On July 28, 2022 MaaT Pharma (EURONEXT: MAAT – the "Company"), a French clinical-stage biotech and a pioneer in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, reported its cash position as of June 30, 2022, and its revenues for the second quarter of 2022 (Press release, MaaT Pharma, JUL 28, 2022, View Source [SID1234617082]).

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 second quarter of 2022 saw further progress in our pipeline and the achievement of a crucial milestone for MaaT Pharma. The announcement of data showing a satisfactory safety profile and robust engraftment for MaaT033, our second drug candidate, opens an attractive market opportunity to expand the development to a wider patient population as we focus on preventing complications in patients receiving allo-HSCT[2] and in haematological malignancies overall," said Hervé Affagard, CEO and co-founder of MaaT Pharma.

Second quarter operational and clinical highlights

Clinical development

In June 2022, the Company confirmed positive results from its Phase 1b study evaluating MaaT033, the Company’s second drug candidate, in blood cancer patients; the clinical trial was completed early due to promising interim results.
MaaT Pharma also indicated that preparations are on track for the upcoming Phase 2/3 trial to evaluate MaaT033’s efficacy in improving overall survival and preventing complications in patients with blood cancers receiving allogeneic hematopoietic stem cell transplantation; based on current plans, this study is expected to start in Q4 2022.
In Europe, MaaT013, the Company’s leading drug candidate, is currently being evaluated in two clinical trials launched in Q1 2022, which are moving forward according to the Company’s expected timelines:
Phase 3 open label, single arm trial for drug candidate MaaT013 in the treatment of acute Graft-versus-Host Disease: in addition to France, Germany, and Spain where the trial is ongoing, the Company has received regulatory approvals to start the clinical trial in Austria and Belgium. An interim review of preliminary data is expected in the first half of 2023.
Phase 2a trial, sponsored by AP-HP[3], evaluating MaaT013 in combination with immune checkpoint inhibitors for patients with melanoma, is ongoing.
In the US, interactions with the U.S. Food and Drug Administration (FDA) are ongoing regarding MaaT013, for which US development is currently on clinical hold.
Operational highlights

On May 31, 2022, MaaT Pharma held its annual general meeting. For further information, please visit: View Source
On June 7, 2022, the Company hosted its first virtual R&D Day conference, attended by 150 participants. The replay is accessible here: View Source
"Over the first half of 2022 we are proud to have delivered to our shareholders the operational and clinical milestones set out at the time of our IPO. Our cash position remains solid, providing us with a cash runway through Q3 2023 by which time we expect to have interim data from our Phase 3 trial of MaaT013, and the first patient treated with MaaT033 in a Phase 2/3," stated Siân Crouzet, CFO and COO of MaaT Pharma.

Cash position1

As of June 30, 2022, total cash and cash equivalents were EUR 38.4 million, as compared to EUR 41.1 million as of March 31, 2022, and EUR 43.3 million as of December 31, 2021. The net change in cash over the first half of 2022 was EUR 4.9 million, including EUR 2.7 million in bank loans from BNP Paribas and Caisse d’Epargne Rhone Alpes (CERA) received over the course of the second quarter of 2022. Additional draws down, up to 4.4 million euros, are expected to be made by the end of 2022 from existing facilities signed with CIC and Bpifrance. The Company believes it has sufficient cash to cover needs of the development programs up until the end of the third quarter of 2023.

Revenues in Q2 20221

MaaT Pharma reported revenues[4] from its compassionate access program of EUR 0.2 million for the quarter ended June 30, 2022, compared with EUR 0.3 million for the first quarter of 2022. Total revenues for the first half of 2022 amount to EUR 0.5 million compared with EUR 0.4 million for the first half of 2021. In 2021, revenues were invoiced as of February 2021 whereas in 2022 the Company benefits from a full 6 months of revenues.

Upcoming financial communication and investor conference participation

September 12-14, 2022 – C. Wainwright 24th Annual Global Investment Conference
September 15-16, 2022 – KBC Securities Life Sciences Conference
September 28, 2022 – 5th edition – Forum LPB Valeurs Régionales
September 29, 2022 – Half-year Results 2022*
October 6-7, 2022 – Investor Access Event
*Indicative calendar that may be subject to change.

[1] Unaudited data
[2] Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a curative treatment of liquid tumors which affect approximately 22,000 patients every year in the 7 major markets
[3] AP-HP: Assistance Publique – Hôpitaux de Paris
[4] Revenues correspond to compensation invoiced in relation to the compassionate access program, as approved by the French National Drug Safety Agency (Agence Nationale de Sécurité du Médicament or ANSM).

On July 28, 2022 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new approaches for the treatment for cancer and fibrosis, reported that further progress across its small molecule, focal adhesion kinase (FAK) inhibitor program and the release of its Appendix 4C Cash Flow Report (attached) for the quarter ending 30 June 2022 (Press release, Amplia Therapeutics, JUL 28, 2022, View Source;[email protected] [SID1234617098]).

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!

Key Highlights from the Quarter
• Positive pre-IND meeting feedback received from US FDA;
• First site opened for recruitment in ACCENT Phase 2 clinical trial of AMP945 in pancreatic cancer;
• Significant progress in manufacturing and toxicology studies of AMP945.

Operations Update
During the Quarter, Amplia received positive pre-IND (Type B) feedback from the US FDA on the Company’s proposed development plans for its investigational focal adhesion kinase inhibitor, AMP945, in people with pancreatic cancer. The Company also sought FDA’s specific feedback on the design of its ACCENT clinical trial of AMP945 in first-line patients with advanced pancreatic cancer.

The FDA agreed that the available and planned pre-clinical data appear to support both the trial and a future marketing application in the proposed indication. The FDA advised that the design of the ACCENT trial, including selection of the first-line patient population and the proposed dose-escalation followed by a Simon 2-stage design, is generally acceptable. FDA also confirmed Amplia’s understanding that dose selection for the Simon 2 stage expansion phase of the trial should be based on a combined view of safety, efficacy, pharmacokinetics and pharmacodynamics across a wide range of doses.

Additionally, during the Quarter, ethics committee approval was received to conduct the trial and the first site for recruitment of patients to the ACCENT trial was opened at Monash Health in Victoria, Australia. Three additional sites are scheduled to be activated in late July/early August. Previously the Company had forecast that the first patient would be recruited to the trial in the second calendar quarter of 2022 but this target was not met, primarily due to a longer than expected timeline to finalise contracts and governance arrangements with the various clinical sites. These matters have now been resolved allowing the ACCENT trial to recruit patients as planned. In order to recover any delays caused by slower than expected clinical trial start-up, the Company is assessing additional sites, increased patient outreach options and is planning an acceleration of South Korean site activation.

The Company has continued to make progress towards the initiation of a Phase 2 clinical study in Idiopathic Pulmonary Fibrosis patients with completion of dosing in the enabling 3-month toxicology studies of AMP945. Draft reports from these studies are expected in August 2022 and the Company will inform the market of any material outcomes.

Manufacture of AMP945 drug substance for use in non-clinical and clinical studies was also conducted with higher than expected yields of AMP945 being obtained, reflecting improved manufacture process understanding. A manufacture process for AMP945 higher potency drug product capsules was also developed. By delivering doses with fewer capsules, patient convenience and adherence to clinical trial protocols will be enhanced. Ongoing stability studies of AMP945 drug substance and drug product also show that AMP945 remains within specification for extended periods of time, supporting a likely long product shelf-life.

In June, new data from preclinical studies was disclosed showing that AMP945 had comparable activity to OFEV, the current market leader in the treatment of idiopathic pulmonary fibrosis. The Company expects that this new information will encourage interest from both clinical investigators and patients.

After joining the Company in February 2021 as Director Operations, Dr Rhiannon Jones was promoted to Chief Operations Officer (COO) effective July 1, 2022. Dr Jones has been leading much of Amplia’s manufacturing activities and her promotion to this broader role is a reflection of Amplia’s growth into a more mature clinical-stage company.

Financial update
Amplia finished the June 2022 quarter with cash of $12.7 million (March 2022: $14.6 million).

During the quarter, the Company had net cash outflows of $1.8 million in relation to operating activities (March 2022: $2.3 million). Operating cashflows included outflows of:
• $0.3 million for staff and administration/corporate costs; and
• $1.2 million for research and development costs, which primarily related to toxicology studies, ACCENT trial clinical costs and manufacturing costs of AMP945 drug substance and product.

Research and development expenditure is forecast to increase in the coming quarters in line with the commencement of the Phase 2 clinical trial for AMP945, which is expected to commence recruitment in the coming weeks with the first patient expected to be dosed in July-August 2022.

Payments to Related Entities
In accordance with Listing Rule 4.7C, payments made to related parties and their associates included in item 6.1 of the Appendix 4C incorporates directors’ fees, salaries and superannuation. Total payments made for the quarter equals $102,230 and relate to payments to the CEO/Managing Director in line with Dr Lambert’s employment contract and payments to the Non-Executive Directors.

Outlook and future activities
In the coming quarter, the Company expects to report on recruitment progress in the ACCENT trial as well as updates on progression towards optimal dose selection. The Company also expects to receive draft study reports from 3-month toxicology studies and will report top-line outcomes from these studies. Work on Amplia’s second FAK inhibitor, AMP886, is ongoing and outcomes from preclinical and manufacturing development work will be provided when ongoing studies are completed.

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

On July 28, 2022 AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, reported that it will report second quarter 2022 financial results on Thursday, August 4, 2022 (Press release, AVEO, JUL 28, 2022, View Source [SID1234617115]). AVEO’s management team will host a conference call and audio webcast at 4:30 p.m. ET on Thursday, August 4, 2022, to discuss the financial results and provide a business update.

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 call can be accessed by dialing (877) 423-9813 (U.S. and Canada) or (201) 689-8573 (international). The passcode for the conference call is 13730553. To access the live webcast, or the subsequent archived recording, please visit the Calendar of Events sub-section within the Investors section of the AVEO website at www.aveooncology.com.

On July 27, 2022 SHINE Technologies, LLC (SHINE), a next-generation nuclear technology company, reported the company has submitted a Drug Master File (DMF) with the U.S. Food and Drug Administration for non-carrier-added lutetium-177 (Lu-177) chloride, a radiopharmaceutical at the forefront of precision cancer treatment (Press release, Shine Medical Technologies, JUL 27, 2022, View Source [SID1234618509]).

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!

In targeted cancer therapy, the cancer-killing radioisotope Lu-177 is paired with a cancer-seeking molecule to form a smart compound that directly targets and attacks cancer cells.

SHINE is the emerging leader in the production of this medical radioisotope. With its proprietary technology, SHINE intends to be the industry’s only vertically integrated producer of Lu-177, providing a reliable and scalable supply without the need for aging nuclear reactors.

The DMF submission provides confidential detailed information about facilities, procedures, or articles used in the manufacturing, processing, and storing of drugs. It is a clear commitment to the several companies that have requested letters of authorization to access SHINE’s drug master file in support of their clinical trials which are underway to fight cancer. And it is also an important step in SHINE’s path to meeting the increasing global demand for Lu-177.

"As global demand for lutetium-177 increases, SHINE is poised to scale our operations and be the preferred partner for customers seeking a high-quality, reliable supply of lutetium-177," said Chris Vessell, general manager of SHINE’s Therapeutics Division.

"We’ve been producing lutetium-177 that meets or exceeds customer specifications for some time now, and the DMF submittal represents the next step in getting our product into regular commercial use." said Greg Piefer, founder and CEO of SHINE Technologies. "We’re looking forward to growing our vertically-integrated and sustainable process to ensure the world has scalable access to these game-changing, cancer-destroying products as new therapies are approved."

On July 27, 2022 Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, reported that it will report the company’s second quarter 2022 financial results on Thursday, August 4, 2022 after the close of the U.S. financial markets (Press release, Aligos Therapeutics, JUL 27, 2022, View Source [SID1234616994]).

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!