On March 30, 2023 Agenus Inc. (Nasdaq: AGEN), an immuno-oncology company with a pipeline of immunological agents targeting cancer and infectious disease, reported that its Board of Directors has declared a dividend of 5 million shares of common stock of its subsidiary, MiNK Therapeutics, Inc. ("MiNK"), to shareholders of Agenus as of April 17, 2023 (the "Record Date") (Press release, Agenus, MAR 30, 2023, View Source [SID1234629573]). MiNK is a clinical-stage precision oncology company developing allogeneic, invariant natural killer T cell therapies and operates as a separate publicly traded company.

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!

"We are excited to declare the distribution of MiNK equity dividend, demonstrating our commitment to delivering additional value for our shareholders," said Garo H. Armen, Chairman and CEO of Agenus. With the upcoming year, MiNK aims to extend its solid tumor program and harness its robust groundwork to expedite the development of cell therapies that hold promise in saving lives. This distribution exemplifies our unwavering confidence in MiNK’s approach and empowers our shareholders to participate in MiNK’s future growth through direct ownership."

On March 15, 2023, MiNK announced plans to present updated clinical data and development plans for its allogeneic invariant natural killer T cells (iNKTs), agenT-797, alone or in combination with pembrolizumab or nivolumab in patients with advanced solid tumors at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 14-19th, 2023.

About the Dividend

The dividend of 5 million shares of MiNK common stock will be made to all Agenus shareholders of record as of April 17, 2023, on a pro rata basis. The Dividend Distribution will be paid no earlier than April 27, 2023, or later than May 17, 2023.

No fractional shares will be issued. Agenus shareholders who otherwise would be entitled to receive fractional shares of the Dividend Distribution shall receive cash (without interest or deduction) in lieu of such fractional shares. The amount will be equal to the product obtained by multiplying (a) the closing price of the MiNK Common Stock on the Nasdaq Capital Market on the Record Date, by (b) the fraction of one share of MiNK Common Stock that such shareholder would have otherwise been entitled to receive as a Dividend in respect of shares of Agenus Common Stock held by such shareholder (after aggregating all such fractional shares otherwise issuable to such shareholder in connection with the Dividend).

On March 30, 2023 Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, reported financial results for the full-year ended December 31, 2022, and provided a corporate update (Press release, Addex Therapeutics, MAR 30, 2023, View Source [SID1234629572]).

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!

"Our partner, Janssen made excellent progress in advancing the ADX71149 phase 2 clinical study in epilepsy patients and we look forward to the recommendation from the independent interim review committee, established to review the data from part 1," said Tim Dyer CEO of Addex. "We continue to make solid progress across our preclinical portfolio. In parallel, we are continuing to focus on pursuing collaborative arrangements to secure the financial resources and specialist expertise to advance development and strengthen our balance sheet."

2022 Operating Highlights:

ADX71149 epilepsy Phase 2 study part 1 completed with Independent interim review committee recommendation expected early Q2 2023
Dipraglurant is Phase 2 ready – future development in PD-LID, post-stroke recovery and pain under evaluation
mGlu7 NAM for stress related disorders, including PTSD – drug candidate selected for IND enabling studies, with study preparation underway
GABAB PAM strategic partnership with Indivior for substance use disorders extended – multiple drug candidates in clinical candidate selection phase
GABAB PAM CMT1A, chronic cough and pain program profiling multiple drug candidates
Continued to progress with mGlu2 NAM mild neurocognitive disorders program
M4 PAM schizophrenia program progressing well through lead optimization
Partnering discussions across the portfolio progressing well
Completed the close-down of dipraglurant PD-LID development and implemented cost saving measures
Completed offering in July 2022 raising gross proceeds of $4.2 million
Key 2022 Financial Data

CHF’ thousands 2022 2021 Change
Income 1,445 3,153 (1,708)
R&D expenses (14,665) (12,840) (1,825)
G&A expenses (7,300) (5,819) (1,481)
Total operating loss (20,520) (15,506) (5,014)
Finance result, net (284) 154 (438)
Net loss for the period (20,804) (15,352) (5,452)
Basic and diluted net loss per share (0.46) (0.45) (0.01)
Net increase / (decrease) in cash and cash equivalents (13,528) 1,790 (15,318)
Cash and cash equivalents 6,957 20,485 (13,528)
Shareholders’ equity 4,913 16,931 (12,018)
Financial Summary:

Income is primarily from our funded research collaboration with Indivior. Income decreased by CHF 1.7 million to CHF 1.4 million in 2022 compared to CHF 3.2 million in 2021. The decrease is a reflection of the positive progression of the collaboration into late stages of clinical candidate selection and the transfer of R&D activities to Indivior.

R&D expenses increased by CHF 1.8 million to CHF 14.6 million in 2022 compared to CHF 12.8 million in 2021, mainly due to increased outsourced R&D expenses for CHF 1.0 million and increased share-based compensation costs for CHF 0.6 million.

G&A expenses increased by CHF 1.5 million to CHF 7.3 million in 2022 compared to CHF 5.8 million in 2021, primarily due to higher share-based compensation costs.

The net loss was CHF 20.8 million in 2022 compared to CHF 15.4 million in 2021. Net loss increased by CHF 5.5 million, primarily due to our increased expenses and decreased income. Basic and diluted loss per share increased to CHF 0.46 for the year ended December 31, 2022, compared to CHF 0.45 for the year ended December 31, 2021.

Cash and cash equivalents decreased to CHF 7.0 million at December 31, 2022, compared to CHF 20.5 million at December 31, 2021. This decrease of CHF 13.5 million is mainly due to our net loss of CHF 20.8 million adjusted for non-cash expense items such as share based compensation of CHF3.7 million and net proceeds of CHF 3.7 million from the offering executed on July 22, 2022.

2022 Consolidated Financial Statements:
The full-year 2022 financial report can be found on the Company’s website in the investor/download section here.

Conference Call Details:
A conference call will be held today, March 30, 2023, at 16:00 CEST (15:00 BST / 10:00 EDT / 07:00 PDT) to review the financial results. Tim Dyer, Chief Executive Officer and Robert Lütjens, Head of Discovery – Biology will deliver a brief presentation followed by a Q&A session.

Joining the Conference Call:

Participants are required to register in advance of the conference using the link provided below. Upon registering, each participant will be provided with Participant Dial-in numbers, and a unique Personal PIN.

In the 10 minutes prior to the call’s start time, participants will need to use the conference access information provided in the e-mail received at the point of registering. Participants may also use the call me feature instead of dialing the nearest dial in number.

Online Registration: https://register.vevent.com/register/BI8f6a1aee693c405ebc85b10adfa18648

Webcast URL: View Source

On March 30, 2023 Abcam plc (Nasdaq: ABCM), a global leader in the supply of life science research tools, reported that, following release on 20 March 2023 of its final results for the year ended 31 December 2022 on Form 20-F with the Securities and Exchange Commission, the Abcam plc Annual Report and Accounts 2022 (the "Annual Report") have been published today and are available on the Abcam plc website at corporate.abcam.com (Press release, Abcam, MAR 30, 2023, View Source [SID1234629571]).

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 Annual Report will also be posted today, together with the Notice of Annual General Meeting, to those shareholders that have elected to receive paper communications. Shareholders that have not elected to receive paper communications will be notified of the availability of these documents on Abcam plc website at corporate.abcam.com. The Form 20-F can also be accessed on the Abcam plc website at corporate.abcam.com. Shareholders that have not elected to receive paper communications may still receive a hard copy of these documents upon request.

On March 30, 2023 AstraZeneca reported that it has completed an exclusive global license agreement with KYM Biosciences Inc for CMG901, a potential first-in-class antibody drug conjugate (ADC) targeting Claudin 18.2, a promising therapeutic target in gastric cancers (Press release, AstraZeneca, MAR 30, 2023, View Source [SID1234629527]).

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!

CMG901 is currently being evaluated in a Phase I trial for the treatment of Claudin 18.2-positive solid tumours, including gastric cancer. Preliminary results from the trial have shown an encouraging profile for CMG901, with early signs of anti-tumour activity across the dose levels tested.

Financial considerations
AstraZeneca has entered into an exclusive global license for the research, development, manufacture and commercialisation of CMG901 for an upfront payment of $63m, with potential development and sales-related milestone payments of up to $1.1bn and tiered royalties up to low double digits.

The transaction does not impact AstraZeneca’s financial guidance for 2023.

i. KYM Biosciences is a joint venture established by affiliates of Keymed Biosciences and Lepu Biopharma.

Notes

CMG901
CMG901 is a novel antibody drug conjugate targeting Claudin 18.2, and consists of an anti-Claudin 18.2 monoclonal antibody, a protease-degradable linker, and a cytotoxic small molecule monomethyl auristatin E (MMAE). CMG901 is being developed for the treatment of solid tumours that express the cell surface protein Claudin 18.2, including gastric cancers. CMG901 is owned by KYM Biosciences Inc. (KYM), a joint venture established by affiliates of Keymed Biosciences (70% of KYM ownership) and Lepu Biopharma (30% of KYM ownership).

AstraZeneca in gastrointestinal cancers
AstraZeneca has a broad development programme for the treatment of gastrointestinal (GI) cancers across several medicines and a variety of tumour types and stages of disease. In 2020, GI cancers collectively represented approximately 5.1 million new cancer cases leading to approximately 3.6 million deaths.1

Within this programme, the Company is committed to improving outcomes in gastric, liver, biliary tract, oesophageal, pancreatic and colorectal cancers.

Imfinzi (durvalumab) is approved in the US in combination with chemotherapy (gemcitabine plus cisplatin) for advanced biliary tract cancer and in combination with Imjudo in unresectable hepatocellular carcinoma. Imfinzi is being assessed in combinations, including with Imjudo in liver, oesophageal and gastric cancers in an extensive development programme spanning early to late-stage disease across settings.

Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate, is approved in HER2-positive advanced gastric cancer and is being assessed in colorectal cancer. Enhertu is jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Lynparza (olaparib), a first-in-class PARP inhibitor, is approved in BRCA-mutated metastatic pancreatic cancer. Lynparza is developed and commercialised in collaboration with MSD (Merck & Co., Inc. inside the US and Canada).

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On March 29, 2023 REGiMMUNE Limited (REGiMMUNE), a biotech company focused on creating innovative immunotherapies for immune disorders and cancer, and San Fu Biotech (SFB), a subsidiary of San Fu Chemical Co., Ltd. (4755.TW) reported to have entered a licensing agreement to develop and commercialize RGI-2001 for the prophylaxis of acute Graft-versus-host disease (aGvHD) in major Asian countries (Press release, REGimmune, MAR 29, 2023, View Source [SID1234642230]).

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!

RGI-2001, with the novel mechanism to improve existing treatments, is a potentially first-in-class small molecule drug candidate targeted for preventing aGvHD, a life-threatening complication resulting from allogeneic hematopoietic stem cell transplantation (HSCT). GvHD is a systemic disorder that occurs when the graft’s immune cells recognize the host as foreign and attack the recipient’s body cells or organs, and leads to skin rash, liver problems, abdominal pain or cramps, diarrhea, and increased risk for infections. Patients undergoing allogeneic HSCT have a high-risk of developing aGVHD associated with significant morbidity and mortality. Despite the use of prophylactic immunosuppressive therapy, clinically significant aGvHD develops in 20%-40% of HLA-matched related and unrelated allogeneic HSCT and severe cases contribute to non-relapse mortality.

Under the terms of agreement, REGiMMUNE and SFB will collaborate closely to accelerate the development of RGI-2001 in major Asian countries and will conduct clinical trials to study the efficacy of the drug in aGvHD. Together, both parties intend to submit an Investigational New Drug Application to the Taiwan Food and Drug Administration to initiate clinical trials in Taiwan for the prophylaxis of aGvHD before the end of 2023. SFB will pay to REGiMMUNE development milestones and royalties on net profit upon successful commercialization of RGI-2001. SFB also retains the first rights of negotiation to develop and commercialize RGI-2001 for new indications in the authorized territories.

RGI-2001 of REGiMMUNE, awarded Orphan Drug Designation by the US FDA in GvHD in 2012, has completed the phase II clinical trial targeting at the prophylaxis of aGvHD in the US. The efficacy and safety results were positive. Furthermore, RGI-2001 was selected for oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2022 and planned to submit phase III IND to US FDA in Q4 of 2023.

Kenzo Kosuda, Chief Executive Officer and President, REGiMMUNE Limited, said: "This agreement underscores our focus and commitment to improve the incumbent therapies of aGvHD prevention and treatment. The fast-growing patients with GvHD in Asia create a high unmet need for more effective treatments."

"We are pleased to collaborate with SFB and San Fu Chemical Group which has a long history in Taiwan. The Group’s abundant biomedical resources, expertise and innovative strategy make San Fu a strong commercial partner for REGiMMUNE in Asia. Together, we look forward to expediting the development of RGI-2001 in this important market."

Simon H.H. Wu, SFB & San Fu Chemical Group Chairman, emphasized: "We are excited to add RGI-2001 to our growing portfolio of innovative therapeutic agents. This enhances our autoimmune pipeline and aligns with our long-term research and development strategy. RGI-2001 has demonstrated promising results in phase II studies in the US and we look forward to working together with REGiMMUNE to deliver treatments that will benefit the lives of patients."