On November 5, 2021 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company primarily focused on targeting virus-associated malignancies, reported that the Company has entered into a loan and security agreement with Silicon Valley Bank (SVB) and Oxford Finance LLC (Oxford) for up to $50.0 million (Press release, Viracta Therapeutics, NOV 5, 2021, View Source [SID1234594576]). In connection with the $50.0 million credit facility, the Company and SVB agreed to terminate the Company’s prior $15.0 million loan and security agreement and the existing $5.0 million debt balance was refinanced. Under this new $50.0 million credit facility, the remaining $45.0 million is available in two additional tranches of $20.0 million and $25.0 million. The Company is under no obligation to draw funds in the future.

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"This expanded credit facility increases our financial strength and provides the Company with significant strategic and operational flexibility by securing access to a non-dilutive and immediately available financing option that carries an attractive single-digit cost of capital," said Dan Chevallard, Chief Operating Officer and Chief Financial Officer at Viracta. "We appreciate SVB’s continued support, are pleased to welcome the Oxford team to Viracta, and believe broadening the relationship at this time offers external validation in addition to valuable access to capital that could potentially support our future prospects and corporate strategy."

Michael White, National Head of Business Development and Managing Director for SVB’s Life Sciences and Healthcare Practice added, "We are excited to expand our already strong relationship with Viracta and partner with the Oxford team. We believe Viracta is well-positioned to advance towards multiple value-creating inflection points, with the initiations of its pivotal NAVAL-1 trial and its Phase 1b/2 solid tumor trial, as well as the progress of its preclinical pipeline."

"Viracta’s platform technology has enabled broad applicability in a variety of EBV positive cancers and has the potential to create therapies for other virus-related cancers through its inducible, synthetic lethality approach," said Christopher A. Herr, Senior Managing Director at Oxford. "Oxford is happy to enter this partnership with SVB and support Viracta’s focus on advancing new medicines for the treatment of virus-associated malignancies."

On November 5, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported that its Immunoscore Colon Cancer test has been included in the Pan-Asian adapted ESMO (Free ESMO Whitepaper)1 Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with localized colon cancer (Press release, Veracyte, NOV 5, 2021, View Source [SID1234594592]). The new guidelines appear online in Annals of Oncology and will be highlighted at the ESMO (Free ESMO Whitepaper) Asia Virtual Oncology Week 2021 meeting, being held November 17-23, 2021.

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Veracyte acquired the Immunoscore Colon Cancer test through its acquisition of HalioDx in August 2021. The test measures patient immune response at the tumor site and is used to inform chemotherapy decision-making for patients with Stage II and III colon cancer.

The Immunoscore Colon Cancer test was included in the 2020 ESMO (Free ESMO Whitepaper) Clinical Practice Guidelines for Diagnosis, Treatment, and Follow-up of Colon Cancer. The new Pan-Asian guidelines take into account ethnic differences associated with the treatment of localized colon cancer in Asian patients. They comprise the consensus opinions reached by 14 experts representing the oncological societies of Japan, China, India, Korea, Malaysia, Singapore and Taiwan.

The 2020 ESMO (Free ESMO Whitepaper) guidelines and the new Pan-Asian adapted version both emphasize that tumor recurrence risk-assessment and expected benefit from chemotherapy are key to the evaluation of adjuvant therapy options. In this context, the Immunoscore Colon Cancer test is recommended for its ability to refine the prognosis of stage II and stage III colon cancer patients, in conjunction with standard cancer staging known as TNM (Tumor, Node, Metastasis).

"There is a need for standardization of approaches with the aim of optimizing clinical outcomes. The Immunoscore test is introduced in these guidelines in the Risk Assessment chapter as it provides a reliable estimate of risk of recurrence, when used in adjunct to standard TNM classification," said Dr. Josep Tabernero, of the Vall d’Hebron Institute of Oncology in Barcelona, Spain. "We are happy to have 100 percent consensus in these up-to-date pan-Asian guidelines for considering the use of the test in stage II and stage III disease."

"We are pleased that Pan-Asian experts recognize the utility of the Immunoscore test in localized colon cancer," said Stephane Debono, general manager, Immunoscore and International Diagnostics Operations at Veracyte. "We consider this a significant milestone in our efforts to facilitate reimbursement for the test so that more patients may benefit from its ability to provide important information that may help guide treatment decisions."

According to the new ESMO (Free ESMO Whitepaper) Pan-Asian guidelines, recent estimates show Asia to account for half of the new cases, deaths and 5-year prevalence for colorectal cancer (CRC). Asian studies suggesting that individuals of Chinese, Japanese and Korean ethnicity might be more susceptible to CRC. CRC represents a major healthcare challenge across Asia, with the incidence predicted to increase sharply over the next decade.

About Immunoscore

The Immunoscore Colon Cancer test accurately measures patient immune response at the tumor site by providing a robust, precise, quantitative, and consensus assessment of lymphocytic infiltration in human tumors and has been shown to predict patient outcome in several indications. The test has been validated in an international study conducted on more than 2,500 Stage I-III colon cancer patients2. This study showed that Immunoscore is a powerful and independent prognostic factor for patient survival which provided the greatest contribution to patient prognostication of all assessed factors. In validation studies of stage III colon cancers, the Immunoscore test provides information that may help physicians determine the optimal duration of FOLFOX treatment. In 2020, the test was included in the ESMO (Free ESMO Whitepaper) Clinical Practice Guidelines for Diagnosis, Treatment, and Follow-up of Colon Cancer and the World Health Organization (WHO), in its latest edition of the Digestive System Tumours, cited immune response as an essential and desirable diagnostic criterion for colorectal cancer, in addition to traditional histological parameters3. Immunoscore is commercially available in more than 20 countries. Immunoscore is CE-IVD marked. The test’s results are delivered worldwide from Veracyte’s CLIA laboratories.

On November 5, 2021 Medivir AB (Nasdaq Stockholm: MVIR) reported that IGM Biosciences, Inc. has initiated its clinical study in solid cancers with birinapant (a k a IGM-9427) in combination with IGM’s DR5 agonist antibody IGM-8444 (NCT04553692) (Press release, Medivir, NOV 5, 2021, View Source [SID1234594624]).

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The combination of IGM-8444 and birinapant has previously shown to enhance anti-tumor activity preclinically. The purpose of this first clinical trial with the combination will be to explore safety and tolerability.

In January 2021, Medivir entered into an exclusive licensing agreement through which IGM Biosciences received global, exclusive development rights for birinapant. Upon signing the agreement, Medivir received USD 1 million, which will now be followed by an additional USD 1.5 million as birinapant is included by IGM Biosciences in clinical phase I studies.

"We are very happy with this important development step in the clinical evaluation of birinapant’s potential within oncology in combination with IGM’s antibody IGM-8444" says Magnus Christensen, interim CEO in Medivir.

On November 5, 2021 AstraZeneca reported that it will present new data underscoring its commitment to transforming haematologic cancer care at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, 11 to 14 December 2021 (Press release, AstraZeneca, NOV 5, 2021, View Source [SID1234594577]).

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More than 25 abstracts will feature data across the Company’s haematology portfolio and pipeline, including new analyses from the Calquence (acalabrutinib) Phase III programme such as an oral presentation of three-year follow-up data from the ASCEND Phase III trial in relapsed or refractory chronic lymphocytic leukaemia (CLL).

Overall, data will span over 10 types of blood cancers and related conditions with a focus on CLL, mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL) and acute myeloid leukaemia.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "Our robust Calquence data at ASH (Free ASH Whitepaper) will include an important new formulation designed to expand the pool of patients who may benefit from Calquence. Moreover, data from three Phase III trials will show the sustained efficacy and safety of Calquence, which is central to our commitment to prioritise the patient experience while providing long-term control of the disease in those with chronic lymphocytic leukaemia."

Anas Younes, Senior Vice President, Haematology R&D, AstraZeneca, said: "Testing new ways of overcoming drug resistance and continually pushing for better and deeper responses for patients are core focus areas of our early haematology portfolio. The preclinical data we are presenting at this year’s ASH (Free ASH Whitepaper) meeting for capivasertib and AZD4573 add to the emerging body of evidence showing the potential for new approaches to become the cornerstones of tomorrow’s combination therapies for hard-to-treat blood cancers."

AstraZeneca’s commitment to putting CLL patients first

A risk-benefit analysis showing quality-adjusted time without symptoms or toxicity (Q-TWiST) from the ELEVATE-RR and ASCEND trials in relapsed or refractory CLL will report the difference between Calquence and either ibrutinib or the combination of rituximab with idelalisib or bendamustine, balancing risk (toxicity) and benefit (prolonged survival without symptoms of progression or adverse events)
Data introducing a maleate tablet formulation of Calquence will establish bioequivalence to the current capsule and would enable co-administration with proton pump inhibitors or via nasogastric tube for patients with swallowing challenges, offering an opportunity to provide Calquence to patients for whom it was previously not an option
Further analyses from Calquence Phase III trial programme reinforce long-term safety and efficacy for patients with CLL

An oral presentation will show durable efficacy for Calquence over three years in relapsed or refractory CLL from the ASCEND trial, evaluating the treatment versus investigator’s choice of rituximab combined with either idelalisib or bendamustine
A sub-analysis from the head-to-head ELEVATE-RR trial for Calquence versus ibrutinib in relapsed or refractory CLL will further characterise adverse events related to Bruton’s tyrosine kinase (BTK) inhibition
A matching-adjusted indirect comparison using data from the ELEVATE-TN trial will compare the safety profile of Calquence alone or in combination with obinutuzumab to either ibrutinib monotherapy or venetoclax in combination with obinutuzumab
Emerging pipeline molecules show therapeutic potential in novel combinations

Preclinical data will be presented showing that capivasertib (AZD5363), an AKT inhibitor being evaluated in a number of solid and haematological tumours, showed significant activity in murine DLBCL models when combined with venetoclax. This data continues to broaden our understanding of the role of AKT inhibitors in B-cell non-Hodgkin lymphomas (NHL). Capivasertib monotherapy is being explored in sub-sets of relapsed or refractory B-cell NHL in the CAPITAL Phase II trial
Additionally, new data will demonstrate AZD4573, a highly selective and potent cyclin dependent kinase 9 inhibitor from AstraZeneca’s cell death portfolio, effectively induces apoptosis in vivo in relapsed or refractory MCL xenograft models both alone and when combined with Calquence
Key AstraZeneca presentations during the 63rd ASH (Free ASH Whitepaper) Annual Meetingi

Lead author

Abstract title

Presentation details

Calquence (acalabrutinib)

Jurczak, W

Three-Year Follow-Up of the ASCEND Trial Investigating Acalabrutinib vs Rituximab plus Idelalisib or Bendamustine in Relapsed/Refractory Chronic Lymphocytic Leukemia

Abstract # 393

Oral Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological I

12 December 2021

10:00 ET

Location: Room B401-B402

Seymour, JF

Characterization of Bruton Tyrosine Kinase Inhibitor (BTKi)-Related Adverse Events in a Head-to-Head Trial of Acalabrutinib Versus Ibrutinib in Previously Treated Chronic Lymphocytic Leukemia (CLL)

Abstract # 3721

Poster Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III

13 December 2021

18:00-20:00 ET

Location: Hall B5

Sharma, S

New Acalabrutinib Formulation Enables Co-administration with Proton Pump Inhibitors and Dosing in Patients Unable to Swallow Capsules (ELEVATE-PLUS)

Abstract # 4365

Online only

Davids, MS

MAJIC: A Phase 3 Prospective, Multicenter, Randomized, Open-Label Trial of Acalabrutinib plus Venetoclax versus Venetoclax plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Abstract # 1553

Poster Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster I

11 December 2021

17:30-19:30 ET

Location: Room B5

Davids, MS

Matching-Adjusted Indirect Treatment Comparison (MAIC) of Acalabrutinib Alone or in Combination With Obinutuzumab Versus Ibrutinib or Venetoclax Plus Obinutuzumab in Patients With Treatment-naïve Chronic Lymphocytic Leukemia

Abstract # 2633

Poster Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster II

12 December 2021

18:00-20:00 ET

Location: Room B5

Seymour, JF

A Quality-Adjusted Survival (Q-TWiST) Analysis to Assess Benefit-Risk of Acalabrutinib Versus Idelalisib/Bendamustine Plus Rituximab or Ibrutinib Among Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) Patients

Abstract # 3722

Poster Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III

13 December 2021

18:00-20:00 ET

Location: Room B5

Roschewski, M

Phase 2 Study of Acalabrutinib Window Prior to Frontline Therapy in Untreated Diffuse Large B-cell Lymphoma: Preliminary Results and Correlatives of Response to Acalabrutinib

Abstract # 524

Oral Session: 626. Aggressive Lymphomas Prospective Therapeutic Trials: Novel Agents and Combinations

12 December 2021

16:45 ET

Location: Thomas Murphy Ballroom 1-2

Capivasertib (AZD5363)

Willis, B

Combination benefit of capivasertib and venetoclax in preclinical models of Diffuse Large B-cell Lymphoma

Abstract # 802

Poster Session: 802. Chemical Biology and Experimental Therapeutics: Poster I

11 December 2021

17:30-19:30 ET

Location: Room B5

AZD4573

Roderick, J

AZD4573 effectively induces apoptosis in r/r MCL as a monotherapy or in combination with acalabrutinib

Abstract # 605

Poster Session: 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster II

12 December 2021

18:00-20:00 ET

Location: Room B5

i28 company-sponsored or supported abstracts will be presented at ASH (Free ASH Whitepaper) 2021.

Notes

Calquence
Calquence (acalabrutinib) is a next-generation, selective inhibitor of BTK. It binds covalently to BTK, thereby inhibiting its activity.1,2 In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.1

Calquence is approved for the treatment of CLL and small lymphocytic lymphoma (SLL) in the US, approved for CLL in the EU and several other countries worldwide, and approved in Japan for relapsed or refractory CLL and SLL. A Phase I trial is currently underway in Japan for the treatment of front-line CLL.

In the US and several other countries, Calquence is also approved for the treatment of adult patients with MCL who have received at least one prior therapy. The US MCL indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Calquence is not currently approved for the treatment of MCL in Europe or Japan.

As part of an extensive clinical development programme, AstraZeneca and Acerta Pharma are currently evaluating Calquence in more than 20 company-sponsored clinical trials. Calquence is being evaluated for the treatment of multiple B-cell blood cancers including CLL, MCL, DLBCL, Waldenström’s macroglobulinaemia, follicular lymphoma and other haematologic malignancies.

AstraZeneca in haematology
AstraZeneca is pushing the boundaries of science to redefine care in haematology. Applying our deep understanding of blood cancers and leveraging our strength in solid tumour oncology, we are driving the development of novel therapies designed to target underlying drivers of disease across six scientific platforms.

By addressing blood cancers with high unmet medical needs, our aim is to deliver innovative medicines and approaches to healthcare services that have a meaningful impact on patients and caregivers, transforming the haematologic cancer care experience.

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 November 5, 2021 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer, bacterial diseases and viral infections, reported the pricing of its follow-on public offering of 3,428,571 American Depositary Shares ("ADSs"), at a public offering price of $7.00 per ADS, with each such ADS representing one ordinary share, DKK 1 nominal value per share, of Evaxion (the "Ordinary Shares") (Press release, Evaxion Biotech, NOV 5, 2021, View Source [SID1234594593]). The gross proceeds from the offering are expected to be approximately $24.0 million before deducting underwriting fees, commissions and other offering expenses. Evaxion has granted the underwriters an option for a period of 30 days from the date of the final prospectus to purchase an additional 514,285 ADSs at the follow-on public offering price.

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The Company is listed on the Nasdaq Capital Market in the United States and the ADSs trade under the symbol "EVAX". The offering is expected to close on November 9, 2021, subject to the satisfaction of customary closing conditions.

Oppenheimer & Co. Inc. is acting as sole book-running manager for the offering. Ladenburg Thalmann & Co. Inc. is acting as lead manager for the offering and Lake Street Capital Markets, LLC is acting as co-manager for the offering.

The Form F-1 registration statement (the "Registration Statement") was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on November 4, 2021. The offering is being made only by means of a prospectus forming part of the effective Registration Statement. The prospectus will be filed with the SEC and will be available on the SEC’s website at: View Source When available, copies of the final prospectus related to the offering may also be obtained from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, by telephone at 212-667-8055, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

The information contained on, or that may be accessed through, the websites referenced in this press release is not incorporated by reference into, and is not a part of, this press release.