On December 1, 2020 Nordic Nanovector ASA (OSE: NANO) reported that it has completed enrolment into the LYMRIT 37-05 Phase 1 clinical trial of Betalutin (177Lu lilotomab satetraxetan) in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) not eligible for autologous stem cell transplantation (ASCT) (Press release, Nordic Nanovector, DEC 1, 2020, View Source [SID1234571999]).

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Eighteen DLBCL patients were enrolled into the trial at clinical trial sites in the US and Europe and were dosed with three escalating treatment doses of Betalutin (10MBq/kg, 15MBq/kg and 20MBq/kg). A preliminary data readout is expected in H1’2021.

As announced in April 2020, LYMRIT 37-05 will be paused pending analysis of these data, which is expected to inform plans for the further development of Betalutin in R/R DLBCL.

Nordic Nanovector’s primary focus is the timely completion of the pivotal Phase 2b PARADIGME trial of Betalutin in 3rd-line follicular lymphoma (3L FL).

Christine Wilkinson Blanc, Chief Medical Officer of Nordic Nanovector, said: "The completion of recruitment into this dose-finding study in patients with DLBCL is an important milestone. DLBCL remains a significant indication with a large unmet medical need. The data analysis from this trial will form the basis of our considerations for the further development of Betalutin in DLBCL and more broadly across non-Hodgkin’s lymphoma."

The LYMRIT 37-05 study is a Phase 1 open-label, single-arm, dose-escalation study in DLBCL designed to determine the dose to be recommended for further studies in DLBCL and assess the safety, tolerability, pharmacokinetic profile and preliminary anti-tumour activity of a single administration of Betalutin. More information on this study can be found at www.clinicaltrials.gov (NCT02658968).

DLBCL is an aggressive form of non-Hodgkin’s Lymphoma (NHL) that accounts for 30% of all NHL cases1,2. The number of diagnosed incident cases of DLBCL in the seven major markets (US, key five European markets and Japan) was 64,172 in 2018 and is expected to grow to 74,927 in 20283.

Approximately 40% of DLBCL patients relapse after first-line combination treatment with rituximab and chemotherapy. These patients have few therapeutic options, with high-dose chemotherapy and autologous stem cell transplant (ASCT) achieving long-term remissions in only a minority of patients4. Relapsed DLBCL therefore remains a serious unmet medical need.

References

Siegel R, Miller K and Jemal A. Cancer Statistics, 2019. CA Cancer J. Clin. 2019;69(1):7-34
View Source
Non-Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL), 2020, Decision Resources Group, Clarivate
Liu Y, Barta SK. Diffuse large B-cell lymphoma: 2019 update on diagnosis, risk stratification, and treatment. Am J Hematol. 2019 May;94(5):604-616.

On November 30, 2020 Transition Bio, Inc. ("Transition Bio" or the "Company") reported forming, funding, and launching with the focused objective to build the best and first-in-class technological capabilities required to evaluate and advance the novel area of cell biology known as condensates (Press release, Transition Bio, NOV 30, 2020, View Source [SID1234648797]).

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The initial closing of the Company’s Series Seed financing occurred at the end of September and was led by Lifeforce Capital.

Transition Bio brings together the unique fundamental knowledge and experience of Professor David Weitz of Harvard University’s John A. Paulson School of Engineering and Applied Sciences and Department of Physics, and Professor Tuomas Knowles of the University of Cambridge’s Departments of Chemistry and Physics.

"After nearly 15 years of supporting each other’s work from an academic point of view, it is extremely exciting to combine the distinctive capabilities of our respective labs," commented Professor Weitz. "It is our strong belief that this area of liquid-liquid phase separation offers an amazing opportunity in human health care advancement."

Professor Knowles added, "David and I have long discussed how we could merge our knowledge and technologies to create something substantial that could genuinely change the world." Knowles continued, "The combination of unique physical science methods with microfluidics and "big data" allows for disruptive advances in the world of drug discovery and diagnostics."

Professors Weitz and Knowles branded the analysis of condensates cell biology based on the Company’s proprietary technology as Condensomics. Transition Bio aims to make the Company the world leader in the field. When fully built, Transition Bio’s condensomics approach will replace the industry’s current reliance on inadequate conventional technologies to study biomolecular condensates.

Leading the Company’s research efforts is Assaf Rotem, Ph.D., who joined as Head of Research and Development based in Cambridge, MA. Assaf was most recently Director and Group Leader of Platform Technology at Repertoire Immune Medicine and was a Postdoctoral Research Fellow in Biomicrofluidics at Harvard University under the direction of Professor Weitz. Assaf will lead a team of scientists based in Cambridge, MA, the Company’s headquarters, and Cambridge, UK, together with William Arter, Ph.D., and Georg Krainer, Ph.D., members of the Knowles Lab who are responsible for the Company’s UK-based scientific operations.

Transition Bio further announced that its Board of Directors will include Professor Weitz, Professor Knowles, Dr. Samuel Cohen (UK), David Zimble, Esq. (Israel), and Executive Chairman, Kelly Martin (U.S.). Owen Hughes (U.S.) will serve as an advisor to the Company.

On November 30, 2020 Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, reported that Gerri Henwood, the Company’s President and Chief Executive Officer, will participate in the Piper Sandler 32nd Annual Virtual Healthcare Conference, being held virtually December 1-3, 2020 (Press release, Baudax Bio, NOV 30, 2020, View Source [SID1234572279]). The company will conduct institutional investor meetings on December 2, 2020; meetings may be requested through Piper Sandler.

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A pre-recorded fireside chat with Ms. Henwood is now available on the Piper Sandler conference site and on the "Events" page within the Investors section of the Baudax Bio website at View Source The recording will be available for a period of 30 days following the event.

On November 30, 2020 AP Biosciences reported In recent years, an increasing number of drugs have been granted breakthrough therapy designation in the United States, encouraging more companies to propose novel cancer treatment solutions (Press release, AP Biosciences, NOV 30, 2020, View Source [SID1234572009]). Currently, there are two companies in Taiwan that are accelerating the development of these therapies and provide innovative treatments.

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AP Biosciences’ target-dependent T-cell activating bi-specific antibodies

AP Biosciences (APBio) is a discovery-stage immunotherapeutic company developing mono- and bi-specific antibodies for various forms of treatment. One of the company’s major products, T-Cube bsAbs, involves bi-specific antibodies that lead T cells to cancer cells. They do so by bridging the T cells to unique antigens found on the surface of cancer cells, resulting in T cell activation which kills the cancer cells.

Unlike many current immune-therapeutic drugs (which activate the immune system to combat cancer cells while inducing a cytokine storm accompanied by strong side effects), APBio’s antibody drugs would benefit patients via improved specificity, leading to higher efficacy and a more favourable safety profile.

"T-Cube bi-specific antibodies activate cytotoxic and memory T cells upon binding to targeted cancer cells. In short, we’re creating better antibodies for better cures," explained Dr. Jeng Her, CEO of APBio. "In the near term, we see these treatments benefiting patients with liver, kidney, and lung cancers. Superiority in efficacy, safety, and cost is what makes our solutions unique and exciting to the medical community."

The strategy employed by APBio has attracted companies such as Innovent Biologics and Tasly Biopharmaceuticals to become development partners for several bi-specific antibodies. IBI302, a bi-specific antibody licensed to Innovent for the wet form of age-related macular degeneration (wet AMD), entered Phase I of clinical trials in April 2019. Further, APBio recently raised US$19.5 million in its series B funding round for the development of three in-house T-Cube antibodies, targeting human trials as early as Q4 2021.

LuminX provides cell GPS positioning in vivo

Most breakthrough therapy designations are granted to cell therapies. These therapies face great challenges in pre-market certification, owing to the difficulty of pre-clinical PK/PD data collection.

LuminX aims to accelerate and fine-tune cell therapies through better understanding of processes in the preclinical stage. With the help of an innovative cell-tracking method, live cells can be detected through fluorescence, thus making them easier to track for an extended period of time. This visibility helps scientists and researchers understand how therapeutic cells are distributed either in vivo or in vitro, how long they survive, and recognize what the cells’ eventual biological fate might be in a research or hospital setting.

According to Dr. Long-Jyun Su, CEO of LuminX, the company’s solution involves labelling cells with LuminX-tracking reagents that are non-toxic and non-genotoxic. The outcome sees labelled cells glow red for easy visual identification and remain potent long thereafter. The executive said that other techniques require 100, 1,000, or even 10,000 cells to elicit detection, whereas LuminX’s method only requires 10.

Dr. Su explained, "LuminX’s cell-tracking service is able to quantify the number of therapeutic cells in an individual organ, allowing us to obtain data on cell biodistribution and PK/PD. This means we’re able to study the movement of drugs through the animal model in the preclinical stage. Additionally for researchers and cell therapy companies, our tech will be a game-changer as it drastically cuts down the time and money otherwise needed for research and development."

On November 30, 2020, Anixa Biosciences, Inc. (the "Company") reported that it entered into an exclusive license agreement (the "Agreement") with The Cleveland Clinic Foundation, a nonprofit Ohio corporation (the "Licensor") (Filing, 8-K, Anixa Biosciences, NOV 30, 2020, View Source [SID1234572027]). Pursuant to the Agreement, the Company has been granted (i) an exclusive worldwide license to certain patents and patent applications (the "Licensed Patents") pertaining to the use of vaccines for the therapeutic treatment or prevention of ovarian cancer and other types of cancers which express the anti-mullerian hormone receptor 2 protein, including an anti-mullerian hormone receptor 2 protein containing an extracellular domain (the "Fields") and (ii) a non-exclusive worldwide license to use certain know-how related to the Licensed Patents that was not previously known by the Company (the "Licensed Know-How" and collectively, with the Licensed Patents, the "Licensed Technology") to make, have made, use, offer to sell, sell and import Licensed Products (as hereinafter defined) in the Fields. The Licensor has also granted the Company the right to sublicense the Licensed Technology in certain circumstances upon receipt of Licensor’s written consent.

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In consideration of its license of the Licensed Technology to the Company, the Company will pay to the Licensor a non-refundable cash fee for the issuance of the license. In addition, the Company has agreed to pay to the Licensor a royalty on the "net sales" (as such term is defined in the Agreement) on (i) any product or part of a product in the Fields the making, use, sale, offer to sell, or import of which infringes or would be expected to infringe a valid claim on the Licensor’s rights, but for the license granted in the Agreement (a "Licensed Patent Product") and (ii) any product or part of a product in the Fields that is sold, transferred, or otherwise disposed of in a jurisdiction where (1) a Licensed Patent has expired; (2) patent protection is not pursued, but the product or part of a product sold, transferred, or otherwise disposed of would be expected to infringe any valid claim on the Licensor’s rights; or (3) that was derived from, utilizes, uses, is used, or made through use of, embodies, contains, incorporates (in each case, in whole or in part), or uses any element of any of the Licensed Know-How (a "Licensed Know-How Product," and collectively with any Licensed Patent Product, the "Licensed Products"). The Company has also agreed to pay to the Licensor a lesser royalty on "net sales" on any Licensed Product that is sold, transferred or otherwise disposed of in a particular territory where no valid claim exists covering the sale of such Licensed Product in such territory.

In addition to the foregoing consideration, the Company will also pay to the Licensor certain cash payments following the completion of certain regulatory milestones with respect to each Licensed Product. Following the first commercial sale of any Licensed Products, the Company will be required to make certain minimum annual royalty payments to the Licensor. In addition, the Company has agreed to pay to the Licensor an annual maintenance fee related to the Licensed Technology. In the event that the Company sublicenses any of the Licensed Technology in accordance with the Agreement, the Company will pay to the Licensor a percentage of revenue received from any sublicense based upon certain milestones.

The Agreement is effective as of October 20, 2020 and will remain in effect, unless earlier terminated, until the later of (i) the five (5) year anniversary of the expiration of the last to expire valid claim that the Licensor has with respect to the Licensed Patents or (ii) the ten (10) year anniversary of the first commercial sale in each jurisdiction. The Licensor may also terminate the Agreement if, among other things, the Company fails to make certain payments under the Agreement, becomes insolvent, or breaches certain of the terms and provisions of the Agreement (subject, in certain circumstances, to a cure period). The Company has the right to terminate this agreement upon any material breach of the Agreement by the Licensor.

The Company has also agreed to certain commercialization and development milestones with respect to the Licensed Technology. If the Company fails to meet these milestones (including following any permissible cure period or following a mutually agreed upon extension), and such failure is not the result of an unforeseeable event, the Agreement may be terminated by the Licensor.

The Licensor is responsible for prosecution of the Licensed Patents, provided that the Company is responsible for all costs associated with such prosecution. The Company is also responsible for all other patenting costs associated with the Licensed Patents and has agreed to reimburse the Licensor for certain costs incurred prior to the Agreement related to the Licensed Patents.

The Company and Licensor will work in tandem to develop Licensed Products. The Company will be responsible for paying the costs associated with any additional development of Licensed Products.

The Company has agreed to indemnify the Licensor in connection with the Agreement and has also agreed to maintain certain insurance.

The Agreement contains typical representations, warranties and covenants. Pursuant to the Agreement, Licensor retains the right to continue to conduct research relating to the License Products in the Fields, provided that the Licensor does not have the right to practice or use the Licensed Technology in connection with the commercial sale of any product or service. Licensor also retains the right to publish the results of its research, even if such research contains Licensed Know-How, provided that the Company has the right to review and delay the publication if there is patentable subject matter in the research such that the Company can file a patent application over such matter.