On March 28, 2022 Loki Therapeutics, a company developing next-generation therapeutics that leverage vaccination recall antigens to enhance longevity and treat immune-system related diseases, including cancer, reported the publications of research in the journal, "Science Translational Medicine", demonstrating the potential of AWAKE-LM-TT in the treatment of pancreatic cancer (Press release, Loki Therapeutics, MAR 28, 2022, View Source [SID1234611075]). AWAKE-LM-TT, which was developed by Claudia Gravekamp, Ph.D., Loki’s Co-Founder and Associated Professor of Microbiology & Immunology at Albert Einstein School of Medicine, capitalizes on the childhood vaccination for tetanus to generate a powerful and immediate immune response to solid tumors and metastases presenting the tetanus antigens.

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The manuscript titled, "Listeria Delivers Tetanus Toxoid Protein to Pancreatic Tumors and Induces Cancer Cell Death in Mice," and co-authored by Dr. Gravekamp, Ph.D., describes research involving a novel approach to treating pancreatic cancer whereby Listeria monocytogenes are used to deliver highly immunogenic tetanus toxoid (TT) proteins directly into tumor cells. This delivery, Listeria-TT, was demonstrated to elicit an immune response, activating tetanus toxoid–specific memory T cells to kill pancreatic ductal adenocarcinoma (PDAC) tumor cells in mice. When combined with gemcitabine (Listeria-TT + GEM), researchers observed an 80% reduction of PDAC tumor burden and an 87% reduction of metastases with an increased survival by 40% compared to nontreated mice, suggesting that Listeria-delivered recall antigens could be an alternative to neoantigen-mediated cancer immunotherapy.

Loki Co-founder and CEO Chris Bradley said, "This study is just the tip of the iceberg when it comes to identifying and finding effective therapeutics to treat difficult cancers. Pancreatic cancer is difficult to identify at an early stage, which makes finding a treatment even more challenging, since it is usually detected at an advanced or late stage. This research demonstrates the significant potential of Loki’s AWAKE-LM-TT as a novel treatment for pancreatic cancer given its ability to harness the childhood vaccination for tetanus toxoid to generate a powerful and immediate immune response to solid tumors and metastases presenting the tetanus antigens."

Dr. Gravekamp commented, "Because of this research, we have a new strategy that can not only be a successful immunotherapy in treating pancreatic cancer, but other cancers as well. Pancreatic tumors are very challenging to treat in that, to the immune system, these tumors do not appear sufficiently ‘foreign’ to attract the immune system’s attention and can usually suppress any immune responses that does occur. Our approach essentially makes these immunologically ‘cold’ tumors hot enough for the immune system to attack and destroy."

Loki is preparing to file an Investigational New Drug (IND) application with the U.S. Food & Drug Administration for a first-in-human clinical program investigating AWAKE-LM-TT in the treatment of pancreatic cancer. Upon receiving FDA clearance for the IND, Loki anticipates initiating a Phase 1 clinical trial in the second half of 2022.

On March 28, 2022 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") (Filing, 6-K, Novo Nordisk, MAR 28, 2022, View Source [SID1234611403]). This programme is part of the overall share repurchase programme of up to DKK 22 billion to be executed during a 12-month period beginning 2 February 2022.

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Under the programme initiated 2 February 2022, Novo Nordisk will repurchase B shares for an amount up to DKK 4.4 billion in the period from 2 February 2022 to 2 May 2022.

Since the announcement 21 March 2022, 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 35,798,396 B shares of DKK 0.20 as treasury shares, corresponding to 1.5% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 22 billion during a 12- month period beginning 2 February 2022. As of 25 March 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 4,012,228 B shares at an average share price of DKK 686.97 per B share equal to a transaction value of DKK 2,756,290,966.

On March 28, 2022 AstraZeneca reported that it will present new data underscoring the breadth of the Company’s early oncology portfolio at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in New Orleans, 8 to 13 April 2022 (Press release, AstraZeneca, MAR 28, 2022, View Source [SID1234611023]).

Data from 60 presentations, including 5 oral and 3 mini-oral presentations, will feature the Company’s next wave of potential cancer medicines spanning its immuno-oncology (IO), DNA Damage Response (DDR) and Antibody Drug Conjugate (ADC) scientific platforms. This includes key data shared from three potential new medicines that illustrate the Company’s innovative approach to designing molecules that address key challenges in treating cancer, including the ability to target different, complementary mechanisms.

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Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "We are serious about leading a revolution in oncology, which is why we continue to pioneer new ways to target cancer earlier and with greater precision, for the benefit of patients. Our data at AACR (Free AACR Whitepaper) from next-wave Immuno-Oncology medicines, PARP inhibitors and antibody drug conjugates demonstrate the potential of our diverse portfolio and reflect our vision to target cancer from every angle."

Introducing the next wave of IO therapies
The first clinical results will be shared for MEDI5752, a novel bispecific antibody, that simultaneously targets the immune checkpoint proteins PD-1 and CTLA-4, in solid tumours. Bispecific antibodies are a promising IO approach that combines the potential benefits of two medicines in one. MEDI5752 was engineered to achieve combined blockade of CTLA-4 and PD-1, to improve the therapeutic index when compared to targeting these proteins using two separate medicines.

A presentation from the NeoCOAST randomised Phase II trial in resectable, early-stage non-small cell lung cancer will highlight improved disease responses with novel Imfinzi (durvalumab) combinations including with oleclumab, an anti-CD73 monoclonal antibody, and with monalizumab1, an anti-NKG2A checkpoint inhibitor, when compared to Imfinzi alone.

Additionally, four presentations will describe novel molecules targeting interleukin-12 (IL-12) and leukaemia inhibitor factor (LIF) and illustrate the potential of targeting non-redundant mechanisms to modulate the immune tumour microenvironment.

Building the next generation of PARP inhibitors
The first data will be presented from the PETRA Phase I clinical trial investigating AZD5305, a next-generation PARP1-selective inhibitor, in patients with tumours harbouring specific homologous recombination repair gene mutations. AZD5305 is designed to selectively target PARP1, killing cancer cells by targeting tumour cell DNA damage repair mechanisms. This approach could allow PARP inhibitors to expand into new settings and offer new opportunities for combinations with DNA damage pathway activating agents such as ADCs. Preclinical data will be presented that support this hypothesis showing the activity of Enhertu (trastuzumab deruxtecan) in combination with DDR agents including PARP1-selective inhibitors.

Additionally, four presentations will describe the discovery of AZD9574, a novel PARP1 selective inhibitor designed to cross the blood brain barrier to enable the targeting of primary and secondary brain malignancies.

Innovative approaches to deliver a next-wave ADC
The first preclinical data will be shared on AZD8205, a novel ADC targeting B7-H4, a protein overexpressed in a range of solid tumours. This molecule is the first ADC to incorporate AstraZeneca’s proprietary linker technology, demonstrating the Company’s progress in establishing in-house ADC expertise and building leadership in this field.

Key AstraZeneca presentations during AACR (Free AACR Whitepaper) 2022

Presenting author

Abstract title

Presentation details

IO
Tran, B

MEDI5752, a novel PD-1/CTLA-4 bispecific checkpoint inhibitor for advanced solid tumors: First-in-human study

Abstract #CT016

Oral

Session CTPL04 – Combination Immunotherapy Clinical Trials

12 April 2022

11:46 – 12:01 CDT

Cascone, T

NeoCOAST-2: a randomized, open-label, phase 2 study of neoadjuvant durvalumab plus novel immunotherapies and chemotherapy (CT) followed by adjuvant durvalumab plus novel agents, in patients with resectable non-small-cell lung cancer (NSCLC)

Abstract #CT124 / 6

Poster – Trial in progress (TiP)

Session PO.CT02.03 – Phase II Trials in Progress

11 April 2022

09:00 – 12:30 CDT

Cascone, T

NeoCOAST: open-label, randomized, phase 2, multidrug platform study of neoadjuvant durvalumab alone or combined with novel agents in patients (pts) with resectable, early-stage non-small-cell lung cancer (NSCLC)

Abstract #CT011

Oral

Session CTPL03 – Neoadjuvant and Perioperative Immunotherapy Clinical Trials

11 April 2022

11:16 – 11:31 CDT

Shrestha, P

Durvalumab (D) + platinum-etoposide (EP) in 1L extensive-stage small-cell lung cancer (ES-SCLC): Exploratory analysis of SCLC molecular subtypes in CASPIAN

Abstract #CT024

Mini-oral

Session CTMS01 – Biomarker Advances in Clinical Trials

10 April 2022

15:50 – 160:00 CDT

Reinmuth, N

Durvalumab (D) plus tremelimumab (T) in platinum-refractory/resistant extensive-stage small cell lung cancer (ES-SCLC): Efficacy, safety and ctDNA dynamics from Arm A of the phase 2 BALTIC study

Abstract #CT533

Poster – Clinical Trial

Session OPO.CT02.01 – Phase II Clinical Trials

8 April 2022

12:00 – 13:00 CDT

Fayette, J

INTERLINK-1: A phase 3, randomized, double-blind, placebo-controlled, multicenter, global study of monalizumab in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma previously treated with an immune checkpoint inhibitor

Abstract #CT236 / 7

Poster – TiP

Session PO.CT03.02 – Phase III Trials in Progress

12 April 2022

13:30 – 17:00 CDT

Carneiro, BA

First-in-human study of MEDI1191 (mRNA encoding IL-12) plus durvalumab in patients (pts) with advanced solid tumors

Abstract #CT183 / 8

Poster – Clinical Trial

Session PO.CT01.02 – Phase I Clinical Trials 2

12 April 2022

09:00 – 12:30 CDT

O’Kane, G

A phase 2 trial of first-line AZD0171 + durvalumab and chemotherapy (CT) in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) and CD8+ T cell infiltration

Abstract #CT126 / 9

Poster – TiP

Session PO.CT02.03 – Phase II Trials in Progress

11 April 2022

09:00 – 12:30 CDT

Purroy, N

First-in-human trial of intravenous MEDI9253, an oncolytic virus, in combination with durvalumab in patients with advanced solid tumors

Abstract #CT218 / 18

Poster – TiP

Session PO.CT01.03 – Phase I Trials in Progress 1

12 April 2022

09:00 – 12:30 CDT

Candido, J

AZD0171 (anti-LIF) combines productively with chemotherapy and anti-PD-L1 in mouse models of cancer

Abstract #1293 / 3

Poster

Session PO.IM02.08 – Immune Mechanisms Invoked by Other Therapies

11 April 2022

09:00 – 12:30 CDT

DDR
Yap, TA

PETRA: First in class, first in human trial of the next generation PARP1-selective inhibitor AZD5305 in patients (pts) with BRCA1/2, PALB2 or RAD51C/D mutations

Abstract #CT007

Oral

Session CTPL02 – Clinical Trials Targeting the DNA Damage Response and KRAS

10 April 2022

16:01 – 16:16 CDT

Pike, A

Evaluation of the CNS penetration of a next generation PARP inhibitor, AZD9574, in cynomolgus monkey using positron emission tomography

Abstract #5076

Poster

Session OPO.CH01.01 – Drug Discovery, Design, and Delivery

8 April 2022

12:00 – 13:00 CDT

Davies, BR

AZD9574 is a novel, brain penetrant PARP-1 selective inhibitor with activity in an orthotopic, intracranial xenograft model with aberrant DNA repair

Abstract #2609 / 22

Poster

Session PO.ET04.02 – DNA Damage Response and Repair

12 April 2022

09:00 – 12:30 CDT

Ghosh, A

Structure-based and property-based drug design of AZD9574, a CNS penetrant PARP1 selective inhibitor and trapper

Abstract #6302

Poster

Session OPO.CH01.01 – Drug Discovery, Design, and Delivery

8 April 2022

12:00 – 13:00 CDT

Schou, M

Discovery and preclinical validation of [11C]AZ3391: A first in class blood-brain barrier permeable, subtype selective PARP-1 PET radioligand

Abstract #5977

Poster

Session OPO.TB07.01 – In Vivo Imaging

8 April 2022

12:00 – 13:00 CDT

Shapiro, GI

Ceralasertib and olaparib in the treatment of homologous recombination repair (HRR)-deficient platinum-sensitive ovarian cancer after progression on PARP inhibitors

Abstract #CT201 / 1

Poster – TiP

Session PO.CT01.03 – Phase I Trials in Progress 1

12 April 2022

09:00 – 12:30 CDT

ADCs
Kinneer, K

Discovery and first disclosure of AZD8205, a B7-H4-targeted antibody-drug conjugate utilizing a novel topoisomerase I linker-warhead

Abstract #1765 / 17

Poster

Session PO.ET01.04 – Antibody-Drug Conjugates

11 April 2022

13:30 – 17:00 CDT

Wortmann, P

Development and implementation of image analysis-based Quantitative Continuous Score (QCS) for B7-H4 IHC to understand AZD8205 pharmacodynamics

Abstract #452 / 3

Poster

Session PO.BCS02.02 – Artificial Intelligence and Digital Pathology

10 April 2022

13:30 – 17:00 CDT

Wallez, Y

Activity and tolerability of combinations of trastuzumab deruxtecan (T-DXd) with inhibitors of the DNA damage response in preclinical models

Abstract #5298

Poster

Session OPO.ET07.01 – Biological Therapeutic Agents

8 April 2022

12:00 – 13:00 CDT

Mettetal, J

Activity and tolerability of combination of trastuzumab deruxtecan with the next generation PARP1-selective inhibitor AZD5305 in preclinical models

Abstract #1142 / 6

Poster

Session PO.ET05.02 – Preclinical and Clinical Pharmacology

11 April 2022

09:00 – 12:30 CDT

1AstraZeneca obtained full oncology rights to monalizumab from Innate Pharma in October 2018 through a co-development and commercialisation agreement initiated in 2015

Notes

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 28, 2022 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the anti-HER2 humanized monoclonal antibodies, Perjeta for intravenous infusion 420mg/14 mL [generic name: pertuzumab] (hereafter, Perjeta) and Herceptin for intravenous infusion 60 and 150 [generic name: trastuzumab] (hereafter, Herceptin), for the additional indication of advanced or recurrent HER2-positive colon cancer or rectal cancer not amenable to curative resection that has progressed after cancer chemotherapy (Press release, Chugai, MAR 28, 2022, View Source [SID1234611046]).

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"There are many effective treatments available for colorectal cancer, however, recent genetic studies have revealed that some patients do not respond adequately to standard treatment. We are very pleased that now we have the opportunity to offer the combination therapy of Perjeta and Herceptin to these patients, as a new treatment option based on personalized medicine," said Chugai’s President and CEO, Dr. Osamu Okuda. "HER2-positive colorectal cancer is a rare subtype that accounts for 1~5% of all colorectal cancers. This approval opens the way for personalized medicine for this subtype for the first time in Japan and overseas. I would like to thank everyone who supported us for this approval, especially those who participated in the investigator-initiated study which formed the basis of this trial, including patients, their families and medical professionals. We are committed to providing information on the proper use of this combination therapy so that it may contribute to the treatment of colorectal cancer."

The approval is based on the results of an investigator-initiated phase II clinical trial (TRIUMPH study) conducted in Japan that evaluated the efficacy and safety of the combination of Perjeta and Herceptin in 30 patients with HER2-positive, curatively unresectable advanced or recurrent colorectal cancer who had previously undergone chemotherapy. The primary endpoint was the objective response rate as determined by the investigator’s judgment. Objective response was observed in 29.6% of patients confirmed HER2 expression in tumor tissue and 28.0% of patients diagnosed with HER2-positive and RAS wild-type by liquid biopsy. Major adverse events included infusion-related reactions, diarrhea, decreased appetite, nausea, stomatitis and nasopharyngitis.

HER2 protein overexpression and gene amplification should be determined with the pathological testing kit VENTANA ultraView Pathway HER2 (4B5) provided by Roche Diagnostics K.K. and Pathvision HER-2 DNA Probe Kit provided by Abbott Japan Joint company. Both tests obtained regulatory approval on March 17, 2022 and March 10, 2022, respectively, as companion diagnostics for Perjeta and Herceptin to identify patients with HER2 positive colorectal cancer who may benefit from the combination therapy.

[Approval Information (Perjeta)] * This additional section only

Indications

Advanced or recurrent HER2-positive colon cancer or rectal cancer not amenable to curative resection that has progressed after cancer chemotherapy
Dosage and administration

For cases of advanced or recurrent HER2-positive colon cancer or rectal cancer not amenable to curative resection that has progressed after cancer chemotherapy, the usual adult dosage is a loading dose of 840 mg pertuzumab (genetical recombination) and subsequent doses of 420 mg every 3 weeks, each administered by intravenous infusion over 60 minutes, in combination with trastuzumab (genetical recombination). If the first infusion is well tolerated, subsequent infusions may be administered over a shorter time of at least 30 minutes.
[Approval Information (Herceptin)] * This additional section only

Indications

Advanced or recurrent HER2-positive colon cancer or rectal cancer not amenable to curative resection that has progressed after cancer chemotherapy
Dosage and administration

Use Regimen B for advanced or recurrent HER2-positive colon cancer or rectal cancer not amenable to curative resection that has progressed after cancer chemotherapy, in combination with pertuzumab (genetical recombination).
Regimen B: The usual adult dosage is a loading dose of 8 mg/kg (body weight) trastuzumab (genetical recombination) and subsequent doses of 6 mg/kg every 3 weeks, each administered by intravenous infusion over at least 90 minutes.

If the first infusion is well tolerated, subsequent infusions may be administered over a shorter time of at least 30 minutes.

About Perjeta

Perjeta is a humanized monoclonal antibody that targets human epidermal growth factor receptor type 2 (HER2), which is involved in the growth of tumor cells. Perjeta in combination with Herceptin blocks the HER-signaling system more extensively. The drug was launched in 2013 for "inoperable or recurrent HER2-positive breast cancer." The indication was amended as "HER-2 positive breast cancer," after obtaining regulatory approval for the additional indication of "neoadjuvant and adjuvant therapy in HER2-positive breast cancer" in 2018.

About Herceptin

Herceptin, like Perjeta, is a humanized monoclonal antibody that targets human epidermal growth factor receptor type 2 (HER2), which is involved in the growth of tumor cells. Herceptin was launched in 2001 for "metastatic breast cancer overexpressing HER2." In 2011, it was approved for the treatment of patients with "advanced or recurrent gastric cancer overexpressing HER2 not amenable to curative resection," and in 2021 for "advanced or recurrent HER2-positive salivary gland cancer not amenable to curative resection."

The product names listed above are protected by law.

On March 28, 2022 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, reported financial results for the fourth quarter ended December 31, 2021 and provided a corporate update (Press release, Immunome, MAR 28, 2022, View Source [SID1234611062]).

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"There remains a clear need for safe and efficacious antibody treatments against COVID-19, especially those less susceptible to mutational drift. We believe our three-antibody cocktail, IMM-BCP-01, has strong potential to address that unmet need. We are pleased the FDA has given us a safe-to-proceed notification and lifted the clinical hold for our Investigational New Drug (IND) application," stated Purnanand Sarma, Ph.D., President and CEO of Immunome.

"Additionally, we continue to progress IMM-ONC-01, our novel, IL-38-targeting innate immune checkpoint inhibitor, towards an IND submission in the second half of 2022," Sarma continued. "Our preclinical work is ongoing, and we have analyzed IL-38 expression across nearly 60 tumor subtypes and we have confirmed a high frequency of expression in difficult to treat cancers, such as head and neck squamous cell carcinoma, gastroesophageal squamous carcinoma, and squamous lung carcinoma."

Fourth Quarter and Subsequent Highlights

·Demonstrated In Vitro Efficacy of IMM-BCP-01 Against SARS-CoV-2 Omicron Variant in Live Virus Testing. In February 2022, Immunome announced that IMM-BCP-01 demonstrated effective neutralization of the Omicron variant of COVID-19 in in vitro testing. The combination of two antibodies in Immunome’s antibody cocktail, IMM20253/IMM20184, demonstrated neutralization of the Omicron variant within 3.5-fold potency compared to a preclinical version of sotrovimab in a head-to-head test using live virus samples. Additionally, IMM20253 exhibited a novel mechanism of action not reported in any other EUA antibodies by promoting a proteolytic cleavage of the portion of the spike protein needed for ACE2 binding.

·IMM-BCP-01 IND Application for the Treatment of COVID-19. In March 2022, the FDA communicated that the clinical study can be initiated for our antibody cocktail for the treatment of SARS-CoV-2 following a brief clinical hold. Immunome is continuing its ongoing clinical preparations ahead of the Phase 1b trial.

This investigational work was funded by the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in collaboration with the Defense Health Agency (DHA) (Contract number: W911QY-20-9-0019).

Financial Highlights

•Cash and cash equivalents: As of December 31, 2021, cash and cash equivalents totaled $49.2M.
•Research and development (R&D) expenses: R&D expenses for the three months ended December 31, 2021 were $4.4M. R&D expenses for the year ended December 31, 2021 were $14.1M.
•General and administrative (G&A) expenses: G&A expenses for the three months ended December 31, 2021 were $3.5M. G&A expenses for the year ended December 31, 2021 were $10.6M.
•Net loss: Net loss attributable to common stockholders was $7.9M, or $.65 per share, for the three months ended December 31, 2021. Net loss attributable to common stockholders was $24.7M, or $2.14 per share, for the year ended December 31, 2021.
•As of December 31, 2021, Immunome has 12,110,373 shares of common stock outstanding.