On June 4, 2020 TVAX Biomedical reported that receipt of Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the use of its vaccine-enhanced adoptive T cell therapy (VACT) for treatment of glioblastoma multiforme, a deadly form of brain cancer (Press release, TVAX Biomedical, JUN 4, 2020, View Source [SID1234560853]).

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"We are very pleased to receive Fast Track Designation by the FDA for glioblastoma multiforme (GBM)," stated Dr. Wayne Carter, Chief Executive Officer. "Glioblastoma is a devastating disease for which there are limited treatment options."

FDA Fast Track Designation is designed to accelerate marketing approval of therapies aimed at treating serious and life-threatening diseases. The Designation creates an opportunity for close and regular communication between TVAX Biomedical and the FDA in order to improve the efficiency of product development. Additionally, it provides a pathway for accelerated approval and rolling review of completed Biological Licensing Application sections by the FDA.

TVAX Biomedical has completed Phase 1 and 2a studies in multiple cancers, including GBM. Significant benefit was demonstrated in GBM patients using TVAX’s patented VACT in those studies. TVAX’s currently planned studies will evaluate VACT in newly diagnosed GBM patients who have healthy immune systems and minimal disease at a time when VACT would be anticipated to generate maximal efficacy.

On June 4, 2020 Genmab A/S (Nasdaq: GMAB) reported that the European Commission (EC) has granted marketing authorization for the subcutaneous (SC) formulation of DARZALEX (daratumumab), for the treatment of adult patients with multiple myeloma in all currently approved daratumumab intravenous (IV) formulation indications in frontline and relapsed / refractory settings (Press release, Genmab, JUN 4, 2020, View Source [SID1234560821]). The approval follows a Positive Opinion by the CHMP of the European Medicines Agency (EMA) in April 2020. The SC formulation is administered as a fixed-dose over approximately three to five minutes, significantly less time than IV daratumumab, which is given over several hours. Patients currently on daratumumab IV will have the choice to switch to the SC formulation. In August 2012, Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

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"We are extremely pleased that patients in Europe with multiple myeloma will now, like patients in the U.S., have the opportunity for treatment with the subcutaneous formulation of daratumumab. With consistent efficacy, and greater convenience for patients and health care providers with dosing time reduced from hours to just minutes and fewer infusion-related reactions, this formulation provides significant benefits for patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab

The approval was based on data from two studies: the Phase III non-inferiority COLUMBA (MMY3012) study, which compared the SC formulation of daratumumab to the IV formulation in patients with relapsed or refractory multiple myeloma, and data from the Phase II PLEIADES (MMY2040) study, which is evaluating SC daratumumab in combination with certain standard multiple myeloma regimens. The topline results from the COLUMBA study were announced in February 2019 and subsequently presented in oral sessions at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the 24th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress. Updated data of the COLUMBA and the PLEIADES studies were presented during poster sessions at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2019.

About the COLUMBA (MMY3012) study
The Phase III trial (NCT03277105) is a randomized, open-label, parallel assignment study that included 522 adults diagnosed with relapsed and refractory multiple myeloma. Patients were randomized to receive either: SC daratumumab, as 1800 mg daratumumab with rHuPH20 2000 U/mL once weekly in Cycle 1 and 2, every two weeks in Cycles 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study; or 16 mg/kg IV daratumumab once weekly in Cycle 1 and 2, every two weeks in Cycles 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The co-primary endpoints of the study are overall response rate and Maximum trough concentration of daratumumab (Ctrough; defined as the serum pre-dose concentration of daratumumab on Cycle 3 Day 1).

About the PLEIADES (MMY2040) study
The Phase II trial (NCT03412565) is a non-randomized, open-label, parallel assignment study that includes 265 adults either newly diagnosed or with relapsed or refractory multiple myeloma. Patients with newly diagnosed multiple myeloma are being treated with 1,800 mg SC daratumumab in combination with either bortezomib, lenalidomide and dexamethasone (D-VRd) or bortezomib, melphalan and prednisone (D-VMP). Patients with relapsed or refractory multiple myeloma are being treated with 1,800 mg SC daratumumab plus lenalidomide and dexamethasone (D-Rd). An additional cohort of patients with relapsed and refractory multiple myeloma treated with daratumumab plus carfilzomib and dexamethasone (D-Kd) was subsequently added to the study. The primary endpoint for the D-VMP, D-Kd and D-Rd cohorts is overall response rate. The primary endpoint for the D-VRd cohort is very good partial response or better rate.

About DARZALEX(daratumumab)
DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma.

DARZALEX is indicated for the treatment of adult patients in Europe via intravenous infusion or subcutaneous administration: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy2. Daratumumab is the first subcutaneous CD38-directed antibody approved in Europe for the treatment of multiple myeloma. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S.

In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit www.DARZALEX.com.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.3 DARZALEX FASPRO is the first subcutaneous CD38-directed antibody approved in the U.S. for the treatment of multiple myeloma.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,4,5,6,7

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis and T-cell acute lymphocytic leukemia (ALL). Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

On June 4, 2020 Cullinan Oncology, LLC reported the closing of a $98.5 million Series B financing, which will be used to support ongoing clinical trials across its small molecule and biologics portfolio (Press release, Cullinan Oncology, JUN 4, 2020, View Source [SID1234560837]). New institutional investors and family offices participated in the financing alongside original commitments from founding investors MPM Capital and F2 Ventures. Following the completion of the fundraising, Tim Anderson of Cowen Healthcare investments (CHI) has joined the Board.

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"This capital infusion positions us well to execute our vision of bringing a diversified portfolio of innovative oncology assets into the clinic," stated Owen Hughes, Cullinan’s CEO. "We are encouraged with the pipeline progress to date and appreciate the confidence of both our existing as well as new investors."

Cullinan Oncology utilizes a portfolio approach to shepherd externally sourced as well as internally developed oncology assets from bench to bedside, focusing primarily on single asset opportunities that can be efficiently developed through the company’s global network of strategic partners. Since the company’s founding in October 2017, Cullinan has progressed a total of 7 assets through in vivo proof-of-concept studies or into human clinical testing, most notably Cullinan Pearl, an orally available tyrosine kinase inhibitor that targets EGFR (Epidermal Growth Factor Receptor) exon 20 mutations.

Concurrent with the financing, Cullinan has hired Jon Wigginton, M.D. as its Chief Medical Officer to lead the clinical development of its small molecule and biologics programs. "We are delighted to have someone of Jon’s caliber and experience join Cullinan at this point time," stated Patrick Baeuerle, Cullinan’s Chief Scientific Officer, Biologics and Co-Founder. "Alongside our existing team, Jon rounds out a distinguished group of senior researchers at Cullinan who have dedicated their careers to developing breakthrough therapeutics for cancer patients."

"I am very excited to be joining the talented team here at Cullinan Oncology," said Dr. Wigginton. "I look forward to serving as the Chief Medical Officer for all of the Cullinan portfolio companies. With such a diversified portfolio, including targeted small molecules, novel, first-in-class immunotherapies, bispecific antibodies and unique multifunctional fusion proteins, I’m hopeful that we will be able to deliver real advances for those living with cancer." In addition to his role at Cullinan Oncology LLC, Dr. Wigginton will serve as an Advisor to MPM Capital, where he will provide input on potential oncology investments and clinical development plans for portfolio companies.

Dr. Wigginton most recently served as the Chief Medical Officer at MacroGenics (NASDAQ:MGNX), where he led the company’s evolution of a fully-integrated, clinical-stage cancer immunotherapy organization. This included the translation of ten new molecules into the clinic, including early phase and/or proof-of-concept studies with bispecific molecules, checkpoint inhibitors, Fc-optimized antibodies and antibody drug conjugates, as well as the design and execution of registration-directed studies. Previously, he served as the Therapeutic Area Head, Immuno-Oncology, Early Clinical Research at Bristol-Myers Squibb (NYSE: BMY). There, he oversaw early clinical development of the BMS Immuno-Oncology portfolio and co-led the BMS International Immuno-Oncology Network (II-ON). These efforts included several studies defining proof-of concept for both anti-PD-1 and anti-PD-L1 antibodies in patients with melanoma, lung cancer and renal cancer, and for the anti-PD-1/anti-CTLA-4 combination in patients with melanoma, work published subsequently in the New England Journal of Medicine. Additional trials from his group established proof-of-concept for anti-PD-1 in patients with hepatocellular carcinoma and Hodgkin’s disease.

During his academic career, Dr. Wigginton served as Head of the Investigational Biologics Section, Center for Cancer Research, NCI, where he led an integrated basic, translational and clinical research effort focused on combination immunotherapy in preclinical models and early clinical studies. He also served previously as president of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). Dr. Wigginton received his M.D. and B.S. in Biology, with distinction, from the University of Michigan.

Lastly, Cullinan is very pleased to announce the promotion of Jennifer Michaelson, Ph.D. to Chief Development Officer, Biologics. "Jen is a key contributor to the Cullinan team; her expertise, knowledge and bandwidth are second-to-none," stated Hughes. "We are quite fortunate to have Jen leading the early development of our biologics programs and her promotion is simply a reflection of her importance to the Cullinan team across multiple functions and her many contributions to our emerging pipeline."

Prior to joining Cullinan, Dr. Michaelson served as Senior Director and Executive Program Leader at Jounce Therapeutics, where she led their flagship anti-ICOS antibody program, JTX-2011, from inception into Phase 2 development. An employee since company launch, she built and led multiple disciplines at Jounce, including Tumor Immunology, Pharmacology, and Preclinical Development. Jennifer was also a member of the Leadership Team at Jounce.

Previously, during her 10-year tenure at Biogen, Dr. Michaelson served as project leader for several monoclonal antibody and bispecific antibody programs in both the Oncology and Immunology therapeutic areas. She has also worked as a consultant at Third Rock Ventures for multiple stealth companies.

Dr. Michaelson received her B.A. in Biology from Princeton University and her Ph.D. from the Department of Cell Biology at Albert Einstein College of Medicine and completed a post-doctoral fellowship in Philip Leder’s laboratory in the Department of Genetics at Harvard Medical School.

On June 4, 2020 Amyris, Inc. (Nasdaq: AMRS), a leading synthetic biotechnology company in Clean Health and Beauty markets through its consumer brands and a top supplier of sustainable and natural ingredients, reported that it has successfully executed a binding funding agreement with leading institutional investors to raise $200 million at $3.00 per common share through a private investment in public equity (PIPE) in the Company (Press release, Amyris Biotechnologies, JUN 4, 2020, View Source [SID1234560854]). The offering includes 49% of common stock and 51% of preferred stock, convertible into common stock following stockholder approval. The private investment is subject to customary closing conditions.

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The investment is being made by a consortium of high quality institutional and accredited investors and mutual funds with expertise in health care, biotechnology or a consumer orientation consisting of approximately 70% new investors and 30% existing investors.

Following closing of the investment, the Company expects to use the proceeds from the offering for general corporate purposes and to repay certain outstanding indebtedness by approximately $61 million to lower total debt to about $162 million. Of this reduction, $24 million is from conversions to equity and, thus, not from using proceeds from the transaction. The reduced debt results in significantly lower future debt servicing expense.

"We are very excited to have obtained funding that will enable us to execute our strategic priorities, support business growth, further reduce debt and simplify our balance sheet and help us attain positive cash flow from operations," said Han Kieftenbeld, Chief Financial Officer.

"We believe that this financing positions us very well for continued industry leading revenue growth with our consumer brands and ingredients portfolio, toward our goal of profit and positive cash generation. We are committed to strong value generation for shareholders while making our planet healthier," commented John Melo, President and Chief Executive Officer.

Jefferies LLC and Cowen and Company LLC served as joint lead placement agents for the financing. Oppenheimer & Co. Inc. served as co-placement agent.

The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended, or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the "SEC") registering the resale of the shares of common stock sold in the private placement and the shares of common stock issuable upon exercise of the preferred stock.

On June 4, 2020 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, reported that it has entered into a collaboration agreement with the Explorations in Global Health (ExGloH) Division of Leidos to evaluate the potential of using ONCOS oncolytic adenoviruses as a vector to encode Microtide checkpoint inhibitor peptides (Press release, Targovax, JUN 4, 2020, View Source [SID1234564001]).

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Targovax’s clinical program is focused on combining ONCOS viruses with checkpoint inhibitors. This combination is promising since checkpoint inhibition complements oncolytic virotherapy by blocking the tumor’s main defense mechanism against the anti-tumor immune response generated by the oncolytic virus.

ExGloH has developed a unique, proprietary portfolio of microbially-derived peptides, called MicrotideTM, that act as immune checkpoint inhibitors. The simple structure and small size of Microtide peptides make them well-suited for delivery by DNA vectors, and the parties will explore whether this capability can be extended to ONCOS viruses. If successful, this could potentially circumvent the need to combine ONCOS with classical systemically delivered checkpoint inhibitors.

Under the agreement, Leidos and Targovax will investigate the technical feasibility, in vitro and in vivo immune modulatory, and anti-cancer properties of encoding Microtide checkpoint peptides in the ONCOS adenovirus backbone. If successful, the combined ONCOS and Microtide constructs may serve as a platform where additional functionality can be built in to stimulate multiple complementary anti-tumor mechanisms.

Dr. Erik Digman Wiklund, Chief Business Officer of Targovax, said: "We are continuously looking for new strategies to enhance the immune activation potential and explore novel payloads for our ONCOS viruses. In ExGloH we have found a collaborator with a unique class of checkpoint inhibitors that we believe perfectly complements ONCOS. We are very excited to jointly explore whether the ONCOS and Microtide combination can enhance the second generation of ONCOS viruses and serve as a platform for future clinical product candidates to fulfil important medical needs."