Teneobio Licenses Oncology Multispecific Product to Janssen

On September 30, 2019 Teneobio, Inc., a clinical-stage biotechnology company developing engineered bispecific antibodies for the treatment of cancer reported that as a result of its work with scientists from Janssen Research & Development, LLC, Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has elected to exercise a commercial option to license and advance an undisclosed multispecific product for development in an oncology indication (Press release, TeneoBio, SEP 30, 2019, View Source [SID1234539982]). Under the terms of the collaboration agreement, which was first announced in Q3 of 2018, Janssen will receive exclusive global licensing rights to the multispecific product for clinical development and commercialization. Teneobio will receive a milestone payment from Janssen for the commercial license and is eligible for additional development and commercial milestones as well as royalties on world-wide net sales of the multispecific product.

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!

Omid Vafa, CBO of Teneobio, Inc., added, "We are very pleased with the outcome of our collaboration with the Janssen R&D oncology team. The rapid advance of our program from discovery to preclinical proof-of-concept in less than a year and a half is a testament to Teneobio’s technology platforms and speed to enable drug discovery and to deliver. Janssen’s collaborative spirit allowed both teams to rapidly advance the multispecific antibody lead clinical candidate beyond preclinical proof-of-concept. We are eager to advance this asset to clinical stage, and Janssen’s deep expertise in the oncology space is a real advantage."

Entry into a Material Definitive Agreement

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.

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 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.

ASLAN PHARMACEUTICALS AND BUKWANG PHARMACEUTICAL ESTABLISH A JOINT VENTURE, JAGUAHR THERAPEUTICS, TO DEVELOP NOVEL IMMUNO-ONCOLOGY THERAPIES

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.

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!

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]

BiomX to Present at the Cantor Fitzgerald Global Healthcare Conference

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.

Medicenna Presented Promising Preclinical Results from its IL-2 Superkine Platform at the 5th Annual International Cancer Immunotherapy Conference

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.