On November 5, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that an abstract summarizing the most recent clinical data from an ongoing clinical trial of its differentiated CD47 antibody lemzoparlimab (also known as TJC4), will be presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH 2021), taking place December 11 – 14, 2021 (Press release, I-Mab Biopharma, NOV 5, 2021, View Source [SID1234594580]).

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The clinical data provide updates on the safety and efficacy of lemzoparlimab in combination with rituximab (Rituxan) in relapsed or refractory non-Hodgkin’s lymphoma (NHL). The trial (NCT03934814) is continuing to enroll more patients in the U.S., and has expanded to include clinical sites in China as an international multi-center clinical trial (IMCT). The study may potentially lead to the initiation of a registrational trial in 2022 in China .

The abstract is available online on the ASH (Free ASH Whitepaper) 2021 website, and the presentation details are listed below.

Title Lemzoparlimab, a Differentiated Anti-CD47 Antibody in Combination with Rituximab in Relapsed and Refractory Non-Hodgkin’s Lymphoma: Initial Clinical Results
Session name 623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III
Abstract number 3542
Corresponding Presenter
Amitkumar Mehta, MD

University of Alabama at Birmingham

I-Mab will also host an investor call on December 14, 2021, at 8:00 a.m. ET to discuss the data presented at the conference.

About CD47 and Lemzoparlimab

CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don’t eat me" signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells. However, development of CD47 antibody as a cancer therapy is hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. Scientists at I-Mab have discovered a novel CD47 antibody, lemzoparlimab, that is designed to target tumor cells while exerting a minimal untoward effect on red blood cells.

I-Mab continues to advance a combination study of lemzoparlimab with Keytruda for solid tumors in the U.S. and with Rituxan for lymphoma in the U.S. and China, in addition to an on-going clinical trial in patients with AML in China.

In September 2020, I-Mab and AbbVie entered into a global strategic collaboration to develop and commercialize lemzoparlimab. This includes the design and conduct of further clinical trials to evaluate lemzoparlimab in multiple cancers through global and China-specific trials. AbbVie has assumed sponsorship of the U.S. study as of April 2021.

On November 5, 2021 Novavax, Inc. (NASDAQ: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, reported its financial results and operational highlights for the third quarter ended September 30, 2021 (Press release, Novavax, NOV 5, 2021, View Source [SID1234594579]).

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"We are excited by the significant progress made over the quarter, including our landmark milestone of gaining the first regulatory approval for our COVID-19 vaccine," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "With additional regulatory submissions around the world, we are prepared to deliver our vaccine globally. We believe the highly encouraging results from our six-month booster study complement the strong efficacy demonstrated by NVX-CoV2373 to date, and we remain confident that our vaccine will serve as an important tool to fight COVID-19 in the years to come."

Third Quarter 2021 and Recent Highlights

COVID-19 Vaccine Regulatory Pathway

Received emergency use authorization (EUA) from National Agency of Drug and Food Control of the Republic of Indonesia, in partnership with Serum Institute of India Pvt. Ltd. (SII)
NVX-CoV2373 to be marketed by SII under the brand name COVOVAX
Novavax completed multiple regulatory submissions
U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for conditional marketing authorization
Australia Therapeutic Goods Administration (TGA) for provisional approval
Health Canada for authorization
New Zealand Medsafe for provisional approval
World Health Organization (WHO) for emergency use listing (EUL)
European Medicines Agency (EMA) (submitted all final data and modules)
SII, our licensee, completed multiple regulatory submissions for our COVID-19 vaccine
Drugs Controller General of India (DCGI) and the Philippines for EUA
WHO for EUL
Expect to submit the complete regulatory package to the U.S. FDA by the end of 2021
COVID-19 Vaccine Advanced Purchase Agreements

Executed advance purchase agreement with European Commission to supply a minimum of 20 million doses and up to 100 million initial doses
Option to purchase an additional 100 million doses through 2023
COVID-19 Vaccine Manufacturing and Supply

Achieved capacity of 100 million doses per month as of the end of the third quarter of 2021, on track to achieve capacity of 150 million doses per month by the end of the fourth quarter of 2021, and expect to have capacity in excess of 2 billion annual doses in 2022
Collaborated with licensed manufacturers to enable distribution of NVX-CoV2373 globally
Expanded partnership with SII through a supply agreement
Takeda Pharmaceutical Company Limited finalized agreement with government of Japan’s Ministry of Health, Labour and Welfare for purchase of 150 million doses, with anticipated distribution in 2022
COVID-19 Vaccine Clinical Development

Completed crossover arms in U.K. Phase 3, South Africa Phase 2b, PREVENT-19 Phase 3, and pediatric expansion of PREVENT-19 trials
Ongoing pediatric expansion of PREVENT-19 Phase 3 trial
Completed enrollment of 2,248 adolescents aged 12-17 years across up to 75 sites in the U.S.
Expect to have a regulatory package available for global submission in the first quarter of 2022
Advanced booster study in the Phase 2 portion of U.S. and Australia Phase 1/2 trial
Data from 6-month booster study demonstrated positive results
Wild-type neutralizing antibodies increased more than 4-fold versus primary vaccination series
Cross-reactive functional antibodies to the Delta (B.1.617.2) variant strain detected after primary vaccination series and increased more than 6-fold following boosting
Initiated twelve-month booster dose for select participants following completion of 6-month booster study
Combination Vaccine

Completed enrollment of Phase 1/2 clinical trial for COVID-NanoFlu combination vaccine in Australia across 10 sites
Enrolled 642 healthy adults aged 50 to 70 years
Evaluating the safety, tolerability and immune response of a COVID-NanoFlu combination vaccine formulated with Matrix-M adjuvant
Data is expected in the first half of 2022
Publication Highlights

Final analysis from multiple Phase 3 trials accepted by a peer-reviewed journal and posted via the preprint server on medRxiv.org
PREVENT-19 U.S. and Mexico study
U.K. influenza co-administration sub-study
Final analysis from pivotal Phase 3 clinical trial for NanoFlu published in The Lancet Infectious Diseases
Final analysis from Phase 2 Australia and U.S. dosing regimen study published in PLOS Medicine
Corporate Highlights

Strengthened corporate leadership with executive hiring and promotions
Jim Kelly as Executive Vice President, Chief Financial Officer and Treasurer
Denny Kim, M.D. as Senior Vice President, Chief Safety Officer
Marco Cacciuttolo, Ph.D. promoted to Senior Vice President, Process and Analytical Development
Raburn Mallory, M.D. promoted to Senior Vice President, Head of Clinical Development
Financial Results for the Three Months Ended September 30, 2021

Novavax reported a net loss of $322.4 million, or $4.31 per share, for the third quarter of 2021, compared to a net loss of $197.3 million, or $3.21 per share, for the third quarter of 2020.

Novavax revenue in the third quarter of 2021 was $178.8 million, compared to $157.0 million in the same period in 2020. This increase was due to increased development activities relating to NVX-CoV2373 for services performed under the U.S. government agreement and royalties under Novavax’ licensing agreements.

Research and development expenses increased to $408.2 million in the third quarter of 2021, compared to $294.1 million in the same period in 2020. The increase was primarily due to the development and manufacturing for NVX-CoV2373.

General and administrative expenses increased to $77.8 million in the third quarter of 2021, compared to $56.9 million for the same period in 2020. The increase was primarily due to costs associated supporting our NVX-CoV2373 program.

As of September 30, 2021, Novavax had $1.9 billion in cash, cash equivalents and restricted cash, compared to $0.8 billion as of December 31, 2020. The increase in cash provided was primarily due to $1.2 billion in payments under advance purchase agreements recorded as deferred revenue and $565 million net proceeds raised through utilization of At-the-market (ATM) offerings during the first quarter of 2021.

Conference Call

Novavax will host its quarterly conference call today at 4:30 p.m. ET. The dial-in numbers for the conference call are (877) 870-4263 (Domestic) or (412) 317-0790 (International). Participants will be prompted to request to join the Novavax, Inc. call. A replay of the conference call will be available starting at 7:30 p.m. ET on November 4, 2021 until 11:59 p.m. ET on November 11, 2021. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412) 317-0088 (International) and use passcode 10161242.

A webcast of the conference call can also be accessed on the Novavax website at novavax.com/events. A replay of the webcast will be available on the Novavax website until February 4, 2022.

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’ patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate nor can it cause COVID-19.

Novavax’ COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 microgram antigen and 50 microgram Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels.

About NanoFlu

NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax’ patented saponin-based Matrix-M adjuvant.

About Matrix-M Adjuvant

Novavax’ patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

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 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 4, 2021 ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. reported that IMM27M, the newly developed ADCC-enhanced CTLA-4 antibody was approved by NMPA for clinical trial research (Press release, ImmuneOnco Biopharma, NOV 4, 2021, View Source [SID1234655627]). This is another major milestone for ImmueOnco.

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CTLA-4 is the first clinically proven check point for immunotherapy, as the first antibody approved in 2011, Ipilimumab is still the only approved drug in the global market. Three weeks ago, the first prescription came out priced at￥28,000 per dose in China.

The IMM27M is an IgG1 antibody targeting CTLA-4. It has been genetically modified to enhance ADCC activity. In the preclinical research, IMM27M appeared to be more efficacious than that of Ipilimumab since it completely removes tumors at a lower dose (0.3 mg/kg) in animal models.

Dr. Tian, Wenzhi, the founder and chairman of ImmueOnco said, "We are pleased that our next-generation CTLA-4 antibody program has been approved by NMPA for clinical trial research. Repeatable in vivo studies have demonstrated that IMM27M has robust anti-tumor activity and also, can be used in combination with a variety of drugs in the company’s pipeline for clinical research. We believe that the IMM27M has great value for clinical development. "

"We will make our best to develop IMM27M to benefit more patients."