On November 2, 2021 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) ("Infinity" or the "Company") reported its third quarter 2021 financial results and provided a corporate update on eganelisib, its potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic (Press release, Infinity Pharmaceuticals, NOV 2, 2021, View Source [SID1234594123]).

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"Infinity had a very successful 3rd quarter reaching major clinical milestones with eganelisib and welcoming two outstanding R&D executives to our management team," said Adelene Perkins, Chief Executive Officer and Chair, Infinity Pharmaceuticals. "In particular, data presented in July from MARIO-3 and MARIO-275 show that eganelisib, with its unique role in reprogramming macrophages, increases the effectiveness of current checkpoint inhibitors and improves patient outcomes across multiple indications and treatment settings. These data show that eganelisib has the potential to drive the next generation of cancer immuno-therapy."

"The data on prolonged progression-free survival in metastatic triple negative breast cancer, increased overall survival in metastatic urothelial cancer, and translational evidence of modulation of the tumor microenvironment highlight the broad potential of eganelisib to improve immune checkpoint inhibitor-based treatments for patients regardless of PD-L1 status. This is particularly meaningful for PD-L1 negative 1L mTNBC patients for whom no checkpoint inhibitors have been approved and for PD-L1 negative mUC patients for whom checkpoint inhibitors are less effective," said Dr. Robert Ilaria, Chief Medical Officer, Infinity Pharmaceuticals. "We look forward to presenting a TNBC update at SABCS in December for which we are especially interested in seeing if the encouraging PFS data presented this summer is maintained in the maturing data set and to providing an update on eganelisib in UC in our January 5th guidance for 2022."

Recent Updates:

MARIO-3: Updated data was presented from 43 patients (43 patients evaluable for safety and 38 patients evaluable for efficacy) were presented on July 27, 2021, from the Company’s ongoing Phase 2 study evaluating eganelisib in a novel triple combination with Tecentriq (atezolizumab) and Abraxane (nab-paclitaxel) in unresectable locally advanced or metastatic triple negative breast cancer (TNBC). Updated safety and efficacy data will be presented at the San Antonio Breast Cancer Symposium (SABCS) Annual Meeting, December 7-10, 2021.

Encouraging efficacy data presented on July 27, 2021, suggest the addition of eganelisib to Tecentriq and Abraxane has the potential to extend progression-free survival regardless of PD-L1 status.
86.8% (33/38) of evaluable patients demonstrated tumor reduction, with the majority of patients still on treatment.
The addition of eganelisib appears to extend progression-free survival (PFS) in both PD-L1(+) and PD-L1(-) patients relative to the Tecentriq and Abraxane combination from the benchmark IMpassion130 study.
In PD-L1(-) patients, median PFS was 7.3 months (3.5, NA) in MARIO-3, compared to median PFS of 5.6 months for Tecentriq and Abraxane in IMpassion130. There are currently no approved checkpoint inhibitor regimens, including the combination of Tecentriq and Abraxane, for PD-L1 (-) 1L mTNBC patients.
In PD-L1(+) patients, median PFS was 11.2 months (5.3, 11.2) in MARIO-3 compared to 7.5 months for Tecentriq and Abraxane in IMpassion130. The Tecentriq and Abraxane combination is approved in PD-L1(+) 1L mTNBC patients in over 70 countries.
Overall safety in MARIO-3 was consistent with the safety profile of eganelisib and the published safety profile of the marketed products Tecentriq and Abraxane, and no new safety signals were observed. The most common ≥GR3 treatment-related adverse events (AEs) were hepatic AEs (18%); neutropenia AEs (16%); skin AEs (12%); fatigue (6%); peripheral sensory neuropathy (6%); and diarrhea (6%).
MARIO-275: Updated data on 49 patients were presented on July 27, 2021, from the Company’s randomized, placebo-controlled Phase 2 study evaluating the efficacy and safety of eganelisib in combination with Opdivo (nivolumab) in platinum-refractory, I/O naïve patients with locally advanced or metastatic urothelial cancer (UC).

Median overall survival (mOS) in the intent to treat population was 15.4 months (6.2, NE) on the eganelisib plus Opdivo arm compared to 7.9 months (2.3, NE) on the Opdivo control arm (hazard ratio of 0.62 (0.28, 1.36)), reflecting a 38% lower probability of death.
Median overall survival was equally strong in PD-L1(-) patients with a hazard ratio of 0.60 (0.21, 1.71), reflecting a 40% lower probability of death.
The most common ≥Grade 3 treatment-related adverse events (AEs) were, across all doses, all causality, anemia (12.1%), and hepatic AEs including hepatotoxicity (15.2%), increased ALT (12.1%) and increased AST (12.1%) with no Hy’s Law. No Grade 5 hepatic AEs were reported.
Corporate:

Appointed Stéphane Peluso, Ph.D., as Chief Scientific Officer, joining Infinity from Ipsen.
Appointed Robert Ilaria, Jr., M.D. as Chief Medical Officer, joining Infinity from Bristol Myers Squibb/Celgene.
Appointed Brian Schwartz, M.D., to Board of Directors, transitioning from consulting Chief Physician to the Board.
Third Quarter 2021 Financial Results:

At September 30, 2021, Infinity had total cash, cash equivalents and available-for-sale securities of $90.1 million, compared to $97.3 million at June 30, 2021.
Research and development expense for the third quarter of 2021 was $7.1 million, compared to $6.1 million in the same period in 2020. The increase is primarily related to an increase in compensation related expenses and clinical development expenses to support continued development of eganelisib.
General and administrative expense was $3.8 million for the third quarter of 2021, compared to $2.9 million for the same period in 2020. The increase in G&A expense is primarily due to an increase in consulting expenses, professional services and stock compensation.
Net loss for the third quarter of 2021 was $10.7 million, or a basic and diluted loss per common share of $0.12, compared to a net loss of $9.5 million, or a basic and diluted loss per common share of $0.16 in the same period in 2020.
Financial Outlook: Infinity’s 2021 financial guidance remains as follows:

Net Loss: Infinity expects net loss for 2021 to range from $40 million to $50 million.
Cash and Investments: Infinity expects to end 2021 with a year-end-cash, cash equivalents and available for sale securities balance ranging from $70 million to $80 million. Infinity’s financial guidance does not include additional funding or business development activities.
Conference Call Information

Infinity will host a conference call today, November 2, 2021, at 4:30 PM ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors/Media" section of Infinity’s website at www.infi.com. To participate in the conference call, please dial (877) 316-5293 (domestic) and (631) 291-4526 (international) five minutes prior to start time. The conference ID number is 2938945. An archived version of the webcast will be available on Infinity’s website for 30 days.

On November 2, 2021 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of its senior management team are scheduled to participate in the following virtual investor conferences in November (Press release, CRISPR Therapeutics, NOV 2, 2021, View Source [SID1234594142]):

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Credit Suisse 30th Annual Healthcare Conference
Date: Monday, November 8, 2021
Time: 1:00 p.m. ET.

Barclays Gene Editing & Gene Therapy Summit
Date: Monday, November 15, 2021
Time: 10:00 a.m. ET

A live webcast of the events will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcasts will be archived on the Company’s website for 14 days following each presentation.

On November 2, 2021 Medivir reported that (Press release, Medivir, NOV 2, 2021, View Source;interim-report-january–september-2021-301415069.html [SID1234594159])

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Positive MIV-818 data presented at ESMO (Free ESMO Whitepaper). New positive data and renegotiated agreement for remetinostat

July – September
Financial summary for the quarter

Net turnover amounted to SEK 0.8 (1.1) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -11.7 (5.2) million. Basic and diluted earnings per share amounted to SEK -0.26 (0.19) and SEK -0.26 (0.19) respectively.
Cash flow from operating activities amounted to SEK -20.0 (-17.1) million.
Liquid assets and short-term investments at the end of the period amounted to SEK 225.9 (82.7) million.
Significant events during the quarter

In July, Malene Jensen was appointed Vice President Clinical Development. She took on her position in early September.
In August, the positive results from the phase II study with remetinostat against basal cell carcinoma (BCC) were published in the scientific journal Clinical Cancer Research.
In August, it was announced that Medivir, through a renegotiated multi-party agreement, strengthens the business development potential for remetinostat.
End of August, Medivir received regulatory approval from the British UK Medicines & Healthcare products Regulatory Agency (MHRA) for the upcoming phase 1b/2a combination study with MIV-818 against liver cancer.
At the ESMO (Free ESMO Whitepaper) Congress in September, the results from the completed dose escalation part of the phase 1b monotherapy study with MIV-818 were presented. Medivir presented the data at a conference call on the same day.
January – September
Financial summary for the period

Net turnover amounted to SEK 11.6 (12.5) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -36.0 (-27.9) million. Basic and diluted earnings per share amounted to SEK -0.80 (-1.30) and SEK -0.80 (-1.30) respectively.
Cash flow from operating activities amounted to SEK -43.3 (-57.1) million.
Liquid assets and short-term investments at the end of the period amounted to SEK 225.9 (82.7) million.
Significant events after the end of the period

In October, the Board of Directors appointed Jens Lindberg as new CEO of Medivir. Jens Lindberg has extensive experience from the pharmaceutical industry and the field of Oncology. He joins from Sedana Medical where he has been VP Commercial Operations and acting CEO.
Conference call for investors, analysts and the media
The Interim Report January – September 2021 will be presented by Medivir’s interim CEO, Magnus Christensen.

Time: Wednesday, November 3, 2021, at 15.00 (CET).
Phone numbers for participants from:
Sweden + 46 8 505 583 69
Europe +44 33 3300 9032
US +1 646 722 4904

The conference call will also be streamed via a link on the website: www.medivir.com
The presentation will be available on Medivir’s website after completion of the conference.

CEO’s message
Our development strategy to reach the market remains unchanged and we have received the first approval for the upcoming phase 1b/2a combination study with MIV-818. Positive data from the dose escalation part of the monotherapy study presented at ESMO (Free ESMO Whitepaper). New positive data and renegotiated agreement for remetinostat.

Despite a number of new treatments for hepatocellular carcinoma (HCC), the most common form of primary liver cancer, there is still a great need for pharmaceuticals with new mechanisms of action. Our candidate drug MIV-818 represents a new and unique mechanism that can be combined with the most common therapies for HCC. Among the drugs that are already approved or under development, the most common mechanisms are: stimulation of the immune system and blockage of the blood supply. We have therefore chosen to study MIV-818 in combination with two products representing these two different mechanisms, Keytruda (anti-PD-1 checkpoint inhibitor) and Lenvima (tyrosine kinase inhibitor). The goal is to develop a better therapy as second-line treatment for HCC patients.

The third quarter has been characterized by continued work to ensure the start of the next study in the MIV-818 clinical program. This spring, we announced positive data with a good safety and tolerability profile from the first part of the phase 1b study with MIV-818. These data were further strengthened in September when data from the final dose escalation part of the phase 1b study were presented at the leading scientific conference, ESMO (Free ESMO Whitepaper).

A total of nine patients with various types of advanced cancer in the liver were included and evaluated. These patients had exhausted all possible approved treatments prior to being included in the study. The study evaluated safety and tolerability in patients with different types of cancer in the liver, and a positive sign of efficacy was that four patients with HCC showed stable liver disease over an extended period of time. Furthermore, liver biopsies from patients demonstrated delivery of MIV-818 to the liver, and a selective effect of MIV-818 on cancer cells.

The purpose of our next study in patients with HCC is to evaluate safety, tolerability and to also get an indication of the efficacy of MIV-818 in combination with two approved drugs.

At the end of August, we received regulatory approval from MHRA, the regulatory authority in UK, for the upcoming phase 1b/2a combination study with MIV-818. The study will include patients with hepatocellular carcinoma (HCC) who have progressed on, or are intolerant of, first line standard therapy. The study is an open-label phase 1b/2a study starting with a dose escalation part to establish the recommended phase 2 dose (RP2D).

Once the RP2D has been established for the combinations, further cohorts of up to 30 patients with HCC will be enrolled in the expansion part (phase 2a). The study will start in the UK and is planned later to include centers in Spain and South Korea. The first patient is expected to be enrolled before year-end and we look forward with optimism to conducting the study.

Medivir has two more drug development projects in the clinical development phase, remetinostat, and MIV-711. Medivir does not conduct clinical development of these projects on its own, but instead seeks partners for further development.

In August, positive results from a phase II study with remetinostat against Basal Cell Carcinoma (BCC) were published in the scientific journal Clinical Cancer Research. The study was conducted at the Stanford University School of Medicine in California, USA, and the results are very promising and provide further support for the potential of remetinostat as a treatment for a number of skin cancers in addition to cutaneous T-cell lymphoma (CTCL).

In August, the remetinostat agreement was renegotiated to create significantly improved conditions for a potential outlicensing or sale in our continued business development work.

Early this year, the global and exclusive rights to develop Medivir’s project birinapant, were outlicensed to the American company IGM Biosciences. We are looking forward to the start of the clinical study with birinapant in combination with IGM’s antibody IGM-8444 later this year.

In October, we announced that Jens Lindberg has been appointed new CEO of Medivir. Jens, who joins us from his role as VP Commercial Operations at Sedana Medical, has extensive experience from the pharmaceutical industry and the oncology area. We look forward to taking Medivir forward under Jens’ leadership.

The further we advance the clinical program with MIV-818, the more I am impressed by the determination and commitment that prevails at Medivir. We are convinced that MIV-818 has the potential to become an effective drug for liver cancer. Our goal is that it would make a big difference for patients and for healthcare and thus also for the company’s shareholders.

On November 2, 2021 Dunad Therapeutics ("Dunad"), a biopharmaceutical company focusing on the development of next-generation targeted protein degradation therapies, reported that it has entered a strategic collaboration and license agreement with Novartis to generate orally bioavailable covalent and protein degrading small molecule drugs (Press release, Novartis, NOV 2, 2021, View Source [SID1234594197]).

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Under the terms of the agreement, Dunad will apply its tunable and highly selective platform to generate novel covalent and targeted protein degrading small molecule drugs focusing on up to four drug targets agreed with Novartis. Dunad will also be responsible for program execution up to lead optimization. Novartis will contribute target and ligand knowledge as well as access to unique assays and models and will fully fund the research collaboration.

Novartis has an exclusive option to develop and commercialize products resulting from the research programs directed against up to four drug targets. Upon exercise of this option, Novartis will assume responsibility for future development, manufacturing and global commercialization of the small molecule therapeutic products generated against the agreed targets.

Dunad’s unique platform uses mono-valent small molecules to induce selective degradation of disease-causing and often undruggable proteins via direct modification of the target. The Company’s novel molecular approach is fully tunable to be selective and is underpinned by a target-class agnostic mechanism of action that is clearly differentiated from other targeted protein degradation technologies.

Dunad’s platform has the potential to generate orally bioavailable degrader therapeutics that significantly expand the frontiers of protein degradation targets.

Under the terms of the agreement, Dunad will receive $24 million in an upfront payment and equity investment, as well as significant research funding. Dunad will also be eligible for milestone payments that could aggregate to up to $1.3 billion and royalties.

Alongside the equity investment of Novartis, and the founding investor Epidarex Capital, BioGeneration Ventures (BGV) is joining Dunad as a new investor. Oskar Slotboom, General Partner at BGV, has joined Dunad’s Board of Directors.

Prof. Patrick Gunning, Dunad’s co-founder, acting Chief Executive Officer and Chief Scientific Officer commented: "We are thrilled to have entered this collaboration with Novartis, which has already established a world leading position in the protein degradation space. This deal highlights the clear benefits our platform promises for the development of next-generation targeted protein degrader therapeutics. We are confident that with our approach of inducing degradation via direct modulation of target proteins with mono-valent small molecules, we can significantly expand the boundaries of targeted protein degraders as a therapeutic modality."

Dr. Diana Kraskouskaya, co-founder and Chief Operating Officer of Dunad, commented: "This collaboration is an important milestone for Dunad. It allows us to rapidly expand the impact of our platform technology to additional target classes and therapeutic areas, beyond Dunad’s own internal target pipeline. Our growing team is committed to advancing our internal pipeline and partnered programs directed against the most sought-after and previously intractable targets."

Dr. Elizabeth Roper, Partner at Epidarex Capital, Dunad’s founding investor, and board director of Dunad, commented: "We are delighted to see Dunad’s growth continue with such a significant deal with Novartis. This collaboration provides validation of Dunad’s differentiated protein degradation technology and explores the full potential of this new modality as a therapeutic approach. We are also excited to welcome BGV and Novartis as investors to the syndicate and look forward to our continued collaboration with the team."

On November 1, 2021 Curaleaf International (the "Company") (formerly EMMAC Life Sciences Group), part of Curaleaf Holdings (CNSX:CURA), Europe’s largest vertically integrated cannabis company, reported its official rebrand to the European market (Press release, EMMAC Life Sciences, NOV 1, 2021, View Source [SID1234593994]). It has been three years to the day since the UK Government’s landmark decision to legalise cannabis-based products for medicinal use, paving the way for further significant developments to the cannabis sector. In this time Curaleaf International has experienced exponential growth in cannabis revenues, as the demand for premium medicinal cannabis continues to grow.

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Curaleaf International’s cannabis flower products and extracted cannabis-based products now supply five separate markets, including Germany, Europe’s largest market for medicinal cannabis which is expected to be worth over €840 million by 20251. In the UK, specifically over the last 12 months, the number of patients using the Company’s products have increased fivefold.

Building on the momentum within the European medicinal cannabis market, Curaleaf International expects to see significant regulatory change across Europe for adult use (recreational) cannabis over the coming years with expectations that the total European cannabis market will be worth €3.2 billion by 20251. Curaleaf International expects the trends to follow that of Canada and the USA, which both started with the legalisation of medicinal cannabis before moving to legalise cannabis for adult use. With a population of approximately 740 million people, Europe presents a greater market size than that of North America.

The potential commercial impact of cannabis legalisation in Europe is significant. One in 10 Europeans use cannabis every year, while a quarter of people admit to having used cannabis at least once in their lifetime. The annual sales in illicit market cannabis are estimated at around €11 billion1. As highlighted in The European Cannabis Report: 6th Edition1, it is projected that sales of adult-use cannabis will reach €200 million by 2023, coming close to €800 million in 2025. Taking into account growth in the recreational sector due to decreasing stigma and ease of access, Prohibition Partners increased their total market estimate from €800 million to €3.2 billion by 20251.

The Company expects that over the next three to four years significant regulatory changes will occur across the continent. Recent progress has notably occurred in Switzerland, the Netherlands, Italy and Germany. Since May 2021, Switzerland allows the sale of adult use cannabis under a trial basis. In Zurich, the country’s largest city, consumers will be allowed to buy cannabis products from pharmacies and social clubs.3 In the Netherlands, 10 licences have been issued for a recreational cannabis pilot project to supply 79 "coffee shops" in 10 municipalities. In Germany, the largest market in Europe for medical cannabis, the likely new coalition Government under the SPD, Greens and FDP parties are all in favour of legalising adult use cannabis. Additionally, Italy could be the first European nation to make adult use cannabis legal. The country is due to have a referendum proposing the legalisation of adult use cannabis in 2022, with an expected result of 57% voting in favour of legalising4, the potentially €8 billion market presents a lucrative opportunity for first movers such as Curaleaf International.

With the anticipated regulatory changes across Europe, Curaleaf International believes this is a pivotal moment for the European cannabis industry. The Company is uniquely positioned within Europe with a fully vertically integrated model, handling every aspect of the process from seed to shelf. The Company has two operating EU-GMP processing facilities and import and distribution capabilities in place in the UK and Germany.

Commenting on the European opportunity, Antonio Costanzo, CEO of Curaleaf International, said: "We have seen good growth in medicinal cannabis across Europe, and building on this momentum, the official launch of Curaleaf International has been designed to create a European cannabis platform to capitalise on the rapidly emerging opportunities that are accelerating in line with regulatory change and cultural acceptance. The landscape in Europe is changing and we can see similar clear patterns to the progress in North America for adult use cannabis. As the only established fully integrated cannabis company in Europe, our first mover advantage gives us complete control over the supply chain, and this, coupled with our science led approach leaves Curaleaf International best positioned to capitalise on this potentially enormous market."