On June 30, 2020 Magenta Therapeutics, Inc. (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplant to more patients, reported the closing of its previously announced underwritten public offering of 8,625,000 shares of its common stock, including the exercise in full by the underwriters of their option to purchase an additional 1,125,000 shares, at a price to the public of $8.00 per share (Press release, Magenta Therapeutics, JUN 30, 2020, View Source [SID1234561566]). The total gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be $69.0 million.

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Goldman Sachs & Co. LLC and Cowen acted as joint bookrunning managers for the offering. Wedbush PacGrow acted as lead manager for the offering.

Magenta intends to use the net proceeds from this offering to advance its clinical and earlier stage programs and for research and development, working capital and general corporate purposes.

The securities described were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-233127), including a base prospectus. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering was filed with the U.S. Securities and Exchange Commission (the "SEC") on June 24, 2020. The final prospectus supplement relating to the offering was filed with the SEC on June 25, 2020. Copies of the final prospectus supplement and the accompanying prospectus relating to these shares can be obtained from: Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 866-471-2526, facsimile: 212-902-9316, e-mail: [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected].

Important Information

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or 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 30, 2020 Boston Scientific Corporation (NYSE: BSX) reported that it will webcast its conference call discussing financial results and business highlights for the second quarter ended June 30, 2020 on Wednesday, July 29, 2020 at 8:00 a.m. EDT (Press release, Boston Scientific, JUN 30, 2020, View Source [SID1234561565]). The call will be hosted by Mike Mahoney, chairman and chief executive officer, and Dan Brennan, executive vice president and chief financial officer. The company will issue a news release announcing financial results for the second quarter on Wednesday, July 29, 2020, prior to the conference call.

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A live webcast of the conference call will be available on the Investor Relations section of the website at investors.bostonscientific.com.

A replay of the webcast will be archived and available at investors.bostonscientific.com beginning approximately one hour following the completion of the meeting.

On June 30, 2020 PharmEnable, a Cambridge-based drug discovery company using advanced medicinal chemistry and AI-enabled approaches to design the next generation of highly complex and specific drug candidate molecules, reported it has closed a £1.8 million seed financing to support its transition into a drug development company (Press release, PharmEnable, JUN 30, 2020, View Source [SID1234561564]). It aims to develop new treatments for conditions with significant unmet clinical need, by designing highly complex molecules for addressing challenging biological targets.

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The round, which was significantly over-subscribed, was led by Cambridge Enterprise, the commercialisation arm of the University of Cambridge, as well as the University of Cambridge Enterprise Fund VI, managed by Parkwalk Advisors. It also attracted support from a wealth of angel investors and notable life science funds, including Jonathan Milner, serial entrepreneur and founder of Abcam; Andy Richards, Cambridge-based entrepreneur and investor; David Ford, Oxford-based life sciences angel investor; the family office of Paul Forster, co-founder of Indeed.com; Ian Tomlinson, chairman of several bio-incubators, entrepreneur and co- founder of Domantis; KQ Labs at the Francis Crick Institute; Martlet Capital, a Cambridge-based investor with a growing portfolio of innovative life science companies; the fast-growing o2h ventures Human Health EIS fund; and Wren Capital, the established London-based angel investor in science, engineering and software businesses.

A spin-out from the University of Cambridge in 2016, and financed to date by its founders and service-based revenues, PharmEnable will use the funding to evolve its business model and invest in a pipeline of drug discovery programmes across a number of disease areas including cancer and neurodegenerative disease. Additionally, PharmEnable will continue to engage in strategic partnerships with pharma, innovative biotechs and academia.

PharmEnable is led by co-founder and CEO Dr Hannah Sore. It has attracted an experienced Board and management team including Dr Jane Dancer, previously of F-star, who joined recently as the new Board Chair. The financing has enabled PharmEnable to expand its scientific team including Dr David Vidal as Director of Technology, with further expansion, including the addition of a Director of Drug Discovery planned for Q3 2020.

The PharmEnable platform technology can predict improved small molecule hits to targets across a range of disease areas. Its approach focuses on exploring and mapping the possible chemical universe and designing novel small molecules that are highly complex with shapes similar to those found in nature. This approach can identify hits with improved specificity compared with traditional screening methods, and allows PharmEnable to take on particularly challenging biological targets, such as protein-protein interactions and epitranscriptomic modifications that have been undruggable by existing approaches. Its solution consists of two elements: ChemUniverse a diversity-focused virtual database of chemically diverse molecules; and ChemSeek, a suite of gold standard AI-enabled tools for finding drug target matches from structure and ligand data.

On June 30, 2020 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) reported that the Company submits a New Drug Application (NDA) to the U.S. Food and Drug Administration, FDA, for accelerated approval of melflufen (INN melphalan flufenamide) in combination with dexamethasone for the treatment of adult patients with multiple myeloma whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one anti-CD38 monoclonal antibody (i.e., triple-class refractory multiple myeloma patients) (Press release, Oncopeptides, JUN 30, 2020, View Source [SID1234561555]).

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Melflufen is the lead candidate coming out of the Oncopeptides’ proprietary PDC-platform. The product is a first-in-class aminopeptidase-targeting peptide-drug conjugate that rapidly delivers an alkylating payload into tumor cells. The submission is based on the results from the pivotal phase 2 study HORIZON, evaluating intravenous melflufen in combination with dexamethasone in patients with relapsed refractory multiple myeloma (RRMM).

The results from the HORIZON study demonstrates that melflufen in combination with dexamethasone, has a potential to provide a therapeutic option for patients with RRMM that are hard to treat and have a poor prognosis, including patients with triple class refractory myeloma and patients with extramedullary disease (EMD). The responses in the HORIZON study were durable and often deepened with prolonged treatment, suggesting that patients could benefit from staying on treatment for as long as possible.

"I am very proud and humbled by the organizations ability to timely submit the NDA for accelerated approval of melflufen. This is a major milestone for Oncopeptides and is a result of dedicated research and development activities throughout the last decade", says Jakob Lindberg CEO of Oncopeptides. "I would like to express my sincere gratitude to all patients, co-workers, investigators and shareholders who have provided relentless support to enable a novel treatment option for a fast-growing patient population with a significant unmet medical need".

Following the submission to the FDA Oncopeptides will initiate an Expanded Access Program (EAP) in the U.S. to enable melflufen treatment for patients with a significant unmet medical need.

About the HORIZON study
In total 157 multiple myeloma patients have been enrolled and evaluated in the pivotal phase 2 HORIZON study. The study was fully recruited in October 2019, the final data cut was made on January 14th and the final data was presented at the EHA (Free EHA Whitepaper) meeting in June. The patients in the study were refractory to pomalidomide and/or daratumumab after failing on immunomodulatory drugs (IMiDs) and proteasome inhibitors (PIs). The HORIZON study population includes subgroups of patients who were triple?class refractory and/or had extramedullary disease and/or had cytogenetic high?risk features.

Summary of results

End Points Intention to Treat (n=157) Triple Class Refractory (n=119) Extra Medullary Disease (n=55)
Overall Response Rate (ORR) 29% 26% 24%
Median Progression Free Survival (PFS)) 4.2 months 3.9 months 2.9 months
Median Overall Survival (OS) 11.6 months 11.2 months 6.5 months
Responding patients n=45 n=31 n=13
Median Duration of Response (DOR) 5.5 months 4.4 months 5.5 months
Median Progression Free Survival (PFS) 8.5 months 8.5 months 17.3 months
All data were confirmed by the Independent Review Committee (IRC), with only minimal discordance.

About melflufen
Melflufen (INN melphalan flufenamide) is a first-in-class aminopeptidase-targeting peptide-drug conjugate that rapidly delivers an alkylating payload into tumor cells. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately hydrolyzed by peptidases to deliver an entrapped hydrophilic alkylator payload. Peptidases play a key role in protein homeostasis and feature in cellular processes such as cell-cycle progression and programmed cell death. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the increased intracellular alkylator concentration. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies.

Expanded access policy
The preparations for an Expanded Access Program (EAP) in the US are well underway and the program will open in Q3. Oncopeptides encourages awareness of and participation in its clinical trials and believes that participating in clinical trials is a good way for patients to access investigational drugs prior to regulatory approval. Individuals interested in participating in clinical trials for melflufen may visit View Source for information about ongoing clinical trials. Patients are encouraged to consult their physician regarding the possibility of participating in one of the ongoing clinical trials.

On June 30, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed a new drug application to the Ministry of Health, Labour and Welfare (MHLW) for polatuzumab vedotin, an anti-CD79b antibody-drug conjugate, for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) on June 29 (Press release, Chugai, JUN 30, 2020, View Source [SID1234561537]). Polatuzumab vedotin received orphan drug designation from MHLW in November 2019.

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"About 40% of patients with untreated DLBCL experience relapse of the disease after standard therapy and subsequent treatment options are limited. In many cases, therapeutic effects on relapsed or refractory DLBCL are insufficient, and there is a high unmet medical need" said Dr. Osamu Okuda, Chugai’s President and COO. "Polatuzumab vedotin is a therapeutic antibody which bolsters Chugai’s blood cancer franchise following Rituxan and Gazyva. We will continue our efforts to deliver polatuzumab vedotin, an antibody-drug conjugate with a novel mechanism of action, to patients as early as possible and contribute to the realization of better treatment."

This application is based on the results from a multicenter, single-arm Japanese phase II study (JO40762/P-DRIVE study) that evaluated the efficacy and safety of the combination therapy of polatuzumab vedotin with bendamustine and rituximab (BR therapy) in relapsed or refractory DLBCL, and a multicenter overseas phase Ib/II clinical study (GO29365) comparing the efficacy and safety of polatuzumab vedotin in combination with BR therapy to BR therapy. A double-blind, placebo-controlled global phase III study (GO39942/POLARIX study) is ongoing for untreated DLBCL to compare the efficacy and safety of polatuzumab vedotin in combination with rituximab plus cyclophosphamide, doxorubicin, prednisolone (R-CHP) to rituximab plus cyclophosphamide, doxorubicin, vincristine, prednisolone (R-CHOP).

[Reference information]
Polatuzumab Vedotin Achieved Primary Endpoint in the Japanese Phase II study for Relapsed or Refractory Diffuse Large B-cell Lymphoma (Press release issued by Chugai on February 13, 2020)
View Source

European Commission approves Roche’s Policy for people with previously treated aggressive lymphoma (Press release issued by Roche on January 21, 2020)
View Source

Chugai Receives Orphan Drug Designation for Polatuzumab vedotin in Diffuse Large B-Cell Lymphoma from the MHLW (Press release issued by Chugai on November 20, 2019)
View Source

About polatuzumab vedotin
Polatuzumab vedotin was developed by Roche using Seattle Genetics’ ADC technology. It is a first-in-class anti-CD79b antibody-drug conjugate (ADC), comprising the anti-CD79b humanized monoclonal antibody and a tubulin polymerization inhibitor attached together using a linker. The CD79b protein is expressed specifically in the majority of B-cells, making it a promising target for the development of new therapies1, 2). Polatuzumab vedotin binds to CD79b and destroys these B-cells through the delivery of an anti-cancer agent, which is thought to suppress the effects on normal cells3, 4). Polatuzumab vedotin was granted accelerated approval in the US in June 2019 and conditional marketing authorization in the EU in January 2020, respectively.

About diffuse large B-cell lymphoma (DLBCL)
DLBCL is one of the histologic subtypes of non-Hodgkin’s lymphoma (NHL), which is categorized as an aggressive disease that progresses on a monthly basis. DLBCL is the most common form of NHL, accounting for 30-40 percent of NHL5-7). DLBCL frequently occurs in middle-aged and older people, mainly in their 60’s8). The median age at diagnosis has been reported to be 649).

The combination of rituximab and chemotherapy is the standard therapy for untreated DLBCL; however, recurrence has been observed in about 40% of the patients due to insufficient therapeutic effect10). In addition, although autologous stem cell transplantation (ASCT) is recommended in eligible patients with recurrent or refractory DLBCL, ASCT cannot be performed in about half of these patients due to failure of salvage chemotherapy prior to ASCT11). Furthermore, no standard therapy has been established for patients ineligible for ASCT due to reasons including age or complications12). Therefore, more useful new treatment options for relapsed or refractory DLBCL are in great need.

Sources

Dornan D, et al. Therapeutic potential of an anti-CD79b antibody-drug conjugate, anti-CD79b-vc-MMAE, for the treatment of non-Hodgkin lymphoma. Blood 2009; 114:2721-2729
Pfeifer M, et al. Anti-CD22 and anti-CD79B antibody drug conjugates are active in different molecular diffuse large B-cell lymphoma subtypes. Leukemia 2015; 29:1578-1586
Ducry L, Stump B. Antibody-drug conjugates: linking cytotoxic payloads to monoclonal antibodies. Bioconjug Chem. 2010; 21:5-13
ADC Review. What are antibody-drug conjugates? Available from: View Source (accessed in June 2020)
Swerdlow SH, et al. WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues, Revised 4th Edition. Lyon, International Agency for Research on Cancer; 2017
Aoki R, et al. Distribution of malignant lymphoma in Japan: Analysis of 2260 cases.2001-2006. Pathol Int 2008; 58(3):174-182
Chihara D, et al. Differences in incidence and trends of haematological malignancies in Japan and the United States. Br J Haematol 2014 Feb; 164(4):536-545
Niitsu N, Diffuse large B-cell lymphoma. The Journal of the Japanese Society of Internal Medicine 2008; 97:1588-1594
Armitage JO, Weisenburger DD. New approach to classifying non-Hodgkin’s lymphomas: clinical features of the major histologic subtypes. Non-Hodgkin’s Lymphoma Classification Project. J Clin Oncol 1998; 16:2780-2795
Friedberg JW. Relapsed/Refractory Diffuse Large B-Cell Lymphoma. Hematology Am Soc Hematol Educ Program 2011; 2011:498-505
Gisselbrecht C, et al. Salvage Regimens With Autologous Transplantation for Relapsed Large B-Cell Lymphoma in the Rituximab Era. J Clin Oncol 2010; 28: 4184-4190
Japanese Society of Hematology. Practical Guidelines for Hematological Malignancies, 2018, Kanehara & Co., Ltd. (Japanese only)