On December 6, 2022 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported publication of ePosters by ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2022 (ESMO-IO), showing that Compugen’s COM701 (anti-PVRIG) in dual and triple combination with nivolumab ± BMS-986207 (anti-TIGIT) demonstrated preliminary durable anti-tumor activity and immune activation in patients with platinum resistant ovarian cancer with a favorable safety and toxicity profile (Press release, Compugen, DEC 6, 2022, View Source [SID1234624833]).

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The Company plans to host an investor conference call and webcast tomorrow, Wednesday, December 7, 2022, at 8:30 AM ET to review this data and data from a small cohort of metastatic NSCLC patients treated with COM701 ± nivolumab planned to be presented at ESMO (Free ESMO Whitepaper)-IO, December 8, 2022, Geneva, Switzerland. ePosters are available today on the ESMO (Free ESMO Whitepaper)-IO virtual platform, in the e-Poster section and the publication section of Compugen’s website.

"There are few effective and tolerable treatment options for patients with platinum resistant ovarian cancer," said John W. Moroney, M.D., Associate Professor of Gynecologic Oncology in the Dept. of Obstetrics and Gynecology at the University of Chicago. "It is both exciting and a privilege to see heavily pre-treated, chemotherapy refractory patients experience durable responses with this novel PVRIG/TIGIT/PD-1 immune checkpoint targeting combination. We observed deep and durable responses with minimal toxicity. For example, several of our responders continue to maintain full-time employment of more than 6 months into their enrollment. I’m interested in participating in further clinical development of this targeted combination."

Oladapo Yeku, M.D., Ph.D., FACP, Assistant Professor of Medicine, Harvard Medical School, and Director of Translational Research, Gynecologic Oncology Program, Massachusetts General Hospital, Boston, MA, added, "It is encouraging to see anti-tumor activity in these heavily pretreated heterogeneous platinum resistant ovarian cancer patients, with a disease control rate of 45% following both dual and triple combination treatment. The combination of drugs was well tolerated with a favorable safety profile consistent with what has previously been reported for COM701 with nivolumab ± BMS-986207. Because of the anti-tumor activity and tolerability of the combination, our patients on the study reported an improvement in quality of life. I look forward to seeing the further development of COM701 combinations in patients with platinum resistant ovarian cancer."

Anat Cohen-Dayag, Ph.D., President, and CEO of Compugen, continued, "I am delighted to see that patients with hard-to-treat tumor types, who typically do not respond to or show low response rates to immunotherapy, gain benefit from COM701 as part of a dual and triple combination regimen. In November this year at the SITC (Free SITC Whitepaper) conference, we presented anti-tumor activity with responses in MSS-CRC patients with liver metastases, with a clear support of a COM701 mediated effect. Today we published compelling responses from preliminary data in platinum resistant ovarian cancer patients, including a patient who had 7 prior lines of treatment and progressed on nivolumab, and on this study experienced a confirmed partial response after treatment with the dual combination of COM701 and nivolumab. In addition, 3 patients responded to triple combination therapy who are ongoing on study treatment for at least 9 months, including a patient with more than 90% reduction in tumor target lesions."

Dr. Cohen-Dayag, added, "The data suggest a COM701 mediated mechanism of action, which could lead to the responses demonstrated by COM701 combinations. We have demonstrated that PVRIG blockade is associated with driving T cells into the tumor microenvironment, potentially sensitizing the tumors to PD-1 and/or TIGIT blockade and inducing a potent immune activation generally less typical with checkpoint inhibitors in such tumor types. While it is challenging to compare efficacy of the triple and dual combination arms given the small number of patients, the increase in response rate combined with the duration of response does suggest greater benefit with triple treatment, in line with our pre-clinical and translational clinical data. While the studies, including the biomarker and translational work, are still ongoing, the totality of the data, consisting of the disease control rates, the durability of responses, the supportive translational data, and the favorable safety profile, are encouraging considering these hard-to-treat cancers in which the patients have been extensively pretreated. We are looking forward to discussing the data being presented at ESMO (Free ESMO Whitepaper)-IO, during our investor call tomorrow, December 7, 2022."

Next Steps
Based on the data reported in the different studies, Compugen is planning to pursue two studies, with the purpose to strengthen the data it has already published and to build a path to future registration studies:

The first, in up to 20 patients with metastatic MSS-CRC, immune checkpoint inhibitor naïve patients with ≤ 2L of prior therapy, treated with a triple combination of Compugen’s anti-PVRIG, COM701, and its own anti-TIGIT, COM902, and pembrolizumab. Enrolment is expected to be completed in 2023.

The second is a follow up study currently under design in platinum resistant ovarian cancer immune checkpoint inhibitor naïve patients.

Compugen expects to share initial findings by the end of 2023.

The ePosters are published today on the ESMO (Free ESMO Whitepaper)-IO virtual platform in the e-Poster section, and the publication section of Compugen’s website.

To access the Wednesday, December 7, 2022, 8:30 am ET live investor conference call by telephone, please dial 1-866-744-5399 from the U.S., or +972-3-918-0644 internationally. The call will be available via live webcast through Compugen’s website, located at the following link. Following the live webcast, a replay will be available on the Company’s website.

Background

Key findings from poster: "Triple blockade of the DNAM-axis with COM701 + BMS-986207 + nivolumab demonstrates preliminary antitumor activity in patients with platinum resistant OVCA." (NCT04570839), with a cut-off date of November 23, 2022, include:

In 20 patients who had exhausted all standard therapies, with a median number of 4 prior therapies, the triple combination demonstrated:

Encouraging overall response rate of 20%, with 4 confirmed partial responses, out of which 3 are responding for at least 9 months. All 4 responders are still on study treatment at the data cut-off date, therefore median duration of response has not been reached

Disease control rate of 45% (4 confirmed partial responses, 5 stable disease)

Low pre-treatment PD-L1 expression in 2 of the responders (CPS <1 and 3), analysis of the other responders is still ongoing

Translational assessment of peripheral blood, including profiling of cytokines and circulating immune cells, showed a pharmacodynamic activation of the immune system

Most frequent treatment related adverse events grade 1/2, no grade 4/5 treatment related adverse events

55% of the patients had high-grade serous adenocarcinoma, including three of the responders

Key findings from poster: "COM701 in combination with nivolumab demonstrates preliminary antitumor activity in patients with platinum resistant epithelial ovarian cancer" (NCT03667716) with a cut-off date of November 23, 2022, include:

In 20 patients who had exhausted all standard therapies, with a median number of 6 prior therapies, the dual combination demonstrated:

Encouraging overall response rate of 10%, with 2 partial responses and 1 ongoing at the data cut-off date

Disease control rate of 45% (2 confirmed partial responses, 7 stable disease)

Translational assessment of peripheral blood, showed a pharmacodynamic activation of the immune system

One patient with a partial response supported by increased infiltration of CD8 cells into the tumor microenvironment, had high grade serous adenocarcinoma, 7 prior lines of treatment including best response of progressive disease on the combination of nivolumab and lucitanib (an investigational agent)

Most frequent treatment related adverse events grade 1/2, no grade 4/5 adverse events

65% of the patients had high-grade serous adenocarcinoma, including the two responders

On December 6, 2022 Candel Therapeutics presented its corporate presentation (Presentation, Candel Therapeutics, DEC 6, 2022, View Source [SID1234624832]).

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On November 30, 2022, BridgeBio Pharma, Inc. ("BridgeBio" or the "Company") entered into a Second Amendment to Loan and Security Agreement (the "Second Amendment"), by and among (i) U.S. Bank Trust Company, National Association, as successor to U.S. Bank National Association, in its capacity as administrative agent (in such capacity, the "Administrative Agent") and collateral agent (in such capacity, the "Collateral Agent"), (ii) the certain lenders party thereto (the "Lenders"), (iii) the Company, as a borrower, and (iv) certain subsidiaries of the Company, as guarantors (the "Guarantors"), pursuant to which the parties thereto agreed to amend the Loan and Security Agreement, dated as of November 17, 2021, as amended by the First Amendment to Loan and Security Agreement, dated as of May 12, 2022 (the "Existing Loan Agreement", and amended by the Second Amendment, the "Amended Loan Agreement"), by and among the Company, Guarantors, Lenders, the Administrative Agent and the Collateral Agent (Filing, BridgeBio, DEC 6, 2022, View Source [SID1234624830]).

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Pursuant to the terms and conditions of the Second Amendment, the parties thereto agreed to, among other things: (1) acknowledge that the Company’s prior prepayment made with certain cash proceeds received in connection with that certain License, Development and Commercialization Agreement, dated as of May 11, 2022, by and among Navire Pharma, Inc., the Company and Bristol-Myers Squibb Company satisfied the mandatory prepayment requirement under the Amended Loan Agreement, on the terms and conditions specified in the Amended Loan Agreement, (2) permit certain budgeted expenses to be excluded from the definition of cash proceeds subject to Borrower’s mandatory prepayment obligations, on the terms and conditions specified in the Amended Loan Agreement, (3) remove certain threshold amounts applicable to certain prepayment events and (4) terminate the Lenders’ tranche 2 commitments. The Company retains the ability to undertake certain royalty financing transactions that do not exceed ten percent (10%) of the net sales in respect of a product, and royalty financing transactions relating to Acoramidis remain exempt from prepayment, subject to the terms and conditions of the Amended Loan Agreement.

Other terms of the Amended Loan Agreement remain generally identical to those under the Existing Loan Agreement.

The above description of the material terms of the Second Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the Second Amendment, which will be filed, with confidential terms redacted, as an exhibit to the Company’s Annual Report on Form 10-K for the period ending on December 31, 2022.

Item 2.03. Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.

The information set forth above in Item 1.01 of this Current Report on Form 8-K regarding the Company financial obligations under the Second Amendment and the Amended Loan Agreement is incorporated into this Item 2.03 by reference.

On December 6, 2022 Avid Bioservices, Inc. (NASDAQ:CDMO), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported financial results for the second quarter and six months ended October 31, 2022 (Press release, Avid Bioservices, DEC 6, 2022, View Source [SID1234624829]).

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Highlights from the Quarter Ended October 31, 2022, and Other Events:

"The consistent execution by our team has strengthened and expanded our customer base, and significantly improved the company’s financial position as compared to prior years. Our topline revenues remain strong and our backlog continues to show strong growth over the prior year. The investment in our business development team is already showing positive results ahead of the completion of our new capacity and services soon to come online. We fully expect this momentum to continue and for all of these reasons, I am pleased to report that Avid is increasing its revenue guidance for the full fiscal year 2023 to between $145 million and $150 million," stated Nick Green, president and chief executive officer of Avid Bioservices.

"With respect to our facilities and capabilities expansions, work continues to advance according to plan. During the second quarter, we continued to make progress with our cell and gene therapy expansion. We have already launched the analytical and process development capabilities for this business which has allowed us to escalate our dialog with prospective new customers. We are pleased to report that our first customer is already onboarding in this facility. With respect to the GMP suites for our cell and gene therapy business, construction continues on schedule and we expect them to be completed by mid-calendar 2023.

"Likewise, our mammalian cell business capacity expansion is progressing as planned. During the first quarter, much of the downstream equipment was positioned in the Myford facility and validation of this equipment was initiated. During the second quarter, we installed the upstream equipment. As we stand today, the facility is largely mechanically complete and is currently undergoing qualification and validation. We remain on schedule for release to operations during the first quarter of calendar 2023. And finally, expansion of our process development capacity is well underway. The addition of this new capacity is ideally timed as our updated revenue guidance puts our capacity utilization at close to 90% of our current capacity.

"Based on the company’s performance during the first six months, we anticipate that fiscal 2023 will be another strong year for Avid. The company’s strategic transformation is well underway, and we look forward to achieving the milestones that will position us for consistent growth in the future."

Financial Highlights and Guidance

The company is increasing full year revenue guidance for fiscal 2023 from $140 to $145 million to $145 and $150 million.

Revenues for the second quarter of fiscal 2023 were $34.8 million, representing a 33% increase compared to $26.1 million recorded in the prior year period. For the first six months of fiscal 2023, revenues were $71.4 million, a 26% increase compared to $56.9 million in the prior year period. For both the quarter and the year-to-date periods, the increase in revenues can primarily be attributed to increases in process development and manufacturing revenues as compared to the prior year periods.

As of October 31, 2022, revenue backlog was $147 million, representing a net increase of 23% compared to $120 million at the end of second quarter fiscal 2022. The company expects to recognize the majority of this backlog over the next twelve months.

Gross margin for the second quarter of fiscal 2023 was 12%, compared to a gross margin of 35% for the second quarter of fiscal 2022. Gross margin for first six months of fiscal 2023 was 19%, compared to a gross margin of 36% for the same period during fiscal 2022. During fiscal 2023, growth related costs including labor, overhead and depreciation, represented incremental decreases in margin of approximately 11% and 9%, for the second quarter and year-to-date, respectively, split approximately evenly between mammalian and cell and gene therapy operations. Additionally, prior year’s margins included benefits from unutilized capacity fees. Excluding all of these factors, our second quarter and year-to-date gross margins were approximately in-line with the prior year periods.

Selling, general and administrative ("SG&A") expenses for the second quarter of fiscal 2023 were $6.8 million, an increase of 36% compared to $5.0 million recorded for the second quarter of fiscal 2022. SG&A expenses for the first six months of fiscal 2023 were $13.2 million, an increase of 39% as compared to $9.5 million recorded in the prior year period. The increases in SG&A for both the second quarter and the year-to-date periods were primarily due to increases in compensation and benefits, legal, accounting and other professional expenses.

For the second quarter of fiscal 2023, the company recorded a net loss of $1.2 million or $0.02 per basic and diluted share, as compared to net income of $3.5 million or $0.06 per basic and diluted share, for the second quarter of fiscal 2022. For the first six months of fiscal 2023, the company recorded net income of $0.4 million or $0.01 per basic and diluted share, as compared to net income of $9.8 million or $0.16 and $0.15 per basic and diluted share, respectively, during the same prior year period.

Avid reported $77.3 million in cash and cash equivalents as of October 31, 2022, compared to $126.2 million as of April 30, 2022.
More detailed financial information and analysis may be found in Avid Bioservices’ Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.

Recent Corporate Developments

The company’s commercial team signed multiple new orders during the second quarter, totaling approximately net $26 million. These orders are with new and existing customers, and span all areas of the business, from process development to commercial manufacturing.

During the second quarter, the company strengthened its management team.

Michael Alston, Jr. was promoted to the position of vice president, operations, having previously served as Avid’s director of project engineering. Mr. Alston has more than 15 years of experience spanning operational and capital management responsibilities supporting CGMP manufacturing, facilities, engineering, and environmental, health and safety functions.

Oksana Lukash, joined Avid as vice president, people. Ms. Lukash has more than 20 years of human resources experience. Prior to joining Avid, Ms. Lukash served as vice president, people & culture at Oncocyte Corporation. During her three-year tenure with the company, she was instrumental in driving three acquisitions and the successful integration of the acquired entities.

The company continues to make progress with all of its expansion projects, as well as the construction of its new dedicated cell and gene therapy facility. The company currently expects to complete the second phase of its Myford expansion, which includes both upstream and downstream CGMP manufacturing suites, by the end of the first quarter of calendar 2023. With respect to the cell and gene therapy business, the company brought its process and analytical development capacity online in June 2022. The company remains on track to bring the CGMP manufacturing suites online by mid-calendar 2023. Please visit the Avid Bioservices website Facilities page for more information about the company’s expansions and videos documenting progress (View Source).
Statement Regarding Use of Non-GAAP Financial Measures

The company uses certain non-GAAP financial measures such as non-GAAP adjusted net income (loss), free cash flow, as well as adjusted EBITDA. The company uses these non-GAAP financial measures for financial and operational decision making and as a means to evaluate period-to-period comparisons. The company believes that they provide useful information about operating results, enhance the overall understanding of our operating performance and future prospects, and allow for greater transparency with respect to key metrics used by management in our financial and operational decision making. These non-GAAP financial measures exclude amounts that the company does not consider part of ongoing operating results when planning and forecasting and when assessing the performance of the organization and our senior management. The company computes non-GAAP financial measures using the same consistent method from quarter to quarter and year to year, and may consider whether other significant items that arise in the future should be excluded from our non-GAAP financial measures.

The company reports non-GAAP financial measures in addition to, and not as a substitute for, or superior to, measures of financial performance prepared in accordance with U.S. generally accepted accounting principles (GAAP). These non-GAAP financial measures are not based on any comprehensive set of accounting rules or principles, differ from GAAP measures with the same names, and may differ from non-GAAP financial measures with the same or similar names that are used by other companies. The company believes that non-GAAP financial measures should only be used to evaluate our results of operations in conjunction with the corresponding GAAP financial measures, and encourages investors to carefully consider our results under GAAP, as well as the supplemental non-GAAP information and the reconciliations between these presentations, to more fully understand our business.

Non-GAAP net income (loss) excludes stock-based compensation; business transition and related costs including corporate initiatives into new business activities such as initial start-up costs related to our expansion into viral vectors for the cell and gene therapy sector of the market, and severance and related expenses; non-cash interest expense on convertible senior notes for the accretion of the issuance costs associated with our convertible senior notes; and other income or expense items and is adjusted for income taxes. Adjusted EBITDA excludes non-cash operating charges for stock-based compensation, depreciation and amortization as well as non-operating items such as interest income, interest expense, and income tax expense or benefit and is adjusted for income taxes. For the reasons explained above, adjusted EBITDA also excludes certain business transition and related costs. The company also uses measures such as free cash flow, which represents cash flow from operations less cash used in the acquisition and disposition of capital.

Additionally, non-GAAP net income (loss) and adjusted EBITDA are key components of the financial metrics utilized by the company’s compensation committee to measure, in part, management’s performance and determine significant elements of management’s compensation. The company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Reconciliations between GAAP and non-GAAP financial measures included at the end of this press release.

Webcast

Avid will host a webcast this afternoon, December 6, 2022, at 4:30 PM EST (1:30 PM PST).

To listen to the live webcast, or access the archived webcast, please visit: View Source

On December 6, 2022 AbbVie (NYSE: ABBV) and HotSpot Therapeutics, Inc., a biotechnology company pioneering the discovery and development of small molecule allosteric therapies for the treatment of cancer and autoimmune diseases, reported an exclusive worldwide collaboration and option to license agreement for HotSpot’s discovery-stage IRF5 program for the treatment of autoimmune diseases (Press release, AbbVie, DEC 6, 2022, View Source [SID1234624826]).

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"This collaboration with HotSpot has the potential to deliver an entirely new target class of modulators to patients with serious autoimmune diseases, such as systemic lupus erythematosus, and will help to further strengthen our robust immunology pipeline," said Jonathon Sedgwick, Ph.D., vice president and global head of discovery research, AbbVie. "HotSpot’s drug discovery platform has been able to identify molecules that bind to IRF5 in a predictable, reproducible manner potentially enabling effective drugging of what has been considered an undruggable target."

IRF5 is a transcription factor that acts as a key regulator of certain types of immune responses, and its dysregulation is strongly implicated in several poorly treated autoimmune disorders. Efforts to modulate IRF5 using conventional small molecule approaches have been unsuccessful because IRF5 lacks a traditional active site. Leveraging its proprietary Smart Allostery platform, HotSpot discovered what it believes to be the first and only disclosed small molecule IRF5 inhibitor that targets a previously unknown allosteric pocket on the protein that is critical for its endogenous regulation – a "natural hotspot".

"Today’s agreement with AbbVie underscores our significant progress in rapidly building a substantial pipeline of novel allosteric small molecule therapeutic candidates for the treatment of autoimmune diseases and cancer," said Jonathan Montagu, Co-Founder and Chief Executive Officer of HotSpot Therapeutics. "We look forward to collaborating with AbbVie, an industry leader in developing and commercializing important immunology therapeutics."

Under the terms of the agreement, HotSpot will receive an upfront cash payment of $40 million and may be eligible to receive up to $295 million in option fees and research and development milestones, with potential for further commercial milestones as well as tiered royalties on global net sales. Should AbbVie exercise its option to license, AbbVie will conduct all future clinical development, manufacturing and commercialization activities for the IRF5 inhibitor program. In addition, HotSpot would have a one-time option to share in global R&D costs in exchange for increased royalty payments. Aquilo Partners, L.P. acted as financial advisor to HotSpot on this transaction.