On May 7, 2021 Defence Therapeutics Inc. ("Defence" or the "Company"), a Canadian biotech Company focused on the development of novel and highly specific vaccines and antibody-drug conjugates targeting cancer and infectious diseases reported that it begin its trading on the CSE as of today

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The primary objective and business of Defence is the research, development and advancement of three main products using its proprietary Accum technology:
– Dendritic Cell (DC) cancer vaccines using Accum (AccuvacTM).
– A new protein-based vaccine formulation against COVID and infectious disease.
– ADCs (Antibody Drug Conjugates) targeting various cancer.

AccuvacTM: for Dendritic Cell cancer vaccines
Defence has optimized the chemical manufacturing of its experimental antigens to efficiently link the Accum moiety. When used to pulse DCs, these modified antigens were shown to breakdown endosomal membranes leading to efficient processing, presentation and activation of responding T cells. The prophylactic vaccination led to 100% protection against cancer growth. This process was rechallenged three times and led to a continue 100% protection against cancerous tumor growth.

Therapeutic vaccination of animals with pre-established tumors triggered a substantial delay in tumor growth as a stand-alone therapy. Combination of AccuvacTM to the immune-checkpoint inhibitor anti-PD1 cured 70% of treated animals.

To build upon this success, Defence is developing second and third generation Accum moieties to further enhance the potency and the efficacy of the AccuvacTM.
Defence has engineered two Accum variants with direct anti-tumoral effects. The results of the Accum variants displayed efficiency at killing melanoma, lymphoma, colon and breast cancer cells in vitro. In vivo studies are currently ongoing to test the intratumoral delivery of these variants as a means to induce regression of established tumors.

A COVID Vaccine
Defence is using the Accum technology to develop a distinct COVID-19 protein-based vaccine. So far, the vaccine is highly immunogenic in tests with rodent animals with antibody titers lasting for more than 16 weeks. In addition, the generated antibodies "neutralized" the ability of pseudotyped viruses (an artificial virus with COVID-19 S proteins) from infecting cells. Defence is currently preparing the initiation of IND-enabling studies while preparing to begin the Phase I trial.

Antibody Drug Conjugates
Defence has demonstrated that the Accum technology enhances the ability of the ADC Kadcyla (T-DM1) to specifically target and kill breast cancer cells. Defence completed the synthesis of 18 different Accum-variants conjugated to T-DM1 at 10X ratio. A toxicity screening will be performed in the near future on the selected breast cancer cell line to identify additional leads. A Phase 1 clinical trial for breast cancer is currently being prepared.

On May 7, 2021 Luye Pharma Group announced that its biopharmaceutical drug 博优诺 (Bevacizumab Injection), developed by the Group’s holding subsidiary Boan Biotech, has received marketing authorization from China’s National Medical Products Administration (NMPA), for the treatment of advanced, metastatic or recurrent non-small-cell lung cancer (NSCLC), and metastatic colorectal cancer (Press release, Luye Pharma, MAY 7, 2021, View Source [SID1234597708]). 博优诺 is the third biosimilar of Avastin to enter the market in China, as well as the first product from Boan Biotech’s pipeline to receive marketing authorization.

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博优诺 and Avastin are Equivalent in Efficacy – Bevacizumab is a Standard Therapy for the Treatment of Multiple Cancers

The marketing approval for 博优诺 is based on the Guidelines on Similarity Evaluation and Indication Extrapolation of Biosimilars issued by the NMPA’s China Center for Drug Evaluation in February 2021. 博优诺 and Avastin were compared head-to-head in two pivotal clinical studies – the first was a pharmacokinetic(PK) study among healthy subjects, and the second was a comparative study of efficacy and safety in metastatic or recurrent non-squamous NSCLC patients. Both studies met primary endpoints, demonstrating that 博优诺 and Avastin are equivalent in efficacy and highly similar in terms of PK characteristics, safety, and immunogenicity.

As a classic anti-angiogenic oncology drug, Bevacizumab is considered standard therapy and is recommended by a number of guidelines worldwide for treating multiple malignant tumors. The drug is indicated for the treatment of NSCLC, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, ovarian cancer, and other solid tumors worldwide, with its efficacy and safety widely recognized by physicians and patients through its long-term clinical use. According to the Guidelines on Similarity Evaluation and Indication Extrapolation of Biosimilars, all indications for Avastin approved in China can also be gradually applied to 博优诺.

In addition, the combination of Bevacizumab and paclitaxel provides unique advantages in treatment. 博优诺 can be used with Luye Pharma’s core product paclitaxel liposome injection (Lipusu) to achieve a good synergy effect.

Preparing to Market 博优诺 – Meeting Patient Needs

According to data from the World Health Organization’s International Agency for Research on Cancer, the number of new cancer cases reported in 2020 in China was 4.57 million, the highest in the year and accounting for 23.7% of the total in the world. Lung cancer and colorectal cancer are the two cancers with the highest incidence rate in China, with 820 thousand and 560 thousand new cases each, respectively. Based on the high and ever-increasing number of patients in these two disease areas, the approval of 博优诺 is expected to help patients gain access to high-quality medication and address unmet needs.

Meanwhile, Bevacizumab Injection has been included in China’s National Reimbursement Drug List, further increasing accessibility. As the third biosimilar of Avastin to enter Chinese market, 博优诺 is expected to have optimistic prospects. According to the data from IQVIA, global sales of Bevacizumab Injection totaled USD 6.09 billion, with sales in China accounting for RMB 3.63 billion in 2020.

Through comprehensive leverage of its expertise along the whole industry value chain, Boan Biotech has been active in the preparation for 博优诺 entering the market, in manufacturing, sales team building, market access channels, and other areas. In addition, Luye Pharma Group’s long-term accumulated resources and expansive networks in the field of oncology are also expected to bring synergetic effects to enable the success of 博优诺.

Boan Biotech’s Rapid R&D Pipeline Development – Efficiency in Innovation

Boan Biotech’s antibody discovery research is based on three technology platforms: Human Antibody Transgenic Mouse and Phage Display Technology, Bispecific T-cell Engager Technology, and ADC Technology. By leveraging its efficient and innovative capabilities, the company has developed more than 10 innovative antibody product candidates with international intellectual property protection, and 8 biosimilar products including 博优诺 .

"We are delighted to see 博优诺 become the first product from Boan Biotech’s pipeline approved for marketing, and hope it will bring benefit to patients in need of high-quality and affordable anti-angiogenic treatment." said Jiang Hua, Chief Executive Officer of Boan Biotech, "The approval of 博优诺 is an important milestone for us and validates our efforts in the field with a tangible and substantial payoff. Focusing on the development of biopharmaceuticals, we hope to further accelerate R&D progress with more innovative products, serving more patients in China and around the globe."

In addition to 博优诺, Boan Biotech has a series of biopharmaceutical products in various stages of clinical development, including LY-CovMab, an innovative antibody for the treatment of COVID-19, which has completed phase I clinical trial in China and is soon to start the phase II clinical trials in China, the U.S. and Europe. Other Boan Biotech biosimilar products are expected to bear fruit in the near future. Phase III clinical trials in China for LY06006 (a biosimilar of Prolia) are nearing completion, with final administration of the drug completed for all the subjects, and the drug already receiving approval for clinical trials in Europe and the U.S. LY01011 (A biosimilar of Xgeva) is undergoing phase III clinical trials in China and phase I clinical trials in Europe and the U.S., and LY09004, a biosimilar of Eylea is also undergoing phase III clinical trials in China.

On 7 May 2021, Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, MAY 7, 2021, View Source [SID1234580209]). This programme is part of the overall share repurchase programme of up to DKK 18 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 7 May 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.3 billion in the period from 10 May 2021 to 3 August 2021.

Since the announcement of the programme, the following transactions have been made:

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 11,582,275 B shares of DKK 0.20 as treasury shares, corresponding to 0.5% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Transactions related to Novo Nordisk’s incentive programmes have resulted in a net transfer from Novo Nordisk of 54,160 B shares in the period from 10 May 2021 to 12 May 2021. The shares in these transactions were not part of the Safe Harbour repurchase programme.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 18 billion during a 12- month period beginning 3 February 2021. As of 12 May 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 12,743,777 B shares at an average share price of DKK 452.30 per B share equal to a transaction value of DKK 5,763,990,091.

On May 7, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, reported an update on its clinical and preclinical programs (Press release, Immutep, MAY 7, 2021, View Source [SID1234579569]).

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Eftilagimod alpha ("efti") Update

AIPAC – Phase IIb clinical trial

The Company is on track to report final overall survival (OS) data from this metastatic breast cancer trial in H2 of calendar year 2021. Currently the trial has reached approximately 72% of events, indicating 72% of total patients with this late-stage cancer had been followed through until death. Immutep previously reported an improving OS trend from initial data from approximately 60% of events at the San Antonio Breast Cancer Conference in December 2020.

TACTI-002 (also designated KEYNOTE-798) – Phase II clinical trial

The study is continuing to enroll 1st line non-small cell lung cancer (NSCLC) patients (Part A), with 54 patients out of up to 110 patients now enrolled and having received at least the first treatment. Immutep and its collaboration partner, Merck & Co. Inc, Kenilworth, NJ, USA ("MSD") expanded Part A of the TACTI-002 study to up to 110 patients following the encouraging results presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) Congress in November 2020.

Recruitment is also ongoing for patients with 2nd line NSCLC (Part B) which was expanded under the study’s Simon’s two-stage clinical trial design. Currently, 27 patients of a total of 36 patients have received the first treatment. In 2nd line head and neck squamous cell carcinoma (HNSCC, Part C) the recruitment of patients is complete.

Currently the recruitment of TACTI-002 is tracking well and new clinical data from TACTI-002 is planned to be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper) 2021 (4-8 June).

TACTI-003 – a Phase IIb Clinical Trial in 1st line Head and Neck Cancer

Subject to approval by relevant competent authorities, ethics committees and institutional review boards (IRBs), TACTI-003 will evaluate efti in combination with MSD’s KEYTRUDA (pembrolizumab) as a first line

therapy in unresectable recurrent or metastatic HNSCC patients with PD-L1 negative and PD-L1 positive (CPS ³1) tumors. It will be a randomized, controlled clinical study in approximately 154 first line HNSCC patients and will take place across Australia, Europe and the United States of America in up to 35 clinical sites.

The study will evaluate the safety and efficacy of efti in combination with pembrolizumab, compared to pembrolizumab alone in 1st line metastatic or recurrent HNSCC patients with PD-L1 positive (CPS ³1) tumors (cohort A), and determine the efficacy and safety of efti plus pembrolizumab in patients with PD-L1 negative tumors (CPS <1) (cohort B). According to the current plans about 130 patients in cohort A will be randomized 1:1 to receive either efti plus pembrolizumab or pembrolizumab alone. Subjects in cohort B (up to 24 patients) will receive a combination of efti and pembrolizumab.

The primary endpoint of the study is the Overall Response Rate (ORR) according to RECIST 1.1. and iRECIST will be used for treatment decisions. Secondary endpoints include OS and Progression Free Survival (PFS). Following the grant of Fast Track designation for efti to treat 1st line HNSCC patients by the US FDA in early April 2021 and the appointment of a Contract Research Organisation (CRO), Immutep is on track to start the study in mid-2021.

INSIGHT-004 – Phase I clinical trial

The INSIGHT-004 study is expected to deliver final data at ASCO (Free ASCO Whitepaper) 2021 in a poster discussion. INSIGHT-004 is the fourth arm of the INSIGHT trial (INSIGHT-004 is also known as Stratum D of INSIGHT) which is being conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc.

IMP761 Update

The Company has completed the selection of a high-producing CHO cell line for its IMP761 IgG4 mAb and is in the process of selecting a contract manufacturing organization (CMO) for GMP manufacturing of its preclinical candidate IMP761.

Financial Update

Immutep continues to be in a robust financial position with a cash runway into calendar year 2023, beyond the expected timing for several significant data read-outs from its trials.

On May 7, 2021 Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, reported financial results for the first quarter ended March 31, 2021 and provided recent business highlights (Press release, Shattuck Labs, MAY 7, 2021, View Source [SID1234579568]).

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"We have made steady progress across the organization this quarter and remain on-track to present clinical data from both SL-172154 and SL-279252 in the second half of this year," said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. "In addition, we accelerated our expansion of SL-172154 into hematologic malignancies, and we plan to announce our strategy to bridge an immunologically active dose identified in our ovarian cancer study into multiple hematologic indications in the second half of 2021."

First Quarter 2021 Recent Business Highlights and Other Recent Developments

Continued Enrollment of SL-172154 Phase 1 Clinical Trial in Ovarian Cancer: Shattuck continues to enroll patients in a Phase 1 clinical trial for its lead wholly owned asset SL-172154, a dual CD47/SIRPα inhibitor and CD40 agonist. The Phase 1 trial is an open label, multi-center, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154 administered intravenously in patients with ovarian cancer. Initial dose-escalation data from the trial are expected in the second half of 2021.
Continued Enrollment of SL-172154 Phase 1 Clinical Trial in Squamous Cell Carcinoma of the Head and Neck or Skin: Shattuck continues to enroll patients in a Phase 1 clinical trial for SL-172154, administered intratumorally. The Phase 1 trial will evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154 in patients with squamous cell carcinoma of the head and neck or skin. Initial dose-escalation data from the trial are expected in the first half of 2022.
Continued Enrollment of SL-279252 Phase 1 Clinical Trial: Shattuck continues to enroll patients in a Phase 1 clinical trial evaluating SL-279252, a dual PD-1/PD-L1 inhibitor and OX40 receptor agonist. The Phase 1 trial is an open label, multi-center, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-279252 in patients with advanced solid tumors or lymphomas. SL-279252 is currently being developed in collaboration with Takeda Pharmaceuticals. Dose-escalation data from the trial are expected in the second half of 2021.
Presented Preclinical Data for SL-9258: Preclinical data for SL-9258 (TIGIT-Fc-LIGHT), a dual TIGIT inhibitor and HVEM/LTβR agonist, was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April 2021. These data demonstrated that SL-9258 (TIGIT-Fc-LIGHT) was highly active in a PD1 acquired resistance model and outperformed dual checkpoint blockade with anti-PD1 antibodies and anti-TIGIT antibodies.
Presented Continued Preclinical Development of GADLEN Platform: Preclinical proof of concept data on Shattuck’s proprietary Gamma Delta T Cell Engager (GADLEN) platform were presented at the AACR (Free AACR Whitepaper) annual meeting in April 2021. These data demonstrated a multi-layer analysis to uncover the gamma and delta TCR usage in tumors and the butyrophilin expression pattern guiding the design of GADLEN therapeutics, which are intended to target both hematologic malignancies and solid tumor indications.
First Quarter 2021 Financial Results

Cash Position: As of March 31, 2021, cash and cash equivalents and short-term investments were $321.2 million, as compared to $335.4 million as of December 31, 2020.
Research and Development (R&D) Expenses: R&D expenses for the first quarter ended March 31, 2021 were $10.3 million, as compared to $8.1 million for the first quarter ended March 31, 2020. The increase was primarily driven by an increase in our personnel related costs, expanded clinical development, and laboratory capabilities.
General and Administrative (G&A) Expenses: G&A expenses for the first quarter ended March 31, 2021 were $4.4 million, as compared to $1.6 million for the first quarter ended March 31, 2020. The increase was primarily driven by an increase in personnel related costs to support our activities associated with being a public company and operational expansion.
Net Loss: Net loss was $11.8 million for the first quarter ended March 31, 2021, or $0.28 per basic and diluted share, as compared to a net loss of $6.6 million for the first quarter ended March 31, 2020, or $0.86 per basic and diluted share.
Expected 2021 Milestones

Shattuck anticipates achieving the following milestones during 2021:

SL-172154

Initial dose-escalation data from Phase 1 clinical trial in ovarian cancer expected in the second half of 2021
IND filings for SL-172154 in hematologic malignancies anticipated in the second half of 2021
SL-279252

Dose-escalation data from Phase 1 clinical trial expected in the second half of 2021
Initiation of one or more dose-expansion cohorts expected in the second half of 2021
Pipeline Advancements

Nomination of third ARC compound to clinical stage pipeline anticipated in the second half of 2021
Nomination of GADLEN lead compound anticipated in the second half of 2021
2021 Financial Guidance

Shattuck believes its cash and cash equivalents and short-term investments will be sufficient to fund its operations through 2024, which is beyond results from its Phase 1 clinical trials of SL-172154 and SL-279252. This cash runway guidance is based on the Company’s current operational plans and excludes any additional funding that may be received or business development or additional clinical development activities that may be undertaken.

About SL-172154

SL-172154 is an investigational bi-functional fusion protein designed to block the CD47 immune checkpoint and simultaneously agonize the CD40 pathway. SL-172154 is currently being evaluated in Phase 1 clinical trials for the treatment of patients with ovarian and head and neck or skin squamous cell carcinoma.

In preclinical studies, SL-172154, demonstrated evidence of bridging the innate and adaptive immunity, antigen cross-priming to CD8+ T cells, and durable receptor occupancy, leading to superior anti-tumor activity over anti-CD47 antibodies, and anti-CD40 antibodies, both alone or in combination. Additionally, SL-172154 preclinically demonstrated a favorable safety profile with no evidence of hematologic toxicities observed with other CD47 inhibitors.

About SL-279252

SL-279252 is an investigational bi-functional fusion protein designed to block the PD-1 immune checkpoint and simultaneously agonize the OX40 pathway. SL-279252 is currently being evaluated in a Phase 1 clinical trial for the treatment of patients with advanced solid tumors and lymphoma. SL-279252 is part of a collaboration with Takeda Pharmaceuticals.

In preclinical studies, SL-279252, demonstrated evidence of high monotherapy activity, potent stimulation of OX40+ T Cells and superior anti-tumor activity over anti-PD1/L-1 antibodies and anti-OX40 antibodies, both alone or in combination.