On November 18, 2020 Nordic Nanovector ASA (OSE: NANO) reported its results for the third quarter 2020 (Press release, Nordic Nanovector, NOV 18, 2020, View Source [SID1234571373]). A live webcast presentation by Nordic Nanovector’s management team will take place today in Oslo at 08.30 CET, see details below. A link to the webcast and the presentation is available from the company’s homepage (www.nordicnanovector.com).

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Lars Nieba, Interim CEO of Nordic Nanovector, said: "Following the successful interim analysis in August and completion of our private placement in September, we are progressing towards the major value inflection point of three-month top-line data from the PARADIGME clinical study, which is targeted for H2 2021. Generating these data will require us to successfully navigate the latest challenges of increased COVID-19 restrictions. We remain confident in our ability to achieve this goal, aided by the protocol amendments, the possibility to reduce the patient sample, and all the other measures we are actively implementing to drive patient recruitment into PARADIGME."

Q3’2020 Highlights

Result of PARADIGME Interim Analysis: Independent Review Committee recommendation to focus on single arm investigating the "40/15" dosing regimen
Target set to report three-month top-line data in H2’2021
Approval of amendments to PARADIGME protocol is proceeding as planned and completed in the best-recruiting countries
Designed to enlarge the eligible patient population and increase the rate of enrolment into the trial
Pivotal Phase 2b PARADIGME trial of Betalutin progressing in 3rd-line relapsed/refractory follicular lymphoma (3L R/R FL)
COVID-19 pandemic continues to have a negative impact on PARADIGME patient recruitment – the target patient population is a high-risk group for COVID-19
59 patients enrolled as of 18 November 2020
Private placement was oversubscribed and successfully completed raising approximately NOK 231 million (approximately USD 25 million) in gross proceeds, extending cash runway into Q3’2021
Funds to be used to advance PARADIGME study and conduct other essential activities to enable a timely filing pending top-line data
Dr Christine Wilkinson Blanc appointed Chief Medical Officer
Events after Q3’2020

Final two patients enrolled into Archer-1 Phase 1 safety trial of Betalutin plus rituximab in 2L R/R FL
Preliminary data readout expected in H1’2021
Trial to be paused pending analysis of data and evaluation of plans for further development
Results of preclinical studies demonstrating Betalutin reverses tumour resistance to rituximab in NHL disease models published in Journal of Nuclear Medicine
Financial Highlights

(Figures in brackets = same period 2019 unless otherwise stated)

Revenues for the third quarter and for the first nine months of 2020 amounted to NOK 0.0 million (NOK 0.0 million)
Total operating expenses for the third quarter were NOK 88.1 million (NOK 100.2 million); total operating expenses for the first nine months of 2020 were NOK 327.3 million (NOK 301.1 million)
Comprehensive loss for the third quarter amounted to NOK 88.2 million (loss of NOK 93.6 million); comprehensive loss for the first nine months of 2020 was NOK 305.4 (NOK 295.6 million)
Cash and cash equivalents amounted to NOK 380.7 million at the end of September 2020, compared to NOK 470.8 million at the end of December 2019
Outlook

The company continues to target the readout of three-month top line data from PARADIGME in H2’2021. Approval of protocol amendments is proceeding as planned and completed in the best-recruiting countries, and other initiatives to increase the rate of enrolment are underway. The company also targets the readout of three-month top line data from the second cohort of the Archer-1 trial in H1’2021.

However, the impact of the COVID-19 pandemic on patient recruitment has worsened in light of the emergence of a second wave resulting in severe travel restrictions being implemented in the various countries where we are executing our clinical studies. These restrictions and uncertainty around the duration, severity and geographic scope of the COVID-19 outbreak are projected to slow down the enrolment of patients due to re-prioritisation of hospital activities towards COVID-19 patients and away from clinical studies such as PARADIGME. In addition, travel restrictions could create logistical challenges for the shipment of clinical supplies. Several proactive actions have been taken to minimize the impact of these travel restrictions which could blunt further delays in completing enrolment and delivering preliminary results as targeted.

The company has taken steps to conserve cash and following the recent successful private placement, Nordic Nanovector has a cash runway that extends into Q3’2021.

Despite the challenging times, the many positive actions the company has made in the last nine months have improved the prospects of delivering pivotal results from PARADIGME in H2’2021.

The company continues to believe that, if positive, these trial data could represent a significant value inflection point for the company and its shareholders, confirming Betalutin as a highly promising new targeted therapy that can address the unmet needs of R/R FL patients.

Presentation and live webcast – Q3 2020 results

A presentation and live webcast by Nordic Nanovector’s management team will take place today at 8:30 am CET.

The webcast can be accessed from www.nordicnanovector.com in the section: Investors & Media and a recording will also be available on this page after the event.

The results report and the presentation is available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2020.

On November 18, 2020 Obsidian Therapeutics, Inc. and The University of Texas MD Anderson Cancer Center reported a multi-year strategic collaboration designed to expedite the research and development of novel engineered tumor infiltrating lymphocytes (TILs) for the treatment of solid tumors (Press release, Obsidian Therapeutics, NOV 18, 2020, View Source [SID1234571319]). The agreement pairs Obsidian and its novel cytoDRiVE technology platform with MD Anderson’s extensive experience and state-of-the-art capabilities in TIL cell therapy, led by the Biologics Development platform, within the Therapeutics Discovery division.

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The collaboration is focused on developing TIL armored with regulated membrane-bound IL15 (referred to as cytoTIL) with the potential to enhance anti-tumor efficacy and reduce tumor burden in patients suffering from different types of solid tumors. The teams will collaborate to accelerate the development of cytoTIL, including process and analytical development and clinical readiness activities.

"TIL therapy has emerged as a promising option for treating patients with solid tumors, though its widespread use today is limited by safety and efficacy challenges," said Rodabe Amaria, M.D., associate professor of Melanoma Medical Oncology at MD Anderson. "We are pleased to work with Obsidian to advance their novel cytoTIL program, which has the potential to drive more durable treatment responses and expand TIL therapy to a broader group of our patients."

The cytoTIL therapy is engineered using Obsidian’s cytoDRiVE platform technology, which precisely and reversibly controls protein expression and activity using FDA-approved orally bioavailable drugs. By leveraging regulated membrane-bound IL15 to drive antigen-independent expansion of T cells and transactivation of NK cells, cytoTIL therapy is anticipated to improve patient response to TIL treatment and expand patient eligibility to those who currently cannot benefit from this transformative therapy.

"We are delighted to work with MD Anderson’s Biologics Development team to build upon the success of first generation TIL therapies and bring the first controllable TIL therapy to patients as rapidly as possible," said Paul Wotton, Ph.D., CEO of Obsidian Therapeutics. "Through its cell therapy research platforms, deep clinical development experience, and industrial manufacturing capabilities, MD Anderson is a best-in-class collaborator to advance and accelerate cutting-edge cell therapies."

MD Anderson’s Biologics Development platform is built around an experienced team focused on pioneering impactful biologic therapeutics, including antibodies and cell therapies. With a state-of-the-art 60,000 sq. foot GMP cell-therapy manufacturing facility, the platform joins MD Anderson expertise with the rigor of industrial development. Biologics Development offers a strong starting point for early-stage companies to access the breadth of MD Anderson capabilities in cell therapy development.

MD Anderson is implementing an Institutional Conflict of Interest Management and Monitoring Plan for any research related to this relationship.

On November 18, 2020 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec") reported that highlights from its Analyst & Investor Day and Symposium held at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 35th Anniversary Annual Meeting (Press release, OncoSec Medical, NOV 18, 2020, View Source [SID1234571352]). KOLs shared their views and insights regarding the Company’s positive interim data from its KEYNOTE-695 registration-enabled Phase 2b clinical trial evaluating TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), in combination with KEYTRUDA (pembrolizumab) in rigorously defined anti-PD1 checkpoint resistant metastatic melanoma patients as well as other programs leveraging TAVO and its gene electrotransfer platform. The Company also announced that KEYNOTE-695 is now fully enrolled.

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Highlights from the Investor & Analyst Day

Tara C. Mitchell, M.D., Associate Professor of Medicine at Penn Medicine, who exclusively treats patients with melanoma, provided her clinical impressions of the KEYNOTE-695 data and the PD-1 checkpoint refractory patient population. Dr. Mitchell stated, "Patients are eager to have this type of option, with an excellent safety profile and durable efficacy. I see this treatment as promising and look forward to offering it to patients who have progressed on PD-1 blockade and to seeing ongoing study results from this combination."

Dr. Mitchell also commented:

Regarding efficacy, the 30% ORR observed in KEYNOTE-695 is what oncologists want to see in this patient population.
Of note, there was a 35% response rate in M1c and M1d patients, who have organ or brain metastatic disease.
The response rate of 40% in patients who had disease progression after both anti-PD-1 and anti-CTLA-4 (ipilimumab) is promising.
The safety data presented in KEYNOTE-695 are highly convincing, with only 3 patients experiencing Grade 3 SAE’s (~5%) and reassuring that TAVO did not add to any unexpected toxicities with KEYTRUDA.
Matteo Carlino, M.D., Medical Oncologist and Clinical Senior Lecturer at Westmead and Blacktown Hospitals and University of Sydney, and one of the KEYNOTE-695 trial investigators, commented, "I’m confident that the KEYNOTE-695 data will remain positive and now that we have completed enrollment of 100 patients, we expect to continue to see deepened responses over time. Since a number of patients with stable disease over several months have become responders with continued treatment, we believe the data has the potential to improve over time."

Dr. Carlino also provided his perspective on other therapeutic approaches in the checkpoint refractory metastatic melanoma patient population and where the TAVO plus KEYTRUDA combination fits in the field:

Not all intratumoral approaches are equal, as some do not elicit a distant immune response; however, the combination of TAVO and KEYTRUDA has been shown to exhibit an immune response in both local and distant visceral tumor responses.
The toxicity profile for TAVO and KEYTRUDA is exceptionally favorable.
Additional topics covered included OncoSec’s CORVax12 vaccine, the Company’s novel DNA-encodable vaccine that combines TAVO with the National Institute of Health (NIH)/ National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center’s SARS-CoV-2 virus "spike" protein. OncoSec is developing CORVax12 in collaboration with Portland Providence Medical Center and the vaccine candidate is expected to enter a Phase 1 clinical trial shortly, after the recent acceptance of an Investigational New Drug application.

Bernard Fox, Ph.D., Harder Family Chair for Cancer Research, Chief of the Laboratory of Molecular Tumor Immunology at Earle A. Chiles Research Institute, said, "By combining the immune stimulant IL-12, we aim to augment the vaccine response to produce more durable neutralizing antibodies. This approach is relevant particularly for the most vulnerable populations, such as the elderly, patients with immunodeficiencies or immunocompromised cancer patients. We look forward to seeing if IL-12 can help these patients boost their immune system against the virus."

Experts also shared insights about OncoSec’s new neoadjuvant melanoma clinical trial and opinions on the VLA program, looking to the future of gene electrotransfer in both lung and liver tumors.

A replay of the Analyst and Investor Day webcast can be accessed here via the OncoSec website.

Highlights from the SITC (Free SITC Whitepaper) Symposium

Based on KEYNOTE-695 data, additional KOLs presenting at the Symposium highlighted TAVO’s potential to improve upon current systemic or local delivery of immuno-stimulant IL-12 by providing clinically relevant efficacy without severe side effects.
TAVO has the unique ability to produce a vaccine-like effect through the local delivery of plasmid IL-12, which catalyzes endogenous IL-12, resulting in heightened antigenicity in both the treated and distant lesions, with the potential to be an effective treatment option across several oncologic indications.
Among the advantages of Gene ElectroTransfer for Immunotherapy (GET-IT), OncoSec’s approach for the delivery of TAVO, include rapid transfection, versatility in the type of molecules delivered and cells targeted and the opportunity to treat both surface and visceral lesions with a non-invasive method of cell transfection that does not include chemical or toxic substances.
Positive preclinical data from OncoSec’s VLA program showed promise for the development of intratumoral immunotherapy treatments with TAVO or other immunologically relevant genes in deep visceral tumors.
The SITC (Free SITC Whitepaper) Symposium presentation can be accessed here.

Key highlights from the CORVax12 poster presentation include:

Early pre-clinical data show that intramuscular and/or intradermal injection of plasmids encoding the SAR-CoV-2 spike protein with plasmid-encoded murine IL-12, followed by electroporation (EP), can induce spike-specific IgG antibodies, as well as the disruption of SARS-CoV-2 binding to targets.
EP of CORVax12 elicited anti-spike IgG antibodies, as well as IgG antibodies targeting the receptor binding domain of the spike protein approximately 40 days after a booster vaccination.
The addition of IL-12, at least transiently, increased Surrogate Virus Neutralization Test titers, a marker detecting increasing levels of neutralizing antibodies to SARS-CoV-2.
Preliminary data up to 150 days post vaccination showed that EP of CORVax alone or with IL-12 was safe and continued to produce anti-viral antibodies.
On November 3, the Company announced FDA acceptance of its Investigational New Drug application approval for a first-in-human Phase 1 trial to evaluate the safety and immunogenicity of CORVax12. The poster presentation can be accessed here.

Key highlights from the TNBC poster presentation include:

Intratumoral injection of TAVO in several pre-clinical models of TNBC led to complete tumor regression and long-term survival in a significant proportion of mice.
An increase in T cell infiltration and induction of PD-1/PD-L1 in the tumor microenvironment was observed. This signature was also demonstrated in patient samples from a single arm, prospective clinical trial of TAVO monotherapy in TNBC (OMS-I140).
The poster presentation can be accessed here.

About KEYNOTE-695
KEYNOTE-695 is OncoSec’s registration-directed Phase 2b trial (NCT#03132675) evaluating TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12) + KEYTRUDA (pembrolizumab) in patients with rigorously confirmed anti-PD-1 checkpoint resistant metastatic melanoma. The trial aims to enroll up to 100 patients with refractory, locally advanced or metastatic disease defined as unresectable Stage III/IV metastatic melanoma that had definitively progressed on a full-course of anti-PD-1 treatment with KEYTRUDA (pembrolizumab) or OPDIVO (nivolumab). TAVO has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of metastatic melanoma following progression on KEYTRUDA or OPDIVO.

About TAVO
OncoSec’s gene therapy technology combines TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), with an intratumoral electroporation gene delivery platform to achieve endogenous IL-12 production in the tumor microenvironment that enables the immune system to target and attack tumors throughout the body. TAVO has demonstrated a local and systemic anti-tumor response in several clinical trials, including the pivotal Phase 2b trial KEYNOTE-695 for metastatic melanoma and the KEYNOTE-890 Phase 2 trial in triple negative breast cancer (TNBC). TAVO has received Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration (FDA) for the treatment of metastatic melanoma following progression on KEYTRUDA or OPDIVO.

About CORVax12
CORVax12 is the only known DNA vaccine that uses an immune stimulant to promote an immune response against the SARS-CoV-2 virus. The CORVax12 vaccine approach combines the co-administration of a DNA-encodable version of the stabilized SARS-CoV-2 spike or "S" glycoprotein trimer with TAVO (plasmid IL-12) to enhance the immunogenicity of this vaccine developed by scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. CORVax12 is designed to drive a coordinated vaccine response, capable of drawing upon the innate and adaptive humoral and cellular arms. This multi-pronged immune response has the potential to generate a robust and durable anti-viral response.

On November 18, 2020 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, reported that Aoife Brennan, M.B. Ch.B., Synlogic’s President and Chief Executive Officer, and other members of the executive team will present at the following virtual banking conference (Press release, Synlogic, NOV 18, 2020, View Source [SID1234571320]):

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Piper Sandler 32nd Annual Virtual Healthcare Conference: Dr. Brennan will participate in a ‘Fireside Chat’ at 10:00 am on Monday, November 23, 2020.
These are virtual events. Presentations will be available for registered attendees via the Piper Sandler conference site from November 23 to December 3. A live webcast of the presentations can be accessed under "Event Calendar" in the Investors & Media section of the Company’s website. An archived copy of the webcast will be available on the Synlogic website for approximately 30 days after the event.

On November 18, 2020 NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer cell-based therapeutics company, reported its participation in the virtual 32nd Annual Piper Sandler Healthcare conference, which takes place December 1-3, 2020 (Press release, NantKwest, NOV 18, 2020, https://ir.nantkwest.com/news-releases/news-release-details/nantkwest-participate-32nd-annual-piper-sandler-healthcare?field_nir_news_date_value[min]= [SID1234571353]). NantKwest Executive Chairman Patrick Soon-Shiong, M.D., and Chief Executive Officer Rich Adcock will participate in institutional investor meetings on Tuesday, December 1; meetings may be requested through Piper Sandler.

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Additionally, a pre-recorded fireside chat with Dr. Soon-Shiong and Mr. Adcock will be accessible beginning November 23, 2020 on the Piper Sandler conference site and in the Investors section of NantKwest’s website, NantKwest.com. The recording will be available on the NantKwest website through December 31, 2020.