On February 28, 2022 AB Science S.A. (the "Company" or "AB Science", Euronext – FR0010557264 – AB) reported that it reached an agreement with a historical investor on a financing of USD 8.5 million through the issuance of bonds convertible into new ordinary shares (the "OCA") with attached warrants (the "Warrants" and, with the OCA, the "OCABSA") (Press release, AB Science, FEB 28, 2022, View Source [SID1234609089]).

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50,000 OCABSA will be issued, representing a nominal value of USD 8.5 million. It will reinforce the cash position of AB Science for the development of its clinical research program.

Terms of the issuance
The settlement delivery of the OCABSA will happen at the latest on March 7, 2022. The board of AB Science authorized, on February 27, 2022, this issuance based on the 20th resolution of the June 20, 2021 shareholders’ meeting. The OCABSA will be issued through a private placement (withing the meaning of article L. 411-2 of the French Financial and Monetary Code) without preferential subscription right for existing shareholders.

The issuance of the OCABSA, the conversion of the OCA into ordinary shares of AB Science and the exercise of the Warrants, as the case may be, will not be subject to any prospectus to be filed with the French Autorité des marchés financiers.

Main terms and conditions of the OCA
50,000 OCA will be issued at their par value of USD 170,0 each (the "PV"), representing a total par value of USD 8.5 million.

The OCA will not be listed on Euronext Paris.

The OCA will be freely tradable. They will mature withing three years from their issuance date (the "Maturity Date") and they will bear an interest based on the one-month Bloomberg Short Term Bank Yield (1M BSBY) + 350 basis points per year, payable on a monthly basis.

Each OCA will be convertible at any time, at the option of its holder only, into a number of ordinary shares equals to the result of the following formula: "PV / 14" (the "Conversion Basis"). Each OCA will be convertible, at the option of AB Science (during 10 trading days), on the same Conversion Basis, (i) if the AB Science closing market price, during a trading session, is above EUR 18.0, and (ii) the average daily trading volume (during a minimum of 10 consecutive trading days before the conversion) is above EUR 1,0 million.

The OCA that will not be converted before the Maturity Date will be redeemed by AB Science at their par value.

In any case, the number of ordinary shares that could be issued following the conversion of the OCA will be caped so that AB Science will not break the 20% threshold of article 1st§5 a) and b) of the EU Regulation 2017/1129. The OCA that will not be converted pursuant to this cap will be redeemed in cash.

Main terms of the Warrants
One Warrant will be attached to each OCA. It will be detached from the OCABSA immediately after the issuance.

The Warrants will not be listed on Euronext Paris.

The Warrants will be freely tradable and will be exercisable from their issuance until December 31, 2030 (the "Exercise Period"). The Warrants not exercised at the end of the Exercise Period will be null and void.

Each Warrant will give the right to its holder, during the Exercise Period, to subscribe to one ordinary share of AB Science. The subscription price of one ordinary share upon exercise of a Warrant will be equal to 12.65 euros.

Ordinary shares issued following the conversion of the OCABSA or exercise of the Warrants
The ordinary shares to be issued upon conversion of the OCA or following the exercise of the Warrants will be fungible in all respects with AB Science existing ordinary shares. They will be admitted to trade on the regulated market of Euronext Paris under the existing ISIN securities identification code for AB Science’s ordinary shares (code ISIN FR0010557264).

Impacts of the issuance in term of cash management
AB Science expects that, based on its gross cash position on December 31, 2021, its financial option with the EBI and the amount of research tax credit to be collected, the issuance of the OCA and the potential exercise of the Warrants will allow AB Science to finance its activities for the coming 12 months at least.

AB Science shareholding structure after issuance of the OCABSA, conversion of the OCA and exercise of Warrants (based on the euro/dollar conversion rate on February 25, 2022, i.e. 1/1.1272)
Following the issuance of the OCABSA, AB Science share capital will be EUR 537,078.85 (with 47,399,948 ordinary shares) and EUR 537,578.85 (with 47,449,948 ordinary shares) in the event of exercise of all the Warrants, representing 101.01% of the total current share capital of AB Science (or 101.11% in the event of exercise of all the Warrants).

On an illustrative basis, a shareholder holding 1% of AB Science’s share capital before the conversion of the OCA and who did not participate in will hold 0.9900% of the AB Science’s shares after the conversion of the OCA and 0.9891% if all the Warrants are exercised.

Shareholder

Before issuance of the OCABSA After conversion of the OCA After exercise of the BSA
Ordinary shares % Ordinary shares % Ordinary shares %
A. Moussy 1,255,362 2.68% 1,255,362 2.65% 1,255,362 2.65%
AMY SAS 12,273,000 26.19% 12,273,000 25.89% 12,273,000 25.87%
Concert (A. Moussy and AMY SAS excluded) 5,257,931 11.22% 5,257,931 11.09% 5,257,931 11.08%
Other investors 28,075,036 59.91% 28,613,665 60.37% 28,663,665 60.41%
Total 46,861,329 100.00% 47.399.958 100.00% 47.449.958 100.00%
Disclaimer
In France, the offer of AB Science securities described above will take place solely as a private placement, in accordance with Article L. 411-2 of the of the French Monetary and Financial Code and applicable regulations. The offering does not constitute a public offering in France, as defined in Article L. 411-1 of the French Monetary and Financial Code.

With regard to the Member States of the European Economic Area which have transposed Directive 2003/71/CE of the European Parliament and of the Council of November 4, 2003 (as amended in particular by Directive 2010/73/EU, insofar as this directive has been transposed in each of the Member States of the European Economic Area), no action has been taken and will not be taken to allow a public offer of the securities subject of this press release making necessary to publish a prospectus in either of the Member States.

This press release and the information it contains does not, and will not, constitute a public offering to subscribe for or sell, nor the solicitation of an offer to subscribe for or buy, securities of AB Science in the United States or any other jurisdiction where restrictions may apply. Securities may not be offered or sold in the United States absent registration or an exemption from registration under the US Securities Act of 1933, as amended and applicable State securities laws. AB Science does not intend to register securities or conduct a public offering in the United States.

This distribution of this press release may be subject to legal or regulatory restrictions in certain jurisdictions. Any person who comes into possession of this press release must inform him or herself of and comply with any such restrictions.

On February 28, 2022 Harbour BioMed ("HBM", HKEX: 02142) reported that, it has been approved by the Institutional Review Boards (the "IRBs") to commence phase I trial of its B7H4x4-1BB bispecific antibody (HBM7008) in Australia (Press release, Harbour BioMed, FEB 28, 2022, View Source [SID1234609083]). This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of HBM7008 in patients with solid tumors.

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HBM7008 is generated from our unique and innovative HBICE platform. It targets Tumor Associated Antigen (B7H4), mediated crosslinking T cell activation through 4-1BB. B7H4 is overexpressed on a variety of solid malignancies, including breast, ovarian, endometrial and non-small cell lung cancers. With its crosslinking dependent specificity on tumors and potent immune modulation activity, HBM7008 has shown excellent safety profile with strong anti-tumor efficacy in the pre-clinical study, including completed response observed in mouse tumor model.

"4-1BB is one of the most promising anti-tumor immune targets, providing new solutions for tumor treatment. Based on preclinical study data, we are highly confident in B7H4x4-1BB bispecific antibody. We will efficiently promote this clinical study to provide an novel, effective and safe treatment for patients, so that more tumor patients can benefit from the innovative therapeutic." said Dr. Xiaoxiang Chen, Chief Development Officer of Harbour BioMed.

About HBM7008

HBM7008 is a bispecific antibody targeting Tumor Associated Antigen B7H4x4-1BB that not only displays high potency in the T cell co-stimulation and tumor growth inhibition, and potentially may also translate to better safety due to its strict dependency of TAA-mediated crosslinking T cell activation. HBM7008 is one of the fully human bispecific antibodies developed from the HBICE platform of the Company. It is the only bispecific antibody against these two targets globally. Its unique specificity on tumors and immune modulation activity makes it a promising therapeutics in PD-L1 negative or PD-1/PD-L1 resistant patients. It also has the potential to avoid 4-1BB liver toxicity risk observed in other products with the benefit of its innovative biology mechanisms and bispecific design.

On February 28, 2022 Patrys reported that it has now developed and optimised a stable cell line for production of our full-sized IgG deoxymab, PAT-DX3 (Press release, Patrys, FEB 28, 2022, View Source [SID1234609081]).

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Establishing a stable, high-yield cell line suitable for commercial production of clinical-grade material is a critical milestone for the Company. Work can now commence on the development of a commercial scale manufacturing process for GMP‑grade (Good Manufacturing Practice) PAT-DX3 deoxymab.

Patrys CEO and Managing Director, Dr James Campbell said:

"There is significant of interest in PAT-DX3 both as a therapeutic agent in its own right and for the intracellular delivery of therapeutic payloads intracellularly, and across the blood brain barrier. With this key reagent now developed and in hand, we can rapidly move into optimising a commercial-scale production process to support both the clinical and partnering opportunities we have for PAT-DX3."

On February 27, 2022 JW Therapeutics (HKEx: 2126), an independent, innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, reported that the National Medical Products Administration (NMPA) of China accepted the supplemental New Drug Application (sNDA) for its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva (relmacabtagene autoleucel injection) for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) (Press release, JW Therapeutics, FEB 27, 2022, View Source [SID1234609085]). This is the second marketing application on Carteyva submitted by JW Therapeutics, and is expected to be the first cell therapy product approved in China for the treatment of r/r FL patients. Carteyva was granted Breakthrough Therapy Designation by NMPA in September 2020.

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The sNDA was supported by the clinical results from cohort B of a single-arm, multi-center, pivotal study (RELIANCE study) on Carteyva in adult patients with relapsed or refractory B cell non-hodgkin lymphoma in China. The study results were presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2021. The cohort B results showed that Carteyva demonstrated very high rates of durable disease response (Best Complete Response Rate and Overall Response Rate at 3 months was 92.6% and 100%, respectively) and controllable CAR-T associated toxicities in patients with r/r FL (42.9% and 17.9% of the patients had any grade Cytokine Release Syndrome (CRS) and Neurotoxicity (NT), while 0% and 3.6% of the patients experienced CRS and NT of Grade 3 or above).

Professor Yuqin Song, Chief Physician of Lymphoma Department at Peking University Cancer Hospital, Director of China Society of Clinical Oncology (CSCO), noted at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting: "The RELIANCE study results show that Carteyva demonstrated very excellent efficacy and safety profile in patients with r/r FL and we are looking forward to the sNDA approval in China."

About Relmacabtagene Autoleucel Injection (trade name: Carteyva)

Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name: Carteyva) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, relma-cel was approved by the China National Medical Products Administration (NMPA) in September 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, making it the first CAR-T product approved as Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, granted priority review and breakthrough therapy designations.

About RELIANCE Study (NCT04089215)

RELIANCE study was a single-arm, multi-center, pivotal study to evaluate the efficacy and safety of Carteyva in adult patients with relapsed or refractory B cell non-hodgkin lymphoma (cohort A: relapsed or refractory large B-cell lymphoma, cohort B: relapsed or refractory follicular lymphoma) in China.

RELIANCE cohort B study enrolled 28 patients with r/r FL who had failed the second-line (or above) therapy, including an anti-CD20 agent and anthracycline. Patients received 100*106 CAR-T or 150*106 CAR-T cell of Carteyva infusion, and followed up until 2 years or above for long term outcomes. As of the cut-off date of September 10, 2021, of 27 evaluable patients, the Complete Response Rate (CRR) and Overall Response Rate (ORR) at 3 months were 85.19% and 100%, and the Best Complete Response Rate and Overall Response Rate was 92.6% and 100%, respectively. Of 28 treated patients, 42.9% and 17.9% of the patients had any grade Cytokine Release Syndrome (CRS) and Neurotoxicity (NT), Among these AEs, no CRS of Grade 3 or above occurred, and only 3.6% of the patients experienced NT of Grade 3 or above.

On February 27, 2022 Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, reported the successful dosing of first patient in China Phase IIa Study of TST001, a Claudin18.2 monoclonal antibody, combined with Cisplatin and Gemcitabine for the first line treatment of systemic treatment-naïve locally advanced or metastatic biliary tract cancer patients (Press release, Transcenta, FEB 27, 2022, View Source [SID1234609084]). Globally Transcenta is the first company exploring the potential of Claudin 18.2 targeting agent in biliary tract cancer.

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Biliary tract cancer is a relatively rare malignancy, which includes cholangiocarcinoma and gallbladder carcinoma. Cholangiocarcinoma is further classified into extrahepatic and intrahepatic cholangiocarcinoma. In the treatment of biliary tract cancer, radical resection is the standard and only approach for patients at the early stage. However, most of the patients cannot receive surgical resection, as the cancer has stepped into the metastatic stage by the time of diagnosis. For biliary tract cancer, few effective therapies are available for these patients, which leaves significant unmet clinical needs.

This Phase IIa clinical trial is an open-label, single-arm, multi-center study designed to evaluate the safety, tolerability, and anti-tumor efficacy of TST001 in patients with systemic treatment-naïve locally advanced or metastatic biliary tract cancer. These patients will be screened using an immunohistochemistry assay developed by Transcenta and validated by central lab that specifically detects Claudin18.2 but not Claudin 18.1.

"Biliary tract cancer has poor prognosis and the combination of Cisplatin and Gemcitabine is the standard of care for first line treatment." said Dr. Michael Shi, EVP, Head of Global R&D and CMO of Transcenta." Using our proprietary IHC antibody, Transcenta has shown that Claudin18.2 is over-expressed in the tumor of a subset of biliary tract cancer patients. As the combination of Claudin18.2 targeting agent with chemo backbone has shown promising activity in first line gastric cancer, the addition of TST001 to the first line chemotherapy regimen may also provide better treatment benefit to biliary tract cancer patients with Claudin18.2-expressing tumor."

About TST001
TST001 is a high affinity humanized anti-Claudin18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) activities and potent anti-tumor activities in tumor xenograft models. TST001 is the second Claudin18.2 targeting antibody therapeutic candidate being developed globally. TST001 is generated using Transcenta’s Immune Tolerance Breaking Technology (IMTB) platform. TST001 kills Claudin18.2 expressing tumor cells by mechanisms of antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Leveraging advanced bioprocessing technology, the fucose content of TST001 was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of TST001. Clinical trials for TST001 are ongoing in China and US (NCT04396821, NCT04495296/CTR20201281). TST001 was granted Orphan Drug Designation in the US by FDA for the treatment of patients with gastric cancer or gastroesophageal junction (GC/GEJ).