On January 18, 2022 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, reported it has entered an exclusive license agreement with Mitsubishi Tanabe Pharma Corporation (MTPC) for the development and commercialization of ZYNLONTA (loncastuximab tesirine-lpyl) for all hematologic and solid tumor indications in Japan (Press release, ADC Therapeutics, JAN 18, 2022, View Source [SID1234605512]).

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Under the terms of the agreement, ADC Therapeutics will receive an upfront payment of $30 million and up to an additional $205 million in milestones if certain development and commercial events are achieved. ADC Therapeutics will also receive royalties ranging in percentage from the high teens to the low twenties based on net sales of the product in Japan. MTPC will conduct clinical studies of ZYNLONTA in Japan and will have the right to participate in any global clinical studies of the product by bearing a portion of the costs of the study.

In April 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to ZYNLONTA as the first and only CD19-targeted ADC as a single-agent treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. A Marketing Authorization Application (MAA) for ZYNLONTA has been validated by the European Medicines Agency (EMA) and is under review by the EMA’s Committee for Medicinal Products for Human Use (CHMP). ZYNLONTA has also received Orphan Drug designation in Europe for DLBCL. In addition, Overland ADCT BioPharma, a joint venture formed by Overland Pharmaceuticals and ADC Therapeutics, is working to develop and commercialize ZYNLONTA in greater China and Singapore. Overland ADCT BioPharma is now conducting a pivotal Phase 2 clinical trial of ZYNLONTA in relapsed or refractory DLBCL in China, which is intended to support the anticipated registration of ZYNLONTA in China.

About ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

On January 17, 2022 Tyligand Bioscience, a clinical-stage biotechnology company developing innovative small-molecule therapeutics against drug resistant cancers, reported that its investigational new drug (IND) application of TSN084 has been approved by China’s National Medical Products Administration (NMPA) (Press release, Tyligand Bioscience, JAN 17, 2022, View Source [SID1234644991]).

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TSN084 is a first-in-class phosphorylation inhibitor targeting CDK8/19 and several other kinases implicated in tumorigenesis and immune evasions. Phase I enrollment will be conducted at the Cancer Hospital of the Chinese Academy of Medical Sciences and other clinical centers. In Oct 2021, the company has received IND approval from the US FDA for the experimental drug and dose escalation studies are expected to commence soon.

Dr. Tony Zhang, cofounder and CEO of Tyligand Bioscience, commented, "We are excited about this important milestone and the potential of TSN084 for helping patients with tough to treat tumors. Accomplishing this goal is testimonial to the quality and speed of the Tyligand team at transforming novel molecules into quality drug candidates. It is an important step toward testing our approach of selective and simultaneous inhibition of multiple factors responsible for the major hallmarks of cancer."

On January 17, 2022 Aclys Bio Corp ("Aclys"), a company discovering and developing precision biologics for the treatment of cancer, earlier this month reported a new exclusive research and commercial license option agreement with Genmab A/S (Nasdaq: GMAB), an international biotech company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer (Press release, Virtici, JAN 17, 2022, View Source [SID1234608857]).

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Under the terms of the agreement, Genmab secures exclusive rights to Aclys antibodies (specific to an undisclosed target) for further research in conjunction with Genmab’s proprietary platforms. Genmab is also granted the option to advance development and commercialization of resulting products.

Aclys has built a broad range of antibodies using its PILA platform to create targeted therapeutics for solid tumors. The agreement with Genmab recognizes the capability of the Aclys PILA platform to identify novel precision targets.

"We have differentiated, high value targets, unique antibody engineering capabilities, and a team that has delivered some of the most valuable monoclonal antibodies currently in development.", said Dr. Tony Cooper, Aclys Cofounder and CEO. "This agreement with Genmab is integral to advancing our goal of delivering life-saving therapies to patients." Aclys is a leader in the emerging field of precision immune medicine. Aclys utilizes a proprietary set of patient molecular data to select differentiated targets and create precision biologics with the safety profile and response rates only achievable with precision biologics.

On January 18, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that the Company has entered into a drug discovery collaboration with Eli Lilly and Company ("Lilly") in the field of metabolic diseases with a focus on kidney diseases and diabetes (Press release, Evotec, JAN 17, 2022, View Source [SID1234605514]).

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The collaboration leverages Evotec’s extensive experience and track record of delivering in the field of metabolic diseases, as well as its unique and extensive kidney disease patient database, to identify and validate promising novel targets for therapeutic intervention. Evotec will be responsible for the discovery of potential drug candidates for the treatment of diabetes and chronic kidney diseases from targets identified by Lilly or by Evotec. Lilly reserves the right to select up to five programmes developed within this partnership and to continue with any subsequent development, clinical validation and commercialisation.

The collaboration initially runs for a term of three years. In addition to an undisclosed upfront payment, Evotec will be eligible to receive success-based discovery development, regulatory and commercial milestone payments of up to US$ 180 m per programme, as well as tiered royalties on net sales of any products resulting from the collaboration, for a potential overall value up to US$ 1 bn.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "We are excited to enter into this research partnership with Lilly. Over a period of several years, Evotec has systematically built a proprietary patient database by conducting multi-omics analyses of biospecimens from patient biobanks covering metabolic and kidney diseases. Evotec’s patient-derived molecular data in combination with our omics-supported multimodality drug discovery platform delivers highest quality drug candidates for our partners. We are proud to collaborate with Lilly in diabetes and kidney diseases as they are one of the leading companies in these areas.

On January 17, 2022 MaaT Pharma (EURONEXT: MAAT – the "Company"), a French clinical-stage biotech and a pioneer in the development of microbiome-based ecosystem therapies dedicated to improving survival outcomes for patients with cancer, reported business objectives and clinical milestones for 2022(Press release, MaaT Pharma, JAN 17, 2022, View Source [SID1234605510]).

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"Despite the ongoing pandemic, 2021 was a turning point in MaaT Pharma history, as we became the first microbiome therapeutic company to be listed on Euronext, we established a Phase 2 proof of concept with MaaT013 in acute Graft-vs-Host-Disease, and we expanded our hemato-oncology program with the initiation of a Phase 1b trial of MaaT033, our oral formulation," stated Hervé Affagard, CEO and co-founder of MaaT Pharma. "We expect new achievements in 2022, with 3 clinical programs either ongoing or starting. This year should see key clinical milestones in hemato-oncology with MaaT013 ready to enter Phase 3 and new clinical data for MaaT033 expected in the first half of 2022. Moreover, our immuno-oncology program leveraging a new generation of products, MaaT03X to address solid tumors, is currently in nonclinical validation. Since our creation, we have been pioneering the development of Microbiome Ecosystem Therapies to bring these innovations to millions of patients fighting cancer globally."

Expected milestones in 2022

Hemato-oncology– Clinical programs:

MaaT013 for the treatment of aGvHD (Orphan Drug Designation by the FDA and the EMA):

MaaT013 is a full-ecosystem, off-the-shelf, standardized, pooled-donor Microbiome Ecosystem Therapy for enema administration.
MaaT013 is ready to start its pivotal Phase 3 in Europe. MaaT Pharma has already received regulatory authorization to start this trial in France and Germany. The Company will communicate upon the inclusion of the first patient (FPI).
The initiation of the clinical trials for MaaT013 in the United States will depend on the outcome of ongoing exchanges with the Food and Drug Administration (FDA) in response to the August 2021 clinical hold letter regarding the IND for MaaT013 in the US.
MaaT013 has been successfully evaluated in Phase 2 clinical trial in patients with steroid-resistant grade III-IV gastro-intestinal (GI) aGvHD as well as in an ongoing compassionate use program (EAP) in France in patients with Grade II-IV GI-aGvHD having failed previous therapies, with promising results.
To date, more than 100 patients with aGvHD have been safely treated with MaaT013, including:
24 patients in the Phase 2 trial.
96 patients in the Early Access Program in France (EAP). This program has also been an opportunity for the Company to strengthen its supply chain and manufacturing capacities to deliver MaaT013 regularly and safely to 18 hospital transplant centers as of today.
Additionally, MaaT Pharma has recently honored two requests for compassionate use of MaaT013 originating from two other European countries.

MaaT033 for the prevention of complications due to allogeneic hematopoietic stem cell transplantation (allo-HSCT)

MaaT033 is a donor-derived, standardized, high-richness, high-diversity Microbiome Ecosystem Therapy for oral administration.
MaaT033, is currently being evaluated to define dose regimen in a Phase 1b clinical trial in patients with acute myeloid leukemia (AML) following intensive chemotherapy.
There have been 4 meetings of an independent safety review Board (DSMB) to date evaluating the safety of the trial and that concluded in support of the continuation of the study.
In Q1 2022, the Company will provide interim results of engraftment data for the Phase 1b clinical trial.
Complete results are expected in the first half of 2022 and a pivotal Phase 2/3 may be initiated at the end of 2022 to evaluate MaaT033 as a prophylactic treatment for blood cancer patients undergoing allo-HSCT.

Immuno-oncology – Clinical and nonclinical programs

MaaT013 for the improvement of a patient’s response to Immune Checkpoint Inhibitors (ICI) –proof of concept clinical trial sponsored by AP-HP

MaaT013 is ready to enter a randomized, placebo-controlled Phase 2a trial to evaluate its effect on the efficacy of ICI treatment in patients with metastatic melanoma. AP-HP is the sponsor of this trial. MaaT Pharma will supply the drugs and perform the microbiome profiling of patients using its proprietary gutPrint platform.
French regulatory authorities have approved the trial and the Company will communicate upon inclusion of the first patient.
MaaT03X for the increase in the response rate to Immune Checkpoint Inhibitors in patients with solid tumors

MaaT03X is a fermented, high diversity, rationally designed Microbiome Ecosystem Therapy for oral administration. MaaT03X’s design is based on clinical and microbiome data analyses from hundreds of patients.
MaaT Pharma is leveraging its proprietary gutPrint computational biology platform and full ecosystem co-fermentation technology to develop this new generation of candidates.
The first MaaT03X candidate is currently in nonclinical testing and will aim to improve the anti-cancer efficacy of ICI in patients with an undisclosed solid tumor with a high unmet need. A first clinical study is expected to start in the first half of 2023.
In 2021, the MaaT03X program received a €1.9M grant to support industrialization of the manufacturing process.

cGMP manufacturing facilities

MaaT Pharma has entered negotiations with a potential partner to secure the expansion of the Company’s cGMP manufacturing capacities, as stated in a letter of intent signed in November 2021. A new cGMP manufacturing plant, entirely dedicated to the Company’s high-diversity and high-richness Microbiome Ecosystem Therapies, would be built in the Auvergne-Rhône-Alpes region allowing the Company to operate its own equipment and processes while benefitting from full associated cGMP services provided by the partner. Contracting is expected to take place in H1 2022.

Initiation of coverage of MaaT Pharma stock

To date, three brokerage firms have initiated coverage of MaaT Pharma (EURONEXT: MAAT):

2021 – KBC Securities: research report "More than a Gut Feeling"
2021 – Kempen: research report "No Guts no Glory"
Jan 2022 – Portzamparc / Groupe BNP Paribas: research report "Échec et MaaT pour le cancer"

2022 Financial calendar

February 28, 2022 – Revenues and Cash Position as of December 31st, 2021
April 15, 2022 – Annual Results 2021
May 05, 2022 – Revenues and Cash Position Quarter 1
May 23, 2022 – General Meeting
July 28, 2022 – Revenues and Cash Position Quarter 2
September 29, 2022 – Half-year Results (April – September)
November 08, 2022 – Revenues and Cash Position Quarter 3