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Lantern Pharma Receives FDA Authorization to Initiate its Phase 2 Clinical Trial, Harmonic™, for LP-300 in Never Smokers with Non-Small Cell Lung Cancer

On July 14, 2022 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") and machine learning ("ML") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that the Food and Drug Administration (FDA) has cleared the Company to proceed with its Phase 2 clinical trial, Harmonic, for its investigational new drug LP-300 (Press release, Lantern Pharma, JUL 14, 2022, View Source [SID1234616680]). The Harmonic trial will be a 90 patient, multi-center, two arm, open-label, and randomized clinical trial evaluating LP-300 in combination with chemotherapy for never smoker patients with advanced non-small cell lung cancer (NSCLC).

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"The launch of the Harmonic trial is a major milestone for LP-300. Our team is looking forward to beginning patient enrollment during the third quarter," said Panna Sharma, CEO and President of Lantern. "LP-300 is an innovative therapy that is being developed for never smokers with NSCLC, a unique and growing population of lung cancer patients whose cancer is genetically different from smokers with lung cancer. LP-300 will be delivered in combination with standard of care chemotherapy. Importantly, LP-300 has been well tolerated in prior clinical trials and has shown potential to protect against harmful effects of chemotherapy while also de-naturing many of the tyrosine kinase receptors through cysteine modification that are involved with NSCLC," continued Sharma.

About the Harmonic Trial and LP-300:

The Harmonic trial is a Phase 2 clinical trial that will assess the effect of Lantern’s investigational new drug LP-300 in combination with standard of care (SOC) chemotherapy, pemetrexed and carboplatin, on the overall and progression-free survival of never smoker patients with advanced NSCLC. The study has been designed as a 90 patient trial with approximately 2/3rds of the patients receiving LP-300 with chemotherapy and the remaining 1/3rd receiving chemotherapy alone. Lantern expects that initial patients will be enrolled into the Harmonic trial during the third quarter of 2022. Enrollment is expected to occur over the next 12 to 16 months across multiple sites in the US.

In a previous multi-center Phase 3 clinical trial, a subset of never smoker NSCLC patients who received LP-300 with chemotherapy showed increased overall and two-year survival of 91% and 125%, respectively, compared to patients who only received chemotherapy. In addition, LP-300 has been administered in multiple clinical trials to more than 1,000 people and has been generally well tolerated. LP-300 has also exhibited chemoprotective properties that may reduce side effects from chemotherapy. Additional information on the Harmonic trial can be found in the table below and at the link for the study’s registration and listing on the ClinicalTrials.gov website View Source

Protocol Title

A study of LP-300 with carboplatin and pemetrexed in never smokers with advanced lung adenocarcinoma (HARMONIC)

Study Design

90 patient, two arm study; approximately 60 patients will receive LP-300 with pemetrexed and carboplatin, approximately 30 patients will receive only pemetrexed and carboplatin.

Investigational Product

LP-300 in combination with pemetrexed and carboplatin

Summary of Key Eligibility Criteria

Adult never smoker patients with inoperable and advanced primary adenocarcinoma of the lung. Patients may have received prior treatment of tyrosine kinase inhibitors (TKIs).

Primary Outcome Measures

Progression free and overall survival

Secondary Outcome Measures

Objective response rate, duration of objective response, clinical benefit rate

About Lung Cancer in Never Smokers:

According to the American Cancer Society lung cancer is the second leading cause of cancer in the US. In 2021 there were an estimated 218,000 total patients diagnosed with lung cancer representing approximately a $11.5 billion market size. Historically, never smokers with NSCLC make up about 15-20% of all lung cancer patients, representing an approximate market size of $1.5 to 2.0 billion.

NSCLC presents differently in never smokers, which are defined by the CDC as a person who has smoked 100 cigarettes or less in their life, compared to smokers. These differences are believed due to a higher percentage of genetic mutations in a family of cancer-promoting genes called Tyrosine Kinases (TK). Changes in TK genes, such as EGFR, ALK, ROS and MET, can contribute to the development of healthy cells into cancer cells, leading to tumor formation and growth. LP-300’s intended mechanism is to work together with chemotherapy by strongly interacting in the TK gene pathways, interrupting their activity to slow or prevent tumor growth and spread.

ImmunoGen Announces Conference Call to Discuss Its Second Quarter 2022 Operating Results

On July 14, 2022 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the Company will host a conference call at 8:00 a.m. ET on Friday, July 29, 2022 to discuss its second quarter 2022 operating results (Press release, ImmunoGen, JUL 14, 2022, View Source [SID1234616679]). Management will also provide a brief update on the business.

CONFERENCE CALL INFORMATION

To access the live call by phone, please register here. A dial-in and unique PIN will be provided to join the call. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.

Manifold Bio Raises $40 Million Series A to Expand In Vivo Biologics Design Platform

On July 14, 2022 Manifold Bio, a next-generation protein therapeutics company pioneering an in vivo biologics design platform, reported the close of a $40 million Series A financing round led by Triatomic Capital and joined by new investors Section 32, FPV Ventures, Horizons Ventures, and Tencent (Press release, Manifold Bio, JUL 14, 2022, View Source [SID1234616677]). Existing investors Playground Global, Fifty Years, and FAST by GETTYLAB also participated. The investment will enable Manifold Bio to advance its internal drug programs and expand its next-generation protein engineering platform to support additional programs and partnerships.

Founded by Professor George Church, PhD, and leading biological engineers from his laboratory at Harvard Medical School and the Wyss Institute for Biologically Inspired Engineering, Manifold Bio’s mission is to leverage technological innovation to address key translational bottlenecks in drug creation. The company is pursuing a pipeline of targeting-enhanced protein therapeutics, powered by a platform that features massively parallel in vivo testing of protein therapeutic designs.

"Despite a growing understanding of surface targets of diseased cells and the promise of new complex antibody formats, drug programs continue to face significant clinical challenges, including major dose limiting toxicities caused by imprecise targeting," said Manifold Bio co-founder and CEO Gleb Kuznetsov, PhD. "This comes from fundamental limitations of the current paradigm of protein therapeutics development, where engineering of these targeted drugs is largely decoupled from the complex mammalian environment they are meant to navigate. By bringing high-throughput in vivo measurement into the earliest phases of drug development, Manifold Bio is positioned to unlock the full potential of a whole class of protein therapeutics that we call targeted effectors — drugs like cell engagers and ADCs (antibody drug conjugates) where a powerful effect is driven to a precise location by an engineered targeting domain."

Since raising $5.4 million in seed funding in 2020 led by Playground Global, Manifold Bio has advanced their novel protein barcoding technology, the foundation for their in vivo discovery platform and other pooled measurement capabilities. Using this platform, the company has initiated several internal programs focused in oncology.

"We are using our in vivo design engine in several internal programs while continuing to invest in scaling our platform," said co-founder and CSO Pierce Ogden, PhD. "By making it possible to eventually test thousands of designs simultaneously, we can generate unprecedented data on the in vivo targeting behavior of our drug candidates and significantly change the clinical risk equation."

"The Manifold Bio team has made excellent progress in their mission to enable the engineering of increasingly targeted and effective protein-based drugs through iterative massively-parallelized in vivo refinement," said Jory Bell, Manifold Bio board director and general partner at Playground Global. "This entirely new approach fundamentally changes the paradigm for protein therapeutics and we’re delighted to deepen our investment in the company and its world-class team."

With this funding, Triatomic Capital founding partner Jeff Huber will join Manifold Bio’s board of directors. Huber was previously founder and CEO of Grail and co-founder of Google’s life sciences efforts.

"Manifold Bio’s platform is the type of paradigm-shifting technology that has the potential to redefine how drug discovery is done," said Jeff Huber, general partner at Triatomic Capital, a new fund created to support century-defining companies. "This exemplifies the power of engineered biology, one of the key pillars of our fund. Combined with the strength of the team and their rapid progress on platform and programs is why we’re excited to partner with Manifold Bio as our first investment."

Reminder: Invitation to Roche’s Half Year Results 2022 Webinar

On July 14, 2022 Roche reported that it will publish its Half Year Results of 2022 prior to the opening of the Swiss Stock Exchange on Thursday, 21 July 2022 (Press release, Hoffmann-La Roche, JUL 14, 2022, View Source [SID1234616676]).

The webinar will start with presentations by senior management, followed by a Q&A session.

Presenters:

Severin Schwan, CEO Roche Group
Bill Anderson, CEO Roche Pharmaceuticals
Thomas Schinecker, CEO Roche Diagnostics
Alan Hippe, Chief Financial and IT Officer
We would like to invite all interested parties to participate in the webinar and to pre-register for the event here.*
Should you be unable to register for the webinar due to your company IT policy, please send an email to [email protected].

Enveric Biosciences Announces Reverse Stock Split

On July 14, 2022 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a neuroscience-focused biotechnology company developing next-generation, psychedelic-inspired mental health medicines, reported that it intends to effect a reverse stock split of its common stock at a ratio of 1 post-split share for every 50 pre-split shares (Press release, Enveric Biosciences, JUL 14, 2022, View Source [SID1234616675]). The reverse stock split will become effective at 4:05 p.m., New York time, on Thursday, July 14, 2022. Enveric’s common stock will continue to be traded on the Nasdaq Capital Market under the symbol "ENVB" and will begin trading on a split-adjusted basis when the market opens on Friday, July 15, 2022.

At a special meeting of stockholders held on July 14, 2022, Enveric’s stockholders granted the Company’s Board of Directors the discretion to effect a reverse stock split of Enveric’s common stock through an amendment to its Amended and Restated Certificate of Incorporation, as amended, at a ratio of not less than 1-for-10 and not more than 1-for-100, such ratio to be determined by the Company’s Board of Directors.

At the effective time of the reverse stock split, every 50 shares of Enveric’s issued and outstanding common stock will be converted automatically into one issued and outstanding share of common stock without any change in the par value per share. Stockholders holding shares through a brokerage account will have their shares automatically adjusted to reflect the 1-for-50 reverse stock split. It is not necessary for stockholders holding shares of the Company’s common stock in certificated form to exchange their existing stock certificates for new stock certificates of the Company in connection with the reverse stock split, although stockholders may do so if they wish.

The reverse stock split will affect all stockholders uniformly and will not alter any stockholder’s percentage interest in the Company’s equity, except to the extent that the reverse stock split would result in a stockholder owning a fractional share. Any fractional share of a stockholder resulting from the reverse stock split will be rounded up to the nearest whole number of shares. The reverse stock split will reduce the number of shares of Enveric’s common stock outstanding from 52,684,548 shares to approximately 1,053,691 shares. Proportional adjustments will be made to the number of shares of Enveric’s common stock issuable upon exercise or conversion of Enveric’s equity awards and warrants, as well as the applicable exercise price. Stockholders whose shares are held in brokerage accounts should direct any questions concerning the reverse stock split to their broker. All stockholders of record may direct questions to the Company’s transfer agent, American Stock Transfer & Trust Company, LLC, at 1-877-248-6417 or 1-718-921-8317.