On January 19, 2021 Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate and breast cancer, reported the online publication of an article in Nature Medicine, Volume 27, Issue 2, February, 2021, entitled: "The Androgen Receptor is a Tumor Suppressor in Estrogen Receptor-Positive Breast Cancer" (View Source or DOI # 10.1038/s41591-020-01168-7) by an international team headed by Drs (Press release, Veru, JAN 19, 2021, View Source [SID1234574197]). Theresa Hickey and Wayne Tilley at the University of Adelaide in collaboration with scientists at the Garvan Institute of Medical Research in Australia.

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In the Nature Medicine publication, Dr. Hickey and colleagues provide scientific evidence supporting a new discovery in breast cancer demonstrating that the androgen receptor acts like a tumor suppressor. Using human cell line and patient derived breast cancer models, they demonstrate that androgen receptor activation by androgens and enobosarm, a selective androgen receptor agonist, had potent antitumor activity in all ER positive breast cancer preclinical models tested including those that have become resistant to estrogen receptor targeted endocrine therapy as well as CDK 4/6 inhibitors, which are standard of care treatments for advanced, ER+ breast cancer. Further, enobosarm, by activating the androgen receptor, has demonstrated antitumor activity in both estrogen receptor targeted endocrine therapy resistant and CDK4/6 inhibitor resistant metastatic human breast cancer models. In contrast, androgen receptor inhibitors, like enzalutamide, had no effect. This study clears up the confusion in the scientific field regarding the role that the androgen receptor is playing in ER+ breast cancer.

"We provide compelling new experimental evidence that androgen receptor activating drugs, like enobosarm, can be more effective than existing (e.g., Tamoxifen) or new (e.g., Palbociclib) standard-of-care treatments and, in the case of the latter, can be combined to enhance growth inhibition. Moreover, enobosarm as a selective androgen receptor activating agent lacks the undesirable masculinizing side effects of natural androgens and has potential additional clinical benefits in women including promotion of bone, muscle and physical function, and mental health," said Professor Wayne Tilley, Director of the Dame Roma Mitchell Cancer Research Laboratories, and Associate Professor Theresa Hickey, Head of the Breast Cancer Group, who led the Nature Medicine study.

"This important new work establishes that the androgen receptor is a tumor suppressor and that enobosarm, as an AR targeted agent, has anti-tumor activity not only in AR+ ER+ metastatic breast cancer that has become resistant to estrogen receptor targeted endocrine and CDK4/6 inhibitor treatments, but also that enobosarm in combination with a CDK4/6 inhibitor (e.g. Palbociclib) restores CDK4/6 inhibitor sensitivity in ER+ breast cancer that has become resistant to CDK4/6 inhibition," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. "I would like to congratulate Dr. Tilley and his international team for this landmark study which provides deep scientific evidence for the novel therapeutic approach Veru has taken to address estrogen receptor targeted endocrine therapy and CDK4/6 inhibitor resistance in patients with AR+ ER+ metastatic breast cancer. We are excited to be advancing enobosarm, our AR activating targeted agent, into a Phase 3 registration ARTEST clinical trial scheduled for next quarter."

Enobosarm is an oral, first-in-class, new chemical entity, selective androgen receptor targeting agonist that activates the androgen receptor in AR+ER+HER2- metastatic breast cancer without unwanted masculinizing side effects and has potentially beneficial effects including increase in muscle mass and physical function and the promotion of bone strength and healing. Enobosarm is the first new class of targeted endocrine therapy for advanced breast cancer in decades. Last quarter the FDA agreed to the ARTEST Phase 3 registration clinical trial design to evaluate the efficacy and safety of enobosarm, a selective androgen receptor targeted agent, versus physician’s choice of either exemestane or tamoxifen as an active comparator for the treatment of metastatic ER+/HER2- breast cancer in approximately 240 patients who have failed a nonsteroidal aromatase inhibitor (anastrozole or letrozole), fulvestrant, and a CDK4/6 inhibitor. The primary endpoint is radiographic progression-free survival.

On January 19, 2021 Servier reported that Group revenue for the 2019/20 financial year amounted to €4.7 billion, an increase of 1.6% at real exchange rates, compared with the previous financial year (Press release, Servier, JAN 19, 2021, View Source;utm_medium=rss&utm_campaign=servier-presents-its-2019-20-annual-results-its-rd-strategy-and-pipeline [SID1234575049]). Revenue from brand-name medicines represents 70% of the Group revenue, and generics 30%. This progression is mainly due to the increase in the volume of brand-name medicine sales (+2.9% in boxes distributed compared with the previous financial year) and a good performance in oncology.

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"During the Covid-19 global health crisis, Servier was able to adapt to maintain the production and distribution of its medicines so that they remain available to patients, while ensuring the health and safety of its employees. Results for the 2019/20 financial year are in line with our objectives […]," comments Pascal Lemaire, Executive Vice President Finance at Servier.

The conference was also the opportunity to present Servier’s strategic objectives: "The Group has set ambitious objectives for 2025 that aim to improve its current performance in order to develop new medicines to the benefit of patients," states Olivier Laureau, President of Servier. "This is why we accelerate the Group’s global transformation dynamic, across all its business segments. This, in order to be ever more committed to therapeutic progress and to guarantee our sustainability and our independence."

Claude Bertrand, Executive Vice President, R&D, highlighted the transformation of R&D activities, recently initiated in order to foster innovation and meet the Group’s 2025 strategic objectives, in particular that of launching a new molecular entity every three year: "[…] An initial action plan has been deployed within R&D. This plan focuses on de novo innovation, which consists of accelerating the discovery and development of new medicines to meet therapeutic needs in oncology, neurology, and immuno-inflammation. It is also based on innovation linked to medicine life-cycle management, through incremental research, particularly for medicines in the cardio-metabolic field. This transformation project is based on the commitment and adaptability demonstrated by all our teams since the beginning of the health crisis."

On January 18, 2021 Sana Biotechnology reported that filed with the U.S. Securities and Exchange Commission (SEC) to launch an initial public offering (IPO) worth $150 million (Press release, Sana Biotechnology, JAN 18, 2021, View Source [SID1234574125]). But that number doesn’t quite reflect the company’s likely market valuation, which is expected to be between $9 billion and $12 billion.

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Based in Seattle, Washington, Sana focuses on in vivo and ex vivo cell engineering platforms to develop therapies for cancer, diabetes, cardiovascular disease, CNS disorders, and genetic diseases. Despite its lofty valuation, the company does not yet have any drugs in the clinic, although it expects to submit Investigational New Drug (IND) applications in 2022 and 2023.

Launched in 2019, the company raised $700 million in June 2020 in its initial financing. Those funds were used to advance its discovery and development programs.

It was founded by the former chief executive officer of Juno Therapeutics, Hans Bishop. Sana’s initial investments came from Flagship Pioneering, ARCH Venture Partners, and F-Prime Capital. In addition to that initial investment, investors included the Canada Pension Plan Investment Board, Baillie Gifford, Alaska Permanent Fund, the Public Sector Pension Investment Board, Bezos Expeditions, GV, Omega Funds, Altitude Life Science Ventures, and several unnamed institutional investors.

In a June 2020 statement, chief executive officer Steve Harr said, "Sana is dedicated to modulating genes in cells as well as replacing damaged cells in the body. I am proud of our progress to date in turning our technologies into potential therapies for serious diseases such as cancer, central nervous system diseases, heart disease and various genetic disorders."

Shortly after its 2019 launch, the company licensed technology from Harvard University that could potentially improve the success of cell therapy treatments. The technology provides a way of producing hypoimmunogenic stem cells that can be differentiated into any cell type. These cells can then be transplanted into a patient without causing immune rejection. The company’s plans are to take that technology platform and create hypoimmunogenic pluripotent stem cells that it can use to create novel cell therapies.

Sana’s ambitions and broad reach comes with a high burn rate. It currently has $459 million in cash and cash equivalents, but it spent $153 million on R&D in the first nine months of 2020, an increase from $80 million in the same period in 2019.

Of course, this is how biotech investments work. Early-stage companies are often years, often a decade or longer, from a marketable product. And once Phase II and Phase III clinical trials begin, the expenses add up fast and usually require either partnerships, IPOs or continued venture tranches.

The Wall Street Journal notes that Moderna, currently one of two companies to have an authorized COVID-19 vaccine in the U.S., had a trajectory similar to Sana—plenty of investor interest and a sky-high valuation, with no marketable products. When the company launched an IPO in late 2018, its valuation was $7 billion, which at the time was a record biotech IPO. Investors who bought then and held on have seen a sevenfold return on investment in two years.

Harr’s track record undoubtedly gave investors confidence as well. Juno Therapeutics was sold to Celgene in 2018 for $9 billion. Harr was also a director for Loxo Oncology. Loxo sold to Eli Lilly in 2019 for about $8 billion.

On October 30, 2020, Sana acquired Oscine Corp. Oscine focused on developing possibly curative or disease modifying cell therapies for brain and CNS diseases. The combination, they said at the time, would integrate Oscine’s glial progenitor cell program and technologies with Sana’s broader platform. Glial progenitor cells are a major support system of the brain. These cells differentiate into oligodendrocytes, which are the only source of myelin production the adult CNS, and astrocytes, which support neurons and are associated with many neurodegenerative and myelin diseases.

At this time, Sana’s in vivo cell engineering programs, all in the preclinical stage, are focused on non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), multiple myeloma, ornithine transcarbamylase deficiency (OTC), sickle cell disease and beta-thalassemia. Its ex vivo cell engineering programs, also all preclinical, are focused on NHL, ALL, CLL, multiple myeloma, and type 1 diabetes, Huntington’s disease, Pelizaeus-Merzbacher disease, secondary progressive multiple sclerosis, and heart failure.

On January 18, 2021 AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) reported that it has been approved in the US for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen (Press release, AstraZeneca, JAN 18, 2021, View Source [SID1234574074]).

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In the US, gastric cancer is most frequently diagnosed in the advanced stage, with only approximately 5% of patients surviving beyond five years.1,2 Approximately one in five gastric cancers are HER2 positive.3

The approval by the Food and Drug Administration (FDA) was based on the positive results from the randomised DESTINY-Gastric01 Phase II trial conducted in Japan and South Korea. In the trial, Enhertu demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) and objective response rate (ORR) versus chemotherapy (irinotecan or paclitaxel) in patients with advanced gastric cancer or GEJ adenocarcinoma who had progressed on at least two or more prior regimens including trastuzumab plus a fluoropyrimidine- and platinum-based chemotherapy combination.4

Ronan Kelly, MD, MBA, Director of the Charles A. Sammons Cancer Center and the W.W. Caruth, Jr. Chair of Immunology at Baylor University Medical Center, Dallas, Texas, US, said: "Patients with metastatic HER2-positive gastric cancer with progression following 1st-line treatment have historically faced poor outcomes, including low response to treatment and rapid disease progression. This approval represents the first time a HER2-directed medicine has demonstrated a significant improvement in survival compared to chemotherapy following initial treatment in the metastatic setting, and it has the potential to become the new standard of care for this patient population."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: "Today’s approval of Enhertu represents the first HER2-directed medicine approved in a decade for patients with HER2-positive metastatic gastric cancer. The results from the DESTINY-Gastric01 trial highlight the potential to change clinical practice, showing a 41 per cent improvement in survival and a response rate more than three times higher with Enhertu compared to chemotherapy. We are thrilled to bring this important medicine to more patients and physicians in the US."

Antoine Yver, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo, said: "Enhertu is the first antibody drug conjugate to receive approval in the US for the treatment of patients with metastatic gastric cancer, and represents a major advance in managing this difficult-to-treat disease. This second indication in the US represents an important step forward in our ambitious plan to accelerate the development of Enhertu across a broad range of HER2-targetable cancers."

In a pre-specified interim analysis from the DESTINY-Gastric01 trial, patients treated with Enhertu had a 41% reduction in the risk of death versus patients treated with chemotherapy (based on a hazard ratio [HR] of 0.59; 95% confidence interval [CI] 0.39-0.88; p=0.0097) with a median OS of 12.5 months versus 8.4 months.3

Confirmed ORR, assessed by independent central review was a major efficacy outcome. Results showed a confirmed ORR of 40.5% in patients treated with Enhertu (n=126) compared to 11.3% in patients treated with chemotherapy (n=62). Patients treated with Enhertu had a 7.9% complete response rate and a 32.5% partial response rate compared to a complete response rate of 0% and a partial response rate of 11.3% for patients treated with chemotherapy.4

Enhertu demonstrated a median progression-free survival (PFS) of 5.6 months compared to 3.5 months with chemotherapy (HR=0.47; 95% CI 0.31-0.71). Additionally, Enhertu showed a median duration of response (DoR) of 11.3 months versus 3.9 months with chemotherapy.4

Results from the DESTINY-Gastric01 trial were published in The New England Journal of Medicine in June 2020.5

The most common adverse reactions, including laboratory abnormalities, of any grade (greater than or equal to 20%) for patients treated with Enhertu (n=125) in the DESTINY-Gastric01 trial were anaemia, leukopenia, neutropenia, lymphocytopenia, thrombocytopenia, nausea, decreased appetite, increased aspartate aminotransferase, fatigue, increased blood alkaline phosphatase, increased alanine aminotransferase, diarrhoea, hypokalaemia, vomiting, constipation, increased blood bilirubin, pyrexia and alopecia. Interstitial lung disease or pneumonitis occurred in 10% of patients.4

This is the second indication approved for Enhertu in the US following the accelerated approval for adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting based on the DESTINY-Breast01 trial.

Enhertu was previously granted Priority Review, Breakthrough Therapy Designation (BTD) in HER2-positive metastatic gastric cancer and Orphan Drug Designation for gastric cancer by the FDA. Two additional Phase II trials, DESTINY-Gastric02 and DESTINY-Gastric03, are underway, further evaluating treatment with Enhertu in patients with HER2-positive metastatic gastric cancer.

Financial considerations
Following US approval, an amount of $115m is due from AstraZeneca to Daiichi Sankyo as a combined 2nd-line and 3rd-line milestone payment in HER2-positive gastric cancer. In AstraZeneca, the milestones paid will be capitalised as an addition to the upfront payment made in 2019 and subsequent capitalised milestones and amortised through the profit and loss.

Sales of Enhertu in the US are recognised by Daiichi Sankyo. AstraZeneca reports its share of gross profit margin from Enhertu sales in the US as collaboration revenue in the Company’s financial statements. For further details on the financial arrangements, please consult the collaboration agreement from March 2019.

Gastric cancer
Gastric (stomach) cancer is the fifth most common cancer worldwide and the third leading cause of cancer mortality with a five-year survival rate of 5% for metastatic disease; there were approximately one million new cases reported in 2020 and more than 768,000 deaths.6 In the US, it is estimated that 27,600 new cases of gastric cancer were diagnosed in 2020 and more than 11,000 people died from the disease.7

Approximately one in five gastric cancers are HER2 positive.1 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast, gastric, lung and colorectal cancers. Gastric cancer is usually diagnosed in the advanced stage, but even when diagnosed in earlier stages of the disease the survival rate remains modest.2 Recommended 1st-line treatment for HER2-positive advanced or metastatic gastric cancer is combination chemotherapy plus trastuzumab, an anti-HER2 medicine, which has been shown to improve survival outcomes when added to chemotherapy. For patients with metastatic gastric cancer that progresses following initial treatment with a trastuzumab-based regimen, there were previously no other approved HER2-targeted medicines prior to the approval of Enhertu.8

DESTINY-Gastric01
DESTINY-Gastric01 is a Phase II, open-label, multi-centre, randomised controlled trial testing the safety and efficacy of Enhertu (6.4 mg/kg) versus investigator’s choice of chemotherapy in a primary cohort of patients from Japan and South Korea with HER2-positive (defined as IHC3+ or IHC2+/ISH+), locally advanced or metastatic gastric cancer or GEJ adenocarcinoma who have progressed on at least two or more prior regimens including trastuzumab plus a fluoropyrimidine- and platinum-based chemotherapy combination. Patients (n=188) were randomised 2:1 to receive Enhertu or physician’s choice of chemotherapy (paclitaxel or irinotecan monotherapy). Patients were treated with Enhertu 6.4mg/kg once every three weeks or chemotherapy.

The main efficacy outcome measures were ORR, assessed by independent central review, and OS. Additional efficacy outcome measures were PFS and DoR.4

Enhertu
Enhertu (trastuzumab deruxtecan; fam-trastuzuab deruxtecan-nxki in the US) is a HER2-directed antibody drug conjugate (ADC). It is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform.

ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy (‘payload’) to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Enhertu is comprised of a humanised anti-HER2 IgG1 monoclonal antibody with the same amino acid sequence as trastuzumab attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a tetrapeptide-based cleavable linker.

Enhertu (5.4mg/kg) is approved in the US under accelerated approval, and in Japan under the conditional early approval system, for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting based on the DESTINY-Breast01 trial. In addition to the US, Enhertu (6.4mg/kg) is also approved in Japan for patients with HER2-positive unresectable advanced or recurrent gastric cancer that progressed after chemotherapy based on the DESTINY-Gastric01 trial.

Development programme
A comprehensive development programme is underway globally, with nine registrational trials evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2 cancers, including breast, gastric and lung cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

In May 2020, Enhertu received a BTD for the treatment of patients with metastatic non-small cell lung cancer whose tumours have a HER2 mutation and with disease progression on or after platinum-based therapy.

Daiichi Sankyo collaboration
Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialise Enhertu (a HER2-directed ADC) in March 2019, and datopotamab deruxtecan (a TROP2-directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for manufacturing and supply of Enhertu and datopotamab deruxtecan.

AstraZeneca in gastrointestinal cancers
AstraZeneca has a broad development programme for the treatment of gastrointestinal (GI) cancers across several medicines spanning a variety of tumour types and stages of disease. In 2020, GI cancers collectively represented over five million new cancer cases leading to more than 3.5 million deaths.6 Within this programme, the Company is committed to improving outcomes in gastric, liver, oesophageal, pancreatic, and colorectal cancers.

The Company aims to understand the potential of Enhertu in the two most common GI cancers, colorectal and gastric cancers. Imfinzi (durvalumab) is being assessed as both as monotherapy and in combinations including with tremelimumab across the two main types of liver cancer, hepatocellular carcinoma and biliary tract cancer, and in oesophageal and gastric cancers. Lynparza (olaparib) is a first-in-class PARP inhibitor with a broad and advanced clinical trial programme across multiple GI tumour types including pancreatic and colorectal cancers. Lynparza is developed and commercialised in collaboration with MSD (Merck & Co., Inc. inside the US and Canada).

AstraZeneca in oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With seven new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers.

By harnessing the power of six scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

On January 18, 2021 Propanc Biopharma, Inc. (OTC: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that the Company has received expressions of interest to evaluate proenzyme therapy as a method to prevent recurrence and metastasis of solid tumors in pancreatic and ovarian cancers (Press release, Propanc, JAN 18, 2021, View Source [SID1234574079]). The letters of interest were confirmed by Drs Natalia Luque Caro and Fernando Gálvez Montosa, medical oncologists specializing in pancreatic and ovarian cancers, respectively, from the University Hospital of Jaén, in Granada, Spain. The evaluation will most likely be conducted as separate Phase IIa proof of concept (POC), multi-trial center studies for each target indication.

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The expressions of interest were confirmed after evaluation of Propanc’s scientific literature supporting the use of proenzymes in pancreatic and ovarian cancers. The Phase IIa POC studies will be conducted after a Phase Ib dose escalation study evaluating the tolerability and activity of proenzyme therapy in patients with advanced solid tumors is completed, planned for 2021, at the Peter Mac Cancer Center, Melbourne, Australia.

"Receiving expressions of interest from Drs Caro and Montoya at the University Hospital of Jaén provides important infrastructure to plan our multi-trial center studies, which will likely require up to 60 patients for each study in pancreatic and ovarian cancers, which is why we were thinking of running these trials in Europe, due to the larger patient populations," said James Nathanielsz, Propanc’s Chief Executive Officer. "By running multi-trial centre studies for our Phase IIa studies, we ensure that we have sufficient numbers to complete the trials more efficiently than if we ran the trials in Australia, alone. Furthermore, the University Hospital of Jaén is located in Granada, Spain, and is a well-known biopharmaceutical hub with a strong reputation among multi-national companies. We look forward to a potential collaboration with the clinical trial investigators from this reputable institution."