On May 3, 2021 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality (SL) approach to the discovery and development of novel therapeutics, reported the first patient has been dosed in the Company’s Phase 1 clinical trial of RP-6306, a first-in-class small molecule product candidate targeting PKMYT1, which is a novel target that Repare discovered to be synthetic lethal with CCNE1 amplification and other genomic mutations to treat CCNE1-amplified, FBXW7-altered and other PKMYT1 inhibitor-sensitive cancers (Press release, Repare Therapeutics, MAY 3, 2021, View Source [SID1234579022]).

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"The dosing of the first patient in this RP-6306 trial marks a key milestone in Repare’s development of targeted cancer therapeutics. We are pleased to have initiated this trial six months ahead of what we projected at our IPO launch last June," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "Patients with tumors carrying CCNE1, FBXW7 and certain other genetic alterations we have identified as sensitive to PKMYT1 inhibition have few treatment options available, and the incidence of these cancers is rising. This Phase 1 trial will assess the safety and tolerability of RP-6306, as well as dosing schedule, to inform Repare’s planned Phase 2 program."

The Phase 1 multi-center clinical trial is expected to enroll approximately 70 patients with recurrent tumors characterized by specific genomic alterations predicted by Repare’s SNIPRx platform to render sensitivity to RP-6306. The primary goal of the Phase 1 clinical trial is to assess preliminary safety and tolerability in patients and to establish the recommended Phase 2 dose and dosing schedule for RP-6306 for evaluation in further trials. Subject to completion and review of the Phase 1 clinical trial, the Company expects to advance RP-6306, both as monotherapy and in combination with chemotherapies and other treatment modalities, into proof-of-concept studies in 2022, targeting a variety of patient populations, including those with tumors with CCNE1 amplification, FBXW7 loss or other alterations identified through Repare’s proprietary STEP2 screens.

About RP-6306

RP-6306 is a first-in-class, selective, orally available inhibitor of PKMYT1 that was discovered and developed entirely in-house by Repare. Through Repare’s SNIPRx screen campaign for targets that are SL with CCNE1 amplification, the Company identified and validated this novel SL gene that has the characteristics of a therapeutic target. Repare has developed novel and selective inhibitors against PKMYT1, which demonstrated compelling pre-clinical anti-tumor activity alone and in combination with certain anticancer agents, and subsequently announced the advancement of a clinical candidate to this potential, first-in-class program.

On May 3, 2021 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported the appointment of Richard Paulson as Karyopharm’s President and Chief Executive Officer, effective May 3, 2021 (Press release, Karyopharm, MAY 3, 2021, View Source [SID1234578977]). Mr. Paulson will also remain a member of the Board of Directors. He will succeed Michael G. Kauffman, MD, PhD, as Chief Executive Officer and Sharon Shacham, PhD, MBA, as President. Dr. Kauffman will continue in his role as a member of the Board of Directors and assume a new role with the Company as Senior Clinical Advisor. Dr. Shacham will continue in her roles as Chief Scientific Officer overseeing research, development and regulatory affairs and as Chair of the Company’s Scientific Advisory Board. Mr. Paulson, who most recently served as Executive Vice President of Ipsen Pharmaceuticals, Inc. and Chief Executive Officer of Ipsen North America, a global biopharmaceutical company focused on innovation and specialty care, has been a member of Karyopharm’s Board of Directors since February 2020 and brings over 25 years of global biopharmaceutical industry experience, including various international leadership roles transforming organizations and developing highly successful teams across three continents, where he has launched best-in-class products across multiple therapeutic areas including oncology medicines.

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"I am honored to serve as Karyopharm’s next President and Chief Executive Officer and can’t thank Drs. Kauffman and Shacham enough for their vision, leadership, and immense contributions to the scientific and initial commercial success achieved by Karyopharm," said Mr. Paulson. "Under Michael and Sharon’s leadership, the Company’s lead medicine, XPOVIO, has received three separate FDA approvals in the past two years, along with an approval in the European Union, and the resulting impact on improving the lives of patients with cancer has been remarkable."

Mr. Paulson continued, "As Karyopharm is now at a pivotal point in its commercialization efforts, I am excited to lead the Company in its next chapter of growth and innovation as we seek to expand XPOVIO’s impact across indications and geographies. Importantly, Karyopharm’s culture is rooted in a commitment to patients, which is in complete alignment with my personal value system. I look forward to leveraging my experience in global product commercialization and executive leadership to further advance Karyopharm’s impact on patients and their caregivers with the goal of continuing to build our myeloma franchise and expand into additional hematologic and solid tumor indications."

In Dr. Kauffman’s new role as Senior Clinical Advisor, he will help guide additional clinical development for Karyopharm’s robust pipeline of programs, with an increasing focus on solid tumor indications.

"It has been the privilege of a lifetime to help found and lead Karyopharm, along with Dr. Sharon Shacham, over the past twelve years," said Dr. Kauffman. "With three FDA approvals as well as our first marketing authorization in Europe, I believe now more than ever that flawless commercial execution will be imperative for Karyopharm to achieve its long-term goals. Having worked closely with Richard over the past year, I am confident that he is extremely well positioned to lead Karyopharm as we continue the important work ahead for the Company. Richard has a tremendous track record of success in leading commercial companies and I look forward to working with him as our Company’s next CEO."

"Mr. Paulson is a passionate, highly accomplished biopharmaceutical leader whose understanding of the commercial oncology space will be critical to Karyopharm as we seek to expand our commercial reach," said Barry Greene, Karyopharm’s lead independent director and Chair of the Nominating, Corporate Governance & Compliance Committee. "Having worked directly with Richard as a fellow Board member, we are thrilled to have him take on an even greater role as Karyopharm’s next Chief Executive Officer and on behalf of the entire Board, I would like thank both Michael and Sharon for their tremendous leadership and dedication to Karyopharm’s past and future success."

About Richard Paulson

Mr. Paulson has served as a member of Karyopharm’s Board of Directors since February 2020. He was previously an Executive Vice President of Ipsen Pharmaceuticals, Inc. and Chief Executive Officer of Ipsen North America, a global biopharmaceutical company focused on innovation and specialty care in areas of oncology, neuroscience and rare diseases, from February 2018 to May 2021. Mr. Paulson previously worked at Amgen for 10 years holding varying leadership positions across Europe and North America, including Vice President and General Manager of Amgen’s U.S. Oncology Business Unit, and prior to that served as the Vice President of Marketing for Amgen’s U.S. Oncology Business, General Manager of Amgen Germany, and General Manager of Amgen Central & Eastern Europe. Prior to Amgen, Mr. Paulson held a number of global leadership positions at Pfizer Inc., including serving as General Manager of Pfizer South Africa and Pfizer Czech Republic. Mr. Paulson also previously held a variety of sales, marketing, and market access roles with increasing seniority at GlaxoWellcome in Canada. Mr. Paulson has an MBA from the University of Toronto, Canada and an undergraduate degree in commerce from the University of Saskatchewan, Canada.

On May 3, 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 financial results for the first quarter ended March 31, 2021 (Press release, Lantern Pharma, MAY 3, 2021, View Source [SID1234579006]).

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"We are very pleased with our continued rapid progress in expanding and advancing our pipeline of targeted cancer drug candidates and are on pace to launch the Phase 2 trial of LP-300 in non-small cell lung cancer among non-smokers in the third quarter of this year," stated Panna Sharma, President and CEO of Lantern Pharma. "During the first quarter, we dramatically accelerated the pace with which we gather, curate, tag and assemble biologically relevant data for our RADR A.I. platform. Our RADR A.I. platform now exceeds 4.6 billion datapoints, representing a nearly 16-fold increase in the number of datapoints since our IPO in June 2020. RADR grew by approximately 1 billion datapoints per month during the first quarter of 2021. The size and scope of our RADR A.I. platform is opening up new insights and areas of opportunity for the discovery of additional indications for our existing drug candidates, as well as the identification of entirely new drug candidates and new therapeutic indications for existing molecules in the fight against cancer."

"Perhaps most exciting, as our RADR A.I. platform grows, potential partnerships with biopharma companies are now even more clearly in our sights," continued Sharma. "Earlier today, we announced that we have entered into an equity-based collaboration with Actuate Therapeutics to apply the remarkable power of RADR to better understand the mechanism of action of Actuate’s 9-ING-41 drug candidate and utilize these insights to advance a biomarker signature of response and a biomarker guided development strategy. We are excited about the opportunity to continue to build additional value-driven partnerships in the quarters ahead."

The collaboration will focus on leveraging the RADR machine learning technology, large-scale oncology datasets, and the A.I. platform to accelerate key aspects of Actuate’s 9-ING-41 drug candidate, a best-in-class GSK-3β inhibitor in active development in multiple Phase 2 clinical trials, including for pancreatic cancer. The collaboration is expected to start immediately and will potentially generate novel intellectual property that will be jointly owned by the companies. Lantern will receive upfront equity in Actuate Therapeutics subject to meeting certain conditions of the collaboration, as well as development milestones in the form of additional equity if results from the collaboration are utilized in future development efforts.

Lantern is developing four drug candidates and an ADC program across seven disclosed targets, including:

●LP-100 (Irofulven), in a Phase 2 trial for the treatment of metastatic castration resistant prostate cancer (mCRPC) which is out-licensed to Allarity Therapeutics.

●LP-300, a small molecule candidate that is preparing to enter a Phase 2 trial as a combination therapy in non-smokers with Non-Small Cell Lung Cancer (NSCLC).

●LP-184, a small molecule DNA damaging candidate anticipated to enter clinical development in 1H’22, with opportunities in several genomically-defined cancers, including: prostate, pancreatic, glioblastoma multiforme (GBM), atypical teratoid rhabdoid tumors (ATRT) and potentially additional tumors defined by the overexpression of PTGR1.

●LP-284, an alkylating agent in the research optimization stage, that appears to be preferentially active in certain hematologic cancers.

●Antibody Drug Conjugate (ADC) program leveraging RADR A.I. to identify targeted or therapeutic antibodies and aimed at utilizing a unique library of linkers to conjugate with LP-184 and other compounds.

First Quarter 2021 Financial Highlights

-Cash Position: Cash and cash equivalents were $81.4 million as of March 31, 2021 compared to $19.2 million as of December 31, 2020. The increase in cash and cash equivalents reflects the proceeds from our January 20, 2021 follow-on public offering with gross proceeds of $69.0 million.

-R&D Expenses: Research and development expenses were $1,279,037 for the quarter ended March 31, 2021, compared to $137,104 for the quarter ended March 31, 2020. The increase was primarily attributable to increases in research studies, expansion of the company’s research team, and research and development related stock option compensation expense of approximately $116,000 (a non-cash item) for the quarter ended March 31, 2021.

-G&A Expenses: General and administrative expenses were $1,173,258 for the quarter ended March 31, 2021, compared to $340,172 for the quarter ended March 31, 2020. The increase was primarily attributable to expenses associated with operating as a public company and general and administrative related stock option compensation expense of approximately $130,000 (a non-cash item) for the quarter ended March 31, 2021.

-Net Loss: Net losses were $2,452,295 for the quarter ended March 31, 2021, or $0.24 per share, compared to a net loss of $477,276 for the quarter ended March 31, 2020, or $0.24 per share. The net loss includes non-cash expenses related to employee stock options of approximately $246,000 for the quarter ended March 31, 2021.

Mr. Sharma concluded, "We will continue to aggressively advance our portfolio, both clinically and in new preclinical indications, and continue to leverage our A.I. platform to uncover new rescue or repurposing opportunities on our own or with partners. Our team is committed to building Lantern into a best-of-breed biopharma company that transforms the cost, pace and risk of oncology drug development by leveraging insight from our RADR A.I. platform with the experience and expertise of our cancer-focused research team and a roster of collaborations with world-renowned cancer research institutions. Our financial position has never been stronger and our portfolio of targeted oncology drug candidates is positioned to deliver significant ongoing value for shareholders."

On May 3, 2021 Synthekine Inc., an engineered cytokine therapeutics company, reported that it has appointed Naiyer Rizvi, M.D., as Chief Medical Officer, effective today (Press release, Synthekine, MAY 3, 2021, View Source [SID1234579023]). Dr. Rizvi is an internationally recognized leader in cancer immunotherapy drug development whose clinical research has helped deliver FDA approvals of several landmark immunotherapies, including nivolumab in squamous lung cancer and pembrolizumab in non-small cell lung cancer. He will lead Synthekine’s efforts in advancing its maturing pipeline through clinical investigation.

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"Naiyer is a physician scientist with a track record of success in the development of breakthrough oncology treatments. We are thrilled to have him join as our CMO as we move our first cytokine therapeutics into clinical development later this year," said Debanjan Ray, CEO of Synthekine. "Naiyer’s leadership and exceptional track record in immuno-oncology clinical development complement our deep cytokine expertise and will enable Synthekine to advance our broad pipeline of cytokine therapeutics and cytokine enabled cell therapies to clinical proof of concept."

As a medical oncologist and expert in clinical immuno-oncology, Dr. Rizvi’s research into mechanisms of sensitivity and resistance to immunotherapy has laid the foundation to the understanding of clinical responses to immune checkpoint inhibitors. Dr. Rizvi conducted clinical studies of novel immunotherapy drugs and immunotherapy combinations, including the landmark study to demonstrate a correlation between mutations and neoantigens with durable benefit to immune-checkpoint blockade. His work has been published in leading journals including Science, Nature, and the New England Journal of Medicine.

"Synthekine has assembled an impressive portfolio of cytokine therapeutic candidates that has the potential to address a spectrum of diseases, and I look forward to leading our clinical development and strategy to advance these promising medicines," said Dr. Rizvi. "I’ve treated patients with cytokine drugs and understand both the promise but also the toxicity that these potent therapeutics can deliver. Synthekine’s two lead programs, an IL-2 partial agonist (STK-012) and a CD-19 CAR-T with orthogonal IL-2 (SYNCAR-001 + STK-009), have demonstrated compelling efficacy, safety, and selectivity in preclinical models and I look forward to advancing them to clinical studies."

Dr. Rizvi most recently served as the Price Family Professor of Medicine, Director of Thoracic Oncology and Co-Director of Cancer Immunotherapy at Columbia University Medical Center. In addition, Dr. Rizvi was recently Research Director of the Price Family Comprehensive Center for Chest Care at New York-Presbyterian Hospital. Dr. Rizvi received his medical doctorate from the University of Manitoba Faculty of Medicine and completed his residency training at the University of Manitoba Affiliated Hospital and fellowship at Beth Israel Deaconess Medical Center/Harvard Medical School. He was a co-founder of Gritstone Oncology.

On May 3, 2021 Geron Corporation (Nasdaq: GERN) reported that it will release its first quarter 2021 financial results after the market closes on Monday, May 10, 2021 via press release, which will be available on the Company’s website at www.geron.com/investors (Press release, Geron, MAY 3, 2021, View Source [SID1234579007]). Geron will host a conference call to discuss the financial results as well as recent events at 4:30 p.m. ET the same day.

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A live, listen-only webcast will be available on the Company’s website at www.geron.com/investors/events. An archive of the webcast will be available on the Company’s website for 30 days.

Participants may access the conference call live via telephone by pre-registering online using the following link, View Source Upon registration, a phone number, Direct Event Passcode and unique Registrant ID will be sent via email. This information will be needed in order to enter the conference call. Participants are advised to pre-register at least 10 minutes prior to joining the call.