On September 30, 2019 BiomX Ltd., a microbiome company developing both natural and engineered phage therapies, reported that BiomX’s Chief Executive Officer, Jonathan Solomon, will present at the Cantor Fitzgerald Global Healthcare Conference in New York on Wednesday, October 2nd, at 8:55am ET (Press release, BiomX, SEP 30, 2019, View Source [SID1234539963]).

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 webcast of the presentation will be available on the News and Events page of the company’s website at View Source A replay of the webcast will be available approximately two hours after the event and archived on the website for 90 days.

On September 30, 2019 Medicenna Therapeutics Corp. ("Medicenna" or "the Company") (TSX: MDNA,OTCQB: MDNAF), a clinical stage immunotherapy company developing first-in-class Superkines and Empowered Cytokines, reported the presentation of new pre-clinical data from its IL-2 Superkine program (Press release, Medicenna Therapeutics, SEP 30, 2019, View Source [SID1234539962]). The data was presented as a poster entitled "Long-acting MDNA109: Emerging IL-2 Superkines displaying potent anti-tumoral responses" this past weekend on September 27th, 2019 at the International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) held in Paris, France.

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!

The presentation by Dr. Minh To, Director of Pre-clinical Development at Medicenna, reported additional preclinical data to support the differentiating characteristics of long-acting MDNA109 variants and their potency in vitro and in vivo from other long-acting IL2 programs.

"In preclinical studies, we have combined MDNA109 variants with checkpoint inhibitors and we see very dramatic cure rates in mice," states Dr. Minh To. "In addition, when you re-challenge these mice on the opposite flank with more tumor, these tumors simply don’t grow, showing long-term protection against tumor development and prevention of relapse."

"We have an exciting pre-clinical program being built around the IL-2 Superkine platform, where we just announced our lead clinical candidate, MDNA19," states Rosemina Merchant, Chief Development Officer of Medicenna. "By engineering a potent CD122 directed Superkine with a superior safety and PK profile, we believe that MDNA19 could emerge as a best-in-class IL-2 with its unique ability to preferentially stimulate cancer killing T cells as reported by an independent study published last month in Nature Communications."

Highlights from the presentation are summarized below:

High potency towards naïve effector T cells but diminished potency on unwanted regulatory T cells (Tregs). Of the long-acting MDNA109 variants, MDNA19 is superior in having decreased binding to CD25 and increased affinity to CD122, therefore selectively activating cancer killing CD8 T cells instead of tumor protecting Tregs.

Potent effects as monotherapy with improved PK characteristics. In CT26 (mouse colon cancer) and B16F10 (mouse melanoma) models, treatment with long acting variants of MDNA109 (bi-weekly for 2 weeks or once weekly for 2 or 3 weeks) potently inhibited tumor growth. These data suggest that long-acting MDN109 variants could lead to potent therapeutic effects with a dosing schedule similar to that used for immune checkpoint inhibitors (CPI). In addition, the results also confirm that different protein scaffolds may be used to extend the half life of MDNA109 and can provide similar tumor control as MDNA19.

Compelling preclinical synergism with immune checkpoint inhibition: In a pre-established colon cancer CT26 model, long-acting MDNA109 variants co-administered with the immune-checkpoint blocker anti-cytotoxic T-Lymphocyte-Associated Protein (CTLA)4, showed significant tumor growth inhibition with as many as 89% of animals remaining tumor-free for over 175 days.

Strong Memory Response. Furthermore, tumor free animals receiving a second and third re-challenge of the tumor without further treatment remained tumor free in up to 100% of mice, demonstrating development of a strong memory response with the ability to prevent tumor relapses.
About MDNA109

Developed by scientists at Stanford University, MDNA109 is an engineered version of IL-2 that binds up to 200 times more effectively to IL-2Rβ (CD122), thus greatly increasing its ability to activate and proliferate the immune cells needed to fight cancer. MDNA109 is an IL-2 Superkine that preferentially drives the expansion and responses of effector T cells and Natural Killer (NK) cells over Treg cells. It is the only IL-2 in development with a distinct mechanism by virtue of its high affinity towards CD122 allowing it to effectively combat NK cell anergy (exhaustion) which occurs frequently after cancer immunotherapy. MDNA19 is a long-acting version of MDNA109 with diminished binding to Tregs.

On September 30, 2019 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") reported that it will be attending the 2019 Cell & Gene Meeting on the Mesa being held October 2nd – October 4th in Carlsbad, CA (Press release, Actinium Pharmaceuticals, SEP 30, 2019, View Source;gene-meeting-on-the-mesa-300927503.html [SID1234539961]). Members of Actinium’s executive and R&D teams will highlight the Iomab-ACT program at the meeting. To schedule a meeting with Actinium please email Eileen Geoghegan, Ph.D., at [email protected] or through the meeting’s partnering system View Source

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!

Actinium is developing its Iomab-ACT program to be a universal lymphodepletion regimen to replace chemotherapy-based regimens such as Flu/Cy (Fludarabine and Cyclophosphamide) that are used in standard practice today. Actinium proposes that Iomab-ACT has a multi-modal mechanism of action that can; 1) deplete lymphocytes to create a suitable homeostatic cytokine environment; 2) deplete immune suppressive cell populations that may hinder activation of CAR-T cells; (3) deplete macrophages that may secrete cytokines implicated in CRS and neurotoxicity; and (4) potential anti-tumor effect on CD45+ blood cancer cells.

Iomab-ACT is an ARC or Antibody Radiation-Conjugate that targets the antigen CD45, which is uniquely expressed on leukemia, lymphoma and immune cells making it an ideal target for targeted condition prior to CAR-T and adoptive cell therapies. Iomab-ACT is a lower, outpatient, non-myeloablative dose of Actinium’s lead program, Iomab-B, which has been studied in over 300 patients and is currently being studied as a targeted conditioning agent prior to bone marrow transplant in a pivotal Phase 3 trial.

Actinium presented initial feasibility data for its ACT program at the Transplantation and Cellular Therapies Meeting in February 2019. The data demonstrated that a CD45 targeting antibody labeled with the radioisotope Iodine-131 effectively depleted greater than 90% of lymphocytes and other immune cells while sparing platelets, neutrophils and bone marrow stem cells in preclinical animal models (Click here for TCT poster). Additionally, in a preclinical model of adoptive cell therapy, the CD45-targeted ARC enabled improved tumor control. Actinium also presented data at the Society of Nuclear Medicine and Molecular Imaging demonstrating that the Iomab-ACT program could utilize the radioisotope Lutetium-177 with an anti-CD45 antibody to achieve targeted lymphodepletion prior to adoptive cell therapy (Click here for SNMMI poster).

About the Cell & Gene Meeting on the Mesa

The Cell & Gene Meeting on the Mesa is the sector’s foremost annual conference bringing together senior executives and top decision-makers in the industry to advance cutting-edge research into cures. Tackling the commercialization hurdles facing the cell and gene therapy sector today, this meeting covers a wide range of topics from clinical trial design to alternative payment models to scale-up and supply chain platforms for advanced therapies. The program features expert-led panels, extensive partnering capabilities, exclusive networking opportunities, and 70+ dedicated presentations by the leading publicly traded and privately held companies in the space. Attracting over 1,150 attendees – over 20% of which are C-level executives – this conference enables key partnerships through more than 2,200 one-on-one meetings while highlighting the significant clinical and commercial progress in the field.

On September 30, 2019 SkylineDx reported, during the European Society for Medical Oncology congress (Barcelona, EU), that it successfully validated the performance of their skin cancer (melanoma) diagnostic test on the first, independent, European dataset (Press release, SkylineDx, SEP 30, 2019, View Source [SID1234539960]). This melanoma test combines genetic information from a patient’s tumor cells (taken during a diagnostic biopsy) with tumor – and patient specific characteristics. Based on this unique combination, the test is able to accurately predict the risk of having metastasis present in the lymph nodes without a patient having to undergo a surgery to remove (part of the) lymph nodes. The discovery came from an US patient population and remains robust in the Dutch validation population, saving 41% of patients an unnecessary surgical intervention [2].

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!

These positive results follow last week’s announcement of launching a pilot study to evaluate and optimize the diagnostic services in clinical practice with a renowned US hospital in Q4 2019 and the start of a national trial in the US in 2020 [3]. "I am always anxious going into validation. If you optimize the performance of a test too much on the initial dataset, it will only work in that dataset and fails in an independent dataset," says Dharminder Chahal, CEO SkylineDx. "That we may present these positive results today during this major conference, is fantastic news for our team and gives everyone the needed energy and enthusiasm to continue the developments in our Falcon R&D Program to get this test from bench to bedside as quickly as possible."

On September 30, 2019 GlaxoSmithKline plc (LSE/NYSE: GSK ) reported an inducible T cell costimulatory molecule (ICOS) designed to selectively enhance T cell function The agonist antibody GSK3359609 exhibits promising antitumor activity in combination with pemizumab in the treatment of patients with head and neck squamous cell carcinoma (HNSCC) PD-1/L1 (Press release, GlaxoSmithKline, SEP 30, 2019, View Source;834146127.html [SID1234539959]). The results of the INDUCE-1 study also showed that GSK3359609 has a single drug activity in the treatment of patients with head and neck squamous cell carcinoma PD-1/L1.

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!

The safety and tolerability of GSK3359609 is consistent with the results reported in the INDUCE-1 (dose escalation phase). The data was released at the 2019 European Conference of Cancer Society in Barcelona, ​​Spain.

GlaxoSmithKline reported that the inducible T cell costimulatory molecule (ICOS) agonist antibody GSK3359609, which is designed to selectively enhance T cell function, is combined with pemizumab for the treatment of head and neck squamous cell carcinoma (HNSCC) PD- The 1/L1 initial treatment patient showed promising anti-tumor activity.

Dr. Axel Hoos , senior vice president and head of oncology research and development , said: "GSK3359609 and other immunotherapy are key components in the field of oncology. INDUCE-1 data demonstrates that GSK3359609 enhances antitumor activity (beyond We are encouraged by the potential of PD-1 to block the anti-tumor activity. The observed clinical response is very encouraging. Based on the precedent of CTLA-4 or PD-1, we want to prove our ICOS The main effect of agonists is to improve patient survival, and this requires further research. Based on these results, we will launch the INDUCE-3 registration trial, which combines the use of GSK3359609 and pemizumab to treat first-line recurrence/metascale head and neck scales. Potential survival benefits of patients with squamous cell carcinoma (PD-L1 positive)."

The published data comes from the development phase of INDUCE-1, the first open-label study in humans to study GSK3359609 as a monotherapy and a combination of other regimens. The patients in the study had relapsed or metastatic head and neck squamous cell carcinoma, and had previously received up to five therapies in the late stages. Patients in the monotherapy group were previously treated with PD-1/L1 and 1 mg/kg GSK3359609. Patients in the combination drug group received PD-1/L1 treatment for the first time, taking 0.3 mg/kg GSK3359609 and 200 mg pemizumab. Patients in both groups received a two-year assessment until the condition progressed or unacceptable toxicity occurred.

Of the 34 patients who received combination therapy, the overall response rate was 24% (n=8; 95% CI: 11,58.7). Remission in the combination drug group was long-lasting, and all responders maintained a 6-month or longer improvement (no median; 95% CI: 4.2 months, NR); median progression-free survival (PFS) ) for 5.6 months (95% CI: 2.4, 7.4). Among the 21 patients with known PD-L1 expression data, most responders and stable patients had a PD-L1 score of less than 20 points. Among the 16 patients who underwent monotherapy, the overall response rate was 6% (n = 1; 95% CI: 0.2, 30.2).

The INDUCE-1 study was conducted in accordance with an agreement between GlaxoSmithKline and Merck & Co, Inc. ("MSD" outside the United States and Canada). GlaxoSmithKline will continue to work with MSD to support the INDUCE-3 Phase II/III combination drug trials to be launched by the end of 2019.

Head and neck squamous cell carcinoma is a cancer developed from squamous cells in the mouth, nose and throat mucosa. It is the seventh most common cancer in the world, with approximately 600,000 newly diagnosed cases each year. i Although head and neck squamous cell carcinoma is more common in the over 50-year-old or 60-year-old men, but the incidence in younger individuals is increasing. Ii Head and neck squamous cell carcinoma tumors are highly immunogenic and have high expression of immunological checkpoint regulators (including ICOS and PD-1). Iii

The GSK3359609 Clinical Development Program
GSK3359609 clinical development program aims to investigate the anti-tumor potential of a variety of tumor-targeted ICOS receptors by single agonist antibodies in combination with other immunological checkpoint therapies.

GSK3359609 is not currently approved for use anywhere in the world.

i Genetics Home Reference. Head and neck squamous cell carcinoma – Genetics Home Reference – NIH. US National Library of Medicine. View Source Statistics. Published January 2015 . Accessed September 1, 2019 .

I National Institute of Health. Head and neck squamous cell carcinoma. US National Library of Medicine. View Source. Published August 20, 2019 .

Iii Canning M, et al. Heterogeneity of the Head and Neck Squamous Cell Carcinoma Immune Landscape and Its Impact on Immunotherapy. Front Cell Dev Biol. 2019; 7: 52.

###

GlaxoSmithKline’s performance in the field of oncology

GlaxoSmithKline is committed to maximizing patient survival by converting drugs. GlaxoSmithKline focuses on immuno-oncology, cell therapy, cancer epigenetics and overall mortality. The company’s goal is to achieve a sustainable flow of new therapies based on a diverse portfolio of research drugs, using small molecules, antibodies, antibody drug combinations and cells, either alone or in combination.