On March 15, 2022 Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, reported that the first patient has been dosed in a Phase 1/2 trial of WU-CART-007 for the treatment of relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL) (Press release, Wugen, MAR 15, 2022, View Source [SID1234610114]). WU-CART-007 is an off-the-shelf, fratricide-resistant CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat CD7+ hematological malignancies. Additionally, Wugen announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to WU-CART-007 for the treatment of acute lymphoblastic leukemia.

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"The dosing of the first patient in our Phase 1/2 trial for R/R T-ALL/LBL is a significant milestone as we continue to advance the first, off-the-shelf allogeneic CAR-T cell therapy for T-Cell malignancies in the United States into the clinic," said Dan Kemp, Ph.D., President and Chief Executive Officer of Wugen. "We are also pleased to have received FDA Orphan Drug Designation for WU-CART-007, which further augments our efforts to deliver this therapy to patients in an area of great unmet need."

"Globally, about 11,000 patients are diagnosed with T-ALL/LBL every year. About half of these patients are either resistant to frontline therapy or relapse even after initial remission, and are ultimately left with very limited treatment options," added Dr. Armin Ghobadi, M.D., Associate Professor of Medicine, Division of Medical Oncology, and principal investigator of the site at the Washington University School of Medicine. "Nelarabine is the only FDA approved therapy for R/R T-ALL, and for more than a decade, no other advances have been made for this patient population. We look forward to advancing WU-CART-007, which has the potential to transform the care paradigm for these patients."

The Phase 1/2 trial is a first-in-human, multi-site, global, open-label study of WU-CART-007 to evaluate its safety and clinical efficacy in patients with R/R T-ALL/LBL. Phase 1 of the study is designed to characterize the safety and tolerability of a single dose of WU-CART-007 following lymphodepleting conditioning therapy and to define the recommended Phase 2 dose (RP2D), cellular kinetics, and pharmacodynamics. Phase 2 of the study will investigate preliminary anti-tumor activity as measured by objective response rate (ORR) and duration of response (DOR). Additional information is available on clinicaltrials.gov, identifier NCT# 04984356.

The FDA Office of Orphan Products Development grants orphan designation for novel drugs or biologics being developed to treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. ODD qualifies the sponsor of the drug for various development incentives of the Orphan Drug Act, including potentially a seven-year period of U.S. marketing exclusivity, tax credits for clinical research costs, clinical research trial design assistance, the ability to apply for annual grant funding and waiver of Prescription Drug User Fee Act (PDUFA) filing fees.

About WU-CART-007

WU-CART-007 is an off-the-shelf, fratricide-resistant CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat CD7+ hematological malignancies. Wugen is deploying CRISPR/Cas9 gene editing technology to delete CD7 and the T-cell receptor alpha constant (TRAC), preventing CAR-T cell fratricide and mitigating the risk of graft-versus-host-disease (GvHD). WU-CART-007 is manufactured using healthy donor-derived T-cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. WU-CART-007 is currently being evaluated in a global Phase 1/2 clinical trial for the treatment of relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL). Additional information is available on clinicaltrials.gov, identifier NCT# 04984356.

On March 15, 2022 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported financial results for the quarter and full-year ended December 31, 2021, and provided an update on recent accomplishments and upcoming events (Press release, Syros Pharmaceuticals, MAR 15, 2022, View Source [SID1234610130]).

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"2021 was a pivotal year for Syros, marked by the initiations of three clinical trials and one expansion cohort across our targeted hematology and CDK inhibitor portfolios, promising data from our SY-5609 program, as well as the appointments of two key leadership team members," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "We believe we are well-positioned to build on this momentum in 2022. We expect three data readouts this year, including pharmacokinetic and safety data from our dose confirmation trial of SY-2101 in APL as well as clinical activity data from the safety lead-in portions of the SELECT-AML-1 Phase 2 trial and the expansion cohort of SY-5609 in pancreatic cancer. These results have the potential to deliver important insights into each of our investigational medicines as we continue to advance towards becoming a fully integrated biopharmaceutical company with the aim to make a profound difference for patients."

UPCOMING MILESTONES

Targeted Hematology

Tamibarotene: Oral RARα agonist

Report clinical activity data from safety lead-in portion of ongoing SELECT-AML-1 Phase 2 trial in newly diagnosed unfit RARA-positive patients with acute myeloid leukemia (AML) in the second half of 2022.
Report data from ongoing SELECT-MDS-1 Phase 3 trial in newly diagnosed RARA-positive patients with higher-risk myelodysplastic syndrome (HR-MDS) in the fourth quarter of 2023 or first quarter of 2024, with a potential new drug application (NDA) filing expected in 2024.
SY-2101: Oral arsenic trioxide (ATO)

Report pharmacokinetic (PK) and safety data from ongoing dose confirmation trial in newly diagnosed acute promyelocytic leukemia (APL) patients in mid-2022.
Initiate Phase 3 trial in first quarter of 2023 with data expected in 2025.
CDK Inhibition

SY-5609: Oral Selective CDK7 Inhibitor

Report clinical activity data from safety lead-in portion of ongoing expansion cohort evaluating SY-5609 in combination with chemotherapy in relapsed/refractory metastatic pancreatic cancer patients in the second half of 2022.
Roche plans for the arm of its ongoing Phase 1/1b INTRINSIC trial investigating SY-5609 in combination with atezolizumab in BRAF-mutant colorectal cancer (CRC) to be open for enrollment in the first half of this year. Under the terms of our agreement with Roche, Roche is the sponsor of the trial and Syros is supplying SY-5609.
Initiate Phase 1 trial evaluating SY-5609 in relapsed/refractory hematologic malignancies in the second half of 2022, with initial data expected mid-2023.
Gene Control Discovery Engine

Plan to present new preclinical data on the CDK12 inhibitor program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, taking place from April 8-13.
Nominate next development candidate, a CDK12 inhibitor, in the second half of 2022.
RECENT PIPELINE HIGHLIGHTS

In February, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to tamibarotene for the treatment of HR-MDS. The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 200,000 people in the United States. Orphan drug designation may provide certain benefits, including a seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees.
CORPORATE

In March, Syros entered into a Master Collaboration Agreement with QIAGEN to develop and commercialize an assay as a companion diagnostic for Syros’ proprietary RARA biomarker for use with tamibarotene in newly diagnosed HR-MDS patients. QIAGEN will also be responsible for obtaining and maintaining regulatory approvals for the commercial diagnostic test.
FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS

Revenues were $7.8 million for the fourth quarter of 2021, consisting of $6.5 million in revenue recognized under Syros’ collaboration with Global Blood Therapeutics, Inc. (GBT) and $1.3 million recognized under its collaboration with Incyte Corporation (Incyte). Revenues were $23.5 million for the year ended December 31, 2021, consisting of $19.4 million and $4.1 million from Syros’ collaborations with GBT and Incyte, respectively. Syros recognized $5.7 million in revenue in the fourth quarter of 2020, consisting of $3.6 million in revenue recognized under its collaboration with GBT and $2.1 million recognized under its collaboration with Incyte, and $15.1 million for the year ended December 31, 2020, consisting of $11.7 million and $3.4 million from its collaborations with GBT and Incyte, respectively.
Research and development expenses were $26.8 million for the fourth quarter of 2021 and $99.9 million for the year ended December 31, 2021, as compared to $29.0 million for the fourth quarter of 2020 and $76.1 million for the year ended December 31, 2020. The decrease for the fourth quarter of 2021 compared to the same period in 2020 was primarily due to the purchase of SY-2101 in the fourth quarter of 2020. The increase for the year ended December 31, 2021 was primarily due to the increase in costs associated with the continued advancement of our clinical and preclinical programs and employee-related expenses.
General and administrative (G&A) expenses were $6.4 million for the fourth quarter of 2021 and $23.0 million for the year ended December 31, 2021, as compared to $5.9 million for the fourth quarter of 2020 and $21.3 million for the year ended December 31, 2020.
For the fourth quarter of 2021, Syros reported a net loss of $23.8 million, or $0.38 per share, compared to a net loss of $30.1 million, or $0.62 per share, for the same period in 2020. For the full year ended December 31, 2021, Syros reported a net loss of $86.6 million, or $1.38 per share, compared to a net loss of $84.0 million, or $1.82 per share, for the same period in 2020.
Cash and Financial Guidance

Cash, cash equivalents and marketable securities as of December 31, 2021 were $143.4 million, as compared with $174.0 million on December 31, 2020. This change reflects cash used to fund Syros’ operations during the full year ended December 31, 2021, partially offset by gross proceeds of $75.6 million that Syros received from its January 2021 public offering.

Based on its current plans, Syros believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its planned operating expenses and capital expenditure requirements into the first quarter of 2023.

Conference Call and Webcast

Syros will host a conference call today at 8:30 a.m. ET to discuss these fourth quarter and full year 2021 financial results and provide a corporate update.

To access the live conference call, please dial (866) 595-4538 (domestic) or (636) 812-6496 (international) and refer to conference ID 9682507. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.

On March 15, 2022 ASLAN Pharmaceuticals (NASDAQ: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, reported the appointment of Alex Kaoukhov, MD, as Chief Medical Officer based in ASLAN’s US office, effective immediately (Press release, ASLAN Pharmaceuticals, MAR 15, 2022, View Source [SID1234610069]).

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Alex was most recently Head of Clinical Development, Senior Vice President at Bioniz Therapeutics where he established and managed a team responsible for the development of therapeutic assets for the treatment of skin and gastrointestinal autoimmune diseases.

Prior to this, from 2018 to 2020, Alex served as Head of Global Development at Almirall. His responsibilities included global clinical and non-clinical development, in addition to contributing to business development activities relating to building out the company’s medical dermatology pipeline, including the in-licensing of lebrikizumab for Europe.

Alex was also Associate Vice President of Clinical Development at Allergan in the US, with oversight of the medical dermatology pipeline. Before this, he served in clinical development leadership roles at Novartis and Galderma. During his career, Alex has designed and led large clinical trials, secured several product approvals for global programs and led the development of numerous innovative early-stage programs. At ASLAN, Alex replaces Dr Kenneth Kobayashi, who has left the company.

Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: "We’re pleased to welcome Alex to the executive team. Alex brings a great breadth of international dermatology and immunology experience, with a particular focus in atopic dermatitis, and track record of strong project leadership and team building, especially related to developing and running late-stage clinical studies. As eblasakimab advances through the Phase 2b study and we firm up our development plans for ASLAN003, we are looking forward to benefitting from his insights and expertise. We are grateful to Ken for his contribution to the early eblasakimab program and wish him well."

Dr Alex Kaoukhov, Chief Medical Officer, ASLAN Pharmaceuticals, commented: "ASLAN is building an impressive pipeline of clinical assets that have the potential to offer truly differentiated options for patients. I am looking forward to working closely with the management team to lead the development of these programs at this critical stage and am very excited to join as eblasakimab is advancing through late-stage studies in atopic dermatitis."

Prior to joining industry, Alex trained in dermatology at the Université de Paris 7 – Denis Diderot and conducted clinical research at Hôpital Saint-Louis in Paris, France.

On March 15, 2022 MorphoSys U.S. Inc., a fully owned subsidiary of MorphoSys AG (FSE: MOR; NASDAQ: MOR), reported that the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines (NCCN Guidelines) in Oncology for B-cell Lymphomas have been updated, and the designation for Monjuvi (tafasitamab-cxix) in combination with lenalidomide is now a Preferred Regimen for second-line therapy in patients with Diffuse Large B-cell Lymphoma (DLBCL) who are not candidates for transplant (Press release, MorphoSys, MAR 15, 2022, View Source [SID1234610095]).

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"Updates to NCCN Guidelines are made periodically when additional efficacy and safety data are available, providing current information on the use of cancer therapies," said Joe Horvat, U.S. General Manager, MorphoSys. "Monjuvi is a targeted immunotherapy that addresses an immediate medical need for certain adult patients living with Diffuse Large B-cell Lymphoma. We are gratified the NCCN panel acknowledged the additional data submitted for Monjuvi and updated the designation of Monjuvi in combination with lenalidomide to a Preferred Regimen in its Clinical Practice Guidelines in Oncology."

In July 2020, the U.S. Food and Drug Administration (FDA) approved Monjuvi 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 (ORR) from the one-year primary analysis of the L-MIND study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). In the U.S., Monjuvi is the only approved second-line targeted immunotherapy for this patient population.

The NCCN is a not-for-profit alliance of 30 leading cancer centers devoted to patient care, research, and education. The intent of the NCCN Guidelines is to assist in the decision-making process of individuals involved in cancer care – including physicians, nurses, pharmacists, payers, patients, and their families – with the ultimate goal of improving patient care and outcomes. The updated NCCN Guidelines are available at www.nccn.org.
NCCN and the NCCN Guidelines are registered trademarks of National Comprehensive Cancer Network.
About Diffuse Large B-cell Lymphoma (DLBCL)
DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide, characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs.1 It is an aggressive disease with about 40% of patients not responding to initial therapy or relapsing thereafter, leading to a high medical need for new, effective therapies, especially for patients who are not eligible for an autologous stem cell transplant in this setting.2
About Monjuvi (tafasitamab-cxix)
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeted immunotherapy. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb 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 United States, Monjuvi (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 (tafasitamab) received conditional marketing authorization 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.
Monjuvi and Minjuvi are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the U.S., and marketed by Incyte under the brand name Minjuvi in the EU.
XmAb is a registered trademark of Xencor, Inc.
Important Safety Information
What are the possible side effects of MONJUVI?
MONJUVI may cause serious side effects, including:
•Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get fever, chills, rash, flushing, headache, or shortness of breath during an infusion of MONJUVI.
•Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4ºF (38ºC) or above, or any bruising or bleeding.
•Infections. Serious infections, including infections that can cause death, have happened in people during treatments with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4ºF (38ºC) or above, or develop any signs and symptoms of an infection.
The most common side effects of MONJUVI include:
•Feeling tired or weak
•Diarrhea
•Cough
•Fever
•Swelling of lower legs or hands
•Respiratory tract infection
•Decreased appetite
These are not all the possible side effects of MONJUVI.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you
•Have an active infection or have had one recently.
•Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.
◦You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.
◦Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.
•Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.
You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.
Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

On March 15, 2022 Coherus BioSciences, Inc. (Nasdaq: "CHRS", "the Company", "Coherus") reported Rosh Dias, MD, MRCP, has been appointed Chief Medical Officer. Dr. Dias will serve as a member of the Company’s executive leadership team and oversee a number of clinical functions including medical affairs, clinical operations, pharmacovigilance and clinical development (Press release, Coherus Biosciences, MAR 15, 2022, View Source [SID1234610115]).

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"Rosh is a terrific addition to Coherus at a time when we are sharply focused on successful execution of new product launches and on the advancement of our immuno-oncology development pipeline," said Denny Lanfear, CEO of Coherus. "A seasoned pharmaceutical executive with a demonstrated record of success leading medical affairs across multiple therapeutic areas, including oncology, he brings important experience and expertise as we prepare for the launch of up to four new products over the next 18 months."

"I am excited to join Coherus at this pivotal moment when the Company is preparing for the launch of multiple new products in immuno-oncology, immunology and ophthalmology," said Dr. Dias. "With toripalimab and its clinical and pre-clinical pipeline of PD-1 combination candidates, Coherus is well positioned to become a leader in innovative immuno-oncology drug development and commercialization. I am very excited about Coherus’ work advancing these novel treatments and about the possibilities to impact and help patients with cancer across multiple tumor types."

Dr. Dias brings more than 20 years of pharmaceutical and biotechnology industry experience leading United States and global teams in clinical development and medical affairs across multiple disease areas including oncology, cardiometabolic health and rare diseases. Dr. Dias joins Coherus most recently from Spruce Biosciences, Inc., where he was the Chief Medical Officer overseeing global clinical development and strategy. Prior to Spruce, he served as Chief Medical Officer at Indivior PLC, a global commercial pharmaceutical company focused on substance abuse and other serious mental disorders. From 2014 to 2018, Dr. Dias held senior leadership positions at Amgen, Inc., most recently as Vice President, Global Scientific Affairs, and at Amgen’s subsidiary, Onxy Pharmaceuticals, Inc., as Head of Global Medical and Scientific Affairs. Prior to Onyx, Dr. Dias worked for 10 years at Novartis Oncology in roles of increasing responsibility, including leadership roles in the global organization, the United States and in Australia, where he directed clinical development and medical affairs efforts with a focus on oncology, hematology and rare diseases.

Dr. Dias holds a Medical Doctor degree from Charing Cross and Westminster Medical School in the UK, and is a Member of the Royal College of Physicians through postgraduate qualification in Internal Medicine.