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]).

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!

"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

On January 17, 2022 Ipsen reported that under the liquidity agreement entrusted by it to NATIXIS ODDO BHF, as of December 31, 2021, the following resources were included to the dedicated liquidity account(Press release, Ipsen, JAN 17, 2022, View Source [SID1234605509]):

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!

34,053 shares
€1,433,400.74
It is reminded that as of the date of the implementation of the agreement, the following resources were allocated to the liquidity account:

12,751 shares
€3,137,935
Between July 1st, 2021 and December 31, 2021 have been executed:

1,350 purchase transactions
1,425 sell transactions
Under the same period, the volumes traded represented:

178,366 shares and €15,275,528.42 to the purchase
168,568 shares and €14,644,572.90 to the sell

On January 17, 2022 Hamlet Pharma reported the successful completion of a Phase I/II study using a 1.7 mM dose of Alpha1H (Press release, HAMLET Pharma, JAN 17, 2022, View Source;utm_medium=rss&utm_campaign=successful-completion-of-the-dose-escalation-study-in-patients-with-bladder-cancer [SID1234605508]). We are now excited to report the successful completion of the dose escalation extension of the Phase I/II trial, demonstrating more potent effects of Alpha1H for key study parameters. The results are very encouraging for our continued work towards Phase III trials.

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 tumors were more strongly affected by Alpha1H at higher doses than in patients treated with the lower dose, as shown by more extensive shedding of tumor cells and tumor fragments into patient urine. As shown earlier, significant cell shedding or apoptosis did not occur in the placebo group, confirming the treatment effect.

Tissue analysis detected tumor fragmentation and shedding of tumor fragments from the remaining tumor, with large affected areas. In addition to the changes in the tumors, a pronounced apoptotic response was detected in cells and tumor fragments shed by the treated patients, confirming that Alpha1H accelerates cell death in the tumor. Apoptosis is a beneficial, non-toxic form of cell death, and therapies inducing apoptosis in growing tumors are highly desirable to limit the side effects of cancer therapy.

Furthermore, the tumor fragments in urine were shown to contain large amounts of Alpha1H, confirming the efficiency with which the higher doses of Alpha1H reach tumor tissue. The results suggest that the uptake of Alpha1H by tumor cells is a direct trigger of apoptosis, tumor fragmentation and release of the affected tumor fragments into the urine.

Dose-finding studies are essential to understand the potential of new drugs and define the optimal therapeutic window. The dose-dependent increase in therapeutic efficacy further emphasizes the potential of Alpha1-oleate for use as a drug in bladder cancer.

"’The dose-finding studies are essential for the continued development of Alpha1H for Phase III trials and for the dialogue with authorities like the FDA," says Catharina Svanborg, founder and chairman of the board of Hamlet Pharma Ltd.

"We are delighted to have reached this point in our development towards Phase III trials" says Mats Persson, CEO of Hamlet Pharma Ltd.

On January 17, 2022 Bio-Techne Corporation (NASDAQ: TECH) reported that management will host a conference call and webcast on Tuesday, February 1, 2022, at 8:00 a.m. CST to review second quarter fiscal 2022 financial results (Press release, Bio-Techne, JAN 17, 2022, https://investors.bio-techne.com/news/detail/286/bio-techne-to-host-conference-call-on-february-1-2022-to-announce-second-quarter-2022-financial-results [SID1234605507]).

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!

Access to the discussion may be obtained as follows:

Time:

8:00 a.m. CST

Date:

February 1, 2022

Dial-in:

1-877-407-9208 or 1-201-493-6784 (for international callers)

Conference ID:

13726340

Webcast:

View Source

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-844-512-2921 or 1-412-317-6671 (for international callers) and referencing Conference ID 13726340.

The replay will be available from 11:00 a.m. CST on Tuesday, February 1, 2022, until 11:00 p.m. CST on Tuesday, March 1, 2022.

On January 17, 2022 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that patents no CN108495934 and JP6974350 have been granted by the Chinese and Japanese Patent Offices, respectively (Press release, Targovax, JAN 17, 2022, View Source [SID1234605505]). The patents cover the use of ONCOS-102 in combination with chemotherapy in malignant mesothelioma.

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!

Andreas Berg Storsve, VP Business Development and IP at Targovax, said: "We are delighted that these patents have been granted, further strengthening Targovax’s intellectual property portfolio. The 30-month data from our ONCOS-102 trial in mesothelioma demonstrate very strong survival outcomes in the first-line setting, and this remains an area of high medical need. Securing these patents protects our innovative oncolytic immunotherapy platform and strengthens our future market position in the major Asian markets."

Targovax’s lead product candidate, ONCOS-102, is a genetically modified oncolytic adenovirus, which has been engineered to selectively infect cancer cells and activate the immune system. In December 2021, the 30-month follow-up in the malignant pleural mesothelioma (MPM) trial showed 25.0 months median overall survival (mOS) for patients in first-line treatment with ONCOS-102 plus chemotherapy, which is very encouraging in this patient population with poor prognosis.

The US FDA granted ONCOS-102 Fast Track designation for MPM in February 2021 based on the encouraging pre-clinical and clinical data package. ONCOS-102 also has orphan drug designation for MPM with both the US FDA and the European Medicines Agency.