On May 4, 2021 Certara, Inc. (Nasdaq: CERT), the global leader in biosimulation, reported the launch of its Secondary Intelligence software, the first and only software that quantitatively predicts the risk of adverse effects and safety issues derived from secondary pharmacology that may impede the clinical development of a drug (Press release, Certara, MAY 4, 2021, View Source [SID1234579070]).

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Safety issues account for approximately one quarter of candidate attrition in drug development projects. They can arise from either intended or unintended drug-receptor interactions, also known as primary or secondary pharmacology, respectively. Secondary pharmacological profiling is increasingly applied by drug developers and assessed by regulators to evaluate the potential of off-target effects of novel drugs. To address secondary pharmacology, researchers typically screen their small molecule compounds against a broad panel of off-target receptors. The challenge is interpreting the readouts to understand which receptor interactions will contribute to potential adverse effects in clinical development and post-marketing.

"While drug developers and regulators rely on secondary pharmacology analyses to support critical development decisions, the current process is inefficient, inconsistent, and often imprecise," said William F. Feehery, Ph.D., CEO of Certara. "With our Secondary Intelligence software, drug developers will be able to make faster, more confident go/no go portfolio decisions earlier in the drug discovery and development process which will help to increase the likelihood of success in clinical trials."

Certara’s Secondary Intelligence software is the only software that curates and visualizes secondary pharmacology analyses to evaluate safety liabilities against multiple receptors. It ranks the likelihood of off-target interaction during clinical use to make critical decisions on which compounds to progress or modify.

"We have unlocked the potential of secondary pharmacology data to provide automated intelligence so that safety pharmacologists and toxicologists can more confidently and consistently predict the off-target safety risks associated with their compounds faster and earlier," said Will Redfern, Ph.D., Vice President, Quantitative Systems Toxicology & Safety at Certara. "Secondary Intelligence allows drug developers to de-risk their programs with evidence-based secondary pharmacology insights, which could save significant time, cost, and resources further down the line."

To learn more about the Secondary Intelligence software and consulting services, please visit: View Source

On May 4, 2021 Cartesian Therapeutics, a fully integrated, clinical-stage biopharmaceutical company pioneering RNA cell therapy in and beyond oncology, reported a $2 million competitive R&D award from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) to support its clinical development for Descartes-30, the first RNA cell therapy for respiratory diseases (Press release, Cartesian Therapeutics, MAY 4, 2021, View Source [SID1234579069]).

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This is the fourth Small Business Innovation Research (SBIR) grant awarded to Cartesian to support its clinical-stage investigational therapies developed with the company’s proprietary RNA Armory combination therapy platform. Cartesian previously won research grants from the National Cancer Institute (NCI) for Descartes-11 in multiple myeloma ($2.3 million) and from the National Institute of Allergy and Infectious Diseases (NIAID) for Descartes-08 in generalized myasthenia gravis ($2 million).

"We appreciate NIH’s recognition of the RNA Armory’s potential to treat a wide array of human disease," said Murat Kalayoglu, M.D., Ph.D., President and Chief Executive Officer at Cartesian Therapeutics. "RNA cell therapy is a new class of therapy, combining the safety of conventional (nanoparticle-delivered) RNA therapeutics with the potency of conventional (DNA-engineered) cell therapies. This new funding from NHLBI will accelerate our effort to bring RNA cell therapy to respiratory and critical care disease as we continue to demonstrate that cell therapy can expand beyond oncology."

"The overarching vision behind our RNA Armory platform is to RNA-engineer any cell to express any desired combination of secreted and membrane-bound proteins," said Michael Singer, M.D., Ph.D., Chief Scientific Officer at Cartesian Therapeutics. "The cell – which we can target to any tissue of choice – allows us to deliver a multimodal biologic drug factory directly to the site of disease."

Descartes-30 is an off-the-shelf mesenchymal stem cell (MSC) therapy engineered to secrete two DNases that degrade neutrophil extracellular traps (NETs), which are key drivers of several respiratory, autoimmune and cardiovascular diseases. The MSC acts both as a protein factory, by producing therapeutic DNases for an extended period, and as a vehicle to deliver those therapeutics directly to the lungs, where NETs accumulate. Future clinical candidates aim to engineer three or more therapeutic and targeting proteins within a cell.

On May 4, 2021 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported that it will announce its financial results for the first quarter 2021 on Monday, May 10th, 2021. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the first quarter 2021 (Press release, BioNTech, MAY 4, 2021, View Source [SID1234579068]).

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The slide presentation and audio of the webcast will be available via this link.

To participate in the conference call, please dial the following numbers ten minutes prior to the start and provide the Conference ID:

Participants may also access the slides and the webcast of the conference call via the "Events & Presentations" page of the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

On May 4, 2021 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported positive top-line results from the Company’s GENESIS Phase 3 trial evaluating its lead clinical candidate, Motixafortide, in combination with granulocyte colony stimulating factor (G-CSF, the standard of care in this indication), for hematopoietic stem-cell mobilization for autologous bone marrow transplantation in multiple myeloma patients (Press release, BioLineRx, MAY 4, 2021, View Source [SID1234579067]).

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An analysis of data on all 122 enrolled patients (the intent to treat, or ITT, population) found highly statistically significant evidence across all primary and secondary endpoints favoring Motixafortide in addition to G-CSF, as compared to placebo plus G-CSF. In addition, the combination was found to be safe and well tolerated.

The primary endpoint of the study demonstrated a 4.9-fold increase (70.0% vs 14.3%; difference 54.6%; 95% CI 39.7-69.5%; p<0.0001) in the proportion of patients in the treatment arm, as compared to the control arm mobilizing ≥ 6 million CD34+ cells/kg in up to two apheresis sessions, and after only one administration of Motixafortide. This translates to an odds-ratio of 12.9.

The study also achieved its main secondary endpoint, demonstrating a 14.1-fold increase (67.5% vs 4.8%; difference 61.7%; 95% CI 49.5-73.8%; p<0.0001) in the proportion of patients in the treatment arm, as compared to the control arm, who mobilized ≥ 6 million CD34+ cells/kg in just one apheresis session. This translates to an odds-ratio of 56.0.

Other important data from the study include median number of CD34+ cells collected on the first day of apheresis (8.5 million in the treatment arm vs 1.5 million in the control arm) – a 5.6-fold increase. The addition of Motixafortide to G-CSF also allowed 88.3% of patients to undergo transplantation after only one apheresis session, compared to 10.8% in the G-CSF arm – an 8.2-fold increase. Engraftment endpoints, including the number of days needed for engraftment, success of engraftment and the durability of engraftment 100 days post-transplant, further support the study’s success.

"The results of the GENESIS study are extremely impressive, and all the more so when considering that almost 90% of the patients in the treatment arm proceeded to transplantation after only one apheresis session," stated John DiPersio, MD, Washington University School of Medicine, and lead investigator of the study. "This is a great achievement in alleviating the burden for the patients and reducing hospital resources. I believe these results make the combination of Motixafortide and G-CSF a very attractive candidate for use in all patients with multiple myeloma undergoing autologous stem-cell transplantation."

"These strikingly positive data significantly exceeded our expectations, and are truly transformational for our company," stated Philip Serlin, Chief Executive Officer of BioLineRx. "The statistical significance across all primary and secondary endpoints was consistent across twelve different sensitivity analyses. These results support our goal of becoming the standard of care for autologous bone-marrow transplantation, providing a strong clinical and pharmaco-economic advantage for its use, on top of G-CSF, in all transplant procedures.

"We are working aggressively to gain regulatory approval for Motixafortide in this transplant setting for multiple myeloma patients – with plans to make an NDA submission in the first half of next year – and we are also pressing forward to unlock the full potential of this therapy in this and other stem-cell mobilization indications. I would like to express our sincere thanks to the patients and investigators who participated in the study and enabled its great success," Mr. Serlin concluded.

Conference Call and Webcast Information
BioLineRx will hold a conference call today, Tuesday, May 4, 2021 at 10:00 a.m. EDT. To access the conference call, please dial +1-866-860-9642 from the US or +972-3-918-0644 internationally. The call will also be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

A replay of the conference call will be available for a limited time approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until May 6, 2021; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

About the GENESIS Trial
The GENESIS trial (NCT03246529) was initiated in December 2017. GENESIS was a randomized, placebo-controlled, multicenter study, evaluating the safety, tolerability and efficacy of Motixafortide and G-CSF, compared to placebo and G-CSF, for the mobilization of hematopoietic stem-cells for autologous transplantation in multiple myeloma patients. The primary objective of the study was to demonstrate that only one dose of Motixafortide on top of G-CSF is superior to G-CSF alone in the ability to mobilize ≥ 6 million CD34+ cells in up to two apheresis sessions. Additional objectives included time to engraftment of neutrophils and platelets and durability of engraftment, as well as other efficacy and safety parameters. Local laboratories and a central laboratory were used to determine CD34+ cell yields. For regulatory purposes, efficacy endpoints were calculated using the percentage of CD34+ cells determined by the central laboratory. The local laboratory values were used for all clinical decisions, including the number of apheresis days and the decision to proceed to transplantation.

On May 4, 2021 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company" or "we") reported its first-quarter 2021 financial results (Press release, Bausch Health, MAY 4, 2021, View Source [SID1234579066]).

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"Bausch Health entered 2021 with strong momentum as our recovery from the COVID-19 pandemic continues. Our business is generating strong cash flow, many of our leading products have increased market share in key markets, and we are advancing our pipeline," said Joseph C. Papa, chairman and CEO, Bausch Health.

"We are taking action to accelerate the strategic alternatives process to expedite the spinoff of Bausch + Lomb as we remain committed to unlocking value across our two attractive businesses. We are focused on execution and growth as we position these two strong, but dissimilar businesses as attractive growth opportunities in the markets they serve," continued Mr. Papa.

Select Company Highlights

Increased total Company reported revenue by 1% compared to the first quarter of 2020
Launched Solta Medical’s Clear + Brilliant Touch laser in the United States
Launched Bausch + Lomb’s Alaway Preservative Free (ketotifen fumarate ophthalmic solution, 0.035%), antihistamine eye drops in the United States
Entered into an agreement to divest Amoun Pharmaceutical Company S.A.E. to Abu-Dhabi based ADQ; the transaction is expected to close in the first half of 2021
Repaid debt by $200 million in the first quarter of 2021 using cash generated from operations; Bausch Health has no mandatory amortization payments or debt maturities until 2024
Announced in March that Sam Eldessouky, the Company’s current Controller and Chief Accounting Officer, has been appointed to the role of Chief Financial Officer (CFO) and will succeed Bausch Health’s current CFO Paul S. Herendeen, effective June 1, 2021. Mr. Herendeen will remain at Bausch Health in the newly created role of Advisor to the Chairman and CEO
Pipeline Advancements

VYZULTA (latanoprostene bunod ophthalmic solution), 0.024%, received regulatory approval in South Korea, Brazil and Qatar, and has launched in Taiwan
LUMIFY (brimonidine tartrate ophthalmic solution 0.025%) redness reliever eye drops received regulatory approval in South Korea
BAUSCH + LOMB ULTRA ONE DAY daily disposable silicone hydrogel contact lenses received regulatory approval in Taiwan
Announced statistically significant topline results from the first Phase 3 trial evaluating the investigational NOV032 (perfluorohexyloctane) as a first-in-class eye drop with a novel mechanism of action to treat the signs and symptoms of dry eye disease associated with meibomian gland dysfunction
Announced statistically significant topline results from the second pivotal Phase 3 trial evaluating the investigational IDP-126 gel in acne vulgaris
Progress on Planned Separation of Eye Health Business
Today, the Company announced that Joseph C. Papa and Sam Eldessouky will serve as CEO and CFO of Bausch + Lomb upon separation of the Bausch + Lomb eye health business.3 In addition, the Company continued to make progress toward internal objectives necessary for the separation, including operating in five reportable segments commencing with the first quarter of 2021.

First-Quarter 2021 Revenue Performance
Total reported revenues were $2.027 billion for the first quarter of 2021, as compared to $2.012 billion in the first quarter of 2020, an increase of $15 million. Revenue was negatively impacted by approximately $100 million in the first quarter of 2021 due to the COVID-19 pandemic. Excluding the favorable impact of foreign exchange of $33 million and the impact of divestitures and discontinuations of $10 million, revenue declined organically1,4 by $8 million compared to the first quarter of 2020.