On September 30, 2019, Delcath Systems, Inc (the "Company") and holders of a majority of the Company’s Series E and Series E-1 Convertible Preferred Stock entered into an amendment to those certain registration rights agreements, dated as of July 11, 2019 (effective as of July 15, 2019) (the "July Registration Rights Agreement") and August 15, 2019 (the "August Registration Rights Agreement"), between the Company and the holders signatory thereto (the "Amendment") (Filing, 8-K, Delcath Systems, SEP 30, 2019, View Source [SID1234539977]). The Amendment extends the applicable deadline for having a registration statement declared effective by the Securities and Exchange Commission (the "SEC") under certain circumstances from 75 days to 120 days following the date of the July Registration Rights Agreement.

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The foregoing description of certain terms contained in the Amendment does not purport to be complete and is qualified in its entirety by reference to: (i) the copy of the Amendment filed as Exhibit 10.1 to this Current Report on Form 8-K, (ii) the copy of the Form of Registration Rights Agreement between the Company and each other party a signatory thereto filed as Exhibit 4.2 to the Current Report on Form 8-K filed with the SEC on July 11, 2019 and (iii) the copy of the Form of Registration Rights Agreement between the Company and each other party a signatory thereto filed as Exhibit 4.2 to the Current Report on Form 8-K filed with the SEC on August 16, 2019.

On September 30, 2019 ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage oncology and immunology focused biopharma company, and Bukwang Pharmaceutical (KRX:003000), a leading R&D focused Korean pharmaceutical company, reported that they have established a new joint venture to develop preclinical aryl hydrocarbon receptor (AhR) antagonists from ASLAN’s early stage pipeline (Press release, ASLAN Pharmaceuticals, SEP 30, 2019, View Source [SID1234539975]). The independent company, JAGUAHR Therapeutics, will focus on developing new immuno-oncology therapeutics for global markets targeting the AhR pathway and will be based in Singapore.

Under the terms of the agreement, ASLAN will transfer the global rights to all of the assets related to AhR technology, originally discovered and developed by ASLAN and its collaborator Dr Mark Graham, into JAGUAHR. Bukwang will invest US$5 million in JAGUAHR in two tranches to fund the development of the assets, identify a lead development compound and file an Investigational New Drug application.

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Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: "The launch of JAGUAHR Therapeutics is an important step by ASLAN to realise the value of our early stage assets and advance the development of our AhR antagonist technology at a time when focus is shifting towards AhR antagonists as a hot new area in immuno-oncology. Bukwang has a strong track record of achievement in the pharma business and creating this spinout together allows both companies to quickly progress these exciting compounds and potentially provide novel clinical assets to enrich the ASLAN pipeline. We look forward to working with the Bukwang team as we focus on identifying JAGUAHR’s first drug candidate."

Dr Hee-Won Yoo, Chief Executive Officer, Bukwang Pharmaceutical, added: ""We are impressed and delighted to partner with ASLAN to establish JAGUAHR Therapeutics. Bukwang has a strong heritage in R&D and this agreement is aligned to our strategy to strengthen our innovative development pipeline and broaden early access to promising technology for treating conditions with unmet needs. We are very excited as the AhR antagonists program further marks Bukwang’s formal participation in the immuno-oncology arena. We look forward to working together with ASLAN to progress these novel immuno-oncology compounds into clinical development in oncology."

AhR is a druggable transcription factor that acts as a master regulator of the immune system. The enzymes IDO1, IDO2 and TDO are frequently overexpressed in numerous tumour types and convert tryptophan into kynurenine (KYN) in the tumour microenvironment. KYN is then actively transported into dendritic cells and effector T-cells that are mobilised to detect and kill tumour cells. KYN signalling via AhR in these cell types converts them into regulatory T-cells, suppressing the immune system and preventing it from attacking tumour cells. Research has demonstrated

that the unique advantages of AhR antagonists include broadly inhibiting the signalling of all AhR ligands1 produced by any enzyme that metabolises tryptophan, and robust activation of the immune response to kill cancer cells.

Ends

Media and IR contacts

For ASLAN Pharmaceuticals Limited

Emma Thompson

Spurwing Communications

Tel: +65 6571 2021

Email: [email protected]

Robert Uhl

Westwicke Partners

Tel: +1 858 356 5932

Email: [email protected]

For Bukwang Pharmaceutical Co., Ltd.

Riswanto

Global Business Development

Tel: +82-2-828-8072

Email: [email protected]

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]).

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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.

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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

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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.