On March 23, 2022 4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, reported that in Part B of its signal finding study of MRx0518 in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with solid tumors that have progressed on a prior immune checkpoint inhibitor (ICI), the renal cell carcinoma (RCC) group has met its primary efficacy endpoint ahead of enrollment completion (Press release, 4d Pharma, MAR 23, 2022, View Source [SID1234610651]).

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The ongoing study is being conducted in heavily pre-treated metastatic patients with solid tumors who have previously experienced clinical benefit on prior ICI therapy and subsequently developed progressive disease. The study is being conducted in collaboration with MSD (Merck & Co., Inc., Kenilworth, NJ, USA). The primary efficacy endpoint for Part B of the study is more than three out of 30 patients per tumor group achieving clinical benefit, defined as complete response, partial response, or stable disease for at least six months.

Part B of the study has to date enrolled 20 patients with RCC, of which four out of the first 16 evaluable patients have achieved clinical benefit, each having achieved at least 6 months of stable disease. To date, Part B of the study has enrolled 47 patients of up to a total of 120 patients with RCC, non-small cell lung cancer, bladder cancer, and head and neck squamous cell carcinoma. MRx0518 continues to be safe and well tolerated.

"Today’s results in renal cell carcinoma, meeting the predefined primary efficacy endpoint early in this difficult to treat population, marks another important step forward for MRx0518 and the increasing importance of the microbiome in cancer treatment," commented Dr. Alex Stevenson, Chief Scientific Officer, 4D pharma. "Meeting the primary efficacy endpoint for this group is crucial for the future development of MRx0518, and these data are highly informative for our strategy going forward as we determine next steps in RCC."
4D pharma intends to discuss next steps with partners and its Genitourinary Cancers Advisory Board regarding the development path of MRx0518 and a potentially pivotal study in patients with ICI-refractory RCC. 4D pharma will continue to recruit patients into the ongoing study of MRx0518 and Keytruda in RCC and the three tumor groups, with potential expansion into other types of ICI resistance.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Conference Call & Webcast Information

4D pharma will host a conference call and live webcast on Wednesday, March 23, 2022, at 10:00 am ET (2:00 pm GMT) to discuss the interim results of the Phase I/II study of the combination of MRx0518 and Keytruda for the treatment of renal cell carcinoma.

4D pharma management will be joined by key opinion leaders (KOLs) Dr. Petros Grivas, Associate Professor Clinical Research Division at the Fred Hutchinson Cancer Research Center, and Dr. Scott T. Tagawa, Professor of Medicine and Urology at Weill Cornell Medicine, both members of the 4D pharma’s Genitourinary Cancers Advisory Board.

To access the live webcast, please visit the ‘Events’ section of the 4D pharma website. To access audio only, please dial (866) 939-3921 (United States) and (678) 302-3550 (International) and reference Confirmation Number 50287940. A replay of the webcast and accompanying slides will be available on the 4D pharma website following the event.

On March 22, 2022 Jacobio Pharmaceuticals reported its 2021 Annual Results (Presentation, Jacobio Pharmaceuticals, MAR 22, 2022, View Source [SID1234644969]).

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On March 22, 2022 Pionyr Immunotherapeutics, Inc., a company developing first-in-class Myeloid TuningTM antibody therapeutics that enhance the body’s antitumor immunity by altering, or "tuning", immune cells within the tumor microenvironment, reported preclinical results from its PY265 program demonstrating efficacy both as single-agent and in combination with anti-PD1 (Press release, Pionyr Immunotherapeutics, MAR 22, 2022, View Source [SID1234621641]). The latest preclinical research from the program was presented in a poster at the Keystone Symposium titled Cancer Immunotherapy: Decoding the Cancer Immunity Interactome and in a talk today, March 22.

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"PY265 further demonstrates our Myeloid Tuning platform by engaging the macrophage receptor, MARCO, to repolarize immunosuppressive myeloid populations in the tumor and induce rapid immune activation," said Kevin P. Baker, Ph.D., SVP and Chief Development Officer at Pionyr. "Our lead programs, PY314 (anti-TREM2) and PY159 (anti-TREM1), are currently in the clinic, and PY265 is on track to complete IND-enabling studies and enter the clinic in 2023."

PY265 targets the macrophage receptor with collagenous structure (MARCO), leveraging a distinct mechanism of action from other myeloid-directed therapeutics currently in development and is expected to be first-in-class. MARCO is expressed on immunosuppressive tumor associated macrophages (TAMs) and monocytic myeloid-derived suppressor cells (mMDSCs), and its expression correlates with aggressive and advanced disease. These subpopulations of tumor myeloid cells are different from those that express the targets of Pionyr’s current lead clinical programs, TREM1 and TREM2. By targeting MARCO, PY265 induces immune activation by reprogramming pro-tumorigenic, M2-like TAMs and mMDSCs to pro-inflammatory macrophages and monocytes, leading to an increase in intra-tumoral infiltration of activated CD8+ T cells and NK cells.

The poster presentation is available on the company website at View Source

On March 22, 2022 argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported that it has commenced a global offering of $500 million (approximately €453 million) of ordinary shares, which may be represented by American Depository Shares ("ADSs") (Press release, argenx, MAR 22, 2022, View Source [SID1234610983]). The global offering will be comprised of an offering of ordinary shares represented by ADSs in the United States and certain other countries outside of the European Economic Area and a simultaneous private placement of ordinary shares in the European Economic Area and the United Kingdom. Each of the ADSs represents the right to receive one ordinary share, nominal value of €0.10 per share. The U.S. offering and the European private placement are expected to close simultaneously.

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In addition, argenx intends to grant the underwriters of the offering a 30-day option to purchase additional ordinary shares (which may be represented by ADSs) in an aggregate amount of up to 15% of the total number of ordinary shares (including represented by ADSs) proposed to be sold in the offering, on the same terms and conditions.

Baillie Gifford Overseas Limited and entities affiliated with it have indicated an interest in purchasing on behalf of their clients an aggregate of up to $170.0 million of ordinary shares in the offering at the offering price per share and on the same terms as the other purchasers in the offering. However, because indications of interest are not binding agreements or commitments to purchase, the underwriters could determine to sell more, fewer or no ordinary shares to these potential purchasers, and these potential purchasers could determine to purchase more, fewer or no shares in the offering.

argenx’s ADSs are currently listed on the Nasdaq Global Select Market under the symbol "ARGX" and argenx’s ordinary shares are currently listed on Euronext Brussels under the symbol "ARGX".

J.P. Morgan, Morgan Stanley, Cowen and SVB Leerink are acting as joint bookrunning managers for the offering.

The securities are being offered in the United States pursuant to an automatically effective shelf registration statement that was previously filed with the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement relating to the securities being offered in the United States will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities being offered in the United States may be obtained for free 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]; from Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attn: Prospectus Department, by email at [email protected], or by telephone at (866) 718-1649; from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected], or by telephone at (833) 297-2926.; or from SVB Securities LLC, Attn: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at 1-800-808-7525, ext. 6105, or by email at [email protected].

A request for the admission to listing and trading of the ordinary shares (including the ordinary shares underlying the ADSs) on the regulated market of Euronext Brussels will be made following pricing of the offering.

This press release is for information purposes only and does not constitute, and should not be construed as, an offer to sell or the solicitation of an offer to buy or subscribe to any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale is not permitted or to any person or entity to whom it is unlawful to make such offer, solicitation or sale. Reference is also made to the restrictions set out in "Important information" below. This press release is not for publication or distribution, directly or indirectly, in or into any state or jurisdiction into which doing so would be unlawful or where a prior registration or approval is required for such purpose.

On March 22, 2022 MorphoSys AG (FSE: MOR; NASDAQ: MOR) and Incyte (Nasdaq: INCY) reported that the Swiss agency for therapeutic products (Swissmedic), has granted temporary approval for Minjuvi(R) (tafasitamab) in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), after at least one prior line of systemic therapy including an anti-CD20 antibody, who are not eligible for autologous stem cell transplant (ASCT) (Press release, MorphoSys, MAR 22, 2022, View Source [SID1234610750]). Incyte holds exclusive commercialization rights for Minjuvi in Switzerland.

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"The approval of Minjuvi by Swissmedic is excellent news," said Jonathan Dickinson, Executive Vice President and General Manager, Incyte Europe. "There are a substantial number of people living with relapsed or refractory DLBCL in Switzerland and we’re pleased to be able to offer them a new treatment option."

"DLBCL is a fast-growing cancer and can be very hard to treat. Up to 40% of DLBCL patients either relapse after they have been treated or don’t respond to initial treatment at all," said Mike Akimov, M.D., Ph.D., Head of Global Drug Development, MorphoSys. "Minjuvi addresses this unmet need and its approval in Switzerland is a crucial milestone for these patients."

The approval is based on the results from the L-MIND study evaluating the safety and efficacy of tafasitamab in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT). The results showed a best objective response rate (ORR) of 56.8% (primary endpoint), including a complete response (CR) rate of 39.5% and a partial response rate (PR) of 17.3%, as assessed by an independent review committee. The median duration of response (mDOR) was 43.9 months after a minimum follow up of 35 months (secondary endpoint). Tafasitamab together with lenalidomide was shown to provide a clinically meaningful response and the side effects were manageable.[2]

Incyte and MorphoSys share global development rights to tafasitamab; Incyte has exclusive commercialization rights to tafasitamab outside the U.S. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi(R) (tafasitamab-cxix) in the U.S., and is marketed by Incyte under the brand name Minjuvi in Europe, the UK and Canada.

About Diffuse Large B-Cell Lymphoma
DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide, comprising 40% of all cases[3]. Each year around 16,000 patients in Europe are diagnosed with relapsed or refractory DLBCL[4],[5],[6]. The condition is characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs[7]. It is an aggressive disease with about one in three patients not responding to initial therapy or relapsing thereafter[8],[9],[10],[11].

About L-MIND
The L-MIND trial is a single arm, open-label Phase 2 study (NCT02399085) investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g., rituximab), who are not eligible for high-dose chemotherapy (HDC) or autologous stem cell transplant (ASCT). The study’s primary endpoint is overall response rate (ORR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS). The study reached its primary completion in May 2019.

For more information about L-MIND, visit View Source

About Minjuvi(R) (tafasitamab)
Tafasitamab is a humanized Fc-modified CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the U.S., Monjuvi(R) (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This 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 a confirmatory trial(s).

In Europe, Minjuvi(R) (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Minjuvi(R) and Monjuvi(R) are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi(R) in the U.S., and marketed by Incyte under the brand name Minjuvi(R) in Europe, the UK and Canada.

XmAb(R) is a registered trademark of Xencor, Inc.