On October 20, 2021 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that it has entered into an exclusive worldwide license agreement with Dana-Farber Cancer Institute (Dana-Farber) and a sponsored research agreement (SRA) with Stanford Medicine for a portfolio of novel small molecule inhibitors of Epidermal Growth Factor Receptor (EGFR) designed for the treatment of EGFR-mutant lung cancers (Press release, SpringWorks Therapeutics, OCT 20, 2021, View Source [SID1234591670]). The portfolio, which was originally developed in the laboratory of Nathanael Gray, Ph.D., Professor of Chemical and Systems Biology, Co-Director of Cancer Drug Discovery, and Co-Leader of the Cancer Therapeutics Research Program at Stanford Medicine, includes several differentiated, first-in-class chemical series representing novel approaches to targeting mutant EGFR and is designed to address both de novo oncogenic drivers and emerging resistance mutations to existing EGFR inhibitors. The most advanced asset in the portfolio is currently in lead optimization and targets the C797S resistance mutation.

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"We are very pleased to expand our portfolio with the in-license of these selective and differentiated EGFR inhibitors, which are complementary to our strategy of developing novel targeted therapies for patients with biomarker-defined solid tumors," said Saqib Islam, Chief Executive Officer of SpringWorks. "In addition to the monotherapy opportunities in lung cancer, where a significant unmet medical need remains, these EGFR inhibitors provide several avenues for combination therapy development as well."

"Since our lab discovered the initial compounds that could address EGFR T790M mutations, we have been exploring additional strategies to create next-generation agents for patients with EGFR-mutant lung cancers in order to address the resistance mutations that inevitably arise upon treatment with osimertinib and other therapies," said Dr. Gray. "I am grateful for the SRA support from SpringWorks and continued collaboration with my former colleagues at Dana-Farber to further this exciting science with the goal of translating our initial discoveries into meaningful new therapies for cancer patients."

Under the terms of the license agreement, SpringWorks will provide Dana-Farber with an upfront payment and Dana-Farber will be eligible to receive development and commercial milestones and royalties based on any future net sales. Concurrent with this license, SpringWorks has entered a multi-year SRA to fund continued research and development in Dr. Gray’s laboratory at Stanford Medicine as well as collaborating laboratories at Dana-Farber, including those of Pasi Jänne, M.D., Ph.D., Director of the Lowe Center for Thoracic Oncology at Dana-Farber and Professor of Medicine at Harvard Medical School, Michael Eck, M.D., Ph.D., Professor of Biological Chemistry and Molecular Pharmacology at Dana-Farber and Harvard Medical School, and Jarrod Marto, Ph.D., Principal Investigator at Dana-Farber and Associate Professor of Pathology at Brigham and Women’s Hospital and Harvard Medical School. This SRA is intended to support lead optimization and translational biology efforts as the portfolio advances towards development candidate nomination.

"Drs. Gray, Jänne, Eck and Marto have been pioneers in the discovery and development of precision medicines for cancer patients. Through this license agreement and multi-year research collaboration, we have the opportunity to advance programs at the leading edge of targeted oncology development, potentially delivering first- and best-in-class medicines to address emerging drivers of therapeutic resistance," said Mike Burgess M.B.Ch.B., Ph.D., Head of Research & Development at SpringWorks.

On October 20, 2021 Celdara Medical, LLC reported the awarding of six DRIVEN Accelerator Hub grants to outstanding researchers and innovators in the Northeast region (Press release, Celdara Medical, OCT 20, 2021, View Source [SID1234591669]). In this most recent round of funding, two Acceleration Awards (up to $50,000 per early-stage company) were awarded to Olfax Medical (Vermont) and ResusciTech (Rhode Island) and 4 Ignition Awards (up to $25,000 per faculty innovator) were awarded to Andre Khalil, PhD (University of Maine), Gian Ignacio, MD Candidate (Brown), Michael Cole, PhD (Dartmouth), and Yina Huang, PhD (Dartmouth). Awardees were selected from a competitive pool of applicants from the five states DRIVEN serves: DE, RI, VT, ME, NH.

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"We are very pleased to provide recognition and funding to these innovators," said Julie Coleman, PhD, Program Lead at Celdara Medical. "This is a great opportunity for Celdara Medical to deliver on our commitment to give back to the community by supporting early-stage biomedical companies and researchers in their mission to improve patient outcomes and save lives. I am assured that these awards will have a tangible impact on advancing critical technologies, ultimately bringing treatments closer to patients. This round of awardees addresses an array of indications including migraine, myocardial infarction, and multiple cancer types. I am very excited to see the how the DRIVEN awards accelerate these innovative projects."

"On behalf of Celdara Medical and the DRIVEN Accelerator Hub, I’m delighted to recognize this outstanding group of DRIVEN awardees," said Jake Reder, Celdara Medical CEO and Principal Investigator of the DRIVEN Accelerator Hub. "The entrepreneurial spirit – the momentum – in our region is palpable. Engaging with this cohort of world-changing scientists and entrepreneurs has been exceptionally rewarding."

Since the DRIVEN Accelerator Hub’s founding in 2018, 12 awards have been made across Northeast IDeA states. A complete list of awardees with brief technology description are listed below.

Acceleration Fund Awardees ($50,000 to early-stage companies):
Clairways (New Hampshire): Clairways is developing a small, unobtrusive, chest-worn lung health monitor that provides continuous, burden-free tracking of common respiratory signs, including coughing, wheezing, and respiratory patterns, which cannot be practically monitored today.
Extrave Bioscience (Delaware): Extrave uses extracellular vesicles (EV) as a delivery platform to treat damaged/degenerative muscle tissue in patients with muscle diseases, with a primary initial focus on Duchenne muscular dystrophy.
Lodestone Biomedical (New Hampshire): Lodestone enables immediate, in vivo, real-time monitoring of treatment response in immuno-oncology by measuring immune modulators in the tumor microenvironment with a needle implantable biosensor and external magnetic reader.
Olfax Medical (Vermont): Olfax is developing a novel, fast-acting migraine treatment for individuals of all ages who have been diagnosed with acute migraine and cluster headaches.
ResuciTech (Rhode Island): ResusciTech is addressing shortcomings in current CPR training and out-of-hospital cardiac arrest bystander response. The team is marketing a product that utilizes smartphone sensors to measure the depth and rate of chest compressions during CPR and to simultaneously provide audio-visual feedback. This feedback provides the user information needed to adjust compressions for the best possible outcome: saving a life.
Ignition Fund Awardees ($25,000 to innovative faculty)
Andre Khalil (University of Maine): Diagnostic technology that may detect breast cancer 1-4 years earlier than current practices, leading to pre-detection of the disease.
Brent Osborne (University of Vermont): First-in-class PKG-targeted therapies for the treatment of hypertension.
Gian Ignacio (Brown University): Embolic protection device for cardiothoracic procedures to prevent major and minor cerebral complications (e.g., strokes).
Louis Lapierre (Brown University): Targeting XPO1 and the autophagy pathway as a treatment for Alzheimer’s Disease.
Michael Cole (Dartmouth College): Novel platform technology to identify small molecules as inhibitors of the MYC:TRAPP interaction for cancer treatment.
Paul Baures (Keene State University): Fatty acid synthase (FASN) inhibitor to augment cancer chemotherapy and improve clinical outcomes.
Yina Huang (Dartmouth College): Novel CAR T cell platform that enables treatment of solid tumors including metastatic melanoma.

On October 20, 2021 OncoSec Medical Incorporated (NASDAQ: ONCS) (the "Company" or "OncoSec"), a clinical-stage biotechnology company focused on developing cytokine-based intratumoral immunotherapies to stimulate the body’s immune system to target and attack cancer, reported that Chris Twitty, Ph.D., Chief Scientific Officer, will be stepping down to pursue a new opportunity with a private oncology company (Press release, OncoSec Medical, OCT 20, 2021, View Source [SID1234591668]).

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Margaret Dalesandro, Ph.D., Chair of the Board of Directors and Member of the Leadership Committee of OncoSec, remarked, "On behalf of the Board of Directors and the other members of the Leadership Committee, we are grateful to Dr. Twitty for leading OncoSec’s R&D team over the last five years and we thank him for his contributions to our significant progress towards bringing TAVO to patients."

Sandra Aung, Ph.D., Chief Clinical Development Officer, added, "We continue to be encouraged with the maturing data from the KEYNOTE-695 study and look forward to engaging with the health authorities on what we believe is an effective therapy for these patients with no standard of care options."

The formal analysis of KEYNOTE-695 and top-line results of the primary endpoint, Overall Response Rate (ORR) by blinded independent central review (BICR) based on RECIST, will be announced in the first quarter of 2022.

TAVO updated data from the KEYNOTE-695 clinical trial will be made available at 7am EST on Friday, November 12, 2021, in a poster presentation at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting in Washington D.C. The SITC (Free SITC Whitepaper) poster presentation is # 383, entitled: ‘Durable responses with intratumoral electroporation of plasmid interleukin 12 plus pembrolizumab in patients with advanced melanoma progressing on an anti-PD-1 antibody: updated data from Keynote 695.’ OncoSec will make the poster presentation available on its website following publication at SITC (Free SITC Whitepaper) 2021 and will host a SITC (Free SITC Whitepaper) symposium KOL webinar on November 12 at 7am EST for SITC (Free SITC Whitepaper) attendees and investors. Please click here to register for the webinar.

Dr. Herbert Kim Lyerly, Duke University School of Medicine, OncoSec Board of Directors and Member of the Leadership Committee, added, "As an oncologist focused on intra-tumoral cytokine immunotherapies, TAVO is an active drug with a remarkable safety profile, which will serve a PD-1 refractory patient population for whom there are no approved therapies. We are excited to update the community at SITC (Free SITC Whitepaper) 2021."

There will also be updated TAVO data from the ongoing KEYNOTE-890 clinical trial at the 2021 San Antonio Breast Cancer Symposium (SABCS), December 7-10, 2021, in a poster presentation abstract #2196, entitled: ‘Trial in progress: Phase 2 study of intratumoral plasmid interleukin-12 (tavokinogene telseplasmid; TAVO) plus electroporation in combination with pembrolizumab with or without chemotherapy in patients with inoperable locally advanced or metastatic triple-negative breast cancer (KEYNOTE-890/OMS-I141).’ OncoSec will make the poster available on its website following publication at SABCS 2021.

Lastly, regarding the CEO search, the Leadership Committee continues to meet with high quality candidates and expects to name a new CEO in the near-term.

On October 20, 2021 Carbon Re, a spinout based on innovative research from UCL and Cambridge University, reported that it has secured £1m funding to accelerate its AI technology which could help the global cement industry and energy-intensive industries to reach Net Zero targets (Press release, UCLB, OCT 20, 2021, https://www.uclb.com/2021/10/20/portico-ventures-spinout-carbon-re-secures-1m-investment/ [SID1234591638]).

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Investment was secured from the Clean Growth Fund, alongside the UCL Technology Fund (managed by Albion VC in collaboration with UCL Business), the University of Cambridge Enterprise Fund (co-managed by Parkwalk Advisors), and Blue Impact Ventures (founded by Tier CEO, Lawrence Leuschner).

The company’s cloud-based platform, Delta Zero, utilises powerful AI tools to achieve operational efficiencies in energy-intensive industries, such as cement production, reducing operational costs and carbon emissions to otherwise unachievable levels. Delta Zero enables immediate reductions in energy consumption, cost and carbon emissions, with no capital expenditure.

Carbon Re was supported through UCLB’s Portico Ventures commercialisation route, which helps researchers to set up businesses that can thrive in a fast-moving ecosystem. The spinout combines world-class deep reinforcement learning, a field of artificial intelligence best suited to managing complex decision-making, and industrial sustainability expertise from academics at the two universities.

On October 20, 2021 Biogen Inc. (Nasdaq: BIIB) reported third quarter 2021 financial results (Press release, Biogen, OCT 20, 2021, View Source [SID1234591629]).

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"The potential uptake of ADUHELM in the U.S. is delayed, but we continue to believe in its long-term potential. At the same time, Biogen has continued to execute well across its leading MS, SMA and biosimilars businesses, and we are particularly encouraged by the ongoing launch of VUMERITY," said Michel Vounatsos, Biogen’s Chief Executive Officer. "2021 continues to be a transformative year for Biogen with the launch of ADUHELM and the initiation of the rolling submission for lecanemab in Alzheimer’s disease. In addition, along with Sage Therapeutics we are pursuing a filing for zuranolone in depression."

Third Quarter 2021 Financial Results
• Third quarter total revenue of $2,779 million decreased 18% versus the prior year at both actual currency and constant currency*. o Multiple sclerosis (MS) revenue, including royalties on sales of OCREVUS, of $1,820 million decreased 19% versus the prior year at actual currency and 20% at constant currency. o SPINRAZA revenue of $444 million decreased 10% versus the prior year at actual currency and 11% at constant currency. o ADUHELM revenue was $0.3 million. o Biosimilars revenue of $203 million decreased 2% versus the prior year at actual currency and 4% at constant currency. 2
• Third quarter GAAP net income and diluted earnings per share (EPS) attributable to Biogen Inc. were $329 million and $2.22, respectively.
• Third quarter Non-GAAP net income and diluted EPS attributable to Biogen Inc. were $710 million and $4.77, respectively. A reconciliation of GAAP to Non-GAAP financial measures included in this news release can be found in Table 4 at the end of this news release. * Percentage changes in revenue growth at constant currency are presented excluding the impact of changes in foreign currency exchange rates and hedging gains or losses. The current period’s foreign currency revenue values are converted into U.S. dollars using the average exchange rates from the prior period.Beginning in the second quarter of 2021 material upfront payments and premiums paid on the acquisition of common stock associated with significant collaboration and licensing arrangements along with the related transaction costs incurred are no longer excluded from Non-GAAP R&D and SG&A expenses. Non-GAAP financial results for the third quarter of 2020 have been updated to reflect the $601 million payment related to the collaboration with Denali Therapeutics Inc. along with the associated transaction costs and income tax effect. o Third quarter 2021 GAAP and Non-GAAP R&D expense includes a $125 million upfront payment related to our collaboration with InnoCare Pharma Limited. In addition, during the third quarter we suspended further development of BIIB111 (timrepigene emparvovec) in choroideremia and BIIB112 (cotoretigene toliparvovec) in X-linked retinitis pigmentosa and recorded $39 million of estimated clinical trial close-out costs and manufacturing commitments. o Third quarter 2021 GAAP and Non-GAAP SG&A expense increased versus the prior year primarily due to investments in support of the launch of ADUHELM. Beginning in the second quarter, upon FDA approval, the reimbursement from Eisai for its share of U.S. ADUHELM SG&A expenses is reflected in collaboration profit sharing rather than SG&A.

3 • Third quarter 2021 GAAP amortization and impairment of acquired intangible assets was $111 million, including an impairment charge of $15 million related to BIIB111 and a $28 million impairment charge related to BIIB112. These amounts are excluded from Non-GAAP financial results. Non-GAAP amortization was $7 million.
• Third quarter 2021 GAAP and Non-GAAP collaboration profit sharing was a net expense of $21 million, which includes a reimbursement of $51 million from Eisai Co., Ltd. (Eisai) related to the commercialization of ADUHELM in the U.S.
• Third quarter 2021 GAAP other expense was $503 million, primarily driven by unrealized losses on our strategic equity investments of $424 million. Third quarter 2021 Non-GAAP other expense was $79 million, primarily driven by interest expense.
• Third quarter 2021 effective GAAP and Non-GAAP tax rates were (8.9%) and 14.5%, respectively. The third quarter 2021 effective GAAP tax rate was impacted by non-cash tax favorability from both the unrealized losses on our strategic equity investments and the previously described impairment charges related to BIIB111 and BIIB112. Financial Position
• As of September 30, 2021, Biogen had $7,271 million in total debt. Cash, cash equivalents, and marketable securities totaled $3,923 million. This resulted in net debt of $3,348 million.
• In the third quarter of 2021 Biogen repurchased approximately 2.2 million shares of the Company’s common stock for a total value of $750 million.
As of September 30, 2021, there was $2,800 million remaining under the share repurchase program authorized in October 2020.
• For the third quarter of 2021 the Company’s weighted average diluted shares were 149 million.
• Third quarter 2021 cash from operations was $805 million. Capital expenditures were $42 million, and free cash flow, defined as cash flow from operations less capital expenditures, was $763 million.