of the Society for NeuroOncology

On November 15, 2018 Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN), a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions by improving the body’s ability to bring oxygen to the areas where it’s needed most, reported that Chief Scientific Officer Dr. John L. Gainer will join leading clinicians and researchers from around the world in presenting a poster at the 2018 Annual Meeting of the Society for NeuroOncology (SNO) on Saturday, November 17, 2018 from 5:00-7:00pm EST (Press release, Diffusion Pharmaceuticals, NOV 15, 2018, View Source [SID1234531433]).

SNO’s 23rd Annual Scientific Meeting and Education Day will be held from Thursday, November 15, 8:00am through Sunday, November 18, 1:00pm at the Marriott Hotel, New Orleans, Louisiana. SNO is a "multidisciplinary organization dedicated to promoting advances in neuro-oncology through research and education" whose annual conference is an opportunity for top health care professionals who specialize in central nervous system tumors to gather and present the latest advancements to fellow researchers, hospital administrators, and potential investors.

Dr. Gainer, who in addition to serving as the Chief Scientific Officer of Diffusion is also the inventor of Trans Sodium Crocinate (TSC), will present a poster on the Company’s Phase 3 INTACT (INvestigation of TSC Against Cancerous Tumors) clinical trial for the treatment of glioblastoma multiforme (GBM) brain cancer in biopsy-only patients. Phase 2 of Diffusion’s INTACT trial showed potentially breakthrough results in the use of TSC in treatment: a fourfold increase in the two-year survival rate of biopsy-only patients, which jumped from 10 percent to 40 percent. This result is especially promising for these patients and their families: biopsy-only patients have historically faced lower survival rates than patients for whom resection (surgery for removal of the tumor) is an option.

"Dr. Gainer’s focus on innovation is what drew me to his research in the first place, and resulted in our co-founding of Diffusion, where we continue our efforts to find new and effective treatments for life-threatening diseases like GBM brain cancer," said David Kalergis, Chairman and CEO of Diffusion. "At the 2018 Annual Meeting of the Society of NeuroOncology, Dr. Gainer will have an opportunity to present the exciting results from our Phase 2 GBM cancer trial and share our continued Phase 3 efforts for biopsy-only participants – work which represents real potential and promise for patients and their families"

"Finding effective and life-saving treatment for patients living with biopsy-only GBM brain cancer has long been a significant challenge for researchers, scientists, and physicians, so I’m looking forward to my poster presentation at the 2018 Annual Meeting of the Society of NeuroOncology, as it’s a chance to share the progress we’ve made on this front," said Dr. John L. Gainer, Chief Scientific Officer of Diffusion. "Hypoxic tumors are resistant to radiation therapy, and our Phase 2 results showed that using TSC – which was developed to fight hypoxia by bringing oxygen to the areas where it’s needed most – in conjunction with radiation and temozolomide (TMZ) treatment led to a significant increase in survival for biopsy only patients. Our Phase 3 study will focus on these biopsy-only patients, and I am eager to share that work with my colleagues from around the world at SNO’s 2018 Annual Meeting."

Diffusion’s Phase 3 INTACT program is using TSC to target inoperable GBM brain cancer. Historically, these biopsy-only patients have faced lower survival rates and increased obstacles to inclusion in clinical trials. Current standard of care for these GBM patients following diagnosis involves 6 weeks of radiation therapy along with daily temozolomide (TMZ), followed by six 4-week chemotheraphy sessions which include a high dosage of TMZ. Phase 2 of INTACT saw treatment with TSC added to the initial six weeks of radiation therapy and TMZ treatment. Phase 3 of INTACT will include treatment with TSC during the initial six week of radiation therapy and TMZ treatment, but will also include administration of TSC during the six months of chemotheraphy. The Company is currently engaged in an FDA-requested, 8-patient lead-in, scheduled to complete in January 2019. Randomization can begin following read out and reporting of that data."

Dr. Gainer’s presentation at SNO is just the latest development for Diffusion, which recently received FDA approval to enroll patients in an ambulance-based Phase 2 clinical trial testing TSC for the treatment of both ischemic and hemorrhagic stroke. The Company also recently appointed William "Bill" Hornung to the position of Chief Financial Officer.