On May 13, 2021 Certara, Inc. (Nasdaq: CERT), the global leader in biosimulation, reported the launch of new versions of its Immunogenicity (IG) and Immuno-oncology (IO) Quantitative Systems Pharmacology (QSP) Simulators to help address the challenges in the development of biologics and cancer Therapies (Press release, Certara, MAY 13, 2021, View Source [SID1234579906]). These new versions further expand applications of QSP and advance the field of using virtual patients to conduct computer-based trials throughout drug discovery and development.

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"We have seen an increasing interest in the potential of QSP to guide regulatory decisions and anticipate that this will only continue to grow, much like physiologically-based pharmacokinetic (PBPK) modeling, which is now a critical component in many regulatory submissions," said William F. Feehery, Ph.D., CEO of Certara.

QSP addresses the most complex challenges in drug development by combining computational modeling and experimental data to examine the relationships between a drug, biological system, and disease process. Immunogenicity is a key challenge for developing biologics, including novel modalities such as gene and cell therapies. Researchers use Certara’s IG Simulator to simulate immunogenicity in virtual patients. Version 4.0 of the IG Simulator now allows for the extrapolation of ex vivo patient assays in addition to in vitro assays to better inform the model and predict clinical outcomes. The IG Simulator has now been used in more than 20 case examples. Certara and its customers will be presenting several of these case examples at an upcoming FDA workshop in June.

In immuno-oncology, the sheer number of possible therapy combinations requires a quantitative framework to integrate the complex and dynamic factors that determine efficacy and historically have led to the selection of suboptimal combinations. Certara’s IO Simulator uses virtual patients to quickly test these different combinations to determine the optimal combination of therapies and dosing regimens. Version 3.0 of the IO Simulator vastly expands the number of targets and cell types including cytokines, immune cell types, and tumor neoantigens. It can also now test combinations of chemotherapy and radiotherapy. The IO Simulator has correctly predicted therapeutic outcomes of using drugs in various cancer types, including solid tumors and blood cancers.

"QSP is demonstrating its capacity to improve biopharmaceutical R&D, improving confidence in both the drug compound and target to increase the likelihood of success," said Piet van der Graaf, Ph.D., Senior Vice President, QSP at Certara. "The IG Simulator can use first-in-human data to design Phase II/III trials, predict impact of disease and co-medication, extrapolate to new populations, and predict if IG can be managed via dosing regimens. In tandem with the rise of IO therapeutics, we’ve expanded the number of drug targets and cell types in our IO Simulator enabling us to better predict optimal drug combinations and dosing regimens for more patient populations."

In recent years, the emergence of QSP has attracted increasing interest and is now becoming an essential part in model-informed drug discovery and development. The U.S. Food and Drug Administration (FDA) has seen an increase in evaluating QSP approaches in regulatory submissions.

On May 13, 2021 Southern Research reported that Two prominent Birmingham leaders have been named to leadership – the scientific discovery and research institution headquartered on Birmingham’s Southside (Press release, Southern Research Institute, MAY 13, 2021, View Source [SID1234579905]).

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Josh Carpenter has been named president and CEO, and Allen Bolton has been named executive vice president for strategy and finance. They begin the new roles on June 1.

They’ll be taking the reins at an organization with vast potential for shaping the future of Birmingham’s economy and its innovation ecosystem.

Carpenter, a Rhodes Scholar, most recently served as director of innovation and economic opportunity for the city of Birmingham. He previously worked at UAB.

Bolton most recently was senior vice president for finance and administration at UAB where he also served on the board of Southern Research.

"I couldn’t be more enthusiastic about what’s in front of us because of the people who are there," Carpenter said.

In addition to the expertise of the people and the legacy of Southern Research, Carpenter said he was attracted to the role because of the organization’s potential to transform the region’s economy.

Historically, he said Birmingham has been home to many islands of innovation. One of his goals is to create a better through-line to connect those pockets of R&D excellence in the community and raise their collective impact.

"Southern Research, perhaps better than any other organization, is specifically geared toward playing the role of that translational bridge – translating ideas to innovation and economic opportunity," Carpenter said. "If we can create the storefront to access those immense capabilities, we can present ourselves as the next frontier market in biotech."

Carpenter said Birmingham is well-positioned for growth in life sciences, precision medicine and related fields, and he said Southern Research, with expertise in those fields and others, can play a critical role in that innovation economy.

With the way the medical sector is trending, Carpenter sees a growing need for the type of capability expertise that can be found on the campus of Southern Research, which has 400 employees.

He’s also excited about the role the organization can play in building the local innovation ecosystem – an effort with vast implications for Birmingham’s economy.

There have been numerous examples of successful biotech companies that have originated from research conducted in Birmingham but ultimately moved elsewhere. One of his goals at Southern Research is to help build an environment that keeps those companies – and the jobs they create – in metro Birmingham.

"Southern Research is at it’s finest when the halls are brimming with first-rate intellect that come up with a novel discovery that becomes a commercial enterprise and creates jobs right here in Birmingham," he said.

Carpenter said there will be a focus on having a deeper and more profound relationship with UAB, which is located adjacent to Southern Research’s campus.

"We have not tapped the potential of working to integrate our approach," he said.

Carpenter also said a priority will be adapting Southern Research’s business model to capitalize on the opportunities at hand. What that will entail is likely to become more clear with a strategic plan that could be released later this year to coincide with Southern Research’s 80th anniversary.

He said he’s happy to have a veteran leader like Bolton joining him at Southern Research.

"No one has better experience navigating not just the UAB ecosystem, but a labyrinth of medical systems," Carpenter said. "He’s going to be a really effective arbiter of our strategic and financial interests."

On May 13, 2021 Helix BioPharma Corp. (TSX:HBP) ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported that it has closed the first tranche of the previously announced private placement pursuant to the convertible security funding agreement (the "Agreement") with Lind Global Macro Fund, LP, a New York based institutional investment fund managed by The Lind Partners, LLC (together, "Lind") for gross proceeds of CAD$3.5 million (the "First Tranche") (Press release, Helix BioPharma, MAY 13, 2021, View Source [SID1234579904]).

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Pursuant to the First Tranche, the Company has issued a convertible security (the "Convertible Security") with a twoyear term and a face value of $4,112,500 and an aggregate of 1,957,056 common share purchase warrants exercisable into common shares in the capital of the Company ("Common Shares") for a period of 48 months at an exercise price of CAD$1.0283 per Common Share. The Convertible Security accrues a simple interest rate obligation of 8.75% per annum on the amount funded, which interest is prepaid and attributed to the face value of the Convertible Security. The Company has paid Lind a 3% commitment fee on the amount funded under the First Tranche and Alpha Bronze LLC is entitled to a finder’s fee equal to 5% of the amount funded.

As previously disclosed, Lind is entitled to convert the Convertible Security into Common Shares over the two year term, subject to certain limitations, at a conversion price equal to 85% of the five-day trailing volume-weighted average price of the Common Shares prior to the date a notice of conversion is provided to the Company by Lind. The Agreement includes certain restrictions on the maximum face value of each of the Convertible Securities that may be converted in any particular month. In addition, Helix has the option to buy-back 66.7% of the Convertible Security in cash at any time with no penalty, subject to the option of Lind to convert up to 1/3 of the face value of the Convertible Security into Common Shares at the time of such buy-back. If the Convertible Security is repaid by the Company within 180 days of issuance, the face value amount owed will be reduced pursuant to the terms of the Agreement. Lind is also entitled to accelerate its conversion right to the full amount of the face value or demand repayment of the face value in cash upon a default and other designated events as set out in the Agreement. To the extent that the full face value of the Convertible Security has not been converted at the maturity date of the Convertible Security, the outstanding balance of such face value shall be to be repaid to Lind by the Company in cash.

The securities issued in connection with the First Tranche are subject to a hold period pursuant to Canadian securities laws, expiring on September 14, 2021.

The Agreement also contemplates the issuance of a second Convertible Security upon the mutual agreement of the Company and Lind for gross proceeds to the Company of up to CAD$6.5 million.

On May 13, 2021 Eli Lilly and Company (NYSE: LLY) will participate in the UBS Global Healthcare Virtual Conference on Wednesday, May 26, 2021 (Press release, Eli Lilly, MAY 13, 2021, View Source [SID1234579903]). Anat Ashkenazi, senior vice president and chief financial officer, will participate in a virtual fireside chat at 10:00 a.m., Eastern Time.

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

On May 13, 2021 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that Nai-Kong V. Cheung, MD, PhD, Enid A. Haupt Endowed Chair, Pediatric Oncology, Memorial Sloan Kettering Cancer Center ("MSK") will present a research update on the Company’s SADA technology platform at PEGS Boston Virtual Conference on May 13, 2021 at 1:20 p.m. Eastern Time (Press release, Y-mAbs Therapeutics, MAY 13, 2021, View Source [SID1234579902]). The SADA technology was licensed by the Company from MSK and the Massachusetts Institute of Technology ("MIT").

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Dr. Cheung’s presentation will focus on cancer therapeutics failing in development because of dose-limiting toxicities or subtherapeutic dosing as a consequence of insufficient therapeutic index ("TI"). The two step SADA technology uses unique pharmacokinetics to potentially improve the TI. When applied to pre-targeted radioimmunotherapy ("PRIT"), the bispecific SADA antibodies visualize tumors with high precision using PET (diagnostic approach) and has been shown to ablate aggressive solid tumors using both beta and alpha emitters such as 177Lu or 225Ac (therapeutic approach), potentially without significant toxicity to bone marrow, liver, kidney, or CNS. Furthermore, the modularity of the SADA platform might allow easy adaptation to different tumor targets and a variety of payloads.

Researchers at MSK, including Dr. Cheung, developed the SADA technology for radioimmunotherapy, which is exclusively licensed by MSK to Y-mAbs. Dr. Cheung has intellectual property rights and interests in the technology, and as a result of this licensing arrangement, MSK has institutional financial interests in the technology and Y-mAbs.