On March 17, 2021 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology," NASDAQ: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported financial results for the fourth quarter and full year ended December 31, 2020 and provided a business update (Press release, Olema Oncology, MAR 17, 2021, View Source [SID1234576804]).

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"2020 was a momentous year for Olema, marked by the achievement of several important milestones including the initiation of our Phase 1/2 clinical trial for OP-1250 in ER+ / HER2- breast cancer as well as Series B and C financings, culminating in our Initial Public Offering in November." said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "We continue to execute on our strategy and enrollment in our ongoing clinical trial remains on-track, with data to be presented at a scientific meeting later this year."

2020 Corporate Highlights

Advanced Olema’s lead program, OP-1250, through investigational new drug (IND) filing and initiated a Phase 1/2 dose escalation and dose expansion clinical trial for the treatment of recurrent, locally advanced or metastatic estrogen receptor (ER)-positive, or ER+, human epidermal growth factor receptor 2-negative, or HER2-, breast cancer. Initial data from this trial are expected to be reported in the second half of 2021.
In July 2020, entered into non-exclusive clinical collaboration with Novartis to evaluate the combination of OP-1250 and ribociclib (KISQALI), a CDK4/6 inhibitor, as well as apelisib (PIQRAY), a PI3Kα inhibitor in patients with ER+ / HER2- breast cancer.
In November 2020, entered into non-exclusive clinical trial agreement with Pfizer to evaluate the combination of OP-1250 and palbociclib (IBRANCE), a CDK4/6 inhibitor in patients with ER+ / HER2- breast cancer.
Expanded discovery research efforts with additions to the research team as well as new laboratory facilities.
Raised approximately $382 million in gross proceeds across Series B, Series C and Initial Public Offering financings before deducting underwriting discounts, commissions and other offering expenses.
Strengthened Olema’s management team and Board of Directors in 2020 by adding seasoned and experienced industry leaders across the executive functions.
Financial Highlights

Cash and cash equivalents as of December 31, 2020 were $338.5 million. The company anticipates that the year-end balance of cash will be sufficient to fund operations through 2022.
Net loss for the fourth quarter ended December 31, 2020 was $10.1 million compared to $1.0 million for the fourth quarter ended December 31, 2019. Net loss for the year ended December 31, 2020 was $24.0 million compared to $4.3 million for the year ended December 31, 2019.
Research and development (R&D) expenses were $6.3 million for the fourth quarter ended December 31, 2020 compared to $0.9 million for the fourth quarter ended December 31, 2019. Research and development expenses were $13.7 million for the year ended December 31, 2020 compared to $3.9 million for the year ended December 31, 2019. The increase in R&D expenses was primarily related to increase in preclinical development activities, the IND filing and initiation of the Phase 1/2 clinical trial of OP-1250 and higher non-cash stock-based compensation expenses.
General and administrative (G&A) expenses were $3.8 million for the fourth quarter ended December 31, 2020, compared to $0.1 million for the fourth quarter ended December 31, 2019. General and administrative expenses were $7.8 million for the year ended December 31, 2020, compared to $0.4 million for the year ended December 31, 2019. The increase in G&A expenses was primarily due to an increase in personnel, public company-related expenses, other corporate costs and higher non-cash stock-based compensation expenses.

On March 17, 2021 Selvita reported that it will participate in the upcoming BIO-Europe Spring 2021 – global life science partnering event held March 22-25 in a fully digital format (Press release, Selvita, MAR 17, 2021, View Source;utm_medium=rss&utm_campaign=selvita-will-participate-in-the-upcoming-26th-annual-bio-europe-2 [SID1234576803]). The Company will be represented by Edyta Jaworska, Member of the Management Board, Integrated Drug Discovery, and Tom Coulter, PhD, Integrated Drug Discovery Director. To schedule a one-on-one meeting with Selvita representatives, please contact us at [email protected]. We look forward to participating in virtual partnering meetings, on-line panel sessions, and the virtual exhibit.

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On March 17, 2021 M2GEN, a leading oncology-focused data and informatics company, reported a significant new five-year agreement with Merck, known as MSD outside the United States and Canada (Press release, M2Gen, MAR 17, 2021, View Source [SID1234576801]). Under the terms of the agreement, M2GEN will provide valuable patient-consented, de-identified, linked clinical and genomic data in support of Merck’s oncology efforts.

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This data will be accessed through M2GEN’s Oncology Research Information Exchange Network (ORIEN), a network of 18 leading cancer centers across the United States. ORIEN Avatar is a collaboration between this network, pharmaceutical companies and M2GEN, which manages the program. Patients donate clinical and molecular data through their consent to the Total Cancer Care research protocol; that data follows patients pre-and post-treatment and is then utilized by the ORIEN cancer center members and pharmaceutical partners to speed discoveries and match eligible patients to cutting-edge trials. The program represents an unprecedented, pre-competitive approach to fighting cancer, designed to accelerate the discovery and development of novel therapies for patients around the world.

Merck’s participation in the program builds on a history of collaboration dating back to the founding of M2GEN in 2006, when the companies operationalized a multi-year agreement based on the Total Cancer Care protocol. The collaboration with M2GEN has provided important utility in Merck’s oncology development programs including indications for KEYTRUDA (pembrolizumab).

"Merck has been a key strategic partner to M2GEN since helping to found the Total Cancer Care protocol 15 years ago, and we are very proud of what we have accomplished together," said M2GEN President and CEO Helge Bastian, PhD. "We greatly value Merck’s long-term partnership and see tremendous potential in it for the future."

"We see this new partnership as an important milestone in the fight against cancer," said Sandra E. Peterson, Chair of the M2GEN Board of Directors. "We are thrilled to expand our collaboration with Merck to enable the development of more effective medicines and patient care."

"Our work with M2GEN yielded valuable insights that have informed our oncology development strategy," said Dr. Eric Rubin, SVP Oncology Clinical Development, Merck Research Laboratories. "We look forward to continuing our collaboration and building on our shared commitment to improving cancer care."

On March 17, 2021 M2GEN reported a significant new investment by Clayton, Dubilier & Rice ("CD&R") funds, the Merck Global Health Innovation Fund ("Merck GHI"), and McKesson Ventures to recapitalize M2GEN, a leading oncology data and informatics platform focused on transforming cancer care, in partnership with its existing shareholders (Press release, M2Gen, MAR 17, 2021, View Source [SID1234576800]). The financial terms of the transaction, which closed today, were not disclosed.

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Merck GHI and McKesson Ventures invested alongside CD&R funds, collectively now the company’s largest shareholder. Existing shareholders Moffitt Cancer Center, Hearst Healthcare, and The Ohio State University Foundation continue to hold a significant minority interest M2GEN. Proceeds from the transaction are expected to accelerate growth of M2GEN’s consented, linked clinical and genomic data asset and advance the technology and informatics capabilities of the company. In conjunction with the recapitalization, Sandra E. Peterson, CD&R Operating Partner and former Group Worldwide Chairman of Johnson & Johnson, has assumed the role of Chair of the M2GEN board.

In conjunction with the transaction, M2GEN will bolster its existing senior management team led by President and CEO Helge Bastian, Ph.D., with two experienced executive hires: Todd Johnson, M.D., most recently Senior Vice President of Life Sciences Commercialization and Clinical Research Groups at Optum, as Chief Growth Officer, and Wilf Russell, a seasoned technology leader with experience from companies including Volvo, Nike, and Microsoft, as Chief Technology Officer.

M2GEN runs one the world’s largest observational research studies in cancer, which tracks patients throughout their lifetime, links longitudinal clinical data with molecular information, and enables a deeper understanding of a patient’s disease. M2GEN has established one of the largest and most comprehensive linked clinical and genomic databases in the country, empowering innovative, collaborative cancer research and supporting the development of novel oncology drugs by its biopharmaceutical partners.

M2GEN’s data platform includes more than 300,000 patients across its alliance of leading cancer research centers, known as the Oncology Research Information Exchange Network (ORIEN). ORIEN members benefit through collaborative research and shared data; M2GEN’s biopharmaceutical partners benefit through access to the network and a dataset that supports clinical trial design, patient recruiting and new therapy development; and the ultimate beneficiaries are patients, as this process informs new drug treatment options.

"M2GEN is purpose-driven and patient-centric, and we believe it will impact healthcare for the next generation by connecting patients, providers, researchers, and pharma R&D to fundamentally change the way cancer is studied and treated," said Sarah Kim, CD&R Partner. "CD&R has spent significant time evaluating the real-world data market within pharma services and sees a tremendous opportunity to join forces with an exceptional group of shareholders to support M2GEN’s next phase of growth, drive operational excellence, and further its mission to connect patients to a cure by accelerating the discovery, development and delivery of more personalized therapies."

"Merck GHI closely tracked M2GEN for many years through our research colleagues’ collaborations first with Moffitt Cancer Center and then with M2GEN’s spin-out from Moffitt," said David M. Rubin, Ph.D., Managing Director, Merck GHI. "This syndicated investment will support the build of scaled resources that have the potential to enable the development of new medicines and precision cancer care."

"McKesson Ventures is proud to support M2GEN’s leading and comprehensive linked clinical and genomic data platform. Our investment directly reflects McKesson’s broader commitment to advance and improve community oncology care through The US Oncology Network and Ontada, our innovative oncology technology and insights business," said Dave Schulte, Senior Vice President and Managing Director, McKesson Ventures.

Ropes & Gray LLP acted as legal advisor to CD&R in connection with the transaction. Perella Weinberg Partners LP served as exclusive financial advisor and Shumaker, Loop & Kendrick, LLP acted as legal advisor to M2GEN. Green Shoots Consulting, LLC served as advisor and McDermott Will & Emery LLP acted as legal advisor to Merck GHI.

On March 17, 2021 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform oncology drug discovery and development reported that it has filed seven patent applications globally on a novel DNA-damaging agent with anticancer properties (Press release, Lantern Pharma, MAR 17, 2021, View Source;utm_medium=rss&utm_campaign=lantern-pharma-announces-patents-on-novel-anti-cancer-agents [SID1234576799]). These patent applications include claims directed to a newly synthesized compound with promising in-vitro anticancer activity in a range of indications that are distinct from LP-184. This compound, newly designated as LP-284, is believed to act through mechanisms that are related to DNA-damage and DNA-repair inhibition in certain cancer cells.

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LP-284 is a small molecule drug candidate currently in preclinical development for certain cancers that have shown sensitivity to the compound. LP-284 is the stereoisomer (enantiomer) of LP-184 and has the potential for development as monotherapy and also as a synergistic agent in combination with other drugs. Stereoisomers can have differing and unique characteristics from one another and can be viewed as distinct pharmaceutical agents. These unique characteristics may allow LP-284 to also be considered for inclusion in Lantern Pharma’s antibody drug conjugate (ADC) program.

The individual stereoisomers of a biologically active molecule may often differ in potency, pharmacological action, metabolism, toxicity, and kinetics. This phenomenon applies to chiral anticancer agents such as LP-184 and LP-284. The enantiomers, which are different molecules, possess distinct cancer cell-killing activity. Due to these differences, we can expand the range of potential cancer indications that can be addressed by the Lantern portfolio. These differences can be better understood though the use of data-driven methodologies, such as large-scale genomic analysis and in-silico studies. Lantern expects to apply these insights to develop LP-284 in cancer indications that are different and complementary to those being targeted by LP-184.

"The insights and developments from our team are rapidly leading to new therapy opportunities in a targeted and cost-effective manner. The designation of LP-284 as a new drug candidate demonstrates our continued ability to efficiently advance and expand Lantern’s portfolio of targeted therapies," stated Panna Sharma, CEO & President of Lantern Pharma.

LP-284 will be advanced using Lantern’s proprietary RADR A.I. platform that leverages over 1.2 billion data points, machine learning, genomics, and computational biology to accelerate the discovery of potential mechanisms of action, and biomarker signatures that correlate to drug response in cancers and in cancer patients.

Based on Lantern’s previously filed PCT ("Patent Cooperation Treaty") patent application, Lantern has filed national stage patent applications to seek protection for LP-284 in major market countries throughout the world. The national stage patent applications allow, if granted, for patent protection of LP-284. The filed, multi-national patent applications are directed to both the composition and manufacture of LP-284. Lantern previously licensed patents related to LP-184 from AF Chemicals, LLC. Lantern has also filed an additional 8 patent applications that include method and use claims directed to LP-184 in specific solid tumors and also in combination with other drug compounds in specific tumors. Lantern’s patent applications also include claims related to the manufacture of LP-184 in a fully synthetic manner.

"Our patent strategy will continue to be highly focused on protecting our insights and developmental pathways for our drug candidates on a global basis. These seven patent applications are consistent with our focus on becoming a leader in the global development of precision oncology therapies," said Mr. Sharma of Lantern Pharma.