On June 22, 2021 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the European Commission (EC) has granted marketing authorisation for the expanded use of DARZALEX▼ (daratumumab) subcutaneous (SC) formulation in two new indications (Press release, Johnson & Johnson, JUN 22, 2021, View Source [SID1234584245]). The first authorisation of these new indications is for the use of daratumumab SC in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adults with newly diagnosed systemic light chain (AL) amyloidosis. This approval makes this daratumumab-based regimen the first approved therapy for AL amyloidosis in Europe.

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The second authorisation is for the use of daratumumab SC in combination with pomalidomide and dexamethasone (D-Pd) for the treatment of adults with multiple myeloma (MM) who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on or after the last therapy.

Both AL amyloidosis and MM are complex, incurable blood disorders. AL amyloidosis is a rare and potentially life-threatening disorder caused by a build-up of amyloid, an insoluble protein, in tissues and organs.1,2 This eventually causes organ deterioration, most commonly in the heart, kidneys and liver.3

Multiple myeloma remains an incurable cancer of the plasma cells found in the bone marrow.4 While there have been several developments in treatments over the years, the complex nature of the disease means that patients can often become resistant to therapy.5 Outcomes worsen with each relapse and the need for effective treatment options becomes crucial.5,6

"Today’s approvals mark significant progress for patients living with these blood disorders, especially for AL amyloidosis where patients have long faced an urgent need for approved treatment options," said Edmond Chan, Senior Director, EMEA Therapeutic Area Lead Hematology, Janssen-Cilag Limited. "The outlook for untreated patients has been poor with an average survival of 12-18 months, and only six months for those with severely impaired heart function. Our goal is to change these statistics and offer new hope to patients facing an AL amyloidosis diagnosis."

The EC approval for the AL amyloidosis indication is based on positive results from the Phase 3 ANDROMEDA study, recently presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and at the 26th European Haematology Association (EHA) (Free EHA Whitepaper) Congress.7,8 The study evaluated D-VCd compared with VCd alone, a common treatment regimen used in adult patients with newly diagnosed AL amyloidosis. Patients receiving treatment with daratumumab experienced a significantly higher haematologic complete response rate (haemCR) compared to patients receiving VCd alone (59 percent vs. 19 percent; p<0.0001).7 Furthermore, at 20.3 months median follow up, more patients achieved a very good partial response or better (≥VGPR) with D-VCd than VCd (79 percent vs 50 percent).7 Overall, D-VCd had a safety profile consistent with that previously observed for each of the agents alone.7

"AL amyloidosis is a rare haematological disorder and can be incredibly challenging to diagnose as symptoms are often subtle and can mimic other conditions. This challenge is further compounded by limited treatment options," said Efstathios Kastritis*, M.D., Professor of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine, Athens, Greece and ANDROMEDA study investigator. "The approval of daratumumab is therefore welcome news for patients and the medical community as the addition of daratumumab to VCd, which has until now been the standard-of-care regimen for treating AL amyloidosis, has been shown to induce deep responses in patients, not only inducing remission at a significantly greater rate than VCd alone, but also significantly improving cardiac and renal responses and delaying major organ deterioration."

"At Janssen, our goal is to deliver transformative innovations to patients with complex blood disorders," said Jessica Vermeulen, M.D., Ph.D., Vice President Clinical R&D, Late Stage Development, Hematology, Janssen Biologics B.V. "We are focused on the continued research and development of daratumumab for patients who are in need of additional treatment options, and we look forward to realising the impact daratumumab will have in these new indications."

The EC approval for daratumumab SC in combination with Pd in the treatment of pre-treated MM is based on positive findings from the Phase 3 APOLLO study recently published in The Lancet Oncology. An updated analysis of the study, featuring health-related quality of life data, was also presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the 26th European Hematology Association (EHA) (Free EHA Whitepaper) Congress.

The APOLLO study met its primary endpoint of improved progression-free survival (PFS), demonstrating that D-Pd significantly reduced the risk of progression or death by 37 percent, compared to Pd alone (hazard ratio, 0.63; 95 percent confidence interval [CI], 0.47-0.85; P=0.0018).9 The median PFS for the D-Pd arm vs. Pd arm was 12.4 vs. 6.9 months, respectively.9 Study findings additionally showed the rate of overall response to be significantly higher in D-Pd compared to Pd alone (69 percent vs 46 percent), as well as rates of complete response or better (25 percent vs 4 percent) and very good partial response or better (51 percent vs 20 percent).9 Additionally, more patients treated with D-Pd showed a negative status for minimal residual disease than patients receiving Pd alone (9 percent vs 2 percent).9 Furthermore, D-Pd demonstrated a consistent safety profile with the known profiles of daratumumab SC or Pd alone.9

#ENDS#

About the ANDROMEDA Study7
ANDROMEDA (NCT03201965) is an ongoing Phase 3, randomised, open-label study investigating the safety and efficacy of daratumumab SC in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd), compared to VCd alone, in the treatment of patients with newly diagnosed light chain (AL) amyloidosis. The study includes 388 patients with newly diagnosed AL amyloidosis with measurable haematologic disease and one or more organs affected. The primary endpoint is overall complete haematologic response rate by intent-to-treat (ITT). Secondary endpoints include major organ deterioration, progression free survival, major organ deterioration event free survival, organ response rate, overall survival, and time to haematologic response, among others.7

About the APOLLO Study10
APOLLO (NCT03180736) is an ongoing multicentre, Phase 3, randomised, open-label study comparing daratumumab SC, pomalidomide and low-dose dexamethasone with pomalidomide and low-dose dexamethasone alone in patients with relapsed or refractory multiple myeloma (MM) who have received at least one prior treatment regimen with both lenalidomide and a proteasome inhibitor and have demonstrated disease progression. The study, which was conducted in collaboration with the European Myeloma Network, enrolled 304 participants.10

The primary endpoint is progression-free survival (PFS) between treatment arms. Secondary endpoints include rates of overall response rate (ORR), very good partial response (VGPR) or better, complete response (CR) or better and duration of response, among others.10 The study reinforces findings from the Phase 1b EQUULEUS (MMY1001) trial, supported the U.S. Food and Drug Administration (FDA) approval of intravenous D-Pd in 2017 for the treatment of relapsed and refractory MM.11 In November 2020, Janssen submitted regulatory applications to the U.S. FDA and European Medicines Agency (EMA) seeking approval of the combination of D-Pd for the treatment of patients with relapsed or refractory MM.

About daratumumab and daratumumab SC
In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialise daratumumab. Since launch, it is estimated that nearly 190,000 patients have been treated with daratumumab worldwide.12 Daratumumab is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma (MM). Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.13

CD38 is a surface protein that is highly expressed across MM cells, regardless of the stage of disease. Daratumumab SC binds to CD38 and induces myeloma cell death through multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as well as through apoptosis, in which a series of molecular steps in a cell lead to its death.14

Data across nine Phase 3 clinical trials in the frontline and relapsed settings for MM and newly diagnosed light chain (AL) amyloidosis, have shown that daratumumab-based regimens resulted in significant improvement in progression free survival and/or overall survival.15,16,17,18,19,20,21,22,23 Additional studies have been designed to assess the efficacy and safety of daratumumab SC in the treatment of other malignant and pre-malignant haematologic diseases in which CD38 is expressed.24

For further information on daratumumab, please see the Summary of Product Characteristics at View Source

About AL Amyloidosis
Light chain (AL) amyloidosis is a rare and potentially fatal haematologic disorder that can affect the function of multiple organs.1,2 The disease occurs when bone marrow produces abnormal antibodies called light chains, which clump together to form a substance called amyloid. These clumps of amyloid are deposited in tissues and vital organs and interfere with normal organ function, eventually causing organ deterioration.1,2 AL amyloidosis is the most common type of systemic amyloidosis.25 It frequently affects the heart, kidneys, digestive tract, liver and nervous system.3 Diagnosis is often delayed and prognosis is poor due to advanced, multi-organ, particularly cardiac, involvement. Approximately 30,000 to 45,000 patients in the European Union and the United States have AL amyloidosis.3

About Multiple Myeloma
Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells.5 In Europe, more than 50,900 people were diagnosed with MM in 2020, and more than 32,500 patients died.26 Around 50 percent of newly diagnosed patients do not reach five-year survival,27 and almost 29 percent of patients with MM will die within one year of diagnosis.28

Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.6 Relapsed and refractory MM is defined as disease that is nonresponsive while on salvage therapy, or progresses within 60 days of last therapy in patients who have achieved minimal response (MR) or better at some point previously before then progressing in their disease course.29 While some patients with MM have no symptoms at all, others are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.30 Patients who relapse after treatment with standard therapies, including proteasome inhibitors and immunomodulatory agents, have poor prognoses and require new therapies for continued disease control.5

On June 22, 2021 Targovax ASA (OSE: TRVX), a clinical stage immune-oncology company developing immune activators to target hard-to-treat solid tumors, reported that its lead clinical candidate ONCOS-102 has received Fast Track designation in PD-1-refractory advanced melanoma from the US FDA (Press release, Targovax, JUN 22, 2021, View Source [SID1234584210]).

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The US FDA has granted Fast Track designation to ONCOS-102 based on the current pre-clinical and clinical data package, including mechanistic evidence showing an association between ONCOS-102-induced immune activation and tumor responses. Receiving this designation is an endorsement by the US FDA of the strength and importance of the ONCOS-102 data package in PD-1-refractory advanced melanoma. This Fast Track approval comes in addition to ONCOS-102´s existing Fast Track designation in malignant pleural mesothelioma.

The FDA Fast Track designation is awarded to therapies with potential to address unmet medical needs in serious medical conditions and allows for more frequent interactions with the FDA to expedite clinical development, as well as the regulatory review processes. Fast Track products have high likelihood of receiving Priority Review for a future Biologics License Application (BLA) and may be allowed to submit parts of the application for rolling review to shorten the approval timeline.

Dr. Ingunn Munch Lindvig, VP Regulatory Affairs of Targovax said: "Securing yet another Fast Track designation is a strong endorsement of the potential for ONCOS-102 to benefit a patient population with high unmet medical need. Fast Track simplifies and expedites the regulatory interactions and review process, and further supports the rationale for initiating a Phase 2 trial to target accelerated approval for ONCOS-102 in PD-1-refractory advanced melanoma".

On June 22, 2021 Blackstone (NYSE: BX) reported that funds managed by Blackstone Life Sciences have committed $250 million towards the launch of a new autologous and allogeneic universal chimeric antigen receptor (CAR) T-cell therapy company, along with Intellia Therapeutics, Inc. (NASDAQ: NTLA) and Cellex Cell Professionals GmbH ("Cellex"), the parent company of GEMoaB GmbH ("GEMoaB"), a clinical-stage cell therapy company (Press release, Intellia Therapeutics, JUN 22, 2021, View Source [SID1234584227]). The new company will combine GEMoaB’s world-leading clinical-stage universal CAR-T platforms with Intellia’s differentiated allogeneic cell platform and CRISPR cell engineering.

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Intellia Therapeutics is a clinical stage, leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology. Cellex Cell Professionals GmbH holds the clinical-stage biopharmaceutical company GEMoaB, which is focused on the development of next-generation immunotherapies and cell therapies for hard-to-treat cancers.

The new company will be headquartered in Cambridge, Massachusetts and will acquire Cellex’s subsidiary GEMoaB GmbH with established offices and labs in Dresden, Germany. GEMoaB is developing a switchable universal platform to improve the therapeutic window of CAR T-cell therapies. This approach enables increased efficacy and safety across a range of cancers, including solid tumors, that are currently a challenge for existing cell therapies. In addition, the new company and Intellia will gain access to Cellex’s established cell therapy manufacturing capabilities to accelerate their respective ex vivo programs.

Andrew Schiermeier, Ph.D., current Executive Vice President and Chief Operating Officer of Intellia, will lead the launch as President and Chief Executive Officer.

"This launch represents the first of many steps to addressing the various limitations that currently exist in the cell therapy space, and I am both humbled and excited to be leading the creation of this company with a team of extremely talented individuals," said Schiermeier. "Bringing together GEMoaB’s universal CAR-T platform with Intellia’s differentiated allogeneic T cell platform and CRISPR-based cell engineering provides a unique opportunity to move cell therapy technology to new heights. Our focus is on providing significantly safer and more efficacious treatments to patients who are suffering from hard-to-treat cancers and autoimmune diseases."

"We can now build on our established and ongoing collaboration with Intellia," said Dr. Armin Ehninger, GEMoaB’s Chief Scientific Officer. "With Blackstone’s contribution of funds and expertise, we will be able to combine our switchable CAR-T platform which has broad potential applicability and has already shown early signs of efficacy and a favorable side effect profile in an ongoing Phase Ia trial, with Intellia’s leading genome editing technology," added Gerhard Ehninger, M.D., founder of Cellex and GEMoaB. "This will allow us to potentially replace the living drug, currently manufactured from the patient’s own immune cells, by cells from healthy donors. Our goal is for these cells to be immediately available to patients. This is a good day for patients."

"Collaborations like this one are a key instrument for Intellia to strengthen investment in areas of strategic importance to us, enabling us to more quickly realize the full scope and potential of our genome-editing technology for patients in need of more effective therapies. With today’s announcement, we can drive the expansion of our pipeline into new areas, accelerating clinical validation of what we believe to be a platform for universal, allogeneic CAR-T cell therapies. Further, we can fortify our allogeneic cell engineering capabilities for wholly owned programs through a preferred relationship with Cellex," said Intellia President and Chief Executive Officer, John Leonard, M.D.

"We believe that this exciting effort has the potential to leapfrog current CAR-T technologies and improve the standard of care for a broad range of patients," said Dr. Nicholas Galakatos, Global Head of Blackstone Life Sciences. "As the sole founding investor, Blackstone will be actively involved in building this platform, leveraging our deep expertise in oncology and our scale capital. Our partnership with Intellia and Cellex is customized to address the new company’s needs and set it up for success from day one, and while it is an earlier-stage, growth investment for us, it demonstrates the versatility of our investment platform and commitment to advance potentially transformational technologies to benefit patients."

Business transformation and responsibilities

Key components of the new company upon formation include the following highlights:

The new company will have an exclusive license to combine Intellia’s CRISPR/Cas9 allogeneic platform with GEMoaB’s switchable, universal CAR T-cell platforms (UniCAR and RevCAR).
GEMoaB will become a subsidiary of the newly established company and will continue to advance its clinical stage CAR T-cell programs.
The new company and Intellia will also simultaneously enter into a co-development and co-funding (Co-Co) agreement to develop an allogeneic universal CAR T-cell product for an immuno-oncology indication. Intellia will have one additional option to enter into a second Co-Co agreement from selected allogeneic universal CAR T-cell therapy products that the parties will develop under the collaboration.
Blackstone Life Sciences, Intellia and Cellex (and certain related entities) will each have equal ownership of the new company.
Experienced management to drive growth and scientific advancement

Dr. Schiermeier has spent more than two decades as an executive in the biotech and pharmaceutical industries, with experience ranging from managing the growth and operations for startups to directing the strategic and operational expansion of global brands for large pharma companies. At Intellia, he was responsible for working with the board of directors and executive committee in establishing and overseeing the implementation of Intellia’s strategic direction in both in vivo and ex vivo (engineered cell therapy) areas. He also oversaw the company’s portfolio management, drug development, manufacturing, and business development efforts. Prior to Intellia, he served as SVP and Global Head of Merck KGaA’s Oncology Business, a global operation with revenues in excess of $1 billion across 66 countries.

The new company includes a seasoned management team, including Chief Medical Officer Professor Gerhard Ehninger, a founding shareholder of GEMoaB who served as its Chief Medical Officer. Prof. Ehninger is also a founding shareholder and Chief Executive Officer of GEMoaB’s parent company Cellex. Prof. Ehninger was the Head of Hematology and Oncology at University Hospital Carl Gustav Carus of the Technical University Dresden, Germany, as well as the former President of the German Society of Hematology and Oncology (DGHO). As one of the world’s leading researchers in the areas of acute leukemias and solid tumors, Prof. Ehninger has published more than 700 scientific articles in peer-reviewed journals and was principal investigator for multiple pivotal studies in hematology and oncology. The new company has also appointed Dr. Armin Ehninger as its Chief Scientific Officer. Dr. Ehninger has served as Chief Scientific Officer of GEMoaB since 2014. He has more than 15 years of research and drug discovery experience in oncology and hematology, stem cell biology as well as cancer immunotherapy. Dr. Ehninger’s expertise and leadership were decisive in establishing GEMoaB’s Research & Development and pre-clinical capabilities. At GEMoaB, he was responsible for pre-clinical Research and Development, the translational programs for clinical studies as well as for Quality Systems and Quality Management.

The new company’s Board of Directors will be chaired by Dr. Olivier Brandicourt, a Senior Advisor to Blackstone Life Sciences and the former CEO of Sanofi S.A.

The transaction is expected to close in the third quarter of 2021 and is subject to customary closing conditions, including regulatory clearances.

Goldman Sachs & Co. LLC served as exclusive financial advisor to Intellia and Goodwin Procter and Hogan Lovells (Germany) acted as Intellia’s legal advisors. Ropes & Gray and Freshfields (Germany) acted as legal advisors to Blackstone Life Sciences. Noerr and Morgan Lewis acted as legal advisors to Cellex and GEMoaB.

Intellia Therapeutics Webcast Information

Intellia management will host a live webcast today, June 22, 2021 at 8:00 a.m. E.T. to discuss the corporate development. To join the webcast, please visit this link, or the Events and Presentations page of the Investors & Media section of the company’s website at www.intelliatx.com. A replay of the webcast will be available on Intellia’s website for at least 30 days following the call.

On June 2, 2021 Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT), a company focused on the discovery and development of next-generation synthetically lethal therapies for cancer, reported the closing of its initial public offering of 7,400,000 shares of its common stock at an initial public offering price of $18.00 per share (Press release, Cyteir Therapeutics, JUN 22, 2021, View Source [SID1234584246]). All of the shares are being offered by Cyteir. In addition, Cyteir has granted the underwriters a 30-day option to purchase up to an additional 1,110,000 shares of common stock at the initial public offering price, less the underwriting discounts and commissions. Cyteir’s common stock is listed on The Nasdaq Global Select Market under the ticker symbol "CYT."

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The gross proceeds to Cyteir from the offering were $133.2 million, before deducting underwriting discounts and commissions and other estimated offering expenses.

J.P. Morgan, Morgan Stanley and BofA Securities acted as joint book-running managers for the offering and Wedbush PacGrow acted as co-manager.

A registration statement relating to the shares sold in this offering was declared effective by the Securities and Exchange Commission on June 17, 2021. The offering was made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the final prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by telephone: 1-866-718-1649; or BofA Securities, Inc., NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department or by email at: [email protected].

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

On June 22, 2021 Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, reported that it has entered into a definitive purchase agreement with Deep Track Capital for the issuance and sale of an aggregate of 2,380,953 shares of its common stock at a purchase price of $21.00 per share of common stock a registered direct offering (Press release, Anavex Life Sciences, JUN 22, 2021, View Source [SID1234584212]). The registered direct offering is expected to close on or about June 24, 2021, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds from the offering are expected to be approximately $50 million before deducting placement agent fees and other offering expenses. Anavex currently intends to use the net proceeds from the offering for advancing its pipeline and for working capital and general corporate purposes.

The shares of common stock described above are being offered pursuant to Anavex’s shelf registration statement on Form S-3 (File No. 333-232550) filed with the Securities and Exchange Commission (the "SEC") on July 3, 2019 and declared effective on July 15, 2019. Such shares of common stock may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the shares of common stock being offered in the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by e-mail: [email protected] or by telephone: (212) 856-5711.

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 any of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.