INmune Bio, Inc. Announces Two Presentations at the 2021 British Society of Immunology Congress and Provides 119-day data on First patient in MDS trial.

On December 1, 2021 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported two poster presentations at the 2021 British Society of Immunology Congress, which was held November 28-December 1, in Edinburgh, UK (Press release, INmune Bio, DEC 1, 2021, View Source [SID1234596334]).

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Mark Lowdell, PhD, Chief Scientific Officer of INmune Bio, stated, "I’m delighted to have two of our team presenting our latest data on the mechanism of action of INKmune. These are the first comprehensive data showing that INKmune-mediated priming generates NK cells with memory-like phenotype (mlNK). Before this, mlNK cells could only be produced using multiple combinations of cytokines. These are the data which led us to the concept that INKmune is a ‘pseudokine’ that provides multiple signals to NK cells, akin to the multi-cytokine cocktails used by others. We also show that INKmune priming promotes significant proliferation of mlNK cells in vitro. These in vitro data have been replicated in the first patient treated with three, weekly doses of INKmune for high risk MDS. At 119 days post first treatment, 60% of the patient’s NK cells showed the activated, tumor killing phenotype compared to fewer than 15% before INKmune therapy. The patient remains well and with a significantly improved ECOG status."

Details of the presentations are as follows:

Title: Tumor-priming generates memory-like natural killer cells with universal anti-tumor functions

Poster: P-107

Session: Poster session 1

Natural killer (NK) cells are innate lymphocytes that target virus-infected and tumor cells. NK cells are exciting candidates for cancer immunotherapy due to their fast-acting ‘innate’ ability to mount anti-tumor responses and recently highlighted ‘adaptive’ properties including priming and memory-like functions. Tumor-priming of NK cells through in-vitro exposure to tumor target cells pre-activates NK cells to demonstrate enhanced tumor cell lysis upon restimulation, generating long-term memory-like features. The generation of memory-like NK cells was previously reported following exposure to cytomegalovirus (CMV), interleukin (IL)-12/15/18 combinations or the tumor cell line NALM-16.

Here, we report a novel type of tumor-induced memory-like (TIML) NK cell induced by the acute lymphoblastic leukemia (ALL) cell line, INB16. These TIML NK cells are generated in vitro over a period of seven days to show better expansion, survival, and proliferation relative to other memory-like NK cells, maintaining similar levels of enhanced NK cell anti-tumor functional abilities including tumor lysis, and pro-inflammatory cytokine secretion against a wide range of tumor targets. Their unique phenotypic and gene expression signatures suggest a novel and distinct form of memory-like NK cell governed by tumor-specific signaling pathways. The universal and wide-acting function of these highly expanded NK cells may have important implications in the clinical setting to better mitigate challenges in low NK cell number and lytic ability.

A link to the abstract can be found here.

Title: Tumor-priming defines an intermediate stage in natural killer cell activity between resting and lytic stages for enhanced NK cell function upon re-stimulation

Poster: P-597

Session: Poster session 1

Natural killer (NK) cells are critical effector cells of the innate immune system belonging to the family of group one innate lymphocytes (ILCs). They display direct cytotoxicity against sensitive tumor targets and secrete a wide array of cytokines that help mount an effective immune response against cancer development and progression, making them attractive candidates for cancer immunotherapy.

We previously reported a tumor-priming approach to NK cell activation, whereby exposure to the acute lymphoblastic leukemia cell line CTV-1 specifically activates NK cells to display more enhanced anti-tumoral functions. This has yielded encouraging results in clinical trials against acute myeloid leukemia and myelodysplastic syndrome. Other groups reported a similar tumor-priming strategy for specific activation of NK cell anti-tumor responses using NALM-16. Still, the mechanisms involved in tumor-priming of NK cells remain to be elucidated, and it is unclear how the ‘primed’ state can be achieved for optimal clinical benefit.

Here, we show that tumor-priming stimulates NK cells to a point along the lytic activation pathway for enhanced NK cell function upon re-stimulation. The primed state is achieved through exposure to less sensitive tumor targets that form fewer conjugates, and induce lower levels of avidity, degranulation, activation marker expression, pro-inflammatory cytokine secretion and lysis by NK cells. This tumor-primed state leads to enhanced NK cell function upon re-stimulation and potent NK cell killing of previously insensitive tumor targets. Interestingly, tumor-priming of NK cells is achieved in the presence of inhibitory signals and can be achieved using whole cell or cell lysate preparations, which generate differential activation signatures relative to cytokine stimulation.

This may have important implications in the clinic, where continuous cytokine exposure is associated with a dose-limiting toxicity in patients. These findings help define the tumor-primed NK cell activation state for the development of more optimal NK cell-based immunotherapeutic strategies in cancer.

A link to the abstract can be found here.

About INKmune

INKmune is a pharmaceutical-grade, replication-incompetent human tumor cell line (derived from CTV-1) which conjugates to resting NK cells and delivers multiple, essential priming signals akin to treatment with at least three cytokines in combination. INKmune is stable at -80oC and is delivered by a simple IV infusion. The INKmune:NK interaction ligates multiple activating and co-stimulatory molecules on the NK cell and enhances its avidity of binding to tumor cells; notably those resistant to normal NK-mediated lysis. Tumor-primed NK (TpNK) cells can lyse a wide variety of NK-resistant tumors including leukemias, lymphomas, myeloma, ovarian cancer, breast cancer.

Zymeworks Announces Second Janssen Bispecific Antibody to Begin Clinical Development Utilizing Azymetric™ and EFECT™ Therapeutic Platforms

On December 1, 2021 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that Janssen Biotech, Inc. ("Janssen") dosed the first patient with JNJ-78306358, a bispecific antibody developed using Zymeworks’ Azymetric and EFECT therapeutic platforms (Press release, Zymeworks, DEC 1, 2021, View Source [SID1234596333]). This is the second Janssen bispecific program utilizing Zymeworks’ proprietary technology platforms to enter the clinic this year, following the announcement in August of Janssen’s dosing of the first patient with JNJ-78278343.

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"At Zymeworks, we are delighted to see our collaborator’s therapies reaching patients in the clinic, and we extend our congratulations to everyone at Janssen on this achievement," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "Today, our therapeutic platforms are being leveraged through strategic partnerships with nine biopharmaceutical companies, with a total of six novel therapeutics having entered clinical development to date."

Zymeworks will receive a payment in connection with this milestone under Zymeworks’ 2017 licensing agreement with Janssen. Under the terms of that agreement, Zymeworks provided Janssen with a worldwide, royalty-bearing license to research, develop and commercialize up to six bispecific antibodies directed to Janssen therapeutic targets using Zymeworks’ Azymetric and EFECT platforms. Janssen is responsible for all research, development, and commercial activities under the licensing agreement. Zymeworks received an upfront payment of US$50 million and is eligible to potentially receive up to US$282 million in development milestone payments and up to US$1.12 billion in commercial milestone payments, as well as tiered royalties on potential sales.

About the Azymetric Platform

The Azymetric platform enables the transformation of monospecific antibodies into bispecific and multispecific antibodies, allowing simultaneous binding to several different disease targets. This unique technology enables the development of multifunctional therapeutics that can block multiple signaling pathways, recruit immune cells to tumors, enhance receptor clustering and internalization and increase tumor-specific targeting. These features are designed to enhance efficacy while reducing toxicities and the potential for drug resistance. Azymetric therapeutics have been engineered to retain the desirable drug-like qualities of naturally occurring antibodies, including low immunogenicity, long half-life and high stability. In addition, they are compatible with standard manufacturing processes that deliver high yields and purity, potentially reducing drug development costs and timelines.

About the EFECT Platform

The EFECT platform is a library of antibody Fc modifications engineered to activate or suppress the antibody-mediated immune response. This platform, which is compatible with traditional monoclonal as well as Azymetric bispecific antibodies, further enables the customization and optimization of therapeutic responses for different diseases.

Rubius Therapeutics to Host Virtual Preclinical Pipeline and Platform Technology Day on December 16, 2021

On December 1, 2021 Rubius Therapeutics, Inc. (Nasdaq: RUBY), a clinical-stage biopharmaceutical company that is genetically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics for the treatment of cancer and autoimmune diseases, reported that it will host a virtual investor and analyst event focused on the company’s RED PLATFORM and preclinical pipeline in oncology and autoimmunity, in particular type 1 diabetes (Press release, Rubius Therapeutics, DEC 1, 2021, View Source [SID1234596332]). The event will be held from 11:00 a.m. to 1:00 p.m. ET on Thursday, December 16, 2021. This will be the first of a series of investor and analyst events that the company plans to host periodically.

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The event will feature presentations from Rubius management, providing an overview of the Company’s RED PLATFORM and the translation of the platform into a pipeline of preclinical programs in oncology and autoimmune diseases. In addition, Dr. Gerald T. Nepom, M.D., PhD., will provide an overview of the current and emerging treatment landscape and unmet needs in type 1 diabetes. Dr. Nepom is the Director of the Immune Tolerance Network, sponsored by the National Institutes of Health, and former Director and founder of the Benaroya Research Institute, in Seattle WA, USA. His primary research interests focus on CD4 T cell response in autoimmunity, with an emphasis on type 1 diabetes, as well as the translation of immunological intervention strategies into innovative clinical trials. The Rubius management team and Dr. Nepom will host a Q&A session following the presentations.

A live audio webcast will be available within the Investors & Media section of the Rubius Therapeutics website. An archived replay will be accessible for 90 days following the event.

Inhibrx Receives FDA Orphan-Drug Designation for INBRX-109 in Chondrosarcoma

On December 1, 2021 Inhibrx, Inc. (Nasdaq: INBX), a biotechnology company with four clinical programs in development and a strong emerging pipeline, reported that the U.S. Food and Drug Administration, or FDA, has granted orphan-drug designation for INBRX-109 for the treatment of chondrosarcoma (Press release, Inhibrx, DEC 1, 2021, View Source [SID1234596331]).

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"We believe orphan-drug designation underscores the recognition of INBRX-109 as a promising therapeutic for patients with metastatic or unresectable chondrosarcoma, a patient community currently with no other viable options," said Inhibrx Chief Executive Officer Mark Lappe.

The FDA’s Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan-drug designation provides certain benefits, including financial incentives to support clinical development and the potential for up to seven years of market exclusivity in the U.S. upon regulatory approval.

About Chondrosarcoma

Chondrosarcoma is an orphan bone cancer with approximately 2,800 new patients diagnosed annually in the United States and the European Union. There are currently no therapeutics approved for the treatment of chondrosarcoma.

About INBRX-109

INBRX-109 is a precision-engineered, tetravalent death receptor 5 (DR5) agonist antibody designed to exploit the tumor-biased cell death induced by DR5 activation.
In January 2021, the FDA granted Fast Track designation to INBRX-109 for the treatment of patients with unresectable or metastatic conventional chondrosarcoma.
In November 2021, Inhibrx provided updated results from its ongoing Phase 1 clinical trial evaluating the efficacy and safety of INBRX-109 in patients with conventional chondrosarcoma. Preliminary disease control was observed in 16 of the 18 evaluable patients (89%) measured by RECISTv1.1, with two of the 18 achieving partial responses (11%). Based on preliminary results of the ongoing Phase 1 trial, the median progression-free survival (PFS) is 7.4 months, and the median overall survival has not been reached. Three patients have exceeded 61 weeks on treatment with INBRX-109, with 77 weeks being the longest duration of stable disease observed to date.

In June 2021, Inhibrx initiated a randomized, blinded, placebo-controlled, potential registration-enabling Phase 2 trial of INBRX-109 in conventional chondrosarcoma.

Alligator announces final outcome of rights issue

On December 1, 2021 Alligator Bioscience AB (publ) ("Alligator" or the "Company") reported that the Company’s rights issue of shares (the "Rights Issue"), in which the subscription period ended on 26 November 2021, has been completed (Press release, Alligator Bioscience, DEC 1, 2021, View Source [SID1234596329]). The final count in the Rights Issue shows that 118,371,431 shares, corresponding to approximately 92.1 per cent of the Rights Issue, have been subscribed for by the exercise of subscription rights (including subscription undertakings). Furthermore, 37,602,276 shares were subscribed for without subscription rights, corresponding to approximately 29.3 per cent of the Rights Issue. The final outcome shows that the Rights Issue has been oversubscribed. Through the Rights Issue, Alligator receives approximately SEK 257 million before deduction of transaction costs.

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Outcome

The Rights Issue comprised a maximum of 128,499,507 ordinary shares, of which 118,371,431 shares, corresponding to approximately 92.1 per cent of the Rights issue, has been subscribed for by exercise of subscription rights. 37,602,276 shares, corresponding to approximately 29.3 per cent of the Rights Issue, has been subscribed for without the exercise of subscription rights. Thus, 155,973,707 shares, corresponding to approximately 121.4 per cent of the Rights Issue, has been subscribed for with and without the exercise of subscription rights. The Rights Issue is thus oversubscribed and no guarantee commitments have been utilized.

Notification regarding allocation

Allocation of shares has been made in accordance with the allocation principles described in the prospectus that was published in connection with the Rights Issue (the "Prospectus"). A notification regarding allocation of shares subscribed for without the exercise of subscription rights will be made by post of a settlement note to each subscriber. Allocated shares subscribed for without the exercise of subscription rights shall be paid for in accordance with the instructions in the settlement note.

Trading in BTA

Trading in BTA (Sw. betald tecknad aktie) is currently taking place at Nasdaq Stockholm and will cease when the Rights Issue has been registered by the Swedish Companies Registration Office, which is expected to take place around week 50, 2021. BTA:s will then be converted to ordinary shares.

Number of shares and share capital

The Rights Issue provides Alligator with proceeds amounting to approximately SEK 257 million before transaction costs. As a result of the Rights Issue, Alligator’s share capital will increase by SEK 51,399,802.80 to a total of SEK 85,666,338 and the total number of shares will increase by 128,499,507 shares to a total of 214,165,845 shares, all ordinary shares.

Guarantee Commitments

In connection with the Rights Issue, the Company has entered into agreements on guarantee commitments. For the guarantee commitments, a commission is paid, either in cash or in the form of newly issued shares in the Company. The subscription price for any shares issued to guarantors has been set to SEK 2.10, corresponding to 90 per cent of the volume-weighted average share price (VWAP) for the Company’s share on Nasdaq Stockholm during the subscription period in the Rights Issue (i.e. during the period 12 – 26 November 2021. In case all guarantors would choose to receive guarantee commission in shares, a total of a maximum of 10,660,763 new shares would be issued as guarantee commission.

Supplementary prospectus

With reference to a formatting error through which information about an individual guarantor (Nyenburgh Holding BV), as well as subtotals for subscription undertakings was mistakenly excluded from the Prospectus’ summary of guarantee commitments and subscription undertakings, the Company will prepare and publish a supplementary prospectus. The supplementary prospectus will be made available on the Company’s website.

Advisers

DNB Markets, a part of DNB Bank ASA, Sweden Branch and Redeye AB act as Joint Global Coordinators in connection with the Rights Issue. Setterwalls Advokatbyrå AB acts as legal adviser to Alligator and Baker & McKenzie Advokatbyrå KB acts as legal adviser to the Joint Global Coordinators in connection with the Rights Issue. Aktieinvest FK AB acts as the issuing agent in the Rights Issue.