On June 8, 2023 Enochian BioSciences Inc. (the Company) reported that it remains confident in submitting an Investigational New Drug Application (IND) for its innovative Cancer Platform in early/mid 2024 following review of comments made by the US Food and Drug Administration on the Company’s Pre-IND submission (Press release, Enochian BioSciences, JUN 8, 2023, View Source [SID1234632590]). If successful, that would allow clinical trials to begin by the first half of 2024.

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The Company’s proprietary, novel technology uses cell- and gene-therapy to promote a renewed immune response against solid tumors. The important confirmatory results from two humanized mouse models using our novel dendritic-cell based therapy, independently conducted by Dr. Anahid Jewett, a renowned cancer researcher in the field of immunotherapy from the University of California, Los Angeles (UCLA), were presented previously at two scientific conferences* and were the foundation supporting potential benefit to people and, therefore, of the Pre-IND submission.

The initial studies have been conducted in a pancreatic cancer mouse model developed and published by Dr. Jewett’s laboratory. Pancreatic cancer is diagnosed globally and in the USA in approximately 495,000 and 64,000 people, respectively, each year; nearly 466,000 and 51,000, respectively, die. Because of limited treatment options, life expectancy is very poor— approximately 10 percent survival at 5 years. Additionally, the platform technology could be potent against other solid tumors. The Pre-IND submission included a human study plan covering pancreatic cancer as well as other cancers that are difficult to treat, potentially including triple-negative breast cancer, oral cancers, and mesothelioma.

"In addition to previously reported data, my laboratory recently reviewed the tumors removed from the humanized mice," said Dr. Jewett. "There was a significant infiltration of key immune cells in mice treated with the cell- and gene-therapy with very little tumor remaining. The data also indicate that while we saw, approximately, an 80 to 90 percent reduction in tumor size and volume across the two studies, a significant amount of what remained were immune cells – and not cancer cells. These are among some of the most promising results that we have seen working in this field. I very much look forward to beginning studies in humans and, potentially, to provide hope to many people suffering with intractable and deadly cancers."

Dr. Mark Dybul, CEO of the Company, said: "We are grateful to the FDA for the very timely, thorough, and clear direction that was provided. After a comprehensive review by our management, scientific, regulatory, and clinical operations teams, we believe we have a clear path forward to submit an IND in early/mid 2024 with clinical trials potentially beginning in first half of 2024."

On June 8, 2023 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported promising interim data from the Company’s Phase 1/2 dose escalation and expansion trial of ARV-766 in men with metastatic castration-resistant prostate cancer (mCRPC). ARV-766 is an investigational orally bioavailable PROTAC protein degrader designed to degrade all clinically relevant resistance-driving point mutations of the androgen receptor (AR), including L702H, a mutation associated with resistance to abiraterone and other AR-pathway novel hormonal agents (NHA) (Press release, Arvinas, JUN 8, 2023, View Source [SID1234632585]). The company will provide an overview of these data during a fireside chat at the Jefferies Healthcare Conference today, June 8, 2023, at 11 a.m. ET, which will be available to view in the Investors and Media section of the Arvinas website.

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Data from the Phase 1/2 dose escalation and expansion trial show that ARV-766 was well-tolerated and demonstrated promising activity in a heavily pre-treated, post-NHA, all-comers patient population:

42% of patients with AR ligand binding domain (LBD) mutations achieved PSA50
In all patients with L702H mutations, 3 of 5 achieved PSA50
In patients with co-occurring T878/H875/L702 mutations, 3 of 3 achieved PSA50
RECIST (Response Evaluation Criteria in Solid Tumors) partial responses were observed:
Of four RECIST-evaluable patients with AR LBD mutations, one achieved a confirmed partial response, and one achieved an unconfirmed partial response
ARV-766 has been well tolerated and the majority of treatment-related adverse events (TRAEs) have been Grade 1 or 2, with no Grade ≥4 TRAEs and no dose limiting toxicities
Low rates of discontinuation (1 of 47) and dose reductions (2 of 47)
"Tumor resistance mechanisms such as AR LBD mutations are increasing with earlier use of NHAs, leaving limited treatment options for men with prostate cancer in the post-NHA setting," said John Houston, Ph.D., president and chief executive officer at Arvinas. "It’s very exciting to see ARV-766 show signs of efficacy in these late-line patients, including in patients with L702H mutations. Our AR franchise now includes data showing two active clinical compounds with good tolerability profiles and the potential to address high unmet need in castrate-resistant and castrate-sensitive prostate cancer."

"The patients in this trial received extensive prior therapy for mCRPC and had limited alternative treatment options," said Ron Peck, M.D., chief medical officer at Arvinas. "These data increase our confidence in our ability to bring innovative treatment options to a patient population with significant unmet need. We are excited by the progress in our AR franchise and the potential for bavdegalutamide and ARV-766 to address settings across the continuum of prostate cancer and potentially other AR-driven cancers."

About the Phase 1/2 dose escalation and expansion trial of ARV-766

The Phase 1/2 dose escalation and expansion trial of ARV-766 is a seamless trial that includes a Phase 1 dose escalation portion and a Phase 2 dose expansion portion (data cutoff: April 2023). The Phase 1 dose escalation of ARV-766 was designed to assess its safety, tolerability, and pharmacokinetics (PK) in men with mCRPC who have progressed on standard of care therapies, as well as to identify recommended Phase 2 doses for further dose optimization. The Phase 2 expansion cohort is designed to evaluate the antitumor activity of ARV-766 at the two recommended doses (100 mg and 300 mg) and determine the appropriate dose for future development.

In both the Phase 1 dose escalation and Phase 2 dose expansion, 100% of patients were previously treated with at least one or more novel hormonal agents. Patients had a median of 4 prior lines of therapy in the Phase 1 trial and 5 prior lines of therapy in the Phase 2 trial. Multiple prior therapies have been associated with a decreased responsiveness to AR-directed therapies and an increase in tumor heterogeneity.

AR LBD mutations were present in 28% (13 of 47) of patients’ tumors in the Phase 1/2 trial as determined by plasma DNA analysis.

Efficacy

Across the Phase 1 and interim Phase 2 data, ARV-766 achieved a 42% PSA50 in patients with AR LBD mutations. Three of 5 patients with AR L702H mutations achieved PSA50; the three responding AR L702H patients had co-occurring T878/H875 mutations.

Two of 4 RECIST-evaluable patients with tumors harboring AR LBD mutations had a best observed response of partial response (1 confirmed partial response, 1 unconfirmed partial response).

Safety

ARV-766 has been well tolerated to date and the majority of TRAEs in the Phase 1 dose escalation data and the Phase 2 interim dose expansion data were Grade 1/2. There have been no Grade ≥4 TRAEs. None of the 34 patients treated in the Phase 1 dose escalation portion experienced a dose limiting toxicity. The most frequent TRAEs (>10%) in Phase 1 have been fatigue, nausea, and diarrhea. At the time of data cutoff, no TRAE of >10% frequency was observed in Phase 2.

Forty-seven (47) patients across the Phase 1 and 2 trials were evaluable for safety. No patients discontinued treatment of ARV-766 due to TRAEs in Phase 1, and one patient discontinued treatment due to a TRAE in Phase 2. Two of 47 patients (both in Phase 1) were dose reduced due to TRAEs.

Based on pharmacokinetics, tolerability, and signals of activity in the Phase 1 dose escalation trial, 100 mg and 300 mg, once daily, were selected as the recommended Phase 2 expansion doses. The Phase 2 expansion (N = ~80) began enrolling in October 2022.

Anticipated 2023AR Franchise (bavdegalutamide/ARV-766) Milestones

Submit and present updated data, including radiographic progression free survival, from the ongoing Phase 1/2 trial with bavdegalutamide at a medical congress (2H 2023).
Initiate a global Phase 3 trial with bavdegalutamide in mCRPC (2H 2023).
Complete enrollment in the Phase 1b combination study with bavdegalutamide plus abiraterone (2H 2023).
Initiate a Phase 1b/2 trial with ARV-766 in combination with abiraterone in patients who have not previously received novel hormonal agents (2H 2023).
About bavdegalutamide (ARV-110) and ARV-766
Bavdegalutamide (ARV-110) and ARV-766 are investigational orally bioavailable PROTAC protein degraders designed to selectively target and degrade the androgen receptor (AR). Bavdegalutamide and ARV-766 are being developed as potential treatments for men with prostate cancer. Preclinically, both investigational agents have demonstrated activity in models of wild type tumors in addition to tumors with AR mutation or amplification, both common mechanisms of resistance to currently available AR-targeted therapies.

On June 7, 2023 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported the pricing of its public offering of 8,700,000 shares of common stock (the "Offering") at a public offering price of $5.00 per share for gross proceeds of approximately $43.5 million, without giving effect to the underwriting discount and commission as well as estimated expenses payable by Akoya (Press release, Akoya Biosciences, JUN 8, 2023, View Source [SID1234632584]). Akoya has granted the underwriters a 30-day option to purchase up to an additional 1,305,000 shares of its common stock at the public offering price. The closing of the Offering is expected to occur on June 12, 2023, subject to the satisfaction of customary closing conditions.

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Akoya intends to use the net proceeds from the Offering for working capital and general corporate purposes.

Morgan Stanley and Piper Sandler are acting as joint book-running managers for the Offering.

The securities described above are being offered by Akoya pursuant to a shelf registration statement on Form S-3 that was filed with the U.S. Securities and Exchange Commission (the "SEC") and was declared effective on November 21, 2022. A preliminary prospectus supplement and the accompanying prospectus relating to the Offering was filed by Akoya with the SEC and is available on the SEC’s website at www.sec.gov. A final prospectus supplement and the accompanying prospectus relating to the Offering will be filed by Akoya with the SEC. The Offering may only be made by means of a prospectus, including a prospectus supplement, that forms part of the registration statement referred to above. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the Offering may be obtained by contacting: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, by phone at 1-866-718-1649 or by email at [email protected] and Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Maill J12S03, Minneapolis, Minnesota 55402, by telephone at 1-800-747-3924 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On June 8, 2023 Sandoz reported to host the first of two Capital Markets Days (CMDs) for investors, in New York City, to set out its plans for growth and success as a standalone company, following the proposed 100% spin-off from Novartis (Press release, Novartis, JUN 8, 2023, View Source [SID1234632568]).

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Sandoz reported sales of USD 9.1 bn in 2022, with a record of six consecutive quarters of single-digit growth. At the CMD today, the company will forecast mid-single digit net sales growth for 2023 as well as for the mid term (2024 to 2028). The core EBITDA margin is expected to expand to 24–26% in the mid term, from a forecast 18-19% in 2023, with the initial decrease from 21.2% in 2022 driven by ongoing inflation and investments required to stand up Sandoz as a separate company.

Free cash flow is expected to more than double by 2028, from a reported USD 0.8 bn in 2022. This should enable Sandoz, with a targeted investment grade credit profile and a prudent capital structure, to pay shareholders a full-year dividend of 20-30% of FY 2023 core net income, increasing to 30-40% in the mid term.

"I am honored to have the opportunity to lead Sandoz into its exciting new future and believe this company will have the Board, Executive team and key capabilities it needs to succeed as a standalone company", said Gilbert Ghostine, Chairman-designate of the proposed new company, who will open the event later today. "Sandoz is an established European champion and global leader in generics and biosimilars with an impressive scientific heritage, a powerful purpose-driven strategy and one of the strongest brands in the industry. I am confident that our new company represents a compelling opportunity for both equity and debt investors."

Sandoz CEO Richard Saynor said: "In recent years, we have reshaped our business for the future, driven by a strong leadership team with clear alignment on our vision. We are focused on sales execution, while significantly expanding our pipeline, investing in targeted build-up of capabilities and developing strategic partnerships. Looking forward, six strategic levers will drive long-term investor value: attractive market fundamentals, leadership and scale, multiple growth drivers, margin improvement, accelerated cash generation, and a compelling sustainability story. The proposed spin-off would enable us to deliver our full potential, with an attractive and sustainable financial outlook including an expected shareholder dividend."

The expanding Sandoz product pipeline is expected to contribute an additional USD 3 billion in potential net sales over the next five years, with the mix shifting increasingly towards high-value biosimilars and complex generics. The biosimilar pipeline has trebled in size over recent years, now with 24 products, on top of a core generic pipeline of more than 400 products.

Concluding, Saynor said: "We actively pioneer access for patients by shaping the global healthcare environment, strengthening healthcare systems worldwide by delivering over USD 17 billion in annual savings in Europe and the US alone, reaching 500 million patients a year in over 100 countries, and generating a total social impact estimated in the hundreds of billions of dollars".

Sandoz will host a second CMD, in London on June 12, where investors and analysts will have another opportunity to meet Sandoz leadership.

Both events will also be webcast; to register online for access, visit the Investor Relations section of the Novartis website at www.novartis.com, or click directly below:
Capital Markets Day – New York (media-server.com)
Capital Markets Day – London (media-server.com)

Additional Transaction Details

The proposed 100% spin-off of Sandoz is expected to occur in the second half of 2023. Completion of the proposed spin-off is subject to satisfaction of certain conditions, including consultation with works councils and employee representatives (as required), general market conditions, receipt of favorable tax rulings and opinions, final endorsement by the Board of Directors of Novartis AG and shareholder approval. There can be no assurance regarding the ultimate timing of the proposed transaction or that the transaction will be completed. Further details of the proposed spin-off will be provided at a later date.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

On June 8, 2023 Sandoz reported to host the first of two Capital Markets Days (CMDs) for investors, in New York City, to set out its plans for growth and success as a standalone company, following the proposed 100% spin-off from Novartis (Press release, Novartis, JUN 8, 2023, View Source [SID1234632568]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Sandoz reported sales of USD 9.1 bn in 2022, with a record of six consecutive quarters of single-digit growth. At the CMD today, the company will forecast mid-single digit net sales growth for 2023 as well as for the mid term (2024 to 2028). The core EBITDA margin is expected to expand to 24–26% in the mid term, from a forecast 18-19% in 2023, with the initial decrease from 21.2% in 2022 driven by ongoing inflation and investments required to stand up Sandoz as a separate company.

Free cash flow is expected to more than double by 2028, from a reported USD 0.8 bn in 2022. This should enable Sandoz, with a targeted investment grade credit profile and a prudent capital structure, to pay shareholders a full-year dividend of 20-30% of FY 2023 core net income, increasing to 30-40% in the mid term.

"I am honored to have the opportunity to lead Sandoz into its exciting new future and believe this company will have the Board, Executive team and key capabilities it needs to succeed as a standalone company", said Gilbert Ghostine, Chairman-designate of the proposed new company, who will open the event later today. "Sandoz is an established European champion and global leader in generics and biosimilars with an impressive scientific heritage, a powerful purpose-driven strategy and one of the strongest brands in the industry. I am confident that our new company represents a compelling opportunity for both equity and debt investors."

Sandoz CEO Richard Saynor said: "In recent years, we have reshaped our business for the future, driven by a strong leadership team with clear alignment on our vision. We are focused on sales execution, while significantly expanding our pipeline, investing in targeted build-up of capabilities and developing strategic partnerships. Looking forward, six strategic levers will drive long-term investor value: attractive market fundamentals, leadership and scale, multiple growth drivers, margin improvement, accelerated cash generation, and a compelling sustainability story. The proposed spin-off would enable us to deliver our full potential, with an attractive and sustainable financial outlook including an expected shareholder dividend."

The expanding Sandoz product pipeline is expected to contribute an additional USD 3 billion in potential net sales over the next five years, with the mix shifting increasingly towards high-value biosimilars and complex generics. The biosimilar pipeline has trebled in size over recent years, now with 24 products, on top of a core generic pipeline of more than 400 products.

Concluding, Saynor said: "We actively pioneer access for patients by shaping the global healthcare environment, strengthening healthcare systems worldwide by delivering over USD 17 billion in annual savings in Europe and the US alone, reaching 500 million patients a year in over 100 countries, and generating a total social impact estimated in the hundreds of billions of dollars".

Sandoz will host a second CMD, in London on June 12, where investors and analysts will have another opportunity to meet Sandoz leadership.

Both events will also be webcast; to register online for access, visit the Investor Relations section of the Novartis website at www.novartis.com, or click directly below:
Capital Markets Day – New York (media-server.com)
Capital Markets Day – London (media-server.com)

Additional Transaction Details

The proposed 100% spin-off of Sandoz is expected to occur in the second half of 2023. Completion of the proposed spin-off is subject to satisfaction of certain conditions, including consultation with works councils and employee representatives (as required), general market conditions, receipt of favorable tax rulings and opinions, final endorsement by the Board of Directors of Novartis AG and shareholder approval. There can be no assurance regarding the ultimate timing of the proposed transaction or that the transaction will be completed. Further details of the proposed spin-off will be provided at a later date.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.