On April 19, 2021 Amgen (NASDAQ: AMGN) reported the launch of Biomarker Assist, a program to help more patients with metastatic (stage IV) non-small cell lung cancer (NSCLC) gain access to biomarker testing (Press release, Amgen, APR 19, 2021, View Source [SID1234578189]). Biomarker testing at the time of diagnosis is a critical first step in getting patients on the right treatment. Through Biomarker Assist, eligible patients may save on biomarker testing.

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Professional clinical guidelines, including the College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), the Association for Molecular Pathology (AMP) and the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) recommend comprehensive biomarker testing of multiple genes simultaneously—for both actionable and emerging biomarkers—for patients diagnosed with advanced NSCLC regardless of clinical characteristics such as age, race or smoking status.1

"Approximately half of all patients with non-small cell lung cancer have oncogene biomarkers, yet despite the integral role that biomarkers play in lung cancer to identify patients who may benefit from targeted therapies, many patients are not tested," said Darryl Sleep, M.D., chief medical officer and senior vice president of Global Medical at Amgen.2,3 "Amgen is excited to launch Biomarker Assist, a patient support program that demonstrates our commitment to closing the gap in testing rates. Based on a patient’s biomarker status, clinicians and patients can make informed decisions on personalized treatment plans and targeted therapies which have significantly improved the prognosis for many patients."

NSCLC is a heterogeneous disease associated with different driver mutations that are responsible for cancer development and growth.1 There are currently seven different actionable driver mutations in NSCLC with a number of emerging therapies under investigation for other molecular mutational drivers, including KRAS.

"The advancement of personalized medicine has transformed the treatment of lung cancer leading to the development of innovative targeted immunotherapies and personalized treatment plans for patients," said Jennifer C. King, Ph.D., chief scientific officer of GO2 Foundation for Lung Cancer. "Over the last decade, the cancer community has learned a great deal about precision medicine, particularly for non-small cell lung cancer, but if patients aren’t getting comprehensive biomarker testing, then they are less likely to benefit from all of the therapeutic advancements. We welcome programs like Amgen’s Biomarker Assist because we need support from all stakeholders, including industry, so that comprehensive biomarker testing becomes universal for everyone who is diagnosed with lung cancer."

About Amgen Biomarker Assist
Biomarker Assist is comprised of two programs: the Next Generation Sequencing (NGS) Affordability Program and the KRAS Single Gene Test (SGT) Program. The NGS Affordability Program offers assistance to eligible patients with out-of-pocket costs for a comprehensive biomarker panel for patients who have advanced or metastatic (stage IV) NSCLC. This panel must include the KRAS gene. The program is for commercially or privately insured patients. The KRAS Single Gene Test Program will provide a KRAS Mutation Analysis at no cost to any eligible patient, regardless of a patient’s results and insurance. Patients will receive results from participating NeoGenomics Laboratories. Both programs are valid for testing performed through Dec. 31, 2021. To learn more about eligibility for these programs and read the full Terms and Conditions, visit www.BiomarkerAssist.com or contact 1-888-4ASSIST with questions.

About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient’s life – not just their cancer journey – so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

On April 19, 2021 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of antibody therapeutics, reported that the company has entered into an agreement with MSD to initiate a Phase II combination trial of olinvacimab, an anti-VEGFR2 antibody, and KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy, in metastatic Triple-Negative Breast Cancer(mTNBC) (Press release, PharmAbcine, APR 19, 2021, View Source [SID1234578205]).

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The phase II clinical trial, an open-label, multicenter trial, will enroll immuno-oncology drug naïve mTNBC patients regardless of their PD-L1 expression level to evaluate the clinical efficacy, safety, pharmacodynamics, and the expression level of VEGFR-2 and PD-L1 after administering 16mg/kg of olinvacimab and 200mg of pembrolizumab.

The companies have entered this collaboration based on the promising clinical data obtained from the phase Ib olinvacimab and pembrolizumab study in mTNBC which is currently ongoing in Australia. According to the interim result as of September 2020, the combo therapy showed a manageable safety profile with 50% ORR (Overall Response Rate) and 67% DCR (Disease Control Rate) in patients who received olinvacimab plus pembrolizumab at the recommended phase 2 dose (RP2D) (N=6pts). In addition, 1 patient in PR (Partial Response) showed CR (Complete Response) in the target lesion and another PR patient showed CR in a non-target lesion.

Under the terms of the agreement, PharmAbcine will sponsor a phase II clinical trial that will take place in both Australia and South Korea, and MSD will supply KEYTRUDA.

"Helping cancer patients is core to our mission. Based on the safety profile and early clinical efficacy observed in the phase Ib trial, we feel we have a responsibility to explore olinvacimab in combination with pembrolizumab in mTNBC patients further in phase II," said Dr. Jin-San Yoo, CEO of PharmAbcine. "We will try our best so the multinational clinical study can begin in the first half of 2021."

About Metastatic Triple Negative Breast Cancer (TNBC)
mTNBC is a highly malignant type of cancer that shows a high recurrence rate within the first five years after the diagnosis. mTNBC accounts for 15-20% of all breast cancers and shows a 5-year survival rate of approximately 11%. Unlike some other breast cancers, mTNBC does not express estrogen receptor, progesterone receptors and human epidermal growth factor receptor 2 (HER2), and it does not respond to existing cancer drugs designed to target these markers. mTNBC is still very difficult to treat, and there are very few FDA approved treatment options for these patients.

About Olinvacimab

PharmAbcine’s leading pipeline, olinvacimab, an anti-VEGFR2 neutralizing fully human IgG, is currently in a phase II study for bevacizumab-nonresponding rGBM (recurrent glioblastoma multiforme) patients in both US and Australia. In addition to the combination of olinvacimab and pembrolizumab trial in mTNBC, another olinvacimab plus pembrolizumab Phase Ib trial for rGBM is ongoing in Australia.

On April 19, 2021 Adaptate Biotherapeutics (Adaptate), a company focussed on developing antibody-based therapeutics for modulation of gamma delta T cells, reported that its existing investors, Abingworth and Takeda Pharmaceutical Company Limited (Takeda) have together made a further equity investment of $18 million (circa. £13 million) (Press release, Adaptate Biotherapeutic, APR 19, 2021, View Source;utm_medium=rss&utm_campaign=adaptate-biotherapeutics-raises-18-million-in-series-a2-funding [SID1234578168]). This funding brings the total raised since Adaptate’s inception in late 2019 to $34 million (circa. £25 million).

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The investment results from the rapid progress made by the Company over the past 18 months. The funds will be used to accelerate the progression of Adaptate’s lead therapeutic antibody programme towards the clinic and to expand its internal product pipeline. The Company’s growing portfolio includes both monoclonal and bispecific antibodies which target gamma delta T cells, a unique class of lymphocytes that bridge innate and adaptive immunity. The Company’s most advanced programmes are focussed on treatments for cancer patients with solid tumours. Adaptate’s antibodies selectively target gamma delta T cells, thereby offering the opportunity for superior efficacy and safety compared to conventional immunomodulatory therapies such as pan T cell activators.

The financing will also support the Company’s expansion, including further recruitment and increased laboratory and office space. This expansion exemplifies Adaptate’s rapid growth plans and the additional capacity will play a key role in further boosting research and development activities.

Dr Natalie Mount, CEO of Adaptate Biotherapeutics, said: "The funding is a great vote of confidence from our existing investors and testimony to the hard work and rapid progress we have made in the novel field of gamma delta T cell targeting antibodies. We are excited to continue this growth path and to progress our unique therapeutic antibodies towards clinical trials where we look forward to them making an impact on the treatments available to cancer patients."

Tim Haines, Chairman & Managing Partner, Abingworth, commented: "We have been impressed with the potential of Adaptate’s therapeutic antibody technology and the significant progress to date.. We are delighted to invest further, to enable the team to accelerate its very promising portfolio towards the clinic."

Loic Vincent, Head, Oncology Drug Discovery Unit, Takeda, added: "Takeda’s ongoing investment in Adaptate aligns closely with our pursuit of potentially life-changing treatments for cancer patients through novel immuno-oncology approaches. We look forward to continuing to work together on the potential of gamma delta T cell targeted therapies to achieve this goal."

On April 19, 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, APR 19, 2021, View Source [SID1234578190]). This programme is part of the overall share repurchase programme of up to DKK 17 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 3 February 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.0 billion in the period from 3 February 2021 to 3 May 2021.

Since the announcement as of 12 April 2021, the following transactions have been made:

With the transactions stated above, Novo Nordisk owns a total of 44,549,889 B shares of DKK 0.20 as treasury shares, corresponding to 1.9% of the share capital. The total amount of A and B shares in the company is 2,350,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 17 billion during a 12- month period beginning 3 February 2021. As of 16 April 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 5,647,277 B shares at an average share price of DKK 441.86 per B share equal to a transaction value of DKK 2,495,309,191.

Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 45,000 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.

On April 19, 2021 Medivir AB (Nasdaq Stockholm: MVIR) reported that the last patient has undergone the safety follow-up to identify potentially dose-limiting toxicity from the first part of the phase Ib study with the company’s leading candidate drug, MIV-818, against liver cancer (Press release, Medivir, APR 19, 2021, View Source [SID1234578206]). The results were positive and the recommended dose for the next phase has thus been determined.

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At present, three patients continue to be active on treatment within the study, and they will continue treatment until intolerable side effects or disease progression occur. The second part of the phase Ib study, where MIV-818 is given together with standard treatment, is planned to be initiated during the second half of 2021.

The results continue to be promising and show a good safety and tolerability profile. The study is proceeding according to plan and now the recommended starting dose has been set for the next study where we combine MIV-818 with standard treatment. We now look forward to initiating that study during the second half of 2021, said Yilmaz Mahshid, CEO of Medivir.
Details of the coming study are planned to be presented during the second quarter of 2021. Detailed results from the first part of the phase Ib study are expected to be presented at an upcoming scientific conference.

For further information, please contact:
Yilmaz Mahshid, CEO, Medivir AB, phone: +46 (0)8 5468 3100.
[email protected]

About MIV-818
MIV-818 is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted, orally administered drug for patients with HCC and other forms of liver cancer.

About liver cancer
Liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. HCC is a very diverse disease with multiple cancer cell types and without specific mutations seen in other tumor types. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.